Full Press Release Details
Amends and Expands Distribution Agreement for Its PainShield and PainShield Plus
Pain Products, Inc. to Distribute Company's Pain Management Devices to DME Market Under a Private Label in U.S.
N.Y., December 11, 2020 (Business Wire) -- NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces
the UroShield , PainShield and WoundShield Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices,
today announced that it has expanded and replaced its original distribution agreement with Ultra Pain Products, Inc. ("UPPI").
Under the terms of the new agreement, which extend the term and increase minimum purchase requirements, UPPI will be the exclusive
distributor of privately labeled PainShield and PainShield PlusTM devices to the Durable Medical Equipment
(DME) distribution sector of the healthcare market in the United States.
this year, NanoVibronix officially phased out its original PainShield DV0057 - and associated hydrogel patches with an updated
version - the PainShield 10-100-0008 - the PainShield Kit: PainShield .
NanoVibronix entered into a distribution agreement with UPPI granting UPPI the exclusive right to sell the updated PainShield
products to and through distributors within the DME sector.
a few short months after starting distribution of our PainShield products under our original agreement, UPPI was
already looking to exceed our minimum purchase requirements," stated Brian Murphy, CEO of NanoVibronix. "It is also
worth noting that UPPI's robust DME channels of distribution seem to have delivered exceptional results despite various
challenges in the current business environment stemming from the COVID-19 pandemic."
from a more traditional distribution to a private label arrangement is intended to better enable us to meet increased demand for
our product, while leveraging Ultra Pain Products' extensive U.S. DME network and established billing capabilities across
workers' compensation, motor vehicle, and private insurance," added Murphy. "By this new private label agreement,
we have expanded our revenue opportunity with UPPI, effectively increasing what was an initial revenue target of $1.1 million
over two years to $7.8 million over three years. Just as important, we continue to target additional markets outside of the DME
segment for our newly redesigned PainShield products, especially veteran's facilities and the Department of Justice, as
well as other specialty segment. The success and efficacy of the new PainShield has increased interest from new and existing distributors,
as it has been shown to provide opioid-free pain relief for a wide variety of applications, administered at home, at a time when
the need has never been greater for socially distanced administration. PainShield enables consumers to relieve pain while minimizing
visits to the doctor or pain clinics, which is critical and necessary under social distancing restrictions. We are optimistic
that this increased interest will result in increased sales."
the terms of the three-year agreement, the Company's PainShield and PainShield Plus TM
will be sold solely within the domestic DME channel by Ultra Pain Products, Inc. under a private label through its U.S.
distributor network. Additionally, UPPI is required to pay an up-front payment to NanoVibronix for the custom design of the privately
labeled products and to meet quarterly and annual minimum purchase requirements in order to retain exclusive distribution rights
within the territory. The company expects the initial sales to begin in the second quarter of 2021.
is an ultrasound device, consisting of a reusable driver unit and disposables, which includes a proprietary therapeutic transducer
and cover adhesive. 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. PainShield can be used by patients at home, work, or in a clinical
setting. Most patients use PainShield 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.
company recently introduced its patent pending, PainShield Plus, which expands on the original technology, essentially doubling
the surface area that can be treated for pain in the same amount of time. The devices provide an effective solution for avoiding
opioid treatments and support social distancing by equipping patients to receive therapy independently in the comfort and safety
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.
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, and include, among others, statements regarding projected sales of PainShield and
PainShield Plus to UPPI and others; 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.
Maas, Managing Principal, Hayden IR, LLC