InVivo wins initial clearance to add UK trial sites to Inspire study

InVivo Therapeutics (NSDQ:NVIV) said today it won approval to commence clinical trials in the UK from the Medicines Healthcare Products Regulatory Agency.

The Cambridge, Mass.-based company said it is in late-stage conversation with various clinical sites in the UK to join the Inspire study of its neuro-spinal scaffold, with a hopeful 1st opening “in the coming weeks.” Approval of the trial is still dependent on approval from the Research Ethics Committee and from the Health Regulatory Approval.

InVivo Therapeutic’s neuro-spinal scaffold is designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.

“We are very pleased to be expanding the Inspire study beyond the U.S. and Canada to Europe. The benefits of working within the MHRA regulatory construct are readily apparent: only one REC needs to review the study for the whole of UK, compared with individual IRB approvals in the US; site specific assessments are fairly quick; and patients are treated at designated centers of excellence. We look forward to announcing our first UK site,” CEO Mark Perrin said in a press release.

Last week, InVivo saw shares rise after the medical device developer posted 4th quarter and full year 2016 earnings that mostly fell in line with consensus on Wall Street.

The company posted losses of $5.4 million, or 17¢ per share for the 3 months ended December 31, with losses growing 14.8% while losses per share stayed steady. Adjusted to exclude 1-time items, losses were $6.8 million, or 21¢ per share, slightly higher than expectations on Wall Street of 19¢.

For the full year, InVivo Therapeutics posted losses of $23.4 million, or 76¢ per share, with losses and losses per share shrinking 29.6% and 39.7%, respectively, compared with the prior year. Non-GAAP losses per share were 78¢ for the year, down 8.2% from last year and in line with expectations on The Street.

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