In the United States, 25 million people suffer from chronic lower back pain each year, half of whom have or will be diagnosed with disc degeneration. Current treatments–including opioid pain relievers, steroid injections, and physical therapy–simply manage pain, ignoring the root causes of the problem.  Many patients reluctantly progress to surgical interventions, which are highly invasive and clinical outcomes have demonstrated limited, if any, therapeutic benefits.



BRTX-100 is a novel product to treat damaged, degenerating discs, and is anticipated to be safer, cheaper, and more effective upon a single treatment. Specifically, BRTX-100 is an autologous stem cell product that uses your own stem cells that are harvested, cultured, and then injected directly into the affected disc to start the repair process.

These cells are created in a low-oxygen environment which transforms the cell into one with enhanced inflammatory markers, enhanced circulation, and enhanced regenerative and remodeling capability of the extracellular matrix. 



BioRestorative Therapies has received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs.

Obesity, diabetes, hypertension, hyperlipidemia and certain heart related disorders, have long been seen as contributing to a pandemic in the US—40% of Americans are obese; 30% have type 2 diabetes or pre-diabetes, and half of Americans have at least one major risk factor for heart disease.

To target obesity and metabolic disorders, BioRestorative Therapies developed their ThermoStem® program that uses brown adipose-derived (“brown fat”) stem cells to generate new brown fat tissue. It was one of the first companies to identify and publish data about this novel stem cell population. This population of fat is known to burn, rather than store, energy.  Elevated levels of brown fat have been demonstrated to increase metabolism and facilitate weight loss.

Initial preclinical research indicates that increased amounts of activated brown fat in the body may be responsible for additional caloric burning, as well as reduced glucose and lipid levels. Further, researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

While this program is in relatively early stages, with a Pre-IND meeting with the FDA scheduled for 2023, it has already shown incredible promise.

BioRestorative Therapies is creating solutions for two very significant global problems, both with strong potential for creating economic and shareholder value.

The disc degeneration opportunity alone is sizable and Biorestorative is sitting at the intersection between the $40 billion and 2.5 million patient invasive surgery market and the $32 billion conventional pain management non invasive market (32 million Americans have been diagnosed with and treated for disc degeneration, averaging around $1,000 per year for oral pain management).

Additionally, we all know that obesity is a pressing issue in many countries around the world. How much of an issue is it? According to Reports and Data, The global obesity treatment market was valued at $8.4 billion USD in 2020 and is expected to reach $27.08 billion USD by year 2028, leading to a CAGR of 15.7%. 

BioRestorative Therapies is positioning themselves well to create significant economic value in the treatment of these two pressing problems.

Experience Matters

When it comes to drug commercialization, a wide variety of different skill sets and knowledge bases are needed. While the science and the location of an unmet need are obviously critical, much more is needed. The ability to effectively raise capital to create a long enough runway is critical, as is the ability to create and execute on a go-to-market strategy and strong knowledge of the various regulatory frameworks. BioRestorative Therapies' management team is incredibly well versed on all of these issues, well positioning them to succeed.

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