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CLEARWATER, Fla. - Apyx Medical Corporation (NASDAQ:APYX), a developer of medical devices with a market capitalization of $41.76 million, has announced the U.S. Food and Drug Administration (FDA) clearance for its AYON Body Contouring System. The company, which maintains a healthy gross margin of 61.49%, is gearing up to launch the product with key opinion leader surgeons in various important regions during the second half of 2025.
The AYON system is designed to provide an integrated solution for body contouring procedures, combining fat removal, tissue contraction, and electrosurgical capabilities in one platform. It incorporates the company’s proprietary Renuvion technology, which is aimed at treating loose and lax skin. The FDA clearance covers a wide range of aesthetic treatments, and Apyx Medical plans to seek additional clearances for expanded indications later this year. According to InvestingPro data, the company maintains strong liquidity with a current ratio of 5.45, suggesting robust operational capability for the product launch.
President and CEO Charlie Goodwin stated that the FDA approval marks a significant milestone in their mission to provide surgeons with advanced tools for enhancing patient outcomes. The company anticipates a surge in demand for body contouring procedures as patients experiencing weight loss from GLP-1 drugs look for treatments to address excess skin. With annual revenue of $47.29 million, InvestingPro analysis indicates the company faces near-term profitability challenges, though it maintains moderate debt levels.
Apyx Medical’s product portfolio includes the Helium Plasma Platform Technology, which is marketed as Renuvion for cosmetic surgery and J-Plasma for hospital surgical markets. The effectiveness of these technologies is backed by over 90 clinical documents. For detailed analysis of Apyx Medical’s financial health and growth prospects, investors can access comprehensive research reports and additional ProTips through InvestingPro’s extensive database of over 1,400 US stocks.
The company cautions that this announcement contains forward-looking statements subject to risks and uncertainties, such as regulatory approvals, supply chain disruptions, and general market conditions, which could impact actual results. Based on current InvestingPro Fair Value calculations, the stock appears to be trading near its Fair Value, with analysts setting a consensus target suggesting potential upside.
This news is based on a press release statement from Apyx Medical Corporation.
In other recent news, Apyx Medical reported its first-quarter 2025 earnings, which surpassed analyst expectations. The company recorded an earnings per share (EPS) of -$0.10, compared to the forecasted -$0.12, and revenue reached $9.4 million, slightly above the projected $9.35 million. This performance marks a positive shift from previous quarters, with Apyx Medical reducing its net loss to $4.2 million from $7.6 million a year earlier. The company also reported a 6% increase in sales of its Advanced Energy products, contributing to a gross profit margin increase to 60.1% from 58.1% the previous year. Operating expenses were significantly reduced to $8.7 million from $12.6 million, showcasing effective cost management. Despite macroeconomic challenges in the aesthetic market, Apyx Medical remains optimistic about its financial strategy and projects total revenue between $47.6 million and $49 million for 2025. The company plans to launch its AON body contouring platform in the second half of the year, pending FDA clearance. Analyst feedback from firms such as Craig Hallum Capital Group and BTIG has highlighted the company’s strategic direction and cost management efforts.
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