Made Scientific and Regenicin Announce Manufacturing Relationship to Advance NovaDerm Toward FDA Product Approval

Made Scientific to support clinical manufacturing of NovaDerm, an autologous cultured skin substitute for the treatment of severe burns and chronic wounds

PRINCETON, N.J., April 22, 2026 /PRNewswire/ -- Made Scientific, Inc., a U.S.-based cell therapy contract development and manufacturing organization (CDMO), and Regenicin, Inc., a biotechnology company specializing in the development and commercialization of regenerative cell therapies to restore the health of damaged tissues and organs, today announced a manufacturing relationship to advance NovaDerm, an autologous cultured skin substitute for severe burns and chronic wounds, toward a U.S. FDA Orphan product approval.

Under the agreement, Made Scientific will serve as the manufacturing partner for NovaDerm, providing end-to-end services at its Princeton, New Jersey GMP facility. The program establishes a clear pathway from technology transfer through GMP clinical production and regulatory support of Regenicin's Investigational New Drug (IND) submission and upcoming clinical trial.

"We are proud to work with Regenicin to advance NovaDerm into the clinic," said Syed T. Husain, Chairman and CEO of Made Scientific. "This collaboration reflects the strength of our manufacturing platform and our ability to execute complex autologous programs with the precision and regulatory rigor required for clinical success."

"Manufacturing a patient-specific treatment like NovaDerm requires a level of consistency and traceability that few CDMOs can deliver. Made Scientific's proven expertise in autologous manufacturing gives us confidence as we move toward our IND submission and first-in-human clinical trial," said Dr. K. E. Castro, PhD, Director of Clinical Studies at Regenicin.

With industry-leading development and manufacturing capabilities and continued investment in state-of-the art infrastructure and technology, Made Scientific remains focused on its mission to defy limits and deliver results.

About Made Scientific

Made Scientific is a U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, Made Scientific combines the agility of a specialist CDMO with the deep technical expertise to deliver reliable and scalable solutions, supported by their long-term strategic backer, GC Corporation, a global leader in the pharmaceutical and biotechnology sectors.  For more information, visit madescientific.com.

About Regenicin

Regenicin, Inc. (www.Regenicin.com) is a biotechnology company dedicated to advancing regenerative cell therapies to repair and restore damaged tissues and organs. Founded in 2010, Regenicin has built a world-class management team with a strong track record in developing and commercializing innovative medical devices and biotechnology products. The company is focused on bringing NovaDerm^®—a breakthrough autologous cultured skin substitute—to market. NovaDerm^® is a tissue-engineered skin graft that utilizes a patient's own skin cells to create living, regenerative skin for treating severe burns and chronic wounds, while requiring less tissue harvesting and reducing days of hospitalization for patients.

Media Contacts

Made Scientific

[email protected] | LinkedIn: @MadeScientific

Regenicin

[email protected] | LinkedIn: @Regenicin

SOURCE Made Scientific, Inc.