INVIVO THERAPEUTICS HOLDINGS CORP. (NASDAQ:NVIV) Files An 8-K Regulation FD Disclosure

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INVIVO THERAPEUTICS HOLDINGS CORP. (NASDAQ:NVIV) Files An 8-K Regulation FD Disclosure
Item 9.01 Regulation FD Disclosure.

On January3, 2018,InVivo Therapeutics Holdings Corp. (the “Company”) issued a press release announcing certain updates on its clinical development program, including The INSPIRE Study and a proposed randomized controlled trial. A copy of the press release is furnished herewith. Also on January3, 2018, the Company posted an updated corporate presentation in the “Investor Relations” section of its website at www.invivotherapeutics.com. The information contained in this Item 9.01 is being furnished and shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that Section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Other Events.

On January3, 2018, the Company announced the latest results from 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 primary endpoint of the study is defined as improvement in ASIA Impairment Scale (AIS) grade from baseline for all evaluable patients at the six-month visit. Nineteen patients have been implanted with the Neuro-Spinal Scaffold. Three patients died within two weeks of implantation. The 16 evaluable patients have now all reached the six-month primary endpoint visit. Seven of the 16 (43.8%) evaluable patients had an AIS grade improvement from baseline at six months. The Objective Performance Criterion (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.

The most recent patient to reach the primary endpoint visit was assessed to be AIS C (motor incomplete) at six months, meaning that some motor function was detected at the sacral level. Of the seven INSPIRE patients who had AIS improvements at six months, five patients improved from complete AIS A SCI to sensory incomplete AIS B SCI, and two patients improved from complete AIS A SCI to motor incomplete AIS C SCI. Two of the five patients who were assessed to be AIS B at six months later improved to AIS C at 12 or 24 months.

In July2017, enrollment of patients in The INSPIRE Study was placed on hold following the third patient death. Although the Company and the respective site principal investigators believe these deaths were not related to the Neuro-Spinal Scaffold investigational device, the Company is in discussions with the United States Food and Drug Administration to ensure that these cases have been comprehensively evaluated and to ensure that all appropriate risk mitigation measures have been implemented. As part of those ongoing discussions, the Company has proposed a randomized controlled trial to supplement the existing clinical evidence for the Neuro-Spinal Scaffold. The Company does not anticipate reopening enrollment in INSPIRE and expects to provide additional clarity on its clinical path forward in the second quarter of 2018.

Item 9.01. Financial Statements and Exhibits.

(d)Exhibits

*This exhibit is being furnished and shall not be deemed “filed” for purposes of Section18 of the Exchange Act or otherwise subject to the liabilities under that Section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Cautionary Note on Forward Looking Statements

Any statements contained in this 8-K 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 Company’s clinical program. 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 discussions and engagement with the United States Food and Drug Administration; the Company’s ability to initiate, conduct and complete clinical trials; the expected benefits and potential efficacy of the Company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical trials and future product commercialization; and other risks associated with the Company’s business, research, product development, attainment of 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 September30, 2017, and its other filings with the SEC, including the company’s most recent Form10-K, its Form10-Qs and its current reports on Form8-K. The Company does not undertake to update these forward-looking statements.


INVIVO THERAPEUTICS HOLDINGS CORP. Exhibit
EX-99.1 2 a17-29062_3ex99d1.htm EX-99.1 Exhibit 99.1         InVivo Therapeutics Announces Latest Results from INSPIRE and Provides Update on Proposed Clinical Path Forward   CAMBRIDGE,…
To view the full exhibit click here

About INVIVO THERAPEUTICS HOLDINGS CORP. (NASDAQ:NVIV)

InVivo Therapeutics Holdings Corp., formerly Design Source, Inc., is a research and clinical-stage biomaterials and biotechnology company. The Company is engaged in developing and commercializing biopolymer-scaffolding devices for the treatment of spinal cord injuries (SCI). The Company’s approach to treating acute SCIs is based on its investigational Neuro Spinal Scaffold implant, an investigational bioresorbable polymer scaffold that is designed for implantation at the site of injury within a spinal cord contusion and is intended to treat acute spinal cord injury. The Neuro-Spinal Scaffold consists of biocompatible and bioresorbable polymers, which include poly lactic-co-glycolic acid (PLGA) and Poly-L-Lysine (PLL). The Company is also evaluating other technologies and therapeutics that may be complementary to its development of the Neuro-Spinal Scaffold implant. The Company has a clinical development program for acute SCI and a preclinical development program for chronic SCI.