Health Canada Clears Cutera’s AviClear
This Health Canada announcement comes on the heels of the U.S. Food and Drug Administration’s 510(k) clearance of AviClear, in March 2022.
Health Canada has cleared Cutera, Inc.’s AviClear for the treatment of mild, moderate, and severe acne.
This Health Canada announcement comes on the heels of the U.S. Food and Drug Administration’s 510(k) clearance of AviClear, in March 2022.
In addition to reducing existing acne, clinical trials show that future breakout episodes are shorter, less intense, and more infrequent following three 30-minute treatment sessions. Further, acne clearance results continue to improve over time, demonstrating the long-term efficacy of this novel treatment. Importantly, no pain mitigation was utilized or required by any clinical study participant.
Acne vulgaris is a nearly universal skin disease, with approximately 50 million North American teens and young adults seeking treatment each year. AviClear’s 1726nm wavelength treats acne at the source by selectively targeting the sebocytes and suppressing sebum production. Overproduction of sebum by the sebaceous glands is one of the leading causes of acne.
“Acne affects so many people – from teens to women in menopause, and everyone in between,” says Jerry K. L. Tan, MD, FRCPC, an adjunct professor of internal medicine and dermatology at the University of Western Ontario and in private practice in Windsor, Ontario, in a news release.“I am thrilled that AviClear can offer patients a safe, effective, and drug-free treatment option that will help them face the world without the worry, frustration or self-consciousness that often accompanies acne.”
“We are ecstatic with AviClear’s expansion into the Canadian market as an innovative tool for dermatologists and as a treatment that inspires hope for acne patients,” says David Mowry, CEO of Cutera. "Developed with extensive physician and patient input, AviClear is helping to redefine and optimize modern acne care.”
Cutera is planning for measured expansion of AviClear to Canadian providers in their limited commercial release over the course of 2022.