Apyx Medical Corporation Announces Two Peer-Reviewed Publications on the Use of Renuvion in Abdominal Body Contouring Procedures
Apyx Medical announced two significant peer-reviewed publications validating the use of their Renuvion technology in abdominal body contouring procedures. The first study, published in Aesthetic Plastic Surgery, was a randomized controlled trial with 76 patients comparing lipoabdominoplasty with and without Renuvion. Results showed higher patient satisfaction and better improvements in skin laxity for the Renuvion group over a 2-year period.
The second study in Aesthetic Surgery Journal Open Forum examined 77 patients undergoing ultrasound-assisted lipoabdominoplasty. The research confirmed that adding Renuvion did not increase complications, despite longer surgical times. Notably, CEO Charlie Goodwin highlighted that with over 15 million patients using GLP-1 drugs, Renuvion is uniquely positioned as the only FDA-cleared device for addressing loose skin post-liposuction in aesthetic procedures.
Apyx Medical ha annunciato due importanti pubblicazioni peer-reviewed che confermano l'efficacia della loro tecnologia Renuvion nelle procedure di rimodellamento addominale. Il primo studio, pubblicato su Aesthetic Plastic Surgery, è stato un trial controllato randomizzato su 76 pazienti che ha confrontato la lipoaddominoplastica con e senza Renuvion. I risultati hanno evidenziato una maggiore soddisfazione dei pazienti e un miglioramento più significativo della lassità cutanea nel gruppo trattato con Renuvion nel corso di due anni.
Il secondo studio, pubblicato su Aesthetic Surgery Journal Open Forum, ha analizzato 77 pazienti sottoposti a lipoaddominoplastica assistita da ultrasuoni. La ricerca ha confermato che l’aggiunta di Renuvion non ha aumentato le complicazioni, nonostante tempi chirurgici più lunghi. In particolare, il CEO Charlie Goodwin ha sottolineato che, con oltre 15 milioni di pazienti che utilizzano farmaci GLP-1, Renuvion si distingue come l’unico dispositivo approvato dalla FDA per trattare la pelle flaccida post-liposuzione nelle procedure estetiche.
Apyx Medical anunció dos importantes publicaciones revisadas por pares que validan el uso de su tecnología Renuvion en procedimientos de contorno corporal abdominal. El primer estudio, publicado en Aesthetic Plastic Surgery, fue un ensayo controlado aleatorizado con 76 pacientes que comparó lipoabdominoplastia con y sin Renuvion. Los resultados mostraron una mayor satisfacción de los pacientes y mejores mejoras en la laxitud de la piel para el grupo con Renuvion durante un período de 2 años.
El segundo estudio en Aesthetic Surgery Journal Open Forum examinó a 77 pacientes sometidos a lipoabdominoplastia asistida por ultrasonido. La investigación confirmó que añadir Renuvion no incrementó las complicaciones, a pesar de tiempos quirúrgicos más largos. Cabe destacar que el CEO Charlie Goodwin resaltó que, con más de 15 millones de pacientes usando medicamentos GLP-1, Renuvion está posicionado de manera única como el único dispositivo aprobado por la FDA para tratar la piel flácida tras la liposucción en procedimientos estéticos.
Apyx Medical는 복부 바디 컨투어링 시술에 자사의 Renuvion 기술 사용을 입증하는 두 건의 중요한 동료 검토 논문을 발표했습니다. 첫 번째 연구는 Aesthetic Plastic Surgery에 게재된 무작위 대조 시험으로, 76명의 환자를 대상으로 Renuvion을 사용한 리포복부성형술과 사용하지 않은 경우를 비교했습니다. 결과는 2년 동안 Renuvion 그룹에서 환자 만족도와 피부 탄력 개선이 더 높게 나타났습니다.
두 번째 연구는 Aesthetic Surgery Journal Open Forum에 실렸으며, 초음파 보조 리포복부성형술을 받은 77명의 환자를 조사했습니다. 연구 결과 Renuvion 추가 시 수술 시간이 길어졌음에도 불구하고 합병증이 증가하지 않았음을 확인했습니다. 특히 CEO Charlie Goodwin은 GLP-1 약물을 사용하는 환자가 1,500만 명이 넘는 상황에서, Renuvion이 지방흡입 후 느슨해진 피부를 치료하는 FDA 승인 유일의 기기로 독보적인 위치에 있다고 강조했습니다.
