AVAVA Receives FDA 510(k) Clearance for its First-in-Class High Energy Skin Renewal Platform – MIRIA Skin Treatment System
WALTHAM, Mass., Wednesday, December 07, 2022 — AVAVA Inc. (“AVAVA” or the “Company”), a disruptive medical aesthetics platform company advancing a new class of focused intradermal laser products for breakthrough treatments of all skin tones, today announced that its MIRIA Skin Treatment System (“MIRIA system”) has received FDA 510(k) clearance for prevention (pre-rejuvenation) and treatment (rejuvenation) of skin aging. This marks a first of its kind regulatory clearance for a high energy focused intradermal laser, powered by Focal Point Technology™, that delivers energy at any depth in the skin with pinpoint accuracy, making it ideal for patients with darker skin tones.
The MIRIA system is the only FDA cleared laser product that more than doubles the current therapeutic energy dose, creating a fundamental shift in how laser energy is used to treat the deepest layers of the skin. Laser systems used in aesthetics today have a maximum pulse energy of 70mj and are broadly considered unsafe for darker skin tones. The MIRIA System with Focal Point Technology delivers up to 150mj of conical energy to the dermis and spares the sensitive epidermis from unwanted damage – all while maintaining patient comfort and with minimal downtime.
Extensive MIRIA clinical studies have demonstrated improvement in all signs of skin aging, including wrinkles, sun damage, and skin quality, as well as reduction in pitted acne scarring and large pore size.
Dr. Valerie Callender, a cosmetic and medical dermatologist in Glenn Dale MD, said, “There is a severe lack of safe and effective aesthetic treatment options for patients with skin of color. With the MIRIA system, we now have the ability to safely renew the deeper levels of the skin and improve skin conditions that include deep acne scars and Pseudofolliculitis Barbae (caused by ingrown hair), which afflicts up to 83% of black men. In my practice, this is transformative, particularly for patients with darker skin types for whom conventional laser treatments are unsafe or ineffective.”
Dr. Irina Erenburg, CEO of AVAVA, said, “We are excited to announce FDA clearance of our MIRIA System, the industry’s first and only intradermally focused high energy laser system that enables precision therapy delivering optimal provider and patient experience. This remarkable system opens up the world of lasers to a broader range of patients who have previously had limited options.” Dr. Erenburg added, “We look forward to a commercial introduction of our MIRIA System next year, as we address the needs of over 11.7 million US-individuals of all skin tones that seek facial rejuvenation each year.”
AVAVA is a disruptive medical aesthetics technology platform company providing breakthrough treatments for all skin types. AVAVA develops and markets a new class of FDA cleared, non-invasive medical aesthetic products that utilize patented precision Focal Point Technology and proprietary skin AI visualization to provide best in class patient and provider experience for all skin tones. The AVAVA Focal Point Technology™ is complemented by a IntelliView, a high-resolution interactive imaging system, which provides treatment intelligence to map and guide real-time therapy with actionable data, to unlock safe and effective treatments. For more information, please visit avavaaesthetics.com.