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InVivo Therapeutics Announces Complete 12-Month Data from the INSPIRE Study of the Investigational Neuro-Spinal Scaffold™ in Acute Thoracic Complete Spinal Cord Injury


InVivo Therapeutics Holdings Corp. (NASDAQ:NVIV) today announced
the complete 12-month results from the company's single-arm INSPIRE
study (InVivo Study of Probable Benefit of the Neuro-Spinal
™ for Safety and Neurologic Recovery in Subjects with
Complete Thoracic AIS A Spinal Cord Injury).

As previously announced by InVivo, 7 of 16 (44%) patients who reached
the six-month primary endpoint visit in the INSPIRE study had an ASIA
Impairment Scale (AIS) conversion at 6 months, which is the primary
endpoint of the trial (defined as improvement in AIS grade from baseline
for all evaluable patients at the six-month visit). The Objective
Performance Criterion (OPC) (study success definition) for the study was
a 25% AIS conversion rate based on the published conversion rates for
thoracic spinal cord injury (SCI) reported in the literature.

Patients are scheduled to have full follow up visits at 12 and 24
months, and the visits include AIS conversion assessments. All patients
evaluated at the 12-month visit who had converted an AIS grade at the 6
month visit remained converted at the 12 month visit. One patient was
lost to follow up after the 6-month visit and was not assessed at a
12-month visit. Altogether, 19 patients have been implanted with the Neuro-Spinal
in the INSPIRE study. As previously disclosed, three
patients died within two weeks of implantation.

Richard Toselli, M.D., President and Chief Executive Officer of InVivo,
commented, "We will continue to follow this cohort of patients as they
progress through their 24-month follow up visit and remain encouraged by
the continued stability of the AIS conversion rate past the six-month
primary endpoint visit."

InVivo has officially closed the INSPIRE study and has received
supplemental Investigational Device Exemption (IDE) approval from the US
Food and Drug Administration (FDA) for a second pivotal clinical study
of the company's Neuro-Spinal Scaffold™ in patients with
acute SCI. The 20-patient (10 subjects in each study arm), randomized,
controlled trial, or INSPIRE 2.0, is designed to enhance the existing
clinical evidence for the Neuro-Spinal Scaffold™ from the
company's single-arm INSPIRE study. InVivo is currently focused on the
initiation of the INSPIRE 2.0 study.

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. In January 2018, the company announced
updated clinical evidence, including improvements in patients with acute
spinal cord injury (SCI), from its INSPIRE study of the Neuro-Spinal
™. The publicly traded company is headquartered in
Cambridge, MA. For more details, visit

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 future clinical investigation of the
Company's Neuro-Spinal Scaffold. 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:
successfully decreasing costs and spending and successfully opening
additional clinical sites for enrollment and enrolling additional
patients if such trial is initiated; the timing of the Institutional
Review Board process; the company's ability to obtain FDA approval to
commercialize its products; the company's ability to develop, market and
sell products based on its technology; the expected benefits and
efficacy of the company's products and technology in connection with
spinal cord injuries; 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
Annual Report on Form 10-K for the year ended December 31, 2017 and its
other filings with the SEC, including the company's quarterly reports on
Form 10-Q and current reports on Form 8-K.
The company does not
undertake to update these forward-looking statements.

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