InVivo Therapeutics (NSDQ:NVIV) said today it won FDA investigational device exemption for a new pivotal trial of its neuro-spinal scaffold after ending the previous Inspire study of the device in January.
The Cambridge, Mass.-based company’s neuro-spinal scaffold is a novel, biodegradable device designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
“InVivo has achieved important milestones with the FDA over the past seven months under Dr. Toselli’s leadership. I wish to commend Rich and his team in their continuing interactions with the FDA and their strategy for advancing this important program in the clinic,” board chair Ann Merrifield said in a press release.
The newly cleared trial is slated to enroll 20 patients with acute spinal cord injuries to explore the use of the company’s neuro-spinal scaffold in hopes that results will “enhance existing clinical evidence for the neuro-spinal scaffold from the company’s single-arm Inspire study,” according to a press release.
The study’s primary endpoint is a difference of at least 20% or greater in the proportion of subjects who demonstrate AIS improvements of at least one grade at six months after the primary endpoint follow-up visit, as compared between the control and treatment arm, the company said.
“We are pleased to announce the FDA’s approval of this randomized, controlled trial and appreciate the agency’s collaboration with us on the development of a protocol to address the substantial unmet needs in this patient population. We believe this now sets us in a direction towards a clear and efficient path to approval under the HDE regulatory program, and we are focused on engaging with the investment community and exploring financing mechanisms to support this approved randomized study. We look forward to providing further updates as we obtain clarity on financing and the timing for our second pivotal trial,” prez & CEO Dr. Richard Toselli said in a prepared statement.
In the Inspire trial, which ended in January after an enrollment pause last July, the company said that 43.8% of the 16 living patients in the trial who had been implanted with the scaffold had reached the primary endpoint of an AIS grade improvement at six months. The objective performance criterion for he study had been a 25% AIS conversion rate, InVivo said.