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

Rhea-AI Summary

Cutera, Inc. (CUTR) announced the international limited commercial release of AviClear, the first energy-based device FDA-cleared for the long-term treatment of acne. The device, available in select practices in the United Kingdom, Europe, and Australia, uses a 1726nm laser to target and suppress sebum production. The pivotal clinical trial showed a 92% response rate and a 79% median reduction in inflammatory lesions at the 12-month mark. AviClear has received positive feedback from dermatologists and has been recognized by major beauty publications and awarded Cosmopolitan's 2023 Acne Award as Best Pro Treatment for Active Acne.

Insights

Dermatology Expert

The introduction of AviClear, a 1726nm laser device, into the U.K., European and Australian markets represents a significant advancement in the treatment of acne. This technology's ability to target sebaceous glands and suppress sebum production addresses acne at its root cause. The clinical data indicating a 92% response rate and a 79% median reduction in inflammatory lesion count at the 12-month mark is particularly noteworthy. These figures suggest that AviClear could potentially disrupt the current acne treatment paradigm, which often relies on pharmaceuticals that may have systemic side effects or require ongoing use.

Furthermore, the durability of the treatment, with some patients experiencing continued benefits at 18 months, highlights the potential for long-term cost savings for patients who might otherwise rely on continuous medication or alternative treatments. This could lead to a shift in consumer preferences towards such durable solutions, potentially increasing market share for CUTERA, INC. in the aesthetic and dermatology sector.

Medical Device Market Analyst

The strategic decision by CUTERA to roll out AviClear in select practices provides an opportunity to establish a solid market presence in key regions outside of North America. This limited release approach allows for a controlled evaluation of market response and practitioner adoption, which is crucial for aesthetic devices that require a significant investment in training and capital by providers. Moreover, the recognition by beauty publications and awards signifies a positive reception in the consumer market, which could translate into increased demand and sales momentum.

Given the competitive landscape of the aesthetic device market, the FDA clearance of AviClear not only serves as a validation of its efficacy but also as a differentiator that may attract investors' attention. The steady rollout planned for 2024 across the U.K. and EU suggests a calculated approach to scaling, which is likely to be well-received by stakeholders looking for sustainable growth rather than rapid, potentially unsustainable expansion.

Financial Analyst

The commercial release of AviClear in new international markets is poised to impact CUTERA's financial performance positively. With the aesthetic and dermatology solutions market being highly receptive to innovation, AviClear's novel approach to acne treatment could capture a significant market share. The device's long-term treatment efficacy and the potential to reduce the reliance on pharmaceuticals could see it becoming the preferred choice for both providers and patients.

Investors should monitor the adoption rate of AviClear among dermatology practices and the subsequent financial performance of CUTERA in these regions. The company's ability to capitalize on the high demand for innovative acne treatments and execute a successful rollout could be indicative of its future revenue trajectory. It is also important to consider the operational and logistical challenges of international expansion, such as regulatory compliance, supply chain management and market-specific consumer behavior, which could affect the speed and profitability of the rollout.

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 now available in select practices in the United Kingdom, Europe, and Australia (Photo: Cutera)

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20240208963950/en/

Media:

EvolveMKD

Cutera@EvolveMKD.com

Investor Relations:

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

IR@Cutera.com

Source: Cutera, Inc.

FAQ

What is the ticker symbol for Cutera, Inc.?

The ticker symbol for Cutera, Inc. is CUTR.

What is AviClear?

AviClear is the first energy-based device FDA-cleared for the long-term treatment of acne.

Where is AviClear available?

AviClear is available in select practices in the United Kingdom, Europe, and Australia.

What is the wavelength of the laser used in AviClear?

AviClear uses a 1726nm laser to target and suppress sebum production.

What were the results of the pivotal clinical trial for AviClear?

The pivotal clinical trial showed a 92% response rate and a 79% median reduction in inflammatory lesions at the 12-month mark.