Strategic alliance for rare diseases: RHEACELL and AOP Health enter into strategic partnership to commercialize novel somatic cell therapies in Europe

• RHEACELL, a biopharmaceutical company specializing in the development of somatic cell therapies, and AOP Health Group, a pioneer in integrated therapeutic solutions for rare diseases, have entered into a strategic partnership.
• The partnership agreement covers the products EBESANAR® (systemic allogeneic ABCB5+ mesenchymal stem cells for treatment of the rare disease epidermolysis bullosa) and AMESANAR® (topical allogeneic ABCB5+ mesenchymal stem cells for treatment of chronic venous ulcer (CVU) disease).
• AOP Health receives the commercialization rights for EBESANAR® and AMESANAR® in Europe, Turkey, Israel and the MENA region (Middle East and Northern Africa).
• RHEACELL retains full commercialization rights to EBESANAR® and AMESANAR® in the US and other major markets.
• Promising Phase 3 clinical trial for EBESANAR® remains on track with planned submission of European marketing authorization application in Q1 2026.

Heidelberg/Germany, May 27, 2025. RHEACELL announced today that it has entered into an exclusive partnership agreement with the AOP Health Group, who will commercialize RHEACELL’s two stem cell products, EBESANAR® and AMESANAR®, in Europe, Turkey, Israel and the MENA region (Middle East and Northern Africa). RHEACELL retains full commercialization rights to EBESANAR® and AMESANAR® in other major markets, including North America, Asia-Pacific and Latin America, and will seek strategic distribution partners in those markets.

Innovative portfolio in late-stage development RHEACELL’s somatic cell therapeutics are at an advanced stage of clinical development and are seen as a beacon of hope for patients with non-healing venous wounds (chronic venous ulcers) and the rare pediatric disease – Epidermolysis bullosa (“butterfly disease”). RHEACELL will continue to be responsible for the clinical phase 3 trials study program for EBESANAR® and AMESANAR®. Initial topline data from the EBESANAR® Phase 3 trial is expected by the end of 2025. The AMESANAR® Phase 3 clinical trial in chronic venous ulcer disease is also progressing according to plan and is expected to be completed in 2026.

Following expected marketing approval in Europe, AOP Health will take the lead in all commercialization and sales activities in the agreed regions, in addition to overseeing medical and regulatory responsibilities. This reflects AOP Health’s strong track record of successfully bringing integrated therapies to market across Europe. RHEACELL will retain manufacturing rights and produce both therapies at its state-of-the-art facility in Heidelberg. United by a shared commitment, both companies are working toward a clear goal: making advanced therapeutic solutions available to patients with high unmet medical needs as swiftly as possible. The financial terms of the agreement remain confidential.

“This partnership marks a significant milestone for RHEACELL and the further development of our cell therapy programs. Working with such an established partner as AOP Health to commercialize our cell therapeutics will enable us to bring our innovative therapies faster and more efficiently to the markets across Europe,” said Dr. Christoph Ganss, MD, CEO of RHEACELL.

“Our mission is to provide patients with rare diseases access to urgently needed therapeutic innovation. This partnership with stem cell pioneer RHEACELL enables us to jointly bring new treatment options to patients living with Epidermolysis bullosa or chronic venous ulcers, who currently have limited or no treatment options. Our teams are fully committed to making these groundbreaking treatments available to all patients affected, ” said Dr. Martin Steinhart, CEO of AOP Health.