Full Press Release Details
Receives FDA 510(k) Premarket Clearance for PainShield Plus
Key Milestone to Advance Commercialization
N.Y., November 28, 2022 -- 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.
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."
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.
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.
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.
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.
Maas, Managing Principal, Hayden IR, LLC