InVivo Therapeutics (OTC:NVIV) said this week it enrolled the last patient in a trial of its neuro-spinal scaffold, but CEO Mark Perrin said the company will continue to enroll patients and expanded the trial to a new site.
The company announced a 5th patient in the pilot trial was enrolled yesterday, the last it needed for the study examining the biodegradable scaffold meant to treat acute spinal cord injuries.
“Enrolling the 5th patient in our 1st clinical study is a momentous milestone for the company, and we are pleased this accomplishment came ahead of previous guidance. We are in productive discussions with the FDA regarding the transition to the pivotal probable benefit study, and our plan is to incorporate the pilot study into the pivotal probable benefit study. We expect to use this single study as the basis for a Humanitarian Device Exemption application, which would allow us to dramatically reduce the time to approval and commercialization,” Perrin said in a press release.
While the pilot spinal cord injury study capped out at 5 patients, Perrin told the Boston Business Journal that the company plans to keep enrolling for the study.
“The main takeaway is, we don’t want to do anything to stop enrollment,” Perrin told the Boston Business Journal. “We’re getting calls more frequently. I think there’s some feeling that this really could change the standard of care, and (hospitals) want to be in on it as early as possible.”
InVivo will seek Humanitarian Device Exemption for the device, though the company said it is unsure how many patients implanted with the device the FDA will require before it can grant the approval.
The company said today it added New York City’s Mount Sinai Hospital as a new site for the trial, bringing the total sites up to 14.
“I see the enormous unmet medical need presented by spinal cord injury first-hand in my practice. InVivo is taking steps to fill that need, and I’m looking forward to being a part of this study,” Mt. Sinai principal investigator for the trial Dr. Arthur Jenkins said in a press release.