MOVE

Hello, everyone. Thank you for joining us, and welcome to Corvex Q1 2026 Earnings Call. I will now hand the call over to J. Cogan, CFO. Please go ahead, sir.

Thanks, Kara. Good afternoon, everyone, welcome to Corvex's Q1 2026 Earnings Conference Call. Joining me today are Corvex CEO Jay Crystal and co-founder and director Seth Demsey. A press release detailing our results was issued this afternoon and is available in the investor relations section of our website. A replay and transcript will be posted following the call. During today's call, we will make forward-looking statements based on current expectations. Our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with Corvex are included in our SEC filings, which could be accessed through our website. Today's discussion also includes references to non-GAAP financial measures. Reconciliation to the most directly comparable GAAP measure is included in our press release and on our IR website.

On March 19, 2026, Corvex Inc, formerly known as Movano Inc, acquired Corvex Legacy Holdings Inc, also known as Corvex OpCo. The company was renamed Corvex Inc, effective March 23, 2026. Pursuant to the merger agreement, at closing, we issued to the prior security holders of Corvex OpCo 240.562 shares of Series B convertible preferred stock, representing no more than 19.9% of our outstanding common stock immediately prior to closing, as well as 23,551.5195 shares of Series C preferred stock and 30,227.0524 shares of Series D preferred stock. On March 31, 2026, each share of Series B preferred stock automatically converted into 1,000 shares of common stock.

In the coming weeks, subject to stockholder approval of the conversion proposal at our upcoming annual meeting, each share of Series C preferred stock will automatically convert into 1,000 shares of common stock, and each share of Series D preferred stock will be convertible into 1,000 shares of common stock. As part of the merger agreement, we also declared a stock dividend of 0.358 shares of common stock for every share outstanding at the close of business on March 30, 2026. The stock dividend was distributed on April 6, 2026. Turning to Q1 2026 results. Our reported financial results for the Q1 reflect our legacy healthcare business for the entire period and the inclusion of Corvex's AI platform for the 12 days following the March 19 merger closing.

In today's press release and in a separate 8-K we published this afternoon alongside our March 2026 quarter Form 10-Q, we also provided pro forma results for the Q1 of 2026 and fiscal year 2025. We believe the disclosure of pro forma financials provides further insight into the combined company's recent operating performance. On a reported basis, our revenue was $510,000 in the Q1 of 2026, and we reported an operating loss of $4.8 million for the period. Again, the reported results only reflect Corvex's AI platform for 12 days in the quarter, whereas our legacy healthcare operations were included on a full quarter basis.

On a pro forma basis, which assumes the acquisition closed on January 1, 2025, our Q1 2026 revenue was $3.65 million, nearly all of which was generated from Corvex's AI platform. Adjusted pro forma EBITDA for the March quarter, which excludes depreciation, stock compensation expense, interest expense and taxes, as well as one-time merger transaction costs, was a loss of $933,000. At March 31, 2026, total assets were $604 million, including more than $29 million in cash. With that, I'll turn the call over to Corvex's CEO, Jay Crystal.

Thanks, J. Cogan. Good afternoon, everyone, thank you for joining Corvex's first earnings call as a public company. We believe AI is driving a once-in-a-generation transformation in global computing infrastructure. As AI models become larger, more capable, and more deeply integrated into enterprise and government workflows, demand for secure, scalable, high-performance AI infrastructure is accelerating. Corvex is being built to address this shift. Our platform combines AI infrastructure, AI inference software, and confidential computing technology to help customers train, deploy, and secure AI workloads at industrial scale. We believe Corvex represents one of a limited number of publicly traded companies that provide investors with direct exposure to the emerging Neocloud and AI inference markets. At Corvex, we're building a vertically integrated AI infrastructure platform that's designed to address what we believe are some of the most important requirements emerging in the AI computing market.

Scalable infrastructure capacity, efficient inference delivery, and security for sensitive AI workloads. Our strategy is centered on operating across three complementary layers of the AI stack. AI infrastructure through our AI Factory platform, AI inference through our Token Factory, and confidential computing software designed to secure AI workloads and sensitive data. We believe integrating these layers into a unified platform differentiates Corvex from more commodity-oriented computing providers. Within AI Factories, we're primarily focused on serving the needs of AI model labs, hyperscalers, government-backed AI initiatives, and enterprises. These customer segments increasingly require dedicated production scale computing infrastructure, as well as greater speed to deployment and security. We're investing in capabilities intended to support deployments ranging from approximately 2,000 GPUs to hyperscale clusters exceeding 100,000 GPUs.

We believe one of our key differentiators is how we seek to accelerate customer access to power and computing capacity through strategic partnerships, and over time, a vertically integrated approach that spans data center capacity and computing capacity. At the same time, we're extending beyond traditional bare metal infrastructure through software and orchestration capabilities that support flexible deployment environments, including Kubernetes and Swarm. We believe this combination of infrastructure scale, deployment speed, flexibility, and operational support well positions Corvex to address the needs of AI Factory customers. Our upcoming Token Factory represents the second layer of our strategy and is focused on delivering scalable AI inference capabilities for AI native companies, enterprise customers, and federal organizations. We believe the AI inference market increasingly requires inference platforms capable of delivering reliability, auto-scaling, cost efficiency, and enhanced security across environments.

Corvex's upcoming Token Factory is designed to provide scalable API access to premium open-source and customer-provided AI models operated across both Corvex-owned infrastructure and third-party computing environments. We're also investing into inference optimization technologies intended to improve model performance and economics. We believe this software-centric layer creates opportunities for more recurring and asset-light revenue over time, while also positioning Corvex to grow Token Factory customer relationships into consuming additional layers of our platform. Finally, confidential computing represents the third layer of our strategy and an increasingly important area of differentiation for Corvex. We believe confidential computing will become foundational for regulated enterprises, federal customers, and AI model labs seeking stronger security assurances around sensitive intellectual property, regulated datasets, and proprietary inference workloads.

Our confidential computing technologies are being designed to secure model weights, inference requests, and proprietary training data through a layered security architecture that combines hardware-based confidential computing with software that's designed to protect sensitive AI assets throughout deployment and runtime operations. While we intend to license our confidential computing software for use on third-party infrastructure in addition to our own, we believe that third-party licensing will ultimately serve as a lead source for future Corvex AI Factory deployments. We also intend to embed confidential computing directly into our Token Factory in order to strengthen our ability to serve security-conscious and regulated customers. Our capabilities in confidential computing further differentiate Corvex from commodity infrastructure providers. More broadly, we believe our strategy is differentiated by our focus on investing in higher value layers of the AI stack rather than participating solely as a provider of commodity compute infrastructure.

By combining infrastructure deployment and orchestration capabilities, inference software, and confidential computing into a scalable, unified platform, we believe Corvex is positioned to address the evolving performance, economic, and security requirements of rapidly growing attractive customer segments while also expanding our opportunities for recurring infrastructure and software revenue over time. While we are early in our development as a public company, we believe the strategic foundation we are building positions Corvex well for the evolving demands of the AI infrastructure market. Given our reported results reflect only a limited operating period during the Q1, we will not be taking questions on today's call. However, we are excited about the opportunities ahead and very much look forward to updating investors on our execution and progress in the quarters to come.

Ladies and gentlemen, thank you for joining us. This concludes today's call. You may now disconnect.

Ladies and gentlemen, greetings, and welcome to the Movano Health Third Quarter Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, J. Cogan. Please go ahead, sir.

Thanks, operator. Good afternoon, everyone, and thank you for joining us today. Movano Health's CEO, John Mastrototaro will open today's call with prepared remarks about the progress the company made during the third quarter of 2024 and in recent weeks. Our CMO, Tyla Bucher, will provide some remarks on the company's D2C plans, followed again by John. And then I will provide highlights of the company's quarterly operating results and current financial position. Then we will open the call for a Q&A. John, J, and Tyla will be joined by our Chief Technology Officer and Founder, Michael Leabman; as well as our Chief Commercial Officer, Michael Soule. Movano Health issued a news release this afternoon detailing third quarter 2024 financial results. Before we begin, I'd like to remind everyone that the company will make forward-looking statements during today's call based on current expectations. These forward-looking statements are subject to inherent risks and uncertainties, and actual results may be materially different from such statements. These risks and uncertainties are detailed in the Risk Factors section of Movano Health's filings with the Securities and Exchange Commission, specifically in the company's Forms 10-Q and 10-K. Except as otherwise required by federal securities laws, Movano Health disclaims any obligation to update or make revisions to such forward-looking statements contained herein or elsewhere to reflect changes in expectations with regards to those events, conditions and circumstances. And with that, I'll turn the call over to our CEO, John Mastrototaro.

Good afternoon, everyone. Since we last reported earnings in August, we have continued to make progress on our key business initiatives as follows: First is the ongoing successful sale and fulfillment of Evie Rings, following our back in stock announcement on September 17; second, we're continuing to work closely with the FDA in anticipation of a 510(k) clearance for the EvieMED Ring; third, we're preparing to deliver our first B2B commercial opportunities with healthcare partners shortly after gaining an FDA clearance; and lastly, we're analyzing the results of our recent blood pressure clinical trial utilizing our updated wearable device, which incorporates our proprietary radio frequency solution. As mentioned previously, we continue to be judicious with our capital spending and methodical in our approach to building out our business strategies. And as we prepare for the opportunities that will emerge with a 510(k) clearance, I want to take a minute to reflect on what I see as a watershed moment at this critical intersection of wellness and medical devices. The wearables industry is growing rapidly, and smart rings are quickly becoming the IT factor in the sector with almost 10 new players entering the market in the last 24 months, all making various claims about features, accuracy, and compatibility. Whereas major tech companies are selling more than 100 million wellness devices globally each year, we estimate there will be approximately 1 million smart rings sold in 2024, just 1 million. The leading smart ring competitor recently announced that it is on track to generate about $500 million in revenue in 2024. In our view, smart rings are a particularly attractive form factor compared to other wearables on the market as they can help improve engagement, especially at night, while the user is sleeping where the collection of longitudinal baseline data is a big positive for both consumers and our B2B partners. Additionally, our award-winning open ring design, which can flex to accommodate any swelling, also sets us apart from the competition in a very distinct way and caters effectively to both the D2C and B2B consumer. Movano Health has made significant strides over the last several months with our first commercial device, the Evie Ring, and we look forward to many more enhancements in the coming months as well as future generations of Evie. With an upcoming launch of EvieMED and the ongoing distribution of the Evie wellness ring, Movano Health will be the only player in the space with a ring that effectively serves both B2C and B2B markets built on the reliable foundation of a medical device company and providing a highly differentiated proposition for major healthcare partners across global pharma, med device, remote patient monitoring, and insurers, given our medical device roots, processes, and infrastructure. In our view, it would take years and many millions of dollars in investment for competitors to potentially transition from a wellness to medical device, which positions Movano Health as a very valuable asset in this emerging sector. And the progress we have made to date in blood pressure detection opens the door for yet a third device under the Movano Health umbrella, a cuffless blood pressure detection band. We have now completed our seventh cuffless blood pressure clinical trial with our proprietary and highly patented RF technology as well as several glucose studies. For the past 6.5 years, we have steadily invested in our RF chip, wrist-worn prototypes, clinical evaluations and algorithm development and continue to work towards addressing these significant opportunities. The vast majority of our R&D investment dollars have been spent here, helping to improve the risk profile of our RF technology and related commercial opportunities going forward. As I mentioned earlier, we're in the final stages of the FDA 510(k) review process for the EvieMED Ring. You'll recall the EvieMED Ring is designed to not only provide medical device functionality with its pulse oximetry feature but also offer numerous wellness metrics related to sleep, activity, and logging of mood, energy, and health symptoms. This is a unique combination of features and required some clarification with the FDA, which we resolved this past summer. We then received additional questions from the agency in September related to the medical aspects of EvieMED, which we responded to the week of October 28. Now in the last stage of the process, we are standing by to answer any additional inquiries the agency may have. In anticipation of an expected 510(k) clearance, we have reengaged with a number of potential partners across the full spectrum of healthcare use cases, including condition management, remote patient monitoring, clinical trials, and corporate wellness. We are in active discussions with a major global pharmaceutical company looking to leverage EvieMED in building unique solutions for both clinical and consumer applications. We have also entered into discussions with a clinical research organization, or CRO, that is looking to add our ring into their offering for large pharmaceutical companies and research organizations. Additionally, we have entered into the agreement phase with a large healthcare company who's preparing a pilot in Q1 of 2025 using the EvieMED Ring as part of an overall metabolic solution to address chronic disease. All three of these strategic partners as well as the others in our funnel, the EvieMED as a game-changing solution with a number of potential applications. And finally, as we continue to deliver on our commitment to providing the most accurate data to all of our consumers, we are planning two third-party studies around sleep and menstrual cycle tracking in the coming months. I will now turn it over to our CMO, Tyla Bucher, to provide an update on our DTC plans for the Evie Ring.

Thanks, John. On our last call, we were preparing for a September 17 back-in-stock date, and I'm pleased to share that it has gone extremely well. And we are continuing to welcome new users to the Evie community every day. With a consistent 90%-plus customer service approval score, we are seeing a very positive response to all our improvements across app features, operations, delivery, and customer service. And I'm excited for the upcoming Black Friday/Cyber Monday marketing campaign we planned as well as our strategy for the holiday period and into Q1 2025. It is worth noting that our back-in-stock marketing campaign has been entirely organic. We've effectively leveraged our 120,000 contact e-mail list and our 17,000 followers on social as well as a stable of organic influencers and members of the press to continue to get the word out about the Evie Ring. This has resulted in an extremely efficient customer acquisition cost and a great start as we head into the holidays. We also have a series of exciting announcements that have and will continue to generate organic interest and conversion, including first off, we shared the official announcement of our brand partnership with digital creator, wife, mom and entrepreneur, Heidi D'Amelio. Aligned with our mission of empowering women with better data and insights to help them with healthier lives, Heidi has become a true fan of the ring and has been spreading the word to her audience of more than 12 million followers across TikTok and Instagram. We couldn't be more excited to have Heidi as part of the Evie family. And stay tuned for some fun holiday promotions that we are working on together. Secondly, our launch of the Android version of the app. We've announced that we'll be dropping right in time for holiday. This is planned perfectly as part of our Black Friday promotion as Android has been one of our most requested features since we launched. We're very pleased to be able to offer the Evie experience to Android users. Third, we're going to be announcing a revised 60-day return policy. We know that it takes time to really dig in on a device like ours, and this will allow new Evie consumers to take their time getting to know our product without any worrisome timing restriction. And finally, we're going to be participating in a holiday sweepstakes with Blueshift Nutrition. They are a leader in the supplement space and will be cross-promoting and getting Evie in front of the new and likely-to-buy audience. In addition to all of these initiatives, we are also continuing to improve the functionality of our products, particularly our insights engine. Designed to really illustrate the why behind what women are experiencing with their bodies, the AI-powered engine is getting smarter every day. And we're discovering new ways to correlate the data for our consumers that can really help them understand trends and gain clarity around how they can improve their overall health and well-being. We're excited about the possibilities that this will unlock for our user base and look forward to sharing more updates around this in the near future. And with that, I'll turn things back over to John.

