stk_maniac
2月前
Made Scientific and Regenicin Announce Manufacturing Relationship to Advance NovaDerm Toward FDA Product Approval
Made Scientific, Inc. (PRNewsfoto/Made Scientific, Inc)
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Made Scientific, Inc.
Apr 22, 2026, 09:30 ET
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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
media@madescientific.com | LinkedIn: @MadeScientific
Regenicin
Info@Regenicin.com | LinkedIn: @Regenicin
SOURCE Made Scientific, Inc.
BubbaCheese
5年前
Overview
During the quarter ended, December 31, 2019, the Company continued to position its product, NovaDerm®, to enter clinical trials to gain FDA product approval. Having secured Orphan Drug Designation as a biologic for NovaDerm®, we complied with the FDA annual reporting requirements. In addition, as part of an asset purchase agreement, we granted Amarantus Bioscience Holdings, Inc., a right of first refusal for the purchase of any engineered skin technology designed for treatment of severe burns in humans that we developed. This right of first refusal expired during this quarter on November 7, 2019.
Recently, the risk of introducing pathogens when using materials from animals to produce drugs, devices, and biologics has increased awareness of the safety issues. NovaDerm® and future Regenicin products use animal sourced materials like collagen to produce the life-saving products. We have worked with our collagen supplier and the FDA to ensure we are meeting the expectations for traceability and purity of the FDA for NovaDerm® production. We have arranged for sufficient Bovine Closed Herd corium to produce sufficient collagen scaffolds to meet our needs for the clinical trials, ensuring compliance with FDA requirements.
Our major objective for 2021 is to secure the required funding to finalize some additional requirements of the IND application and begin the clinical trials. As previously reported, our goal in obtaining the required funding has been to minimize shareholders’ dilution as much as possible. Consequently, we are primarily pursuing financing through the issuance of debt instruments, international licensing agreements and governmental grants. We have completed all the administrative requirements to allow us to apply for grants. Regenicin is now registered with System For Award Management (“SAM”) which is required to do business with the US Government. We must have our IND submitted before we can request financial assistance from The US FDA Office of Orphan Products Clinical Trials Grant. We intend to take full advantage of working with OOPD to develop our clinical protocol according to suggestions from the FDA during our Pre-IND meeting.
The Orphan Drug Act created the Orphan Product Grants Program, which is administered by OOPD, to stimulate the development of promising products for rare diseases and conditions. Orphan product grants are a proven method of fostering and encouraging the development of new safe and effective medical products for rare diseases and conditions. These grants support new and continuing extramural research projects that test the safety and efficacy of promising new drugs, biologics, devices, and medical foods through human clinical trials in very vulnerable populations often with life-threatening conditions.
Scotttrader80
7年前
Shareholders might as well sell out recouping what ever pennies are left of their dollar investment. Just look at the company progress, the PR's of achievement the quarterly and annual filings to see this one is a loser stock only lining the pockets of fatboy McCoy.
There are other companies actively using a derma product while McCoy continues to develop his product on paper that NO ONE seems to want.
It was a good story line, helping burn victim and Veterans, unfortunately that story line is useless, no one has been helped besides McCoy.
The only thing RGIN shareholders have banked on so far is the prospect of Hope,
Hope doesnt pay the bills
skept
7年前
Could not agree with you more applevision. It amazes me. Even on this msg board, - on the company summary above, showing 5% shareholders, there are 2 Discala entities right there. If that doesn't scare everyone for miles, I don't know what would. I've concluded that this is the downside of the bell curve - always someone at one end or the other that will believe anything. I guess these are the same people who believe in chemtrails, and that the earth is flat. Lucky we are not all the same I guess.....