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enVVeno Medical receives FDA IDE for pivotal TAVVE study

enVVeno Medical has received an Investigational Device Exemption (IDE) from the FDA for an approval‑enabling study of the transcatheter enVVe venous valve system; the TAVVE study is slated to begin in H2 2026 with about 230 patients at up to 40 U.S. sites. In the second quarter the company reported a net loss of USD 3.6 million (USD 5.37 per share) versus USD 6.7 million a year earlier and ended the quarter with cash and investments of approximately USD 21.5 million. enVVeno expects quarterly cash burn to rise to USD 4–5 million in the second half of 2026; current capital is projected to extend into Q3 2027. The company also expanded its U.S. patent portfolio with a new patent covering components of the enVVe system. » Plus sur de.investing.com
enVVeno Medical reports quarterly loss of $5.76 per share

enVVeno Medical released figures for the quarter ended 31 December 2025 and reported a loss per share of $5.76 (prior-year quarter: -$10.50). For the fiscal year a loss per share of $33.06 was reported, after -$44.45 in the prior year. The announcement contains no further operational details. » Plus sur finanzen.net

Au dernier trimestre, enVVeno Medical a réalisé un chiffre d'affaires de 0 € et un bénéfice net de -3,15 M €