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.

Medical Research Analyst

The FDA clearance for Morpheus8 marks a significant milestone for InMode Ltd. as it enables the technology to be used specifically for soft tissue contraction in dermatologic procedures. This expands the potential applications and patient demographics for Morpheus8, a procedure already known for its effectiveness and popularity. Soft tissue contraction is a desirable feature in cosmetic medicine because it can lead to improved skin texture and appearance, which could drive higher adoption rates among dermatologists and aesthetic practitioners. Clinical validation through FDA clearance also boosts the credibility and market positioning of Morpheus8, potentially translating to increased sales and market share in the competitive aesthetic devices industry.

Additionally, the launch of the IgniteRF and OptimasMAX platforms provides a more versatile and comprehensive offering for practitioners, which is likely to result in higher revenue per customer. The introduction of modular handpieces and various pin configurations further underscores the versatility of InMode's solutions, adding value to the investment for healthcare providers and enhancing the potential for repeated use and up-selling of additional services.

However, one must consider the competitive landscape. While Morpheus8’s unique FDA clearance for soft tissue contraction is a strong differentiator, competitors may respond by enhancing their offerings or pursuing similar clearances. The fast pace of technological advancement in the aesthetic devices industry necessitates continuous innovation to maintain competitive advantage.

Market Research Analyst

The additional FDA clearance and the launch of new platforms come at a time when the global market for aesthetic devices is rapidly expanding. The global aesthetic devices market is projected to grow significantly over the next few years, driven by rising consumer demand for minimally invasive and non-invasive procedures. InMode is well-positioned to capitalize on this trend with its expanded Morpheus8 offerings, which cater to a broad range of dermatologic applications.

The branding strength of Morpheus8, evident from its widespread recognition and celebrity endorsements, offers a competitive edge. The integration of multiple technologies into the IgniteRF and OptimasMAX platforms increases the likelihood of adoption by clinics looking for multi-functional devices that offer a comprehensive suite of treatments. This could lead to increased market penetration in both existing and new markets.

From a retail investor's perspective, the FDA clearance and new product launches are likely to be viewed positively as they indicate potential for revenue growth and enhanced market position. Investors should monitor key metrics such as sales growth, market share and customer adoption rates to gauge the long-term success of these initiatives. While the immediate impact on stock price may be positive, long-term value will depend on the company's ability to sustain innovation and defend its market position against competitors.

Financial Analyst

For InMode Ltd., the additional FDA clearance and product launches could have significant financial implications. The approval expands the company's potential for revenue growth by broadening the applications of Morpheus8 technology, which is already a key driver of the company's sales. The new products under the IgniteRF and OptimasMAX platforms could lead to incremental revenue streams by offering healthcare providers more comprehensive treatment options.

The market's initial reaction might see an uptick in stock price due to the perceived increase in the company's growth prospects. However, investors should consider the costs associated with these product launches, including R&D expenses, marketing and distribution. These factors could impact the company's short-term margins until the products gain significant traction in the market.

The broader impact on InMode's financials will also depend on how quickly the new technologies are adopted by medical professionals and the efficacy of their marketing strategies. Given the company's history of successful product launches and strong brand recognition, the long-term outlook appears promising. Nevertheless, investors should watch for quarterly earnings reports to assess how well these new products are performing and contributing to overall revenue and profitability.

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

Logo - https://mma.prnewswire.com/media/1064477/4815375/InMode_Logo.jpg

View original content to download multimedia:https://www.prnewswire.com/news-releases/morpheus8-secures-first-and-only-fda-clearance-for-soft-tissue-contraction-for-fractional-radiofrequency-microneedling-302198891.html

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.