Topline data announced from pivotal INSPIRE 2.0 study of Neuro-Spinal Scaffold for acute spinal cord injury.-InVivo Therapeutics
InVivo Therapeutics Holdings Corp. a research and clinical-stage biomaterials and biotechnology company with a focus on the treatment of spinal cord injuries (SCI),announced topline results from the company's INSPIRE 2.0 tudy, which was designed to evaluate the safety and probable benefit of InVivo's investigational Neuro-Spinal Scaffold, a bioresorbable scaffold-based device in development for patients with acute SCI.
The study did not meet its primary endpoint, which was assessed by the proportion of treated patients achieving an improvement of at least one American Spinal Injury Association (ASIA) Impairment Scale (“AIS”) grade at six months post-scaffold implantation, versus a control group that received standard of care surgery.
InVivo management will conduct a full assessment of the study data set and plans to share its findings in full in a peer-reviewed medical venue at a later date. The company will also evaluate its strategic options and provide an update on corporate direction when appropriate.
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