Myomo: FDA Approval, Press Recognition, New CEO-Now, Customers?
Myomo, the privately held Boston-based startup, has a lot to be thankful for this holiday season. The company won FDA approval in July for its first product: the “e100 NeuroRobotic System,” an elbow brace that helps stroke victims recover use of their arms by detecting tiny electric signals from the skin’s surface. Earlier this month, Popular Science cited Myomo’s brace one of the top technological innovations of 2007. And the company recently announced that it has brought on board, as CEO, Thomas Glover, a veteran manager with more than 25 years of experience marketing medical devices, most recently as CEO of New York-based Vasomedical (a leading provider of non-invasive cardiovascular technologies), and formerly an executive at Johnson & Johnson. Now the question is: can Myomo make the leap to build distribution to reach the millions of patients who could potentially benefit from its product?
Steve Kelly, Myomo board chairman and founding CEO, says the key to the company’s technology is that it is “the first personal robotic wearable device controlled by the patient.” The concept was central enough, he says, that it feeds into the firm’s name, which is short for “my own motion.” With technology covered by MIT patents garnered by its founding inventors John McBean and Kailas Narendran, Myomo uses electrodes to detect subtle electrical signals on the skin to determine when a patient is trying to move. Then, much like power steering in a car, the company’s brace assists the effort. Myomo’s initial elbow brace has been shown to help patients move their arms whether 10 days or 10 years following a stroke.
Most remarkably, though, Myomo’s technology has also shown promise in helping stroke victims regain independent use of their so-called hemiparetic, or partially paralyzed limbs, taking advantage of so-called “neuroplasticity” whereby the brain essentially re-wires itself to recapture at least some mobility. Much more clinical work is needed, but early studies offer hope that Myomo’s technology can allow at least some stroke victims’ neurologic pathways to be strengthened enough that they can ultimately regain unassisted use of their formerly incapacitated arms.
Myomo’s initial FDA clearance for its brace is only for hospital or clinic-based use with arm dysfunction caused by stroke (Myriad other applications of the technology may be possible; more on that in a bit.) But even the arm application represents a remarkably big market. Stroke is the leading cause of long-term disability in the U.S. with some 5.7 million current stroke survivors. Roughly half of these patients have some one-side paralysis that often impairs their use of their arms. And, with some 78 million baby boomers approaching retirement, the numbers are sure to grow.
Myomo is the first out of the gate with a noninvasive, straightforward device with the potential to help a large number of patients. But the fields of neurological research and robotics are burgeoning. Scores of research groups around the world are now working on similar devices and robotically assisted therapies to treat stroke patients and others with brain or neurological disorders. Myomo, meanwhile, has just 17 employees and, despite is promise and positive press, the effects of its sole product have only been documented in two tiny clinical studies to date. The market may be big, but there is no doubt that incoming CEO Thomas Glover will have his work cut out for him.
Step one, Kelly says, is to build distribution channels by selling Myomo braces to rehabilitation hospitals and clinics. Then, next year, Myomo spokesperson Maureen Liberty adds, the company hopes to work toward approval for home use.
But Kelly’s also thinking beyond that. “We’re at the very beginning,” he says. “We see Myomo as a kind of foundational platform technology.” In addition to helping stroke patients, he says, Myomo’s technology could potentially be useful for people with spinal cord injuries, or even degenerative conditions like multiple sclerosis. “With all the medical breakthroughs to come for people with paralysis,” Kelly says—whether stem cell injections to treat spinal cord injuries or other treatments as yet unimagined—”rehabilitation will play a central role and Myomo devices could help patients make the most of their treatments.” Without too much prompting, Kelly envisions an entire system of Myomo devices, with “patients being wheeled in and, depending on their situation, regaining enough function to ultimately walk away unassisted.”
Kelly’s vision might even sound too good to be true—and it still may prove to be so—but the company’s strong track record to date bodes well. The fact is, Myomo’s path from idea to startup could hardly have been smoother. The company began as a graduate student project at MIT in 2002 and even then it won awards, bagging top honors in MIT’s well-known “50K” competition (now the 100K) for its initial business plan. Early development occurred on campus in the so-called MIT Active Joint Brace Research Group with two rounds of “ignition grants” from MIT’s Deshpande Center to help it spin out as a privately held firm in 2004. (The company is fairly tight-lipped about what capital it has raised since then.) Now, with a strong patent portfolio, swift and trouble-free FDA approval and a new CEO, Kelly seems right when he notes that, so far at least, “this has been a project blessed with serial good luck.”