Brixton Biosciences’ Coolio™ Therapy Granted Breakthrough Device Designation by the FDA
CAMBRIDGE, Mass., Nov. 13, 2023 /PRNewswire/ — Brixton Biosciences, a clinical-stage life sciences company developing novel therapies for chronic and acute pain, is delighted to announce that its groundbreaking Coolio™ Therapy has received the prestigious Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
Coolio™ Therapy is a novel approach intended to deliver long-lasting pain control in targeted areas with a single injection. Animal models have demonstrated the remarkable capability of this treatment to provide relief for 3+ months, offering a simple and effective solution to pain management.
“The potential for Coolio Therapy to offer reliable, targeted and long-lasting pain control is a game-changer in physicians’ toolkit. The Breakthrough Device Designation recognizes the profound impact this therapy could have on the lives of patient living with Osteoarthritis. This is just the beginning of Brixton’s promising journey in acute, perioperative, and chronic pain care,” said 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 is a testament to Coolio™ Therapy’s potential to address crucial unmet needs in the field of pain management and accelerates the development and regulatory review process, bringing Coolio™ Therapy one step closer to reaching patients in need.
“We are thrilled to have Coolio™ Therapy designated as a Breakthrough Device by the FDA,” said 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.”
Achieving Breakthrough designation from the FDA improves the likelihood that Coolio will qualify for transitional pass-through status, which assures separate payment by Medicare for devices in hospital outpatient and ASC payment systems for approximately 3 years. For devices with Breakthrough Designation from the FDA, the substantial clinical improvement criterion for pass-through status – the most difficult criterion to meet – is deemed to be satisfied.
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SOURCE Brixton Biosciences
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