BioRestorative Therapies Inc (NASDAQ:BRTX) is expanding its ThermoStem® intellectual property portfolio for treatments targeting obesity, diabetes and other indications related to metabolic syndrome with another patent notice of allowance from the United States Patent Office, adding to its already 19 issued patents under the ThermoStem® patent family. BioRestorative’s ThermoStem® program is a novel cell-based therapy program using cells that have metabolic activity, that once transplanted may be able to regulate the bodies metabolic homeostasis (balance) and potentially induce weight loss and a better metabolic state.

Pioneering research conducted by Biorestorative Therapies demonstrated that brown tissue burns rather than stores energy. This work was published in Stem cells and was performed in a collaboration with the University of Utah. Increased levels of brown tissue support weight loss by increasing metabolism and reducing glucose and cholesterol in the blood. Thus, increasing brown fat levels and activity may be a powerful way to treat metabolic syndrome's significant mortality and morbidity. 

The obesity and metabolic syndrome management space is the subject of intense clinical development and interest in the medical community. ThermoStem® will provide physicians with a therapeutic alternative to drugs with a different mechanism of action currently on the market. with Altimmune (NASDAQ:ALT), Eli Lilly Co (NYSE:LLY) and Pfizer Inc (NYSE:PFE) looking to emulate the success of  Semaglutide, marketed by  Novo Nordisk A/S (NYSE:NVO) for the treatment of obesity and type 2 diabetes. Semaglutide was FDA-approved in 2021 for “chronic weight management” and was the first drug approved for this indication since 2014.  Because ThermoStem® is a biologic rather than a synthetic drug, it might be a safer alternative to drugs currently under development that have demonstrated safety issues, such as Altimmunes (NASDAQ:ALT) weight loss drug that demonstrated gastrointestinal side effects when used.

Type 2 diabetes is caused by excess weight, poor diet and lack of exercise, leading to too much glucose (sugar) in the bloodstream. Cells in the body cannot respond as they would normally by removing glucose from the blood, a condition called insulin resistance. Type 2 diabetes can often be managed through diet and lifestyle changes such as eating a balanced diet, exercising regularly and maintaining a healthy weight. However, some people with type 2 diabetes may also need medication or insulin injections to manage their condition. Regardless of the type of diabetes, increased blood sugar can cause diseases of the heart, eyes and kidneys and may result in infection and amputation of the feet. 

The health economic burden of obesity and type 2 diabetes is profound. According to the Centers for Disease Control and Prevention (CDC), over 37 million Americans have diabetes (about 1 in 10), with up to 95% having type 2 diabetes. Type 2 diabetes has historically been considered a disease of adults; however, given the current obesity epidemic, it is becoming more common in children, adolescents and younger adults. By 2030, over one billion individuals will be obese, with 1 in 7 men and 1 in 5 women living with the condition. The World Health Organization has designated obesity as a global epidemic.

The burden of obesity and type 2 diabetes is not limited to economic factors alone. The impact of these conditions on the quality of life for patients and carers can be immense. People living with obesity and diabetes are at greater risk for physical, mental, social and emotional difficulties stemming from their condition. Mental health disorders such as anxiety and depression are common among people living with these conditions, partly due to the discrimination they can experience. Physical disability is also an issue for many people living with these conditions. The emotional toll of living with a chronic illness can be immense, leading to feelings of isolation, fear and frustration.

ThermoStem® could potentially help with this burden through its novel approach. The novelty of the ThermoStem® technology was acknowledged by the United States Patent Office’s The Notice of Allowance was issued on February 24th of 2023. By expanding the ThermoSTem® patent family with another issued patent, BioRestorative is positioned to further strengthen and secure its novel cell-based approach to treat obesity.