enVVeno Medical Corporation
0.7188+0.00 (+0.67%)
Oct 29, 4:00:01 PM EDT · NasdaqCM · NVNO · USD
Key Stats
Market Cap
13.83MP/E (TTM)
-Basic EPS (TTM)
-1.20Dividend Yield
0%Recent Filings
8-K
Nasdaq delisting warning issued
enVVeno Medical Corporation received a Nasdaq notice on October 7, 2025, for failing to meet the $1.00 minimum bid price over 30 consecutive days, risking delisting from the Capital Market. The company has 180 days until April 6, 2026, to push its stock above $1.00 for 10 straight trading days and regain compliance. No immediate impact hits the listing. Yet a reverse stock split looms if prices stay low.
8-K
FDA rejects VenoValve approval
enVVeno Medical received a not approvable letter from the FDA on August 20, 2025, for its Premarket Approval application of the VenoValve, a surgical replacement valve for severe deep chronic venous insufficiency. The agency cited insufficient hemodynamic data to confirm clinical benefits from the SAVVE study and safety issues tied to the open procedure, like re-hospitalizations. The company plans to review options for resubmission or appeal. This setback delays U.S. market entry for the device.
10-Q
Q2 FY2025 results
enVVeno Medical posted a Q2 net loss of $6.7 million, up 35% year-over-year from $5.0 million, driven by a $1.6 million spike in selling, general, and administrative expenses to $4.2 million amid higher stock-based compensation, severance, and a $0.6 million reserve for uncollectible clinical costs, while research and development held steady at $2.9 million. For the first half, the net loss widened 13% to $11.2 million, with operating cash use climbing to $7.7 million from $7.5 million. Cash and equivalents stood at $2.0 million, bolstered by $35.1 million in total liquidity and no debt, funding operations through mid-2026. The VenoValve PMA awaits FDA decision in H2 2025, with two-year data showing 83% clinical benefit. Cash burn is rising. Regulatory approval delays pose the main risk.
8-K
CFO Appointment at enVVeno
enVVeno Medical Corporation appointed Jennifer Bright as Chief Financial Officer on May 19, 2025, replacing Craig Glynn who resigned without disagreements and will consult for a smooth transition. Bright, a CPA with over 25 years in finance, joins with a $300,000 annual salary, up to 40% bonus, and 350,000 stock options vesting over three years at $3.62 per share. Her employment agreement offers severance up to one year and standard protections. This leadership shift bolsters financial expertise amid ongoing operations.
10-Q
Q1 FY2025 results
enVVeno Medical narrowed its Q1 FY2025 net loss to $4.5 million from $5.0 million a year earlier, a 10% improvement driven by 19% lower research and development expenses at $2.6 million, mainly from reduced VenoValve pivotal study follow-up costs, while selling, general, and administrative expenses dipped 4% to $2.4 million amid lower stock-based compensation. Operating loss eased to $4.9 million from $5.5 million year-over-year, with the net figure reflecting a $0.1 million drop in other income from investments to $0.5 million. Cash burn from operations rose slightly to $4.0 million quarter-over-quarter, yet the company ended with $2.9 million in cash equivalents and $36.0 million in short-term investments, bolstering $37.8 million in working capital sufficient for at least a year. No revenue yet, as the firm advances its FDA PMA for the VenoValve—submitted November 2024 with a decision eyed in H2 2025—and preps enVVe for IDE filing in Q3 2025. Losses persist without commercialization. Regulatory approval remains uncertain.
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