Thanks, Tyla. As I mentioned in my earlier remarks, our product development plan extends far beyond Evie and EvieMED. We are deeply invested in multi-analyte sensing and pursuing additional FDA clearances with further research and respiration rate, core temperature, and a solution to address sleep disturbances. Some of these metrics may only require a software update, while others may require new hardware components or prevent potentially different form factors. We are in the planning stages now for several clinical trials related to these valuable analytes. Last week, we tested our newly-developed blood pressure wrist wearable as part of a hypoxia clinical trial that took place at the University of California, San Francisco. Our updated device features 12 additional mmWave antennas, which together with our custom RF chip delivers enhanced data collection with less impact of placement while also featuring a slimmer design, making it easier and more comfortable to wear. In addition, the new wearable monitors a host of other vital signs, including pulse rate, blood oxygen saturation, respiration rate, and ECG wave forms. We're currently reviewing the data and look forward to reporting on our progress in accuracy and algorithm development. In summary, we remain committed to improving health monitoring through the introduction of a broad suite of analyte sensors, including blood pressure and glucose using our mmWave radio frequency and AI technology. With that, I'll now hand the call over to J. for the financial review.

Thanks, John. As you'll recall, we began taking direct-to-consumer orders again for the Evie Ring on September 17, and we shipped 339 rings in the sub period of the third quarter of 2024. The expanded launch followed the completion of a series of enhancements to the product and improved operations across manufacturing, logistics, and customer service. The focus during this initial post-launch phase has been on execution and notably on a fully organic basis without marketing dollars. We are generally pleased with the results and consumer feedback to date and have plenty of inventory on hand, positioning us well as we move forward into the winter holiday season with new influencers, our upcoming Android app and other feature upgrades. That, combined with the expectation for FDA clearance of EvieMED should allow us to lean into driving higher sales volumes, both B2B and D2C into year-end 2024 and beyond. The company reported an operating loss of $7.4 million in the third quarter of 2024 versus an operating loss of $9.1 million in the year ago period. We had $11.3 million in cash and cash equivalents on our balance sheet at September 30, 2024. Our cash burn in the quarter was approximately $5.6 million, which included approximately $1 million of onetime or other annual payments. Managing resources continues to be a priority for the company. Recently, on October 29, Movano implemented a 1-for-15 reverse stock split of the issued shares of the company's common stock. The reverse stock split was intended to increase the bid price of the company's common shares to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market. Earlier this week, on November 12, we received notice from Nasdaq that Movano has successfully done so. Connected to the reverse split, the company announced that it is investigating a parent stock manipulation between the announcement of the reverse split on October 25 and its effective date on October 29. A large number of single share transactions were executed in an apparent attempt to take advantage of the convention of rounding up reverse split fractional shares at the beneficial owner level. The company was able to uncover this activity before any roundup shares were issued and continues to expect the number of common shares outstanding to be approximately 6.6 million post reverse split. We have been in direct communication with securities regulators, legal counsel and other interested parties, including similarly affected companies as we pursue this issue to the fullest extent necessary. Now I'll turn it back over to John for his final remarks.

Thanks, J. The team and I couldn't be more excited about all the progress we just highlighted. We are nearing an inflection point for the company as we close in on key milestones. We are laser focused on the expansion of our D2C business, bullish on the B2B opportunities for EvieMED, and optimistic about the potential of our RF chip. We look forward to continuing to share our progress as we close out the year. With that, we'd be happy to take your questions.

Thank you. [Operator Instructions] The first question comes from the line of Bruce Jackson from The Benchmark Company. Please go ahead.

Hi, good afternoon and thank you for taking my questions. So with the blood - the cuffless blood pressure measurement, it sounds like you're pretty excited about it. What are the next steps for that program and when might we see some data?

Thanks for the question, Bruce. Yes, we're very excited about it as well. In the most recent study from this past week, we employed additional antennas in the design of the product that, allows us to not have to get the placement of the device just right over the radial artery of the risk. And in the raw data, as it was being displayed on the screen as we were conducting the study, we were getting exceptionally clean signals from the RF wave forms that we were monitoring. So we feel really good about that. In addition, we were also able to use ECG, PPG sensors. And we're leveraging all of that data as part of our algorithm work for the blood pressure monitoring result. Right now, we're in the stage of merging all the data together. We're going to be looking at the accuracy of this very shortly. We are fairly confident that we should see accuracy at least on par with the study that we ran at the end of last year, where we were able to meet and be within the FDA accuracy criteria for blood pressure monitoring. And so, where we will proceed to from here, is we did a total new design that got more close to what an actual form factor of the product would look like, when this is on the wrist. So we'll continue to iterate there a bit, to slim down the design, and make it look more like what a commercial product would look like. And while that work is going on, we're going to continue to conduct some more studies. We've got a lot more work set up right now in terms of evaluating the ability of the product to monitor changes in blood pressure in real-time. This last study was done using arterial blood sample continuous monitoring, and we're looking at that signal versus our device's output. So what you can expect to see, is some more trials over the course of this year, some enhancements to the prototype. And as we've mentioned earlier, we believe that we're on track to get to the market within the next couple of years or so.

Okay. Great. Great. And then moving over to the Android app. This is also important for the market. Will it have the same functionality as the iOS app? And can you remind us just how big the Android market is potentially for you?

Sure. I'll start and then maybe hand it off to Tyla. In terms of the functionality of the app, the app will have all of the same features and functionality as we do in the iOS app. So whether you're an Android user or an iOS user, you're going to have the exact same experience on both of the apps. And Tyla can comment on the number of people who have come to us looking for Android versus iOS. I think overall in the population, it's like 40% of the users, I think, that we were talking to were Android users. But Tyla, do you have more color for that?

Yes, you're right, John. I think we are looking at around 40% of the market that's currently using Android. I will say for context that it is the number one request that we have received since launch, from all the people who reached out to us both on social and through our customer service team. So I definitely expect that we're going to see, a pretty nice bump once we come out with it.

Okay. Great. And then a question on the financials. So the expense control has been very good. And as we move into the fourth quarter and you're increasing the launch activities may be doing - continue with the research and development, how do you see the operation - the operating expenses unfolding here in the fourth quarter?

John, you want me to take that one?

Yes please, J.

Bruce, so yes, thank you. The focus on managing spend and the company's overall cash burn rate has obviously been a priority, and will continue to be. As we've said in the past, we're going to be really judicious with respect to our capital deployment, and that includes going into the fourth quarter here and into next year. We'd be thoughtful about spend behind marketing as we go through the Black Friday, and overall winter holiday season. We're very excited to be able to make a bigger push as we add additional features such as the Android app, for example. And so, I think you'll see a little bit of incremental spend there. But on an overall basis, we're going to stay very, very focused on managing resources. Obviously, with all the work that the company has put into in regards to the FDA clearance process. We see that as a potential meaningful catalyst for the company. And we're already getting ready to lean into the B2B opportunities for the company. We highlighted today, again, some of the early commercial activity, and agreement phases and all. And there's a real focus internally on making sure we're well prepared from an overall B2B standpoint and, at the same time, still being very thoughtful about how we're deploying capital and managing the burn. So, I would expect to see more of the same on a go-forward basis.

Okay. Okay. Great. And then I've just got one more question if that's okay. With the 510(k) for the EvieMED, just what types of questions are we down to with the FDA? Is it kind of like labeling type questions through routine stuff? Or just give us a sense of where you think we are in the process?

Yes. Thanks, Bruce. So first off, I feel very confident with where we stand right now. As you'll recall, in the summer, we had to go through this process of looking at some of the nonmedical features, and we came out of that really strong. And then the FDA came back with a lot of the questions, related to the medical device aspects of the product. So when we put our responses in at the end of the week of October 28, we felt really good about the responses that we provided to them. They had questions around a variety of topics, including labeling, which was a lot of it. And so, we've addressed everything that was brought up to us by then, and we are sitting here waiting for any additional questions or clarifications that they may have. But one of the things that's really critical to understand about these FDA filings, and being a medical device company, is often people just don't appreciate the commitment that it takes, when you just make the decision to become a medical device company, and the thousands and thousands of pages of documentation that are part of what's required for this to come to fruition. We've been very fortunate in our clinical evaluations. We have exceptional data that's superior to the hospital-based pulse oximeters on the market today and in the clinical trial run by the hospital. They had the great sense to evaluate our product alongside of those, and we came out significantly better. So we feel really good about our clinical evidence, and data that's part of this. And as it relates to all of the testing that's required by the agency, we repeated a few tests. We added more detail to other ones. And the bottom line is that in all cases, we've gone through the testing and passed all the testing and feel like we're in a really strong position with the agency. So it's kind of the 11th hour here now, and we're waiting to get any further feedback from them, since we provided the most recent response.

Okay. Great. That's it for me. Congratulations on the progress and thank you for taking my questions.

Sure. Thank you, Bruce.

Thank you. [Operator Instructions]

Ryan, it looks like there are a few questions on the webcast. So why don't I go ahead and ask those to the team? And if we have any more questions on the phone lines, we'll come back to you in a minute, okay?

All right, sure. Please go ahead.

Okay. John, how about you take the first one? You talked about the big picture. It's early days for smart rings, et cetera. Do all the new entrants concern you at all?

No. Thanks, J. Yes. Good question. As I mentioned in the prepared remarks, smart rings are quickly becoming a preferred form factor, so it's not surprising that others are getting into the game. But we really feel like we're well positioned to address the competition. And when we've spoken to you in the past, we talked about becoming the best - taking the best of what a consumer device offers, and mating it with the best of what a medical device offers. Because we know that people are concerned about form factor. We know the wearability is really important. And of course, we know that they want data that they can trust. So our decision to establish ourselves as a medical device company really gives us a significant advantage and speaks to our drive to provide better and more accurate data, so that people can have health insights from this data, to live better lives. And that's what we've heard over and over again from consumers, for what they're looking for is the accuracy of the data. Now as it relates to the consumer appeal, we're the only ring on the market with an open design. And we've gotten feedback over and over again about the look, the feel, the fit, how it sits on the finger, and we think we're really winning there. In fact, for a lot of folks, who are talking to us now about the fact that there's various stages of inflammation in your lives. And obviously, with the open ring design that has a little bit of a flex, it's critically important in these scenarios. So overall, between the construct of the ring, the form factor and the usability of it, mated with kind of the chops that we have as a medical device company, we feel like we're in a really great position. And assuming that we're successful in the FDA clearance process with EvieMED and the ongoing distribution of Evie wellness, we would be the only player in the space with a ring that effectively serves both the D2C and B2B markets. And as we've mentioned before, the bar for others to become a med device company, and get over that hurdle is significant in terms of investment with people and time and dollars. To get, to what you need to do for a medical device company. So overall, I'm pleased with the fact that we embarked on developing a ring form factor. And the market seems to be gravitating toward it and all the other aspects of what we've done in terms of med device and just overall design and usability. So I feel pretty good.

Okay. Tyla, this one is for you. We mentioned on the call a focus about execution with the relaunch of Evie Rings in September. Can you tell us a little bit more about what we've learned over the last couple of months and plans for the holiday sales period and beyond?

Yes, happy to. I mean, so we're engaging really regularly with our community. And what we've heard and what we're learning is that women continue to look for a device that they can trust, and give them the information and insights and what they're looking for, so that they can live better lives. And this is something that we are singularly focused on, doing these things better than the competition. And so, what this means for us is continually improving the overall experience such as providing better accuracy, making sure that our insights are valuable, delivering a seamless customer service experience, and building out a strong operational backbone as well that has improved yields and quality processes so that the whole wheel is working seamlessly. And then I'll just add, as I noted in our call, our marketing outreach today has been entirely organic. And we're continuing to reach new users with our message of authenticity, and putting women first. But now as we head into the holidays, we will be implementing a focused paid strategy. And I think that will help us break through some of the noise, and reach more women who are looking for a device like Evie. And this will come in addition to the influencer community that we're already leveraging, which includes a number of women with various interests who are all using Evie Ring as well as our partner, Heidi, who I mentioned on the call, she's creating content for us constantly, as she experiences the ring and shares her findings with her followers. And then I'll just add that we continue to deliver content that resonates with our community across all our social channels, our blog and our newsletter. And we really are actively listening to feedback coming in. And a perfect example of this is really actually just what Bruce asked, which is the release of Android. This was, as I noted, the most requested feature, and we've worked really hard to try to get it ready, which we are going to be able to do for this holiday season. So I'm excited about that. And that's also where we decided to do the 60-day return policy, because we were hearing from people that they weren't sure that it would be enough time for them, to really understand the Evie experience. So that's something that we - that came out of our ongoing communication with our customers as well. So, we're continuing to co-create the Evie experience with our community, and I'm really excited about what's to come.

Okay. Thank you. Let's go to Michael Soule for this one. Michael, remind us the details behind these first EvieMED commercial opportunities, how they position the company for growth with pharmaceutical companies and other health partners? And how quickly do you think these will all come to fruition, once the company has the clearance from the FDA?

