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

Rhea-AI Summary

InMode (NASDAQ: INMD) has announced an additional FDA 510(k) clearance for its Morpheus8 technology, making it the first and only fractional radiofrequency (FRF) microneedling technology cleared for soft tissue contraction. This expands Morpheus8's existing FDA clearance, enhancing its versatility for physicians and patients.

Alongside this clearance, InMode is launching the new IgniteRF and OptimasMAX platforms, which include the Morpheus8 family of handpieces. These platforms support 14 technologies, offering a comprehensive solution for various skin treatments.

Morpheus8 has gained significant global brand awareness, with over 2.5 million procedures performed worldwide and an average of 8.2 treatments performed every minute. The technology's popularity has made it a trusted and requested procedure among consumers and celebrities alike.

Positive

• Morpheus8 received FDA clearance for soft tissue contraction, expanding its applications
• Launch of new IgniteRF and OptimasMAX platforms, supporting 14 technologies
• Over 2.5 million Morpheus8 procedures performed worldwide
• High brand awareness and popularity among consumers and celebrities

Negative

• None.

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.

Press Contact:
Behrman Cesa Communications
inmode@behrmancesa.com

Investor Contact:
MS-IR LLC
Miri Segal – Scharia
ir@inmodemd.com
Tel: 917-607-8654

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SOURCE InMode Ltd.

FAQ

What new FDA clearance did InMode's Morpheus8 technology receive?

Morpheus8 received FDA 510(k) clearance for soft tissue contraction, making it the first and only fractional radiofrequency microneedling technology with this specific clearance.

What new platforms did InMode (INMD) launch alongside the FDA clearance?

InMode launched the new IgniteRF and OptimasMAX platforms, which include the Morpheus8 family of handpieces and support 14 different technologies for various skin treatments.

How many Morpheus8 procedures have been performed worldwide?

Over 2.5 million Morpheus8 procedures have been performed worldwide, with an average of 8.2 treatments performed every minute.

What is the significance of the new FDA clearance for InMode's Morpheus8?

The new FDA clearance expands Morpheus8's existing clearance, emphasizing its versatility and allowing practitioners to expand their patient base by offering soft tissue contraction treatments.