ELMSFORD, N.Y., April 2, 2020 /PRNewswire/ -- NanoVibronix,
Inc., (NASDAQ: NAOV), a medical device company that
produces the UroShield®, PainShield® and
WoundShield®, and WoundShield® Surface
Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today
announced that it signed a license agreement with Sanuwave Health,
Inc. for the manufacture and delivery of its WoundShield
technology.
Under the terms of the agreement, NanoVibronix will receive
100,000 warrants of Sanuwave stock, a $250,000 milestone payment based on FDA approval,
and 10% royalty on Sanuwave's gross revenues from sales or
rentals of WoundShield. In return, Sanuwave has received the
worldwide, exclusive rights to the company's WoundShield product
and technology. In addition, Sanuwave will bear the costs and
clinical validation responsibilities associated with obtaining
approval for WoundShield from the U.S. Food and Drug Administration
and other regulatory agencies around the world.
"Licensing our WoundShield technology with a leader in wound
care devices provides a pathway for worldwide distribution and a
growing royalty revenue stream on future sales," said Brian Murphy, CEO of NanoVibronix. "This
agreement is consistent with our strategy of partnering with
category leaders with significant sales resources in our key
technology markets with UroShield, PainShield and now
WoundShield."
WoundShield is an advanced therapeutic ultrasound system that is
intended to accelerate wound healing by increasing blood flow and
oxygenation of tissue. The system includes a portable,
battery-powered electronic unit that delivers localized energy via
an actuator that is applied adjacent to the wound creating a
therapeutic effect without interfering with the wound dressing.
WoundShield may be integrated with Negative Pressure Wound Therapy
to provide a synergetic wound healing effect by angiogenesis
and tissue regeneration resulting from a further increase in
fibroblast migration
"We are excited to license WoundShield as many of our existing
Key Opinion Leaders (KOL's) have mentioned how synergistic such a
product would be to compliment dermaPACE system," commented Kevin
A. Richardson II CEO and Chairman of Sanuwave. "Sanuwave has an
established international distribution network which we will
initially leverage to grow and establish WoundShield and we plan to
begin clinical work in the U.S. in the third quarter of 2020. We
are glad to be collaborating with other innovative companies we
have known for many years."
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.
About Sanuwave Health, Inc.
Sanuwave Health, Inc. (OTCQB: SNWV) is a shockwave technology
company initially focused on development and commercialization
noninvasive, biological response-activating devices for repair and
regeneration of skin, musculoskeletal tissues, and vascular
structures. Sanuwave's proprietary technology portfolio includes
regenerative medicine products and product candidates for
activation of biologic signaling and angiogenic responses,
producing new vascularization and microcirculatory improvements,
which helps restore the body's normal healing processes and
regeneration. Sanuwave applies its patented PACE®
technology in wound healing, orthopedic/spine, plastic/cosmetic and
cardiac conditions. Its lead product candidate for the global wound
care market, dermaPACE®, has been cleared for the
treatment of diabetic foot ulcers by the U.S. FDA, CE Marked
throughout Europe, and has device
license approval for treatment of skin and subcutaneous soft
tissues in Canada, South Korea, Australia, and New
Zealand. Sanuwave researches, designs, manufactures, markets
and services its products worldwide, and believes it has
demonstrated that its technology is safe and effective in
stimulating healing in chronic conditions of the foot (plantar
fasciitis) and the elbow (lateral epicondylitis) through its U.S.
Class III PMA approved OssaTron® device, as well as
stimulating bone and chronic tendonitis regeneration in the
musculoskeletal environment through the utilization of its
OssaTron®, Evotron® and
orthoPACE® devices in Europe, Asia
and Asia/Pacific. New licensing
and/or partnership opportunities may also exist for various
non-medical uses of Sanuwave's shockwave technology, particularly
in the energy, agricultural, and industrial markets.
Additional information about Sanuwave is available at:
www.SANUWAVE.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; and (xiii) 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. 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.
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SOURCE NanoVibronix, Inc.