Nuvectra Files Regulatory Submission with FDA for Algovita® MRI-Conditional Approval
June 21 2017 - 7:00AM
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 MRI-conditional approval for the Company’s Algovita SCS
system.
Scott Drees, Chief Executive Officer, commented,
“This submission to the FDA represents our continued commitment to
the advancement of the Algovita system. The addition of a full body
MRI-compatibility label will further enhance the product features
making the Algovita system more attractive to potential customers
and improving our competitive positioning. We look forward to
working collaboratively with FDA through the review period, and
upon approval, will be excited to offer new MRI capabilities for
patients that choose the Algovita SCS system.”
This submission, pending regulatory approval from
the FDA, would position the Company to achieve MRI-conditional
approval at or around year end 2017 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 neurological
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 pain of the trunk and/or limbs. Our
innovative technology platform also has capabilities under
development to support other neurological indications such as
sacral nerve stimulation (SNS), and deep brain stimulation (DBS).
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)
the timing of the commercial launch of Algovita in the United
States; (ii) our ability to successfully commercialize Algovita and
develop and commercialize enhancements to Algovita; (iii) the
uncertainty of obtaining regulatory approvals in the United States
and Europe for our Virtis SNS system, (iv) our ability to
successfully launch and commercialize the Virtis SNS system if it
receives regulatory approval, (v) 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; (vi) 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;
(vii) the performance by our development partners, including Aleva
Neurotherapeutics, S.A., of their obligations under their
agreements with us; (viii) the scope of protection for our
intellectual property rights covering Algovita and other products
using our neurostimulation technology platform, along with any
product enhancements; (ix) our ability to successfully build an
effective commercial infrastructure and sales force in the United
States; (x) our compliance with all regulatory and legal
requirements regarding implantable medical devices and interactions
with healthcare professionals; and (xi) any product recalls or the
receipt of any warning letters from any governmental or regulatory
agency. Please see the sections entitled "Cautionary
Statement Concerning Forward-Looking Statements" and "Risk Factors"
in Nuvectra's Registration Statement on Form 10 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, Chief Operating Officer and Chief Financial Officer
(214) 474-3102
wberger@nuvectramed.com
Jennifer Armstrong, Media Relations
(214) 474-3110
jarmstrong@nuvectramed.com
Investor Contacts:
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com
Brian Johnston
(646) 536-7028
bjohnston@theruthgroup.com
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