NVNO

Company ended the first quarter with approximately $25 million in cash and investments Capital on hand should fund operations through multiple key milestones into Q3 2027 Company recently received FDA IDE approval to commence TAVVE U.S. Pivotal Study for non-surgical replacement venous valve, enVVe System TAVVE site selection is underway with patient enrollment expected to commence later this year IRVINE, CA / ACCESS Newswire / May 7, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today reported financial results for the first quarter 2026, ending the quarter with approximately $25 million in cash and investments and confirming the Company's strategic focus on the development of its next-generation enVVeﾮ System for the treatment of deep venous insufficiency. "With a strong balance sheet, significant physician interest in the enVVe valve, and a clearly defined regulatory pathway, we are well positioned to execute the TAVVE study and advance the Company towards multiple near-term and long-term milestones," said Robert Berman, Chief Executive Officer of enVVeno Medical. Landmark FDA IDE Approval for TAVVE Study In April 2026, enVVeno Medical announced that the U.S. Food and Drug Administration (FDA) granted IDE approval for the Company's Transcatheter Venous Valve Endoprosthesis (TAVVE) pivotal study, marking the first-ever FDA approval for a U.S. pivotal study of a non-surgical replacement venous valve. The study will evaluate the Company's minimally invasive enVVeﾮ System for the treatment of patients with severe deep chronic venous insufficiency (CVI), a condition affecting approximately 3 million patients in the United States with limited treatment options. Summary of Financial Results for the First Quarter 2026 Cash and investments totaled $24.9 million as of March 31, 2026, compared to $28.2 million as of December 31, 2025. The Company believes its current cash and investment resources are sufficient to fund operations into the third quarter of 2027, including advancement of the TAVVE pivotal study. Cash burn for the first quarter was $3.3 million, consistent with the Company's projected cash burn rate of approximately $3 million to $4 million per quarter. The Company anticipates that its cash burn rate may increase to approximately $4 million to $5 million per quarter in 2026 as it prepares for and initiates the T...

Company accelerated development of the enVVe® System, completing pre-clinical studies and progressing toward a 2026 pivotal trial initiation Strong financial position expected to provide an operating runway into mid-2027 through the achievement of key clinical milestones IRVINE, CA / ACCESS Newswire / March 27, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today announced financial results for the year ended December 31, 2025 and provided a corporate update highlighting its strategic focus on the development of its next-generation enVVeﾮ System. Robert Berman, Chief Executive Officer of enVVeno Medical Corporation, stated, "2025 represented a significant inflection point for the Company. Following the FDA's decision regarding the VenoValveﾮ, we made the strategic determination to accelerate development of the enVVe System, a less invasive, transcatheter-based approach designed to address prior regulatory considerations while broadening the potential physician adoption base." Mr. Berman added, "With pre-clinical development complete and active discussions underway with the FDA, we are now focused on initiating our pivotal trial in 2026 and believe the enVVe System represents a transformative opportunity to address a large and underserved patient population suffering from severe chronic venous insufficiency." Chronic venous disease is the most prevalent chronic condition in the United States, affecting an estimated 70% of the adult population. Severe chronic venous insufficiency (CVI), a more advanced form of the disease, impacts approximately 3.5 million patients in the United States, including roughly 1.5 million individuals with venous leg ulcers. Currently, there are no approved surgical or non-surgical replacement venous valves available, highlighting a significant unmet medical need. The enVVe System is a first-in-class, non-surgical, transcatheter-based replacement venous valve designed to treat severe deep CVI by restoring proper one-way blood flow in the leg veins. The system is intended to eliminate the need for open surgery, reduce procedural risk, expand adoption across multiple physician specialties and improve patient quality of life. Looking ahead, the Company's primary focus in 2026 will be advancing the enVVe System into clinical development, including finalizing alignment with the FDA on the pivota...

