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Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® to Coagulate and Contract Soft Tissues, Including Subcutaneous Tissue, Where Needed
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Rhea-AI Summary
Apyx Medical Corporation (NASDAQ:APYX) has received 510(k) clearance from the U.S. FDA for its Renuvion APR Handpiece. This device is approved for delivering radiofrequency energy and/or helium plasma for soft tissue coagulation and contraction, specifically subcutaneous tissue. CEO Charlie Goodwin emphasized this clearance underscores Renuvion's safety and effectiveness. Apyx is currently seeking an additional indication for use following liposuction, which remains under FDA review. The company specializes in advanced energy technology, aiming to elevate patient outcomes in cosmetic and surgical markets.
Positive
Received FDA 510(k) clearance for Renuvion APR Handpiece, indicating regulatory approval and market readiness.
Demonstrates safety and effectiveness of Renuvion technology, enhancing credibility.
Potential for expanded applications with ongoing FDA review for additional indications.
Negative
None.
CLEARWATER, Fla.--(BUSINESS WIRE)--
Apyx Medical Corporation (NASDAQ:APYX) (the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the use of the Renuvion APR Handpiece “for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.”
“We are pleased to receive this 510(k) clearance with specific indication language related to the use of the Renuvion APR Handpiece for the contraction of soft tissues, including subcutaneous tissue, where needed,” said Charlie Goodwin, President and Chief Executive Officer. “The receipt of this 510(k) clearance further demonstrates the safety and effectiveness of Renuvion, and our commitment to working with the FDA to secure specific clinical indications related to its use. To this end, our 510(k) submission to obtain an additional specific indication for the use of the Renuvion APR Handpiece for the contraction of subcutaneous soft tissues where needed following liposuction remains under review by the FDA, and we look forward to receiving the Agency’s decision.”
About Apyx Medical Corporation:
Apyx Medical Corporation is an advanced energy technology company with a passion for elevating people’s lives through innovative products, including its Helium Plasma Technology products marketed and sold as Renuvion® in the cosmetic surgery market and J-Plasma® in the hospital surgical market. Renuvion® and J-Plasma® offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results. The Company also leverages its deep expertise and decades of experience in unique waveforms through OEM agreements with other medical device manufacturers. For further information about the Company and its products, please refer to the Apyx Medical Corporation website at www.ApyxMedical.com.
Cautionary Statement on Forward-Looking Statements:
Certain matters discussed in this release and oral statements made from time to time by representatives of the Company may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved.
All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but not limited to, any statements regarding the potential impact of the COVID-19 pandemic and the actions by governments, businesses and individuals in response to the situation; projections of net revenue, margins, expenses, net earnings, net earnings per share, or other financial items; projections or assumptions concerning the possible receipt by the Company of any regulatory approvals from any government agency or instrumentality including but not limited to the U.S. Food and Drug Administration, supply chain disruptions, component shortages, manufacturing disruptions or logistics challenges; or macroeconomic or geopolitical matters and the impact of those matters on the Company’s financial performance.
Forward-looking statements and information are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the Company’s ability to control or predict. Important factors that may cause the Company’s actual results to differ materially and that could impact the Company and the statements contained in this release include but are not limited to risks, uncertainties and assumptions relating to the regulatory environment in which the Company is subject to, including the Company’s ability to gain requisite approvals for its products from the U.S. Food and Drug Administration and other governmental and regulatory bodies, both domestically and internationally; the impact of the recent FDA Safety Communication on our business and operations; factors relating to the effects of the COVID-19 pandemic; sudden or extreme volatility in commodity prices and availability, including supply chain disruptions; changes in general economic, business or demographic conditions or trends; changes in and effects of the geopolitical environment; liabilities and costs which the Company may incur from pending or threatened litigations, claims, disputes or investigations; and other risks that are described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and the Company’s other filings with the Securities and Exchange Commission. For forward-looking statements in this release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.
