IRVINE, Calif. - InMode Ltd . (NASDAQ: NASDAQ:INMD), a prominent global provider of medical technology, announced today that the U.S. Food and Drug Administration (FDA) has granted an additional 510(k) clearance for its Morpheus8 technology. The clearance positions Morpheus8 as the first and only fractional radiofrequency (FRF) microneedling technology approved for the contraction of soft tissue.
The FDA's recent clearance allows for the use of Morpheus8 Applicators in dermatologic skin procedures requiring coagulation or contraction of soft tissue, or hemostasis. This expansion of Morpheus8's capabilities underscores the technology's adaptability for both physicians and patients.
In conjunction with this FDA approval, InMode is launching two new platforms, IgniteRF and OptimasMAX, which incorporate the Morpheus8 handpieces. The platforms' modular tips, including Prime 12 pin, Morpheus8 24 pin, Resurfacing 24 pin, and Morpheus8 40 pin, are designed to offer a versatile range of treatments.
The IgniteRF and OptimasMAX platforms support 14 different technologies, encompassing both minimally invasive and non-invasive procedures for skin and soft tissue.
Moshe Mizrahy, CEO of InMode, expressed the company's commitment to ongoing research and development to provide medical professionals with advanced tools for high-quality care. The new FDA clearance for soft tissue contraction is expected to broaden the patient base for Morpheus8 practitioners.
Since its launch, Morpheus8 has experienced significant global brand recognition, with over 2.5 million procedures conducted worldwide, averaging 8.2 treatments per minute. The brand's popularity extends to consumer and celebrity endorsements, known for achieving both natural and profound results.
InMode's portfolio includes a variety of medical devices that utilize radiofrequency technology for surgical and non-surgical procedures in different medical specialties, including plastic surgery, dermatology, and gynecology. This news is based on a press release statement from InMode Ltd.
In other recent news, InMode Ltd. has seen a series of developments. The medical technology company reported first-quarter 2024 earnings with total revenue of $80.3 million. However, due to industry headwinds, the company lowered its full-year guidance, citing a slowdown in sales.
In response to this, Jefferies and UBS have both adjusted their price targets for InMode, with Jefferies reducing it to $21 from $24 and UBS to $20 from $26, while maintaining their respective Buy and Neutral ratings.
InMode's second-quarter pro forma sales fell short of the consensus estimate, resulting in a reduction of their full-year 2024 revenue forecast to a range of $430 million to $440 million. In an attempt to manage these challenges, the company launched two platforms, IgniteRF and Optimus Max, and expects market demand to pick up in the second half of 2024 given a more favorable interest rate environment.
Despite a significant miss on operating margins, which came in at 27.5% compared to the anticipated 40%, InMode remains focused on fulfilling pre-orders and continuing its business investments. The company's updated 2024 guidance includes non-GAAP gross margins of 82%-84%, and non-GAAP EPS of $2.01-$2.05. These developments are part of InMode's recent strategic efforts to navigate the current economic landscape.
InvestingPro Insights
Following the recent FDA clearance for InMode Ltd.'s Morpheus8, the company's financial health and market performance are of particular interest to investors monitoring the potential impact of this development. InMode holds a robust position, as indicated by a market capitalization of 1.61 billion USD, signaling a strong presence in the industry.
InvestingPro data shows that the company's P/E ratio stands at 8.91 when adjusted for the last twelve months as of Q1 2024. This metric suggests that InMode's shares are trading at a value that reflects its earnings, potentially attracting value-oriented investors. The company's gross profit margin for the same period is an impressive 83.1%, highlighting efficient operations and a strong command over cost management.
An InvestingPro Tip worth noting is that InMode has more cash than debt on its balance sheet, providing it with financial flexibility and resilience. Moreover, analysts predict that the company will be profitable this year, which is a reassuring sign for stakeholders considering the company's growth trajectory amidst its latest FDA approval.
For those seeking deeper insights into InMode's financial performance and future outlook, InvestingPro offers additional tips, including recent analyst earnings revisions and stock price volatility. There are 11 more InvestingPro Tips available for InMode, which can be accessed by visiting: https://www.investing.com/pro/INMD. To enhance your investing strategy with these insights, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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