Apyx Medical (APYX) FDA Approvals

Apyx Medical's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Apyx Medical (APYX). Over the past two years, Apyx Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Renuvion. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Renuvion FDA Regulatory Timeline and Events

Renuvion is a drug developed by Apyx Medical for the following indication: Contracting subcutaneous soft tissue following liposuction in multiple areas of the body. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Publication - May 14,2026

• Drug: Renuvion
• Announced Date: May 14, 2026
• Indication: Contracting subcutaneous soft tissue following liposuction in multiple areas of the body

Apyx Medical Corporation announced the publication of a new retrospective investigator-initiated study in Plastic and Reconstructive Surgery - Global Open1.

Apyx Medical Corporation announced that a new retrospective investigator-initiated study was published in Plastic and Reconstructive Surgery - Global Open. The 113-patient study looked at long-term results after liposuction, including patient satisfaction, safety, and the need for more surgery. It found that adding Renuvion to power-assisted liposuction led to better patient-reported satisfaction with abdominal appearance, skin quality, and excess skin. The Renuvion group also had lower rates of abdominoplasty and surgical revisions.

Importantly, these benefits were achieved without raising complication rates compared with liposuction alone. The study suggests that Renuvion may help improve body contouring results while keeping safety similar. Apyx said the findings add to the clinical evidence supporting its technology and its newer AYON Body Contouring System.

Provided Update - October 13,2025

• Drug: Renuvion
• Announced Date: October 13, 2025
• Indication: Contracting subcutaneous soft tissue following liposuction in multiple areas of the body

Apyx Medical Corporation announced the submission of a new 510(k) premarket notification to the U.S. Food and Drug Administration (the "FDA") for the label expansion of the AYON Body Contouring System ("AYON") to include power liposuction.

Apyx Medical Corporation submitted a 510(k) premarket notification to the U.S. Food and Drug Administration to expand the label of its AYON Body Contouring System to include power liposuction. This could make AYON the first fully integrated contouring platform cleared for powered fat removal in one device.

If cleared, surgeons will be able to treat all aspects of body contouring with a single system. The power liposuction feature uses a reciprocating cannula that removes fat more efficiently, reducing manual effort and improving procedure speed. Apyx plans to activate the new functionality remotely in AYON systems already installed at surgical centers nationwide.

Following a nationwide commercial launch in September, Apyx is hosting a virtual key opinion leader event on October 14, 2025, to discuss AYON’s rollout and collect feedback from aesthetic surgeons.

Provided Update - January 6,2025

• Drug: Renuvion
• Announced Date: January 6, 2025
• Indication: Contracting subcutaneous soft tissue following liposuction in multiple areas of the body

Apyx® Medical 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.

Apyx Medical Corporation has announced that it submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its new AYON Body Contouring System. This announcement highlights the company’s efforts toward innovation in the field of aesthetic surgery. The AYON system is designed to be an all-in-one solution, offering surgeons the versatility needed for comprehensive body contouring procedures.

The device integrates multiple advanced technologies to remove unwanted fat, enhance tissue contraction, and address a range of patient needs including skin tightening. Key features include ultrasound-assisted liposuction, dual aspiration, electrocoagulation, and volume enhancement, along with the use of Renuvion treatment for loose skin. Apyx Medical views the AYON Body Contouring System as a breakthrough that could broaden treatment capabilities for surgeons.