There will be no more monkey business for InVivo Therapeutics Inc., which says it’s ready for human trials on its implantable treatment for acute spinal cord injury.
The Cambridge, Mass.-based firm, which is developing a treatment using implantable polymers developed at the Langer Lab at MIT, said it applied for an investigational device exemption from the Food & Drug Administration to move from primate testing to human trials.
In a mass email sent out early Dec. 1, CEO Frank Reynolds was upbeat about the start-up’s chances of obtaining the regulatory nod and waxed confident about what it means for people suffering from spinal cord injuries.
“We believe that this represents the most significant development in the history [of] spinal cord injury treatment,” he wrote. “This is Huge!!”
Reynolds said he believes the company could get approval to begin clinical trials sometime in 2010 and wasn’t shy about touting the technology’s money-making potential.
“We anticipate annual revenue for our first product to exceed a billion dollars,” he said in a prepared statement. “Our organization looks forward to providing humanitarian benefit to the millions of people waiting for us to succeed.”
In October, InVivo said it was well into its second primate study at St. Kitts Biomedical Research Facility in the U.S. Virgin Islands. The primate study originally commenced at Oregon Health & Science University in early 2009, but was terminated when some of the laboratory monkeys had to be euthanized after developing severe bladder infections. Each organization blamed the other for the complications; InVivo filed suit against OHSU in September, claiming the setback cost the company more than $500,000 and significantly derailed its plans to the point that the firm may be in serious jeopardy, according to court documents. It’s a contention that OHSU vigorously denies.
According to the lawsuit, InVivo’s primate studies involve the surgical severing of the spinal cord and the implantation of the company’s patented device. The firm has been bullish about the results, claiming a nearly 100 percent success rate in getting monkeys to run two weeks after implantation.