InVivo Therapeutics Announces Strategic Corporate Restructuring
August 28 2017 - 4:30PM
Business Wire
- Company Focuses Resources on INSPIRE -
InVivo Therapeutics Holdings Corp. (NVIV) today announced
that it is executing a strategic restructuring in order to focus on
The INSPIRE 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 strategic restructuring will allow the company to
concentrate its efforts on reopening patient enrollment for
INSPIRE, completing INSPIRE, and filing a Humanitarian Device
Exemption (HDE) submission for the Neuro-Spinal Scaffold. The
INSPIRE Study is designed to demonstrate the safety and probable
benefit of the Neuro-Spinal Scaffold in patients with complete
thoracic spinal cord injury, and currently has 16 patients in
follow-up.
As part of the decision to focus exclusively on INSPIRE, the
company also has announced the suspension of its chronic SCI stem
cell and gene therapy research programs and a halt in enrollment
into its Canadian cervical study of the Neuro-Spinal Scaffold. The
company is evaluating strategic options for allowing the cell and
gene therapy programs to move forward outside of the company and
plans to restart the cervical study once the FDA approves a
protocol that allows for enrollment in the United States.
In conjunction with the corporate restructuring, the company is
undergoing a reduction in force (RIF), in which it is eliminating
13 positions, or approximately 39% of its workforce. The RIF, the
recent update to the INSPIRE timeline, the suspension of the
chronic SCI programs, and the halt to the cervical study together
are projected to result in 2018 operating expense savings of
approximately $7.3 million and to reduce 2018 cash burn from
approximately $2.0 million per month to approximately $1.5 million
per month.
“I feel confident that going forward, we have aligned our
operational efforts and financial resources to fully support our
core goal of bringing the Neuro-Spinal Scaffold to market. We
continue to work with the FDA as expeditiously as possible with the
goal of reopening enrollment in INSPIRE, and we look forward to
completing the study and submitting our HDE application,” InVivo’s
CEO and Chairman Mark Perrin said.
About InVivo TherapeuticsInVivo 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. In 2011, the
company earned the David S. Apple Award from the American Spinal
Injury Association for its outstanding contribution to spinal cord
injury medicine. In 2015, the company’s investigational
Neuro-Spinal Scaffold™ received the 2015 Becker’s Healthcare Spine
Device Award. The publicly-traded company is headquartered in
Cambridge, MA. For more details, visit
www.invivotherapeutics.com.
Safe Harbor StatementAny 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," “designed to,” “potentially,” and similar
expressions, and include statements regarding the status of the
clinical program, the timing for re-opening enrollment in the
INSPIRE Study and the submission of an HDE application to the FDA,
and the impact of the restructuring and the reduction in force on
the Company’s balance sheet, financial position and cash burn. 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 availability of
substantial additional funding for the company to continue its
operations and to conduct research and development, clinical
studies and future product commercialization; 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 of the three months ended June 30, 2017,
and its other filings with the SEC, including the company’s Form
10-Qs and current reports on Form 8-K. The company does not
undertake to update these forward-looking statements.
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InVivo Therapeutics Holdings Corp.Heather Hamel,
617-863-5530Investor
RelationsInvestor-relations@invivotherapeutics.com
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