AVAVA™ Receives FDA Clearance for Revolutionary Acne Scar Treatment using Focal Point Technology™

/EIN News/ -- BOSTON, April 22, 2025 (GLOBE NEWSWIRE) -- AVAVA™, a medical aesthetics innovation company redefining energy-based skin therapy, announced today that its advanced acne scar treatment using Focal Point Technology™ has received clearance from the U.S. Food and Drug Administration (FDA). This clinical indication affirms the platform’s ability to treat acne scarring effectively with high energies in all Fitzpatrick skin types (I–VI).

Acne is the most common skin condition in the U.S., affecting up to 50 million people annually (AAD). Globally, it ranks as the eighth most prevalent disease, impacting 9.4% of the population (NIH). Scarring is a frequent consequence—43% of patients show signs of acne scarring, even in mild to moderate cases (JDD). Post-inflammatory hyperpigmentation (PIH) affects 65% of Black and 53% of Hispanic acne patients (JAAD), and acne prevalence is highest among African Americans at 37% (MDacne), underscoring the need for treatment solutions that address all skin tones

AVAVA’s non-ablative platform addresses this long-standing gap—delivering high-energy, targeted treatments while sparing surrounding tissue. The result: a visibly smoother skin surface, achieved across all skin tones with minimal downtime.

“This milestone reflects the strength of our clinical data and the innovation driving AVAVA’s technology,” said Richard Bankowski, Executive VP, Global Clinical & Regulatory. “By delivering consistent outcomes with minimal downtime—across all skin tones—we’re not only addressing the needs of today’s aesthetic patient, we’re also shaping the direction of the industry."

About the Study

The FDA clearance is based on a prospective, IRB-approved, multi-center clinical trial. A total of 47 subjects were treated and evaluated by expert blinded dermatologists. Participants ranged in age from 21 to 72, with a gender split of 59% women and 41% men. Importantly, 75% of participants identified as African American, Asian, or Hispanic/Latino.

Key Clinical Findings

• More than 90% of subjects experienced visible improvement in acne scarring with a median of 50% reduction in acne scar severity (based on a validated ECCA grading scale)
• Multiple patients in the study achieved complete scar clearance
• 87% of subjects were treated at or above 120mJ, with some reaching 150mJ—only possible with AVAVA’s proprietary Focal Point Technology™
• Even subjects who received only one treatment showed improvement
• Mild redness and swelling were observed post-treatment and resolved within 1-2 days
• With ComfortCool™ integrated into the handpiece, patients reported an average pain score of 3 out of 10

“We saw consistent improvement in acne scarring across all patients,” said Roy Geronemus, MD. “The results, including patients with skin of color, are impressive. AVAVA’s technology is a true step forward in laser dermatology.”

Looking Ahead
AVAVA’s breakthrough platform delivers energy precisely where it’s needed—deep into the skin, without compromising the surface. This first clinical indication paves the way for future applications.

AVAVA will showcase 14 accepted abstracts and podium presentations at the upcoming ASLMS 2025 Conference in Orlando, underscoring the platform’s broad clinical potential.

About AVAVA™
AVAVA™ is a trailblazer in medical aesthetics, redefining how energy is delivered to the skin. Backed by decades of innovation and founded by industry giants, AVAVA is pioneering the next generation of non-ablative treatments through its proprietary Focal Point Technology™. Designed for precision, performance, and inclusivity, AVAVA’s platform delivers targeted energy deep into the skin—minimizing downtime and maximizing visible results for all skin tones. With fearless vision and boundless energy, AVAVA is changing what’s possible in skin revitalization.

www.avavaskin.com

Media Contact
Stephanie Mitchell
AVAVA, Inc.
Email: smitchell@avavaskin.com
Phone: 949.751.9879

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A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ef76545a-97d5-4d63-9025-ce09a857913c

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6cbb81ae-dd22-44ac-9d97-066af19b1397

Acne Before & Afrter

2 months post 3 Treatments

Acne Before & After 2

6 months post 4 treatments

Acne Before & After 3

6 months post 5 treatments