Press Release Details
InVivo Therapeutics Announces FDA Acceptance of Preclinical Module in Support of Company’s Complete HDE Submission
The FDA previously approved the Company’s proposed HDE modular shell submission and review process for the Neuro-Spinal Scaffold™ implant. The HDE modular shell is comprised of three modules: the preclinical studies module, a manufacturing module and a clinical data module. The Company believes that the modular shell submission could allow for potentially more efficient review processes and timelines with the FDA. As part of the process, the FDA reviews each module on a rolling basis.
The preclinical module is the first module that the Company has submitted for review to the FDA. The HDE submission will not be complete until the manufacturing and clinical modules are also submitted.
InVivo is actively enrolling patients with acute spinal cord injury into its INSPIRE 2.0 study, a pivotal trial of the Neuro-Spinal Scaffold™. INSPIRE 2.0 is a 20-patient, randomized, controlled trial that is designed to expand upon the existing clinical evidence for the Neuro-Spinal Scaffold™ from the Company’s INSPIRE 1.0 study.
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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 future modular submissions for the Company’s Neuro-Spinal Scaffold implant and the timing and processes involved for review of such submissions. 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
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