About Apyx Medical

Apyx Medical Corporation operates as an advanced energy technology company. The company continues to focus its efforts to increase the adoption of its Advanced Energy technology and utilization of its handpieces by surgeons in the U.S. and fulfilling demand from distributors in its international markets. Management estimates that the company’s products have been sold in more than 60 countries. As of December 31, 2022, the company had a direct sales force of 35 field-based selling professionals and utilized 3 independent sales agencies. The company also had 4 sales managers. This selling organization is focused on the use of Renuvion and J-Plasma in the cosmetic and hospital surgical markets, supported by its global medical affairs team. This global team of clinical support specialists focuses on supporting the company’s users to ensure optimal outcomes for their patients. In addition, the company has invested in training programs and marketing-related activities to support accelerated adoption of Renuvion into surgeons' practices. Apyx Bulgaria, EOOD is a wholly owned limited liability company incorporated under Bulgarian law, located in Sofia, Bulgaria. It is engaged in the business of development and manufacturing of the company’s advanced energy generators, as well as the manufacturing of its disposable handpieces and accessories, and development and manufacturing of original equipment manufacturing (OEM) generators and related accessories. The facility also distributes products directly to customers in certain international markets and provides warranty and repair services. Segments The company operates through two segments, Advanced Energy and OEM. Advanced Energy segment The company’s product portfolio consists of its Helium Plasma Technology that is marketed and sold as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market. The company’s primary focus is on the cosmetic surgery market where Renuvion offers plastic surgeons, fascial plastic surgeons and cosmetic physicians a unique ability to provide controlled heat to the tissue to achieve their desired results. This technology has the U.S. Food and Drug Administration (FDA) clearance, CE mark, and clearance for sale in multiple other countries and is generally indicated for the cutting, coagulation and ablation of soft tissue. The system consists of an electrosurgical generator unit (ESU), a handpiece and a supply of helium gas. The proprietary radiofrequency (RF) energy is delivered to the handpiece by the electrosurgical generator unit (ESU) and used to energize an electrode. When helium gas passes over the energized electrode, helium plasma is generated which allows for conduction of the RF energy from the electrode to the patient in the form of a precise helium plasma beam. The energy delivered to the patient via the helium plasma beam is unique in that it allows for the application of heat to tissue in a way that is not possible with traditional monopolar or bipolar technologies. This technology has been the subject of over ninety peer-reviewed journal articles, book chapters, abstracts, and posters. It also continues to be the subject of numerous presentations at traditional and cosmetic surgery conferences around the world. This technology initially received FDA clearance in 2012 and a CE mark in December 2014, which enables the company to sell the product in the European Union. In 2014, the company created and trained a direct sales force dedicated to sell this technology. In 2015, the company continued the commercialization process for its Helium Plasma Technology with a multi-faceted strategy designed to accelerate adoption of the product. This strategy primarily involved deployment of a dedicated sales force, developing product line extensions and expanding the specialties in which this technology can become the ‘standard of care’ for certain procedures. During 2022, the company continued its full-scale, global, commercialization efforts for Renuvion in the cosmetic and plastic surgery markets. As of December 31, 2022, the company had a direct sales force of 35 field-based selling professionals and utilized 3 independent sales agencies. The company also had 4 sales managers. This selling organization is focused on the use of Renuvion in the cosmetic surgery market, supported by its global medical affairs team. This global team of clinical support specialists focuses on supporting the company’s users to ensure optimal outcomes for their patients. In addition, the company has invested in training programs and marketing-related activities to support accelerated adoption of Renuvion into physicians’ practices. From 2015 through 2022, the company launched numerous new extensions to its Helium Plasma product lines in an effort to target new surgical procedures, users, and markets. Most notably, throughout 2021, the company continued its launch of its Renuvion Apyx Plasma RF handpieces (APR) around the world. These handpieces were designed with improved ergonomics and usability for the company’s Renuvion customers. As a result of the company’s sales, marketing and product development initiatives, it has significantly increased the number of physicians using its Helium Plasma Technology by expanding usage to include the cosmetic surgery market in the U.S., and the cosmetic surgery market, as well as the surgical oncology market outside the U.S. In late January 2023, the company launched its recently FDA approved Apyx One Console in the U.S. This is a multi-functional generator incorporating an advanced 3-in-1 energy system that enables plastic and cosmetic surgeons to utilize Renuvion technology, together with full monopolar and bipolar energy. Key features of the Apyx One Console include adaptive and intuitive touch screens, procedural presets by body part, cloud