NanoVibronix Announces FDA 510(k) Submission for PainShield® MD PLUS
May 04 2022 - 8:30AM
Business Wire
NanoVibronix, Inc. (NASDAQ: NAOV), a medical device
company that produces the UroShield® and PainShield® Surface
Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today
announced it has submitted a 510(k) application to the U.S. Food
and Drug Administration (FDA) for its PainShield® MD PLUS, its
dual-actuator ultrasound pain therapy device.
Brian Murphy, CEO of NanoVibronix, stated, “This submission is
an important step towards full commercialization of our product and
underscores our continued progress towards making PainShield Plus
widely available for patients seeking an effective, non-drug
therapy to treat pain.”
A Special 510(k) submission facilitates the submission, review
and clearance of a change to a manufacturer’s own legally marketed
predicate device that is already authorized for commercial
distribution through 510(k) clearance. PainShield MD, the Company’s
predicate device, received market clearance in 2008, and was the
first Low Level Low Frequency pain device available in the US. This
Special 510(k) submission for PainShield MD PLUS leverages this
standing. PainShield MD PLUS was realized with only a few minor
design changes to the time-tested and proven mechanism-of-action of
the PainShield MD design.
PainShield Plus, like the original PainShield, utilizes
ultrasound therapy for the treatment of pain and various soft
tissue injuries either directly over joints or orthopedic hardware
and without the need for messy ultrasound gels. The device is an
effective solution for avoiding opioid treatments and equips
patients to receive therapy independently in the comfort and safety
of their own homes. The device consists of a reusable driver unit
and disposables, which includes a proprietary therapeutic
transducer and cover adhesive to deliver a localized ultrasound
effect to treat pain and induce soft tissue healing in a targeted
area, while keeping the level of ultrasound energy at a safe and
consistent level. Its range of applications includes acute and
chronic pain resolution through its many mechanisms of action and
can be used by patients at home, work or in a clinical setting and
can be used even while the patient is sleeping. Patient benefits
include ease of application and use, faster recovery time, high
compliance, and increased safety and efficacy over existing devices
that rely on higher-frequency ultrasound.
About NanoVibronix, Inc.
NanoVibronix, Inc. (Nasdaq: NAOV) is a medical device company
headquartered in Elmsford, New York, with research and development
in Nesher, Israel, focused on developing medical devices utilizing
its patented low intensity surface acoustic wave (SAW) technology.
The proprietary technology allows for the creation of low-frequency
ultrasound waves that can be utilized for a variety of medical
applications, including for disruption of biofilms and bacterial
colonization, as well as for pain relief. The Company’s primary
products include PainShield® and UroShield®, which are portable
devices suitable for administration at home without assistance of
medical professionals. Additional information about NanoVibronix is
available at www.nanovibronix.com.
Forward-looking Statements
This press release contains “forward-looking statements.” Such
statements may be preceded by the words “intends,” “may,” “will,”
“plans,” “expects,” “anticipates,” “projects,” “predicts,”
“estimates,” “aims,” “believes,” “hopes,” “potential” or similar
words. Forward-looking statements are not guarantees of future
performance, are based on certain assumptions and are subject to
various known and unknown risks and uncertainties, many of which
are beyond the Company’s control, and cannot be predicted or
quantified; consequently, actual results may differ materially from
those expressed or implied by such forward-looking statements. Such
risks and uncertainties include, without limitation, risks and
uncertainties associated with: (i) the geographic, social and
economic impact of COVID-19 on the Company’s ability to conduct its
business and raise capital in the future when needed, (ii) market
acceptance of our existing and new products or lengthy product
delays in key markets; (iii) negative or unreliable clinical trial
results; (iv) inability to secure regulatory approvals for the sale
of our products; (v) intense competition in the medical device
industry from much larger, multinational companies; (vi) product
liability claims; (vii) product malfunctions; (viii) our limited
manufacturing capabilities and reliance on subcontractor
assistance; (ix) insufficient or inadequate reimbursements by
governmental and/or other third party payers for our products; (x)
our ability to successfully obtain and maintain intellectual
property protection covering our products; (xi) legislative or
regulatory reform impacting the healthcare system in the U.S. or in
foreign jurisdictions; (xii) our reliance on single suppliers for
certain product components, (xiii) the need to raise additional
capital to meet our future business requirements and obligations,
given the fact that such capital may not be available, or may be
costly, dilutive or difficult to obtain; (xiv) our conducting
business in foreign jurisdictions exposing us to additional
challenges, such as foreign currency exchange rate fluctuations,
logistical and communications challenges, the burden and cost of
compliance with foreign laws, and political and/or economic
instabilities in specific jurisdictions; and (xv) market and other
conditions. More detailed information about the Company and the
risk factors that may affect the realization of forward looking
statements is set forth in the Company’s filings with the
Securities and Exchange Commission (SEC), including the Company’s
Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.
Investors and security holders are urged to read these documents
free of charge on the SEC’s web site at: http://www.sec.gov. The
Company assumes no obligation to publicly update or revise its
forward-looking statements as a result of new information, future
events, or otherwise, except as required by law.
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Investor Contacts: Brett Maas, Managing Principal, Hayden
IR, LLC brett@haydenir.com (646) 536-7331
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