Did Apyx Medical seek any regulatory changes for AYON related to liposuction?

Yes. Apyx Medical states that in October 2025 it filed an additional 510(k) submission seeking a label expansion for the AYON Body Contouring System to include power liposuction, building on its existing FDA-cleared status as a body contouring platform.

Apyx Medical (NASDAQ: APYX) study shows Renuvion boosts liposuction satisfaction

Filing Impact

(Moderate)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Apyx Medical Corporation filed an 8-K to highlight a new retrospective, investigator-initiated clinical publication evaluating its Renuvion® technology used with liposuction. The 113-patient study in Plastic and Reconstructive Surgery – Global Open found that adding helium plasma radiofrequency (Renuvion) after liposuction was associated with higher patient-reported satisfaction with abdominal appearance and excess skin, lower abdominoplasty and surgical revision rates, and complication rates comparable to conventional power-assisted liposuction alone.

The company notes this study adds to a body of more than 90 clinical documents supporting Renuvion and J-Plasma®. It also reiterates that its AYON Body Contouring System™ is an FDA-cleared, surgeon-designed platform integrating fat removal, contouring and Renuvion-based tissue contraction, and that an additional 510(k) for AYON label expansion to include power liposuction was filed in October 2025.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Study size: 113 patients Follow-up duration: >12 months Global liposuction volume: More than 2 million procedures +2 more

5 metrics

Study size 113 patients Retrospective Renuvion plus liposuction outcomes study

Follow-up duration >12 months Long-term Body-Q patient-reported outcomes in study

Global liposuction volume More than 2 million procedures Annual global liposuction procedures cited from ISAPS 2024 Survey

Clinical documents More than 90 Clinical documents supporting Renuvion and J-Plasma effectiveness

AYON 510(k) submission timing October 2025 Additional 510(k) filed for AYON label expansion to power liposuction

Key Terms

retrospective investigator-initiated study, helium plasma radiofrequency, Body-Q, 510(k), +2 more

6 terms

retrospective investigator-initiated study medical

"publication of a new retrospective investigator-initiated study in Plastic and Reconstructive Surgery - Global Open"

helium plasma radiofrequency medical

"liposuction with and without helium plasma radiofrequency (Renuvion)"

A medical technology that uses a stream of helium gas energized by radiofrequency to deliver controlled heat to tissue, often used to tighten skin and assist in surgical cutting or coagulation. Think of it like a precisely controlled mini blowtorch that firms and reshapes underlying tissue without large incisions; investors watch it because device sales, regulatory approval, and clinical adoption directly affect revenue potential and market share in the aesthetic and surgical device sector.

Body-Q medical

"evaluated long-term (>12 month) Body-Q® patient-reported outcomes"

BODY-Q is a validated patient questionnaire used to measure how people feel about their bodies and the outcomes of surgeries or treatments that change appearance or shape. Think of it as a standardized customer satisfaction and quality-of-life survey for medical procedures; its results help clinicians, regulators and payers judge whether a treatment actually improves patients’ lives. For investors, strong BODY-Q results can signal clinical value, higher adoption, better reimbursement prospects and lower regulatory or commercial risk.

510(k) regulatory

"In October 2025, the Company filed an additional 510(k) for the label expansion of AYON"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

label expansion regulatory

"filed an additional 510(k) for the label expansion of AYON to include power liposuction"

Label expansion is the process of getting official approval to add new approved uses, age groups, dosages or forms to a drug or medical device beyond its original approval. For investors, it matters because expanding a product’s labeled uses is like opening new doors to more customers and sales potential, often increasing revenue prospects, extending a product’s commercial life and reducing the risk tied to a single narrow market.

OEM agreements financial

"leverages its deep expertise and decades of experience in unique waveforms through OEM agreements with other medical device manufacturers"

OEM agreements are contracts where one company makes products or components that another company sells under its own brand, like a bakery baking cakes that a café sells with the café’s name. For investors, these deals matter because they influence cost structure, product quality, supply reliability and how much control a brand has over manufacturing; strong OEM partnerships can speed growth but can also create dependence on outside suppliers.

Understanding 8-K Material Events →

05/14/2026 - 08:05 AM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

May 14, 2026

Date of Report (date of earliest event reported)

APYX MEDICAL CORPORATION

(Exact name of registrant as specified in its charter)

Delaware	001-31885	11-2644611
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification No.)

5115 Ulmerton Road, Clearwater, Florida 33760

(Address of principal executive offices, zip code)

(727) 384-2323

(Issuer's telephone number)

_____________________________________________________________

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Class A common stock	APYX	Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Item 8.01 Other Events

On May 14, 2026, Apyx Medical Corporation issued a press release announcing the publication of a new retrospective investigator-initiated stud in Plastic and Reconstructive Surgery - Global Open. The study evaluated patient-reported outcomes following liposuction with and without helium plasma radiofrequency (Renuvion^®). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

Exhibit No.	Description

99.1	Press release dated May 14, 2026
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: May 14, 2026	Apyx Medical Corporation

	By:	/s/ Matthew Hill
		Matthew Hill
		Chief Financial Officer, Secretary and Treasurer

EXHIBIT 99.1

Apyx Medical Corporation Announces Retrospective Clinical Publication Evaluating Clinical Benefit of Renuvion^® Used In Combination With Liposuction

Analysis showed that liposuction followed by helium plasma RF was associated with higher patient-reported satisfaction with abdominal appearance, lower abdominoplasty and revision rates, and comparable complication rates versus conventional liposuction alone.