Apyx Medical a annoncé deux publications importantes évaluées par des pairs validant l’utilisation de leur technologie Renuvion dans les procédures de remodelage abdominal. La première étude, publiée dans Aesthetic Plastic Surgery, était un essai contrôlé randomisé portant sur 76 patients comparant la lipoabdominoplastie avec et sans Renuvion. Les résultats ont montré une satisfaction plus élevée des patients et une meilleure amélioration du relâchement cutané pour le groupe Renuvion sur une période de 2 ans.
La deuxième étude, publiée dans Aesthetic Surgery Journal Open Forum, a examiné 77 patients ayant subi une lipoabdominoplastie assistée par ultrasons. La recherche a confirmé que l’ajout de Renuvion n’augmentait pas les complications, malgré des durées opératoires plus longues. Notamment, le PDG Charlie Goodwin a souligné qu’avec plus de 15 millions de patients utilisant des médicaments GLP-1, Renuvion se positionne comme le seul dispositif approuvé par la FDA pour traiter la peau relâchée après une liposuccion dans les procédures esthétiques.
Apyx Medical gab zwei bedeutende, peer-reviewte Publikationen bekannt, die den Einsatz ihrer Renuvion-Technologie bei abdominalen Körperkonturierungsverfahren validieren. Die erste Studie, veröffentlicht in Aesthetic Plastic Surgery, war eine randomisierte kontrollierte Studie mit 76 Patienten, die Lipoabdominoplastik mit und ohne Renuvion verglich. Die Ergebnisse zeigten über einen Zeitraum von 2 Jahren eine höhere Patientenzufriedenheit und bessere Verbesserungen der Hauterschlaffung in der Renuvion-Gruppe.
Die zweite Studie im Aesthetic Surgery Journal Open Forum untersuchte 77 Patienten, die sich einer ultraschallassistierten Lipoabdominoplastik unterzogen. Die Forschung bestätigte, dass die Zugabe von Renuvion trotz längerer Operationszeiten keine Komplikationen erhöhte. Besonders hob CEO Charlie Goodwin hervor, dass mit über 15 Millionen Patienten, die GLP-1-Medikamente verwenden, Renuvion als einziges von der FDA zugelassenes Gerät zur Behandlung von schlaffer Haut nach einer Fettabsaugung bei ästhetischen Eingriffen eine einzigartige Position einnimmt.
- Two peer-reviewed clinical studies validate Renuvion's safety and effectiveness in body contouring procedures
- Large market opportunity with over 15 million potential patients using GLP-1 drugs who may need skin tightening treatments
- Renuvion is the only FDA-cleared device for addressing loose skin post-liposuction
- Clinical data shows higher patient satisfaction scores at 6 months, 1 year, and 2 years post-procedure
- No increased complications reported when adding Renuvion to standard procedures
- Longer surgical times reported when using Renuvion with concurrent procedures
- Subject to regulatory risks and FDA oversight as mentioned in forward-looking statements
- Exposed to supply chain disruptions and component shortages risks
- Potential litigation and investigation risks disclosed in cautionary statements
Insights
Apyx's Renuvion shows clinical superiority in skin tightening studies without increased complications, strengthening physician adoption case.
The publication of two peer-reviewed clinical studies evaluating Apyx Medical's Renuvion device represents significant scientific validation for the company's technology. The first study, a prospective, randomized controlled trial (gold standard in clinical research), demonstrated that patients treated with Renuvion during lipoabdominoplasty showed superior improvements in abdominal skin laxity and higher satisfaction scores at 6 months, 1 year, and 2 years post-procedure compared to control groups.
Critically, both studies reported no increased rate of complications when Renuvion was incorporated into procedures. The second study examined 77 patients and similarly found no statistically significant difference in adverse events between groups, despite the Renuvion group undergoing more concurrent procedures and longer surgical times.
This safety profile directly addresses a primary adoption barrier for medical devices - physicians require evidence that benefits outweigh risks. The publication in respected journals (Aesthetic Plastic Surgery and Aesthetic Surgery Journal Open Forum) adds substantial credibility to Renuvion's clinical evidence base.
For physicians considering incorporating Renuvion into their practice, these studies provide compelling evidence that adding the technology can deliver superior aesthetic outcomes without compromising patient safety - a rare combination that should drive clinical adoption.
Apyx targets 15M GLP-1 users needing skin tightening, holding unique FDA clearance in rapidly expanding market.