Sure, J. So very near term, as John mentioned earlier on the call, we have entered into the agreement phase with a large healthcare company, who is preparing a pilot in Q1 of next year, using the EvieMED Ring as part of an overall metabolic solution to address chronic disease. We continue to engage with many of our beta partners who are looking forward, and keeping a very close eye on our FDA clearance. And then additionally, we expect the 510 clearance to unlock a host of initiatives, across channels such as large pharma, medical device, and remote patient monitoring. And are currently building all the back-end systems that would be required for these partnerships that we can hit the ground running.

We have a question on the audio line, which is from the line of John Libabakis, an Investor. Please go ahead.

Hi guys, it was quite an impressive call, in my view. The management quality is so high and selling at two times cash per share, and the intellectual property and product superiority, the size of the markets, the pending strategics and pending FDA clearance, it's profoundly undervalued. Any thoughts about how you might address that discrepancy and the valuation to its peers?

J., would you like to take this one?

Sure. I'd be happy to. Hi John, thanks for the question.

Hi.

And the comments and all. I would just say that we understand, as we've laid out in this call and others, that we're going after some pretty big things in the world of health. Obviously, the capital markets have been swinging back and forth over the last few years from position of very bullishness to, over the last couple of years, very challenging for start-ups broadly, private and public. And capital market conditions with higher interest rates, have obviously weighed on valuations for small companies like Movano. That said, I guess we just get up every day, do the work. We know what the strategy is, where we're trying to take this and, over time, things generally work out as they should. So we hear you. And I think from a management team standpoint and from our partners. We're just working to execute the best we can, whether it's the Evie Ring or the FDA clearance in EvieMED and then obviously, some of the holy grail opportunities with respect to blood pressure, glucose, et cetera. And obviously, on today's call, we were trying to also highlight a little bit about where we are - big picture with respect to this new form factor, a smart ring. And relative to the opportunity. On a D2C basis, but also from a B2B standpoint, it's wide open. So I appreciate the thoughts, the sentiment, and we're just going to be as opportunistic as possible, as we continue to move through time and further the progress.

I have a lot of confidence in you, guys, yes.

Thank you, John. I'd like to just add one other comment. I thank you for everything that you said. We agree with your assessment. And one of the things that we're trying to do as an organization is also just to become more visible out there. We think a lot of the reasons why maybe all of the assets we have aren't reflected in the valuation is, because of visibility. And so, we are doing quite a bit these days to be more vocal about ourselves, to get the word out. Just in the past month, I participated in an American Medical Association meeting in Chicago and a Diabetes Technology Society meeting in Northern California, and just getting the word out more broadly to more folks. Because I think that as people hear more about our story, and we expand broader with the number of folks who are able to see what we're all about, I think that will help in the regard that you brought up in terms of valuation, versus the assets of the company.

Well said. Thank you so much.

Okay. Operator, I think that does it for the questions on the webcast, and I don't see any more in the telephone Q&A. So perhaps we conclude the call at this time.

Thank you. Ladies and gentlemen, the conference of Movano Health has now concluded. Thank you for your participation. You may now disconnect your lines.

Greetings and welcome to Movano Health Q2 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Jay Cogan, Chief Financial Officer. Thank you, Mr. Cogan. You may begin.

Thanks, Operator. Good afternoon, everyone, and thank you for joining us today. Movano Health’s CEO John Mastrototaro will open today's call with prepared remarks about the progress the company has made during the second quarter of 2024 and in recent weeks. Our CMO, Tyla Bucher, will provide some remarks on the company's upcoming B2C plans, followed again by John, and then I'll provide highlights on the company's quarterly operating results and current financial position. Then we'll open the call for Q&A. John, Jay, and Tyler will be joined by our Chief Technology Officer and Founder, Michael Leabman, Chief Commercial Officer, Michael Soule, and Vice President of Product and Strategy, Stacy Salvi. Movano Health issued a news release this afternoon detailing second quarter 2024 financial results. Before we begin, I'd like to remind everyone that the company will make forward-looking statements during today's call based on current expectations. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties, and actual results may be materially different from such statements. These risks and uncertainties are detailed in the risk factors section of Movano Health's filings with the Securities and Exchange Commission, specifically in the company's Forms 10-Q and 10-K. Except as otherwise required by federal securities laws, Movano Health disclaims any obligation to update or make revisions to such forward-looking statements contained herein or elsewhere to reflect changes in expectations with regards to those events, conditions, and circumstances. With that, I'll turn the call over to our CEO, John Mastrototaro.

Good afternoon, everyone. Since we last reported earnings in May, we have been working diligently to prioritize the efficient use of our recent capital infusion while continuing to make progress on our key business initiatives as follows. Preparing for expansion of the direct-to-consumer launch at Evie Ring and taking orders again starting September 17. Continuing to work with the FDA to secure a 510(k) clearance for the EV Med Ring. Delivering our first B2B commercial opportunities with healthcare partners. And lastly, preparing for upcoming blood pressure and glucose clinical trials using the most recent iteration of our wearable device, incorporating our proprietary RF solution. We continue to be judicious with our capital and methodical in our approach to building out our direct-to-consumer and business-to-business market opportunities. I will provide an update on our progress with the FDA and preparations for B2B launch at EV Med. And we'll then turn the call over to our CMO, Tyla Bucher, to discuss plans for the D2C business, including our plan to begin taking orders again and shipping product in September. In preparation for the launch of EV Med, we're working closely with the FDA to secure a 510(k) clearance. As we highlighted in a press release last week, we plan to meet with the FDA this month. You'll recall the EV Med Ring is designed to not only provide medical device functionality with its pulse oximetry feature, but also offer numerous wellness metrics related to sleep, activity, and logging of mood, energy, and health symptoms. Subsequent to our April 510(k) filing, in May and early June, the FDA review team requested two minor clarifications and our team promptly responded. In late June, the FDA review team requested some additional information related to the wellness aspects of Evie Med. Along with our regulatory advisors, Movano Health provided a draft response to the FDA's questions on July 10 and requested a meeting with the agency to review our draft response, which is now scheduled, as I noted earlier. We look forward to meeting with the FDA and working towards resolving this issue in order to move forward with the review process. We remain steadfast in our commitment to the opportunity Evie Med could unlock, given the clinical evidence provided as part of the filing related to the pulse oximetry feature and our desire to work collaboratively with the agency. With regard to the Evie opportunity, we have three new B2B commercial opportunities to highlight for you today. In anticipation of an expected 510(k) clearance, we are engaged with two global pharmaceutical companies that could leverage Evie Med in building unique solutions for both clinical and consumer applications. In the first case, we are in the agreement phase for a program that could begin in late 2024 and, assuming success, would be expected to develop into a larger commercial opportunity in 2025. In the second case, Evie Med is expected to be evaluated this fall by a Tier 1 global pharmaceutical company for a clinical trial that is scheduled to commence in 2025. We are also engaged with a large payer looking to better manage high-risk populations utilizing Evie Med. This opportunity is expected to kick off around the New Year and, assuming a positive outcome, the commercial opportunity could build into 2025. All three of these strategic partners, as well as the others in our funnel, see Evie Med as a game-changing solution that is not currently available in the market. This is in addition to our recent announcement of the partnership with the Tal Research Group at MIT to use Evie Ring for its MAESTRO clinical study on the long-term health impacts of Lyme disease and lung COVID. To explain these health care opportunities in more depth, we recently hosted our first virtual event titled B2B, The Next Wearables Boom, where Managing Director of Allele Capital, Matt Hughes, moderated a panel that included myself, our Chief Commercial Officer, Michael Soule; and Stanford Cardiologist, Doctor Fatima Rodriguez. During the event, we identified and discussed the significant B2B possibilities that could be unlocked specifically for clinical trials and remote patient monitoring following a 510(k) clearance. As you'll recall, the clinical trials market we seek to address consists of pharmaceutical companies that need to gather data from FDA-cleared devices as part of their drug trials for FDA and other regulatory submissions. We've identified the TAM for FDA-cleared wearables in this market to be as much as 5 billion annually. Currently, trials are offering cumbersome, expensive and suboptimal requiring in-person checkups, which can result in poor compliance. We believe Evie Med's unique offering and design aesthetic would improve compliance lower cost significantly and enable quicker enrolment, better data and improved quality of results. The three examples I highlighted a few minutes ago speak to this need and we are aggressively pursuing opportunities across clinical trials and post-market surveillance. For Remote Patient Monitoring or RPM market barely existed four years ago, However, COVID unlocked the reality that RPM can reduce the need for in-office visits, expand access and reduce costs. We believe Evie Med will be able to automate the collection of more complete and accurate data resulting in an RPM solution with meaningful advantages over RPM products on the market today. During our conversation, Doctor Rodriguez also validated the need for RPM in her role as a physician, which would enable her to manage our patients in between visits and easily identified patterns. We recently completed beta testing our wearable technology with a leading U.S. RPM company that serves over 450 health care organizations and is the exclusive platform for one of the largest medical device companies in the world. In anticipation of these partnerships and more, we are preparing our back-end operations to be able to meet our partners' requirements including positioning the company to scale efficiently, establishing app and labelling modifications to support a medical device and building our API and data sharing framework. I will now turn it over to our CMO, Tyla Bucher, to provide an update on our D2C plans for the Evie Ring.

Thanks, John. As you all know, we've been out of stock on the Evie Ring since Q1 and we've been using this time to implement a series of improvements for our existing and prospective customers, including operational and delivery time lines, better and more accurate ring functionality, best-in-class customer service and finalizing some new and necessary features. From an operations standpoint, we improved production yields and cycle times as well as our logistics and warehouse management system. This will result in greater efficiency on the production floor and allow us to keep more accurate real-time track of inventory and the flow of orders. From a software perspective, we updated our Ring algorithms, improving accuracy across sleep and wake times, sleep stages, heart rate measurement during activity and steps. In addition, we expanded our proprietary AI generated insights engine to include hundreds of new insights for our users, customized for individual wellness journey and informed by a combination of track and log data. An example of one of our newer insights would be, when you beat your average step by more than 1,000, you tend to report a better mood. Regarding customer service, we built out a new team of representatives with a combined 25-plus years of service in the direct-to-consumer space. Who have a solid understanding of the pace and real-time knowledge delivery that a product like ours required. This team is currently responding live to all inquiries within 48 hours and has drafted a comprehensive library of useful articles and tips and tricks that can be shared with Evie Ring consumers as they work through any issues together or the customers can use to if they prefer. In addition, these articles feed into our AI-powered chatbot who can mitigate many easily solvable issues and get smarter as it ingests both the inquiries and our information, responding quickly and accurately to customers in friendly and native language. In addition to all these enhancements, we are also working on an auto activity detect workout feature, which will allow you to understand that you're working out even if you have not started to work out on the app. And following the work out, we'll be able to provide you with your results. Users will also be able to modify the details of their work out after the fact. And finally, we expect to have an Android version of the app ready for our prospective Android users, of which there are quite a few to purchase by Black Friday in November of this year. We are pleased to announce that we'll be back in stock on September 17. This is post summer season and time for when consumers begin turning their attention to the holidays and gift giving. We have a full paid in organic social campaign prepared to support our launch which includes influencer and user-generated content across Instagram, Facebook, YouTube and TikTok as well as Google Search and Shop. We also have a robust e-mail lead list that has grown exponentially with consumers ready to buy, and we will be engaging them with a comprehensive outreach strategy. And we have a satellite press are lined up with key tech and consumer press as well as a pitch campaign for holiday gift guides across print and television. And finally, we could be more excited to share the introduction of our brand partnership with digital creator, wife, mom and entrepreneur Heidi D'Amelio. Heidi has been using the Evie Ring for several months and has really become a true fan. Aligned with our mission of empowering women with better data and insights to help them live healthier lives, we have formed a strategic partnership with Heidi where we'll continue to grow the brand, drive awareness around women's health and improve the ring experience together. We couldn't be more excited to welcome Heidi to the Evie family. As you can see, we've been working around the clock to get the ring back in the hands of consumers, and we truly believe it will be worth the wait. And with that, I'll turn things back over to John.

Thanks, Tyla. As you are aware, our product development plan extends far beyond Evie and Evie Med. We are deeply invested in multi-analyte sensing and pursuing additional FDA clearances with further research in respiration rate, core temperature and a solution to address sleep disturbances. Some of these metrics may only require a software update, while others may require new hardware components or potentially different form factors. We are in the planning stages now for several clinical trials related to these valuable analytes. As a follow-on to the successful blood pressure study we conducted in Q4 '23, we completed our most recent blood pressure clinical study in June, which included the use of an arterial blood pressure line. We learned a great deal about improved ways to collect data, and we'll be redesigning for the next study with better placement of the sensors on the body to maximize their utility. We're also in the process of designing a more consumer-friendly form factor as we focus on commercializing the solution. We will continue to develop this into Q4 with another study plan before year-end. In summary, we remain committed to improving health monitoring through the introduction of additional analyte sensing, including blood pressure and glucose using our millimeter wave radio frequency and AI technology. With that, I'll now hand the call over to Jay for the financial review.

Thanks, John. We shipped 1,837 Evie Ring in the second quarter of 2024 as we completed fulfilment of our initial launch phase. You'll recall that we shipped approximately 5,300 Rings in the first quarter and stopped taking orders in mid-February given capital market conditions. The company did not report any revenue for the second quarter as previously deferred revenues offset by refunds. As we noted earlier in the call, we expect to begin taking orders and shipping rings again in September. We plan to have ample inventory prior to taking orders again in September. And as Tyla highlighted, we have made important strides across product manufacturing and customer service that should position us well for both an expanded launch of Evie Ring in D2C and eventual launch of Evie Med in B2B upon an FDA clearance decision. Following our successful type of placement in April, where the company raised $24.1 million in gross proceeds, including a strategic seed investment from a Tier 1 multibillion-dollar medical device company, we recently executed a turnkey agreement with our production partner, which should free up both working capital and people resources for Movano Health going forward. The company reported an operating loss of $6.4 million in the second quarter of 2024 versus an operating loss of $7.4 million in the year ago period. And we had $16.9 million in cash and cash equivalents on our balance sheet at June 30, which takes into account our catching up on more than $3 million of outstanding payables following the April private placement putting us in good standing with our partners as we position the company to execute against key future milestones. Excluding the catch-up, our cash burn in the quarter was approximately $4.4 million as managing resources continues to be a priority for the company. Now I'll turn it back over to John for final remarks.

