Cutera’s AviClear™ Clinical Data Presented at the Annual Meeting of the American Society for Laser Medicine and Surgery (ASLMS)

Rhea-AI Summary

Cutera Inc. (CUTR) announced the presentation of clinical data for its FDA-cleared device AviClear at the American Society for Laser Medicine and Surgery meeting held between April 27-30, 2022, in San Diego, CA. AviClear is a 1726 nm laser designed to treat mild, moderate, and severe acne. The device's efficacy and safety were showcased through two oral and four poster presentations by expert physicians. Following FDA clearance in March 2022, AviClear is set for national availability in the U.S. in 2022, with select treatments starting in April.

Positive

• AviClear received FDA clearance in March 2022, demonstrating its compliance with safety and efficacy standards.
• Strong clinical data was presented at a major scientific meeting, enhancing the credibility of AviClear.
• National availability for AviClear is expected in 2022, expanding market reach.

Negative

• None.

BRISBANE, Calif.,--(BUSINESS WIRE)-- CUTERA, INC. (Nasdaq: CUTR) ("Cutera" or the "Company"), a leading provider of dermatology solutions, today announced that clinical data related to AviClear, the first and only FDA cleared energy-based device for the treatment of mild, moderate, and severe acne; was presented during the annual meeting of the American Society for Laser Medicine and Surgery (ASLMS) which took place from April 27-30 in San Diego, CA.

(Photo: Business Wire)

AviClear’s 1726 nm laser was highlighted throughout the Meeting in the two oral presentations and four poster presentations:

Oral Presentations

Treatment of Moderate and Severe Acne; A Multi-Center Open Label Pivotal Study Using a Novel 1726 nm Laser for Treatment of Acne Vulgaris
David J. Goldberg, MD, JD

A Multicenter Open Label Feasibility Study Using a Novel 1726 nm Laser for Treatment Of Facial Acne Scarring
Jeffrey S. Dover, MD, FRCPC

Poster Presentations

A Novel 1726 nm Laser for Treatment of Acne Vulgaris
Michael Karavitis, Ph. D, Executive Vice President, Chief Technology Officer, Cutera

A Safety and Efficacy Study of A 1726 nm Laser for The Treatment of Acne Vulgaris: Subject Satisfaction of Treatment
David J. Goldberg, MD, JD

Picture Based Acne Lesion Counting; Validation Study to Evaluate the Accuracy and Reliability of a Novel Methodology
Jeffrey S. Dover, MD, FRCPC

A Single-Center, Open-Label Study Of 1726 nm Laser for Treatment of Acne Vulgaris
Ashish C. Bhatia, MD, FAAD

“With a long history of engineering and innovation, Cutera continues to pioneer new, safe, and effective treatments for medical and aesthetic providers and their patients,” said Michael Karavitis, Ph.D, Executive Vice President, Chief Technology Officer, Cutera. “We are thrilled to have presented such strong clinical data at one of the premier scientific meetings in the field of medical lasers and energy-based technologies.”

AviClear received FDA clearance in March 2022 following extensive clinical trials. Select physicians began treating patients in April as part of Cutera’s limited commercial release.

National availability for AviClear will be offered throughout the United States in 2022. Interested providers are encouraged to visit www.aviclear.com to sign up for updates and product alerts.

About Cutera, Inc.

Brisbane, California-based Cutera is a leading laser and other energy-based systems provider 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.

Disclaimer for ACCME Compliance

The American Society for Laser Medicine and Surgery has the ultimate responsibility for the planning, development and content of continuing education programs and presentations, including those highlighted above. Cutera did not direct content or influence the planning or implementation of The ASLMS Annual Conference. The opinions expressed by speakers and participants during these activities belong to those individuals.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220502005126/en/

EvolveMKD

Bridget Callahan

Cutera@EvolveMKD.com

Source: Cutera, Inc.

FAQ

What is AviClear and how does it work?

AviClear is an FDA-cleared energy-based device using a 1726 nm laser to treat mild, moderate, and severe acne.

When was AviClear presented at a conference?

Clinical data for AviClear was presented at the American Society for Laser Medicine and Surgery meeting from April 27-30, 2022.

What are the expected next steps for AviClear?

AviClear is anticipated for national availability in the United States throughout 2022.

What is the significance of the clinical data presented?

The clinical data supports AviClear's efficacy and safety, bolstering its position in the market.

What studies were conducted regarding AviClear?

Multiple pivotal and feasibility studies were presented, focusing on acne treatment and patient satisfaction.