FDA Clears Accure Laser System for Acne Treatment

The US Food and Drug Administration (FDA) has cleared Accure Acne, Inc.’s Accure Laser System for the treatment of mild to severe inflammatory acne vulgaris.¹ The success of the Accure Laser System is based on its unique 12726nm laser wavelength, adding proprietary technology to carefully control thermal gradient depth. The latest system uses Accure’s unique pulsing algorithm, integrated temperature monitoring, and automated laser control.

The FDA clearance is based on the Accure Laser System’s ability to selectively target sebaceous glands and the precise control of the laser and laser delivery into the dermis. Accure’s precise acne targeting also established the laser system as a breakthrough device among energy-based devices. The Accure Laser System is the first 1726nm-based laser platform with both FDA and CE Mark clearances.

"Acne is the number 1 or 2 skin disease in dermatology and patients are interested in energy based device treatment of acne. Dr. Rox Anderson found the wavelength for sebum (1726 nm) and used physics and engineering to create a laser that selectively targets sebaceous glands. The initial research from Dr. Sakamoto shows permanent damage of the sebecaous glands. Dr. Emil Tangheeti has been the lead primary investigator and has worked to insure the mechanism of action gives both efficacy and safety," said Jill Waibel, MD, medical director of the Miami Cancer Institute's Multidisciplinary Skin Cancer Clinic and Dermatology Times® Editorial Advisory Board member.

The lead clinician of the Accure Laser System’s clinical development program, Emil A Tanghetti, MD, based out of The Center for Dermatology and Laser Surgery in Sacramento, California, stated that there is sufficient evidence suggesting sebaceous gland damage at depths unique to the Accure Laser System’s unique mechanism of action. Accure’s system is groundbreaking, but still simple to use, making it accessible to physicians across the industry.

Fernanda Sakamoto, MD, PhD, assistant professor of dermatology at Harvard Medical School and the lead author of the seminal research of 1726nm laser wavelength selectivity of sebaceous glands, noted that many patients with acne can fail treatments due to lack of compliance or contraindications to conventional medications. The Accure Laser System is a new energy-based device that dermatologists can learn to use in a controlled environment to treat their patients safely and effectively.

"The major question for the market place is will patients cash pay for a device for acne when insurance-based opportunities exist? Will these devices have a permanent effect? If the devices give “a cure” (the name of the laser company is Accure) then this has the potential to change the treatment of acne forever," said Waibel.

According to Accure Acne, acne vulgaris affects more than 50 million adolescents and adults annually, making acne of the most commonly treated skin conditions by healthcare providers.

"I am very impressed with how Accure is letting science lead the way to better patient outcomes. This is the ONLY acne technology platform that uses temperature-driven algorithms to determine both safety and efficacy endpoints. This is a significant step-change in how we use laser-based devices, and as a dermatologist who sees acne patients daily I very much look forward to using this tool as a stand-alone modality or in combination with our other acne therapies," said Matthew Elias, DO, FAAD, dermatologist at Elias Dermatology, LLC in Fort Lauderdale, Florida, and Dermatology Times® Editorial Advisory Board Member.

Reference

1. FDA clears the accure laser system for the treatment of mild to severe inflammatory acne vulgaris. Accure Acne. Published November 22, 2022. Accessed November 28, 2022. https://www.accureacne.com/fda-clears-accure-laser-system-treatment-mild-severe-inflammatory-acne-vulgaris