BioRestorative Therapies Inc. is a biotechnology company focused on developing therapeutic products using cell and tissue protocols primarily involving adult stem cells. The company's core programs target disc and spine disease through its BRTX-100 candidate and metabolic disorders such as obesity and diabetes via its ThermoStem Program utilizing brown adipose derived stem cells. Additionally BioRestorative Therapies Inc. operates a commercial biocosmeceutical platform…
BioRestorative Therapies Inc. is a biotechnology company focused on developing therapeutic products using cell and tissue protocols primarily involving adult stem cells. The company's core programs target disc and spine disease through its BRTX-100 candidate and metabolic disorders such as obesity and diabetes via its ThermoStem Program utilizing brown adipose derived stem cells. Additionally BioRestorative Therapies Inc. operates a commercial biocosmeceutical platform offering a cell-based secretome serum for cosmetic applications such as reducing fine lines and wrinkles.
The company has not generated significant revenues to date as its primary activities remain in research development and clinical trials. Revenue generation is anticipated upon regulatory approval of its product candidates including BRTX-100 for disc disorders and ThermoStem-based therapies for metabolic conditions. Future revenue may also stem from licensing agreements for its technology or products and potential commercialization of its biocosmeceutical offerings to distributors medical spas and direct consumers.
The company operates through the following segments: Disc/Spine Program Metabolic Program and BioCosmeceuticals.
- The Disc/Spine Program centers on BRTX-100 an autologous hypoxic cultured mesenchymal stem cell product derived from a patient's own bone marrow formulated with a proprietary biomaterial carrier to increase potency viability and survivability for injection into painful lumbar discs. The product is intended for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapy to surgical procedures and is currently under evaluation in a Phase 2 clinical trial for chronic lower back pain arising from degenerative disc disease.
- The Metabolic Program referred to as ThermoStem focuses on developing cell-based therapy candidates targeting obesity and metabolic disorders using brown adipose derived stem cells to generate brown adipose tissue and exosomes. The program aims to create a bioengineered implantable brown adipose tissue construct to mimic naturally occurring depots that regulate metabolic homeostasis with preclinical research indicating potential benefits for caloric burning glucose and lipid levels.
- The BioCosmeceuticals segment operates a commercial platform offering a cell-based secretome containing exosomes proteins and growth factors formulated and manufactured in a cGMP ISO-7 certified clean room. This proprietary biologic serum is engineered to reduce the appearance of fine lines and wrinkles and provide other cosmetic effects with plans to expand the offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies aiming for FDA approvals in the emerging biocosmeceuticals space.
BioRestorative Therapies Inc. operates in the competitive regenerative medicine and biotechnology industry where it faces competition from larger established companies with greater financial and research resources. In the disc and spine space competitors include Mesoblast Fibrogenesis DiscGenics and Isto Biologics while in the metabolic disorder space it competes with Novo Nordisk Sanofi Merck Eli Lilly Roche Pfizer Regeneron and Altimmune. The company believes its competitive advantages lie in the use of autologous cells in BRTX-100 which reduces rejection risk and may streamline regulatory approval the hypoxic culturing process enhancing cell proliferation and therapeutic potential and its proprietary biomaterial carrier providing growth factors for improved cell survival.
The company intends to market its cell product candidates upon regulatory approval to physicians other health care professionals hospitals research institutions pharmaceutical companies and the medical spas and direct consumers for its biocosmeceutical products. Physicians trained in spinal injections such as interventional physiatrists pain management anesthesiologists interventional radiologists and neurosurgeons are expected to be the primary administrators of BRTX-100 for disc disorders upon approval.