Thanks, Jay. The team and I couldn't are excited about all of the progress we just highlighted. We are nearing an inflection point for the company as we close in on key Evie and Evie Med milestones. We are laser focused on the expansion of our D2C business, bullish on the B2B opportunities for Evie Med and optimistic about the potential of our RF chip. We look forward to continuing to share our progress as we head into the back half of the year. With that, we'd be happy to take your questions.

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] The first question comes from the line of Bruce Jackson with Benchmark Company. Please go ahead.

Hi, good afternoon. Thank you for taking my questions. With the new Evie that's going to launch with the auto activity detect features, is that the same thing as the new heart rate and motion algo that you just developed?

Michael Leabman, would you like to go ahead and respond to that question from Bruce?

Yeah, sure. I think the first big fix we've added is we've changed our heart rate algorithm to be really based on machine or deep learning to get much more accurate heart remotion if you're walking, jogging, running et cetera. That's kind of stand-alone algorithm. The auto activity is really to twofold. One, to kind of identify what activities you're doing as well as Tyla mentioned, to be able to start to work out and start collecting this data, even if you don't tell your watch or your ring or your app to start collecting. So there are kind of two separate things that combine to give you much better results for a workout.

Okay. Great. And then moving over to the business-to-business side. With the provider organization where you've got an engagement, can you maybe go into a little bit more detail about that as to the depth of the engagement? Is it like on parallel activities? Or do they have any like minimum orders attached to the engagement?

Thanks Bruce. Michael Soule, do you want to go ahead and take that question?

Yeah. So we are -- as we said earlier, we are engaged with a number of different channels, providers as one of them payers, remote patient monitoring. In the anticipation of our FDA approval they are working with us in various formats through beta testing. We're also in the initial agreement conversations with a number of folks, including providers, payers and the remote patient monitoring channels as well.

Okay. Great. And then last question for me. Any changes on the mid-August date for meeting with the FDA?

I'll take that one, Bruce. Thanks for the question. No, no changes there. I'd just like to make a couple of comments about it. We still are very optimistic with regard to our ability to work with the agency for a few reasons. First off, we've got a pretty seasoned and deep regulatory team in the company itself, but we've gone one step beyond that. And in fact, we're also working with the leading regulatory firm in the U.S. and probably the principle of whom has probably had more meetings with the FDA than anyone ever so through their career. So we've really got the top team that we could possibly have working on this to assure that we're complying with all the FDA policies. When you're doing something new, with our Ring and we've got the wellness and medical devices in the product. It can raise some new questions of the agency, but we feel really good about where we stand. We've had some already recent communication in preparation for the meeting, and it's all trending in the right direction. So that is all positive. And then lastly, one thing we always kind of remember is that the whole filing is built on a really strong foundation of incredibly strong clinical data and results for the pulse oximetry feature. So because of all of these reasons, we still feel really good about where we are and being able to work through the FDA and gain a clearance.

Okay. Great. Congratulations on all of the progress. And thank you for taking my questions.

Thank you, Bruce.

Thanks, Bruce. Operator, it looks like we have some questions on the webcast. I can go ahead and ask those and we'll see what happens with the phone lines thereafter. John, I guess, if there's anything else, there's a question here about the 510(k) submission. If there's anything else you wanted to add in terms of our confidence in securing or just anything else beyond the press release that we issued last week, if there's anything to discuss otherwise, we can move on to the next question.

Yeah, I saw that question. I saw that question online, and I tried to answer it at the same time that I answered Bruce. So I think that covered it pretty well. Bottom line is we still feel really confident and optimistic in where we stand and are very much looking forward to meeting with the agency soon to resolve this and move on to the next topic.

Okay, great. I think the next couple of questions can be for Tyla. Tyla, there's a couple of questions about the press and marketing plan for the expanded launch of Evie Ring? And then also, what are the biggest changes that we've made to the ring and app heading into this expanded launch?

Sure. So I think as I noted on the call, we've obviously spent the last few months focusing on improvements across the board, including updating and fine-tuning the algorithms. I think the big focus has also been on our insights engine because really that is a key differentiator for us. And then I talked a little bit about our improved processes that we have on the operations side. But I think the other pieces are the auto activity detect that Bruce just mentioned as well as an Android version of the app. Both of these are key features that consumers have been asking for. And we really do want our community to know that we're listening and we're really excited to actually roll out these enhancements. So those, I think, are the big pieces on the experience side. And then as it relates to marketing, we have a full campaign ready to go that includes influencer and user-generated content across Instagram, Facebook, YouTube, all the other things I said, Google Search and Shop. We have a really engaged, leadless and a comprehensive outreach strategy. But above and beyond, we're just thrilled with the announcement of our partnership with influencer and digital creator, Heidi D'Amelio. Not only does she have a passion for fitness, but she has a highly and wonderfully engaged audience, and she really shared the vision of improving women's health with better data and insights. I think the idea that we'll be able to work closely with someone like Heidi who, again, has such an engaged audience to drive awareness around the Evie Ring as well as the importance of a wellness device for women is a big step forward for us.

Great. All right. Michael Soule, you might have answered some of this or most of this in the prior question from Bruce. But a question on the webcast relates to taking a deeper dive into the first Evie Med commercial opportunities that we've announced recently and how they position the company for growth with pharma and other health partners in the future.

Yeah. Sure. Yeah. And I saw that as well online. I think in the last call, we talked a little bit about our data partners, right? And we ran the gamut across various channels with our beta partners. But since coming out of that data phase, other large strategic partners have come to us looking to work with us. And so they ran channels for medical device to pharma, to payers who are looking forward to our FDA clearance. And so we -- when that clearance comes, we expect to unlock a host of initiatives across clinical trials, remote patient monitoring. And we're also, as John had mentioned earlier, building the back-end systems required for these partnerships so we can hit the ground running. So in advance of that clearance, we've moved, as I said, into some agreement discussions with a number of folks, and we're very excited about the pace with which this is happening.

Perfect. Next question for Michael Leabman. What did you learn in your most recent blood pressure clinical study?

Yeah. Great. So I think as John mentioned, we concluded our study in June, and we've been analyzing the data using arterial line, which is really new to us giving us continuous data. And it's really allowed us to kind of fine tune our device, including new antennas that we've already completed designing as well as accommodating different risk sizes with a smaller form factor, which gets us closer and closer to commercializing it. I think all these changes will really allow us to begin testing with B2B customers when we're ready and the expected new design, we expect to arrive somewhere at the end of September, early October as we get ready for our next clinical arterial line study in November. And I think everything is kind of coming together nicely with this first study, and we really look forward to getting this hardware back and taking the next step.

Okay. Thanks, Michael. John and Tyla, there's a question about the company taking the path of being a medical device company and with blood pressure and glucose on horizon specific to of gender, is Movano planning to expand its marketing to target beyond women?

Yeah. From the Med Device perspective, I'll take that aspect. Certainly, as you're aware and alluded to for direct-to-consumer, we have had a female focus and Tyla can expand upon that in a moment. But for these opportunities that we have in the health care space, there are some which are products that are specific for women. So this dovetails in very nicely, but many of the opportunities that we've been looking at are for anyone. And just because we've targeted women with some aspects of the app experience and design and whatnot. It doesn't mean that it's not of tremendous value for anyone. And so all of our partners, no one said, well, this won't suit all of our customers or subscribers to a plan or whatever it may be. They're looking at using it universally. And you're right, whether it's work related to continuous glucose monitoring in the future or the blood pressure and what we have today with heart rate, Sp02 and other future analytes, they're important to measuring everybody. And we're all suffering from chronic conditions and in the U.S., it's a major problem. We've got half of people over age 20 in the U.S. have high blood pressure are pre-hypertensive, and diabetes is about a third of the people. And so having products like this that can be worn and used at home in a very user-friendly way, that feel good and look good on the finger, something that doesn't interfere with your lifestyle and is able to collect just a wealth of important data and can bring to light changes in your health are needed. And I think it's going to change the way health care is delivered in the future to bring more of this into the home with folks. And I think we're all more aware of our health than ever before after what's happened through the course of COVID and whatnot. So it's -- we're finding it to just be a massive opportunity, quite frankly, and are speaking to all the who's whom in the health care space about products like this that can be leveraged seamlessly and help support the health and wellness of people. Tyla, do you have anything to add specifically about the D2C and the female focus there that you want to comment on?

Sure. I mean I think you captured it really well. I think the only comment that I would make is to sort of echo your notes about we didn't design the Evie Ring to the exclusion of the male gender, but rather to really be present for an opportunity that we see among women who prioritize their health prior to the health of their family, control the pulse strings, make decisions for the family and really coming up with a solution for them to make sure that they're taking good care of themselves and that they're prioritizing their wellness. You can wear the Evie Ring now if you are whatever gender you are. And I think what we tried to do is really take into consideration how women would like to receive the data, how they want to see it displayed in their app, a comfortable fit and make sure that we're delivering insights that make them feel like this is a worthwhile endeavor and that they understand what to do with that data. So I think as we move forward, nothing is necessarily off the table, but certainly, the priority was to make something available to women where we see a tremendous, tremendous opportunity. But again, having said that, anyone came wear the ring. And it will still work, and it will still track your health and well-being.

Thanks, Tyla, thanks John. I'll take the last question. It looks like you've made some good progress on reducing your quarterly burn rates, how we see the trend in our expanded launch of Evie Ring and eventually Evie Med? We appreciate the feedback. We continue to be focused as an organization on the highest and best use of our capital and the margin profile of the D2C and B2B businesses that we're rolling out. We believe the product manufacturing and customer service improvements that we've implemented over the past few months should definitely help position us for growth and cash flow. In addition, the turnkey agreement, which -- we've mentioned a couple of times over the last few calls, and which we've now executed with our contract manufacturing partner, that should very much improve our company's cash flow profile, better lining up sales and the actual cost of goods. Operator, I'm just saying in closing, if investors like to stay up to date on Movano Health please continue to check into ir.movano.com. We look forward to staying in touch to see you next quarter, and thank you for your support.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Greetings, and welcome to the Movano Health Q1 2024 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jay Cogan. Thank you. You may begin.

Thanks, operator. Good afternoon, everyone, and thank you for joining us today. Movano Health's CEO, John Mastrototaro will open today's call with prepared remarks about the progress the company has made during the first quarter of 2024 in recent weeks. I will then provide highlights of the company's quarterly operating results and current financial position. Then we'll open up the call for Q&A. John and I will be joined by our Chief Marketing Officer, Tyler Bucher, our Vice President of Business Development, Michael Soule; and Vice President of Product and Strategy, Stacy Salvi. Movano Health issued a news release this afternoon detailing first quarter 2024 financial results. Before we begin, I'd like to remind everyone that the company will make forward-looking statements during today's call based on current expectations. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties, and actual results may be materially different from such statements. These risks and uncertainties are detailed in the Risk Factors section of Movano Health's filings with the Securities and Exchange Commission, specifically in the company's forms 10-Q and 10-K. Except as otherwise required by federal securities laws, Movano Health disclaims any obligation to update or make revisions to such forward-looking statements contained herein or elsewhere to reflect changes in expectations with regards to those events, conditions and circumstances. And with that, I'll turn the call over to CEO, John Mastrototaro.

Good afternoon, everyone. As you are aware, we reported our Q4 2023 earnings just over a month ago on April 4, where we were very excited to share the news of our recent $24 million private placement, which included a strategic seed investment from a Tier 1 multibillion dollar medical device company. While we plan to be judicious with our capital spend and methodical in our approach to build out our Evie Ring direct-to-consumer and Evie Med business-to-business market opportunities, we are committed to establishing a solid foundation for both our B2C and B2B businesses so we can successfully serve all our customers. As such, our priorities are threefold: one, to prepare to take B2C orders against the Evie Ring; two, to secure FDA 510(k) clearance for its pulse oximeter feature under the Evie Med brand; and three, to refine our risk worn prototype with the mmWave RF system on a chip in preparation for additional blood pressure and glucose studies. As to the first priority, we are laser focused on preparing to take orders again for the Evie Ring, which requires that we deliver an excellent product experience, ensure a seamless delivery timeline for all orders and provide an improved customer service response to any issue. From a product standpoint, we are diligently working to improve the customer experience across both hardware and software. We are developing more robust hardware with improved chemical, environmental and physical resistance. In software, we are improving our heart rate in motion and sleep algorithms employ [indiscernible] cementing a more comprehensive AI-driven suite of insights and are initiating the process to develop an Android version of the app. On the production side, we are enhancing our automation, tooling and assembly and test processes to increase yield and throughput as we prepare for relaunch. We are also in conversations with our key production partner to implement a turnkey solution, which would further increase our efficiencies. We have bolstered our customer service capacity and have implemented an AI-powered customer response chatbot on our site as well as onboarded a new head of customer service with over 25 years' experience in the D2C space. All these efforts will ensure an enhanced customer experience, whether users reach us through D2C or B2B channels. Regarding our second priority, we are working closely with the FDA in anticipation of the 510(k) clearance on the medical device version of the Ring, which we will launch under the brand name Evie Med. We announced last week that we successfully submitted exemplary clinical trial results from a Q1 Hypoxia trial to the FDA on April 22, 2024, which is a significant milestone for our organization. During the trial, each subject wore 4 Evie Med rings, 2 on fingers and 2 held on fingertips. When evaluating accuracy versus arterial blood gas levels, the 4 Evie Med Rings achieved a root mean square error of 2.46%, well within the FDA guidance of 3.5%. In addition, our range factors exceeded that of the 2 commercially available hospital-grade reference [indiscernible], one of which [Technical Difficulty]. We continue to expect our FDA decision regarding our 510(k) in July 2024. In preparation for a positive FDA decision, we remain bullish on the enterprise opportunities that we believe a clearance will unlock for our organization. And as we get closer to securing this distinction, we are already engaged with our strategic partners in the pharmaceutical, medical device and payer channels. These partners have all expressed the immediate challenge they face in obtaining continuous and secure medical-grade data and see our solution as an integral part of their future initiatives. We see opportunistic applications in chronic management of cardiovascular, metabolic, obesity and pulmonary patients, which, in aggregate, we've identified as a $20 billion per year market opportunity. And finally, we continue to focus on the breakthrough technology of our ultra compact and efficient health monitoring system on a chip, which measures just 4 x 6.7 millimeters and has yielded breakthrough advances in blood pressure monitoring, enabling accurate, cuffless and automated tracking. As you'll recall, we previously announced the results of a blood pressure clinical study in October 2023, where our product type achieved an overall mean absolute difference or MAD of 5.9 millimeters of mercury below the 7 millimeter mercury MAD required for an FDA recognized standard for wearable, cuffless, blood pressure measuring devices. We have been making enhancements to this prototype to be evaluated in that study, and we expect that our next blood pressure study will take place this June and will be the first study we've done with an arterial line, which is the precursor to an FDA pivotal study. Unlike a cuff, which provides only one blood pressure value, an arterial line will provide continuous data on a number of patients. In addition, we are also evaluating AI-based individual calibration efforts to further enhance the future performance of our platform. Ultimately, we expect blood pressure monitoring will be a significant addition to the suite of analytes we currently offer in Evie as over half the adults in the U.S. over age 20 are pre-hypertensive, or have hypertension. Continuous monitoring of blood pressure holds the promise of dramatically enhancing the management of these conditions. With that, I'll now hand the call over to Jay for the financial review.

