Brief: InVivo says announces conditional approval for INSPIRE pivotal probable benefit clinical study

InVivo Therapeutics Holdings

03/12/2015 13:01

Dec 3 (Reuters) - InVivo Therapeutics Holdings Corp  NVIV.O : 
 * Announces conditional approval for INSPIRE pivotal probable benefit clinical 
   study of the neuro-spinal Scaffold(TM) 
 * Approval is conditional solely upon minor change to the informed consent form 
   that has already been submitted to the FDA 
 * Says full approval of the amendment is expected in the next 30 days 
 * Says inspire study is conditionally approved to enroll up to 12 patients, but 
   co expects that FDA will approve full 20 patients 
 * Says plans to submit 6-month safety data for the first five patients in the 
   second quarter of 2016 
 * Says in addition to U.S. sites, the company plans to initiate the study in 
   Canada and the United Kingdom 
 * Does not consider a patient's unchanged ais classification or a medically 
   insignificant adverse event to be material 
 * Source text for Eikon  ID:nBw69WB6Sa  
 * Further company coverage  NVIV.O   
 
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