VenoValve trial shows sustained patient benefits at 24 months

IRVINE, CA - enVVeno Medical (TASE:PMCN) Corporation (NASDAQ:NVNO), a medical device company with a market capitalization of $54.5 million, reported interim two-year follow-up data from its pivotal trial of the VenoValve, indicating sustained clinical improvement and patient benefit. According to InvestingPro analysis, the company maintains a "Fair" overall financial health score, with particularly strong liquidity metrics. The data, presented at the Vascular and Endovascular Surgery Society (VESS) 2025 Annual Winter Meeting, showed that 78% of subjects maintained a clinically meaningful benefit, with an average improvement of 8.2 points in the revised Venous Clinical Severity Score (rVCSS) among the responder cohort.

Patients continued to experience a median 75% reduction in pain at 24 months, and improvements were sustained across all venous specific quality-of-life indicators. The device also demonstrated a 100% patency rate among subjects with core lab-evaluable data at 24 months.

The VenoValve is being developed as a surgical replacement venous valve for the treatment of deep venous Chronic Venous Insufficiency (CVI), a debilitating disease that can lead to severe symptoms and high healthcare costs. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. InvestingPro data shows the company holds more cash than debt on its balance sheet, with a current ratio of 22.01, indicating strong short-term financial stability despite ongoing R&D investments.

enVVeno Medical submitted a pre-market authorization (PMA) application for the VenoValve to the U.S. Food and Drug Administration (FDA) in November 2024, with a decision expected in the second half of 2025. The FDA has previously indicated that an improvement of 3 or more points in rVCSS would be evidence of the VenoValve’s clinical benefit.

The company’s CEO, Robert Berman, stated that the positive data support the safety and effectiveness of the VenoValve and the SAVVE procedure, with plans to continue presenting new data at medical conferences to raise awareness. With the next earnings report scheduled for February 27, 2025, investors following this development can access additional insights and 6 more exclusive ProTips through InvestingPro, including detailed analysis of the company’s cash burn rate and profitability outlook.

This news is based on a press release statement from enVVeno Medical Corporation.

In other recent news, enVVeno Medical Corporation has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the VenoValve, a device aimed at treating Chronic Venous Insufficiency (CVI). The FDA has already approved four out of five modules of the PMA application, with the final module, containing clinical data and proposed device labeling, currently under review. Notably, the VenoValve has been designated as a breakthrough device, granting it priority review status.

In addition to the VenoValve, enVVeno is developing a non-surgical transcatheter-based replacement venous valve, enVVe, expected to enter a pivotal trial by mid-2025. The company’s CEO, Robert Berman, has expressed optimism regarding the final phase of the PMA review process, with a decision potentially arriving in the second half of 2025.

These developments are part of enVVeno’s ongoing efforts to advance bioprosthetic solutions for venous disease treatment. The VenoValve, the company’s lead product, is currently under evaluation in the SAVVE U.S. pivotal study. These are recent developments in the company’s operations.

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