Because around 80 percent of SCAs happen in the home, that's the focus of the product. But for the 20 percent of attacks that happen while out and about, Greene says they're considering adding a cell phone or beeper read-out device that would alert passers-by when an SCA is detected.

"If they're, say, traveling through an airport and suddenly collapse, the beeper would go off and say, 'Please apply defibrillator immediately,'" Greene says.


An ICD alternative

Of course, there are already implantable cardiac defibrillators (ICDs) -- surgically implanted devices that monitor arrhythmia and send mild corrective jolts to fix them when they detect an SCA.

But Greene sees his product as an option for those who are at risk for SCAs, but who don't choose implantation -- which turns out to be the majority of such folks.

According to Dr. Zipes, only a third of people who meet the risk guidelines for SCA -- guidelines which Dr. Zipes helped write -- have ICDs implanted.

There are many reasons for the low level of adoption, Dr. Zipes says, from fears of unreliability (there have been several widely publicized recalls) to cost. In general, the combined price of the device and the surgery to implant an ICD runs from $50,000 to $60,000, Dr. Zipes says.

And usually, the ICD is never even needed. "You have to implant five to 12 of these devices to save one life," Dr. Zipes says. "I think recognition of that has affected the decision to have implants."

But whether or not the patient gets an ICD, Greene sees his system as something patients could wear while a doctor decides what to do. "SCAs tend to repeat themselves, so we also see our system as a 'smart gauge' for the doctor to decide on the implantation of an ICD," adds Greene. "We see our system as a complement to all defibrillators, whether external or internal."

To the market

Greene says his company is still raising money for clinical trials, which they hope to have completed by next year. Greene is optimistic. "I expect commercialization by late 2010," he says.

Currently, there are about three working prototypes, and each is bigger than a band-aid. But when finished, Greene expects them to be shrunk to around that size.

In addition to gathering funds, OmniMedics is looking for potential partners. It's also beginning to get the word out about HeartStrip, after its public debut at the Mass Medic Society conference this month.

As for Dr. Zipes, he thinks something like the HeartStrip could be useful for patients who are "transiently at risk."

"After a heart attack, those first six months we know you're at risk [for an SCA], particularly the first month," he says. "It might be appropriate to have [a device like] that, and not have them saddled with an implant their whole lives when the risk decreases."

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