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Monday, June 3, 2019

Misonix Gets FDA OK for Ultrasonic Surgical Platform

 Misonix, Inc. (Nasdaq: MSON) (“Misonix” or the “Company”), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today announced that it received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for Nexus, its revolutionary ultrasonic surgical platform. Misonix will commence the commercialization of the Nexus platform in the United States in July.
Nexus is a next-generation 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.
Physicians will be able to utilize 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.

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