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.
Overview
Apyx Medical Corporation is an energy technology company distinguished by its innovative plasma‐based medical devices utilized in both the cosmetic and hospital surgical markets. The company develops, manufactures, and markets advanced energy solutions that provide surgeons with precise and controlled heat applications, addressing both tissue cutting and coagulation needs. Operating under a dual-segment framework, its services are divided into Advanced Energy and Original Equipment Manufacturing (OEM), each contributing uniquely to its overall market presence. Its technology portfolio, including the Renuvion and J-Plasma systems, leverages patented helium plasma technology and specialized waveforms, enabling high-performance surgical applications and reducing unintended tissue trauma.
Advanced Energy Solutions
The Advanced Energy segment of Apyx Medical Corporation centers on its core plasma-based technologies. These systems are designed to offer enhanced control during surgical and cosmetic procedures by delivering precise energy in the form of helium plasma. Surgeons in both cosmetic and hospital surgical environments benefit from these technologies through improved accuracy and reduced collateral tissue damage. The company has strategically engineered its products to support various applications, ranging from body contouring and soft tissue ablation to coagulation, positioning itself as a key player in the energy technology medical device industry. The integration of over 90 clinical documents demonstrates a consistent level of clinical validation and supports the efficacy and safety profiles of these advanced energy solutions.
OEM Manufacturing Capabilities
In addition to its Advanced Energy segment, Apyx Medical Corporation is also prominently involved in the Original Equipment Manufacturing (OEM) sector. By designing and producing electrosurgical generators and related accessories, the company not only markets its own devices but also partners with other leading medical device manufacturers. This dual approach enables Apyx to extend its technological expertise to a wider market, enhancing its revenue streams while fostering innovation across the medical device landscape. The OEM segment benefits from the company’s deep experience in developing unique waveform technologies and precision energy delivery, making it an indispensable partner in the creation of next-generation medical devices.
Technology and Innovation
The technological backbone of Apyx Medical Corporation lies in its pursuit of innovation within the energy technology sector. The company’s patented plasma-based systems, marketed under brands such as Renuvion and J-Plasma, are at the forefront of modern electrosurgical applications. These systems enable controlled energy delivery, allowing surgeons to work with enhanced precision and significantly reducing the risk of unintended tissue trauma. The controlled heat delivery mechanisms are particularly critical in cosmetic and reconstructive procedures, where precision is paramount. The company’s considerable investment in research and clinical studies underpins its commitment to technological excellence, providing a robust foundation for continuous improvements and product enhancements.
Market Position and Industry Impact
Apyx Medical Corporation occupies a distinct position within the broader energy technology and medical device sectors. With a reputation for developing innovative plasma-based surgical solutions, the company serves a diverse clientele including plastic surgeons, facial plastic surgeons, and cosmetic physicians. Its technologies are integral in procedures that demand high precision and minimal invasiveness. The advanced energy solutions not only address existing surgical challenges but also set new standards in terms of device performance and patient safety. This strategic positioning is further reinforced by the company’s OEM collaborations, which enable it to disseminate its expertise across various facets of the medical device industry. While navigating a competitive environment that includes both established and emerging players, Apyx distinguishes itself through its commitment to refining technological innovations and adhering to rigorous clinical standards.
Operational Excellence and Quality Assurance
Operational excellence is a core tenet of Apyx Medical Corporation’s business model. The company emphasizes rigorous quality control processes during the design, development, and manufacturing phases of its products. Such practices ensure that every device meets stringent safety and performance criteria, a crucial factor in the highly regulated medical device industry. Through continuous process improvements and quality management systems, the company maintains a robust operational framework that supports its long-term sustainability and reliability as a technology provider. This commitment to excellence enhances trust among healthcare professionals and institutional partners alike.
Clinical and Surgical Applications
The practical applications of Apyx Medical Corporation’s technologies span a wide range of clinical and surgical environments. In cosmetic surgery, the Renuvion system offers a transformative approach to body contouring by providing controlled energy delivery tailored for precision and minimal invasiveness. Similarly, the J-Plasma system is engineered to meet the rigorous demands of hospital surgical procedures, ensuring that surgeons can achieve effective tissue modification with enhanced safety. The integration of clinical evidence into its product development process further confirms the efficacy of these applications, thereby fortifying the company’s reputation in the clinical community. This dual-application strategy not only broadens the market reach but also underscores the versatility and adaptability of the company’s technological solutions.
Strategic Collaborations and Market Expansion
Apyx Medical Corporation’s strategic approach includes forging key partnerships within the medical device sector through OEM arrangements. These collaborations facilitate the integration of its advanced energy technologies into the broader ecosystem of medical devices, thereby driving market expansion. By leveraging the expertise of established industry partners, the company is able to refine its product offerings, gain new insights into market demands, and maintain a competitive edge. Such collaborations ensure that Apyx remains at the cutting edge of medical technology innovation, thereby continuously reinforcing its value proposition.
