InVivo Therapeutics Corp. (OTC:NVIV) inked a lease for a manufacturing and development plant in Medford, Mass., as it gears up for possible human clinical trials of its regenerative spine treatment.
Cambridge, Massachusetts-based InVivo netted about $9 million as part of a reverse merger last week with a holding company, Design Source Inc. Stock in the company is now sold on the OTC exchange under the NVIV symbol.
InVivo is hoping for a nod from the Food & Drug Administration to begin human trials of its regenerative treatment for traumatic spinal cord injury. In December 2009, InVivo applied for an investigational device exemption from the FDA to move from primate testing to human trials. Announcing the reverse merger last week, the company said it expects to begin the trial as soon as it lands FDA approval.
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The reverse merger also included $500,000 in bridge debt conversion, the repayment of the accelerator loan InVivo landed from the Mass. Life Sciences Center last year (earlier this year, Good Start Genetics was the first company to pay back its $500,000 accelerator loan). When it won the accelerator loan in April 2009, CEO Frank Reynolds told MassDevice that the loan would be used to build a manufacturing facility near the UMass-Lowell campus.
The InVivo treatment uses a scaffold made of a biodegradable polymer designed to act as a “synthetic extracellular matrix” and to reduce scar formation called astrogliosis. Looking to speed up its trip through the regulatory wilds at the FDA, the company said it will submit for clearance for the scaffold device alone. Down the road, it may apply for additional clearances for using the device with anti-inflammatory drugs or stem-cell-based compounds.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
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