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enVVeno Medical Corporation (NASDAQ:NVNO), based in Irvine, California, is a late-stage clinical medical device company dedicated to developing innovative bioprosthetic (tissue-based) solutions for treating venous disease. The company's flagship product, the VenoValve®, is a first-in-class surgical replacement venous valve designed to treat severe deep venous Chronic Venous Insufficiency (CVI). CVI occurs when leg vein valves fail, leading to blood reflux, pooling, venous hypertension, severe pain, leg swelling, and recurrent ulcers.
The VenoValve is currently undergoing evaluation in the SAVVE U.S. pivotal study, where it has shown promising results, with 97% of patients demonstrating clinical improvement and 74% achieving a clinically meaningful benefit after six months. The company plans to file for FDA pre-market approval in Q4 2024. Additionally, enVVeno is developing the enVVe™, a non-surgical, transcatheter-based replacement venous valve, expected to enter pivotal trials in Q4 of 2024.
In recent updates, enVVeno presented positive preliminary safety data from the SAVVE study at the 50th Annual VEITH Symposium and shared encouraging topline efficacy data at the American Venous Forum and Charing Cross International Symposium. Financially, the company reported ending the first quarter of 2024 with $42.9 million in cash and investments, sufficient to fund operations through 2025.
enVVeno's mission is to address the unmet needs of approximately 2.5 million new CVI patients annually in the U.S. with no effective current treatments. For more information on their groundbreaking products, visit enVVeno.com.
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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