FDA Clears BioRestorative Therapies’ Phase 2 BRTX-100 Clinical Study Protocol Amendment

April 16, 2024

DENVER, Colo., Apr 16, 2024 (247marketnews.com)- BioRestorative Therapies, Inc. (NASDAQ:BRTX) stated that the U.S. Food and Drug Administration (“FDA”) cleared an important amendment to the protocol of the ongoing Phase 2 study investigating the use of BRTX-100, the Company’s lead cell therapy candidate, in treating chronic lumbar disc disease.

“The FDA clearance of this important amendment highlights our positive relationship with the agency, brings additional safety to our subject participants, and helps preclude the possibility of transient clinical outcomes in the control group, which can impact end of study readouts,” stated Lance Alstodt, BioRestorative’s Chief Executive Officer. “To further clarify, control patients in our Phase 2 clinical trial will now have a needle placed in close proximity to the target disc, but the disc will not be pierced, nor will it have saline injected into it. This positive change in our protocol will not have any impact from a timing perspective, affirming our already established 2024 enrollment completion target.”

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