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The  CONTEMPO Registry Study: A Complement to INSPIRE

As evidenced by the passing of the 21st Century Cures Act, regulators and policy makers have recently highlighted the benefits and utility of Real-World Evidence (RWE) as it pertains to the Food and Drug Administration (FDA) regulatory decision-making for medical devices. RWE is derived from Real World Data (RWD) collected outside of a traditional clinical trial and includes sources such as patient registries. InVivo is committed to providing regulatory agencies with a comprehensive benchmark comparator dataset using RWE to help support the assessment of the safety and probable benefit of its Neuro-Spinal Scaffold™.

The CONTEMPO Registry Study will utilize several large, high-quality spinal cord injury (SCI) registries that have formed the basis of dozens of high-impact, peer-reviewed publications. To the extent possible, the CONTEMPO Registry Study will apply similar inclusion/exclusion criteria to INSPIRE in order to identify appropriate patients to include into a well-matched benchmark comparator group.  Furthermore, the study will only include patients injured since 2006 in order to minimize the impacts of any temporal changes in standard of care or rehabilitation when compared to INSPIRE study data. We expect that the CONTEMPO Registry Study will provide a robust characterization of the contemporary natural history of traumatic, complete, thoracic spinal cord injury.

We are thrilled to announce that data from the Christopher & Dana Reeve Foundation North American Clinical Trials Network (NACTN) Registry will be included in the CONTEMPO Registry Study. The NACTN Registry collects extensive acute care data that will allow for close matching of registry patient characteristics with INSPIRE inclusion and exclusion criteria.

Previously, InVivo had communicated that it was considering adding a Benchmark Arm to the INSPIRE Study by gathering retrospective data from patients that presented at INSPIRE sites since 2016 but were not implanted with the Neuro-Spinal Scaffold. Given the comprehensiveness and strength of the data available in the NACTN Registry, InVivo has decided not to move forward with the Benchmark Arm.  The company believes that the CONTEMPO Registry Study will not only provide superior comparator benchmarks using prospectively gathered data but will also avoid the operational complexities and cost of a Benchmark Arm.

Since the CONTEMPO Registry Study will involve analysis of existing registries, we do not believe that it will affect any of our communicated timelines for the INSPIRE Study.  We anticipate full enrollment in the INSPIRE Study in Q3 2017 with full HDE submission of the final module of our HDE application (including the results of the CONTEMPO Registry Study) in early 2018. We believe the combined information in the INSPIRE study and the CONTEMPO Registry Study will provide a rigorous body of evidence for the demonstration of safety and probable benefit as required by the HDE approval process.

I look forward to updating you on our progress regarding this landmark clinical program.

Mark Perrin
CEO & Chairman
May 30, 2017

Safe Harbor Statement
Any statements contained in this document 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 safety and effectiveness of the Neuro-Spinal Scaffold and the progress of the 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 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 complete The INSPIRE Study, submit an HDE application, and receive regulatory approval for the Neuro-Spinal Scaffold, the company’s ability 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 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 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 March 31, 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.

Archives

Cervical Spinal Cord Injury: Higher Risk/Higher Reward - March 23 2017
How the 21st Century Cures Act Impacts InVivo - December 19, 2016
CEO's Perspective - October 19, 2016
Epidemiology and Market Opportunity Around the World - July 13, 2016
The INSPIRE Study - February 29, 2016
InVivo in 2016: Looking Ahead - December 17, 2015
Building Value in a Pre-commercialization Biotech Company: Importance of Increased Exposure Within the Scientific and Medical Communities - September 21, 2015
Corporate Financing - What are the options? - July 29, 2015
Social Media: The New Frontier - June 3, 2015
What NASDAQ has to Offer - April 16, 2015
Reverse Splits and Uplisting - March 24, 2015

This blog may contain forward-looking statements within the meaning of federal securities laws. Forward-looking statements can be identified by words such as “anticipates,” “believes,” “plans,” “will,” “intends,” “expects,” and similar references to the future, and include statements InVivo may make regarding its product development strategy, business prospects, and operational milestones. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance and are subject to a number of risks and uncertainties, many of which are outside InVivo’s control, which could cause its actual business and operating results to differ. For more information on the many factors that can result in actual performance differing from these forward-looking statements, please see the risk factors detailed in InVivo’s SEC filings. InVivo does not undertake to update these forward-looking statements.