InVivo Therapeutics Announces Publication of 12- and 24-month Data for INSPIRE 1.0 Study in Peer-Reviewed Neurosurgery
June 08 2022 - 08:30AM
Business Wire
Manuscript details patient outcomes through
24-month follow up visit
InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV) today
announced the publication of a peer-reviewed manuscript in
Neurosurgery describing the previously disclosed 12- and 24-month
data from the Company's single-arm INSPIRE 1.0 Study (InVivo Study
of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and
Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal
Cord Injury). The publication is titled “Acute Implantation of a
Bioresorbable Polymer Scaffold in Patients with Complete Thoracic
Spinal Cord Injury: 24-Month Follow-up from the INSPIRE Study.”
Richard Toselli, M.D., InVivo’s President and Chief Executive
Officer, said, “In addition to the previous six-month publication
covering INSPIRE 1.0 data in the Journal of Neurosurgery: Spine, we
are pleased to see the evaluation of patient outcomes through the
24-month follow up visit. We are encouraged that these data support
further evaluation of the investigational Neuro-Spinal Scaffold™
and its potential benefit to patients in the ongoing INSPIRE 2.0
Study.”
InVivo has officially closed the INSPIRE 1.0 study and recently
completed enrollment into a second pivotal clinical study of the
investigational Neuro-Spinal Scaffold™ in patients with acute SCI
(INSPIRE 2.0). InVivo anticipates presenting topline data from the
INSPIRE 2.0 Study in first quarter of 2023. The INSPIRE 2.0 study
is a 20-patient (10 subjects in each study arm), randomized,
controlled trial that is designed to enhance the existing clinical
evidence for the Neuro-Spinal Scaffold™ from the INSPIRE 1.0 study.
For more information about the INSPIRE 2.0 clinical trial, please
visit ClinicalTrials.gov.
The publication is now available electronically at this
link.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and
clinical-stage biomaterials and biotechnology company with a focus
on treatment of spinal cord injuries. The company was founded in
2005 with proprietary technology co-invented by Robert Langer,
Sc.D., Professor at Massachusetts Institute of Technology, and
Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital
and who now is affiliated with Massachusetts General Hospital. The
publicly traded company is headquartered in Cambridge, MA. For more
details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
within the meaning of the federal securities laws. These statements
can be identified by words such as “believe,” “anticipate,”
“intend,” “estimate,” “will,” “may,” “should,” “expect” and similar
expressions, and include statements regarding the company’s
expectation regarding the timing for the announcement of topline
data and ability to serve the spinal cord injury patient
population. Any forward-looking statements contained herein are
based on current expectations and are subject to a number of risks
and uncertainties. Factors that could cause actual future results
to differ materially from current expectations include, but are not
limited to, risks and uncertainties relating to: the company’s
ability to obtain additional funding to support the ongoing
clinical and potential commercialization program for the
investigational Neuro-Spinal Scaffold™, the varied interpretation
of clinical data, the timing, cost and expense of regulatory
filings, the potential for regulatory authorities granting or
delaying approval for our Neuro-Spinal Scaffold, and other risks
associated with the company’s business, research, product
development, regulatory approval, marketing and distribution plans
and strategies identified and described in more detail in the
company’s Quarterly Report on Form 10-Q for the quarter ended March
31, 2022, and in other filings that the company may make with the
Securities and Exchange Commission in the future. The company does
not undertake to update these forward-looking statements.
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Investor Contact: Bret Shapiro, Managing Partner CORE IR
brets@coreir.com 516-222-2560
Media Contact Gina Nugent Ten Bridge Communications
gina@tenbridgecommunications.com 617-460-3579
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