Misonix today announced that it received 510(k) clearance by the US Food and Drug Administration (FDA) for Nexus, its ultrasonic surgical platform. Misonix will commence the commercialisation of the Nexus platform in the USA in July.
Nexus is an integrated ultrasonic surgical platform that combines all the features of Misonix’s existing solutions, including BoneScalpel, SonicOne and Sonastar, into a single fully integrated platform that will also serve to power future solutions. The Nexus platform is driven by a new proprietary digital algorithm that results in more power, efficiency and control. Nexus uniquely incorporates RF capabilities, allowing for use in general surgery procedures. The device also incorporates Smart Technology that allows for easier setup and use.
According to a press release, physicians will be able to utilise Nexus’ increased power to improve tissue resection rates, in concert with its proprietary digital algorithm to perform more efficient bone removal procedures. In addition, Nexus’ ease of use will enable physicians to fully leverage Nexus’ impressive capabilities via its digital touchscreen display and smart system setup.
Stavros Vizirgianakis, president and chief executive officer of Misonix, commented, “We are very pleased to have achieved this critical approval, marking a significant milestone for Misonix and the culmination of years of hard work. Nexus is a powerful, highly integrated and easy-to-use system that will benefit both healthcare providers and patients by incorporating the latest advances in ultrasonic technology allowing for increased efficiency and efficacy, and thus improved outcomes. It is truly a transformational product.
“The overwhelmingly positive feedback we have received from the surgeon community since first unveiling Nexus reinforces our confidence in its potential to serve as a significant growth engine for Misonix. Nexus is a key component of our strategy to increase our presence in the neuro, spine, ortho, wound and general surgery markets. Nexus provides us with a unique opportunity to leverage our robust consignment business model, further drive the sale of consumables competitively, and extend our ability to cross-sell into multiple physician specialties. The commercialszation of Nexus will expand the utilisation of ultrasonic surgical applications as we continue to strategically invest in our products to become the standard of care in operating rooms and hospital outpatient departments.”