enVVeno Medical posts Q2 2026 results, gets FDA nod for venous valve trial

enVVeno Medical Corporation (NASDAQ: NVNO) reported its second quarter 2026 financial results and disclosed that it received U.S. Food and Drug Administration Investigational Device Exemption (IDE) approval to begin a pivotal trial for its enVVe System, a minimally invasive replacement venous valve designed for patients with severe deep chronic venous insufficiency.

The company recorded a net loss of $3.6 million, or $5.37 per basic and diluted share, for the quarter ended June 30, 2026, compared to a net loss of $6.7 million, or $11.52 per basic and diluted share, for the same period in 2025.

As of June 30, 2026, enVVeno Medical held approximately $21.5 million in total cash and investments, consisting of $2.8 million in cash and cash equivalents and $18.7 million in short-term investments. The company reported a quarterly cash burn of $3.4 million and projects cash burn will rise to between $4 million and $5 million per quarter in the second half of 2026 as the TAVVE pivotal study begins enrolling patients. Management believes current funds will support operations into the third quarter of 2027.

The TAVVE pivotal study is expected to begin enrolling patients during the second half of 2026, with a planned enrollment of approximately 230 patients across up to 40 U.S. clinical sites.

"As we enter the second half of 2026, our focus is squarely on executing the TAVVE pivotal study, getting our clinical sites up and running, and treating the first patients," said Rob Berman, Chief Executive Officer of enVVeno Medical.

The company also reported the addition of a new U.S. patent covering key components of the enVVe System during the quarter.

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