Apyx Medical Corporation Submits 510(k) Premarket Notification to the U.S. Food and Drug Administration for the AYON Body Contouring System™
Apyx Medical (NASDAQ:APYX) has submitted a 510(k) premarket notification to the FDA for its AYON Body Contouring System, nearly 90 days ahead of schedule. The system is designed as an all-in-one platform for surgical body contouring procedures.
The initial submission includes multiple functionalities: infiltration, dual aspiration for simultaneous users, ultrasound-assisted liposuction, electrocoagulation for excess tissue removal, volume enhancement capabilities, and Renuvion treatment for loose and lax skin. The company plans to expand AYON's indications with an additional 510(k) submission later this year to include power-assisted liposuction.
Apyx Medical (NASDAQ:APYX) ha presentato una notifica 510(k) pre-market all'FDA per il suo AYON Body Contouring System, con quasi 90 giorni di anticipo rispetto al previsto. Il sistema è progettato come una piattaforma integrata per procedure chirurgiche di rimodellamento del corpo.
La presentazione iniziale include molteplici funzionalità: infiltrazione, aspirazione duale per utenti simultanei, liposuzione assistita da ultrasuoni, elettrocoagulazione per la rimozione di tessuti in eccesso, capacità di aumento volumetrico e trattamento Renuvion per la pelle flaccida e rilassata. L'azienda prevede di ampliare le indicazioni di AYON con una ulteriore presentazione 510(k) entro la fine dell'anno per includere la liposuzione assistita da potenza.
Apyx Medical (NASDAQ:APYX) ha presentado una notificación 510(k) a la FDA para su Sistema de Contorno Corporal AYON, casi 90 días antes de lo programado. El sistema está diseñado como una plataforma integral para procedimientos quirúrgicos de contorno corporal.
La presentación inicial incluye múltiples funcionalidades: infiltración, aspiración dual para usuarios simultáneos, liposucción asistida por ultrasonido, electrocoagulación para la eliminación de tejido en exceso, capacidades de realce de volumen y tratamiento Renuvion para la piel suelta y flácida. La empresa planea ampliar las indicaciones de AYON con una presentación adicional 510(k) a finales de este año para incluir la liposucción asistida por potencia.
Apyx Medical (NASDAQ:APYX)는 AYON 바디 컨투어링 시스템에 대한 510(k) 사전 시장 알림을 FDA에 제출했으며, 이는 예정일보다 거의 90일 빠른 것입니다. 이 시스템은 외과적 바디 컨투어링 절차를 위한 올인원 플랫폼으로 설계되었습니다.
초기 제출물에는 여러 기능이 포함됩니다: 주입, 동시 사용자에 대한 이중 흡입, 울트라사운드 보조 리포석션, 과도한 조직 제거를 위한 전기 응고, 볼륨 증대 기능, 그리고 느슨하고 늘어진 피부를 위한 Renuvion 치료. 이 회사는 올해 말 추가 510(k) 제출을 통해 AYON의 적응증을 전원 보조 리포석션을 포함하도록 확대할 계획입니다.
Apyx Medical (NASDAQ:APYX) a soumis une notification de pré-commercialisation 510(k) à la FDA pour son Système de Contournement Corporel AYON, près de 90 jours avant la date prévue. Le système est conçu comme une plateforme tout-en-un pour les procédures chirurgicales de modelage corporel.
La soumission initiale comprend plusieurs fonctionnalités : infiltration, aspiration duale pour utilisateurs simultanés, liposuccion assistée par ultrasons, électrocoagulation pour l'élimination des tissus excédentaires, capacités d'augmentation de volume, et traitement Renuvion pour la peau lâche et flasque. L'entreprise prévoit d'élargir les indications d'AYON avec une soumission 510(k) supplémentaire plus tard cette année pour inclure la liposuccion assistée par puissance.
Apyx Medical (NASDAQ:APYX) hat eine 510(k) Vorabbenachrichtigung bei der FDA für ihr AYON Body Contouring System eingereicht, und zwar nahezu 90 Tage vor dem geplanten Termin. Das System ist als All-in-One-Plattform für chirurgische Körperkonturierungsverfahren konzipiert.
