EXCLUSIVE: BioRestorative Therapies & Northwell Health Ink Trial Pact For Chronic Lower Back Pain Study

BioRestorative Therapies Inc BRTX has signed a clinical trial agreement with Northwell Health and Northwell's Feinstein Institutes for Medical Research to participate in the company's Phase 2 trial of BRTX-100 for chronic lumber disc disease (cLDD).

Last month, BioRestorative Therapies completed enrollment for the safety run-in component of its Phase 2 study of BRTX-100 targeting patients suffering from chronic lumbar disc disease.

The clinical data from the safety run-in is scheduled to be released in the second half of 2023.

Northwell Health in New York State operates 21 hospitals, 850 outpatient facilities, and over 12,000 affiliated physicians. 

The company tells Benzinga that speed of enrollment means faster study & less cost, and prescreened participants implicit stamp of approval from an extensive hospital system.

BRTX-100, the company's lead clinical candidate, is a cell-based therapeutic engineered to target body areas with little blood flow.

The trial will evaluate the safety and preliminary efficacy of a single dose of BRTX-100. A total of up to 99 eligible patients will be randomized at up to 15 clinical sites in the U.S.

In March, BioRestorative Therapies collaborated with Bruder Consulting & Venture Group, a full-service strategic advisory, to assist the company in seeking FDA approval for the expanded clinical application of BRTX-100.

Price Action: BRTX shares closed at $4.40 on Friday.

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