InVivo requests FDA meeting for spinal cord treatment

Cambridge-based InVivo Therapeutics Holdings Corp. (NVIV), which develops treatments for spinal cord injuries (SCI) and other neurological injuries, has requested to meet with the FDA for its second product this year, a hydrogel-based treatment of acute and sub-acute neck, back, and leg pain conditions.

The product is specifically intended for sciatica or radicular pain of the low back and legs and acute and sub-acute radicular pain of the neck or arms, which affect more than 4.2 million patients annually in the U.S., according to a statement. It consists of an injectable compound which slowly releases a number of molecules, including methylprednisolone, an anti-inflammatory drug. A summary of the research was published in the Journal of Biomaterials in January.

For years, InVivo has been pressed by patients like myself to develop treatments for herniated disks and other neurological pain issues associated with the aging baby boomers in the United States, and now we have an answer in InVivos hydrogel platform, said InVivo CEO Frank Reynolds in the statement. We believe that the opportunity for our new treatment could exceed $22 billion annually, and by late 2012, we plan to partner with a global leader in pain therapies to bring this product to market.

In April, the company met with the FDA to discuss its investigational device exemption (IDE) application for biopolymer scaffolding to treat acute spinal cord injuries. The scaffolding is intended to provide support for a damaged spinal cord in order to prevent tissue scarring and improve recovery after a traumatic spinal cord injury.

The company was founded in 2005 based on proprietary technology co-invented by professor Robert S. Langer of MIT and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital.

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InVivo requests FDA meeting for spinal cord treatment