Running in place

CORRECTION

Inc. magazine ran the following correction Dec. 1:

“Frank Reynolds, CEO of InVivo Therapeutics, did not sustain his spinal cord injuries in a December 1992 car accident, as reported in our March feature, ‘What Makes Frank Run.’ Reynolds now says he injured his back loading a truck in 1991, while working as a delivery driver. His spinal problems occurred following surgery in 1992 designed to address the initial injury.”

Reynolds and other InVivo representatives did not respond to repeated requests for comment.

Frank Reynolds taught himself how to walk again after doctors said he couldn’t. He made a monkey run two weeks after a traumatic spinal cord injury. In fact, Frank Reynolds might even hold the cure for paralysis in the palm of his hands.

Who knew that would be the easy part?

Just after an investors conference last fall, Reynolds, the founder and chief executive of Cambridge’s InVivo Therapeutics Corp., stood just outside the conference center at Umass Boston’s Campus Center looking slightly bewildered.

Investors conferences are equal parts debutante ball, speed dating round and game show episode. It’s “Who Wants To Be A Millionaire,” with better odds.

Or they used to be, before AIG became a four-letter word and industry came looking for bailouts. But the ebullient spirit of entrepreneurialism knows no bounds, so, one-by-one, inventors, engineers and CEOs walked to the podium to show the investment community how their medical innovations would change the world.

Reynolds, a robust 44-year-old who speaks in rapid-fire, Bronx-tinged clips, is a master of the pitch. A meeting with Reynolds can leave you light-headed as he weaves through a life story that starts with a debilitating car accident, meanders the halls of M.I.T. and ends in a future where paralysis is a thing of the past. Friends describe him as a real-life “Energizer bunny” with endless enthusiasm and an evangelical zeal for helping the paralyzed.

But, despite Reynold’s animated pitch for InVivo’s spinal implant that November day,the buzz petered out after his presentation. There was glad-handing, business cards were exchanged along with general pleasantries, but Reynolds cut no deals.

{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Reynolds_Frank_100x100.jpg}After a few minutes, standing with a pair of lieutenants at his side, Reynolds flashed a moment of melancholy. Here he is, the man who overcame his own paralysis, who may hold the cure to paralysis, shoulder-to-shoulder with enough cash on the hoof to make the vision a reality, and all he had to show for it was a few kind words and a stack of business cards. Talk about a sign of the times.

“Imagine if this was 1998,” he said to no one in particular.

The monkey tapes

For the millions of people around the world living with paralysis stemming from a spinal cord injury, May 6, 2008, might turn out to be a watershed moment.

It was that spring morning when Reynolds received a video from a primate-testing center in the Caribbean. After a successful 2007 trial of its technology in rats, InVivo had begun testing its product on Rhesus monkeys.

“The primate center sent me an email at 10 a.m. that says, ‘Frank, we notice a level of improvement in one of the animals.’ That’s all it says. So I put them to the side and went about my day,” Reynolds recalls.

When he finally got around to looking at the video almost 12 hours later, what he saw blew his mind: A once-paralyzed monkey running around two weeks after receiving InVivo’s patented therapy. The images were so unbelievable and unexpected that Reynolds initially thought he might be hallucinating.

“It was the greatest day of my life. For a week, every time I watched it I got choked up,” Reynolds remembers.

A window of hope

Paralysis from spinal cord injury is usually the result of traumatic injury. Part of the vertebral column compresses the spinal cord, impinging its ability to relay information between the brain and the rest of the body. Damage to its nerve fibers can result in permanent paralysis.

It’s a puzzling and devastating injury that affects 2.5 million people across the globe, according to a conservative estimate by the International Campaign for Cures of Spinal Cord Injury Paralysis.

For many Americans, the image of “Superman” actor Christopher Reeve in a wheelchair, unable to breathe without the aid or respirator, remains an indelible reminder of the cruelty of SCI paralysis.

Despite major therapeutic advances and millions spent finding others, there is no cure for paralysis. Most patients are men; the average age for-paralyzed is about 33, according to the ICCP.

{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/featureArt/Reynolds_Frank_150x200.jpg}No one knows this better than Reynolds, who was paralyzed by a spinal cord injury in a 1992 car accident. For three years, Reynolds languished in his bed, waiting for doctors to find a therapy to get him walking again. After spending nearly 24 hours a day prostrate, listening to comedy albums to keep his spirits up, Reynolds realized medical science wasn’t going to catch up in time to get him back on his feet.

That prompted him to devise an aggressive physical therapy treatment regime. Reynolds is mobile again, but lives with chronic pain. He can’t pick up his nine-year-old daughter and never bends over unless it’s absolutely necessary.

“I call it the $20 rule,” he says. “I never bend over for anything less than a $20 bill.”

The video that brought him to tears was a symbol, really. It wasn’t just that one monkey that responded to the treatment; all four were fully mobile a mere two weeks after debilitating spinal cord injuries that left them paralyzed.

“We’ve had a 100 percent success rate,” Reynolds says. “Nobody’s ever done this.”

InVivo recently commenced a second, larger primate study involving 16 to 20 primate subjects, but the results won’t be known until June. Until then, that grainy video of monkeys running around a concrete jungle gym will be a critical part of InVivo’s pitch.

In fact, one backer says, it’s often the main reason investors fund the company.

“Of those that have seen the video, probably 95 percent have become investors,” says Richard Chebookjian, principal at Rye Brook Financial in Media, Pa.

Chebookjian, who fondly remembers his first meeting with Reynolds over omelets at the Conshohocken Marriot in Pennsylvania, says he’s put down $200,000 of his own on InVivo and has brought in millions more through his own proselytizing.

Reynolds spoke about InVivo for about two hours without taking a breath, Chebookjian says.

