Clinical TrialMay 6, 2026, 04:19 PM
enVVeno Medical Gets FDA IDE Approval for enVVe System Study
AI Summary
enVVeno Medical received FDA IDE approval for its enVVe System, a non-surgical venous valve, allowing it to commence the TAVVE pivotal study for severe deep CVI patients. For Q1 2026, the company reported a net loss of $3.8 million, an improvement from $4.5 million in Q1 2025, driven by reduced operating expenses. With $24.9 million in cash and investments, management expects to fund operations into Q3 2027, despite an anticipated increase in cash burn.
Key Highlights
- FDA IDE approval received for enVVe System TAVVE pivotal study on April 29, 2026.
- Net loss decreased 15% to $3.8 million in Q1 2026 from $4.5 million in Q1 2025.
- Research and development expenses decreased 17% to $2.1 million in Q1 2026.
- Selling, general and administrative expenses decreased 19% to $2.0 million in Q1 2026.
- Cash and investments totaled $24.9 million as of March 31, 2026.
- Management expects current capital to fund operations into Q3 2027.
- Completed a 1:35 reverse stock split effective January 20, 2026.
- Raised $0.1 million in April 2026 via at-the-market equity offering.