NanoVibronix Applies for CMS Reimbursement Code for UroShield® and PainShield Plus®
August 05 2021 - 8:52AM
Business Wire
Advancing Efforts to Expand Addressable Market
and Increase Access to Products for Millions of Medicare
Beneficiaries
NanoVibronix, Inc., (NASDAQ: NAOV), a Healthcare
device company that produces the UroShield® and PainShield® Surface
Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today
announced the company has completed the application process with
the Centers for Medicare and Medicaid (CMS) to receive a
reimbursement code for its UroShield and PainShield Plus
devices.
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UroShield (Photo: Business Wire)
Brian Murphy, Chief Executive Officer of NanoVibronix Inc.,
commented, "We took the first opportunity in 2021 to apply for a
CMS reimbursement code for UroShield and PainShield Plus as a next
step towards seeking to materially increase the number of providers
who may prescribe our proven effective devices as therapies for
patients, particularly the many millions of Medicare beneficiaries.
Upon approval, we will significantly expand our addressable market
and will be better positioned to serve providers who in turn serve
a growing population of patients seeking effective therapies that
can be administered in non-clinical settings, including the safety
of a patient’s home.”
Murphy continued, “Applying for CMS reimbursement is yet another
step towards seeking to accelerate the availability of our products
in light of the increasing interest from healthcare providers and
demand from our distributors. UroShield is already reimbursable in
government health institutions by virtue of inclusion on the
Federal Supply Schedule (FSS), and our original PainShield, the
predecessor to PainShield Plus, is already reimbursable under the
unique HCPCS code K1004. Receiving a unique CMS reimbursement code
and including each of these devices in the HCPCS manual should be
an important catalyst for our business and is expected to increase
our revenue opportunities.”
Moira Sykstus, CEO of Redemption Revenue Cycle Solutions, LLC,
is serving as the primary consultant for NanoVibronix for this
reimbursement code approval and is spearheading the company’s
efforts toward commercialization within the healthcare coding and
reimbursement system.
“It is extremely gratifying for me to help make potentially life
changing treatment options accessible for more patients,” stated
Moira Sykstus, CEO of Redemption Revenue Cycle Solutions, LLC.
“Working with NanoVibronix is an exciting opportunity because I
know the work we are doing should make a huge difference in the
lives of patients and those who care for them.”
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.
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 less effective
alternative therapies.
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) 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; (xv) our ability to
increase our authorized capital and (xvi) 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 Contact: Brett Maas, Managing Principal, Hayden
IR, LLC brett@haydenir.com (646) 536-7331
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