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Womed Leaf, US’s First-in-Class degradable film for treating intrauterine adhesion received approval by FDA, Tigermed-Jyton CRO service made great contribution

On September 16, Womed Leaf, the first medical device in the United States for treating moderate to severe intrauterine adhesions (also known as Asherman's syndrome), received marketing approval from the U.S. Food and Drug Administration (FDA) . The emergence of this product marks a breakthrough advancement in the field of intrauterine adhesion treatment. Notably, Womed Leaf adopted a 'dual-submission’ strategy to China and the U.S. authorities. Tigermed-Jyton served as the clinical CRO partner in the China region, and successfully passed the FDA inspection.

(Image source: Womed official website)

Breaking Clinical Gaps: Womed Leaf Brings New Hope for Women's Health

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 for pregnant.

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.

(Image source: Womed official website)

Proven Service Quality: Tigermed-Jyton Safeguards Product Approval

Womed Leaf adopted a "dual-submission’ strategy to China and the U.S. authorities, which means the product needs to meet the stringent requirements of both the China National Medical Products Administration (NMPA)  and the U.S. Food and Drug Administration (FDA), making it an extremely complex and rigorous project. As the clinical CRO partner for this project in China, Tigermed-Jyton provided comprehensive support for the clinical trial process in China. Leveraged its deep understanding of both Chinese and global regulations, rich experience in medical device projects, and outstanding trial execution capabilities, the Tigermed-Jyton team delivered high-quality services to Womed Leaf, ensured clinical trial data are scientific, genuine, and reliable, thus laid a solid foundation for the product to pass the strict inspection of the FDA.

The FDA approval is not only based on the comprehensive submission materials but also relies on its rigorous inspection of clinical research data and quality management systems. The successful pass of the FDA inspection by Womed Leaf represents international recognition of the product's safety and efficacy, and is also a high-level affirmation of Tigermed-Jyton 's clinical research service quality, data integrity, and compliance management capabilities.

References:

US FDA Approves First Medical Device For Women With Asherman Syndrome

https://www.businesswire.com/news/home/20250916577037/en/US-FDA-Approves-First-Medical-Device-For-Women-With-Asherman-Syndrome

Source: Some images and text are from the Womed LinkedIn website

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.