Accure Receives CE Mark Approval for First-Ever 1726nm Laser Platform to treat Acne

BOULDER, Colo., May 7, 2020 /PRNewswire/ -- Accure Acne, Inc., a pioneer in innovative energy-based solutions for the acne market, today announced it has been granted the European CE mark for its groundbreaking Accure Laser(TM) system to treat patients with moderate acne vulgaris.(1) The Accure Laser is the first commercially-developed light-based platform in the world to selectively target and injure sebaceous glands, the fundamental source of sebum production and the key to a durable solution for acne.

Founded in 2015, Accure is wholly focused on the elimination of acne through innovative and disruptive non-systemic solutions. Acne represents one of the most common skin conditions in the world, estimated to affect 9.4% of the global population.(2) Recent studies have also shown a significant link between acne and depression, as well as anxiety.(3)

"This achievement represents the culmination from two decades of clinical research led by The Wellman Center for Photomedicine at Massachusetts General Hospital," noted Christopher Carlton, Chairman, Chief Executive Officer and co-Founder of Accure. "This milestone brings an impactful solution to millions of acne sufferers in Europe."

Accure's clinical and technical development teams represent an unmatched collaboration of engineering acumen and clinical expertise, led by Prof. Rox Anderson, M.D., co-Founder of Accure. Dr. Anderson is an influential medical scientist and inventor dedicated to the field of light and energy-based devices used in dermatology, medical aesthetics, and various specialties.

Preliminary clinical data from Accure's on-going IRB-approved Face Trial demonstrates an over 80% inflammatory lesion reduction at three months after treatment.(4 )Accure has compiled hundreds of in vivo human skin histology samples depicting a significant effect on sebaceous glands. ( )Dr. Emil Tanghetti, a principal investigator of the Accure Laser, stated, "I am impressed with Accure's safety-first, data-driven approach. The clinical results thus far are exciting, and the uniqueness of the proprietary temperature and operator feedback control systems makes this much more than just a new laser wavelength. I look forward to on-going advances with this platform."

Accure is proud to partner with Quanta System, S.p.A (El.En. Group), based in Milan, Italy. Quanta has contributed substantial resources and expertise to the development of the Accure Laser and will be the exclusive manufacturing partner of Accure as commercial activities accelerate. The laser platform has been designed with highly unique and innovative technology, resulting in over fourteen granted, pending, and provisional patents issued to Accure through exclusive global licenses. "Quanta is proud to support such an innovative and important device for the field of dermatology", added Paolo Salvadeo, General Manager of El.En. "We look forward to the impact of this technology in Europe and around the world."

The Accure Laser® represents the first commercial product to be released by Accure in Europe, available in the second half of 2020 in several key markets.

For more information: inquire@accureacne.com

About Accure Acne, Inc.

At Accure, we are wholly committed to developing revolutionary solutions to eliminate acne. We know that acne can have a devastating social, psychological, physical and economic impact on patients around the world. We are pioneering transformative solutions that will answer this unmet need and have a positive and profound impact on patients and providers worldwide.

Learn more about Accure and our commitment to acne: www.accureacne.com

About Quanta System, S.p.A

Quanta System S.p.A produces lasers and laser systems for a wide range of scientific, medical and industrial applications.

Quanta System S.p.A. was founded in 1985. Today, with over thirty years of experience in the design of laser sources, laser systems and specific solutions for the OEM market, it is a global company founded on a myriad of local expertise: Italian creativity and research, the methodology and tradition of the German optics industry, American-style Oriented Marketing, and the successful Spanish distribution model. Laser in our DNA is not just a marketing promise: it represents also a way of thinking, working, and creating values to be shared. It is a concrete and profound commitment, the corporate policy of an expert and determined group which makes technological research its own mission every day.

Learn more about Quanta System: www.quantasystem.com

About The Wellman Center for Photomedicine

The Wellman Center for Photomedicine at Massachusetts General Hospital is the world's largest academic research facility dedicated to investigating the effects of light on human biology and to the development of light-mediated, minimally invasive diagnostic and therapeutic technologies. A pioneer in light-based biomedical research, the Center has been the source of many of the most successful transfers of this research to clinical applications.

Learn more about The Wellman Center for Photomedicine: https://wellman.massgeneral.org

(1)CE Mark Intended Use: The Accure Laser is intended for the treatment of moderate inflammatory acne vulgaris.
(2 )A global perspective on the epidemiology of acne. Br J Dermatol. 2015 Jul;172 Suppl 1:3-12. doi: 10.1111/bjd.13462.
(3)Acne vulgaris and risk of depression and anxiety: A meta-analytic review. Samuels, Danielle V. et al. Journal of the American Academy of Dermatology
(4)Tanghetti, E., Geronemus, R., Bloom, B., Anderson, R.R., Ross, E.V., Sakamoto, F.W. Safety and Efficacy Data in A Pilot Study of the Treatment of Acne with A Fiber Laser. Poster accepted for presentation at: 40th ASLMS Annual Conference; 2020 April 29 - May 3; Phoenix, AZ, USA

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SOURCE Accure Acne