Thanks, John. We shipped 5,305 Evie Rings in the first quarter of 2024 and reported $852,000 in revenue in the period. The company reported an operating loss of $5.8 million in the first quarter of 2024 versus an operating loss of $7.2 million in the year ago period. We launched Evie Ring during the Black Friday 2023 holiday period, and we are reporting revenue for the first time as revenue is tied to the timing of Ring shipments, which commenced in January of this year. You'll recall that given capital constraints, we see small paid marketing as of December 1, 2023, and temporarily halted taking orders in February 2024. From December of 2023 through March of this year, we prioritized capital preservation and actions to meet production and customer service needs. Not surprisingly, given the limited initial launch, there were some operating inefficiencies and learnings early on. For example, our launch generated a great deal of excitement and consumers were anxious to receive their Rings. Delays that we experienced with delivery timelines generated a number of cancellations that impacted top and bottom line results of our initial launch. We intend to avoid this issue going forward, as John noted earlier, by ensuring ample inventory prior to taking orders again. We are already making important strides in additional operational improvements across products, manufacturing and customer service that should position us well for both an expanded launch of the Evie Ring and direct-to-consumer and eventual launch of Evie Med in B2B upon an FDA clearance decision. Following our successful private placement in April, where the company raised $24 million in gross proceeds, including a strategic seed investment from a Tier 1 multibillion-dollar medical device company, we believe we have the resources to judiciously drive our D2C business, launch Evie Med, target B2B and accelerate clinical trials related to our proprietary RF technology. Importantly, and as noted before, with these funds now on our balance sheet, we are in conversations with our production partner about a turnkey solution, which should free up both working capital and people resources for Movano Health. A few other financial highlights. Our cash burn in the first quarter of 2024 was $4.1 million, which was inclusive of costs for the Evie ring launch and expenses related to our FDA submission as well as other quarter-to-quarter timing considerations. Whereas we had $2.1 million of cash and cash equivalents on our balance sheet at March 31, pro forma for the early April private placement, we had $24.8 million of cash and cash equivalents at that time. Now I'll turn it back over to John for final remarks.

Thanks, Jay. This past quarter has been a significant one for the company, marked both by valuable lessons from our D2C launch as well as significant progress in our organizational milestones. We are encouraged on all fronts and look forward to a successful D2C reignition, continued positive momentum around our expected 510(k) clearance and advancing to the next phase of our blood pressure clinical studies. We are confident that this combination of positive developments will act as a catalyst for success through the balance of the year, and we look forward to keeping you updated as we continue to make headway. As that concludes our formal remarks, we'd be glad to take your questions.

[Operator Instructions]

Okay. Operator, it looks like -- well, at least while we're waiting for any questions from the phone lines. It looks like we have a few questions on the webcast, so I can go ahead and begin asking those and directing them to the team. The first one, John, I think this should be for you. Could you provide any updates as it relates to the 510(k) process beyond what you mentioned in the call today?

Sure, Jay. Yes, thanks for the question. As I mentioned in the call, we recently refiled with the FDA some new clinical results for another HYPOXIA study where we had 4 Rings worn on 4 different locations for each subject, and we were really pleased with the results, which exceeded our expectations. The Rings not only exceeded far the FDA benchmarks, but they provided more accurate results than 2 FDA-approved hospital-grade control devices that were used during the study. And so I think those results bode very well for us. We've actually since putting in the new data have already had some back-and-forth communication with our reviewer. And thus far, things are going pretty well. So we're going to continue to work closely with the agency along the path of ideally getting this product cleared for market.

I think Michael Soule can answer the next question, which is, can you provide some more detail on your plans for the launch of Evie Med with B2B partners?

Jay, Sure. Yes, that's a good question. So we continue to engage with all of our Beta partners and channels ranging from medical device to pharma, who are looking forward to our FDA clearance in the July timeframe. We expect the [indiscernible] clearance that unlocks a host of initiatives across clinical trials and remote patient monitoring. And we're currently building the back-end data systems required for these partnerships so we can hit the ground running. Coming off our recent announcement of cuffless blood pressure clinical study results, we have another new group of large strategic partners wanting to work with us in channels ranging from pharma to medical device.

Speaking of blood pressure. This next question, I guess, could be for Michael Leabman, or John, do you want to comment on the progress you've seen with blood pressure?

Sure, I could take. Yes. So I think as John mentioned earlier, our next big step, there's 2 big steps actually. One, if we take our blood pressure references on and make it more into a product as we get closer to our pivotal study. And as John said, really trying to improve the algorithm, and arterial line test in June, which is similar to the test we would be doing for FDA pivotal studies. So really just trying to get everything ready and informed to really facilitate fast tracking blood pressure.

Okay. John, do you want to take this next question, I'll throw a couple of questions together because they all relate to the shipping of the Evie Rings. Some questions about when we'll start shipping Evie Rings and then also some questions about features related to Evie, including how far are we from our [indiscernible]?

Sure, Jay. Thanks. Yes, I've seen this question is coming up quite a bit. So as Jay had mentioned in the prepared remarks, we went through a pretty challenging capital situation at the end of last year and into early this year, which kind of hamstrung us a little bit on what we were able to do. However, launching the Ring when we did and getting it out there in the marketplace where we could learn really provided a great opportunity for us. And so now that we have the new funding, we are focused on optimizing our production processes and delivery times as well as working on overall Ring improvements and, of course, the enhancements that we've already been making to our customer service. We are currently working with our manufacturing vendors to order all the raw materials that we need to satisfy increased demand that we expect moving forward. And we're going to hold on taking new Ring orders until we've ensured that we can establish and maintain an ongoing inventory of about 1 to 2 months by SKU at all times. Once we're confident in all these initiatives that we've set up then we will announce a new ship start date, but we are under no huge urgency to do this earlier than when we feel really confident in our ability to fulfill orders. And so having inventory built up and maintained before we turn on this spicate again is very important to us as an organization.

Great. And John, I have another one for you. Someone was asking if there's any update on the strategic investor and other potential partnerships?

Sure. Well, as it relates to the current strategic investor, it's actually been a very really collaborative relationship. That's only a little more than a month old since we did the fund raise. And already, I've had multiple meetings with their team. They've actually offered us some support in a couple of areas where they have more experience and expertise than us, which has been very valuable to us for moving forward. And we've discussed some further opportunities where our Ring in its current embodiment could potentially be beneficial to some of the work that they're doing with customers and where they see the market trends going. And lastly, of course, there's continued interest in what we're doing with our proprietary millimeter-Wave RF technology and the future that, that holds, as I mentioned, as it relates to blood pressure and/or glucose, which are the 2 big brand daddies of metrics that we could be monitoring. So a lot of excitement there as well. So yes, since this engagement started, it's been nothing but positive, I think, both on our side as well as theirs, and we've shared with them our strategic plan for the rest of this year and going into next and gotten some feedback from them about what our plans are and our focus, and we're in complete alignment.

Great. And then a couple of quick ones here. Blood pressure, do we see the first device -- commercial device being a wrist band or a ring. And then for Evie Med, will that also be for men?

Michael, why don't you do the first part of that, and I'll do the second part.

Sure. So I mean our chip, as John mentioned, is 4 by 6 millimeters. So it does have the ability to eventually go into Ring as well. I think in this first go-around, given all of our great data so far that we did in our previous clinical studies, we want to make sure that we get through the FDA as quick as possible with what we've already been testing for the last 1.5 years. And I think once we take that a little bit further along, then we'll start looking at putting it into the Ring as well.

And then as it relates to Evie Med, I can tell you a couple of things that are very important. When we run our clinical trials for SpO2, for example, and heart rate, that was done both men and women. We looked at the entire population as well as very importantly, people with different skin tones because they're optical sensors for SpO2. And so really, that was not limited to only women, it's for all. And in the discussions that we've had and Michael Soule perhaps can elaborate on this, but the discussions that we've had with potential partners in the healthcare space, I mean some of them are developing female-focused solutions. So obviously, that would apply to them, but many others are looking at this for both men and women. And the ring today is worn by some men, albeit a much, much smaller number of men than women but nothing prohibits the ring from being used by either men or women. And certainly, the men on this call and out in the field are using Evie Rings today. And as the medical device comes to market, we will certainly use it on both men and women. And Michael Soule, I don't know if you have anything you'd like to add.

No, John, you covered it well. Just that all of our beta partners, while they see what we're doing in the direct-to-consumer world, and I think it's a really great strategy in the clinical trial areas and medical device areas, the folks, the large strategics that we're dealing with, see this as a unisex device. So I just want to add that.

Okay. And then it looks like our last question for the webcast. And it doesn't look like we have any on the phone lines. So this will be our last question for this call today. You sold $1 million of rings -- I'll take this one by the way. You sold $1 million of rings in the first 10 days of your launch, but netted $850,000 after a full quarter. Can you elaborate on the difference? Sure. As we mentioned on the call, we had a lot of demand at launch, and we are very committed to fulfilling all the orders as quickly as possible. But we did have a series of unexpected delays on the manufacturing side, which caused some frustration for consumers, and they grew retired of waiting and subsequently canceled their orders. So that was disappointing, it was excellent learning for us as an organization. We've since modified our processes and our inventory controls so that when we begin taking orders again in the future, we will have plenty of inventory and be able to deliver all sizes and colors within 5 to 7 business days. Okay, operator, that looks like the end of the Q&A, I will turn it back to you.

Thank you. Do you have any closing remarks you would like to say?

Yes. Thanks for reminding me just one. We appreciate you all be on the call today. And if you'd like to continue to follow Movano Health for news and events, please stay tuned to our website at ir.movano.com.

Ladies and gentlemen, that concludes this conference. Thank you for joining us. You may now disconnect your lines.

Greetings, and welcome to the Movano Health Fourth Quarter 2023 Earnings Call. [Operator Instructions]. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, David Barnard, with LHA Investor Relations. Thank you, David. You may begin.

Thanks, Paul. Good afternoon, everyone, and thank you for joining us today. Movano Health, CEO; John Mastrototaro will open today's call with prepared remarks about the progress the company made during the fourth quarter of 2023 and in recent weeks. Today's guest speaker will be Michael Soule, Vice President of Business Development, who will provide some remarks on the company's B2B activities, followed again by John and then CFO, Jay Cogan, will provide highlights of the company's quarterly operating results and current financial position. Then we'll open the call for Q&A. John, Jay and Michael will be joined by our Chief Marketing Officer, Tyla Bucher, and Vice President of Product Strategy, Stacy Salvi. Movano Health issued a news release this afternoon dealing both fourth quarter and full year 2023 financial results. Before we begin, I would like to remind everyone that the company will make forward-looking statements during today's call based on current expectations. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties, and actual results may be materially different from such statements. These risks and uncertainties are detailed in the Risk Factors section of Movano Health's filings with the Securities and Exchange Commission specifically in the company's Forms 10-Q and 10-K. Except as otherwise required by federal securities laws, Movano Health disclaims any obligation to update or make revisions to such forward-looking statements contained herein or elsewhere to reflect chain expectations with regards to those events, conditions and circumstances. With that, I'll turn the call over to CEO, John Mastrototaro.

