CLEARWATER, Fla. - Apyx Medical (NASDAQ:APYX) Corporation (NASDAQ:APYX), a $62.5 million market cap developer of advanced energy technology that has seen its stock surge over 20% in the past six months, announced today its submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its AYON Body Contouring System. This new system is designed to provide surgeons with a comprehensive solution for body contouring procedures.
The AYON system aims to offer an all-in-one device that can perform a range of functions including fat removal, tissue contraction, and volume enhancement. Its initial submission to the FDA encompasses various modalities such as infiltration, dual aspiration for multiple users, ultrasound-assisted liposuction, electrocoagulation, and Renuvion treatment for skin tightening. According to InvestingPro data, the company maintains a healthy gross profit margin of 60.4% and strong liquidity with a current ratio of 5.46, though analysts note challenges ahead.
Charlie Goodwin, President and CEO of Apyx Medical (TASE:PMCN), expressed confidence that the AYON Body Contouring System will be a significant addition to the company's portfolio and will establish Apyx Medical as a leader in the aesthetic surgical market. The submission was completed nearly three months ahead of schedule, which Goodwin attributes to the dedication of their research and development teams.
Apyx Medical is known for its Helium Plasma Platform Technology, which includes products like Renuvion and J-Plasma, used in cosmetic and hospital surgical markets, respectively. These products are recognized for their precision in delivering controlled heat to tissues, with support from over 90 clinical documents.
The company plans to further expand the indications for AYON with an additional 510(k) submission later this year to include power-assisted liposuction. However, it should be noted that forward-looking statements regarding regulatory approvals and the product's potential market impact involve risks and uncertainties.
This announcement is based on a press release statement from Apyx Medical Corporation. The company's future plans and the success of the AYON Body Contouring System are subject to FDA approval and market reception. With annual revenue of $48.5 million and analysts forecasting near-term challenges, investors seeking deeper insights can access comprehensive analysis through InvestingPro, which offers exclusive ProTips and detailed financial metrics for over 1,400 US stocks, including Apyx Medical's complete Pro Research Report.
In other recent news, Apyx Medical Corporation reported its Q3 results and strategic updates. The company's total revenue for Q3 2024 fell 4% year-on-year to $11.5 million, primarily due to a 6% decrease in Advanced Energy (NASDAQ:AEIS) product sales, partially counterbalanced by a 9% rise in disposable handpiece revenue. Apyx Medical also revealed a net loss attributable to shareholders of $4.7 million, or $0.14 per share.
Despite the revenue decline, Apyx Medical remains positive about the launch of its Ayon body contouring system, anticipated in the second half of 2025, following a 510(k) submission to the FDA by Q1 2025. The company also outlined cost-saving measures, including a nearly 25% workforce reduction expected to save $4.3 million annually.
In terms of future expectations, Apyx Medical anticipates its 2024 total revenue to be between $46.6 million and $47.6 million, a 9% to 11% decrease year-over-year. However, for 2025, the company forecasts a revenue growth of 2% to 6%, with figures estimated between $47.6 million and $49.5 million. These developments are part of Apyx Medical's ongoing strategic adjustments to market pressures while preparing for future growth.
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