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FDA Grants "Safe to Proceed" Status for Britecyte's Novel Osteoarthritis Treatment

• Britecyte's Adipose Tissue Allograft (BRC-OA) receives FDA clearance to proceed with clinical trials, marking a significant milestone in regenerative medicine for osteoarthritis treatment.

• The treatment offers several advantages including on-demand availability, minimally invasive administration, and no requirement for immunosuppression or tissue matching.

• With over 30 million Americans affected by osteoarthritis, BRC-OA's anti-inflammatory and antioxidant properties could provide a promising new approach to managing this debilitating condition.

Britecyte has achieved a significant milestone in regenerative medicine as the U.S. Food and Drug Administration (FDA) grants "safe to proceed" status for its innovative Adipose Tissue Allograft (BRC-OA) therapy, designed to treat osteoarthritis. The announcement comes through their partnership with Amarex, who managed the Investigational New Drug (IND) application process.

Addressing a Critical Medical Need

Osteoarthritis currently affects more than 30 million people in the United States, standing as the leading cause of adult disability. Despite its prevalence, there remains no cure or approved treatments to prevent or slow disease progression, with existing therapies offering only temporary relief.
"Regenerative medicine products may provide renewed hope for patients to walk without pain," states Alla Danilkovitch, Ph.D., Founder and Chief Scientific Officer of Britecyte. "Our collaboration with Amarex has resulted in the successful initiation of the clinical phase for our development program, and we look forward to accelerating the activities that will bring this novel therapy to patients who are in urgent need."

Innovative Treatment Approach

BRC-OA represents a promising advancement in osteoarthritis treatment, featuring several key advantages:
  • Readily available on-demand without quantity limitations
  • Extended storage capability
  • Minimally invasive injection procedure
  • No requirement for tissue matching or immunosuppression
  • Comprehensive quality control through robust manufacturing and testing processes
The therapy's anti-inflammatory and antioxidant properties show potential in reducing pain, improving joint function, and supporting overall joint health, offering a new approach to managing osteoarthritis.

Clinical Development Progress

Kush Dhody, President of Amarex, emphasized the significance of this development: "For millions of people trapped in debilitating pain, this news is a welcome relief. We were proud to handle the Investigational New Drug application for Britecyte and honored to act as their clinical research partner as they bring this life-enhancing product to market."
The FDA's "safe to proceed" status enables Britecyte to advance with clinical trials, marking a crucial step toward bringing this innovative treatment option to patients suffering from osteoarthritis. This development represents a potential breakthrough in addressing the limitations of current osteoarthritis treatments, which typically offer only temporary symptomatic relief.
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