Good afternoon, everyone. Movano Health is at a critical inflection point, and I'm excited to speak with you today about our progress. First, we commercially launched the Evie ring last November ahead of Black Friday, garnering strong views on the aesthetics, technology and form factor. Demand for the Evie Ring bar exceeded our expectations. However, our ability to attain volume production to meet demand was hindered most significantly by capital constraints and to a lesser degree, we experienced some operational challenges. So we paused our ring order intake. I'm pleased to share our team has been diligently addressing the issues and are nearing resolution. During this time, in just 6 weeks, we have amassed a wait list of over 8,000 potential buyers organically without any paid marketing. Our initial direct-to-consumer launch is providing incredibly valuable user feedback as we drive toward both continued D2C growth and multiple business-to-business opportunities. This afternoon, we closed on a $24 million private placement, including a $3 million strategic seed investment from a Tier 1 multibillion-dollar global medical device company. This is a pivotal moment in our company's journey. We're thrilled to partner with this leader in health care and look forward to potential future collaborations. As we highlighted in our press release earlier this week, this strategic investor is keenly interested in the Evie Ring and our proprietary millimeter wave radio frequency technology and then underscores the vast potential of our innovative approach delivering medical grade data to both consumers and enterprises. We're also fortunate to have had the broad participation in the private placement from Movano health management team and Board of Directors totaling more than $3.6 million. Now with the new financing, we are set up to scale commercial production proceed further along the regulatory pathway and pursue multiple market opportunities that should deliver shareholder value. Our goal is to deliver both the consumer and FDA-cleared wearable that combines accessibility, personalization and style with the recognized capabilities of a medical device. Our highest priorities are as follows: one, to achieve our first FDA clearance for pulse rate and blood oxygen monitoring, which sets the stage for our brand expansion to Evie Med. Two, on the heels of this clearance to bring key B2B opportunities to fruition. And three, to accelerate our clinical trials for couples blood pressure and noninvasive glucose monitoring, establishing the foundation to develop additional commercial products forging our proprietary technology. Movano Health is using Evie to set new standards for the possibilities of what wearable health technology can do. We plan to serve consumers through both D2C and B2B channels where regardless of the ate point, our user is ultimately always a consumer wearing a ring. As such, the Evie Ring wireless product is a valuable step on our path to broader commercialization. We're already learning what consumers like and want, and this critical information will help us achieve higher adoption and engagement from future users. Based on early feedback, we've made several software updates to improve the overall experience, including minimizing use of the green LED light and improving the accuracy of our sleep tracking. In March, we launched our Insight Engine, which is the first step to offering our customers personalized insights, which leverage an AI-based framework, correlate disparate data types. We plan to be judicious with our capital position and methodical in our approach to build out our direct-to-consumer and business-to-business market opportunities. In preparation for our B2B launch, we must secure FDA clearance and improve our scale and volume production capabilities. We also plan to execute several initiatives in the next few months, developing an Android version of the app, building sufficient finished inventory to ensure quick order fulfillment and bolstering our customer service capacity. Regarding the FDA pathway, we've been strategically focused on pulse rate and blood oxygen saturation monitoring often referred to as SpO2. In the first quarter of 2024, and we used our commercial ring in a second hypoxia trial with UCSF, in which each subject were 4 Evie Rings, 2 1 fingers and 2 held on fingertips. When evaluating accuracy versus arterial blood gas levels, the 4 Evie Rings achieved a root-mean-square error of 2.46%, well within the FDA guidance of 3.5%. In addition, our rings accuracy also exceeded that of 2 commercially available hospital-grade reference pulse oximeters, one of which failed to meet the FDA standard for accuracy. Later this month, we plan to present this confirmatory data and address the outstanding FDA comments from our prior submission. We believe taking these steps will put Movano Health on track to read the decision regarding the 510(k) clearance in July 2024. We look forward to continuing to work closely with the FDA throughout the review process. In preparation for a positive FDA decision, we have been planning the launch of Evie Med, the medical device version of the ring. It's important to note that because the Evie ring and Evie Med will be the same physical ring, production costs remain the same. The primary difference is that Evie Med will include labeling for the FDA-cleared features as well as some modifications to the app experience. As mentioned earlier, our Evie user base and customer feedback support sizable B2B opportunities. I'll now hand the call over to Michael Soule, our VP of Business Development, to discuss our efforts.

Thank you, John. As noted, there are numerous B2B opportunities for Evie Med. We are actively engaged with potential partners that are performing various beta tests with Evie to assess form and function. Today, I will review 3 of the distinct market segments beyond the medical device partnership that we announced earlier this week. First, the clinical trial market consists of pharmaceutical companies that need to gather data from FDA-cleared devices as part of their drug trials for FDA and other regulatory submissions. We are poised to dominate the $2 billion market annually of FDA-cleared wearables with minimal competition. Currently, trials are in person, cumbersome, expensive enough are suboptimal as they don't capture the subjects in actual realized situations. We believe Evie Med would improve compliance, lower costs significantly and enable quicker enrollment, better data and improved quality of results. Presently, we are in discussions with 5 top-tier pharma companies, one of which has beta tested Evie. All of these potential partners are excited about the prospects for an FDA-cleared low-cost and convenient wearable to take the place of other devices presently used. Second, the payer market consists of insurers that represent more than 130 million patients with chronic diseases, often with comorbidities who have poor and/or unreliable monitoring options. Evie Med would provide an easy-to-implement solution for early detection of dangerous health risks and for the prevention that could greatly reduce costly disease interventions. Already, we have traction with one of the top 3 U.S. payers that covers approximately 50 million lives. If Evie Med is used by just 1% of this insurer's population, that equates to more than 0.5 million rings. The third market I wanted to highlight is the rapidly growing remote patient monitoring channel or RPM. This market barely existed 4 years ago. However, COVID unlocked the reality that health care can reduce the need for in-office visits, expand access and reduce costs. We believe Evie Med will be able to automate more complete and accurate data result in RPM solution with meaningful advantages over RPM products in the market today. Our wearable technology is in beta testing with a leading U.S. RPM company that serves over 450 health care organizations and is the exclusive platform for one of the largest medical device companies in the world. This is just the tip of the iceberg. Other large B2B opportunities include applications and condition management for cardiovascular, metabolic, obesity and pulmonary patients, which, in aggregate, we've identified as a $20 billion per year market opportunity and corporate wellness with an identified TAM of $14 billion. Additionally, we fully anticipate the Evie Med introduction will drive more consumer awareness, leading to greater D2C adoption. I'll now turn the call back to John.

Thanks, Michael. Our product development plan extends far beyond Evie and Evie Med. We're deeply invested in multi-analyte sensing and pursuing additional FDA clearances with further research and respiration rate for temperature and a solution to address sleep disturbances. Some of these metrics may only require a software update while others may require new hardware components or potentially different form factors. Our commitment to innovation and improving health monitoring and intervention has fueled 6 years of intensive R&D work in millimeter wave radio frequency and AI technology. Through these efforts we created our ultra compact and efficient health monitoring system on a chip or SoC, which measures just 4 by 6.7 millimeters in size. Use of this chip yielded breakthrough advances in blood pressure monitoring, enabling accurate, [indiscernible] and automated tracking. We announced the results of a blood pressure clinical study in October 2023, where our prototype achieved an overall mean absolute difference for MAD of 5.9 millimeters of mercury well below the 7-millimeter mercury MAD required for an FDA recognized standard for wearable couplets blood pressure monitoring devices. The results of this clinical trial were a clear catalyst for investment by the Tier 1 medical device company. Looking ahead, we're also evaluating AI-based individual calibration methods to further enhance the future performance of our prototype. Ultimately, we expect blood pressure monitoring will be a significant addition to incorporate into a new product that supplements the suite of analytes we currently offer in Evie. In addition, we believe our single-chip technology can be implemented in products designed to aid in the treatment of patients with multiple chronic conditions, including diabetes, where our platform is being evaluated for noninvasive blood glucose monitoring. Our studies demonstrated that our millimeter wave RF technology surpasses traditional optical sensors and provide high-fidelity data and reliable readings with the ease of continuous data collection. We look forward to additional clinical testing later this year, leveraging the RF chip. With that, I'll now hand the call over to Jay for the financial review.

Thanks, John. Earlier this afternoon, we closed on a $24 million private placement, including a $3 million equity investment by a Tier 1 multibillion-dollar global medical device company and more than $36 million -- $3.6 million in investment by insiders to include members of the company's management team and Board of Directors. Going forward, we believe we now have the resources to judiciously drive our D2C business, launch Evie Med, target B2B and accelerate clinical trials and pre-commercial work related to our proprietary RF technology. Importantly, with these funds now on our balance sheet, our production partners committed to instituting a turnkey process. which should free up both working capital and people resources for Movano Health as our manufacturing partner will now purchase an inventory raw materials, parts and finished goods. We expect this will be a significant benefit for the company. Moving to our financial commentary. While the launch of Evie Ring in late 2023 began the Movano Health transition to a commercial stage company, shipments commenced in January 2024, and revenue will be recognized as a result in 2024. In our first quarter results, we will begin to report revenue, which we expect to be nominal as we paused order intake in mid-February. That said, one of the things we've learned since launching Evie Ring in November is that there is significant demand for the product. The company generated over $1 million in sales during a very efficient Black Friday holiday launch period, given capital constraints, we ceased all paid marketing as of December 1, and we continue to see a steady flow of orders through mid-February when we're taking new orders. From December through March, we prioritized capital preservation and actions to meet production and customer service needs. Looking ahead with an improved capital position and operational improvements across product, manufacturing and customer service, we were building inventory in preparation for relaunching Evie. We'll also be moving with intention along the regulatory pathway as we work toward receiving our first FDA clearance and securing initial B2B contracts with health care partners. For the fourth quarter of 2023, Movano Health reported an operating loss of $6 million, and that compared to an operating loss of $8 million in the year ago period. Our cash burn in the fourth quarter of 2023 was $5.4 million, which was inclusive of costs for the Evie Ring launch and expenses related to our FDA submission as well as other timing considerations. In November, we raised $4.1 million in gross proceeds in an equity financing that partially offset the cash burn. At December 31, 2023, we had $6.1 million of cash and cash equivalents on our balance sheet. And as noted earlier, we closed on the $24 million private placement earlier this afternoon. As that concludes our formal remarks, we'd be glad to take your questions. Operator?

[Operator Instructions]. We'll now be conducting a question-and-answer session.

It doesn't look like we have any questions on the phone line, operator. Let's start with the webcast. And I have a few questions here, which I can begin to ask. And maybe, John, if you can start with this first question, are there any additional updates that you can provide as it relates to our first 510(k) application?

Yes. First off, as I mentioned in the earlier remarks, we've made tremendous progress with the clinical work on the Evie Ring. The results from our latest trial were exceptional, and it was very interesting to see that one of the hospital devices actually did not meet the FDA accuracy criteria. In my experience in working with the FDA, obviously, the clinical results are critically important. And so we feel really good about that. In addition, we've had numerous discussions with the FDA. They have been working with us very collaboratively and we're pleased with that. And we have addressed all of the questions that they have brought to our attention. And so we will be filing the new information to the agency later this month. And as I mentioned, we do expect to have a decision from the agency in July, but I do feel pretty good about where we are based upon the discussions that we've had to the state and the clinical data that we achieved in the latest study.

Okay. And there's another question here in the webcast about Evie Med looking for a little bit more information about what Evie Med and how that compares to Evie Ring as a wellness product.

So the Evie Med hardware is essentially the same as the Evie wellness device that we launched already. But there are some differences. When you have a medical device FDA reviews the labeling in detail. And obviously, for the medical device aspects of it, there are some differences between the 2. And then secondly, beyond just the labeling, the app experience is different. We've separated out the wellness metrics from the medical metric of what like a pulse oximeter would provide as part of the app experience. And that's based upon some discussions that we've had with the agency as well. So we feel pretty good about that. Naturally, we do look forward to talking more about this in the future. And certainly, as we move forward and have more feedback from the agency. Jay, maybe you could spend a moment though and talk a little bit about some of the things that we're thinking about related to pricing and whatnot.

Sure. I would say, given that Evie Med will be an FDA-cleared device, we would expect it to be sold at a premium relative to the Evie Ring. And on top of that, across the B2B space, we see a variety of opportunities to have a recurring revenue stream database revenue, for example, whereas with the Evie Ring, it's a product sale. And so we look forward to talking more about that in the future as well.

Okay. Let's go on to the next question. John or Michael, maybe you can take an update here. The question is related to strategics or this existing strategic partner. If you can talk a little bit about where things stand with potential partners at this stage.

Sure. Thank you, John. Yes. So that's a great question. Just this month, we've had 2 large strategic partners, one in the RPM channel. The other in the payer channel, wrapping up their beta tests. We continue to engage our first set of beta partners from last year in channels ranging from medical device to pharma. And they are all very much looking forward to our FDA clearance coming up in the July time frame. And then most recently coming off our announcement of our cuffless blood pressure clinical study results, we have a whole new tranche of large strategic partners wanting to work with us in channels ranging from pharma to medical device to everything in between. John?

No, that's fine. I think we should move on to the next question. Go ahead, Jay.

Great. Maybe this is for Tyla and Stacy. What has been the customer response to you bring thus far? Can you tell us how users are engaging with the app about their broader user experience.

Yes, I can kick us of. So John already mentioned, we faced a number of operational and customer service challenges out launch, which was obviously frustrating for our customers and very frustrating for us as well as our goal has always been to provide a best-in-class user experience across the board. But despite these initial setbacks, we're still committed to fulfilling this goal, and we have received a tremendous amount of invaluable feedback and support from our early adopters, all of which we are implementing in our go-forward planning. Additionally, the media does continue to review us very positively, which is driving traffic and awareness for the Evie brand. And as John noted, we have over 8,000 people signed up for updates since we paused the site with no paid marketing at all. So I mean this, coupled with our planned media efforts, our influencer program and our upcoming launch on a new social channel will set us up for success once we're ready to start taking orders again. In addition to opening the store back up, our ongoing focus now that we're resourced will be to shore up our customer service and delivery response time, expand our engagement strategy for our existing members and build out our product offering to include new features and insights. And actually, with that, I will turn that over to Stacy.

Thanks, Tyla. So from a strategic product perspective, we're really pleased to see our users highly engaged with the app and using the ring and app as expected. Of course, we're focused on delivering the high-quality experience our users deserve with attention paid to improving sleep and the activity feature first. We're also rolling out the Insights experience as we speak and excited to develop this important feature, which really personalizes and contextualizes the data from the ring in the coming months.

Seeing that there are still no questions on the phone lines. I'm going to ask a few more questions here from the webcast Q&A. And either John or maybe, Tyla, there's a few questions about when we're going to start shipping Evie rings again. What do we need to see before we start taking new orders going forward?

Yes. First off, with the new funding, we're focused on optimizing our production processes and delivery times as well as ordering raw materials, components and working on the overall ring improvements. We're currently working with our vendors to order the materials we need to satisfy increased demand. But we're going to continue to hold on taking new orders until we ensure that we can establish and maintain an ongoing inventory of about a month or 2 by skew at all times. We want to be able to move forward to be able to fulfill orders almost immediately when they come in. Tyla, do you have anything you'd like to add?

No, I think it's good. I think the key is that we're continuing to focus on this goal of making sure that it is a best-in-class customer service experience when people do order the ring. And in the interim, we're going to be focused really heavily on driving engagement with the consumers that we do have. So then when we opened up, there's really solid word of mouth.

Okay. We've got a few here about blood pressure and prototypes for blood pressure and the glucose initiatives. So John made there for you. Can you tell us a little bit more about what this the blood pressure clinical trial that we've been referring to from last fall, what do the results really mean? And how long will it be before a blood pressure product could potentially make it to the market?

