FDA approves Womed's first device for Asherman syndrome offering new hope in reproductive surgery
French medtech company Womed
The U.S. Food and Drug Administration has approved Womed Leaf, the first device in the U.S. specifically indicated for Asherman syndrome - a condition marked by uterine scar tissue that can lead to infertility and pregnancy loss.
The approval for the French medtech company Womed has been granted under the FDA’s most stringent premarket approval (PMA) pathway.
"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, MD at Audubon Fertility and Ochsner Health System, New Orleans, LA, who has treated over five hundred Asherman patients.
"This is the first FDA approved barrier for these patients and marks a significant improvement for their ultimate desired outcome."
Breaking the pattern of uterine adhesions
Asherman syndrome arises when scar tissue forms inside the uterus, often after miscarriage management, cesarean birth, or uterine surgery. Adhesions can cause infertility, recurrent pregnancy loss, or severe menstrual pain.
The standard treatment - hysteroscopic adhesiolysis - removes scar tissue but often sees adhesions reform in as many as 60–70% of severe cases. That cycle of surgery and recurrence has left clinicians with limited tools to break the pattern.
Womed Leaf is a biodegradable barrier film, delivered intrauterinely via a slim applicator in a process resembling an IUD insertion. Once in place, the leaf-shaped device expands to keep the uterine walls from fusing again as they heal.
Unlike reusable barriers like balloons or off-label IUDs, the Leaf is self-expelling: it naturally degrades and is discharged within about a week. That reduces the need for removal procedures and, according to trial data, may lower patient burden.
Significant reduction
The FDA approval follows Womed’s PREG2 pivotal randomized controlled trial, which enrolled 160 women with moderate-to-severe adhesions across multiple centers. According to Womed, the trial showed a significant reduction in adhesion severity compared with surgery alone, with what the FDA deemed an acceptable safety profile.
The PMA designation from the FDA requires robust clinical evidence and is typically reserved for high-risk devices. It also requires a post-approval study - details of which are still emerging. That study will be important for assessing whether adhesion reduction translates into improved fertility and live birth outcomes, the metrics that matter most to patients.
“The meticulous review and inspections performed by the FDA for the PMA are a clear testimony of the rigorous and world-class work that has been accomplished by our team, and makes Womed Leaf the new standard for Asherman syndrome treatment worldwide,” said Gonzague Issenmann, co-founder and CEO of Womed®.
“We are thrilled to help American women in their fight against infertility when Womed Leaf® becomes available in early 2026."
Beyond adhesions, Womed is also positioning its intrauterine delivery platform for broader indications, including fibroids, endometriosis, and acute uterine bleeding.