PRINCETON, NJ — January 7, 2026 — Leads & Copy — Cytora Therapeutics Ltd., Made Scientific, Inc., and Zeo ScientifiX, Inc. have formed a strategic partnership to advance and commercialize Cytora’s allogeneic, off-the-shelf, human oral mucosal stem cell therapy in the United States.
The collaboration will focus on commercializing Cytora’s therapeutic through avenues created by Florida’s stem cell law, which permits the use of non-FDA-approved stem cell therapies compliant with the new regulations for treating wound care, pain, and orthopedic conditions. Simultaneously, the partnership will begin U.S. FDA Phase 2b clinical trials for the therapeutic, aiming for FDA approval.
Under the agreement, Cytora will provide manufacturing rights for its product while continuing clinical and regulatory development. Made Scientific will be the exclusive U.S. manufacturing partner, handling GMP manufacture and quality control release testing of starting tissue-derived cell banks and the final drug product from its facility in Princeton, New Jersey. Zeo will serve as the exclusive U.S. commercial partner, managing market access, distribution infrastructure, and clinical site management.
The partnership will initially pursue commercialization under Florida’s Senate Bill 1768, which allows commercialization of adult allogeneic stem cell therapies for wound care, pain, and orthopedic conditions. Diabetic foot ulcers (DFUs) will be the primary focus, offering a treatment option for an estimated 125,000 new patients annually in Florida. The collaboration intends to expand into additional wound, orthopedic, and pain management indications, representing over 3.6 million annual cases in the state. The partnership will also support a U.S. FDA IND pathway for a Phase 2b clinical trial and future international regulatory submissions.
Cytora’s technology is based on allogeneic human oral mucosal stem cells (hOMSCs), which have shown regenerative potential in Phase 1/2a clinical data. These stem cells can be collected through minimally invasive procedures and exhibit characteristics favorable for tissue regeneration and wound healing.
Yona Geffen, Ph.D., CEO of Cytora Therapeutics, stated that the partnership is a milestone for Cytora, advancing its products toward the market for U.S. patients. Syed T. Husain, Chairman and CEO of Made Scientific, said the partnership exemplifies Made’s commitment to supporting innovative cell therapies. Ian Bothwell, CEO and CFO of Zeo ScientifiX, noted that the partnership allows Zeo to bring a differentiated allogeneic stem cell therapy to physicians and patients.
In a Phase 1/2a randomized, placebo-controlled clinical trial, Cytora’s hOMSC200 demonstrated a favorable safety profile, with statistically significant superiority over placebo in wound surface area reduction. Complete wound closure was achieved in diabetic patients whose ulcers had been open for an average of 27 months.
Contacts:
Made Scientific, Inc.
Lucy Taylor
Head of Marketing
media@madescientific.com
Cytora Therapeutics Ltd.
Tsipi Haitovsky
Global Media Liaison
Tsipihai5@gmail.com
Zeo ScientifiX, Inc.
Jacqueline Domenech
1-888-963-7881
IR@zeoscientifix.com
Source: ZEO ScientifiX, Inc.
