Cytora Therapeutics, Made Scientific, and Zeo ScientifiX Announce Partnership to Manufacture and Commercialize Cytora's Allogeneic Stem Cell Therapy in the United States

Core Perspective - The article discusses a strategic partnership among Cytora Therapeutics, Made Scientific, and Zeo ScientifiX to advance and commercialize an innovative oral mucosal stem cell therapy for non-healing diabetic foot ulcers and other indications in the U.S. market [1][2][3] Group 1: Partnership Objectives - The partnership aims to commercialize Cytora's novel therapeutic under Florida's new stem cell law, allowing non-FDA-approved stem cell therapies for wound care, pain, and orthopedic conditions [2][4] - The collaboration will initiate U.S. FDA Phase 2b clinical trials to obtain FDA approval for the therapy [2][4] Group 2: Roles and Responsibilities - Cytora will manage clinical and regulatory development while granting manufacturing rights for its product [3] - Made Scientific will act as the exclusive U.S. manufacturing partner, handling GMP manufacturing and quality control from its facility in Princeton, New Jersey [3] - Zeo will serve as the exclusive U.S. commercial partner, providing market access, distribution, and clinical site management [3] Group 3: Market Potential - The partnership will initially target diabetic foot ulcers, with an estimated 125,000 new patients annually in Florida, and plans to expand into additional therapeutic areas representing over 3.6 million annual cases [4] - The collaboration supports a U.S. FDA IND pathway for a Phase 2b clinical trial and future international regulatory submissions [4] Group 4: Technology and Clinical Data - Cytora's technology utilizes proprietary allogeneic human oral mucosal stem cells (hOMSCs), which have shown regenerative potential in clinical trials [5][7] - In a completed Phase 1/2a trial, Cytora's hOMSC200 demonstrated a favorable safety profile and significant efficacy in wound healing, achieving complete closure in diabetic patients with chronic ulcers [7]