NanoVibronix Announces UroShield & PainShield Meet New Zealand Medicines & Medical Devices Safety Authority Regulatory Requir...
December 08 2020 - 8:00AM
Business Wire
Obex Medical Ltd to Distribute Products in
New Zealand
NanoVibronix, Inc. (NASDAQ: NAOV),
a medical device company that produces the UroShield® and
PainShield® Surface Acoustic Wave (SAW) Portable Ultrasonic
Therapeutic Devices, today announced that its UroShield and
PainShield meet the New Zealand Medical Devices Safety Authority
regulatory requirements and have been added to the official WAND
database in accordance with the Regulations. Coupled with this
approval, the company signed an agreement, and fulfilled its first
shipment, with Obex Medical Ltd to distribute both of the Company’s
technologies throughout New Zealand.
Brian Murphy, Chief Executive Officer of NanoVibronix Inc.,
commented, “This agreement with Obex Medical Ltd provides us with
strong distribution capabilities in New Zealand and further
advances our strategy to penetrate new markets globally by
partnering with leading organizations with significant sales
resources. Obex Medical has already placed its initial order,
validating their confidence in our technology and the market
potential of our products. UroShield enables clinicians to
potentially prevent the incidence of catheter-related infections
that further complicate patient care, extend the duration of
hospital stays or increase the risk of readmission, which is more
important than ever before given this critical time for healthcare
systems around the world.”
Pieter Wijnhoud, CEO of Obex Medical Ltd, commented, “UroShield
and PainShield meet the New Zealand Medical Devices Safety
Authority regulatory requirements and have been added to the
official WAND database in accordance with the regulations. This
registration comes at a time when utilising UroShield with
vulnerable long-term catheter patients who are at risk of CAUTI may
reduce unplanned clinician visits and hospitalizations, thereby
potentially preventing exposure to SARS-CoV-2 in patients at higher
risk of developing severe disease from COVID-19. We anticipate
strong uptake as we meet the needs of medical professionals with
the supply of minimally invasive, consumable devices that enable
the delivery of the best therapy for the patient.”
UroShield® is an ultrasound-based product that is designed to
prevent bacterial colonization and biofilm on indwelling urinary
catheters and increase antibiotic efficacy, ultimately reducing the
incidence of catheter-associated urinary tract infections (CAUTI).
UroShield is also intended to decrease pain and discomfort
associated with urinary catheter use. The FDA recently exercised
its “enforcement discretion,” which provides access to the product
for patients in the United States for the duration of the Covid-19
pandemic. PainShield has been cleared by the FDA.
PainShield is an ultrasound device, consisting of a reusable
driver unit and a disposable patch, which contains a proprietary
therapeutic transducer. PainShield delivers 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. The
product has been acknowledged by several sports icons and has broad
applications for sports injuries. PainShield can be used by
patients at home or 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 Obex Medical
Obex is an industry leader in advancing clinical education and
has a high level of clinical and technical expertise with a strong
focus on meeting the changing needs of healthcare in Australasia.
Obex’s purpose is to meet the needs of healthcare professionals
with the supply of minimally invasive consumable and implantable
devices which will enable the delivery of the best diagnosis and
therapy to ensure best outcomes for patients.
For further information about Obex Medical, please contact:
Pieter Wijnhoud. NZ +64 9 630 3456 info@obex.co.nz
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®,
UroShield® and WoundShield®, all of 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, e.g., 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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version on businesswire.com: https://www.businesswire.com/news/home/20201208005377/en/
Investor Contacts:
NanoVibronix, Inc. bmurphy@nanovibronix.com (630) 338-5022
Or:
Brett Maas, Managing Principal, Hayden IR, LLC
brett@haydenir.com (646) 536-7331
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