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MELVILLE, N.Y., April 10, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage regenerative medicine innovator focused on stem cell-based therapies and products, is pleased to confirm that it currently faces no material exposure to newly imposed U.S. tariffs.
BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is BioRestorative’s lead clinical candidate. The safety and efficacy of BRTX-100 in treating chronic lumbar disc disease (“cLDD”) is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. The U.S. Food and Drug Administration (“FDA”) recently granted Fast Track designation to the BRTX-100 program for the treatment of cLDD, reflecting the positive preliminary Phase 2 safety and efficacy data reported to date. Also in February, the FDA cleared the Company’s Investigational New Drug (“IND”) application for BRTX-100 for the treatment of chronic cervical discogenic pain (cCDP), expanding BioRestorative’s advanced clinical pipeline for BRTX-100 to include the treatment of both chronic lower back and neck pain.
“Our ‘made-in-America’ production and manufacturing strategy, combined with our use of domestic inputs, enables us to effectively manage costs amid global supply chain shifts,” said Lance Alstodt, BioRestorative’s Chief Executive Officer. “We ended 2024 in a very strong financial position with cash, cash equivalents, marketable securities of over $10 million. We plan on continuing to efficiently manage our cash reserves while executing upon all of our strategic goals.”
About BioRestorative Therapies, Inc.
BioRestorative (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we have also recently begun offering BioCosmeceutical products:
• 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 painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and 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 commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. We have also obtained U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain.