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

– E-poster Presented at the 2019 American Association of Neurological
Surgeons (AANS) Annual Scientific Meeting –

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV) (“InVivo” or
the “Company”) today announced the presentation of the twelve-month
results from the company’s single-arm 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 findings were presented at the 2019 AANS
Meeting in San Diego, CA through an e-poster titled, “Twelve Month
Results from the INSPIRE Study of the Investigational Neuro-Spinal
Scaffold™ in Acute Thoracic Complete Spinal Cord Injury”,
co-authored by Kee Kim, M.D., Department of Neurosurgery, UC-Davis,
Sacramento, CA, K. Stuart Lee, M.D., Division of Neurosurgery, Vidant
Health, Greenville, NC, Lee, Domagoj Coric, M.D., Carolina Neurosurgery
and Spine, Charlotte, NC, Nicholas Theodore M.D., Department of
Neurosurgery, Johns Hopkins Hospital, Baltimore, MD, and Richard
Toselli, M.D., President and Chief Executive Officer of InVivo.

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). Of the seven
patients who reached the six-month primary endpoint visit, six patients
were later evaluated at the 12-month exam and one patient was lost to
follow-up before the 12-month exam. All six patients who were examined
at the 12-month exam and had previously converted at the six-month exam
remained converted at the 12-month exam. Further, two of those six
patients were assessed to have AIS B spinal cord injury (SCI) at the
six-month primary endpoint but were later assessed to have improved to
AIS C SCI at the 12-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 SCI reported
in the literature.

Dr. Toselli commented, “In addition to focusing on enrollment in the
INSPIRE 2.0 Study, we look forward to continuing to follow this cohort
of INSPIRE patients through their 24-month follow up visit, and we
remain encouraged by the continued stability of the AIS conversion
rates.”

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
Scaffold™. 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 expected timing for enrollment in
the Inspire 2.0 Study and expectations regarding continued follow up
with patients in the INSPIRE Study. 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 successfully open additional clinical sites for
enrollment and to enroll additional patients; 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, 2018, 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.

Contacts

IR CONTACT:
Bret Shapiro, Managing Partner
CORE IR
Phone:
(516) 222-2560
[email protected]

MEDIA CONTACT:
Jules Abraham
CORE IR
Phone: (917)
885-7378
[email protected]