Reynolds and his team have developed a device -- a fingertip-size implant that is inserted at the site of the wound -- to help contain the secondary injury. Made of a polymer that has already been approved by the FDA for applications such as biodegradable sutures, InVivo's implant seems to undermine the biological ripple effect that leads to apoptosis, essentially by leading the body to believe that the damage is not that bad, which tones down the immune response and helps the healthier neural tissue survive and heal.
Few companies have focused on treating acute SCI. For the most part, emergency treatment today looks very much as it did at the time of Reynolds's accident. Surgeons clean up and stabilize the backbone with screws and pins, and close the patient up, leaving the spinal cord itself virtually untouched. To reduce spinal cord inflammation, they may also administer a powerful steroid called methylprednisolone -- also used to treat arthritis pain -- although side effects, including an increased risk of infection, make it inappropriate for many SCI patients. Geron, a company in Menlo Park, California, recently received FDA clearance for the first human clinical trials of a human embryonic stem cell–based therapy for acute SCI that scientists believe could generate fresh nerve cells in the spine. "Stem cells have great potential," says Williams. "But we'll need other innovative therapies, too." A device like InVivo's, he says, rather than competing with stem cell treatments would more likely work in synergy with them.
For Reynolds, who has spent five years and some $4.5 million, including most of his own savings, on his quest to change lives, do-or-die time is fast approaching. Primate studies of InVivo's technology have been under way since 2008. Once the final results of those studies are analyzed this spring -- and the early evidence has been encouraging -- the challenge will be to get FDA approval for human trials and then bring the treatment to market. Doing that, Reynolds estimates, will require an additional $15 million. And so far, despite InVivo's A-list team of scientific advisers, including MIT professor and renowned inventor Robert Langer, no major investor has been willing to sign on. But if Reynolds is discouraged, he is not letting it show. For a guy with just 10 full-time employees and a science team made up largely of grad students and consultants paid in company stock, Reynolds exudes a surprising amount of swagger. "Frank is totally committed," says Langer. "If he had to run through a wall, he'd do it. He's got very good people. But anyone can put together a great team -- Frank's strength is this relentless commitment to wanting this to work."
Reynolds's day begins around 6 a.m., when he checks his e-mail from home. It usually ends after midnight -- though predawn e-mails to colleagues suggest that Reynolds seldom truly rests. He pilots a white Lincoln Navigator with "INVIVO" plates from his home in the Boston suburbs to InVivo's headquarters, which occupy three office bays with desks for 14 in the Cambridge Innovation Center, a shared business-incubator space a block away from the main MIT campus. At 9 on a November morning, the building's other tenants are just trickling in as Reynolds begins a meeting in a small conference room overlooking the Charles River. Along with his executive assistant, Lauren Mitarotondo, 24, and his IT manager, George Calapai, also 24, Reynolds is reviewing the data being collected from a primate study that the company is conducting at a research center on the Caribbean island nation of St. Kitts.
Whatever your qualms about animal research, it's hard not to share Reynolds's awe and excitement when you watch the video from InVivo's tests. The pièce de résistance of a presentation Reynolds has been polishing up for meetings with potential investors, the video compares two African green monkeys whose spinal cords have been partially severed to paralyze one of their hind legs. Two days postinjury, both animals drag their feet behind them. But after two weeks, one of the monkeys -- the one with the InVivo implant -- not only walks but runs, curling its tail and pivoting effortlessly on the once-paralyzed leg. Reynolds believes the device will yield equally miraculous results in humans.
The company's first primate trials, in 2008, involved just four animals and achieved similar results. A second trial, with more monkeys, however, got off to a bad start and was halted. Exactly what went wrong remains a matter of dispute, but Reynolds sued the test facility and negotiated a settlement he says he is "very happy" with. Still, that false start threw InVivo off schedule. The company had hoped to begin human trials in early 2010, but they will now be delayed at least until the third quarter.
So InVivo headed back to St. Kitts, where it is testing 16 animals -- enough to yield results that can be presented to the FDA as conclusive. In addition to the video, InVivo has been collecting motion-analysis data and using electromyography, or EMG, implants to directly monitor activity in the animals' muscles. It's a wealth of data, and Reynolds is grilling Calapai to make sure that every piece of it is properly documented and secured. When he submits the company's application to move ahead with human trials, Reynolds wants it to be bulletproof. And he thinks it will be. "This will blow them away," he says. "Nobody's shown up and said, 'Look at this animal running and look at the electrical activity going on.' They've never seen this. We're really excited."
Reynolds has always been something of an optimist. The son of Irish immigrants, Reynolds grew up in the Bronx, New York, with three siblings. He shined shoes on weekends to help out financially. After the family moved to a New Jersey suburb, Reynolds worked two newspaper routes, caddied at a local golf club, and worked in restaurants. He attended Catholic schools and lettered in football, basketball, and golf in high school. When he was 17, his father was debilitated by Parkinson's disease; by the age of 18, Reynolds was managing the family businesses, which included restaurants, bars, and real estate interests, while attending college full time. "When I was becoming a man, my father kind of disappeared from the scene and didn't even know who I was a lot," he says. "It was 25 years of agony and pain on my family."
At the time of his accident, Reynolds was on the verge of starting a new career. But those long years of convalescence had taken a toll on his finances. So when Reynolds returned to the work force, he abandoned hospital administration and looked for higher-paying sales jobs. He felt certain that landing a position would be easy; employers, he believed, would be impressed by his astonishing recovery. Instead, they all seemed to focus on the long gap in his resumé. "It was shocking to have them say that I hadn't been working for six years," Reynolds says. "I was working."
