Nuvectra Provides Update on Virtis™ FDA PMA Submission
January 29 2019 - 4:01PM
Nuvectra Corporation (NASDAQ: NVTR), a medical device company
dedicated to neuromodulation, announced today that the U.S. Food
and Drug Administration (FDA) has advised that its review of
Company’s pre-market approval (PMA) application for its Virtis
Sacral Neuromodulation (SNM) system has been extended beyond the
expiration of the FDA’s 180-day review period.
Scott Drees, Chief Executive Officer, commented, “FDA has
informed us that they have not yet concluded their review and as
such will require an extension of our 180-day review period. To
date, FDA has not identified any additional deficiencies or
requested any additional information. The Company is continuing to
work closely with FDA to conclude our PMA
review.”
About Nuvectra CorporationNuvectra® 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. Visit the Nuvectra
website at www.nuvectramed.com
Cautionary Note Regarding Forward-Looking
StatementsThis 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:Nuvectra
Corporation
Walter Berger, COO & CFO(214)
474-3102wberger@nuvectramed.com
Investor Contacts:The Ruth
Group
Tram Bui / Brian Johnston(646) 536-7035 /
7028investors@nuvectramed.com
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