Biotech Values

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NVIV "InVivo Therapeutics Announces Seventh Patient Conversion in The INSPIRE Study of the Neuro-Spinal Scaffold™

"InVivo Therapeutics Holdings Corp. (NVIV) today announced that the patient enrolled in January in the INSPIRE study of the Neuro-Spinal Scaffold has improved from a complete AIS A spinal cord injury (SCI) to an incomplete AIS B SCI in the time between the one-month and the two-month evaluations. This is the seventh out of the 11 patients (63.6% conversion rate) with at least one month of follow-up to have had an AIS grade improvement. Two additional patients are early in follow-up and have not yet had their one-month visit. The AIS conversion rate observed in the INSPIRE study to date is considerably higher than published rates observed in a range of SCI natural history databases that are all below 25%."

The conversion rate is now set to be better than baseline data even if the ramaining 9 patients to be enrolled fail to advance to AIS B status (which seems unlikely given the rate of conversion so far.) The apparent knock on this company is that they did not enroll a control arm for the study and report that they will use historical data to argue for a natural control. For those not familiar with the co.'s strategy, they are preparing for an HDE application with the FDA.

https://finance.yahoo.com/news/invivo-therapeutics-announces-seventh-patient-120000446.html