Candela Announces FDA-Clearance of New Indication for Matrix™ Multi-Application Radiofrequency Skin Platform

Platform’s Matrix Pro^® RF Microneedling Applicator Now Includes Expanded Indication for Facial Wrinkle Reduction

MARLBOROUGH, Massachusetts, August 14, 2024 – Candela Corporation (Candela), a leading global medical aesthetic device company headquartered in Marlborough, MA, today announced that the Matrix^™ system, a first-of-its-kind radiofrequency (RF) platform for comprehensive skin treatments, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types (FST) I-IV using its Matrix Pro^® RF microneedling applicator. The applicator was previously FDA-cleared for use in general dermatological procedures involving hemostasis and electrocoagulation.

The Matrix multi-application RF skin platform is equipped with three distinct modalities of RF energy to tighten, tone, and improve skin texture at various stages of the aging journey through its Sublime^®, Sublative^™, and Matrix Pro^® applicators. The platform’s Matrix Pro applicator employs short pulse RF microneedling to stimulate collagen and elastin productionⁱ, resulting in smoother skin and a reduction in the appearance of facial wrinkles. Designed with Depth Intelligence^™ technology, real-time impedance monitoring, and an array of the thinnest, stainless-steel microneedles on the market, the applicator delivers a precise amount of energy at one, two, or three depths of the skin, all in a single insertion. The Matrix Pro applicator is the only RF microneedling solution FDA-cleared for percutaneous facial wrinkles that uses an advanced algorithm to continuously measure tissue impedance and make necessary adjustments to pulse duration and power output. This allows the system to deliver superior patient outcomes by preventing unintentional fat loss or other undesirable results.

FDA clearance for the new indication is based on retrospective study data from 32 subjects receiving full-face treatments with the Matrix Pro applicator for facial wrinkle reduction. The study demonstrated a clinically meaningful improvement in facial wrinkle appearance based on blinded evaluation of treatment photos. Additionally, 94% of study subjects rated their treatment outcomes as ‘much improved’ or ‘very much improved.’

“Achieving FDA clearance using the Matrix Pro applicator for wrinkle reduction is a testament to our rigorous testing, clinical validation processes, and dedication to advancing outcomes through proven science and technology," said Geoffrey Crouse, Candela Chief Executive Officer. "This clearance provides healthcare providers and their patients with a reliable, clinically validated treatment option for facial wrinkles. Our Matrix Pro applicator with its expanded facial wrinkle indication, further combined with the unique treatment capabilities of the Sublime and Sublative applicators, exemplifies our unique approach, integrating state-of-the-art research and development of multi-modality solutions to deliver superior results.”

Candela's innovative technology and comprehensive product offering continues to set new standards in the medical aesthetic industry, and the FDA clearance for the Matrix Pro applicator further solidifies the Company's commitment to providing cutting-edge solutions for skin health and rejuvenation.

“The advanced technology of the Matrix Pro applicator ensures minimal discomfort and downtime, making it a preferred choice for patients seeking quick and visible improvements,” said Dr. Konika Schallen, Senior Vice President of Global Clinical Operations and Medical Director of Candela and the Candela Institute of Excellence (CIE). “In addition to serving as a skin tightening solution for aging patients, RF microneedling has promise in the expanding GLP-1 receptor agonist market. The Matrix system's ability to regenerate collagen has promise with addressing the loss of facial volume associated with rapid weight loss induced by these highly sought-after injectable medications.”

For more information about the Matrix system and its Matrix Pro RF microneedling applicator, please visit https://candelamedical.com/products/matrix.

About Candela Corporation
Candela is a leading global medical aesthetic device company with an extensive product portfolio and a global distribution footprint. The company's technology enables physicians to provide advanced solutions for a broad range of medical aesthetic applications including hair removal, wrinkle reduction, tattoo removal, women's health treatments, facial resurfacing, traumatic and surgical scar treatments, body contouring, improving the skin's appearance through the treatment of benign vascular and pigmented lesions, and the treatment of acne, leg veins, and cellulite. Candela’s trusted and leading IPL, RF, and laser-based platforms, including Matrix^™, Vbeam^®, the Gentle^® Family, Nordlys^®, PicoWay^®, Frax Pro^®, and Exceed^™. Acquired by Apax Partners in July 2017, Candela markets, services and supports its products in 86 countries worldwide. It has offices in the United States, Australia, Canada, China, France, Germany, Hong Kong, Israel, Italy, Japan, Portugal, Spain, the United Kingdom, as well as many international distributors.