FDA approved Womed's Leaf resorbable adhesion barrier on September 9, according to the agency's PMA database. The Montpellier company announced the decision on September 16. P240015 covers adult women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions, also known as Asherman syndrome. No device had been approved for that indication in the United States before.
The Leaf is a thin polymer film inserted after adhesiolysis, much like an IUD. It unfolds to keep the uterine walls apart while they heal, then resorbs and passes on its own. Support came from PREG2, a 160-patient trial in which the film cut adhesion severity compared with no barrier. Product code MCN.
FDA logged the PMA on May 10, 2024, so the review ran 487 days. Womed was founded in 2018 by Gonzague Issenmann, Xavier Garric and Stéphanie Huberlant and has held a CE mark since 2021. It raised a 6 million euro Series A in 2023 from family offices, business angels and IRDI Capital Investissement. US availability is planned for early 2026. A 160-patient trial and a 16-month review is a lean path to a first-of-kind Class III approval. Four years of European use under the CE mark did much of the work.