InVivo Therapeutics Announces 75% Target Enrollment Achieved for the INSPIRE 2.0 Spinal Cord Injury Study

InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV), a research and clinical-stage biomaterials and biotechnology company with a focus on the treatment of spinal cord injuries, today announced that it has enrolled 15 patients with acute spinal cord injury into the INSPIRE 2.0 Study, or 75% of the total 20-patient enrollment target for the study. The INSPIRE 2.0 study is a randomized, controlled trial (20-patient, 10 subjects in each study arm), that is designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold™ from the Company’s INSPIRE 1.0 study.

“The enrollment of these 15 patients into this study is an important milestone achievement towards our completion of the INSPIRE 2.0 Study, and we are grateful to the investigators and staff at each of our clinical sites who continue to enroll in this trial throughout the COVID-19 pandemic,” said Richard Toselli, M.D., InVivo's President and Chief Executive Officer. “We remain committed to serving the significant unmet medical need for the spinal cord injury patient population, and we are proud of our progress towards this goal.”

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. 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 about the continued enrollment of the Company’s INSPIRE 2.0 study, the target patient population of the study, and the potential FDA approval of the Company’s investigational scaffold device. 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 enroll additional patients; the impact of the COVID-19 pandemic on the Company’s operations, including its clinical trials; 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 general economic and market conditions and other factors discussed in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, 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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