NanoVibronix Receives FDA 510(k) Premarket Clearance for PainShield Plus
November 28 2022 - 2:18PM
Business Wire
Achieves Key Milestone to Advance
Commercialization
NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company
utilizing the Company's proprietary and patented low intensity
surface acoustic wave (SAW) technology, today announced U.S. Food
and Drug Administration (FDA) 510(k) clearance of its PainShield®
MD PLUS, its dual-actuator ultrasound pain therapy device.
Brian Murphy, CEO of NanoVibronix, stated, “Securing 510(k)
clearance for PainShield Plus is a key milestone towards achieving
permanent clearance from the FDA and full-scale commercial
marketability. Increasingly, healthcare providers and patients are
seeking effective, non-pharmaceutical therapies for the treatment
of chronic pain. PainShield Plus expands on the effectiveness of
its predecessor, our original PainShield M.D., by covering twice
the treatment area and broadening the opportunities for
application. As a result, we have started the process of making the
recommended modifications to the device in order to comply with the
FDA standard. In addition, this approval opens the door for us to
submit a 510(k) application for our Over-The-Counter product,
PainShield Relief, in the near term.”
About PainShield Plus
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 devices can be
administered at home without the assistance of medical
professionals. 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) market acceptance of our
existing and new products or lengthy product delays in key markets;
(ii) negative or unreliable clinical trial results; (iii) inability
to secure regulatory approvals for the sale of our products; (iv)
intense competition in the medical device industry from much
larger, multinational companies; (v) product liability claims; (vi)
product malfunctions; (vii) our limited manufacturing capabilities
and reliance on subcontractor assistance; (viii) insufficient or
inadequate reimbursements by governmental and/or other third party
payers for our products; (ix) our ability to successfully obtain
and maintain intellectual property protection covering our
products; (x) legislative or regulatory reform impacting the
healthcare system in the U.S. or in foreign jurisdictions; (xi) our
reliance on single suppliers for certain product components, (xii)
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; (xiii) 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 (xiv) 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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Brett Maas, Managing Principal, Hayden IR, LLC
brett@haydenir.com (646) 536-7331
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