Die ursprüngliche Einreichung umfasst mehrere Funktionalitäten: Infiltration, doppelte Aspiration für gleichzeitige Nutzer, ultraschallunterstützte Liposuktion, Elektrokoagulation zur Entfernung von überschüssigem Gewebe, Volumensteigerungsmöglichkeiten und Renuvion-Behandlung für lose und schlaffe Haut. Das Unternehmen plant, die Indikationen von AYON mit einer weiteren 510(k)-Einreichung später in diesem Jahr zu erweitern, um die power-assisted Liposuktion einzuschließen.
- 510(k) submission completed 90 days ahead of schedule
- Development of comprehensive all-in-one body contouring platform
- Planned expansion of indications with additional 510(k) submission
- FDA approval still pending
- Additional regulatory submissions required for complete functionality
Insights
This 510(k) submission for the AYON Body Contouring System represents a strategic expansion into the $15.9 billion global body contouring market. The integrated platform approach combining multiple modalities (infiltration, aspiration, ultrasound-assisted liposuction, electrocoagulation and Renuvion) in one system positions APYX to capture larger market share by offering operational efficiency and cost benefits to surgical practices.
The earlier-than-expected submission (90 days ahead) suggests strong execution capabilities and could accelerate time-to-market. The planned follow-up 510(k) for power-assisted liposuction indicates a phased regulatory strategy to maintain momentum. Based on typical FDA review timelines for 510(k) submissions of similar complexity, expect a 4-6 month review period, potentially leading to market entry by Q3 2025.
For simpler understanding: Think of AYON as a Swiss Army knife for body contouring - instead of surgeons needing 5-6 different expensive machines, they get all tools in one integrated system. This saves space, money and makes procedures more efficient.
The all-in-one platform strategy directly addresses key market pain points in the surgical aesthetics space. Current body contouring requires multiple devices from different manufacturers, creating workflow inefficiencies and higher capital costs for practices. By consolidating multiple functions into one system, APYX could capture significant market share from established players like Allergan, InMode and Sientra.
Integration of the company's proprietary Renuvion technology with standard body contouring modalities creates a compelling competitive advantage and potential for premium pricing. The surgical aesthetics market is projected to grow at 9.8% CAGR through 2030, driven by increasing demand for minimally invasive procedures. AYON's timing aligns well with these market dynamics.
Simple explanation: Imagine running a restaurant kitchen - it's much more efficient and cost-effective to have one advanced multipurpose cooking station than buying separate appliances for each cooking method. That's what AYON offers to cosmetic surgeons.
Focusing on advancing body contouring by providing the first all-in-one platform for the surgical suite
CLEARWATER, Fla., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Apyx® Medical Corporation (NASDAQ:APYX) (“Apyx Medical”; the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, is pleased to announce it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (the “FDA”) for the AYON Body Contouring System.
The AYON Body Contouring System was developed with a focus on versatility and innovation. AYON has been designed to be the only device a surgeon needs for comprehensive body contouring solutions. This all-in-one system integrates advanced modalities to perform multiple functions seamlessly, removing unwanted fat, enhancing tissue contraction and addressing the full range of patient needs from contouring to aesthetic enhancement. The initial submission for AYON includes the following:
- Infiltration
- Dual aspiration to facilitate simultaneous users
- Ultrasound-assisted liposuction
- Electrocoagulation to support procedures requiring removal of excess tissue
- Volume enhancement capabilities
- Renuvion treatment to address loose and lax skin
Later this year, the Company plans to expand the indications with an additional 510(k) submission for AYON to include power assisted liposuction.
“We believe the AYON Body Contouring System is a game changer for surgeons, one that will differentiate and further position Apyx Medical as the premier aesthetic surgical company,” said Charlie Goodwin, President, and CEO of Apyx Medical Corporation. “We are pleased to make this announcement almost 90 days earlier than originally expected, a testament to the capabilities of the hard-working research, development, quality and regulatory teams at Apyx Medical.”
About Apyx Medical Corporation:
Apyx Medical Corporation is an advanced energy technology company with a passion for elevating people’s lives through innovative products, including its Helium Plasma Platform Technology products marketed and sold as Renuvion® 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 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, 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, 2023 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.
Investor Relations Contact:
Jeremy Feffer, Managing Director LifeSci Advisors
OP: 212-915-2568
jfeffer@lifesciadvisors.com
FAQ
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