Yes. First off, one thing that was really critical about the work on blood pressure was that we demonstrate that the chip that we produced working in concert with GLOBAL foundries was fully functional and able to provide higher resolution signals that we could use to determine blood pressure values. And so that was a real key for us. And the fact that we were able to gain an accuracy in the study that was commensurate with what the FDA guidelines request of a product like this was really important to us. And it really formed the basis for the investment by this Tier 1 multibillion dollar medical device company because blood pressure is such a huge problem. It's probably -- if you could have one analyte that you could be measuring continuously at home. Blood pressure is first up, half of people over the age of 20 suffer from a hypertension or pre-hypertensive and it's the leading cause of heart disease and stroke and other things. So it's the big grand daddy of them all. Glucose is a bit behind that. And of course, we're making progress there as well. But this is critical. And then in terms of how long to the market, we just completed that feasibility trial with a prototype system. We have already made some enhancements in the layout of the components on the board to optimize it for a next round of studies. And so throughout the course of this year, we'll be conducting more clinical work. We'll be evaluating the product in more like a consumer type form factor. Moving forward, we have done all of our initial studies on the wrist versus the finger, and we will continue to do so, but we may do some experimental work looking at our ability to monitor blood pressure on the finger. And through the course of this time, we will continue to develop what the overall consumer-oriented form factor would look like. as well as continue to not only generate clinical evidence, but look at longitudinal tracking of blood pressure. So we look forward to updating you more over time now that we have the resources that allow us to really put more behind these efforts for blood pressure because it is one of our top initiatives in the company.

And John, I don't think you mentioned it in those comments there, but there's another question here regarding blood pressure and also regarding glucose monitoring and wondering if we would expect the first product to be in a ring or possibly a band or some other form factor.

One of the things we have not evaluated for blood pressure anywhere, but the wrist at this point. We basically focus the RF energy at the radial artery of the wrist for the measurements. We get really clean, very nice pulse pressure wave forms using that. We're going to have to look at whether or not we could do it on the finger. We know that chip is small enough to fit inside a ring that could be used on the finger, but we have not evaluated that site. But we do know that we want to be able to assess a waveform that's coming from an arterial source. As it relates to glucose, it's a little bit more open. Quite frankly, if you're aware of the existing CGMs and something I worked on for a lot of my career, they're done in the inner -- looking at the interstitial fluid. And really, we're looking at interstitial changes in signals based on the RF signature for glucose. So we are also looking at whether we could for glucose monitoring, use other sites of making the measurement. I think there's more flexibility with glucose than there is for blood pressure.

Great. And maybe Stacy or Tyla, there's a question about Apple Health and when Evie is planning on connecting to Apple Health in the future.

I can take this one. Thank you so much for the question. This is certainly near the top of our list. We know our users are also likely Apple products users, of course. And so as we consider the kind of landscape of opportunity out there and where we want to focus our attention, this one is on the short list. I can say that. I can't give an exact date, but certainly something that we are looking at.

Great. And I think the last question for today will be one that I can actually answer. How long will the cash you just raised last. And what we would first want to say is, look, we're incredibly pleased with the results of the $24 million capital raise that we closed earlier this afternoon. As we've mentioned, we got a $3 million strategic seed investment by a Tier 1 multibillion global medical device company. And we also saw very strong demand from existing shareholders and new institutional investors and clearly had significant participation from insiders including members of the management team and the Board of Directors. The capital is going to be able to provide us with the ability to proceed along our major initiatives, including the regulatory pathway to the FDA clearance, that can help us accelerate our blood pressure clinical studies and work around noninvasive glucose monitoring and as we've also been discussing begin to scale commercial production. Okay. With that, operator, I think we are ready to end today's call. Thank you.

Hello and welcome to Movano Health Third Quarter 2023 Earnings Call. I’d like to remind everyone that this call is being recorded and a replay of the call will be available on Movano Health’s website, ir.movano.com. I would now like to hand the conference over to Jay Cogan, Movano Health’s Chief Financial Officer.

Thanks, operator. Good afternoon, everyone or good morning, everyone. Thank you for joining us today. Our CEO, John Mastrototaro, will open today’s call with prepared remarks about the progress we have made during the third quarter of 2023 and in recent weeks. Our Chief Marketing Officer, Tyler Bucher, will join us to give an update on the upcoming launch of the Evie Ring. And afterward, I will cover the highlights of our quarterly operating results and provide a perspective on our financial position. Finally, Movano Health’s Founder and Chief Technology Officer, Michael Leabman; and our Vice President of Product and Strategy, Stacy Salvi, will join John, Tyler and me for the Q&A. Movano Health issued two news releases earlier today detailing both our third quarter financial results and the results of the $3.6 million underwritten public offering of 4.2 million shares of the company’s common stock. The news releases and today’s presentation are available on our website at movanohealth.com. Before we begin, I’d like to remind everyone that we will make forward-looking statements during today’s call based on our current expectations. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties and actual results maybe materially different from such statements. These risks and uncertainties are detailed in the Risk Factors section of our filings with the Securities and Exchange Commission, specifically in the company’s Forms 10-Q and 10-K. Except as otherwise required by federal securities laws, Movano Health disclaims any obligation to update or make revisions to such forward-looking statements contained herein or elsewhere to reflect changes in expectations with regards to those events, conditions and circumstances. Now, I’d like to turn the call over to our CEO, John Mastrototaro.

Thanks, Jay. Welcome, everyone. Thank you for joining us for Movano Health third quarter earnings call. We are less than 1 week away from the launch of the Evie Ring, which is the culmination of more than 2 years of research, innovation and dedication. Our first product represents a major milestone in our company’s evolution, underscoring our commitment to empowering women to take ownership of their health journey through thoughtful product design, with accurate data and meaningful insights. During today’s call, we will share more about how we prepared to meet this moment and our strategic approach to marketing the Evie Ring to consumers through the holiday season and into the new year. In addition, we’ll update you on our FDA submission, which has the potential to unlock a significant enterprise opportunity with partners across healthcare. And we will dive deeper into our blood pressure and glucose initiatives where we have made significant progress following our most recent blood pressure clinical trial. The Evie Ring and app have been fully developed and we have been focused on testing the complete solution to ensure the experience is smooth from the outset. The company’s manufacturing partner is online and production processes are in place. We believe we have set the stage for the successful introduction of Evie into the market and are excited to embark on this new phase of our journey as we shift from pre-revenue to a revenue generating company. The timing for such a product couldn’t be better, with increased interest in medical grade technologies for home use and a strong focus on women’s health and empowerment. Beginning November 20, customers will be able to place an order for the Evie Ring exclusively through our website for $269 and no additional subscription fees. We will offer sizes 5 to 12 to accommodate most women’s fingers and customers can use our complimentary sizing kit to find the right fit. We expect to be again shipping rings to customers before the end of the year. The ring will initially be available to customers in the United States with the iOS devices. We are prioritizing the development of our Android app, which we plan to launch in early 2024. With its unique design and sticky app features, we believe the Evie Ring holds immense potential for our company, our shareholders and the health and wellness of our future customers. The Evie Ring provides trusted health information for every woman at every stage. It combines comfort and portability of the ring, the design of beautiful jewelry, and a suite of advanced sensors. It uses a PPG sensor, a skin temperature sensor and an accelerometer. This sensor suite enables the tracking of key health and wellness metrics you would expect from a wearable, such as sleep stages, heart rate, heart rate variability, respiration rate, SpO2, and activity metrics, including steps, active minutes and calories burned. The companion app enables the logging and estimation of period and ovulation, menstrual symptoms, mood and workouts. Rather than scoring activity or fitness performance, Evie focuses on identifying trends. The Evie app lends passively collected body data with easily large moods, symptoms and circumstances and transforms it into actionable insights that are delivered into the apps’ notification center. The longer the user wears the ring and engages with the app, the more meaningful our health insights become. This goes beyond a quantitative improvement. It includes a qualitative understanding of their body that helps users modify their behavior and/or equip them with context here with their doctors. We know a good day looks different for everyone. And people have varying health goals. So, the center of gravity in the app called Daily Summary is a personalized view of house steps, active minutes, calories burned, sleep, mood and menstrual symptoms, logging come together to complete a healthy day based on the user’s unique goals. The app has a spot check feature enabling users to perform live on-demand reviews of heart rate and SpO2 levels at any time to provide a baseline understanding of their health. As you know, we submitted a 510(k) application to the FDA for the Evie Ring’s Pulse Oximetry feature earlier this year. We have since received a letter from the FDA asking us to respond to questions and provide additional information in a few different areas. Their requests are in line with our expectations and we don’t believe there is anything preventing us from continuing to pursue FDA clearance. The FDA has been very collaborative throughout the process and we continue to dialogue with the agency to ensure we are in sync. We are aiming to formally reply to their letter in Q1 of 2024 and we will communicate next steps from there. With respect to B2B partnership opportunities, we are in the midst of a multi-week testing program with a major health insurer and a leading remote patient monitoring company. We continue to explore new channels and partnerships to expand our reach and drive continued growth. We expect B2B partnership opportunities to ramp up now that our final ring and app solution is developed. Our product launch will be accompanied by a comprehensive marketing campaign that emphasizes Evie’s unique value proposition. We believe this will be instrumental in our successful market entry. I will turn the call over to our CMO, Tyler Bucher to update you on the marketing plans for our launch.

Thanks, John. It’s an exciting time over here on the marketing side of the business as we are just days away from launch. Over the last quarter, we have continued to grow our highly engaged community and build anticipation for the ring. We are currently in the pre-launch phase of our marketing campaign where the goals are to educate consumers across our key segments about what and who we are, drive awareness and build excitement for the brand. We announced our order date at the end of October which was very well received across all our channels, with consumers responding at a high rate to our e-mail and social posts, the majority asking how they could purchase the ring. We also launched our new commercial website on November 6, which was in development for many months and offers a detailed look at the female first features and benefits of Evie solutions. It also gives customers an interactive way to engage in the experience prior to purchase. I encourage you to take a look after the call at eviering.com. We’ve received over 200,000 site visits since we launched our website. And we expect this number to grow significantly once we open orders next week. Our teaser campaign is now live across paid and organic channels designed to drive curiosity and top of funnel site traffic. We have targeted static and video creative assets that showcase the ranks and highlight the benefits reminding you to order soon if you’re already aware and giving you a clear introductory message if this is your first impression of the brand. Once orders open on November 20, we will enter the Phase 2 of our marketing campaign, which is where we harvest our engaged leads list of over 120,000 consumers and drive new conversion traffic to the site throughout the Q4 holiday shopping period. During this phase, we’ll launch our full brand campaigns and introduce new creative to each of our segments as well as add new channels, product reviews, and influencer content. Post-launch, we will be laser focused on customer data and performance analytics. We will be constantly testing our messaging and creative to gain a better understanding of our target segments. We’ll be looking to drive efficiency with our marketing dollars and improve our conversion rates. This data driven approach will allow us to make real time adjustments and optimize our campaigns for maximum reach and engagement. In addition to our marketing campaign, we are continuing to release content for our communities from a variety of contributors, including our first white paper, written by [indiscernible], PhD, entitled Women and Biometrics: Harnessing the Potential of Gender-Specific Health & Wellness Data. This focuses on the impact of gender differences on health and wellness and not only establishes us as a thought leader in the wearable space, but also substantiates the need for a women first wearable. We have very strong open rate of the paper of over 30% and over 3,000 members of our community click through, which is a solid indicator of interest for what we are creating and sharing. We are also deep into preparations for our first exhibition at this year’s Consumer Electronics Show. We will be on the floor at the Las Vegas Convention Center in January with our first real physical showcase of the full Evie solution. We’ll be giving media, potential partners and other attendees the opportunity to size, try on and purchase the Evie Ring. And we will be announcing new features planned for 2024. We will also be participating at CES Unveiled, the official media event of CES to increase our exposure and opportunity for media coverage. And finally, I want to touch on our customer service plans. Because of this all direct-to-consumer businesses, this is the first touch point for our users and is key to building brand loyalty and advocacy. We are taking a customer-centric approach to all our communications and excellent customer service will be instrumental in driving brand loyalty. Customer feedback will be invaluable to our marketing efforts as we continue to evolve and will actively engage with our customers, listen to their experiences and use this information to fine-tune our messaging and our content planning. There is a lot to look forward to on the marketing front and we are in great shape for our launch, next Monday. And with that, I’d like to turn it back to John.

Thanks, Tyler. While we are gearing up to launch the Evie Ring, we are also continuing to build a high value healthcare solutions roadmap, including research and development toward cuffless blood pressure and non-invasive glucose monitoring solutions. As we mentioned earlier, we have had a significant breakthrough in our ongoing initiative to develop a cuffless blood pressure wearable device. And with this breakthrough, we have taken a major step forward on the path to commercialization. There is still more work to do, but we believe it’s important to highlight the significant progress here. During the third quarter, we completed a 44-person Institutional Review Board approved blood pressure trial at our clinical lab to assess the accuracy of our 4/6.7 millimeter system-on-a-chip and prototype. Our solution demonstrated the level of accuracy within the standards recognized by the FDA for blood pressure monitoring devices. We’re incredibly excited about the results of the trial, and believe this is a substantial step forward in realizing our vision of commercializing cuffless RF enable blood pressure wearable medical device. The success of this study can largely be attributed to our proprietary system-on-a-chip, we have invested more than 5 years building the system-on-a-chip from the ground up in an effort to achieve an unprecedented level of precision and wearable health monitoring. After shrinking our multi-chip architecture from four integrated circuits into a single IC in mid-2022. We began using the RF power system-on-a-chip and clinical studies this year. As a result, we’re seeing much cleaner signals and a material improvement in the accuracy of our blood pressure measurements. In terms of next steps, we’ll start configuring our prototype into a form factor suitable for a commercial product. Its compact size gives us the flexibility to add the chip to our ring or risk worn form factors, we will also conduct additional clinical trials, both in-house and with third party investigators. The additional studies will include a multi week study to determine whether periodic calibration is required, and will be helpful in refining our AI models on an individual patient basis, beginning in the fourth quarter of 2023. Following the completion of this longitudinal study, we intend to conduct a pivotal trial for our 510(k) submission to the FDA. This development is especially important for the healthcare industry when you consider the scale of hypertension and lack of day-to-day technology for consumers to continuously monitor their blood pressure. According to the American Heart Association, high blood pressure effects half of Americans aged 20 years and older are more than 122 million people. Movano Health’s cutting-edge technology has the potential to seamlessly fit into a consumers lives and improve day-to-day health monitoring for individuals and their clinicians. We’re very excited about all the recent developments at the company and a well prepared for this pivotal moment of launching our first product. The ring has already generated a lot of interest, and we believe that addresses a significant need in the women’s health sector, we expect the product to be well received by our target market and believe there’s substantial potential for growth. November 20, is just the beginning of an exciting road ahead. Even as we prepare for the product launch, our team continues to work on product enhancements and new features that will keep us at the forefront of women’s health technology. With that, I’ll turn it back to Jay to go over the financials.

