protein-based drug—injected once onto the injured area of the spinal cord during post-trauma surgery—to repair damaged nerves and restore movement and sensory functions. Acorda Therapeutics (NASDAQ:[[ticker:ACOR]]), a Hawthorne, NY-based biotech firm, had advanced to late-stage clinical trials with a molecule called fampridine, intended to prevent damage to nerves after spinal cord injuries, yet the drug failed to meet goals of the studies.
The market for such treatments is small compared with those for cardiovascular disease and cancer. About 11,000 Americans suffer spinal cord injuries annually, according to the Centers for Disease Control and Prevention. Reynolds says that, due to the billions of dollars spent per year to care for these patients, he thinks health insurers are likely to provide reimbursements for InVivo’s device if approved for the market.
I’m often skeptical of market projections for treatments that haven’t entered human clinical trials. Still, InVivo has attracted some big-named scientific advisors such as MIT’s Langer and company director Richard Roberts, a biochemist who shared a Nobel Prize in medicine in 1993 with MIT professor Phillip Sharp for their discovery of split genes.
Reynolds, a former business development executive for Siemens, says that Langer recruited him be the “business guy” for his spinal implant project when Reynolds was studying at the Sloan School of Management at MIT. Reynolds, 44, says he had been introduced to Langer because of the MIT professor’s research of spinal cord injuries with Harvard Medical School neurosurgeon Yang Teng. The project became Reynolds’ MBA thesis and he founded InVivo in November 2005.
When I first met Reynolds in late 2006, his clinical evidence to show the utility of the device was from rodent studies. Then last month, I saw him at MassMEDIC’s annual investor conference in Boston, where he showed the audience a video of a monkey dragging a leg that had been surgically paralyzed. The video then showed the same monkey, two weeks after InVivo’s device had been implanted in its spine, moving around with barely a limp.
The recently launched primate study of InVivo’s implant will include 12 to 16 Rhesus monkeys, expanding from the pilot study of four monkeys. However, the real test for the implant will be human trials, which Reynolds expects to begin next year. That study would include patients with severe spinal cord injuries who are at high risk of paralysis. There are other models of the implant that deliver neural stem cells or drugs, he says, but those would likely be next-generation products.
Reynolds sounds extremely confident about his company’s future: “We only need $15 million and that’s it. We’ll definitely be an IPO company with one round [of funding],” he says. “If it works, we have maybe the biggest IPO in health care in a long time.”
