InVivo reports profit, expects to start human trial

Bob Langer, co-inventor of technology used by InVivo

Spinal cord injury treatment company InVivo Therapeutics Holdings Corp. (OTCBB:NVIV) reported a profit for the first quarter of 2012, and said its biopolymer scaffolding is slated to enter human clinical trials later this year.

InVivo shares were up about 6 percent in mid-morning trading to $2.45.

The company said it expects to start a pilot human clinical trial of the scaffolding in the second half of 2012, pending approval of an Investigational Device Exemption application by the U.S. Food and Drug Administration. Following a meeting with the FDA held in April, the company said it is expecting the product to be regulated under the Humanitarian Use Device/Humanitarian Device Exemption pathway that should accelerate commercialization.

The Cambridge company uses technology co-invented by MIT Professor Robert Langer and Mass General Hospitals Dr. Joseph P. Vacanti. Langer was among the team of InVivo scientists who met with the FDA in April.

The pilot test will be an open label study to evaluate the safety and efficacy in spinal cord injury patients following treatment with the biopolymer scaffolding. The study will follow promising pre-clinical studies completed in non-human primates, according to InVivo.

The company also expects this year to file with the FDA for its injectable hydrogel to treat peripheral nerve and spinal cord injuries. The company is conducting a preclinical study with Geisinger Health System to evaluate the injectable biocompatible hydrogel for the treatment of pain caused by peripheral nerve compression. Some 3.2 million pain injections are performed annually to treat back, neck and leg pain caused by peripheral nerve injuries. InVivos hydrogel is designed to time-release anti-inflammatory drugs for extended pain relief. The product addresses an estimated $15 billion market for peripheral nerve injuries, the company said.

We are off to a strong start for 2012 and the first quarter was marked by significant achievements and milestones for InVivo, Frank Reynolds, InVivos CEO, said in a prepared statement. By the end of 2012, we expect to have several product applications under review by the FDA.

He added that during the first quarter of 2012, InVivo strengthened its balance sheet by closing an oversubscribed $20 million public offering. Net proceeds to InVivo were approximately $18.1 million. InVivo also has the potential to receive an additional $18.6 million of capital from the exercise of previously issued outstanding warrants.

InVivo also has signed a multi-year lease for a 21,000 square foot facility at One Kendall Square in Cambridge that will house corporate offices, a vivarium, laboratory space and a current good manufacturing practices cleanroom for manufacturing.

Link:
InVivo reports profit, expects to start human trial