Nuvectra Receives FDA Head-Only MR-Conditional Approval for Algovita®
December 03 2018 - 8:01AM
Nuvectra Corporation (NASDAQ: NVTR), a neurostimulation medical
device company, announced today that it has received U.S. Food and
Drug Administration (FDA) head-only MR-conditional approval for the
Company’s Algovita SCS system.
Scott Drees, Chief Executive Officer, commented, “This FDA
approval represents our continued commitment to the advancement of
the Algovita system and further enhances our competitive
positioning. We believe that the addition of a head-only
MR-conditional label will drive increased adoption of our system.
As we prepare to submit an application for full-body MR-conditional
approval with the FDA in early 2019, we look forward to continued
growth in the United States.”
About Nuvectra Corporation
Nuvectra® is a neurostimulation company committed to helping
physicians improve the lives of people with chronic conditions. The
Algovita® Spinal Cord Stimulation (SCS) System is our first
commercial offering and is CE marked and FDA approved for the
treatment of chronic intractable pain of the trunk and/or limbs.
Our innovative technology platform also has capabilities under
development to support other indications such as sacral
neuromodulation (SNM) for the treatment of overactive bladder, and
deep brain stimulation (DBS) for the treatment of Parkinson’s
Disease. In addition, our NeuroNexus subsidiary designs,
manufactures and markets leading-edge neural-interface technologies
for the neuroscience clinical research market. Visit the Nuvectra
website at www.nuvectramed.com
Cautionary Note Regarding Forward-Looking
Statements
This press release contains "forward-looking statements,"
including statements we make regarding the outlook
for Nuvectra as an independent publicly-traded company.
Forward-looking statements are based only on our current beliefs,
expectations and assumptions regarding the future of our business,
future plans and strategies, projections, anticipated events and
trends, the economy and other future conditions, and therefore they
are subject to inherent uncertainties, risks and changes in
circumstances that are difficult to predict and may be outside of
our control. Our actual performance may differ materially from
those indicated in the forward-looking statements. Therefore, you
should not rely on any of these forward-looking statements. Any
forward-looking statement made by us is based only on information
currently available to us and speaks only as of the date on which
it is made. Important factors that could cause our actual
results to differ materially from those indicated in the
forward-looking statements include: (i) our ability to successfully
commercialize Algovita and to develop, complete and commercialize
enhancements or improvements to Algovita; (ii) our ability to
successfully compete with our current SCS competitors and the
ability of our U.S. sales representatives to successfully establish
market share and acceptance of Algovita, (iii) the uncertainty and
timing of obtaining regulatory approvals in the United
States and Europe for our Virtis SNM system, (iv)
our ability to successfully launch and commercialize the Virtis SNM
system if and when it receives regulatory approval (v) our ability
to demonstrate the features, perceived benefits and capabilities of
Algovita to physicians and patients in competition with similar
products already well established and sold in the SCS market; (vi)
our ability to anticipate and satisfy customer needs and
preferences and to develop, introduce and commercialize new
products or advancements and improvements to Algovita in order to
successfully meet our customers’ expectations; (vii) the outcome of
our development plans for our neurostimulation technology platform,
including our ability to identify additional indications or
conditions for which we may develop neurostimulation medical
devices or therapies and seek regulatory approval thereof; (viii)
our ability to identify business development and growth
opportunities and to successfully execute on our strategy,
including our ability to seek and develop strategic partnerships
with third parties to, among other things, fund clinical and
development costs for new product offerings; (ix) the performance
by our development partners, including Aleva
Neurotherapeutics, S.A., of their obligations under their
agreements with us; (x) the scope of protection for our
intellectual property rights covering Algovita and other products
using our neurostimulation technology platform, along with any
product enhancements or improvements; (xi) our ability to
successfully build, attract and maintain an effective commercial
infrastructure and qualified sales force in the United
States; (xii) our compliance with all regulatory and legal
requirements regarding implantable medical devices and interactions
with healthcare professionals; (xiii) our reliance on each of
Integer, our exclusive and sole manufacturer and supplier of parts
and components for Algovita, and Minnetronix, Inc., our sole-source
supplier of external peripheral devices; (xiv) any supplier
shortages related to Algovita or its components and any
manufacturing disruptions which may impact our inventory supply as
we expand our business; (xv) any product recalls, or the receipt of
any warning letters, mandatory corrections or fines from any
governmental or regulatory agency; (xvi) our ability to satisfy the
conditions and covenants of our Credit Facility; and (xvii) our
ability to raise capital should it become necessary to do so,
through another public offering of our common stock, private equity
or debt financings, strategic partnerships, or other sources.
Please see the section entitled “Risk Factors” in Nuvectra’s Annual
Report on Form 10-K and in our other quarterly and periodic filings
for a description of these and other risks and uncertainties.
We undertake no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise.
Company Contacts: |
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Investor Contacts: |
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Nuvectra Corporation |
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The Ruth Group |
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Walter Berger, COO & CFO |
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Tram Bui / Brian Johnston |
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(214) 474-3102 |
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(646) 536-7035 / 7028 |
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wberger@nuvectramed.com |
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investors@nuvectramed.com |
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