The FDA has approved Womed Leaf, the first medical device specifically designed to treat women with Asherman syndrome in the United States. The resorbable adhesion barrier received PreMarket Approval for women with moderate to severe intrauterine adhesions, a major cause of female infertility.
Intrauterine adhesions occur when scarring causes pathological binding of uterine walls, typically resulting from procedures such as dilation and curettage or fibroid removal. These adhesions affect 20% to 45% of patients who undergo these treatments and represent a significant cause of infertility, recurrent miscarriages, and pelvic pain.
“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,” said Dr. Keith Isaacson at Audubon Fertility and Ochsner Health System. “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.”
Womed Leaf consists of a soft, thin film made from the company’s proprietary polymer technology. The device is inserted like an IUD following adhesiolysis procedures, expanding within the uterine cavity to prevent contact between uterine walls before being naturally discharged from the body.
The approval was based on results from the PREG2 randomized clinical study, which enrolled 160 patients with severe or moderate intrauterine adhesions. The trial demonstrated that Womed Leaf significantly reduced adhesion severity compared to no prevention method while maintaining an acceptable safety profile.
“This is the first FDA approved barrier for these patients and marks a significant improvement for their ultimate desired outcome,” Isaacson noted.
“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.
Womed Leaf is expected to become available in early 2026. The Montpellier-based company’s pipeline includes treatments for fibroids, endometriosis, and acute uterine bleeding.
