InVivo Therapeutics Announces Publication in Peer-Reviewed Journal of Neurosurgery: Spine
InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV) announced the publication of a peer-reviewed manuscript in the Journal of Neurosurgery: Spine, detailing the results of the six-month INSPIRE 1.0 study on its Neuro-Spinal Scaffold for spinal cord injury. The company has closed the INSPIRE 1.0 study and is enrolling patients for a second pivotal trial, INSPIRE 2.0, aimed at further validating its treatment method. This new study will involve 20 patients and aims to enhance clinical evidence supporting the Neuro-Spinal Scaffold. The publication can be accessed electronically.
- Publication of peer-reviewed manuscript enhances credibility and visibility of the Neuro-Spinal Scaffold.
- Closing of INSPIRE 1.0 study and initiation of INSPIRE 2.0 study indicates ongoing commitment to clinical research and development.
- Dependence on the success of the upcoming INSPIRE 2.0 study to establish treatment efficacy.
- Potential operational risks and uncertainties related to patient enrollment and clinical trials in the context of COVID-19.
InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV) today announced the recent publication of a peer-reviewed manuscript in the Journal of Neurosurgery: Spine describing the previously presented complete six-month primary endpoint results from the company's single-arm INSPIRE 1.0 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), titled “A study of probable benefit of a bioresorbable polymer scaffold for safety and neurological recovery in patients with complete thoracic spinal cord injury: 6-month results from the INSPIRE study.”
Richard Toselli, M.D., InVivo’s President and Chief Executive Officer, said, “It was rewarding to see our manuscript on the six-month INSPIRE 1.0 results published in the peer-reviewed Journal of Neurosurgery: Spine, and we want to thank the investigators and staff at each of the clinical trial sites, as well as the patients, who help us remain optimistic that this data supports the continued clinical investigation of the Neuro-Spinal Scaffold in our INSPIRE 2.0 study.”
InVivo has officially closed the INSPIRE 1.0 study and is actively enrolling patients into a second pivotal clinical study of the Neuro-Spinal Scaffold™ in patients with acute SCI (INSPIRE 2.0). The INSPIRE 2.0 study is a 20-patient (10 subjects in each study arm), randomized, controlled trial that is designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold™ from the INSPIRE 1.0 study. For more information about the INSPIRE 2.0 clinical trial, visit: https://clinicaltrials.gov/ct2/show/NCT03762655.
The publication is now available electronically at: https://thejns.org/spine/view/journals/j-neurosurg-spine/aop/article-10.3171-2020.8.SPINE191507/article-10.3171-2020.8.SPINE191507.xml.
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 clinical investigation of the investigational Neuro-Spinal 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 open additional clinical sites for enrollment and to 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 Annual Report on Form 10-K for the year ended December 31, 2019, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210216005144/en/
FAQ
What are the results of the INSPIRE 1.0 study for NVIV?
What is the INSPIRE 2.0 study for NVIV?
When was the INSPIRE 1.0 study closed by NVIV?
Where can I find the manuscript on INSPIRE 1.0 results?