- Cash and investments are sufficient to fund current operations through Q2 2027, not including VenoValve commercialization and the enVVe IDE study - Cash burn of $4.2 million in Q3 remains in line with projected quarterly range - Ongoing engagement with FDA for supervisory appeal of the VenoValve PMA decision with feedback expected by the end of 2025 IRVINE, CA / ACCESS Newswire / October 31, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today reported financial results for the third quarter 2025. Summary of Financial Results for the Third Quarter 2025 The Company ended the quarter with $31.0 million in cash and investments. With the VenoValve commercializations costs and enVVe IDE expenses currently on hold pending resolution with the FDA, this capital has the potential to fund the Company through the second quarter of 2027. The Company expects its cash burn rate to increase from current levels in the event the Company proceeds to commercialization of the VenoValve and the IDE study with enVVe. Cash burn for the quarter was $4.2 million, consistent with the Company's projected cash burn rate of approximately $4-5 million per quarter. The Company reported net losses of $4.5 million and $5.6 million for the three months ended September 30, 2025 and 2024, respectively, representing a decrease in net loss of $1.1 million, or 20%, due to a decrease in operating expenses of $1.3 million, partially offset by a decrease in other income of $0.2 million. "We are well capitalized and should have sufficient capital to cover the period of our ongoing discussions with the FDA seeking a potential commercial path forward for the VenoValve and clarity for the enVVe IDE study," commented Robert Berman, CEO of enVVeno Medical. "Our recent in-person appeal meeting with the FDA provided a focused setting to address the concerns outlined in the not-approvable letter, including safety concerns raised by the FDA, proposed mitigations, the VenoValve's effectiveness, and also provided the opportunity for the Agency to hear directly from one of our primary investigators and a patient from the VenoValve study. We look forward to our continued interactions with the FDA and remain committed to the 2.5 million patients suffering from severe deep chronic venous insuf...

- Cash burn of $3.8 million in Q2 remains in line with projected quarterly range - Cash and investments are sufficient to fund operations through Q3'2026 at current cash burn rate - Commercial readiness activities underway for a phased launch of VenoValve® subject to FDA decision expected in 2H'2025 - IDE submission for enVVe® on track for 2H'2025 IRVINE, CA / ACCESS Newswire / August 1, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today reported financial results for the second quarter 2025. "As the recent headlines around CVI confirmed, CVI is a pervasive and a progressive disease that is especially debilitating once it becomes severe. Our participation in several of the recent national news stories about CVI fits with our strategy of establishing enVVeno Medical as the world-wide leader in treatments for severe, deep venous disease. With several value driving milestones on the horizon, including FDA decisions on potential approval for the VenoValve and the pivotal study for enVVe, we continue to make strong progress in our mission to bring first-in-category, effective treatments to patients with severe CVI, and are well positioned to lead the ongoing national dialogue about CVI as further events are reported," commented Robert Berman, CEO of enVVeno Medical. Summary of Financial Results for the Second Quarter 2025 The Company ended the quarter with $35.1 million in cash and investments. Based on management's current expectations, this capital has the potential to fund the Company through the third quarter of 2026, including pre-commercialization activities for the VenoValve, and the commencement of the enVVe pivotal study. Cash burn for the quarter was $3.8 million, consistent with the Company's projected cash burn rate of approximately $4-5 million per quarter. The Company anticipates that its cash burn rate will increase from current levels once commercialization of the VenoValve begins. The Company reported net losses of $6.7 million and $5.0 million for the three months ended June 30, 2025 and 2024, respectively, representing an increase in net loss of $1.7 million, or 35%. This increase was primarily due to higher operating expenses of $1.6 million resulting from additional personnel costs, the issuance of option grants,...

Cash Burn of $4.0 million in Q1 remains in line with projected quarterly range Cash and investments on hand are sufficient to fund operations beyond the anticipated FDA decision of VenoValve and the initiation of the enVVe pivotal trial FDA decision on PMA application for the VenoValve expected in the second half of 2025 On track for enVVe IDE application submission in Q3 of 2025, pending GLP study results IRVINE, CA / ACCESS Newswire / May 1, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today reported financial results for the first quarter 2025. Robert Berman, enVVeno Medical's Chief Executive Officer, commented "In the first quarter, we continued to present our compelling 1-year data from the U.S. pivotal trial at leading global, scientific conferences to socialize and engage directly with leading vascular surgeons as we lay the foundation for the potential phased market entry of the VenoValve, pending FDA approval. We have also maintained a strong financial position - an important advantage in the current market conditions. We remain confident that 2025 will be a pivotal year as we prepare for our transition from a development-stage company to a commercial enterprise." Summary of Financial Results for the First Quarter 2025 The Company ended the quarter with $38.9 million in cash and investments. Based on management's current expectations, this capital has the potential to fund the Company through the anticipated FDA decision for VenoValve, the initiation of commercialization preparations for VenoValve and the commencement of the enVVe pivotal study. Cash burn for the quarter was $4.0 million, consistent with the Company's projected cash burn rate of approximately $4-5 million per quarter. The Company anticipates that its cash burn rate will increase from current levels once commercialization of the VenoValve begins. The Company reported net losses of $4.5 million and $5.0 million for the three months ended March 31, 2025 and 2024, respectively, representing a decrease in net loss of $0.5 million, primarily resulting from a decrease in operating expenses. Clinical Program Highlights VenoValve®: Surgical Replacement Venous Valve VenoValve PMA application seeking U.S. Food and Drug Administration (FDA) approval submitted; Decision expected in...