EXCLUSIVE: BioRestorative Therapies Wins License from New York State Department of Health To Act As Tissue Bank for Mesenchymal Stem Cell Processing

BioRestorative Therapies, Inc BRTX, bagged a license from the New York State Department of Health to act as a tissue bank for processing mesenchymal stem cells from autologous donors.

What Happened? Licensure is an intensive and diligent process for all tissue and cell-related activities in New York, including collection, processing, storage, and distribution, and any facility distributing tissues to other states. Holders of a New York State license must comply with regulations to ensure tissues' safe and ethical handling. 

Through a comprehensive on-site survey process, facilities are inspected and assessed for acceptable standards of practice and regulatory compliance.

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.

BioRestorative is the first facility in New York State to be licensed to process mesenchymal stem cells for clinical use.

Why Does It Matter? "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," said CEO Lance Alstodt.

"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," he added.

The company underwent a rigorous inspection from the state and had to provide information and pass particular measures to ensure quality and control, taking months from start to finish, according to the CFO. 

Further, given this license, the company could now offer manufacturing to companies with tissue-related products to utilize its facility and manufacture as a third party providing a source of revenues to offset its clinical development costs. 

After all, microcap Biotech and Biopharma companies burn capital through the drug development stages, so strategic initiatives that potentially offset that will interest investors. 

Price Action: BRTX shares closed higher by 4.95% at $5.72 on Tuesday.