Apyx Medical Corporation Announces Approval and Commercial Launch of Apyx One Console and Single-Use Handpieces for Cosmetic Surgical Procedures in South Korea
Rhea-AI Summary
Apyx Medical (Nasdaq: APYX) announced MFDS approval and the commercial launch of the Apyx One console and single-use handpieces for cosmetic surgical procedures in South Korea.
The company plans to begin shipping to fill initial orders starting in Q4 2025. Apyx One combines Renuvion technology with monopolar and bipolar energy and features adaptive touch screens, procedural presets, energy quantification, and an advanced gas-monitoring system.
Management cited South Korea’s cosmetic surgery market estimate of $1.7 billion in 2024 and a projected increase to $3.9 billion by 2033, and noted increased demand tied to GLP-1 weight-loss drug use and subsequent body-contouring needs.
Positive
- MFDS approval secured for Apyx One in South Korea
- Commercial shipments planned to start in Q4 2025
- Apyx One: 3-in-1 energy system plus advanced monitoring
- Target market: $1.7B (2024) South Korea cosmetic surgery market
Negative
- Forward-looking statements carry no assurance of achievement
- Company cited supply chain disruptions as a risk factor
News Market Reaction – APYX
In the Dec 3 session, APYX declined 1.72%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Dec 03 | International launch | Positive | -1.7% | MFDS approval and launch of Apyx One in South Korea’s cosmetic market. |
| Nov 18 | Equity offering priced | Negative | -5.5% | Underwritten common stock offering priced at $3.62 for about $10M gross. |
| Nov 17 | Offering proposed | Negative | +3.3% | Announcement of proposed public offering under existing Form S-3 shelf. |
| Nov 06 | Q3 earnings | Positive | +6.7% | Q3 revenue growth, margin improvement, narrowed losses and higher 2025 guidance. |
| Oct 27 | Investor conferences | Neutral | -2.5% | Management participation in November investor conferences in New York. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent history shows a mix of aligned and divergent reactions: offerings tended to see aligned weakness, while product and regulatory updates sometimes drew opposite price moves.
Over the last few months, Apyx reported improving Q3 2025 financials with higher revenue and narrowed losses, raised 2025 revenue guidance, and advanced its AYON Body Contouring System. It then filed and priced a $10.0M equity offering under an existing Form S-3, followed by an 8-K confirming the deal’s close. Against this backdrop, today’s MFDS approval and Apyx One launch in South Korea extends the company’s focus on aesthetic indications in new geographies.
Key Terms
single-use handpieces technical
monopolar medical
bipolar medical
GLP-1 medical
FDA regulatory
forward-looking statements regulatory
Ministry of Food and Drug Safety regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Initial commercial orders for the Apyx One console in South Korea are expected in Q4 2025
CLEARWATER, Fla., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Apyx Medical Corporation (Nasdaq: APYX) (the “Company” or “Apyx Medical”) the leader in surgical aesthetics marketed and sold as Renuvion® and the AYON Body Contouring System™ (AYON), today announced the approval and commercial launch of the Apyx One console and single-use handpieces in South Korea following the recent regulatory approval by the Ministry of Food and Drug Safety (MFDS). The Company plans to start shipping Apyx One consoles and single-use handpieces to South Korea to fill initial orders starting in the fourth quarter of 2025.
The Apyx One console is a multi-functional generator incorporating an advanced 3-in-1 energy system that enables plastic and cosmetic surgeons to utilize Renuvion technology, together with full monopolar and bipolar energy. Key features of the Apyx One console include adaptive and intuitive touch screens, procedural presets by body part, quantification of energy delivered to a body area, and an advanced gas system that measures and monitors gas volume and usage.
“Seoul is widely regarded as the cosmetic surgery capital of the world, supported by a thriving medical tourism industry. We are excited to launch commercial sales of the Apyx One console in South Korea, where the cosmetic surgery market is estimated to be
Source:
1) IMARC Group, “South Korea Cosmetic Surgery Market Report, 2024–2033”
Investor Relations Contact:
Jeremy Feffer, Managing Director LifeSci Advisors
OP: 212-915-2568
jfeffer@lifesciadvisors.com
About Apyx Medical Corporation:
Apyx Medical Corporation is a surgical aesthetics company with a passion for elevating people’s lives through innovative products, including its Helium Plasma Platform Technology products marketed and sold as Renuvion® and the AYON Body Contouring System™ in the cosmetic surgery market and J-Plasma® in the hospital surgical market. Renuvion and J-Plasma offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results. The effectiveness of Renuvion and J-Plasma are supported by more than 90 clinical documents. The AYON Body Contouring System is an FDA-cleared, groundbreaking, surgeon-designed body contouring system that combines precision, versatility, and innovation in an all-in-one platform. It seamlessly integrates fat removal, closed loop contouring, tissue contraction, and electrosurgical capabilities, empowering surgeons to deliver the most comprehensive body contouring treatments for patients. The Company also leverages its deep expertise and decades of experience in unique waveforms through OEM agreements with other medical device manufacturers. For further information about the Company and its products, please refer to the Apyx Medical Corporation website at www.ApyxMedical.com.
Cautionary Statement on Forward-Looking Statements:
Certain matters discussed in this release and oral statements made from time to time by representatives of the Company may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved.
All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but not limited to, statements regarding the Company’s anticipated public offering, including the completion of the public offering on the anticipated terms and the use of proceeds therefrom, projections of net revenue, margins, expenses, net earnings, net earnings per share, or other financial items; projections or assumptions concerning the possible receipt by the Company of any regulatory approvals from any government agency or instrumentality including but not limited to the U.S. Food and Drug Administration (the “FDA”), supply chain disruptions, component shortages, manufacturing disruptions or logistics challenges; or macroeconomic or geopolitical matters and the impact of those matters on the Company’s financial performance.
Forward-looking statements and information are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the Company’s ability to control or predict. Important factors that may cause the Company’s actual results to differ materially and that could impact the Company and the statements contained in this release include but are not limited to risks, uncertainties and assumptions relating to the regulatory environment in which the Company is subject to, including the Company’s ability to gain requisite approvals for its products from the FDA and other governmental and regulatory bodies, both domestically and internationally; sudden or extreme volatility in commodity prices and availability, including supply chain disruptions; changes in general economic, business or demographic conditions or trends; changes in and effects of the geopolitical environment; liabilities and costs which the Company may incur from pending or threatened litigations, claims, disputes or investigations; and other risks that are described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and the Company’s other filings with the Securities and Exchange Commission. For forward-looking statements in this release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.
