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Innovation Economy

Founder of start-up says device will one day change treatment of spinal cord injuries

By Scott Kirsner
Globe Correspondent / September 26, 2010

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Frank Reynolds is not afraid of the bold pronouncement.

While most people who suffer a traumatic spinal cord injury never recover their normal functioning, Reynolds has written that his company’s medical device will “restore 80 percent of the patient’s normal functioning.’’ In the company’s early experiments with paralyzed primates, Reynolds has said, “100 percent of our monkeys have gotten up and walked in just about three weeks.’’

He told a Boston audience recently that he hopes to begin a small human trial of the device, which is implanted in the spinal cord immediately after a traumatic injury, later this year, and have it on the market in 2011. The company’s first product, once it is approved by the Food and Drug Administration, will generate one or two billion dollars in revenue “easy,’’ Reynolds says.

Reynolds is hoping to take Cambridge-based InVivo Therapeutics Inc. public soon through a transaction called a reverse-merger, which involves assuming the stock market listing of a functionally defunct company. (Often, the company in question is listed on the lightly traded over-the-counter bulletin board, home of the penny stocks.) Reynolds hopes to raise about $5 million from the forthcoming offering, on top of about $5 million he has raised from individual investors, and a $500,000 loan from the publicly funded Massachusetts Life Sciences Center.

Reynolds is much more of a passionate promoter than the typical, low-key medical device chief executive. And his company is pursuing a fund-raising strategy not often seen in the world of life science start-ups: soliciting nondeductible contributions from individuals through its website, using the online payment system PayPal; Reynolds says he company has raised about $2,000 that way, in the months after Inc. Magazine published an article about Reynolds’s crusade earlier this year.

Reynolds has assembled an all-star team of directors and advisers for tiny, 14-person InVivo, including a Nobel Prize winner, the former CEO of Siemens USA, and Robert Langer, the MIT professor who is one of the most prolific patent-holders in the medical device field. He has managed to move the company toward human trials without raising venture capital, which has enabled Reynolds to hold onto about a third of the company.

Lending the company credence is Reynolds’s personal story: a December 1992 car accident that he says left him paralyzed for eight days, and bedridden for several years afterward. During that period, Reynolds says, “I was praying that somebody I didn’t know was working on a treatment to help me get better. Now, I’m that guy.’’ But giving the story an unusual twist is the fact that Reynolds, now in the midst of developing a medical device, himself sued his surgeons and a maker of spinal implants for improperly putting a medical device into his own body.

Reynolds started the company while he was earning a graduate degree at MIT’s Sloan School of Management. Introduced to Langer by a classmate, Reynolds decided to try to commercialize a scaffold-like implant that Langer’s MIT lab had been testing in rats. The scaffold seemed to protect the tissue of the damaged spinal cord, Reynolds says, and then foster “neuroplasticity,’’ the nervous system’s ability to reorganize itself around the site of an injury and restore some function. (Made of a special polymer, itbiodegrades in about two months.)

When neural stem cells were added to the device before it was implanted, the results were even more impressive. But InVivo will first try to get the FDA to approve the implant on its own, without the stem cells added.

InVivo hopes to prove the implant’s value by putting it into 10 human patients who have suffered the worst kind of spinal cord injuries, within about 48 hours of the injury. “That’s before the inflammation gets bad, and it’s usually when the rods and screws are inserted’’ to stabilize the spinal column itself, Reynolds said. The scaffold, he expects, will “stop the tissue from dying. Then we let neuroplasticity occur. The body will locally reorganize. It’s like using a detour if you’re stuck in traffic.’’

Last December, InVivo applied for FDA approval to conduct those first 10 experimental implants, but the agency requested more animal data, Reynolds says. He says the company will file its final paperwork soon, and hopes for a response from the agency in about two months. People who have suffered spinal cord injuries who post to online communities like the CareCure forums are eagerly hoping the device will win approval.

The company and Reynolds have filed several lawsuits recently. One lawsuit, now settled, involved an Oregon research facility that InVivo alleged had botched a primate study, slowing the progress of its research.

But perhaps the most interesting case involves Reynolds’s own medical history: He says he was injured in a car accident. “I was paralyzed on December 14, 1992,’’ he told a Boston audience last July, “just like everybody else that’s paralyzed: You’re kind of going about your life. Unexpectedly, something occurs. You wake up in a hospital.’’ Reynolds claimed to have developed his own treatment regimen that enabled him to walk again.

Court records from a lawsuit he filed against several surgeons, a nurse, the maker of screws that were used to fuse his vertebrae together, and Pennsylvania Hospital indicate that Reynolds had a December 1992 spinal fusion surgery that caused him many painful after-effects, including nerve damage, infection, and pain. But in the legal documents, Reynolds’s attorneys didn’t check a box indicating that he experienced paralysis as a result of the surgery.

And a 1994 Philadelphia Inquirer article referencing Reynolds’s surgery indicates that it took place to correct an injury incurred “while loading a truck on the job in December 1991.’’ Even the website of the law firm that represented Reynolds in his medical malpractice suit describes the case, Reynolds v. Balderston, this way: “Negligence resulted in neurological injury to snack cake route driver.’’ (Reynolds told Inc. Magazine that he was working as a psychotherapist at the time of his 1992 car accident.)

Though a jury awarded Reynolds $750,000 in his claim against Dr. Balderston, the story in the suit doesn’t jibe with the story Reynolds told Inc., that he was injured in a car accident and rushed into surgery on the same day: Dec. 14, 1992. In the Inquirer article, for instance, Reynolds is quoted as saying that his surgeon promised him that following his surgery, Reynolds would “play tennis, basketball, and golf at full speed.’’

When asked about these details in a phone interview, Reynolds denies he ever drove a delivery truck, and reiterates that he was working as a therapist. “These are clearly errors,’’ he writes in an e-mail.

Venture capitalists who invest in medical devices caution that bringing a new product to market is difficult and expensive. “InVivo is going after a market that has the potential to be enormous, but at the same time faces very difficult challenges in demonstrating safety and efficacy for increasingly risk-averse government bureaucrats’’ at the FDA, writes Jonathan Fleming of Oxford BioScience Partners in an e-mail. One local company, Mansfield-based Innovative Spinal Technologies, filed for bankruptcy last year, even after receiving $75 million in funding and successfully shepherding several products through the FDA approval process. Another company, Alseres Pharmaceuticals Inc. of Hopkinton, touted a drug it was developing to encourage spinal cord healing as “one of the great miracles of science.’’ But that drug never won FDA approval and all mention of it has since vanished from the company’s website.

Reynolds “is indeed an unorthodox guy,’’ says Arnoldo Hax, a professor emeritus at MIT who supervised Reynolds’s thesis, which was a draft business plan for InVivo. “He almost feels he’s on a campaign to save the world. Either you are turned off by his style, or you’re captivated by it. It’s hard to be indifferent.’’

Reynolds says that if only InVivo can get its device into humans, “it might become the stuff of legend. I do want to see a human walk, and then retire, get some time on the beach.’’

Scott Kirsner can be reached at kirsner@pobox.com. Follow him on Twitter @ScottKirsner.