FDA Clears AviClear® as a Long-Term Treatment for Mild to Severe Acne

AviClear by Cutera® makes history with another first to market milestone proving to be safe and effective across all skin types with long lasting results

BRISBANE, Calif.--(BUSINESS WIRE)-- CUTERA, INC. (Nasdaq: CUTR) a global leader in aesthetic and dermatology solutions, today announces a new U.S. Food and Drug Administration Clearance of AviClear as a long-term treatment for mild to severe inflammatory acne vulgaris. This is the first acne therapy to claim long term effectiveness for mild, moderate and severe acne.

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AviClear initially received FDA clearance in March 2022 following an extensive clinical trial. Now after months of clinical data evaluation, the FDA has additionally recognized AviClear as a clinically efficacious and proven treatment for the long-term treatment of acne. AviClear selectively targets and suppresses the sebaceous glands, eliminating acne at the source, offering a durable and prescription free option for patients and providers.

“Those of us who have been using AviClear on our patients since the initial FDA Clearance recognized that the results of the treatment get progressively better with time,” said Emmy M. Graber, MD, MBA, the Founder of The Dermatology Institute of Boston and an internationally known acne expert. “I am thrilled that the FDA has now acknowledged these long-lasting results, giving both patients and dermatology providers greater confidence in the efficacy and durability of AviClear results.”

As the first 1726nm laser to be introduced to the market, AviClear continues to challenge the status quo in the acne landscape. In three, 30-minute treatment sessions 90% of patients experienced visible improvement in their acne six months after their third session.¹ According to 12-month clinical data, improvement increases to 92%², confirming long-term efficacy of acne clearance and skin quality over time.

“We are proud to receive such a significant and landmark designation. The success of AviClear is a testament to Cutera’s ingenuity and innovation as a pioneering force in results-driven technology,” said Sheila A. Hopkins, Interim CEO at Cutera. “Throughout Cutera’s 25-year history, we have continued to develop devices that offer physicians and their patients breakthrough treatment options, and AviClear is a great example of our game changing technologies.”

Interested providers and patients are encouraged to visit www.AviClear.com for more information.

About Cutera, Inc.

Brisbane, California-based Cutera is a leading provider of aesthetic and dermatology solutions for practitioners worldwide. Since 1998, Cutera has been developing innovative, easy-to-use products that harness the power of science and nature to enable medical practitioners to offer safe and effective treatments to their patients. For more information, call +1 415-657-5500 or 1-888-4CUTERA or visit Cutera.com.

^1,2 Data on file. FDA clearance study. Cutera, Inc.

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Media: EvolveMKD – Cutera@EvolveMKD.com

Investor Relations: Greg Barker, VP of FP & A – IR@Cutera.com

Source: Cutera, Inc.