Accure Acne's Laser System Receives FDA Clearance for Long-Term Acne Treatment
Key Insights
Accure Acne (search)'s Accure Laser System (search) has received FDA clearance for the long-term treatment of mild to severe inflammatory acne vulgaris (search), offering a new drug-free alternative.
The Accure Laser System (search) utilizes a unique 1726 nm laser wavelength and proprietary technology to precisely target the sebaceous gland (search) by controlling thermal gradient depth.
Clinical trials demonstrated an average reduction of 70% in inflammatory lesion counts six months after four treatments, with consistent results across various skin types and severities.
Accure Acne (search), Inc. has announced that its Accure Laser System (search) has received FDA clearance for the long-term treatment of mild to severe inflammatory acne vulgaris (search). This clearance marks a significant advancement in acne treatment, providing a drug-free alternative for patients seeking durable results.
The Accure Laser System (search) employs a 1726 nm laser wavelength, a unique feature designed to precisely target the sebaceous gland (search). The system's proprietary technology allows for controlled thermal gradient depth, maximizing impact on the sebaceous gland, which plays a crucial role in acne development.
Clinical Trial Results
Clinical trials conducted in the US, under Institutional Review Board (IRB) approval, validated the "treat-to-temperature" approach of the Accure Laser. The studies demonstrated an average reduction of 70% in inflammatory lesion counts six months following a series of four treatments spaced one month apart. These results were consistent across various skin types and acne severity levels.
Emil Tanghetti, MD, founder of The Center for Dermatology and Laser Surgery and the first Accure Laser investigator, stated, "Our journey in understanding the unique nature of this wavelength and the clinical requirements needed to deliver significant clinical outcomes was certainly challenging. 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."
Commercial Availability and Expansion
Following a limited commercial release in the US earlier in 2024, Accure Acne (search) has expanded the availability of the Accure Laser System (search) to regions including Europe, the Caribbean, the Middle East, and the Asia Pacific. The company reports high satisfaction levels among both providers and patients, with satisfaction scores averaging over 4.4 out of 5 during the initial release.
Christopher Carlton, Accure Acne (search)'s co-founder, chairman of the board, and chief executive officer, commented, "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."
Addressing Acne Vulgaris
Acne vulgaris (search) is a common inflammatory skin disease affecting a significant portion of the population. Effective management requires consideration of disease severity, morphology, and patient characteristics. The Accure Laser System (search) offers a new option for individuals seeking a long-term solution, regardless of skin type or acne severity.