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Cutera, Inc. (CUTR) presented positive 12-month clinical data for AviClear at the Annual Fall Clinical Dermatology Conference held from October 20-23 in Las Vegas. The data indicates that after three treatment sessions, 92% of patients experienced visible improvement in acne after 12 months. Additionally, three-fourths of participants showed significant improvement, and two-thirds were assessed as clear or almost-clear. AviClear, the only FDA-cleared device for acne treatment, aims to provide an alternative to isotretinoin. The findings support the device's long-term effectiveness and safety.
Positive
92% of patients showed improvement in acne after 12 months following AviClear treatment.
Three-fourths of patients demonstrated a 2+ IGA score improvement.
Two-thirds of patients assessed as clear or almost-clear 12 months post-treatment.
Published articles validate AviClear's safety and efficacy.
Negative
None.
BRISBANE, Calif.--(BUSINESS WIRE)--
Cutera, Inc. (Nasdaq: CUTR) ("Cutera" or the "Company"), a leading provider of aesthetic and dermatology solutions, today announced that the 12-month 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 at the Annual Fall Clinical Dermatology Conference, which took place October 20-23 in Las Vegas, Nevada.
(Photo: Business Wire)
Current clinical studies show that after three 30-minute treatment sessions, 90% of patients had a visible improvement in their acne at 6 months.1 New 12-month clinical findings show this improvement increases to 92%,2 confirming the continual improvement of acne clearance and skin quality over time. Studies also demonstrate that three-fourths of patients showed a 2+ IGA score improvement and two-thirds of patients were assessed as clear or almost-clear 12 months after their final treatment session.3
Newly published articles in the Lasers in Medical Science and the Journal of Cosmetic Dermatologyexemplify the proven safety and efficacy of AviClear’s method of action and the validation of Cutera’s research methods for the clinical data assessments.
Oral Presentations
Lasers and Light: Clinical and Aesthetics
David J. Goldberg, MD, JD
Therapeutic Hotline: Acne, Rosacea, AK’s, Eczema, and Others
Gary Goldenberg, MD
What’s New and Hot In Acne and Rosacea
Valerie Callender, MD, FAAD
Recent Publications
A novel 1726‑nm laser system for safe and effective treatment of acne vulgaris
Matteo Giuseppe Scopelliti, Senior Biomedical Engineer, Cutera, Amogh Kothare, VP of Clinical and Regulatory Affairs, Cutera, and Michael Karavitis, Ph. D, Executive Vice President, Chief Technology Officer, Cutera
Picture-based acne lesion counts: A validation study to assess accuracy and reliability of acne lesion counts via photography
Michael H. Gold MD, Ashish Bhatia MD, Arshdeep Kaur MS, Cutera, Margot Doucette, MS, and Amogh Kothare, VP of Clinical and Regulatory Affairs, Cutera
“We are delighted the research supports AviClear’s long-term durability. Many of my patients are thrilled with their results, and with this data , we can visibly display the longstanding effectiveness of the treatment outcomes. This is especially impactful for acne sufferers who are seeking an alternative to isotretinoin; this data proves that AviClear can be that solution for them,” said David J. Goldberg, MD, JD, board-certified dermatologist.
AviClear received FDA clearance in March 2022 following an extensive clinical trial. Select physicians began treating patients in April as part of Cutera’s limited commercial release. Interested providers and patients 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 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 www.cutera.com.
Disclaimer for ACCME Compliance
The Annual Fall Clinical Dermatology Conference 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 Annual Fall Clinical Dermatology Conference. The opinions expressed by speakers and participants during these activities belong to those individuals.
1,2,3 Data on file. FDA clearance study. Cutera, Inc.
What were the results of the AviClear clinical trial presented by Cutera?
The clinical trial results showed that 92% of patients experienced visible improvement in acne after 12 months following three treatment sessions.
What is AviClear and its significance in acne treatment?
AviClear is the first FDA-cleared energy-based device specifically designed for treating mild, moderate, and severe acne, offering an alternative to isotretinoin.
When was AviClear FDA cleared and when did treatments begin?
AviClear received FDA clearance in March 2022, and treatments began in April 2022 as part of Cutera's limited commercial release.
What are the implications of the 12-month data for Cutera's market position?
The positive 12-month data enhances Cutera's market position by demonstrating AviClear's efficacy and safety, potentially attracting more patients and providers.
Where can I find more information about AviClear?
More information about AviClear can be found on its official website at www.aviclear.com.
