Apyx Medical receives FDA clearance for AYON Body Contouring System
FDA Clearance Announcement: Apyx Medical Corporation has received 510(k) clearance from the U.S. FDA for its AYON Body Contouring System.
Commercial Launch Plans: The company is preparing for a commercial launch of AYON with key surgeons in critical regions, expected to start in the second half of 2025.
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- Improved Financial Performance: Apyx Medical reported a narrower net loss of $1.29 million in Q4 2025, translating to a loss of $0.03 per share, a significant improvement from $4.63 million and $0.12 per share in the previous year, indicating enhanced financial health.
- Significant Revenue Growth: Total revenue surged 34.7% to $19.16 million, primarily driven by a 36% increase in surgical aesthetics sales, particularly bolstered by the strong performance of the AYON product since its commercial launch in September 2025, which further propelled overall results.
- Optimistic 2026 Outlook: The company raised its 2026 revenue guidance to between $57.5 million and $58.5 million, reflecting an 8% to 10% increase from $52.8 million in 2025, showcasing confidence in future market demand.
- Strong Cash Position: As of December 31, 2025, Apyx Medical had cash and cash equivalents of $31.74 million, and with stringent cost controls and effective working capital management, the company expects its cash runway to extend through 2027, enhancing financial stability.
- Significant Revenue Growth: Apyx Medical reported a revenue of $19.2 million for Q4 2025, a 35% increase from $14.2 million in Q4 2024, indicating strong performance amid robust market demand.
- Strong Surgical Aesthetics Performance: The surgical aesthetics segment generated $16.7 million, reflecting a 38% year-over-year increase, primarily driven by the successful launch of the Aon body contouring system, showcasing the company's competitive edge in this market.
- Reduced Net Loss: Despite revenue growth, Apyx reported a net loss of $1.3 million for Q4, significantly improved from a loss of $4.6 million in the same quarter last year, highlighting effective cost control and operational efficiency.
- Optimistic 2026 Outlook: The company anticipates total revenue guidance of $57.5 million to $58.5 million for 2026, representing a 9% to 11% increase from 2025, with the surgical aesthetics segment expected to grow by 17% to 19%, reflecting confidence in future growth prospects.
- Record Revenue: Apyx Medical reported a record revenue of $19.2 million for Q4 2025, a 35% increase year-over-year, with surgical aesthetics product sales rising 38% to $16.7 million, primarily driven by the successful launch of the AYON body contouring system, indicating strong performance in the rapidly growing surgical aesthetics market.
- AYON System Innovation: The AYON system integrates fat removal, closed-loop contouring, tissue contraction, and electrosurgical capabilities, designed to address many challenges of existing systems, and is expected to further solidify its position as the first fully integrated body contouring system, with a 510(k) application for expanded functionality anticipated.
- Optimistic Market Outlook: The company expects total revenue for fiscal year 2026 to range between $57.5 million and $58.5 million, representing a 9% to 11% increase, with surgical aesthetics segment revenue guidance set at $53 million to $54 million, reflecting a continued focus and resource allocation to this segment.
- Cost Control and Cash Flow: Operating expenses remained flat at $12 million, while Apyx Medical achieved an adjusted EBITDA of $0.7 million, with cash and cash equivalents standing at $31.7 million, projected to last through 2027, indicating a commitment to maintaining financial health while actively positioning for future growth.
- Earnings Highlights: Apyx Medical reported a Q4 GAAP EPS of -$0.03, beating expectations by $0.03, indicating an improvement in the company's profitability.
- Revenue Growth: The company achieved Q4 revenue of $19.16 million, a 34.7% year-over-year increase, surpassing expectations by $0.04 million, reflecting the growing market acceptance of the AYON platform.
- EBITDA Improvement: Adjusted EBITDA was $0.7 million, a significant turnaround from a loss of $2.2 million in Q4 2024, showcasing the company's effective cost control and operational efficiency.
- Cash Flow Outlook: As of December 31, 2025, the company had cash and cash equivalents of $31.7 million, with management projecting positive cash flow through 2027 based on effective working capital management and strict cost controls.

- Market Entry: Apyx Medical Corporation has received regulatory approval from the Ministry of Food and Drug Safety in South Korea and plans to start shipping the Apyx One console and single-use handpieces in Q4 2025, marking a significant expansion in the global aesthetic surgery market.
- Technological Innovation: The Apyx One console features an advanced 3-in-1 energy system that enables plastic surgeons to utilize Renuvion technology, enhancing surgical flexibility and efficiency, which is expected to boost the company's competitiveness in the rapidly growing South Korean aesthetic market.
- Market Potential: The cosmetic surgery market in South Korea is projected to reach $1.7 billion in 2024 and exceed $3.9 billion by 2033, providing substantial market opportunities for Apyx Medical's products, particularly with the increasing demand for skin tightening solutions following significant weight loss.
- Strategic Positioning: Apyx Medical's CEO highlighted that entering South Korea, known as the cosmetic surgery capital of the world, will support the company's long-term growth strategy in the Asia-Pacific region, especially as the GLP-1 weight-loss drug market rapidly expands, attracting more patients seeking body contouring solutions.

Public Offering Announcement: Apyx Medical Corporation has priced its underwritten public offering of 2,762,431 shares of common stock at $3.62 per share, with the offering expected to close on or about November 19, 2025.
Use of Proceeds: The company plans to use the net proceeds from the offering for working capital and general corporate purposes.
Underwriter Details: Lucid Capital Markets is the sole book-running manager for the offering, which includes a 45-day option for the underwriter to purchase an additional 414,365 shares.
Company Overview: Apyx Medical specializes in surgical aesthetics, offering innovative products like Renuvion and the AYON Body Contouring System, supported by extensive clinical documentation.








