A Massachusetts start-up hopes its "smart band-aid" could help save people from a deadly heart condition that kills almost without warning.

Based in Melrose, Mass., OmniMedics, a two-year-old company founded by Cornell engineers, hopes their tiny alert system, called the HeartStrip, could help save some of the approximately 1,000 Americans who die each day from sudden cardiac arrest (SCA).

"SCA is the biggest killer that most people have never heard about and is the single, most common cause of death in the U.S. and other industrialized nations," Ron Greene, CEO of OmniMedics tells DOTmed News.

"Most people don't understand SCA," he continues. "A massive heart attack is different. A massive heart attack is basically a clotting of the valve of the heart. But an SCA is an electrical malfunction of the heart."

This malfunction puts at risk the almost 5 million Americans afflicted with congestive heart failure.

Tragically, SCA is nearly always fatal. According to Greene, only about five percent of people who experience an SCA are revived. But OmniMedics thinks, with its device, the number could reach more than 70 percent.

Minutes matter

The one thing victims of SCA need is time. "Survival decreases by 10 percent per minute in cardiac arrest," Douglas Zipes, M.D., a cardiologist and spokesman for the American College of Cardiology, tells DOTmed News.

Thus, people laid low by an SCA are generally thought to have a five to 10 minute survival window in which to be revived by receiving an electric jolt from an external defibrillator.

But the catch is that the first really noticeable symptom of SCA, loss of consciousness, can be ambiguous, even for people who know the victim is at risk for the attack. And this, Greene thinks, is where HeartStrip comes in.

How HeartStrip works

HeartStrip is, in essence, a warning system. About the size of a band-aid, it adheres to the skin on the chest, and listens for the heart rhythm irregularities that signal SCA.

Once it detects arrhythmia, HeartStrip wirelessly triggers an audible alarm in the home that would alert anyone nearby that the patient is having an SCA. Meanwhile, it would call chosen neighbors, paramedics and the police by phone.

The hope is that with this instant, clear response, neighbors, spouses or first responders would be able to reach the patient in time to save them with the use of an external defibrillator.

"We're not competing with [external] defibrillators. We're working in conjunction with them, and complementing defibrillators," Greene says. "If we were to place or sell our HeartStrip system, we would also see that an external defibrillator was placed as part of the system."

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."

"I think it'll find a niche," he adds.