FDA Approves First Medical Device For Women With Asherman Syndrome

Womed has secured U.S. Food and Drug Administration (FDA) PreMarket Approval (PMA) to sell the first medical device to treat Asherman syndrome.

The Womed Leaf is designed for adult women undergoing hysteroscopic surgery to treat symptomatic moderate to severe intrauterine adhesions, also referred to as Asherman syndrome. Intrauterine Adhesions (IUAs), which refer to the pathological binding of the uterine walls, are caused by uterine scarring after procedures such as dilation and curettage or fibroid removal, and can occur in 20% to 45% of those procedures. IUAs are a major cause of infertility, recurrent miscarriages, and pain. IUA treatment is plagued with a very high recurrence rate, leaving women unsure and very anxious about their chance to conceive.

“The meticulous review and inspections performed by the FDA for the PMA are a clear testimony of the rigorous and work that has been accomplished by our team, and makes Womed Leaf the new standard for Asherman syndrome treatment worldwide,” Womed Co-Founder/CEO Gonzague Issenmann stated. “We are thrilled to help American women in their fight against infertility when Womed Leaf becomes available in early 2026.”

Womed Leaf is intended to reduce the reoccurrence and severity of post-surgical adhesion formation inside the uterus. It consists of a soft thin film made from Womed’s innovative polymer, which is inserted like an IUD at the end of an adhesiolysis procedure. It expands within the cavity, preventing contact between the uterine walls, and is then naturally and painlessly discharged. The PREG2 randomized clinical study, which enrolled 160 patients with severe or moderate IUA, demonstrated that Womed Leaf significantly reduced intrauterine adhesion severity after hysteroscopic adhesiolysis compared with no prevention method and that Womed Leaf has an acceptable safety profile.

“Asherman syndrome is a condition that prevents tens of thousands of women in the United States from becoming pregnant due to scar tissue in the uterine cavity. When the adhesions are surgically removed, they often return due to the approximation of the uterine walls, which Womed Leaf will prevent during the healing phase,” said Dr. Keith Isaacson, M.D. at Audubon Fertility and Ochsner Health System, New Orleans, who has treated more than 500 Asherman patients. “This is the first FDA approved barrier for these patients and marks a significant improvement for their ultimate desired outcome.”

Womed is a uterine health company developing products based on its disruptive, proprietary, polymer technology platform, designed for intrauterine implantation and local active ingredient administration. Its first product, Womed Leaf, is a drug-free medical device designed to treat and prevent uterine wall bonding, which occurs in particular in one in five women treated for miscarriage. Womed’s pipeline of intrauterine drug delivery products include intended treatments for fibroids, endometriosis and acute uterine bleeding.