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BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person`s own) cultured mesenchymal stem cells collected from the patient`s bone marrow. We intend that the product will be used for the non-surgical treatment of protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. The BRTX-100 production process involves collecting a patient`s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient`s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received clearance from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs. • Metabolic Program (ThermoStem®): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT 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 the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.
Symic is developing a new category of therapeutics that offer an exciting and biologically innovative approach to treating disease. While it is clear that cells play an important role in tissue inflammation and regeneration, it is also known that the extracellular matrix (ECM) plays an equally critical role in maintaining healthy tissue. The ECM is the non-cellular component of the body’s tissues, and proteoglycans are important structural and functional macromolecules native to the ECM that are known to protect against tissue degradation and promote healing during illness or injury. Recognizing the importance of proteoglycans in many acute and chronic disease states, Symic developed a library of proprietary, ECM-specific compounds that mimic the protective effect of natural proteoglycans. For controlled injuries (e.g. incisions, balloon angioplasty), Symic’s ECM-specific compounds allow for local application, enhancing their ability to attenuate inflammation and reduce scarring only at the site of injury. In disease states known for chronic inflammation involving the ECM (e.g. cartilage in osteoarthritis), Symic’s technology can disrupt the cycle of degradation-inflammation by directly targeting and protecting the injured ECM. The ECM plays a critical role in many acute and chronic disease states, many of which have limited or no effective therapeutic options. Symic plans to advance its compounds in a variety of therapeutic areas with unmet clinical needs.
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