Great, thanks, John. We detail the financial results today. In our third quarter earnings release, which you can find on our website. I’ll share a few key line items here. Movano Health reported an operating loss of $9.1 million in the third quarter of 2023, compared to an operating loss of $8.7 million in the year ago period. The increase was primarily related to the accelerated commercialization initiatives described earlier in the call. Our cash burn in the period was $7 million, generally in-line with the run rate for the prior seven quarters, given certain pre-launch costs for the Evie Ring and expenses related to our FDA submission, as well as other timing considerations. Partially offsetting the cash burn, the company raised approximately $200,000 on its $50 million ATM facility in the third period, selling 159,000 common shares and an average price of $1.20 per share. This morning, we announced Movano Health has priced a $3.6 million underwritten offering of the company’s common stock. We’ve granted the underwriter a 30-day option to purchase up to an additional 15% of shares sold the offering at the public offering price of $0.85 per share less the underwriting discount. The transaction is expected to close on November 17. At the end of the third quarter of 2023, Movano Health had $7.7 million of cash and cash equivalents on the balance sheet, pro forma for the affirmation capital raise and before considering the potential overlap month option, the company had $10.8 million in cash and cash equivalents at the end of the third period. As I conclude our formal remarks we’d be glad to take your questions. Operator, we’re ready to begin the Q&A section of the call.

[Operator Instructions]

And while you’re looking at the phone lines, operator, I do see a few questions in the webcast. And maybe we can start there and I can go ahead and see the ask those questions. Okay, so the first question what are your expectations of sales for the Evie Ring this year? Tyler and Stacy, maybe you want to help answer that question.

Yes, happy to. I mean, while we can’t provide, obviously, number guide guidance, we feel with a significant number of indicators that are pointing to a very healthy response to our launch. First and foremost, we have a very engaged leads list of over 120,000 people who every time we send an email out, respond to us asking when they’ll be available to buy the ring. In addition, we have a digital marketing campaign that’s running across paid and organic channels that’s reaching 10s of millions of consumers across all of our different segments. And we’re seeing our business going up significantly on our website every single day. So there’s definitely traffic and people who are looking to see when orders will be open. And the third thing is our social channels, which we monitor pretty significantly all day long. And the comments are constantly when can we buy and not only are individuals acting when they can buy they’re tagging one another. And so that’s building out the flywheel. So we feel really confident that we’re going to have a really nice, healthy response to do our launch date on Monday. And I’ll also ask Stacy, perhaps to give some context around the product.

Yes, absolutely. Thanks, Tyler. So from a strategic and product perspective, what we’re really seeing is a validated product market approach, not just in social and the items that Tyler was mentioning, but really, in the feedback that we’re getting from consumers, and that’s really that focusing on women’s first is long overdue. People are extremely excited about this. And we’re hitting all the points that are important to them. And go back to something we’ve talked about in the past. But we spoke with more than 1,000 women to really understand what they were looking for in an experience. And we’re just really excited to be delivering on all of these high points, but ring is comfortable, the app is super intuitive, the data is presented in a beautiful way. And it kind of turns the wearables experience on its head a bit. But it gets to all of those quality points that you come to expect from a high grade wearable. So we’re just super excited about what we’ve got going.

Okay, we’ll take one more from the webcast. And I do see we also have a call in the – on the phone line. So let’s just do one more here from the webcast. And then we’ll turn it over back to you operator for that one on the phone lines. So, John, maybe you want to answer this question. When would you start shipping rings? What’s your production capacity? And what’s your capacity to receive more than anticipated orders?

Well, thanks, Jay. Yes, as I’ve mentioned on the call, we are on track to begin shipping rings before the end of the year. Now in preparation for orders and what could be a varying amount of orders. We’ve ordered a lot of the raw material, and obviously, especially components that have long lead items, so we have a lot on hand to be able to satisfy increased demand. If that comes to pass, we also have a production process where the cycle time for each unit is relatively short. And that allows us to ramp up capacity fairly rapidly if the need arises. And we also do have the capability to duplicate manufacturing lines, if we need to, we have the space set up we have some of the process equipment duplicated, so that we can flex appropriately based upon where demand goes. And in all of this, we’ve been working very closely daily with our vendors so that they’re on the ready, they’re very aware of the launch dates are very aware of when we’re turning on our website to be taking orders. And they’re all prepared to hit the ground running. So that’s what we’ve been working on specifically to make sure that we’re in a good place regardless of increased demand.

Okay, operator, you want to take that question? A queue that from the frontline.

Yes. Our first question is from [indiscernible] with BTIG. Please proceed with your questions.

Hi, and congrats. And good luck ahead of next week’s launch. I’m excited to see it for you. I wanted to ask a couple questions here on the pipeline. Any more detail you could give us on your interaction with the FDA? What sort of questions that they came back with? Is there anything that you view as sort of a needs a little more work or what you’re focused on now in terms of the questions that came back?

Sure, I will respond to that. First and foremost, it was – it’s been very interesting working with the FDA. And one of the things that we somewhat had expected before we filed is that there is a pretty strong interest on the FDA is part looking at new pulse oximeter is in light of what happened through the course of COVID. And for those of you who aren’t aware, during COVID, many pulse oximeters on the market had some inaccuracies when used on people of color, or people with darker skin tones. It would overread the truth in those folks. And there have been articles published in the New England Journal of Medicine and Wall Street Journal and other outlets, every major outlet about some of these challenges. So you can imagine, based upon that happening, that the FDA is scrutinizing new pulse oximeters at a different level. Now, we had already previewed with ourselves that they were going to focus a little bit more with people with darker skin tone. And so, we overemphasize that as part of our clinical trial. And I should mention that the way our pulse oximeter works is we use the reflected mode, which has not been susceptible to changes in accuracy, regardless of someone’s skin tone. And that’s been very, very positive for us, and one of the reasons I have been really excited about having this filing go into the agency. So, we had already kind of dealt with that in advance. Another thing happened with the agency and we have talked about this before with our product that as a medical device company, patient privacy and the security of the data is very important. And one of the things that we have to do is a cybersecurity assessment as part of the filing that we put in. And so we actually have to work with a third-party firm that looks for vulnerabilities in our data movement from the rate of the app and the app to the cloud. There is a new guidance that just came out in October, after we filed that revolves around cybersecurity and have some more evaluations and things that need to be done. And so, the FDA asked us if we would go ahead and update our filing to the latest standard there. So, it’s those types of things that we have been communicating with the agency on as it relates to the filing. There is nothing there, that’s a showstopper, it’s more of just us going through the motions of putting together the requested information, and then providing it to them. And we have had the opportunity already once and we have another meeting scheduled next month with the agency to just review our package, make sure we have got everything the way they want it, and then put it back in. So, I feel pretty good about where we stand right now with that.

Okay, very good to hear. And then as a follow-up, you have an extensive pipeline of additional parameters you want to add to the ring or other wearables? How will the customers who are early adopters, those who are buying, starting next week, how will they get access to some of those upgrades? Are those mainly software upgrades, or will they need kind of a hardware upgrade as well? Thanks for taking the questions.

Yes, I could probably – as it relates to blood pressure and glucose, the RF chip, that’s the separate product moving in the future, but as it relates to what we are going to do with the first Evie Ring, Stacey, you are best to really give this answer.

Sorry for interrupting you, John. But yes, Murray, it’s a great question. So, anybody who buys the Evie Ring will be able to access the feature updates that we have planned for it over that are launching over time into 2024 that will be accessed through the app, and they can download either new firmware or a new app to get access to that. So, we look forward to keeping those users engaged and which host of new features that we have planned in the upcoming year.

Alright, very helpful. Good luck with it.

Thanks Murray. It looks like we have a few more questions in the webcast. John, I think this question is for you, can you share where you stand with potential strategic partners at this stage?

Sure. First off, we are still engaged with the first four beta partners that we had worked with previously, who were basically at this point, just waiting for us to get to the juncture where we have rings available, and some of them are looking for the 510(k) clearance. So – but we are in communication with them over time. Now, there is two new large groups, as I mentioned on the call, an insurer payer, and as well as the remote patient monitoring company that we have started an additional beta program with. We now – now that we have got our final solution, we have other interested parties who have expressed interest in testing our solution. And with the recent blood pressure clinical results that we just obtained, it has initiated some additional dialoguing with companies who have an interest in blood pressure, specifically. So, these conversations with potential strategics are gearing up right now, both because of the fact that the ring is imminently going to market next week. The FDA, we are working closely with and hopefully we will have a clearance in Q1, and then the results of the blood pressure study. So, I think you are going to see this area, in terms of B2B partnerships, expanding more and more in the coming months.

Okay. And then there is another one. John, I think that you can probably answer here as sort of relates to the blood, excuse me, blood pressure clinical studies. There is a couple of them. So, one of the questions is, what is your trial results? What does it really mean? How long will it be before blood pressure finds its way into a commercial device for the company? And kind of a question alongside, do you expect blood pressure measurements to be made from the ring or from a wrist based device?

Thanks Jay. First off, as it relates to where the measurements will be made, as I mentioned in the call, we do have the ability because the chip that we have developed is so small, that we can put it in both ring or wrist worn form factors. For the purposes of our clinical trials to-date, we have done everything on the wrist. And it may be ultimately that we want to use a bracelet type device to do this, but we do have a bit of flexibility, but we have not initiated any blood pressure trials on the finger yet. We focused on the wrist. And primarily that’s just because of, it’s easier to do it on the wrist, where we have an adjustable band. And we can use a prototype on multiple people versus a ring where we need individual sizes for folks. So, we felt that that was the best way to get out there and conduct trials relatively rapidly. In terms of how long it will take to bring this to the market, our prototype device is a prototype, and we use it in the clinical lab. It’s not to biggest risk warrants. But we do want to convert that into something that’s a bit closer to what the commercial product would look like. And so – and we need to get to that point, ultimately to run our pivotal trials for the FDA. So, we are going to go through the steps of reconfiguring the hardware, putting it into a updated form factor. And then we have got some clinical trial work that we want to conduct. We will continue to use our current prototype to look at some of the longitudinal studies, bringing in people, some are employees, week-after-week-after-week monitoring their blood pressure, looking at the accuracy, determining whether there is any drift or adjustments that we need to make with the algorithms over time. We will run those studies in parallel to bringing up new hardware. And once we get to the point with our internal studies, where we think that we are good to go, we will need to embark on a pivotal trial, which would involve somewhere between probably 80 and 120 individuals monitoring their blood pressure. The FDA has standards for how you conduct these tests, and we know the accuracy requirements that need to be met. And we will do things similar in fashion to what we did for heart rate and oxygen, monitoring before. And the last thing I will mention is that what we have done is scale down the hardware from multiple chips into this really small chip. And it’s unique to us, it’s something that’s patented that has this capability for glucose and blood pressure and potentially other analytes. It’s fully functional, that just getting to that point has been a real stunning achievement. And I credit Michael Leabman and the team with all the work that’s been done, to get to that point with the product right now. The fact that we were able to achieve the accuracy results using it in the clinical study, which were well within the FDA guidance mean absolute errors, the guidance is at 7 millimeters, and we are at 5.9 millimeters of mercury error is just tremendously exciting. And we have seen that from some of the B2B partners we are talking to right now and what this could mean to the healthcare industry at large. I was at a meeting last night and someone was saying that’s like the Holy Grail of how to be able to do this seamlessly and automatically for people to track blood pressure longitudinally over time. So, we are incredibly excited about where we stand on that and the recent results that we were able to achieve. I will stop there.

Okay. Maybe one more for you, John, here. And if I am reading this question correctly, we talk a lot about the potential to work with healthcare partners, whether it’s medical device or pharmaceutical companies, health insurers, etcetera. Believe this question is asking about the possibility to work with large consumer electronics companies, OEMs that may want to incorporate our technology into their devices in the future, any thoughts in regards to that opportunity.

Yes. Often people have said, hey, you have developed this great chip for RF, are you open to looking at potentially either white labeling your product or selling chips to large organizations that would like to incorporate it into many millions of devices? And I would say that, from our perspective, we are certainly open to any opportunity that presents itself to us. And I can tell you that that is not outside the realm that those types of opportunities may come across our table. But we will look at all of them to assure that it’s in the best interests of our shareholders, of the organization, and of course, ultimately, in the customers that we want to serve with these types of solutions.

Okay. And we have one more question in the webcast, I can take this one given the backdrop of what’s been a very challenging capital markets environment over the last year or so, is the company positioned well to invest behind the Evie launch? We can certainly empathize with respect to that broader market environment. We very much appreciate the longstanding support that we have had from our investor base, including those that participate in the company’s capital raise overnight. As you have heard on the call from Tyler and others, we certainly have a lot of interest in what we are doing. We have well over 120,000, primarily women on our kind of email lead list, as we have been building awareness for the Evie Ring over the last several months. And as Tyler mentioned, we have had already in just over a week, well over 200,000 people that have already come to our new commercial site, and we are not selling any product yet, but obviously, we will be positioned to launch starting next Monday the 20th. We think the company is very well positioned to invest behind the launch of the Evie Ring, that will obviously be generating revenue as we go, which will also help to bolster the balance sheet, and we are looking forward to keeping you all posted on our progress in the coming weeks and months. With that, operator, I think we will complete today’s call and thank you for all of your attention. As a reminder, you can stay connected and up-to-date on Movano Health news and events by checking out our investor website at ir.movano.com.