8-K: Apyx Medical Announces Positive Peer-Reviewed Study on Renuvion Safety Post-Liposuction

Apyx Medical's Renuvion technology shows no increased risk when used for soft tissue contraction after liposuction, according to a peer-reviewed study.

Summary

• Apyx Medical Corporation announced the publication of a peer-reviewed study in the Aesthetic Surgery Journal Open Forum.
• The study evaluated the safety of Renuvion for contracting subcutaneous soft tissue following liposuction.
• The analysis included data from 483 patients and 1,184 body areas treated.
• The study found no new or increased risks associated with Renuvion use compared to liposuction alone.
• The study examined various body areas including the abdomen, arms, back, buttocks, breast/axilla, face, hips/flanks, legs, and neck.
• This publication supports the FDA 510(k) clearance for the Renuvion APR Handpiece for coagulation of subcutaneous soft tissues following liposuction.

Sentiment

Score: 8

Explanation: The document presents positive results from a peer-reviewed study, supporting the safety of the company's Renuvion technology. This is a strong positive for the company and its investors.

Positives

• The peer-reviewed publication provides strong evidence of Renuvion's safety when used after liposuction.
• The study's large sample size of 483 patients and 1,184 treated areas enhances the credibility of the findings.
• The results indicate that Renuvion does not introduce new or increased risks compared to liposuction alone.
• The study covers a wide range of body areas, demonstrating the versatility and safety of Renuvion.
• The publication reinforces the FDA clearance for the Renuvion APR Handpiece.

Risks

• The company's future performance is subject to regulatory risks, including obtaining approvals for its products.
• Supply chain disruptions and component shortages could impact the company's operations.
• Changes in economic conditions and geopolitical events could affect the company's financial performance.
• The company faces potential liabilities from litigation and claims.

Future Outlook

The company's future performance is subject to various risks and uncertainties, including regulatory approvals, supply chain issues, and economic conditions. The company assumes no obligation to update forward-looking statements.

Management Comments

• Charlie Goodwin, President and Chief Executive Officer of Apyx Medical, stated that they are excited to see the publication of this real-world 483-patient analysis, demonstrating Renuvion's impressive safety when used after liposuction.
• Mr. Goodwin also noted that the data from this analysis was used to secure FDA 510(k) clearance for the use of the Renuvion APR Handpiece.

Industry Context

This announcement is significant for the cosmetic surgery industry as it provides further evidence of the safety and efficacy of Renuvion, a technology used for soft tissue contraction after liposuction. The study's findings could increase adoption of Renuvion by surgeons.

Comparison to Industry Standards

• The study compares Renuvion's safety profile to published data on liposuction alone, which is a standard benchmark in the field.
• The study's findings suggest that Renuvion does not introduce new or increased risks compared to liposuction, which is a positive outcome.
• The authors noted that there are currently no alternative therapies to Renuvion cleared by the U.S. Food and Drug Administration (FDA) which can claim use following liposuction for the purpose of contracting the subcutaneous soft tissue.

Stakeholder Impact

• The positive study results are likely to be well-received by shareholders.
• The findings may increase surgeon confidence in using Renuvion, potentially benefiting the company's sales.
• Patients may benefit from the increased safety data associated with Renuvion.

Key Dates

Keywords

Renuvion, Liposuction, Subcutaneous Soft Tissue Contraction, Apyx Medical, Cosmetic Surgery, Peer-Reviewed Study, FDA Clearance, Safety, Aesthetic Surgery