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The FDA’s increasing caution over biological grafts has been evident for a while, but seems to have caught investors in InVivo Therapeutics (OTCQB:NVIV) by surprise. The agency has demanded a much slower dosing schedule than had been expected for the company’s five-patient pilot trial of its biopolymer scaffolding, a therapy for acute spinal cord injury, resulting in a delay of roughly two years until trial completion.

And the situation gets worse from there. The company was expecting to file for a humanitarian device exemption (HDE) on data from the pilot trial, enabling it to commercialise the scaffold in the US by around mid-2015. But the FDA appears to have also requested a subsequent controlled pivotal study, meaning that approval could be set back by five years in total. The company’s share price has halved to $1.71 since the revelations emerged on Tuesday.

Sequential

The biodegradable polymer scaffolding is designed to be implanted at the site of an injury to the spinal cord to provide a framework for the cord to regrow. The FDA is instinctively wary of biologically active implants, and has insisted, quite sensibly, that the five patients be treated sequentially.

However, its demand that each patient be followed for three months after the implantation before InVivo can even request permission from the FDA to enrol the next patient is unusual. Because there will be a delay each time the agency decides whether to grant this permission, InVivo estimates that the trial will take at least 21 months to complete. This suggests that data will not be submitted to the FDA before early 2016 – a full two years later than InVivo had planned.

Should the data show the scaffold to be safe, InVivo will then have to conduct a pivotal trial. Jason Napodano, an analyst at Zacks, wrote that InVivo’s former CEO, Frank Reynolds, had always said that the biopolymer scaffolding would reach the market on the strength of the pilot study – not unfeasible given that the company is seeking an HDE, where the efficacy bar is relatively low, rather than the more stringent premarket approval (PMA).

But that dream now looks to be over – according to InVivo another trial will now be required. Mr. Napodano assumes that this pivotal trial will start around mid-2016 and take two years, suggesting that approval under HDE could arrive mid-2019, a full five years after initially expected.

As of June, the Cambridge, Massachusetts company had $23m in cash, having raised almost $16m through the exercise of warrants.

InVivo was already reviewing its other products, which include a hydrogel platform, dural sealants and replacements, nerve conduits and fibrosis treatments. All are still very early in their development – there is no alternative source of revenue for InVivo, so further financing will be necessary.

As of last week InVivo is seeking a new CEO; Mr Reynolds resigned suddenly owing to poor health. The interim leader, Michael Astrue, appears to have undergone a baptism of fire.

Source: InVivo Therapeutics Suffers From FDA's Timidity On Biologic Grafts