Womed Reports the US FDA’s Approval of Womed Leaf to Treat Asherman Syndrome

Womed Reports the US FDA’s Approval of Womed Leaf to Treat Asherman Syndrome


Shots:

  • The US FDA has approved the PMA application of Womed Leaf for women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions (Asherman syndrome); commercial launch expected in early 2026
  • Womed Leaf was evaluated in the PREG2 trial (n=160) for mod. to sev. intrauterine adhesions, showing reduced severity of intrauterine adhesion after hysteroscopic adhesiolysis compared to no prevention method, with favorable safety
  • Womed Leaf is made from Womed’s novel polymer, inserted post-uterine procedure to prevent uterine wall adhesion by expanding before natural discharge

Ref: Businesswire | Image: Womed | Press Release

Related News:- Womed Collaborates with Kebomed Europe & Saesco Medical to Launch Womed Leaf in Europe

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