US FDA Approves First Medical Device For Women With Asherman Syndrome

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MONTPELLIER, France--(BUSINESS WIRE)--Sep 16, 2025--

Womed ®, the uterine health company developing innovative intrauterine treatments to free women from uterine pathologies, today announced that the Food and Drug Administration approved the PreMarket Approval (PMA) application of the Womed Leaf ® for adult women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions, also referred to as Asherman syndrome. Womed Leaf ® is the first medical device to be approved for sale in the United States for that indication.

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Intrauterine Adhesions (IUAs), which refer to the pathological binding of the uterine walls, are caused by scarring of the uterus 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.

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 pivotal PREG2 randomized clinical study that enrolled 160 patients with severe or moderate IUA demonstrated that Womed Leaf ® significantly reduced the severity of intrauterine adhesion 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, 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."

“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."

About WOMED ®
Womed ® is the 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 the bonding of uterine walls, 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.
www.womedtech.com

View source version on businesswire.com:https://www.businesswire.com/news/home/20250916577037/en/

CONTACT: Press contact:

Gonzague Issenmann, CEO, Womed

[email protected]

KEYWORD: EUROPE UNITED STATES NORTH AMERICA FRANCE

INDUSTRY KEYWORD: SURGERY MEDICAL DEVICES MEDICAL SUPPLIES WOMEN FDA CLINICAL TRIALS HEALTH CONSUMER GENERAL HEALTH

SOURCE: Womed

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PUB: 09/16/2025 03:34 AM/DISC: 09/16/2025 03:33 AM

http://www.businesswire.com/news/home/20250916577037/en