Misonix Receives U.S. FDA Clearance for Nexus, its Revolutionary Integrated Ultrasonic Surgical Platform
03 June 2019 - 9:00PM
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.
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
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.”
Forward Looking StatementsThis communication
contains forward-looking statements, which address a variety of
subjects including, for example, our expected timeline of
commercialization of the Nexus platform. Statements that are not
historical facts, including statements about our beliefs, plans and
expectations, are forward-looking statements. Such statements are
based on our current expectations and are subject to a number of
factors and uncertainties, which could cause actual results to
differ materially from those described in the forward-looking
statements. Important factors and uncertainties that could cause
actual results to differ materially from those described in these
forward-looking statements include, but are not limited to, the
risk that our launch of Nexus may not occur on the timeline we
expect. For additional information about factors that could cause
actual results to differ materially from those described in the
forward-looking statements, please refer to Misonix’s filings with
the SEC, including the risk factors contained in Misonix’s most
recent Quarterly Reports on Form 10-Q and Annual Report on Form
10-K. Forward-looking statements represent management’s current
expectations and are inherently uncertain. Except as required by
law, we do not undertake any obligation to update forward-looking
statements made by us to reflect subsequent events or
circumstances.
About Misonix, Inc.Misonix, Inc. (NASDAQ: MSON)
designs, manufactures and markets ultrasonic medical devices for
the precise removal of hard and soft tissue, including bone
removal, wound debridement and ultrasonic aspiration. Misonix is
focused on leveraging its proprietary ultrasonic technology to
become the standard of care in operating rooms and clinics around
the world. Misonix's proprietary ultrasonic medical devices are
used in a growing number of medical procedures, including spine
surgery, neurosurgery, orthopedic surgery, cosmetic surgery,
laparoscopic surgery, and other surgical and medical applications.
At Misonix, Better Matters to us. That is why throughout the
Company’s history, Misonix has maintained its commitment to medical
technology innovation and the development of ultrasonic surgical
products that radically improve patient outcomes. Additional
information is available on the Company's web site at
www.misonix.com.
Contact: |
|
Joe Dwyer |
Norberto Aja, Jennifer Neuman |
Chief Financial Officer |
JCIR |
Misonix, Inc. |
212-835-8500 or mson@jcir.com |
631-927-9113 |
|
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