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FDA Grants Breakthrough Device Designation to Coolio™ Therapy Developed by Brixton Biosciences

Monday, November 13, 2023

Brixton Biosciences, a clinical-stage life sciences company specializing in innovative therapies for chronic and acute pain, is excited to announce that its revolutionary Coolio™ Therapy has been granted the prestigious Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

Coolio™ Therapy represents a groundbreaking approach aimed at providing enduring pain control in specific areas through a single injection. Animal models have demonstrated the remarkable capacity of this treatment to deliver relief for over three months, presenting a straightforward and efficient solution for pain management.

"The potential of Coolio Therapy to offer dependable, targeted, and long-lasting pain control is a game-changer in the physician's toolkit. The Breakthrough Device Designation acknowledges the profound impact this therapy could have on the lives of patients living with Osteoarthritis. This marks just the beginning of Brixton's promising journey in acute, perioperative, and chronic pain care," stated Dr. Michael Fishman, Chief Medical Officer of Brixton Biosciences and a double board-certified Anesthesiologist and Pain Medicine specialist.

The FDA's Breakthrough Device Designation serves as recognition of Coolio™ Therapy's potential to address critical unmet needs in pain management and facilitates an expedited development and regulatory review process, bringing Coolio™ Therapy a step closer to reaching patients in need.

"We are delighted to have Coolio™ Therapy designated as a Breakthrough Device by the FDA," expressed Sameer Sabir, Chief Executive Officer of Brixton Biosciences. "This recognition underscores our commitment to advancing healthcare solutions that significantly benefit patients. The Coolio™ technology has the potential to transform the lives of those suffering from chronic pain."

Attaining Breakthrough designation from the FDA enhances the likelihood that Coolio will qualify for transitional pass-through status, ensuring separate payment by Medicare for devices in hospital outpatient and ASC payment systems for approximately three years. Devices with Breakthrough Designation from the FDA are deemed to satisfy the substantial clinical improvement criterion for pass-through status, which is the most challenging criterion to meet.

 

Source: prnewswire.com

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