FDA Clears Candela's Matrix Radiofrequency Platform for Treatment of Facial Wrinkles

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Candela Corporation announced today that the US Food and Drug Administration (FDA) has cleared its Matrix multi-application radiofrequency skin platform for a new indication.¹

The expanded indication, for use in patients with facial wrinkles and Fitzpatrick Skin Types I-IV, adds to the Matrix platform's existing portfolio of FDA clearances for use in dermatological procedures involving hemostasis and electrocoagulation.² In this indication, treatment of facial wrinkles is performed through the use of the Matrix Pro RF microneedling applicator.

Clearance for the treatment modality was supported by a retrospective study involving 32 participants. The study, which assessed full-face treatments with the Matrix Pro, demonstrated significant clinical improvements in wrinkle appearance. Key findings include:

• Clinically Meaningful Results: The blinded evaluation of treatment photos indicated substantial improvements in facial wrinkle reduction.
• Patient Satisfaction: 94% of participants rated their outcomes as 'much improved' or 'very much improved.'

"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 Konika Schallen, MD, senior vice president of Global Clinical Operations and medical director of Candela and the Candela Institute of Excellence.¹

"In addition to serving as a skin tightening solution for aging patients, RF microneedling has promise in the expanding GLP-1 receptor agonist market," Schallen said. "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."

The Matrix system incorporates 3 modalities designed to address various aspects of skin aging. The Sublime modality uses infrared light and bipolar RF energy to stimulate dermal collagen production, improving skin tone and texture.

The Sublative modality utilizes fractionated RF energy to target deeper layers of the skin, enhancing texture and reducing the appearance of fine lines. The latest innovation, Matrix Pro, employs short pulse RF microneedling to directly address facial wrinkles by stimulating collagen and elastin production.

The Matrix system also incorporates real-time impedance monitoring, ensuring that RF energy is precisely delivered at the appropriate depth. This feature minimizes the risk of complications, such as unintended fat loss.

"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, chief executive officer of Candela.¹

"This clearance provides healthcare providers and their patients with a reliable, clinically validated treatment option for facial wrinkles," Crouse said. "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."

References

1. Candela announces FDA-clearance of new indication for Matrix multi-application radiofrequency skin platform. News release. PR Newswire. August 14, 2024. Accessed August 14, 2024. https://www.prnewswire.com/news-releases/candela-announces-fda-clearance-of-new-indication-for-matrix-multi-application-radiofrequency-skin-platform-302221615.html#:~:text=MARLBOROUGH%2C%20Mass.%2C%20Aug.,has%20received%20U.S.%20Food%20and
2. Candela introduces the new FDA-cleared profound Matrix system. News release. February 6, 2023. Accessed August 14, 2024. https://www.prnewswire.com/news-releases/candela-introduces-the-new-fda-cleared-profound-matrix-system-301739337.html