- Cytora Therapeutics has entered a strategic partnership with Made Scientific and Zeo ScientifiX to commercialise an allogeneic stem cell therapy in the US.
- The collaboration covers manufacturing, clinical development and commercialisation, with initial focus on wound care indications in Florida.
Cytora Therapeutics Ltd. has announced a comprehensive strategic partnership with Made Scientific and Zeo ScientifiX to advance and commercialise its allogeneic, off-the-shelf human oral mucosal stem cell therapy in the United States. The collaboration brings together clinical development, contract manufacturing and commercial capabilities to support market entry and further clinical progress.
The partnership will initially pursue commercialisation under Florida’s Senate Bill 1768, which permits the use of certain non-FDA-approved stem cell therapies that comply with new state regulations for wound care, pain and orthopaedic conditions. In parallel, the parties plan to commence US FDA Phase 2b clinical trials with the objective of securing an approved FDA licence.
Under the agreement, Cytora will retain responsibility for clinical and regulatory development while granting manufacturing rights. Made Scientific will act as the exclusive US manufacturing partner, providing GMP manufacture and quality control release testing of starting tissue-derived cell banks and final drug product from its Princeton, New Jersey facility. Zeo ScientifiX will serve as the exclusive US commercial partner, supporting market access, distribution infrastructure and clinical site management.
“We are excited to partner with Cytora and Zeo on this transformative collaboration that brings together complementary expertise across technology, manufacturing, and commercialization.”
Syed T. Husain, Chairman and CEO of Made Scientific
Diabetic foot ulcers will be the lead indication under the Florida pathway, with the companies citing an estimated 125,000 new patients annually in the state. The collaboration also plans to expand into additional wound, orthopaedic and pain management indications, while supporting an FDA IND pathway and future international regulatory submissions.
“This strategic partnership represents a major milestone for Cytora as we advance our products toward the market for the benefit of U.S. patients.”
Yona Geffen, Chief Executive Officer of Cytora Therapeutics
