FDA Clears Accure Laser System for Acne Vulgaris

The US Food and Drug Administration (FDA) cleared the Accure Laser System for the long-term treatment of patients with mild-to-severe inflammatory acne vulgaris, according to a press release from Accure Acne, Inc.

"This achievement cannot be overstated," Acclure Acne co-founder, chairman of the board, and chief executive officer Christopher Carlton said in the press release. "After many years of rigorous technical, scientific, and clinical development, The Accure Laser has delivered yet another milestone achievement-the ability to provide a significant, sustained, and durable drug-free alternative for acne patients and their providers. This is the vision of Accure Acne and our North Star. Having achieved this, we remain committed to further expanding the use of the Accure Laser and welcome clinicians around the world to partner with us."   

The Accure Laser System, according to the press release, unlocks the unique selectivity of the 1726-nm laser wavelength, adding proprietary and first-in-class technology to precisely control thermal gradient depth to have maximum impact on the sebaceous gland. This treat-to-temperature mechanism of action has been validated through multiple IRB-approved clinical trials in the US, achieving an average inflammatory lesion count reduction of 70% at 6 months after a series of four treatments spaced approximately 1 month apart. This was observed for all skin types and severities of acne.

Accure Acne recently completed a limited commercial release earlier this year in the US, delivering significant clinical outcomes, as well as consistent provider and patient satisfaction scores of over 4.4 out of 5.

"Our journey in understanding the unique nature of this wavelength and the clinical requirements needed to deliver significant clinical outcomes was certainly challenging,”

Emil Tanghetti, MD, founder of The Center for Dermatology and Laser Surgery in Sacramento, California, and the first Accure Laser investigator in the world, said in the press release. “The technical innovations of using temperature as an endpoint, combined with forced air cooling and real-time monitoring algorithms has produced a solution that stands alone from more traditional power-based methods. This unique laser has a platform that can be modified and adjusted to possibly treat a number of other skin conditions. I am excited about the future of this device and technology."

Also posted at Modern Aesthetics.