Morpheus8 Secures First and Only FDA Clearance for Soft Tissue Contraction for Fractional Radiofrequency Microneedling

IRVINE, Calif., July 17, 2024 /PRNewswire/ -- InMode Ltd. (NASDAQ: INMD), a leading global provider of innovative medical technologies, is pleased to announce an additional FDA 510(k) clearance for the Morpheus8 technology. Morpheus8 is the first and only fractional radiofrequency (FRF) microneedling technology cleared for contraction of soft tissue.

The U.S. Food and Drug Administration (FDA) has cleared the use of the Morpheus8 Applicators for the delivery of fractional radiofrequency use in dermatologic skin procedures where coagulation/contraction of soft tissue or hemostasis is needed. This FDA action expands Morpheus8's existing FDA clearance, emphasizing the versatility of the technology for physicians and patients.

Coinciding with this clearance is the launch of the new IgniteRF and OptimasMAX platforms, which include the Morpheus8 family of handpieces. The modular portfolio of tips, including Prime 12 pin, Morpheus8 24 pin, Resurfacing 24 pin, and Morpheus8 40 pin, makes this technology a versatile solution delivering exceptional patient results. The IgniteRF and OptimasMAX platforms support 14 technologies, including minimally invasive radiofrequency assisted soft tissue coagulation and contraction, non-invasive thermal radiofrequency, intense pulsed light skin treatments, and multi-wavelength hair reduction.

"InMode is dedicated to investing in R&D so we can provide medical professionals with continued advancements they need to deliver the highest quality of care and best-in-class results," said Moshe Mizrahy, CEO of InMode. "The new indication for soft tissue contraction enhances the product's intended use, helping Morpheus8 practitioners expand their patient base."

Since inception, Morpheus8 has gained widespread global brand awareness, with more than 2.5 million procedures performed worldwide, and an average of 8.2 treatments performed every minute. The Morpheus8 brand has become so popular that consumers and celebrities request it by name. It is a trusted procedure known for delivering both natural and striking results.

About InMode

InMode is a leading global provider of innovative medical technologies. InMode develops, manufactures, and markets devices harnessing novel radiofrequency ("RF") technology. InMode strives to enable new emerging surgical procedures as well as improve existing treatments. InMode has leveraged its medically accepted minimally invasive RF technologies to offer a comprehensive line of products across several categories for plastic surgery, gynecology, dermatology, otolaryngology, and ophthalmology. For more information about InMode and its wide array of medical technologies, visit www.inmodemd.com.

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SOURCE InMode Ltd.