Inventor taps medical market

Lawrence resident's company wins FDA approval for heart device

Lawrence engineer and inventor John Neet is a co-founder of a start-up company looking to tap into a $1 billion market, but he’ll tell you dollar signs aren’t the primary way he’ll measure his success.

He’ll measure it in lives changed.

JOHN NEET, Lawrence, is an executive vice president for IntraLuminal, a California company that has developed a new system aimed at cutting down the number of heart-bypass surgeries. Neet is a co-inventor of the new device.

Neet is executive vice president and chief technology officer for Carlsbad, Calif.-based IntraLuminal Inc. He and his company are poised to become a major player in how heart doctors treat their patients.

The company last week received Federal Drug Administration clearance to begin selling its product, Safe-Steer Guide Wire System, to U.S. doctors who will use the device to better clear arteries to the heart that are completely blocked.

The device, which Neet began developing with a Kansas City area surgeon in 1990, is grabbing the attention of the technology world. It already has attracted more than $20 million in funding.

“We think it can be wildly successful,” Neet said. “If it gets to the level we think it can, every major hospital would have one of these devices,” Neet said. “Not only every major hospital in the United States, but really in the modern world.”

Neet declined to say what type of profits that level of success could reap for the company, other than to say “multiple millions.” But he said he already may be reaping the biggest benefits from the company now, even though the business is still operating in the red.

“I have gotten to travel around the world hearing stories from people about how our product made their lives significantly better,” Neet said. “It’s hard to beat that type of gratification.

“Don’t get me wrong, it will be great to have a successful company emerge out of our efforts, but I think the biggest benefit is seeing how you can improve someone’s life.”

Showing a path

One of the ways IntraLuminal’s product improves lives is by decreasing the chances a heart patient will need open heart bypass surgery. The device focuses on helping doctors clear arteries that are “totally occluded,” meaning virtually no blood is able to travel through the plaque that has built up in the artery.

IntraLuminal’s product is similar to angioplasty devices that use a wire and balloon that is inserted into the patient’s artery through a vein, usually in the leg. Angioplasty devices are widely used to clear arteries that are not completely clogged but they only are used about 12 percent of the time on totally occluded arteries.

Neet said that’s because when an artery is totally blocked, current X-ray equipment is unable to give doctors a picture of the path the wire needs to take to clear the artery. Without a good picture the chances increase that the doctor may cut the artery wall, which can lead to serious complications.

IntraLuminal adds a new twist to the equation. Instead of being just a regular guide wire, its wire has a fiber-optic beam at its end, which sends back signals to a specialized computer monitor that gives doctors a picture of the path they need to take even when the artery is completely clogged.

“What we realized is that doctors really don’t have the tools to open up most totally occluded arteries,” Neet said. “That’s what this company is about. It is about building the tools doctors need.”

The hope is the product will allow many more patients to have clogged arteries cleared using the less-intrusive angioplasty method rather than open heart surgery, or medication, which many times doesn’t completely clear the artery.

Neet said company officials believe the product may allow up to 70 percent of all completely clogged arteries to be treated without open heart bypass surgery.

“We figure lots of people are going to be interested in it because if you can choose a method to address your problem that may allow you to go home the next day versus having your chest split wide open, we believe most people are going to choose the less intrusive method,” Neet said.

‘A milestone’

Only a select few have benefited from the product thus far. The company has conducted clinical trials on 107 U.S. patients as part of its process to be cleared by the FDA.

FDA officials last week gave the company a green light to begin selling its product in the country.

“It’s a very important milestone,” Neet said. “It feels good to be able to start selling something, but we still have a lot of work to do, but it feels real good to get a revenue stream coming into the company instead of just relying on investors.”

The FDA clearance also is a culmination of sorts for Neet, who has been working on the project since the very beginning. The company was officially formed in 1997, but Neet began working on the idea with Kansas City surgeon Tom Winston in 1990.

“He had an idea for the device, but he needed technical support on how to do that, and that’s where I came in,” said Neet, who is a metallurgical engineer by trade.

In his West Lawrence home, Neet has framed on his wall 18 patents that he and Winston have developed since 1990 for the medical device. More are on the way for the next generation of the current product.

For now, Nees said the company must focus on educating both doctors and patients about the new technology, and likely in the next few years will have to align itself with a major medical device company to penetrate markets across the world.

But Neet figures the company already is doing better than most.

“You always have to have the vision that you are going to succeed, but it is pretty well established that only about one in 10 start-up medical device companies are going to make it,” Neet said.

Moving on

IntraLuminal is making it, but it’s not doing so in the Lawrence or Kansas City market, where it began. Neet and three other employees work out of a small research office in Kansas City, Kan., but the firms other 40 employees are based in Carlsbad, Calif.

Neet said he doesn’t expect the company to ever significantly increase its work force in the Kansas City area, and said the firm’s experience is probably a good example of why it can be difficult to establish a high-tech company in the area.

“In 1998 we moved the company to Carlsbad because we really needed to hire medical device engineers and regulatory people,” Neet said. “The labor market is just so much more conducive to that out there.”

Money also was a factor. Neet said the company knew it would have an easier time raising venture capital on the coast than in the Midwest.

But none of that means the Kansas City and Lawrence area can’t reach some of its goals of building a high-tech economy, with a particular emphasis on companies in the life sciences industry.

“To me success breeds success,” Neet said. “If this area can just experience some success stories with the start-up companies that are here, then people will start to migrate here.

“Venture capitalists like to invest in companies that have managers who have had success before. So if we can get some success stories, then the money will find its way here.”