Welcome to our dedicated page for Apyx Medical Corporation news (Ticker: APYX), a resource for investors and traders seeking the latest updates and insights on Apyx Medical Corporation stock.
Apyx Medical Corporation (NASDAQ: APYX) is a surgical aesthetics and advanced energy technology company whose news flow centers on its Helium Plasma Platform Technology products, including Renuvion, the AYON Body Contouring System, and J-Plasma. Company press releases focus on developments in the cosmetic surgery market, the hospital surgical market, and OEM relationships with other medical device manufacturers.
Investors and observers following APYX news will see regular updates on financial performance, such as quarterly and annual revenue results, preliminary unaudited revenue ranges, and segment-level trends in Surgical Aesthetics and OEM revenue. The company also issues guidance updates and discusses factors influencing its revenue mix, including the commercial rollout of AYON and demand for single-use handpieces and generators.
Another key category of Apyx Medical news involves product and regulatory milestones. Recent announcements describe FDA 510(k) clearances and submissions related to the AYON Body Contouring System, as well as international regulatory approvals like the Ministry of Food and Drug Safety clearance in South Korea for the Apyx One console and single-use handpieces. These items highlight how the company is expanding the indications and geographic reach of its platforms.
APYX news also covers capital markets and corporate actions, including proposed and completed public offerings of common stock under an effective Form S-3 shelf registration statement, as reported in 8-K filings and related press releases. Additional items include notices of investor conference participation, inducement equity awards under Nasdaq Listing Rule 5635(c)(4), and information about annual stockholder meetings and governance matters.
This news page aggregates these disclosures so readers can review Apyx Medical’s earnings releases, product launch updates, regulatory submissions, financing transactions, and investor events in one place.
Apyx Medical Corporation (NASDAQ:APYX) has released positive results from its pivotal Phase II study of the Renuvion device aimed at improving lax skin appearance in the neck and submental area. The study demonstrated key outcomes, with 82.5% of 65 subjects showing improvements at six months, and 96.9% reporting low pain levels post-procedure. Additionally, 85.5% of participants rated their results as improved. No serious adverse events were linked to Renuvion. The company anticipates moving forward with marketing efforts subject to FDA clearance.
Apyx Medical Corporation (NASDAQ:APYX) will release its financial results for Q2 fiscal 2022 on August 11th, after market close. A conference call is scheduled for 5:00 p.m. ET that day, where management will discuss the financial performance and answer questions. Participants can join via phone or a live webcast. Apyx Medical specializes in advanced energy technology, particularly its Helium Plasma Technology products marketed as Renuvion and J-Plasma, used for controlled tissue heating in surgical procedures.
Apyx Medical Corporation (NASDAQ: APYX) announced FDA clearance for its Renuvion Dermal handpiece, allowing for wrinkle reduction procedures in patients with Fitzpatrick skin types I, II, or III. The new treatment, branded as Facial Renewal, offers a nonsurgical method for skin rejuvenation, providing patients with natural-looking results without invasive procedures. According to Dr. Tabasum Mir, the treatment addresses a significant need in cosmetic options. Apyx's President, Charlie Goodwin, highlighted this advancement as a milestone in cosmetic treatments.
Apyx Medical Corporation (NASDAQ:APYX) has received FDA 510(k) clearance for its Renuvion Dermal Handpiece, aimed at treating moderate to severe wrinkles for patients with Fitzpatrick skin types I, II, or III. This milestone allows Apyx to tap into the 200,000 annual U.S. wrinkle reduction procedures. The company plans a limited launch by Q3 2022, with full commercialization anticipated by year-end. CEO Charlie Goodwin highlighted this as a significant achievement for Apyx's long-term strategy in the U.S. cosmetic surgery market.
Apyx Medical Corporation (NASDAQ:APYX), a developer of advanced energy technology and Helium Plasma Technology, announced participation in two upcoming investor conferences. Management will engage in virtual 1x1 meetings at the Craig-Hallum 19th Annual Institutional Investor Conference on June 1, without a formal presentation. They will also take part in a fireside chat at the JMP Securities Life Sciences Conference on June 16 at 9:00 a.m. Eastern Time. An audio webcast of the fireside chat will be available on Apyx's investor relations website.
Apyx Medical Corporation (NASDAQ:APYX) reported a strong financial performance for Q1 2022, with total revenue of $12.5 million, marking a 45% increase year-over-year. The Advanced Energy segment contributed $10.8 million in revenue, a growth of 41%, while OEM revenue surged 72% to $1.7 million. Despite this success, the company reported a net loss of $5.9 million. The outlook for 2022 has been revised to forecast total revenue between $52.5 million and $59.0 million, reflecting growth of 8% to 22%.
Apyx Medical Corporation (NASDAQ:APYX) announced it will release its financial results for Q1 fiscal 2022 on May 12, 2022, before the market opens. Management will host a conference call at 8:00 a.m. ET on the same day to discuss these results and answer questions from investors. Interested parties can join the call by dialing a provided number and using an access code. The results will be available on the company's website.
Apyx Medical Corporation (NASDAQ:APYX) announced the submission of a 510(k) premarket notification to the FDA. This aims to expand indications for the Renuvion APR Handpiece, allowing its use in subcutaneous dermatological and aesthetic procedures to improve lax skin in the neck and submental region. CEO Charlie Goodwin highlighted that this submission aligns with their strategic long-term goals and is backed by safety and effectiveness data from a U.S. IDE clinical study. Successful FDA clearance would enhance market opportunities for Apyx's Renuvion technology.
Apyx Medical reported a strong performance in Q4 2021, with total revenue reaching $16.8 million, a 47% increase year-over-year. Advanced Energy sales surged 52% to $15.0 million, while OEM revenue rose 13% to $1.8 million. Despite a net loss of $2.0 million, improved efficiencies reduced the adjusted EBITDA loss to $0.3 million. For 2022, guidance is set between $50.0 million to $63.0 million in total revenue, indicating potential growth of 3% to 30%.
Apyx Medical Corporation (NASDAQ:APYX) announced that the FDA intends to issue a Medical Device Safety Communication (MDSC) regarding its Advanced Energy products, specifically concerning their off-label use. The company emphasizes ongoing compliance and support for safe practices, despite some products being used for unapproved dermal resurfacing. Apyx continues to work with the FDA for 510(k) clearances for additional clinical indications and maintains its existing clearances. Since 2017, 90 medical device reports (MDRs) have been submitted, although these represent a small fraction of total procedures performed.