Apyx is strategically positioning Renuvion to capitalize on an emerging market opportunity created by the GLP-1 weight loss drug phenomenon. The company estimates approximately 15 million patients are currently using these medications, creating a substantial pool of individuals who may seek treatment for skin laxity following rapid weight loss.
Apyx holds a significant competitive advantage: Renuvion is the only FDA-cleared device specifically for addressing loose skin post-liposuction in aesthetic body contouring procedures. This regulatory differentiation provides Apyx with unique positioning in what could become a rapidly growing segment of aesthetic procedures.
The timing is particularly advantageous as GLP-1 therapies continue gaining widespread adoption across both diabetes and weight management markets. While the conversion rate from GLP-1 users to aesthetic procedure patients remains to be determined, the sheer size of this potential patient pool represents a significant addressable market.
This GLP-1-driven opportunity wasn't necessarily factored into previous market projections for Renuvion. As the only device with the specific FDA clearance for post-liposuction skin tightening, Apyx is well-positioned to become the standard treatment for this emerging patient population, potentially creating a meaningful growth vector beyond traditional aesthetic markets.
Two studies report favorable clinical outcomes and safety data for Renuvion® when used during procedures that include lipoabdominoplasty for the treatment of loose and lax skin
Rapid weight loss due to GLP-1 drugs expected to drive growth in patients seeking treatment for loose and lax skin
CLEARWATER, Fla., April 29, 2025 (GLOBE NEWSWIRE) -- Apyx Medical Corporation (Nasdaq: APYX) (“Apyx Medical” or the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency platform marketed and sold as Renuvion®, today announced the publication of two peer-reviewed clinical studies evaluating the use of Renuvion during body contouring procedures that also included lipoabdominoplasty1.
The first publication, authored by Mauro Barone, MD et al. and published in Aesthetic Plastic Surgery, is the first prospective, randomized controlled trial evaluating Renuvion in procedures that also included lipoabdominoplasty for patients with abdominal skin laxity following significant weight loss. Lipoabdominoplasty is a surgical procedure that combines liposuction and abdominoplasty (tummy tuck). In this study, 76 patients were randomized to undergo lipoabdominoplasty either with or without the use of Renuvion. The authors reported that patients in the Renuvion group demonstrated improvements in abdominal skin laxity and excess skin, along with higher satisfaction scores at 6 months, 1 year, and 2 years post-procedure, as measured by validated BODY-Q questionnaires and independent physician-rated VAS scale scores. The study concluded these data demonstrated a significantly greater improvement in patients treated with Renuvion compared to those who underwent lipoabdominoplasty alone. The authors noted that the addition of Renuvion did not result in an increased rate of complications.
The second publication, authored by Paul Vanek, MD and published in Aesthetic Surgery Journal Open Forum, presents findings from a retrospective study of 77 patients treated with ultrasound-assisted lipoabdominoplasty (UAL), with or without Renuvion. The study groups were similar in size and patient demographics. The study found no statistically significant difference between groups in the occurrence of significant adverse events. Notably, the addition of Renuvion did not increase the incidence of significant complications, despite the Renuvion group undergoing more concurrent procedures and longer surgical times.
“We estimate over 15 million patients are currently using GLP-1 drugs, many of which, we believe, will seek treatment for loose and lax skin due to the associated rapid weight loss. Renuvion is the only FDA-cleared device for addressing loose and lax skin post-liposuction in aesthetic body contouring procedures1 and we are uniquely positioned to treat this growing patient population,” said Charlie Goodwin, President and Chief Executive Officer of Apyx Medical. “We are proud to share these newly published studies which reinforce the growing body of evidence supporting the safety and value of Renuvion in aesthetic body contouring, and these publications further solidify our commitment to advancing evidence-based innovation in aesthetic surgery.”
A digital version of the Barone clinical publication is available via the following link:
Barone clinical publication
A digital version of the Vanek clinical publication is available via the following link:
Vanek clinical publication
1 The Renuvion APR Handpiece is intended for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring.
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, 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.
Investor Relations Contact:
Jeremy Feffer, Managing Director LifeSci Advisors
OP: 212-915-2568
jfeffer@lifesciadvisors.com
FAQ
What are the key findings of Apyx Medical's (APYX) new Renuvion clinical studies in 2025?
How does Apyx Medical (APYX) plan to benefit from the GLP-1 weight loss drug market?
What makes Renuvion unique in the aesthetic body contouring market?
What were the patient outcomes in the 2025 Renuvion clinical trials by APYX?
Is Renuvion safe to use during lipoabdominoplasty procedures?
