BOSTON, Dec. 21, 2016 /PRNewswire/
-- Intrinsic Therapeutics, Inc. announced today that the filing of its
Pre-Market Approval (PMA) application with the Food & Drug Administration
(FDA) for the Barricaid® Anular Closure device is complete. Barricaid has
been shown to improve the outcomes of patients undergoing discectomy for
herniated lumbar discs to relieve sciatica pain.
"Approximately 1 million discectomies are performed
every year around the globe and 40% of these patients will leave the operating
room after discectomy with a large hole remaining in the outer rim of the disc,
the anulus," said Professor Douglas Klassen, Chief of Neurosurgery at
St. Bonifatius Hospital, Lingen, Germany. "By simply sealing these
large defects, patient outcomes can be improved significantly."
The Barricaid Anular Closure device, designed to prevent
repeat disc herniations in patients undergoing back surgery to treat sciatica,
is the first of its kind to be the subject of a prospective, randomized,
superiority trial involving patients who are at higher risk for revision
discectomy surgery to alleviate recurrent pain resulting from reherniation.
The PMA submission was based on the 2-year outcomes of 554 trial participants.
Inclusion criteria for the study ensured enrollment of only subjects with
a high risk of reherniation, subsequent reoperation, and rehospitalization.
"Today, quality patient care and the utilization of
healthcare resources are scrutinized more than ever," said Dr. Matthew
McGirt, a Neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte,
North Carolina. "Technologies that demonstrate fewer repeat surgeries when
compared to traditional treatment will fit into the paradigm of improving
outcomes and conserving healthcare resources."
Further supported by the clinical success demonstrated in
earlier single-arm studies, Barricaid today stands alone as a unique treatment
device for patients wishing to minimize risk of reherniation and resultant
reoperations. Additional benefits include reduction in serious adverse
events, episodic pain events and early hospital readmissions (at 30, 60 and 90
days).
"We are thrilled to have reached this important
milestone and move into the next phase with FDA," said Cary Hagan,
Intrinsic's President and Chief Executive Officer. "Parallel to the PMA
approval process, we continue to focus our efforts on market access including reimbursement
pathways for this compelling new technology with a sharp focus on delivering a
solid Health Economic proposal to payers and hospital systems."
About Intrinsic Therapeutics
Intrinsic Therapeutics is a medical device company focused
on delivering a safe treatment to improve efficacy in patients who are at a
disproportionately high risk of requiring repeat surgeries due to reherniation
following lumbar discectomy surgery. Intrinsic currently markets and
sells the Barricaid in Europe, Australia, the Commonwealth of
Independent States, the Middle East and selected countries in other
regions around the world. In the United States, Intrinsic Therapeutics is
seeking regulatory approval of the Barricaid Anular Closure device. See http://www.in-thera.com for
more information.
Barricaid is a registered trademark of Intrinsic
Therapeutics, Inc.
This press release contains forward-looking statements. Any
statements contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements, including,
without limitation, statements relating to the potential approval by the FDA of
the Company's PMA submissions for the Barricaid Anular Closure device and the
success of the Company's launch preparedness efforts. These forward-looking
statements are based upon Intrinsic's current expectations. Actual results
could differ materially from these forward-looking statements as a result of
certain factors, including, without limitation, risks associated with the
commercialization and market acceptance of, and customer demand for, the
Barricaid Anular Closure device; the uncertain and time-consuming regulatory
process, including the risks that the Company may be required to complete
additional clinical trials in order to obtain approval of its PMA submissions;
that the Company may otherwise encounter unanticipated difficulties complying
with the regulatory requirements related to the Barricaid Anular Closure device
or that the Company's PMA submissions might not be approved by the FDA in a
timely manner or at all; that the Company may not have the resources to support
multiple regulatory submissions; adverse market and economic conditions; and
other risks You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this press
release. Intrinsic does not undertake any obligation to update any
forward-looking statements as a result of new information, future events,
changed assumptions or otherwise.
Contact:
Cary P. Hagan, CEO
Intrinsic Therapeutics, Inc.
+1 781 932-0222
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