Cutera Announces the International Limited Commercial Release of AviClear® at IMCAS World Congress 2024

AviClear^® is now available in select practices in the United Kingdom, Europe, and Australia

BRISBANE, Calif.–(BUSINESS WIRE)–CUTERA, INC. (Nasdaq: CUTR), a leading provider of aesthetic and dermatology solutions, announced the international limited commercial release of AviClear, the first energy-based device FDA-cleared for the long-term treatment of mild, moderate, and severe acne. AviClear received an enthusiastic reception at this year’s International Master Course on Aging Science (IMCAS) conference in Paris, France, held February 1-3.

AviClear is a 1726nm laser, which targets and suppresses the production of sebum, thereby treating acne at its source.^1-3 AviClear delivers high power (100W) selectively to the sebaceous glands, the source of sebum production, while protecting surrounding tissue through Cutera’s AviCool™contact cooling technology.^3,4 In an extensive pivotal clinical trial, 92% of patients were deemed responders to the therapy (resolution of at least half of their acne), with a 79% median reduction in inflammatory lesion count, at the 12-month mark following the final treatment.¹

AviClear was featured in several acne-based sessions at IMCAS, including a presentation by dermatologist Dr. David J. Goldberg. Dr. Goldberg presented the results of 75 patients treated in his practice with AviClear following the FDA clearance in March 2022. The data demonstrated similar efficacy results, in a real-world environment, as seen in the pivotal study, and highlighted the durability of AviClear’s treatment, with some patients reaching 18 months of follow-up.⁵

Following IMCAS, AviClear is now commercially available, on a limited basis, in the U.K., Europe, and Australia. Select practices will begin training on the technology in the coming weeks. London-based dermatologist Dr. Anjali Mahto stated, “AviClear is one of the most exciting innovations in the world of acne in decades. I am thrilled to add this technology to my toolbox for the benefit of our patients.”

As one of the first international AviClear providers, cosmetic physician Dr. Tapan Patel said, “AviClear represents a real step change in energy-based devices as a long-term treatment option for the management of acne. The FDA clearance, long-term data, and real-world results give practitioners confidence that this device offers something novel, effective, and durable.”

Since its initial launch in North America, AviClear has been used to treat thousands of patients. The technology has received recognition from major beauty publications and garnered numerous awards, including Cosmopolitan’s 2023 Acne Award as Best Pro Treatment for Active Acne.

“It was moving to witness the excitement surrounding AviClear at IMCAS. The amount of physician and patient interest we have received since its initial inception has been tremendous,” said Brent Hauser, International President of Cutera, Inc. “We are thrilled to be able to meet the broad demand for this type of treatment by steadily increasing availability and access globally.”

Cutera will commence a steady rollout of AviClear across the U.K. and EU in 2024. Interested providers are encouraged to visit www.aviclear.com for more information.

About Cutera, Inc.

Cutera is a leading provider of aesthetic and dermatology solutions for practitioners worldwide. For over 25 years, Cutera strives to improve lives through medical aesthetic technologies that are driven by science and powered through partnerships. For more information, call 1-888-4-CUTERA or visit Cutera.com.

¹ Data on file. FDA clearance study. Cutera Inc.

² O’Neill AM, Gallo RL. Host-microbiome interactions and recent progress into understanding the biology of acne vulgaris. Microbiome. 2018;6:177.

³ Sakamoto FH, et al. Selective photothermolysis to target sebaceous glands: theoretical estimation of parameters and preliminary results using a free electron laser. Lasers Surg Med. 2012;44(2):175-183.

⁴ Scopelliti MG, et al. Selective photothermolysis in acne treatment: The impact of laser power. J Cosmet Dermatol. 2023;00:1.7. Manuscript in press.

⁵ Data on file. David J. Goldberg, MD, JD

Contacts

Media:
EvolveMKD

Cutera@EvolveMKD.com

Investor Relations:
Greg Barker, VP, Corporate FP&A, and Investor Relations

IR@Cutera.com