Don't Forget To
Rate This Article

Get the Latest Investment Ideas Delivered Straight to Your Inbox. Subscribe


FDA Approves New Skin Resurfacing Device
Trending Company

Share on Stocktwits


Apyx Medical Corp. shares traded 50% higher after the company reported it received U.S. FDA 510(k) clearance for its Renuvion Dermal Handpiece for use in specific cosmetic dermal resurfacing procedures.

Advanced energy tech company Apyx Medical Corp. (APYX:NASDAQ), a medical device and supply manufacturer and developer of Helium Plasma Technology that allows surgeons to provide controlled heat to tissue to achieve their desired results, yesterday announced,  "it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use of the Renuvion Dermal Handpiece for specific dermal resurfacing procedures."

Apyx Medical markets and sells its innovative medical devices and instruments for use in surgical markets under the Renuvion® and J-Plasma® names. The company advised that "the Renuvion Dermal Handpiece is indicated for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III."

The company's President and CEO Charlie Goodwin commented, "We are very pleased to receive FDA 510(k) clearance with a specific clinical indication that enables Apyx Medical to market and sell our Renuvion Cosmetic Technology to surgeons and patients for use in approximately 200,000 wrinkle reduction procedures performed in the U.S. annually…This milestone represents one of the most important achievements of our organization since we began our multi-year strategy to position Apyx Medical for long-term success in the U.S. cosmetic surgery market."

"The receipt of regulatory clearance reflects the strong safety and efficacy profile of our Renuvion Cosmetic Technology, as demonstrated by the results of our U.S. IDE clinical study published in February," Goodwin added.

The company indicated in the news release that its Renuvion Cosmetic Technology will be branded as "Facial Renewal" and will provide patients with new specific clinical options to improve their appearance and reduce wrinkles.

The firm stated that it intends to roll out Renuvion for treatment of this newly approved indication on a limited basis starting in Q3/22 and plans to move forward with a full commercial launch by calendar year-end 2022.

Apyx Medical is an advanced energy tech firm based in Clearwater, Fl. The company operates through two primary business segments. Its advanced energy line includes the firm's innovative Helium Plasma Technology products that are marketed and sold for use in surgical markets under the Renuvion® and J-Plasma® names.

Renuvion® and J-Plasma® offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results. The company claims on its website that Renuvion®, which is engineered to deliver a proprietary balance of helium and RF energy, is ideal for use in medical procedures where precision and control are critical factors in delivering effective treatment. The firm adds that "J-Plasma® is an advanced energy modality which combines the unique properties of helium plasma with a proprietary RF waveform."

The company additionally serves as an original equipment manufacturer (OEM) for other medical device makers that rely on Apyx's depth of experience in technology employing unique directed waveforms.

Apyx Medical started off yesterday with a market cap of around $127.5 million with approximately 34.45 million shares outstanding and a short interest of about 3.4%. APYX shares opened 8% higher yesterday at $4.00 (+$0.30, +8.11%) over Wednesday's $3.70 closing price. The stock traded yesterday between $4.00 and $5.77 per share and was trading at $5.58 (+$1.88, +50.81%) yesterday.

Want to be the first to know about interesting Life Sciences Tools & Diagnostics and Medical Devices investment ideas? Sign up to receive the FREE Streetwise Reports' newsletter. Subscribe

1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of the information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services, or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees, or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in the securities mentioned. Directors, officers, employees, or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees, and contributors to Streetwise Reports are not licensed, medical professionals. Readers should always contact their healthcare professionals for medical advice.

Want to read more about Life Sciences Tools & Diagnostics and Medical Devices investment ideas?
Get Our Streetwise Reports Newsletter Free and be the first to know!

A valid email address is required to subscribe