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enVVeno Medical Corporation develops bioprosthetic venous valve devices for severe deep chronic venous insufficiency in the United States. News about NVNO centers on the company’s enVVe System, a minimally invasive transcatheter replacement venous valve, and its TAVVE pivotal study under FDA investigational device exemption approval.
Recurring updates also cover the VenoValve surgical replacement venous valve, FDA communications tied to device review, clinical-development planning, cash runway and operating losses, Nasdaq listing compliance, shareholder-approved capital-structure actions such as the reverse stock split, and investor communications from this late clinical-stage medical device issuer.
enVVeno Medical (Nasdaq: NVNO) has appointed Sandy Prietto as Vice President of Marketing, strengthening its commercial team ahead of key milestones. The company, focused on treating venous disease, is preparing for the VenoValve monetization and several Q4 2024 events, including:
1. Completion of PMA submission for FDA approval of VenoValve
2. Release of one-year data from VenoValve U.S. Pivotal Study
3. Initiation of GLP pre-clinical study for enVVe
Ms. Prietto brings extensive experience in medical device marketing and successful product launches. enVVeno's lead product, VenoValve, is a surgical replacement venous valve for severe Chronic Venous Insufficiency (CVI). The company is also developing enVVe, a non-surgical transcatheter-based replacement venous valve. With $39.1 million in cash and investments as of Q2, enVVeno is funded through 2025.
enVVeno Medical has made significant progress in its FDA premarket approval (PMA) application for the VenoValve, a surgical replacement venous valve. The company has successfully submitted, and the FDA has approved, four out of five modules required for the PMA application. The fifth and final module, containing clinical data from the SAVVE U.S. pivotal trial, is expected to be filed in Q4 2024.
The VenoValve is being developed as a potential treatment for severe Chronic Venous Insufficiency (CVI), a debilitating disease affecting approximately 2.5 million new patients annually in the U.S. The SAVVE study, involving 75 CVI patients across 21 U.S. sites, is currently collecting one-year clinical data to support the final PMA module submission.
As of June 30, 2024, enVVeno Medical had $39.1 million in cash and investments, which is expected to fund operations through the FDA's decision on the VenoValve PMA application.
enVVeno Medical (NASDAQ:NVNO) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- $39.1 million in cash and investments, sufficient to fund operations through end of 2025
- Positive interim venous ulcer healing data from VenoValve pivotal trial
- On track to file VenoValve FDA approval application in Q4 2024
- Progress on enVVe transcatheter-based replacement venous valve
Financial results:
- Net loss decreased by 23.1% to $5.0 million
- Cash burn of $3.8 million, better than projected $4-5 million
- R&D expenses decreased by 33.3% to $2.8 million
- SG&A expenses remained flat at $2.6 million
enVVeno Medical announced that CEO Robert Berman will participate in the Virtual Investor Closing Bell Series on June 27, 2024. The event will be webcast live at 4:00 PM ET and will feature Berman discussing positive interim data from the SAVVE U.S. pivotal trial for the VenoValve®. The data showed significant improvements in venous ulcer healing, with key safety and efficacy milestones highlighted. Berman will also outline the timeline for the anticipated approval of the VenoValve®. The presentation will include a Q&A session, and a replay will be available on enVVeno's website for 90 days.
enVVeno Medical announced positive interim data from the SAVVE U.S. pivotal trial for the VenoValve, presented at the Society for Vascular Surgery 2024 Annual Meeting. Of the 21 venous ulcer patients evaluated at one year, 91% have either fully healed ulcers or improved conditions. Specifically, 100% of ulcers existing for a year or less before the VenoValve surgery completely healed, and 89% of ulcers older than one year either healed or improved. Impressively, there have been no ulcer recurrences. The company plans to file for FDA approval in Q4 2024.
The SAVVE study is a prospective, non-blinded, single-arm, multi-center study involving 75 CVI patients across 21 U.S. sites. As of March 31, 2024, enVVeno had $42.9 million in cash and investments.
enVVeno Medical announced the presentation of new interim venous ulcer healing data from the VenoValve U.S. pivotal trial at the Society for Vascular Surgery 2024 Vascular Annual Meeting on June 21, 2024. The data, presented by Dr. Cassius Iyad Ochoa Chaar of Yale School of Medicine, includes healing and improvement rates for venous ulcers among 21 patients reaching the one-year milestone. The study involves patients with severe venous ulcers who had undergone multiple existing treatments. The FDA requires one-year data on all SAVVE patients for the VenoValve's PMA application, expected to be filed in Q4 2024.
enVVeno Medical reported financial results for the first quarter of 2024, ending with $42.9 million in cash and investments.
Positive 11-month efficacy data was presented at the Charing Cross Symposium. The Company is on track to file for FDA approval for VenoValve in Q4 2024.
Andrew Cormack joined as Chief Commercial Officer, and progress was made in the development of the enVVe valve and delivery system.
Financially, the Company had a cash burn of $3.5 million, lower than expected, with net losses decreasing by 22% compared to the same period last year.
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