BioRestorative Therapies (NASDAQ: BRTX) Receives Landmark License From New York State

BioRestorative Therapies Inc. BRTX (“BioRestorative”), a clinical-stage company specializing in stem cell-based therapies, has announced that it has been granted a license by the New York State Department of Health to operate as a tissue bank. The license enables BioRestorative to process mesenchymal stem cells obtained from autologous donors. BioRestorative is now the first facility in New York State to be licensed to process mesenchymal stem cells for clinical use, setting the company apart from competitors in the field.

Mesenchymal Stem Cells (MSCs) are a type of adult stem cell that has the potential to be used in the development of treatments for various diseases, including diabetes. MSCs have the ability to turn into different types of cells in the body, such as cartilage, bone and fat cells. These cells each have their own unique structures and functions and are important for the proper functioning of specific tissues in the body. MSCs are like building blocks that can be used to create different types of cells that the body needs to stay healthy. The diversity of MSCs and their ability to be used in a wide variety of treatments is especially exciting for a company like BioRestorative.

“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,” shared CEO Lance Alstodt.

In 2022, the global mesenchymal stem cell market was worth $2.7 billion, and it is expected to grow at a CAGR of 12.8% from 2023 to 2030. The granted license positions BioRestorative as even more of a leader in the stem cell space – in a market growing by a double-digit percentage. 

BioRestorative currently has two major products that are being evaluated for a variety of diseases. BioRestorative’s novel drug BRTX-100 is an autologous stem cell product that uses the patient’s own stem cells, which are harvested, cultured, and then injected directly into the patient’s body. BioRestorative’s other product — ThermoStem® — has highly promising results in the treatment of obesity and related diseases. The license may help accelerate the ongoing BRTX-100 clinical trial, which is now in phase 2.
The company’s facility can also help other regenerative therapeutic companies, and this latest development positions BioRestorative to continue to grow as a leader in the space – potentially making it a company to watch in the coming time.

To learn more about BioRestorative, visit its website. 

Featured photo by Ousa Chea on Unsplash.

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