Sabine Vollmer, Staff Writer
Play-Doh doesn't usually figure into conversations with biochemists and cardiologists, but at InnerPulse the substance is crucial to understanding how the company came to be.
The small company in Research Triangle Park is getting ready to test in people a new kind of defibrillator. This one is skinny and easier to implant, less likely to cause infections and much more comfortable for patients than the older, round defibrillators now on the market.
It owes its form to a Play-Doh snake, but more on that later.
"When I saw this, I said, 'Holy smokes,' " said Dan Pelak, who signed on as InnerPulse's chief executive last year.
Pelak is a former executive at Medtronic, a medical device powerhouse in Minneapolis, and the former chief executive of Closure Medical in Raleigh. He took the job at InnerPulse one month after health-care giant Johnson & Johnson bought Closure for $370 million.
Pelak isn't the only one dazzled by InnerPulse's potential.
The company has attracted $35 million in investments since its inception three years ago, and it is in the final stages of raising an additional $50 million.
Among its investors are Johnson & Johnson, West Coast venture capital firms and Boston Scientific, a rival maker of defibrillator implants.
Implantable defibrillators generate about $5.9 billion in annual sales, according to JP Morgan investment bankers. The market is tightly controlled by three large companies: Medtronic, St. Jude Medical and Boston Scientific.
Product recalls have hurt sales of implantable electronic devices that regulate heart rhythms. But demand has bounced back.
Morgan Stanley investment bankers project that new research about the device's benefits and the number of aging baby boomers will boost the market to about $20 billion over the next six years.
That amount of sales potential is one reason InnerPulse has received so much funding for a small startup. Company executives project that their defibrillator will prevent about 25 percent of sudden cardiac arrests. About 450,000 Americans, or about half of those who die from heart disease every year, suffer sudden cardiac arrest.
Defibrillators are designed to jolt a malfunctioning heart back into a rhythmic beat, but many people don't get them because the current ones, shaped like hockey pucks, are uncomfortable and require surgery and anesthesia to implant them under the skin below the shoulder. The process requires surgery with anesthesia.
InnerPulse co-founders Dr. Richard Stack, a cardiologist and professor emeritus at Duke University, and Bill Starling came up with the idea of implanting defibrillators through a large blood vessel in the groin.
Insertion procedureThe procedure could be performed in 10 minutes by specialists who use the same point of entry to insert stents that keep arteries from clogging and balloon catheters that clean clogged arteries.
Stack told Terry Ransbury, a biochemical engineer, about his idea in 2003.
The way Ransbury saw it, the challenge was to change the form. Goodbye, hockey puck.
To solve the problem, Ransbury bought Play-Doh, formed a hockey puck and then rolled it into a snake the thickness of a pencil. But to find room for all the batteries, microchips and capacitors would have required a snake several feet in length -- too long to fit into the human body. So, Ransbury started calculating.
The next day, after about two hours of sleep, he met Stack for lunch at the Palio restaurant in Chapel Hill and placed a foot-long Play-Doh snake on the table.
All of the electronic components would have to be redesigned and built to order. But the reshaped defibrillator would be much easier to implant and couldn't be felt by patients.
"We're going to have a very simple device," Pelak said. "Our goal is to open the technology. Access to the device is key."
Not long after the Palio meeting, a company was founded and work started on making the implant a reality.
Next testSo far, they know the implant works in pigs and dogs, Pelak said. The $50 million will fund human studies that are expected to start next year in Europe.
If everything goes according to plan, the implant could come to market in the United States in 2010 and would cost no more than its round competitors. To have a defibrillator implanted costs about $20,000, but the procedure is covered by insurance.
The InnerPulse defibrillators that will be implanted in the European tests will be made in the same building where the company has its headquarters. Construction workers are preparing about 7,000 square feet of manufacturing space. By the time the trials begin, Pelak said, InnerPulse will employ about 50. The company's work force has already more than doubled to 32 since he joined it 16 months ago.
And that Play-Doh snake might lead to other devices, too. Innerpulse is also working on a snake-like pacemaker, which would give a boost to hearts that beat too slowly.
"We've advanced so much," said Stack. "It's amazing what challenges they've been able to overcome."
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