FDA Fast Track Designation for BRTX-100
BioRestorative Therapies received FDA Fast Track designation for their BRTX-100 program targeting chronic lumbar disc disease, facilitating development and expediting review processes.
FDA Clearance for Phase II Clinical Trial in cCDP
The FDA cleared BioRestorative's investigational drug application for a Phase II clinical trial of BRTX-100 in chronic cervical discogenic pain, marking it as the first stem cell-based product candidate to be evaluated in cervical degeneration disc disease.
Strong Financial Position
The company ended the quarter with $9.1 million in cash, cash equivalents, and marketable securities, with no outstanding debt.
Positive Preliminary Data for BRTX-100
Preliminary blinded data shows positive trends in safety and efficacy for BRTX-100 in treating chronic lumbar disc disease, with no serious adverse events reported.
Expansion of ThermoStem IP Portfolio
BioRestorative expanded its intellectual property estate for ThermoStem, covering both U.S. and international markets, to protect its potential treatments for obesity and metabolic disorders.