BioRestorative Therapies has achieved a significant intellectual property milestone with the Japanese Patent Office issuing a Notice of Allowance for the company's ThermoStem® platform, strengthening protection for its brown adipose-derived stem cell technology designed to treat obesity and metabolic disorders.
The newly allowed patent provides comprehensive coverage for BioRestorative's allogeneic, off-the-shelf brown adipose-derived stem cell (BADSC) technology. According to the company, these claims are materially stronger than previously granted patents, protecting not only the therapeutic cells themselves but also multiple methods of encapsulation and delivery, including alginate microcapsules, cellulose hydrogels, polymer membranes, and advanced scaffolding systems.
Positioning Against GLP-1 Market
The patent allowance comes as BioRestorative positions its ThermoStem® platform as a potential alternative to GLP-1 drugs, one of the fastest-growing therapeutic categories globally. The global obesity market is projected to exceed $100 billion annually by the end of the decade, driven by unprecedented demand for GLP-1 therapies.
"GLP-1 drugs have captured global attention, but they come with limitations — tolerability issues, muscle mass loss, and potential cardiovascular risks," said Lance Alstodt, BioRestorative's Chief Executive Officer. "We believe our cell-based therapeutic candidates may offer the potential for longer-lasting efficacy with improved safety and dosing advantages."
The ThermoStem® platform is designed to address current market limitations by providing an alternative to chronic GLP-1 injections through a regenerative, cell-based solution while potentially mitigating muscle loss and cardiovascular risk associated with existing GLP-1 therapies.
Technology and Mechanism
BioRestorative's metabolic program utilizes brown adipose-derived stem cells to generate brown adipose tissue (BAT), as well as exosomes secreted by BADSC. The brown adipose tissue is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans.
Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. According to the company, researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss.
Strategic Partnerships
The patent milestone advances BioRestorative's commercial positioning as the company continues discussions with potential strategic partners. The company is currently engaged in ongoing discussions with a commercial-stage regenerative medicine company regarding licensing opportunities for its metabolic intellectual property, though no assurances can be given that a license or partnership agreement will be finalized.
"This latest patent not only strengthens our IP portfolio but also advances BioRestorative into a highly attractive commercial position as we continue discussions with potential strategic partners," Alstodt noted.
Broader Pipeline
Beyond the ThermoStem® platform, BioRestorative operates two additional core programs. The company's disc/spine program features BRTX-100, an autologous mesenchymal stem cell therapy currently in Phase 2 clinical trials for chronic lower back pain arising from degenerative disc disease. The company has also obtained FDA Investigational New Drug clearance to evaluate BRTX-100 for chronic cervical discogenic pain treatment.
Additionally, BioRestorative operates a commercial BioCosmeceutical platform, manufacturing cell-based secretome products containing exosomes, proteins and growth factors in its cGMP ISO-7 certified clean room facility.
