OEM News

KARL STORZ, Womed Team Up for Womed Leaf Distribution in the U.S.

Collaboration gives gynecologists the first FDA-approved option for addressing post-surgical intrauterine adhesions.

KARL STORZ and Womed SAS have set up a strategic distribution partnership under which the former will serve as the exclusive U.S. distributor of Womed Leaf, a product approved by the U.S. Food and Drug Administration for treating women with intrauterine adhesions, also known as Asherman syndrome.

“Intrauterine adhesions represent a significant clinical challenge in gynecologic surgery, particularly for women facing infertility and recurrent procedures,” stated Michael Hendershot, vice president of Sales and Marketing, Urology, and Gynecology at KARL STORZ United States. “By partnering with Womed, we are bringing a clinically validated, patient-centered solution to the U.S. market while further strengthening our comprehensive hysteroscopy portfolio serving our clinicians and patients.”

The Womed Leaf resorbable adhesion barrier reduces the recurrence and severity of post-surgical adhesion formation inside the uterus after hysteroscopic adhesiolysis. The resorbable polymer film acts as a temporary physical barrier within the uterine cavity, naturally degrading and painlessly discharged without the need for removal. Its simple, IUD-like placement supports ease of use across hospitals, ambulatory surgical settings, and offices with minimal training. Clinical studies have demonstrated the product’s safety, tolerability, and effectiveness in reducing the severity of intrauterine adhesion after hysteroscopic adhesiolysis compared with no prevention method.*

“This partnership with KARL STORZ in the United States marks a major milestone for Womed and the global availability of Womed Leaf,” Womed CEO Gonzague Issenmann said. “KARL STORZ’s clinical expertise, customer relationships, and leadership in hysteroscopic technology make them the ideal partner to expand access to Womed Leaf and improve outcomes for women affected by intrauterine adhesions.”

The addition of Womed Leaf complements KARL STORZ’s full suite of diagnostic and operative hysteroscopy solutions, reinforcing the company’s commitment to delivering clinically meaningful innovations that address real unmet needs, bigwigs claim.

KARL STORZ considers itself a global leader in endoscopic technology, providing visualization and surgical solutions across a wide range of medical specialties. With a strong commitment to education, clinical collaboration, and patient outcomes, KARL STORZ aims to advance minimally invasive surgery worldwide.

Spun out of academic research at the University of Montpellier, France, Womed is a uterine health company developing products based on its proprietary polymer technology platform, which is designed for intrauterine implantation and local active ingredient administration. Its first product, Womed Leaf, is a drug-free medical deviceto treat and prevent uterine wall bonding, which occurs in one in five women treated for miscarriage. Womed’s intrauterine drug delivery products pipeline includes intended treatments for fibroids, endometriosis, and acute uterine bleeding.

* Fertil Steril. 2024;122(6):1124-1133. doi: 10.1016/j.fertnstert.2024.07.020.

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