By Mike Musgrove
Washington Post Staff Writer
Friday, August 28, 2009
On a recent morning at the company's headquarters in downtown Washington, BrainScope chief executive Michael Singer was careful to not oversell the latest piece of news from his still-young company.
Earlier this month, the company received clearance from the Food and Drug Administration to market a portable electroencephalogram device that BrainScope hopes will, eventually, make its fortune.
But that doesn't mean BrainScope is ready to start trying to woo potential customers such as the U.S. military, he said. "This puts us on the path of where we want to go," he said. "We're not there yet."
BrainScope is a privately held firm owned by Revolution LLC, a holding company started by AOL founder Steve Case. For Case, the interest in brain research is a personal one; his brother died from brain cancer in 2002. BrainScope, one of several Revolution-owned companies, employs fewer than 20 people and has invested $20 million in its mission to build the device.
One day, the company hopes, military medics in the field will be able to use BrainScope's flagship product to view a patient's electrical brain patterns as a way of determining the severity of a traumatic injury. Broader uses for the device could be down the road.
Today, EEG machines used in hospitals cost hundreds of thousands of dollars and require a high amount of training to use properly. BrainScope's goal is to offer a battery-operated product that is sophisticated but intuitive to use, so that a medic or even an untrained high school sports coach could employ the device without much instruction. It would be priced in the "low thousands" of dollars.
To take an example from recent headlines, actress Natasha Richardson died earlier this year after suffering a fall, involving a blow to the head, that did not appear to be life-threatening. If an emergency technician on the scene had employed a device such as the one BrainScope is developing, the company says, technician could have detected how severe her injury really was -- and possibly taken steps to save her life.
Dan Cohen, a physician by training who works at the Falls Church health-care consultancy Martin, Blanck & Associates, said that while the early results seem encouraging, it's too early to jump ahead with conclusions about BrainScope's future. His firm advises health-care companies on products and services that might be of interest to the federal sector, but does not have a professional relationship with BrainScope.
"They seem to be marching in the right direction," he said. "But you don't write the final chapter until you have all the data." Still, Cohen said he finds BrainScope's work so far to be "clever" and "promising."
While the FDA has signed off on the device's hardware for use as a portable reader of the brain's electrical patterns, BrainScope is still gathering data from head trauma cases around the country with the aim of further building the software that BrainScope hopes will differentiate its product.
Today, military medics in the field use rough and old-fashioned techniques such as getting patients to count backwards after they've gotten shaken up by a nearby blast. As a result, some say, the number of serious head injuries has gone vastly under-reported.
At least one high-ranking military doctor believes this to be the case. In May, BrainScope appointed James Peake, a former secretary of Veterans Affairs and a former Army surgeon general, to chair BrainScope's medical advisory board. "I see this as an acute issue for the military," he said. "Soldiers sometimes underplay it when they're hurting, so you want something that will be systematic when you're assessing them."
BrainScope's next product, which will also require regulatory clearance, is a disposable headset that will be made for use with the EEG reader device. If that headset clears those hurdles, the company intends to use a "razor and razor blade" business model for the two products, in which the company's future revenue would come more from the disposable headsets than from the device itself.
There are other potential uses for the device, if BrainScope is successful in meeting its first goals. Today, the firm is focused on gathering data about head injuries. Eventually, the company could, conceivably, move on to other maladies that could be diagnosed with the measurement of brain waves.
Eventually, the BrainScope product could be used to diagnose dementia and Alzheimer's, and more, for example. "Stroke is the holy grail," Singer said.
The company's focus right now is on gathering more data to identify the exact characteristics of brainwaves in patients who have suffered from a traumatic injury. There are 50 units of the device in use around the country, at medical facilities such as one at the University of Virginia.
"What we're all about right now is clinical validation," Singer said.