Apyx Medical Announces FDA Clearance For AYON Body Contouring System
FDA Clearance: Apyx Medical has received 510(k) clearance from the FDA for its AYON Body Contouring System, which will be commercially launched in late 2025 for various aesthetic treatments.
Future Plans: The company intends to expand AYON's indications to include power liposuction with an additional 510(k) submission planned for later this year.
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Apyx Medical Launches Apyx One Console in South Korea Following Regulatory Approval
- 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.
Apyx Medical Corporation Reveals $10 Million Public Offering of Common Stock Pricing
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.
Apyx Medical Corporation Unveils Plans for Public Offering of Common Stock
Public Offering Announcement: Apyx Medical Corporation has announced the commencement of an underwritten public offering of its common stock, subject to market conditions, with no assurance on the completion or terms of the offering.
Role of Lucid Capital Markets: Lucid Capital Markets is serving as the sole book-running manager for the public offering, which is being made under a previously filed shelf registration statement with the SEC.
Company Overview: Apyx Medical specializes in surgical aesthetics, offering innovative products like Renuvion and the AYON Body Contouring System, which are designed to enhance surgical procedures and patient outcomes.
Forward-Looking Statements Caution: The company has issued a cautionary statement regarding forward-looking statements, highlighting various risks and uncertainties that could affect its financial performance and the success of the public offering.
Apyx Medical Pursues FDA Approval for Broader Application of AYON Body Contouring System
FDA Submission: Apyx Medical Corporation has submitted a new 510(k) premarket notification to the FDA to expand the AYON Body Contouring System's label to include power liposuction.
AYON System Features: The AYON system, already FDA-cleared, combines fat removal, tissue contraction, contouring, and electrosurgical functions in one platform, with plans to activate new functionality upon FDA clearance.
Apyx Medical Corporation to Participate in the Canaccord Genuity 45th Annual Growth Conference
Company Announcement: Apyx Medical Corporation will participate in the Canaccord Genuity 45th Annual Growth Conference on August 12, 2025, where CEO Charlie Goodwin and CFO Matt Hill will engage in a fireside chat and hold one-on-one meetings with investors.
Product Overview: Apyx Medical specializes in advanced energy technology, offering products like Renuvion® and AYON Body Contouring System™, which utilize helium plasma and radiofrequency technology for cosmetic and surgical applications, supported by over 90 clinical publications.
Renuvion® Brings Real Transformations to the Runway at Miami Swim Week
Renuvion at Miami Swim Week: Apyx Medical's Renuvion will showcase real patient transformations at Miami Swim Week, emphasizing the empowerment and confidence gained through their treatments for loose skin.
Innovative Technology: Renuvion utilizes helium plasma and radiofrequency energy to provide effective body contouring solutions, supported by extensive clinical documentation, positioning it as a trusted option in cosmetic surgery.
Apyx Medical Launches Apyx One Console in South Korea Following Regulatory Approval
- 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.
Apyx Medical Corporation Reveals $10 Million Public Offering of Common Stock Pricing
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.
Apyx Medical Corporation Unveils Plans for Public Offering of Common Stock
Public Offering Announcement: Apyx Medical Corporation has announced the commencement of an underwritten public offering of its common stock, subject to market conditions, with no assurance on the completion or terms of the offering.
Role of Lucid Capital Markets: Lucid Capital Markets is serving as the sole book-running manager for the public offering, which is being made under a previously filed shelf registration statement with the SEC.
Company Overview: Apyx Medical specializes in surgical aesthetics, offering innovative products like Renuvion and the AYON Body Contouring System, which are designed to enhance surgical procedures and patient outcomes.
Forward-Looking Statements Caution: The company has issued a cautionary statement regarding forward-looking statements, highlighting various risks and uncertainties that could affect its financial performance and the success of the public offering.
Apyx Medical Pursues FDA Approval for Broader Application of AYON Body Contouring System
FDA Submission: Apyx Medical Corporation has submitted a new 510(k) premarket notification to the FDA to expand the AYON Body Contouring System's label to include power liposuction.
AYON System Features: The AYON system, already FDA-cleared, combines fat removal, tissue contraction, contouring, and electrosurgical functions in one platform, with plans to activate new functionality upon FDA clearance.
Apyx Medical Corporation to Participate in the Canaccord Genuity 45th Annual Growth Conference
Company Announcement: Apyx Medical Corporation will participate in the Canaccord Genuity 45th Annual Growth Conference on August 12, 2025, where CEO Charlie Goodwin and CFO Matt Hill will engage in a fireside chat and hold one-on-one meetings with investors.
Product Overview: Apyx Medical specializes in advanced energy technology, offering products like Renuvion® and AYON Body Contouring System™, which utilize helium plasma and radiofrequency technology for cosmetic and surgical applications, supported by over 90 clinical publications.
Renuvion® Brings Real Transformations to the Runway at Miami Swim Week
Renuvion at Miami Swim Week: Apyx Medical's Renuvion will showcase real patient transformations at Miami Swim Week, emphasizing the empowerment and confidence gained through their treatments for loose skin.
Innovative Technology: Renuvion utilizes helium plasma and radiofrequency energy to provide effective body contouring solutions, supported by extensive clinical documentation, positioning it as a trusted option in cosmetic surgery.
