enVVeno Medical (US:NVNO)2025-10-30 20:06Product Development - enVVeno Medical Corporation is focused on developing innovative bioprosthetic solutions for Chronic Venous Disease (CVD), which affects approximately 70% of the adult population in the U.S.[43] - The lead product, VenoValve, is currently in post-enrollment follow-up of its U.S. pivotal study, with full enrollment of 75 patients achieved on September 1, 2023[53] - The VenoValve has been granted Breakthrough Device designation by the FDA, and the company estimates that 2.5 million people in the U.S. with severe deep venous CVD could be candidates for this device[52] - The VenoValve aims to reduce venous hypertension and improve symptoms of severe deep venous CVD, including the potential to heal recurring venous leg ulcers[52] - The company is also developing a second product, enVVe, a non-surgical replacement venous valve, currently in pre-clinical testing[44] - The Company expects to file the IDE application for enVVe in the first quarter of 2026, pending resolution of regulatory issues with the VenoValve[65] Clinical Study Results - In the pivotal study, 85% of patients experienced a clinically meaningful benefit, with an average improvement of 7.91 points in the revised Venous Clinical Severity Score (rVCSS) at one year[55] Financial Performance - The Company reported net losses of $4.5 million for the three months ended September 30, 2025, a decrease of 20% from a net loss of $5.6 million in the same period of 2024[71] - The Company reported net losses of $15.7 million for the nine months ended September 30, 2025, compared to $15.6 million in the same period of 2024, representing a slight increase of 1%[77] - Research and development expenses decreased by 10% to $2.6 million for the three months ended September 30, 2025, down from $2.9 million in 2024, primarily due to lower costs related to the VenoValve pivotal study[73] - Selling, general and administrative expenses decreased by 31% to $2.3 million for the three months ended September 30, 2025, compared to $3.3 million in 2024[75] - Other income decreased by 35% to $0.3 million for the three months ended September 30, 2025, down from $0.5 million in 2024[76] - The Company finished 2024 with approximately $43.2 million in cash and investments, which decreased to approximately $31.0 million as of September 30, 2025[66] - The Company anticipates an increase in cash burn rate from approximately $4 million per quarter to between $5 million and $7 million per quarter as clinical trials progress[86] - The Company has sufficient capital resources to meet obligations for at least one year after the date of the Quarterly Report[87] Regulatory Matters - The company submitted the final module of its PMA application for the VenoValve to the FDA on November 19, 2024[56] - On August 19, 2025, the company received a not-approvable letter from the FDA regarding the VenoValve PMA application, citing insufficient data to determine the benefit-risk profile[58] - The company filed a request for supervisory appeal of the not-approvable letter on September 18, 2025, with a decision expected by the end of 2025[59] - The Company received a Nasdaq deficiency letter on October 7, 2025, due to the closing bid price of its common stock falling below $1.00 per share for 30 consecutive business days[67] Market Context - The average annual cost for a patient seeking treatment for a venous ulcer is approximately $30,000, with total direct medical costs exceeding $20 billion annually in the U.S.[51]