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IRVINE - enVVeno Medical Corporation (NASDAQ:NVNO) announced Thursday that the U.S. Food and Drug Administration has upheld its earlier decision rejecting the company's Premarket Approval application for VenoValve, a surgical replacement venous valve for treating severe deep chronic venous insufficiency. The news adds pressure to the micro-cap company, which currently has a market capitalization of just $12.96 million.
The FDA maintained its position that the VenoValve did not meet the standard of reasonable assurance of safety and effectiveness, according to the company's press release statement.
Following the unfavorable decision, enVVeno indicated it would shift focus to its next-generation product, enVVe, a transcatheter-based replacement venous valve that the company says is ready for human testing.
"Although the appeal decision was not the result we are looking for, it did provide valuable insight into the criteria that would be necessary for approval of enVVe," said Robert Berman, enVVeno Medical's Chief Executive Officer.According to InvestingPro, NVNO stock generally trades with high price volatility, which investors should consider when evaluating the company's prospects. InvestingPro offers 10 additional insights that could help investors navigate this development.
The company reported $31.5 million in cash and investments at the end of the third quarter with a quarterly cash burn of $4 to $5 million, which it states provides sufficient funding to operate into 2027. InvestingPro data confirms that enVVeno holds more cash than debt on its balance sheet, with a strong current ratio of 13.12, though the company is quickly burning through its reserves while remaining unprofitable over the last twelve months.
Severe deep venous Chronic Venous Insufficiency affects approximately 2.5 million to 3.5 million patients in the U.S., including about 1.5 million who develop venous leg ulcers. Currently, there are no effective treatments for the condition when caused by valvular incompetence in the deep vein system.
enVVeno Medical, based in Irvine, California, focuses on developing bioprosthetic solutions for the treatment of deep venous disease.
In other recent news, enVVeno Medical Corporation announced it has received a notice from The Nasdaq Stock Market LLC for not complying with the minimum bid price requirement. The company's stock price has been below $1.00 per share for 30 consecutive business days, failing to meet the Nasdaq Listing Rule 5550(a)(2). In addition, enVVeno Medical is planning to appeal a not-approvable letter from the U.S. Food and Drug Administration concerning its VenoValve device. The FDA's decision was based on insufficient clinical improvement data to establish a favorable benefit-risk profile for the device. The company intends to file a supervisory appeal by the September 18 deadline to challenge this decision. The VenoValve is designed to treat severe deep chronic venous insufficiency. These developments represent significant challenges for enVVeno Medical as it navigates regulatory and market compliance issues.
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