Clearwater, Fla. - May 14, 2026 – Apyx Medical Corporation (NASDAQ:APYX) (“Apyx Medical”; the “Company”), the leader in surgical aesthetics products marketed and sold as Renuvion® and the AYON Body Contouring System™ (AYON), today announced the publication of a new retrospective investigator-initiated study in Plastic and Reconstructive Surgery - Global Open¹. The study evaluated patient-reported outcomes following liposuction with and without helium plasma radiofrequency (Renuvion).

The results demonstrate that adding Renuvion to liposuction resulted in statistically significant improvements in patient-reported satisfaction with abdominal appearance and excess skin, along with lower rates of abdominoplasty and surgical revisions, while maintaining comparable complication rates to power-assisted liposuction.

Key Findings from the 113‑Patient Study:

●

Patients treated with Renuvion reported statistically higher satisfaction with reduced appearance of excess skin (Body‑Q score 87.8 vs. 73.8; p=0.03)

●

Among patients who did not undergo abdominoplasty, satisfaction with abdominal appearance was also statistically higher (68.8 vs. 45.0; p=0.039)

●

The rate of patients requiring abdominoplasty was more than 50% lower in the Renuvion group compared to the group receiving power-assisted liposuction only (30.0% vs. 67.1%)

●

Revision rates were significantly lower in the Renuvion group (12.0% vs. 37.5%; p=0.038)

●

Complication rates remained similar between groups (2.5% vs. 2.7%)

“This study adds to the growing body of clinical evidence supporting the use of Renuvion in aesthetic body contouring,” said Charlie Goodwin, President and Chief Executive Officer of Apyx Medical. “With more than 2 million liposuction procedures performed globally each year*, these statistically significant improvements in patient satisfaction and reduced revision rates underscore the value Renuvion provides to aesthetic surgeons and their patients.”

The retrospective study, led by Pablo D. Huber, MD, evaluated long-term (>12 month) Body-Q® patient-reported outcomes, procedural data, and safety profiles across 113 patients treated by a single surgeon. The Renuvion cohort (power-assisted liposuction + Renuvion) consistently reported higher satisfaction with skin quality and abdominal contour, with no increase in complications.

Apyx Medical’s latest technology, the AYON Body Contouring System™, builds on the proven foundation and technology of Renuvion, leveraging decades of clinical evidence and real-world experience to deliver precise, efficient, and effective energy-based solutions in an all-in-one system.

¹A digital version of the clinical publication is available via the following link: https://journals.lww.com/prsgo/pages/articleviewer.aspx?year=2026&issue=03000&article=00014&type=Fulltext

*Source: ISAPS 2024 Survey

About AYON Body Contouring System^TM:

AYON is a 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, and Renuvion’s tissue contraction and electrosurgical capabilities, empowering surgeons to deliver the most comprehensive body contouring treatments for patients. With advanced features like LIFT Technology for real-time adjustments and Renuvion for enhanced tissue contraction, AYON sets a new standard in surgical care, streamlining procedures and maximizing patient outcomes. Backed by Apyx Medical’s expertise and evidence-based design, AYON delivers consistent, reliable performance and an unmatched return on investment. As the first of its kind, AYON is revolutionizing body contouring and shaping the future of aesthetic surgery. In October 2025, the Company filed an additional 510(k) for the label expansion of AYON to include power liposuction.

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^TM 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, electrosurgical capabilities and Renuvion for tissue contraction, 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.

Investor Relations Contact:

Jeremy Feffer, Managing Director LifeSci Advisors

OP: 212-915-2568

jfeffer@lifesciadvisors.com

Source: View Original Filing on SEC EDGAR

FAQ

What did Apyx Medical (APYX) announce in this 8-K filing?

Apyx Medical announced publication of a retrospective, investigator-initiated study evaluating Renuvion used with liposuction. The study showed higher patient satisfaction, lower abdominoplasty and revision rates, and comparable complication rates versus conventional power-assisted liposuction alone.

What were the key findings of Apyx Medical’s 113-patient Renuvion liposuction study?

The 113-patient study found that liposuction followed by Renuvion helium plasma RF led to higher patient-reported satisfaction with abdominal appearance and excess skin, lower abdominoplasty and revision rates, and complication rates comparable to power-assisted liposuction alone over more than 12 months.

How does this new study fit into Apyx Medical’s overall clinical evidence for Renuvion?

This retrospective study adds to more than 90 clinical documents supporting Renuvion and J-Plasma. It reinforces evidence that combining Renuvion with liposuction can improve patient-reported outcomes while maintaining similar safety profiles compared with conventional power-assisted liposuction techniques.

What is the AYON Body Contouring System mentioned by Apyx Medical (APYX)?

The AYON Body Contouring System is an FDA-cleared, surgeon-designed platform integrating fat removal, closed loop contouring, electrosurgical capabilities and Renuvion tissue contraction. It aims to deliver comprehensive body contouring treatments with precision, versatility and efficiency in an all-in-one system.

How large is the potential market for Apyx Medical’s Renuvion in liposuction procedures?

The company cites an estimate of more than 2 million liposuction procedures performed globally each year. It suggests statistically significant improvements in patient satisfaction and reduced revision rates could underscore the value of Renuvion in this aesthetic body contouring market.

Filing Exhibits & Attachments

5 documents

Press Releases

EX-99.1 EXHIBIT 99.1 13.4 KB