The once-paralyzed CEO of InVivo Therapeutics designed his own physical therapy program and regained the ability to walk. Not all patients with spinal cord injuries (SCIs) are so lucky, and Frank Reynolds wants to save as many of them as possible from life in a wheelchair with an implant that protects the spinal cord from inflammation, further bleeding, and cell death following SCI.

 

 “About 90% of people with spinal cord injuries arrive in the emergency room and they can’t move,” says Reynolds. “They’re suffering from spinal shock; they’re not paralyzed for life. They can’t move; they can’t feel. That’s basically the central nervous system shutting down [as a protection mechanism].” However, bleeding and inflammation during the subsequent 21 days (known as the secondary injury) is in many cases what causes paralysis. A biopolymer scaffold implant from InVivo Therapeutics (Cambridge, MA) could hold the key to preventing paralysis in a procedure that takes only 15 minutes.

 

“We’ll intervene in the early days—most likely on the day of injury,” says Reynolds. “We’ll implant the technology and then prevent advancement of the inflammation, and that stops the scarring. The restoration of functioning occurs through neuroplasticity.”

 

InVivo Therapeutics was formed in 2005, after Reynolds crossed paths with distinguished MIT professor Robert Langer, who had been working on the scaffold technology for nearly a decade. Once the company was founded, the technology took a new direction in that its fate was to become a true product platform technology, said Reynolds. The biomaterial polymer can be implanted as a solid scaffold or can be injected after being liquefied.

 

The scaffold has been successful in rats and even brought paralyzed monkeys back to movement. “We’ve had unbelievable success in rats and monkeys –no one has ever seen anything like this. We’re confident that we’re going to have good success in humans,” says Reynolds. Last month the company submitted an investigational device exemption to FDA to initiate a human study, which could begin by Q1 2012. Reynolds is hoping for FDA approval by the end of next year or early 2013.

 

Although you can’t put a price tag on preventing paralysis from a quality of life standpoint, the technology could lead to palpable savings for the healthcare system. “The first-year course of care for a quadriplegic is about $1.2 million. You’ll need about $6.1 million to take care of a quadriplegic for life,” says Reynolds. “From an economic standpoint, we’re in a healthcare environment where cost containment is paramount. Last year more than $39 billion was spent to care for people in the United States with spinal cord injuries.”

 

The innovation doesn’t stop there. InVivo Therapeutics has more than 100 patents to protect the technology and plans on expanding its use to more areas, including peripheral nerves, prostate nerves, the retina, and the brain. The company is now working on the next generation of the technology, an injectable hydrogel that doesn’t require major surgery.