enVVeno Medical Reports Third Quarter Results as TAVVE Study Prepares for First Patients
enVVeno Medical reported third-quarter 2026 financial results and outlined plans to start the initial 10-patient stage of its TAVVE U.S. pivotal study before year end.
enVVeno Medical Corporation (NASDAQ:NVNO) reported its financial results for the third quarter ended September 30, 2026, and said it remains on schedule to begin the first stage of its TAVVE U.S. pivotal study before year end. The study is being conducted under an FDA-approved Investigational Device Exemption (IDE) for the company’s enVVe System.
Clinical sites for the study are being activated, and Chief Executive Officer Robert Berman said the company is scheduled to enrol its first patient before the end of the year. Part 1 is expected to include up to 10 patients, who will initially be monitored for safety.
After the initial patients produce 30-day safety data, enVVeno Medical plans to submit those results to the FDA. The participants will continue to be followed as a separate cohort, with safety and efficacy results reported periodically.
Following submission of the initial cohort’s 30-day safety results and subject to applicable FDA requirements, the second stage is expected to enrol 220 patients randomized 3:1. Of those patients, 165 are expected to receive the enVVe System and 55 are expected to receive standard-of-care treatment.
The company said participating investigators are expected to include vascular surgeons, interventional radiologists and interventional cardiologists. The primary safety endpoint will combine all cause mortality, pulmonary embolism, enVVe Valve embolization, enVVe valve infection, thrombus in the treated vein segment, Target Vein Zone perforation and access site bleeding.
The enVVe System is a catheter-delivered, non-surgical replacement venous valve designed for permanently damaged valves in the deep veins of the leg. The device is designed to restore one-way blood flow towards the heart and reduce backward blood flow.
For the randomized stage, the primary efficacy measures are expected to assess 12-month changes in backward blood flow, measured as regurgitant volume in the target vein zone and evaluated by a core laboratory, along with clinical improvement measured using the revised Venous Clinical Severity Score (rVCSS).
Following completion of the randomized stage’s 12-month follow-up and analysis of the results, enVVeno Medical intends to submit a premarket approval (PMA) application to the FDA. The potential submission remains subject to the TAVVE pivotal study results and applicable regulatory requirements.
enVVeno Medical had $18.5 million in cash and investments at September 30, 2026. The balance comprised $2.6 million in cash and cash equivalents and $15.9 million in short-term investments. Cash burn for the quarter was $3 million.
Total operating expenses were $4.5 million, compared with $4.9 million in the third quarter of 2025. The company reported a third-quarter 2026 net loss of $4.4 million, or $6.29 per basic and diluted share, compared with a net loss of $4.5 million, or $7.89 per basic and diluted share, in the same quarter of 2025.
enVVeno Medical believes its cash and investments will fund operations into the fourth quarter of 2027, including the planned initiation of TAVVE. The company said its cash burn rate will likely increase to between $4 million and $5 million in the first half of 2027 as the study continues enrolling patients.
During the quarter, the company advanced product development, testing and operational preparations after the FDA approved the IDE. Karen B. Garby, MD, DABVLM, RPhS, presented the investigational enVVe System at The VEINS 2026 Innovation Summit in Las Vegas, Nevada.
enVVeno Medical is based in Irvine, California, and describes itself as a late clinical-stage medical device company focused on bioprosthetic, or tissue-based, solutions for deep venous disease.
enVVeno Medical reported a third-quarter 2026 net loss of $4.4 million, or $6.29 per basic and diluted share.
The company had $18.5 million in cash and investments at September 30, 2026, including $2.6 million in cash and cash equivalents and $15.9 million in short-term investments.
Part 1 of the FDA-approved TAVVE pivotal study is expected to begin before year end with up to 10 patients.
The second stage is expected to enrol 220 patients randomized 3:1, subject to submission of the initial safety results and applicable FDA requirements.
enVVeno Medical intends to submit a PMA application after the randomized stage’s 12-month follow-up and results analysis, subject to study results and applicable regulatory requirements.
enVVeno Medical reported financial results for the third quarter ended September 30, 2026, and said it was on track to begin Part 1 of the TAVVE U.S. pivotal study in the fourth quarter of 2026. The study is being conducted under an FDA-approved Investigational Device Exemption (IDE).
enVVeno Medical announced the results on October 30, 2026, covering the third quarter ended September 30, 2026. The company compared the quarter's net loss and operating expenses with the third quarter of 2025.
enVVeno Medical had approximately $18.5 million in cash and investments as of September 30, 2026. This comprised $2.6 million in cash and cash equivalents and $15.9 million in short-term investments.
enVVeno Medical reported cash burn of $3 million for the quarter and total operating expenses of $4.5 million. Operating expenses were $4.9 million in the third quarter of 2025.
enVVeno Medical reported a net loss of $4.4 million, or $6.29 per basic and diluted share, for the third quarter of 2026. This compared with a net loss of $4.5 million, or $7.89 per basic and diluted share, for the third quarter of 2025.
enVVeno Medical believes its cash and investments will fund operations into the fourth quarter of 2027, including the planned initiation of TAVVE. The company also said its cash burn rate will likely increase to between $4 million and $5 million in the first half of 2027 as the TAVVE study continues enrolling patients.
The TAVVE pivotal study is a U.S. study of enVVeno Medical's enVVe System, and Part 1 is expected to begin before year end. Robert Berman, Chief Executive Officer of enVVeno Medical, said clinical sites were being activated and the company was on schedule to enrol its first patient before the end of the year.
Part 1 of enVVeno Medical's TAVVE pivotal study will consist of up to 10 patients who will initially be monitored for safety. The 30-day safety data will be submitted to the FDA, and the patients will continue to be followed as a separate cohort, with safety and efficacy results reported periodically.
Part 2 of enVVeno Medical's TAVVE study is expected to enrol 220 patients randomized 3:1, with 165 receiving the enVVe System and 55 receiving standard-of-care treatment. This stage is subject to submission of the initial cohort's 30-day safety results and applicable FDA requirements.
The primary safety endpoint for all TAVVE patients will be a composite covering all cause mortaility, pulmonary embolism, enVVe Valve embolization, enVVe valve infection, thrombus in the treated vein segment, Target vein Zone perforation and access site bleeding. The primary efficacy endpoints will assess changes in backward blood flow, measured as regurgitant volume in the target vein zone at 12 months and evaluated by a core laboratory, as well as clinical improvement using the revised Venous Clinical Severity Score (rVCSS).
enVVeno Medical's enVVe System is a first-in-class, non-surgical replacement venous valve designed to treat permanently damaged valves in the deep veins of the leg. Delivered through a catheter, the enVVe valve is designed to restore one-way blood flow towards the heart and reduce backward blood flow.
enVVeno Medical intends to submit a premarket approval (PMA) application to the FDA after completion of the randomized stage's 12-month follow-up and analysis of the results. The potential submission is subject to the TAVVE pivotal study results and applicable regulatory requirements.
enVVeno Medical shares trade on NASDAQ under the ticker symbol NVNO. The source identifies the company as enVVeno Medical Corporation (NASDAQ:NVNO).
enVVeno Medical is an Irvine, California-based, late clinical-stage medical device company focused on innovative bioprosthetic, or tissue-based, solutions for the treatment of deep venous disease. Its stated aim is to improve the standard of care for that treatment.