Nuvectra Files Regulatory Submission with FDA for Algovita® Full-Body MR-Conditional Approval
11 Junho 2019 - 5:05PM
Nuvectra Corporation (NASDAQ: NVTR), a neurostimulation medical
device company, announced today that it has filed its regulatory
submission with the U.S. Food and Drug Administration (FDA) for
full-body MR-conditional approval for the Company’s Algovita SCS
system.
Fred Parks, Chief Executive Officer, commented, “We
believe full-body MR-conditional approval in the United States, in
addition to Algovita’s full-body MR-conditional CE Mark approval,
will supplement our existing competitive advantages and expand the
number of eligible patients. We look forward to continually
providing physicians with an innovative SCS system focused on
improving patient outcomes worldwide.”
This submission, pending regulatory approval from
the FDA, would position the Company to achieve MR-conditional
approval at or around year end 2019 following a 180-day review
process.
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. 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:Nuvectra
Corporation |
Investor Contacts:The Ruth
Group |
|
|
Jennifer Kosharek(214)
474-3107jkosharek@nuvectramed.com |
Tram Bui (646) 536-7035investors@nuvectramed.com |
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