Loading APYX…
APYX • CIK 0000719135
NOTE 1. DESCRIPTION OF BUSINESS Apyx Medical Corporation (“Company”, “Apyx”, “it” and similar terms) was incorporated in 1982, under the laws of the State of Delaware and has its principal executive office at 5115 Ulmerton Road, Clearwater, FL 33760. The Company is a surgical aesthetics company with a passion for elevating people’s lives through innovative products, including its Helium Plasma Platform Technology products marketed and sold as Renuvion ® and the AYON Body Contouring System TM (“AYON”) 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. AYON is an FDA-cleared, surgeon-designed body contouring system that combines precision, versatility, and innovation in an all-in- one platform. It seamlessly integrates fat removal, closed loop contouring, and Renuvion’s tissue contraction and electrosurgical capabilities, empowering surgeons to deliver comprehensive body contouring treatments for patients. The Company also leverages its deep expertise and decades of experience in unique waveforms through OEM agreements with other medical device manufacturers. Recent Business Developments On May 13, 2025, the Company announced that it had received 510 (k) clearance from the U.S. Food and Drug Administration (the “FDA”) for AYON. The Company completed the soft launch of AYON, leveraging its relationships with key surgeons in critical geographies. Additionally, the Company commenced the commercial launch of AYON in September 2025. AYON was developed with a focus on versatility and innovation. AYON has been designed to be the only device a surgeon needs for comprehensive body contouring solutions. This all-in- one system integrates advanced modalities to perform multiple functions seamlessly, removing unwanted fat, enhancing tissue contraction and addressing the full range of patient needs from contouring to aesthetic enhancement. The initial submission for AYON includes the following: • Infiltration • Dual aspiration to facilitate simultaneous users • Ultrasound-assisted liposuction • Electrocoagulation to support procedures requiring removal of excess tissue • Volume enhancement capabilities • Renuvion treatment to address loose and lax skin On October 13, 2025, the Company announced that it had submitted the 510 (k) premarket notification to the FDA for the label expansion of AYON to include power liposuction. The Company anticipates receiving clearance in the second quarter 2026. On July 28, 2025, the Company announced the launch of Renuvion in China following receipt of initial market clearance from the National Medical Products Administration of China. Liquidity The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. The going concern basis of presentation assumes that the Company will continue in operation one year after the date these financial statements are issued and will be able to realize its assets and discharge its liabilities and commitments in the normal course of business. Pursuant to the requirements of the Financial Accounting Standards Board’s Accounting Standards Codification (“ASC”) Topic 205 - 40, Disclosure of Uncertainties about an Entity ’ s Ability to Continue as a Going Concern , management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for one year from the date these consolidated financial statements are issued. This evaluation does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented or are not within control of the Company as of the date the condensed consolidated financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern.…