AVAVA, a medical aesthetics innovation company, announced that its advanced acne scar treatment using Focal Point Technology has received clearance from the U.S. Food and Drug Administration (FDA). This milestone approval specifically validates the platform's ability to effectively treat acne scarring with high-energy treatments across all Fitzpatrick skin types (I–VI), addressing a critical gap in treatment options for patients with darker skin tones.
Addressing a Widespread Clinical Need
Acne represents the most common skin condition in the United States, affecting up to 50 million people annually according to the American Academy of Dermatology. Globally, it ranks as the eighth most prevalent disease, impacting 9.4% of the population based on National Institutes of Health data.
Scarring occurs in approximately 43% of patients, even in those with mild to moderate acne cases, according to the Journal of Drugs in Dermatology. Post-inflammatory hyperpigmentation (PIH) disproportionately affects communities of color, with 65% of Black and 53% of Hispanic acne patients experiencing this condition. With acne prevalence highest among African Americans at 37%, the need for inclusive treatment solutions has been particularly acute.
Breakthrough Technology and Clinical Results
AVAVA's non-ablative platform delivers high-energy, targeted treatments while sparing surrounding tissue. This approach results in a visibly smoother skin surface across all skin tones with minimal downtime—a significant advancement in laser dermatology.
"This milestone reflects the strength of our clinical data and the innovation driving AVAVA's technology," said Richard Bankowski, Executive VP of Global Clinical & Regulatory at AVAVA. "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."
The FDA clearance was based on a prospective, IRB-approved, multi-center clinical trial involving 47 subjects evaluated by expert blinded dermatologists. Participants ranged in age from 21 to 72, with a gender distribution of 59% women and 41% men. Notably, 75% of participants identified as African American, Asian, or Hispanic/Latino, making the study particularly relevant for assessing efficacy across diverse skin types.
Impressive Efficacy and Safety Profile
The clinical findings demonstrated remarkable efficacy:
- More than 90% of subjects experienced visible improvement in acne scarring
- Median reduction in acne scar severity reached 50% based on the validated ECCA grading scale
- Multiple patients achieved complete scar clearance
- 87% of subjects were treated at or above 120mJ, with some reaching 150mJ—energy levels only possible with AVAVA's proprietary Focal Point Technology
- Even subjects who received only one treatment showed improvement
The safety profile proved equally impressive, with mild redness and swelling typically resolving within 1-2 days. The device's integrated ComfortCool technology contributed to patient comfort, with an average reported pain score of just 3 out of 10.
Dr. Roy Geronemus, a prominent dermatologist involved in the clinical evaluation, noted: "We saw consistent improvement in acne scarring across all patients. The results, including patients with skin of color, are impressive. AVAVA's technology is a true step forward in laser dermatology."
Expert Perspectives on the Technology
Dermatologists have expressed enthusiasm about the technology's capabilities and its potential impact on clinical practice.
Dr. Matthew Elias, a Fort Lauderdale dermatologist, explained the mechanism of action: "AVAVA enables the delivery of higher energies directly into the dermis—levels that were previously unattainable—by precisely sparing the epidermis. This initiates remodeling of fibrotic scar tissue through new collagen formation, leading to visible improvements in the depth and texture of atrophic scars with minimal surface disruption."
Dr. Rohini Shantharam from Fresno highlighted the technology's position in the treatment landscape: "Acne scarring is notoriously difficult to treat and often requires multiple sessions with various technologies to see even modest improvement, especially when aiming for minimal downtime. Traditional aggressive options like ablative CO2 or Erbium lasers can yield dramatic results, but come with significant recovery." She described AVAVA as offering a "balanced alternative" that creates real results without extensive downtime.
Future Applications and Development
AVAVA's breakthrough platform delivers energy precisely where needed—deep into the skin, without compromising the surface. This first clinical indication potentially paves the way for future applications, with the company noting that several more indications are under consideration.
The company plans to showcase 14 accepted abstracts and podium presentations at the upcoming ASLMS 2025 Conference in Orlando, further demonstrating the platform's broad clinical potential.
Founded by industry veterans, AVAVA positions itself as a trailblazer in medical aesthetics, redefining energy delivery to the skin through its proprietary Focal Point Technology. The platform is designed for precision, performance, and inclusivity—delivering targeted energy deep into the skin while minimizing downtime and maximizing visible results for all skin tones.
