8-K: Apyx Medical's Renuvion Technology Showcased at Cosmetic Surgery Conference

Apyx Medical's Renuvion technology will be featured in three educational sessions at the American Academy of Cosmetic Surgery's annual meeting, highlighting a study showing fewer adverse events compared to a competing technology.

Summary

• Apyx Medical Corporation announced that its Renuvion technology will be featured in three educational sessions at the American Academy of Cosmetic Surgery's 40th Annual Scientific Meeting.
• The meeting will take place in New Orleans, LA from February 22nd to 24th.
• One presentation will feature a retrospective clinical study comparing Renuvion to a competing technology when used with liposuction or body contouring.
• The study, involving over 450 patients, found significantly fewer adverse events with Renuvion, including fewer burns, hematomas, hypertrophic scars, and seromas.
• The study compared 229 patients treated with Renuvion to 236 patients treated with a bipolar RF system.
• The p-value for the difference in adverse events was less than 0.0001, indicating a statistically significant difference.

Sentiment

Score: 8

Explanation: The document presents positive clinical study results and highlights the company's technology at a major industry event. The tone is optimistic and focused on the benefits of Renuvion. The study results are statistically significant and the company is clearly trying to promote the safety of their product.

Positives

• The presentation of Renuvion at the AACS meeting is expected to increase awareness of the technology.
• The retrospective study provides evidence of Renuvion's strong safety profile.
• The study demonstrated a statistically significant reduction in adverse events compared to a competing technology.
• The results support the use of Renuvion in cosmetic surgery procedures.

Risks

• The company's future performance is subject to regulatory approvals, supply chain issues, and economic conditions.
• The company is subject to risks related to litigation, claims, disputes, and investigations.
• The company's forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially.

Future Outlook

The company anticipates that the presentations at the AACS meeting will help expand awareness of their Helium Plasma Technology and its benefits. The company also states that they assume no obligation to update or supplement any forward-looking statements.

Management Comments

• Charlie Goodwin, President and Chief Executive Officer of Apyx Medical, stated that they are pleased to see Renuvion featured in educational presentations during AACS 2024.
• Charlie Goodwin believes the presentations will help expand awareness of their Helium Plasma Technology and its benefits.
• Charlie Goodwin also mentioned that they look forward to the presentation by Dr. Michael Kluska, featuring the results of a new retrospective clinical study that demonstrates the strong safety profile of Renuvion.

Industry Context

This announcement highlights Apyx Medical's efforts to promote its Renuvion technology within the cosmetic surgery market. The presentation of clinical study results at a major industry conference is a common strategy for medical device companies to build credibility and market awareness. The comparison to a competing technology is a direct attempt to show superiority.

Comparison to Industry Standards

• The study compares Renuvion to InMode's Bipolar RF system, a competitor in the energy-based cosmetic device market.
• The reported p-value of <0.0001 indicates a statistically significant difference in adverse events, which is a strong result in clinical research.
• The study's focus on adverse events is a key metric for evaluating the safety of cosmetic procedures, and the results suggest Renuvion may have a better safety profile than the compared technology.
• Other companies in the cosmetic device space, such as Cynosure and Cutera, also focus on safety and efficacy, and this study positions Apyx Medical as a competitor with a strong safety profile.

Stakeholder Impact

• Shareholders may view the positive study results and increased visibility at the conference as favorable.
• Surgeons may be more inclined to use Renuvion based on the study's findings.
• Patients may benefit from the improved safety profile of Renuvion.

Next Steps

• Apyx Medical will participate in the American Academy of Cosmetic Surgery's 40th Annual Scientific Meeting from February 22nd to 24th.
• The company will continue to promote the Renuvion technology and its benefits.

Key Dates

Keywords

Renuvion, Apyx Medical, Cosmetic Surgery, Helium Plasma Technology, Liposuction, Body Contouring, Adverse Events, Clinical Study, American Academy of Cosmetic Surgery, Safety Profile