The NIH Has Given BioRestorative Therapies A Stamp Of Approval

BioRestorative Therapies Inc. BRTX is working on products that may be solutions to conditions that affect millions of Americans with lower back pain and diabetes. 

BioRestorative’s novel drug BRTX-100, which is approved by the Food and Drug Administration (FDA) to enter Phase 2 clinical trials, targets damaged and degenerating discs. The Company is well into its trial, a 99-patient prospective, randomized, double-blinded, controlled study, the gold standard of its kind. BRTX-100 is an autologous stem cell product that uses the patient’s own stem cells, which are harvested, cultured, combined with their own autologous platelet lysate and then injected directly into the affected disc to initiate the healing and repair process. Previous human investigator-initiated studies using a similar product to BRTX-100 (but arguably less potent) have shown a reduction in pain and increase in function in excess of the stated primary endpoints in BioRestorative’s phase 2 protocol. This fascinating opportunity presents a study that is highly suggestive of the potential outcomes for which they are currently processing.  In addition, the treatment is anticipated to be safer, cheaper and more effective with a single treatment.  

BioRestorative’s other product — ThermoStem — has highly promising results in the treatment of obesity and related diseases. Obesity affects over 40% of Americans, and BioRestorative is developing a novel stem-cell population — brown adipose tissue — that shows signs of regulating metabolic activity  and reducing excess fat.  

BioRestorative Therapies Has Joined The Leagues Of 23andMe, Qualcomm and Naviscan 

In September 2021, BioRestorative was awarded a Small Business Technology Transfer (STTR) phase I grant for $256,000. The project seeks to evaluate the therapeutic effects on the company’s hypoxic cultured bone marrow derived mesenchymal stem cells (BRTX-100) after encapsulation with a PEG-peptide hydrogel. The work is being done in collaboration with Dr. Lori Setton, Chair of the Department of Biomedical Engineering at Washington University in St. Louis. SBIR is a federal program coordinated by the Small Business Administration that funds research and development. STTR is a Small Business Innovation Research (SBIR) sister program. 

The programs are one of the largest sources of funding for early-stage companies. Big-name companies like 23andMe Holding Co. ME, Qualcomm Inc. QCOM and Naviscan Inc. were awarded SBIR and STTR funding, which helped them become the companies they are today. SBIR and STTR programs are highly competitive programs that foster and encourage small businesses to engage in Federal Research/Research and Development (R/R&D) with the potential for product commercialization. Through this highly competitive awards-based program, SBIR and STTR enable small businesses to explore their technological potential and provide the incentive to profit from its commercialization. 

SBIR and STTR are like gold mines for smaller companies. Borrowing from a bank is often difficult for new, innovative businesses because they lack collateral and revenue to help secure loans. While venture capital often fills the gap, it’s not always available and companies can lose autonomy if a venture capital firm wants to have a heavier hand in decisions.

With the SBIR and STTR programs, funding is stable and predictable as it is an award, not a loan. Small businesses retain intellectual property rights. Additionally, the National Institute of Health (NIH), which oversees the programs, provides recognition, validation and visibility to early-stage companies that they might not otherwise have with either a loan from a bank or venture capital. Receiving an SBIR and STTR award can also help attract more funding because of the prestige associated with the programs.  

SBIR and STTR programs have supported the development of 99 drugs from 1996-2020. Of these drugs, 16% of all treatments made a “significant” advance over available medicines. Companies that receive SBIR and STTR awards are put on the map and can credibly say they were backed by the NIH. With the recent grants BioRestorative Therapies has received, the NIH has given the company a stamp of approval.

To learn more about BioRestorative Therapies, visit its website. 

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Featured photo by National Cancer Institute on Unsplash