LONGMONT — For years, Dr. Norman Paradis knew he was onto to something hot by creating a new medical device to induce mild hypothermia in heart patients.
But getting government grants to research such a device turned out to be a tough sell for the medical director of the emergency department at the University of Colorado Health Sciences Center in Denver.
“Cancer researchers can bring patients with them,” he said. “But when we would go to Congress to get funding, we couldn’t do that. They’re all in the graveyard. ... The number of people dying every day (in the U.S.) from cardiac arrest is the equivalent of three jumbo jets full of people crashing with no survivors.”
Unlike a heart attack, which blocks an artery and produces symptoms as the heart muscle dies, cardiac arrest typically gives no warning and is usually fatal for the way it throws the heart into a wildly inefficient rhythm that fails to deliver oxygenated blood.
Ultimately, Paradis privately funded research and development to produce Arctic Sun — a patented cooling device that uses a pump and chiller about the size of a dorm-room refrigerator along with pads that stick directly on the skin like a clammy wet swimming suit.
The venture began in 1998, when Paradis gave seed money to Robert Kline — then the director of business development at Valleylab, a Pfizer division, in Boulder — to launch a medical device company named Medivance.
It relocated from the Colorado Tech Center to a sharp-looking office in Louisville in April and now employs 25 people and contracts 10 more. But in the early days, Kline was on his own, though president and CEO.
“It was really strange because I came from this big job in a big company and you’re busy all the time. And then you’re put into this position where things only happen if you make them happen,” he said.
“It” in this case meant developing a safe, conve-nient and efficient system to cool both cardiac arrest and heart attack patients to as low as 92 degrees Fahrenheit for 24 to 72 hours after the incident. Such mild hypothermia can halt residual tissue damage to decrease mortality and increase function in survivors.
“Hypothermia for the treatment of brain injury is understood by regular people, with all the stories of kids (surviving) falling into cold lakes,” Paradis said. “But the Ph.D.s and medical doctors don’t understand it at a molecular level.”
They still don’t know why relatively chilly core body temperatures slow the biological cascade of death. But if someone could convert the old-fashioned methods of water blankets, rubbing alcohol, fans and ice packs into a more precise application, it could make a big difference in outcome — not only for heart patients, but those suffering from stroke, head trauma and dangerously high fever, he said.
To understand the wish list of clinicians, Kline, now 47, hit the road his first nine months to interview cardiologists, neurologists and nurses across the country and in Canada.
“You have to keep an open mind to what your clinicians are telling you,” he said. “That means you have to change everything and solve problems you didn’t count on having to solve.”
Two months after he first dropped the information dragnet, a former colleague at Valleylab, Gary A. Carson, 50, joined him as vice president and the engineer responsible for engineering Arctic Sun.
Once he designed the pads, Carson ran through 50 vendors before finding someone who could make them, he said.
Like a mouse pad, the Arctic Sun pads easily conform to the recommended 40 percent of body surface area to cool the body efficiently. A hydrogel causes them to stick to the chest, back and legs. But the sticky gel does not leave any residue on the skin when removed, nor does it yank out hair.
The miniature labyrinth of waterways within the pads make the 100 percent contact with skin efficient, as hoses hooked to the Arctic Sun machine take up precisely cooled water. The patented device also resists leaking — even when cut across the middle. And it remains easy to use.
“Right out of the box, anyone can see how to set it up,” Paradis said.
This convenience differentiates it considerably from conventional hospital setting devices such as the bypass machine used in surgery to cool blood outside the body before recirculating it or the catheter device, which staff can put into the femoral artery at the groin and snake up the heart to cool blood there.
The first version of Arctic Sun launched in 2002 and used the pad system to heat patients coming out of surgery. Medivance sold the warming part of the business to Kimberly Clark for $17 million a year ago, Kline said, to focus on Arctic Sun’s cooling potential — something he hopes will change recovery statistics if installed in both emergency rooms and ambulances.
This Food and Drug Administration-approved cooling aspect of Arctic Sun debuted in 2003. The first Arctic Sun patient at University Hospital, a man in his 20s who had attempted to commit suicide by asphyxiation, died.
But the second patient, 52-year-old Darrell Griffin, survived and recovered completely after having a cardiac arrest while removing carpet at a friend’s apartment and being without oxygen for at least 12 minutes.
“When my colleague called to say he was waking up, I was speechless,” Paradis said.
Despite the lifesaving potential, he said, attracting investors initially proved challenging because no one else seemed to be tackling temperature regulation as a new medical device, much less along the Front Range.
“My colleagues out in New York, they think I’m out here with a bunch of cowboys,” he said. “It isn’t that way. It’s a very vibrant biotech place. There are a lot of people trying to solve the hardest problems here, and there are not many niches left in biotech this big.”