connectivity, data sharing and logging, remote upgrade capabilities and system diagnostics, and an advanced gas system that measures and monitors gas volume and usage. In order to assist the company in leveraging its Helium Plasma Technology’s precision and effectiveness in multiple surgical specialties, the company continues to utilize its Medical Advisory Board which consists of 5 members representing the plastic surgery, fascial plastic surgery, and cosmetic procedure specialties. The company’s commercial strategy in the U.S. and outside the U.S. is primarily focused on advancing the usage of Renuvion in the cosmetic surgery market. In some of its international markets, the company continues to provide support to its customers who have adopted its J-Plasma technology for the hospital surgical market. The company continues to develop a clinical and regulatory strategy, and corresponding marketing campaigns, to support its market focus. The company also continues to expand the reach of its global medical affairs team in order to provide clinical support to its customers in all markets. Customers In the U.S., the company primarily sells its Renuvion products through its direct sales force to physicians, cosmetic surgery offices and surgical centers. Outside of the U.S., all of the company’s products are sold primarily through its distributor network. Products The company’s Advanced Energy Products consist of its Helium Plasma Technology lines (Renuvion and J-Plasma). These product lines consist of a multifunction generator, a handpiece and a supply of helium gas. RF energy is delivered to the handpiece by the generator and used to energize an electrode. When helium gas passes over the energized electrode, helium plasma is generated which allows for conduction of the RF energy from the electrode to the patient in the form of a precise helium plasma beam. The energy delivered to the patient via the helium plasma beam is unique in that it allows for the application of heat to tissue in a way that is not possible with traditional monopolar or bipolar technologies. Helium Plasma Generator While the company did a limited launch of its Apyx Once Console in the U.S. in the fourth quarter of 2022, full commercial launch of the generator in the U.S. started in January 2023. Internationally, during 2022, the company continued its launch of the Renuvion System 3 generator, to markets outside the U.S. This high frequency electrosurgical generator can be used for delivery of RF energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. This new generator was built for use with the company’s Renuvion APR handpieces, and features enhanced capabilities, such as a joule counter, capable of displaying energy delivered to the patient, and new Auto-Bipolar functionality, which expands the surgical capabilities of the system. These new product releases continue to expand the procedure base for the company’s Helium Plasma Technology by providing surgeons with the tools they need to access additional anatomic locations and perform specific procedures. Disposables Portfolio The company offers a variety of different hand pieces for open and laparoscopic procedures. The helium-based plasma generated from these devices has been shown to provide increased precision and control and cause less thermal damage to tissue than CO2 laser, argon plasma and RF energy products available on the market. The technology has a general indication and can be used for cutting, coagulating and ablating soft tissue. In 2020, the company completed the launch of its new generation APR handpieces in the U.S. market. During 2021, the company began to launch these new handpieces in its international markets, designed specifically for minimally invasive use, with improved ergonomics and safety features. OEM segment The company leverages its expertise in the design, development and manufacturing of electrosurgical equipment and medical devices by producing generators, medical devices and related accessories for large, well-known medical device manufacturers through original equipment manufacturing (OEM) agreements, as well as start-up companies with the need for the company’s energy-based designs. Intellectual Property The company has been issued 40 patents in the United States and 28 foreign patents. The company has 22 pending patent applications in the United States and 58 pending foreign applications. The company has 9 U.S. registered trademarks, 5 international registered trademarks, and 4 pending international trademark applications. Regulation The company manufactures the majority of its products on its premises in Clearwater, Florida and at its facility located in Sofia, Bulgaria, both of which are certified under the ISO13485:2016 international quality standards and are subject to continuing regulation and routine inspections by the FDA and other regulatory agencies to ensure compliance with regulations relating to the company’s quality management system, medical device complaint reporting, and adherence to FDA and other country restrictions on promotion and advertising. In addition, the company is subject to regulations under the Occupational Safety and Health Act, the Environmental Protection Act and other federal, state and local regulations, as well as international laws and regulations. On March 14, 2022, the U.S. Food and Drug Administration (FDA) posted a Safety Communication that warns consumers and health care providers against the use of the company’s Advanced Energy products outside of their FDA-cleared indications for general use in cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures. History The company was incorporated in 1982 under the laws of the state of Delaware. It was formerly known as Bovie Medical Corporation and changed its name to Apyx Medical Corporation in 2019.