Expertise and Authoritativeness
The company’s extensive experience and technical expertise in the field of energy-based surgical solutions are evident in its comprehensive portfolio and the clinical validation of its products. With a heritage rooted in decades of research and innovation, Apyx Medical Corporation has developed a robust framework for understanding and addressing the complex challenges inherent in both cosmetic and surgical treatments. This depth of expertise is reflected in the strategic development and deployment of its technologies, which combine precision engineering with a clear understanding of clinical needs. The company’s ability to deliver solutions that optimize surgical outcomes while minimizing risks highlights its authoritative presence in the energy technology space.
Competitive Landscape and Differentiation
Within a competitive market populated by several established players, Apyx Medical Corporation differentiates itself through its unique blend of advanced energy technology and strategic OEM partnerships. Its focus on precision, safety, and controlled heat delivery distinguishes its product offerings from traditional electrosurgical instruments. The company’s approach to integrating clinical evidence with innovative technology ensures that its solutions are both effective and reliable. This differentiation is critical in an industry where technological nuances can significantly impact surgical outcomes and patient safety. By continually investing in research and maintaining rigorous quality standards, Apyx positions itself as a trusted provider of cutting-edge medical technologies.
Conclusion
In summary, Apyx Medical Corporation exemplifies the convergence of energy technology and advanced medical device manufacturing. Its dual-segment operation, spanning both advanced energy products and OEM manufacturing, enables the company to offer comprehensive solutions that address critical needs in cosmetic and surgical applications. Through its innovative plasma-based systems, the company delivers unmatched precision and safety, supported by an extensive body of clinical research and a commitment to operational excellence. As a respected contributor to the energy technology and medical device industries, Apyx continues to influence the standard of care in surgical procedures, making it a subject of ongoing interest for investors, healthcare professionals, and industry analysts alike.
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.
Apyx Medical Corporation (NASDAQ:APYX) announced the submission of an FDA 510(k) premarket notification for its Renuvion® Dermal Handpiece aimed at dermatological procedures requiring ablation and resurfacing. This follows the publication of a peer-reviewed study in Lasers in Surgery and Medicine, confirming that 100% of subjects experienced an improvement in wrinkle scores after treatment. The study reports high satisfaction rates and no serious adverse events, supporting Apyx's regulatory strategy and market expansion goals in the U.S. cosmetic surgery market.
Apyx Medical Corporation (NASDAQ:APYX) is set to release its financial results for the fourth quarter and fiscal year 2021 on March 17th, before the market opening. A conference call will be held at 8:00 a.m. ET on the same day, allowing stakeholders to discuss the results and participate in a Q&A session. The call can be accessed via phone or a live webcast on the Company's website. A replay will be available until March 31, 2022.
Apyx Medical specializes in innovative medical devices, showcasing its Helium Plasma Technology.
Apyx Medical Corporation (NASDAQ:APYX) announced its preliminary revenue results for Q4 and full year 2021, revealing $16.3 to $16.8 million in Q4, a year-over-year growth of 42% to 46%.
Advanced Energy sales ranged from $14.7 to $15.0 million, indicating a 49% to 52% increase compared to last year. For the full year, total revenue reached $48.0 to $48.5 million, a growth of 73% to 75%. However, OEM revenue faced a slight decline.
CEO Charlie Goodwin highlighted strong adoption of their Renuvion® technology in the U.S., driving sales above expectations.
Apyx Medical Corporation (NASDAQ:APYX) reported strong Q3 2021 results, with total revenue reaching $11.8 million, a 70% increase year-over-year. Advanced Energy sales surged 88% to $10.3 million, driven by increased demand for Renuvion® products. Net loss attributable to stockholders was $4.2 million, slightly higher than $3.7 million in Q3 2020. Full year revenue guidance was raised to $44-45 million, reflecting a year-over-year growth of 59%-62%. As of September 30, 2021, the company held $30.9 million in cash and equivalents.
Apyx Medical Corporation (NASDAQ:APYX) announced its participation in several upcoming investor conferences. Events include virtual 1x1 meetings at the Craig-Hallum Alpha Select Conference on November 16, a presentation at the Stifel 2021 Virtual Healthcare Conference on November 17 at 3:20 p.m. ET, and additional meetings at the Canaccord Genuity Forum on November 18. A fireside chat will be available on-demand at the Piper Sandler Conference starting November 22. Audio webcasts will be accessible on their investor relations website.
Apyx Medical Corporation (NASDAQ:APYX) will release its financial results for Q3 FY2021 on November 11, 2021, after market closure. The Company specializes in medical devices using its Helium Plasma Technology, marketed as Renuvion® and J-Plasma®. A conference call will be held at 5:00 p.m. ET the same day to discuss these results. The call can be accessed by phone or via a live webcast. A telephonic replay will be available post-call. Apyx aims to enhance surgical precision and minimize tissue trauma with its innovative technology.