FDA Clears Cutera’s AviClear™ Acne Device

Rhea-AI Summary

AviClear has received FDA 510(k) clearance, becoming the first energy-based device approved for treating mild, moderate, and severe acne. This laser treatment is designed to provide a safe, prescription-free solution, targeting the source of acne by suppressing sebum production. Clinical trials demonstrate that AviClear not only reduces existing acne but also improves future breakout patterns, showing long-term efficacy without requiring pain mitigation. Cutera aims to introduce AviClear to physicians in the U.S. throughout 2022, revolutionizing acne treatment.

Positive

• AviClear is the first FDA-cleared device for treating mild, moderate, and severe acne, setting it apart from competitors.
• Clinical trials indicate long-term efficacy, showing reduced intensity and frequency of future breakouts.
• The treatment does not require pain mitigation, making it more appealing to patients.

Negative

• None.

AviClear is the First Device Cleared for the Treatment of Mild, Moderate and Severe Acne

AviClear has been Proven Safe and Effective Through an Extensive Clinical Trial

Provides Long-term Resolution of Acne Across All Skin Types

BRISBANE, Calif.--(BUSINESS WIRE)-- CUTERA, INC. (Nasdaq: CUTR) ("Cutera" or the "Company"), a leading provider of dermatology solutions, today announced the U.S. Food and Drug Administration’s 510(k) clearance of AviClear, the first and only energy-based device to receive this designation for the treatment of mild, moderate, and severe acne.

(Photo: Business Wire)

AviClear is a laser treatment that offers a safe, prescription-free solution for acne.¹ In addition to reducing existing acne, clinical trials show that future breakout episodes are shorter, less intense, and more infrequent following the AviClear procedure. Further, acne clearance results continue to improve over time, demonstrating the long-term efficacy of this novel treatment. Importantly, no pain mitigation was utilized or required by any clinical study participant.

Acne vulgaris is a nearly universal skin disease, with approximately 50 million North American teens and young adults seeking treatment each year.² Overproduction of sebum by the sebaceous glands is one of the leading causes of acne.³ AviClear resolves acne at the source by selectively targeting the sebocytes and suppressing sebum production.

“Existing device treatments for acne are neither long-lasting nor particularly effective,” said Jeffrey S. Dover, MD, FRCPC, board-certified dermatologist and Cutera advisory board member. “Topical therapies yield temporary results and oral medications present several challenges. AviClear offers patients a safe, well-tolerated, drug-free approach with durable results, which significantly shifts the treatment paradigm for acne.”

"Physicians and patients have long sought a modern alternative to the acne pills, peels and topicals that have been static for nearly 30 years,” said David Mowry, CEO of Cutera. "Developed with extensive physician and patient input, AviClear was created to redefine the treatment of acne – all without a prescription.”

AviClear is expected to be made available to physicians throughout the United States over the course of 2022. Doctors and consumers are encouraged to visit www.AviClear.com and sign up for updates on product availability and local treatment providers.

About Cutera, Inc.
Brisbane, California-based Cutera is a leading provider of laser and other energy-based systems for dermatologists and aesthetic practitioners worldwide. Since 1998, Cutera has been developing innovative, easy-to-use products that harness the power of science and nature to enable physicians and other qualified practitioners to offer safe and effective treatments to their patients. For more information, call +1 415-657- 5500 or 1-888-4CUTERA or visit www.cutera.com.

References

1. Data on file, FDA clearance study. Cutera, Inc.
2. https://jamanetwork.com/journals/jamadermatology/fullarticle/479093
3. O’Neill AM, Gallo RL. Host-microbiome interactions and recent progress into understanding the biology of acne vulgaris. Microbiome 2018;6: 177.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20220317006022/en/

EvolveMKD

Bridget Callahan

Cutera@EvolveMKD.com

Source: Cutera, Inc.

FAQ

What is AviClear and what approval did it receive?

AviClear is the first energy-based device cleared by the FDA for the treatment of mild, moderate, and severe acne.

What are the benefits of using AviClear for acne treatment?

AviClear offers a safe, prescription-free solution that reduces existing acne and leads to less intense future breakouts.

When will AviClear be available to physicians in the U.S.?

AviClear is expected to be made available to physicians throughout the U.S. over the course of 2022.

How does AviClear work to treat acne?

AviClear targets sebocytes to suppress sebum production, addressing one of the primary causes of acne.

Who is the CEO of Cutera?

David Mowry is the CEO of Cutera.