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BioRestorative Therapies Receives License from New York State Department of


–License will enable expanded clinical operations for investigator-initiated trials and potential “right to try” uses of BRTX-100.—

MELVILLE, N.Y., May 31, 2023 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that it has received a license from the New York State Department of Health to act as a tissue bank for the processing of mesenchymal stem cells from autologous donors.

Licensure is an intensive and diligent process, and is required for all tissue and cell-related activities in New York, including collection, processing, storage, and distribution, as well as for any facility distributing tissues to other states. Holders of a New York State license are required to comply with regulations to ensure safe and ethical handling of tissues. Through a comprehensive on-site survey process, facilities are inspected and assessed for acceptable standards of practice and regulatory compliance.

“This is a significant milestone for BRTX as we now can further optimize our ISO 7 certified clean room and manufacturing facility. In addition, we are exploring the ability to do contract manufacturing on behalf of other regenerative medicine companies. Our state of the art facility along with our manufacturing capabilities could provide revenues and help us offset some cash burn related to our laboratory. Finally, what is most exciting about this license is the ability to act as a tissue bank. This will enable us to bank BRTX-100 on behalf of future patients and, if FDA approved, provide those patients with an “off the shelf” autologous cell therapy product once commercially available in the United States”, said CEO Lance Alstodt

There are numerous entities that are licensed to operate tissue banks and non-transplant anatomic banks in New York State. The Blood and Tissue Resources Program oversees all human tissue banking activities and services provided in New York State, from donor solicitation to clinical use. The tissue bank regulatory program, being the first comprehensive oversight program for tissue banks in the country, has served as a model for the development of national and other state oversight programs. BioRestorative is the first facility in New York State to be licensed to process mesenchymal stem cells for clinical use.

BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is the Company’s lead clinical candidate. BRTX-100 is currently being evaluated in connection with a Phase 2 clinical trial to treat chronic lumbar disc disease (“cLDD”). The trial is prospective, randomized, double-blinded and controlled. The trial will evaluate the safety and preliminary efficacy of a single dose of BRTX-100. A total of up to 99 eligible patients will be randomized at up to 15 clinical sites in the…

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