Cutera (CUTR) Status Update summary

Market opportunity and unmet need

• Acne affects 50 million Americans annually, with significant impact on adults, especially women, and a high emotional toll including increased depression risk.

• Current acne treatments have changed little in 40 years, with limitations in efficacy, side effects, and patient compliance, especially for moderate to severe cases.

• AviClear offers a non-invasive, non-systemic, light-based therapy targeting the sebaceous gland, addressing both inflammatory and non-inflammatory acne.

Clinical efficacy and safety data

• Pivotal study included 104 subjects, mostly with moderate to severe acne, showing 51% achieved >50% reduction in inflammatory lesions at 52 weeks.

• Median inflammatory lesion count reduced by 79%, with results comparable to standard oral isotretinoin but without systemic side effects.

• Adverse events were mild and transient, with no pigmentation issues across all skin types.

Real-world adoption and practice integration

• AviClear is positioned as a durable, three-treatment solution, appealing to patients seeking non-pharmacologic options and those with compliance challenges.

• Adoption is growing, with dermatologists integrating AviClear alongside other therapies to mitigate flares and optimize outcomes.

• High patient conversion rates observed, with positive halo effects for practices, including increased engagement from patients and their families.