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NurExone Biologic Inc, a biotechnology company developing exosome-based regenerative therapies, announced that its wholly owned US subsidiary, Exo-Top Inc, together with the company, has signed a binding memorandum of understanding with Made Scientific Inc, (Made Scientific) to establish an exclusive US Good Manufacturing Practice (GMP) manufacturing and commercial exosome supply partnership to support NurExone’s clinical and commercial activities.
The proposed partnership brings together two companies with a shared vision for building scalable US manufacturing infrastructure to support exosome-based therapeutics and commercial exosome products - two rapidly growing markets.
The parties intend to immediately begin the transfer of NurExone technology in parallel with negotiation of a definitive partnership agreement, with a target of initiating first GMP exosome batches in H1 2027.
"Partnering with highly regarded organizations is essential to building world-class manufacturing around novel therapeutic approaches, including exosome-based therapies," said Dr. Lior Shaltiel, chief executive officer of NurExone. "This allows us to focus on what we do best and create shareholder value, while working with specialized partners to support execution. Made Scientific is an ideal strategic partner because of its manufacturing capabilities, operational expertise, and shared long-term vision. Together, we have an opportunity to establish a US manufacturing and commercialization platform to accelerate NurExone’s therapeutic pipeline, including lead candidate ExoPTEN, while creating a foundation for company revenue, commercial growth and leadership in the emerging exosome market.”
Syed T. Husain, chairman and CEO of Made Scientific, commented, "NurExone has developed a differentiated exosome platform with significant clinical and commercial potential. This collaboration combines NurExone's innovative bone marrow-derived exosome platform with Made Scientific's manufacturing and regulatory expertise, creating an integrated pathway to bring exosome-based therapies from development through commercial supply.”
The proposed collaboration builds on NurExone's broader manufacturing strategy, including bioprocess optimization with Novasign GmbH announced on July 30, 2026. Together, these initiatives are intended to strengthen the infrastructure supporting both NurExone’s therapeutic pipeline and future commercial exosome activities, positioning the Company for long-term, sustainable commercial success.
Under the binding MoU, Made Scientific will serve as NurExone's exclusive US partner for the manufacturing and aseptic fill-finish of NurExone’s bone marrow-derived exosomes. The MoU contemplates that the definitive agreement, if executed, will feature an initial term of five years, with options for successive five-year renewals. If the parties do not execute a definitive agreement within six months of MoU execution, the MoU and ongoing obligations, including exclusivity grants, will automatically terminate, subject to specified surviving obligations.
The company also announced that Exo-Top has mutually agreed with Florida-based BioXtek Inc not to proceed with the non-binding Letter of Intent previously announced on April 7, 2026. This decision follows NurExone's strategic pivot to consolidate its US GMP exosome manufacturing infrastructure under the proposed collaboration with Made Scientific. NurExone and BioXtek intend to explore potential collaborative business opportunities outside of direct production in the near future.
Made Scientific is a US-based cell therapy contract development and manufacturing organization which operates a 60,000-square-foot US FDA and EU GMP Annex 1 compliant facility in Princeton, New Jersey.
NurExone is a TSX Venture Exchange, OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve damage. Regulatory milestones, including obtaining the Orphan Drug Designation, support the Company’s roadmap towards clinical trials in the US and Europe. Commercially, the Company intends to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top to anchor its North American activity and growth strategy.
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