July 28, 2008
NeuroVista, Emerging from Stealth Mode, Unveils Technology to Predict Epileptic Seizures
NeuroVista has said next to nothing in public about how its technology works, until today. After sitting down for an exclusive interview with CEO John Harris at his office in Seattle's Fisher Plaza, all I can say is that if its technology is half as good as he envisions, NeuroVista will transform the way people live with severe forms of epilepsy, and possibly other neurological diseases that affect millions of people.The company, founded in 2005, generated curiosity a year ago when it raised $33.8 million in a second round financing led by big-name venture firms like Advanced Technology Ventures, Delphi Ventures, Three Arch Partners, Sprout Group, and Foundation Medical Partners. Harris gave just one interview at the time, and issued a bland statement about improving quality of life for patients with epilepsy, without saying how the product works. "We haven't even shown this technology to many venture groups," he says.So now the big secret can be let out: NeuroVista is developing an implantable device that is designed to predict a seizure before it happens, and can warn a patient to get ready. The concept has tantalized neurologists since the 1970s, because some, but not all, patients can feel a seizure coming on and prepare accordingly. But a systematic warning system has never come close to becoming a reality. If it can be done by detecting a coming storm in the brain's electrical wave readout (known as an EEG), then patients could stop living in fear, and find a safe place to lie down right before a seizure, or maybe take a fast-acting drug to prevent it.Or, if such a device could signal when the brain is behaving normally, then patients could feel confident going to work, or going out to a restaurant. An estimated 750,000 people in the U.S. could potentially benefit from such a system, because their seizures aren't controlled by existing neuro-suppressant drugs, Harris says."People have been talking about this since the 1970s, and I wouldn't say this is proven, but this the best approach I've seen," says Brian Litt, a neurology and bioengineering professor at the University of Pennsylvania, and a member of the company's scientific advisory board. "I decided these guys are coming up with a significant solution, and I can either help them with the concept or watch this bus pass my station."So there's a big dream here, for sure. But how is this thing really supposed to work?Harris showed me. It starts with a thin wire electrode that a neurologist would insert through the skull onto the surface of the brain to record EEG brain waves (hey, nobody said anything about this being minimally-invasive). The wire would run down the back of the neck to a pacemaker-style device, about the size of a book of matches, implanted under the collarbone. That component, called a telemetry device, receives the brain wave data and beams it to another device about the size of a cell phone, that clips onto a belt or fits in a purse.That receiver, programmed with proprietary mathematical algorithms, transforms the information into a real-time warning system. It has three lights, which can tell the patient if they have a low, moderate, or high likelihood of suffering a seizure soon. Sort of like a traffic light, the settings are color-coded. Blue light for low susceptibility, white light for moderate probability, and red light for high.This is all easier said than done, of course. To make it happen, NeuroVista gathered hundreds of high-resolution EEG readouts from patients who had severe enough epilepsy that they were hospitalized for more than a week and continuously monitored. NeuroVista's computers mined the massive reams of data to detect statistical abnormalities that can't be spotted by a neurologist's eye, and built them into its algorithms. Then comes the engineering challenge. Getting the electrode to be sensitive and durable enough for long-term use, making a telemetry device small enough to be implantable yet with enough battery power to transmit a lot of data, and then having an easy-to-wear receiver that can warn patients of the coming storm.Diabetics already have automatic insulin pumps that can monitor and control their disease, and heart patients have implantable defibrillators that can shock their heart back into a normal rhythm in a cardiac arrest. But there is nothing out there like this real-time warning system for neurological disorders that can have unpredictable flare-ups, like migraine headaches, bouts of severe depression, schizophrenia, or psychotic episodes. "This device may actually be a platform for a number of conditions," Litt says.OK, before we go too far down that road, where's the proof? So far, the company has yet to run a clinical trial to see how patients use its system in real life and how accurate it is. The algorithms that determine the seizure risk are proprietary and aren't being published in the scientific literature for prying eyes to see.NeuroVista plans to run its first feasibility clinical trial in 2009, which will be followed later by a pivotal trial that could lead to FDA approval, Harris says. "The proof will be in the pudding," Litt says.Harris already has a reputation as an innovator in Seattle medical devices, as a co-founder of Heartstream, which developed automatic defibrillators like the ones posted at airports in case of a sudden cardiac arrest. He also co-founded Northstar Neuroscience (NASDAQ: NSTR), which didn't have such good luck, as its electrical stimulation device failed in January to restore arm movement in a trial of stroke patients.Harris left Northstar before it went public, and did a stint as an entrepreneur-in-residence at Versant Ventures in Menlo Park, CA. That's when he heard about the seizure prediction concepts that led him to start NeuroVista in January 2005. It now has 47 employees, mainly with backgrounds in engineering, biostatistics, mathematics, and clinical research.Without overpromising to patients, Harris can get bullish in a hurry on the subject of the company. "This will be a very important company," he says. "We're not just creating a widget, we're creating a platform that will affect all sorts of neurological conditions, and will lead to a revolution in therapies."