Nuvectra Provides Update on FDA and TÜV SÜD Review of Virtis™ PMA and CE Mark Applications
02 July 2018 - 9:30PM
Nuvectra Corporation (NASDAQ:NVTR), a neurostimulation medical
device company, today provided an update on its U.S. Food and Drug
Administration (FDA) pre-market approval (PMA) application and its
TÜV SÜD application for CE Mark in Europe for VirtisTM, the
Company’s Sacral Neuromodulation (SNM) System for the treatment of
chronic urinary retention and the symptoms of overactive bladder.
As part of its review of the Virtis PMA original application and
the amendment submitted in April 2018, the FDA recently requested
that the Company provide supplemental information related to any
modifications or changes to the Virtis device, labeling and
manufacturing, as well as clarifications of data related to MRI.
The Company has been in active communications with the FDA
and intends to promptly file comprehensive responses to address the
FDA's requests. The FDA will then have up to 180 days to review the
Company's responses. The Company plans to work proactively
with the FDA to complete the review process as soon as
possible.
Also, TÜV SÜD recently informed the Company that clinical study
data will be required before it can recommend approval of CE Mark
for the Virtis system. The Company is continuing its
discussions with TÜV SÜD regarding its application to clarify the
breadth of clinical data that may be requested.
Scott Drees, Chief Executive Officer, commented, “Our primary
focus is gaining FDA approval of the Virtis system in order to both
provide therapy to patients and to address the significant market
opportunity for SNM in the U.S. We remain encouraged by our recent
interactions with the FDA and believe that our responses will
adequately address the FDA’s requests. We are pleased that
our facility and pre-PMA audit have been completed without
findings. We will continue to work cooperatively with the FDA to
conclude the review of our application expeditiously and look
forward to entering the U.S. SNM market as soon as possible
following FDA approval.”
Mr. Drees continued, “We will revisit our corporate strategy to
enter the SNM market in Europe and will engage with TÜV SÜD to
determine a reasonable clinical pathway to CE Mark approval.”
About Nuvectra Corporation NuvectraTM 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
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 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 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) any supplier shortages
related to Algovita or its components and any manufacturing
disruptions which may impact our inventory supply as we expand our
business; (xiv) any product recalls, or the receipt of any warning
letters, mandatory corrections or fines from any governmental or
regulatory agency; (xv) our ability to satisfy the conditions and
covenants, including trailing six month revenue milestones, of our
Credit Facility; and (xvi) our ability to raise capital through
means other than or in addition to the Credit Facility should it
become necessary to do so, through a 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 / 7028
investors@nuvectramed.com
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