“Normally, when you meet someone for the first time there’s some give and take. With Frank, there’s more take than give,” he explains. “You have to wait for the enthusiasm to wane, but it never does for him.”

A chance meeting

Reynolds founded InVivo in 2005 while completing a fellowship at MIT’s Sloan School of Business. Attending an executive education program as Siemens Corp.’s director of global business development, a chance meeting with MIT’s Robert Langer changed his future.

{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Langer_Robert_100x100.jpg}Langer, a winner of the 2008 Millennium Technology Prize, focuses on the study and development of polymers to deliver drugs and genetically engineered proteins at controlled rates and for prolonged periods of time. When he met Reynolds, he was working on a small implant he believed could make major strides in stopping the spread of dead tissue after a spinal cord injury.

Despite being what he calls the fast track for the top job at one of the world’s largest medical device makers, Reynolds decided to jump ship and start a new company with Langer.

InVivo is stingy with details on its technology, but the company’s web site describes it as a polymer-based implant that periodically releases neural stem cells at the site of injury. InVivo holds 10 U.S. patents, two pending U.S. patents and 67 issued international patents on the product, which is designed to stop the debilitating avalanche of symptoms that follow an initial injury.

“What the majority of people don’t understand is that 90 percent of spinal cord injuries don’t result in the person being put in a wheelchair for life,” Reynolds explains. “What puts a person in a wheelchair for life occurs on days two through 30. There is a window of opportunity to intervene and stop what’s called a ‘secondary injury’ from cascading to a medical situation that’s irreversible.”

Reynolds says that the InVivo implant complements spinal cord decompression surgery and will cost about $45,000. The company is planning on a commercial debut in 2010 or 2011; Reynolds estimates a total market for the treatment of roughly $10 billion.

Doubt springs eternal

Despite major leaps in medical innovation, there’s a healthy degree of skepticism about curing paralysis.

“Twenty-five or 30 years ago, people talked about a cure,” says Susan Howley, director for research at the Christopher Reeve Paralysis Foundation in Springfield, N.J. “People thought about it like Lazarus springing from his wheelchair and walking away. However, what we’ve learned is that it is an enormously complicated injury. There’s no magic bullet.”

Instead, the focus is on incremental improvements in the lives of paraplegics and quadriplegics, Howley says.

“Improvement of just one level could make all the difference in the world. If a quadriplegic could just regain hand function, think about the world of difference that would make,” she explains.

Howley’s foundation funds 544 laboratories worldwide with more than $39 million in grants. Though unaware of InVivo’s research until speaking with MassDevice, Howley cautions against making the leap from positive results in lab animal tests to marketing an effective treatment for humans.

“There are rats walking in labs all over the place, but no human being is walking yet from a treatment that worked in a rat,” she notes.

Reynolds says such skepticism is par for the course. He has been questioned many times by competitors and potential partners about the validity of his test results, ambitious timeline and the investment required to bring the InVivo product to market.

Fifteen million dollars will do the trick, Reynolds maintains, though most potential investors tell him it’ll take $50 million to $80 million to bring the product to market and take the company to a successful exit.

Reynolds backs his figures by citing InVivo’s efficient cash burn; using only his Rolodex and juggernaut charm, he’s raised $3 million from a friends-and-family pool of about 24 people. He says he expects the regulatory path for InVivo to hold fewer pitfalls than for other medical device areas, citing the lack of comparable treatments on the market.

InVivo can expect FDA clearance by the end of 2009, Reynolds says, skeptics be damned.

“I think it’s a fair assessment, that it can sometimes sound too good to be true,” admits Chebookjian, though he calls InVivo a “once-in-a-lifetime opportunity.”

But Chebookjian is quick to add that someone of Langer’s stature wouldn’t risk his reputation on a product that didn’t deliver. And all he’s seen of Reynolds’ stewardship of InVivo reinforces his belief that his investment will pay off.

“Somebody was around when these great inventions of the past were made. Why can’t it be us?” he says. “I think they’re paving a new path and proving things that people thought couldn’t ever happen.”

Funding proves elusive

InVivo hasn’t had much luck attracting venture capital’s eye, despite Langer’s presence on InVivo’s Scientific Advisory board and the tissue regeneration guru’s ties to a prominent local VC outfit.

Waltham-based Polaris Venture backed Langer on more than 13 companies in the last 15 years. Langer companies are so familiar at Polaris that the MIT scientist told the Wall Street Journal last year that Polaris is often his first stop for funding.

“When we end up doing deals, it’s a 20-second phone call,” Langer told the journal.

Reynolds says he hasn’t pitched InVivo to Polaris and calls the image of Polaris as a bunch of “Langer’s boys” overblown.

Besides, Reynolds insists, fundraising isn’t problem. Many of his investors are poised to dig a little deeper once the results of the second primate study become public.

The real issue, he says, is the impression that the recession has made entrepreneurs desperate enough to snatch at the lowest of lowball offers.

“We’ve had to be more careful with what we deal with,” he says. “People are going to want 80 percent of the company because they think we’re desperate.”

Instead, the company is biding its time, patiently awaiting the right offer. Reynolds says two successful primate studies and a clear regulatory path will make their own friends in the investment world. In fact, he claims the company is very close to raising its entire $15 million goal from an unnamed VC source.

And although the hurdles are certainly substantial, tempering his enthusiasm may be even harder for Reynolds than learning to walk again. The company would rather undersell its results for now, then shock the scientific community in the long run, he says.

But, regardless of dazzling results in rats and primates, healing a human being’s paralysis remains the ultimate test for InVivo and the fulfillment of a personal mission for Reynolds.

“The most devastating thing in the world is watching someone who, the week before, was riding a bike or driving a car, trying to learn how to move their wheelchair by blowing into a straw,” he says.