Misonix gains FDA clearance for ultrasonic surgical platform

 

Misonix (NSDQ:MSON) said today that it received FDA 510(k) clearance for a new ultrasonic surgical platform.

The Nexus platform combines all the features of Misonix’s existing solutions, including BoneScalpel, SonicOne and Sonastar, into a single, fully integrated platform that was also designed to accommodate future solutions.

The Nexus platform is driven by a new proprietary digital algorithm that results in more power, efficiency and control, according to the Farmingdale, N.Y.-based ultrasound device maker. Nexus incorporates RF capabilities, allowing for use in general surgery procedures, as well as smart technology designed to allow for easier setup and use.  Nexus’ increased power may improve tissue resection rates, in concert with its proprietary digital algorithm to perform more efficient bone removal procedures, the company said.

Misonix will begin selling the Nexus platform in the United States in July.

“We are very pleased to have achieved this critical approval, marking a significant milestone for Misonix and the culmination of years of hard work,” said Misonix president and CEO Stavros Vizirgianakis in a news release. “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,” Vizirgianakis added. “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 commercialization of Nexus will expand the utilization 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.”

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