Pathway Medical Tool Shows Early Signs of Emerging as “Real Winner”

Xconomy Seattle — 

It’s still early in the ballgame for Pathway Medical Technologies, but the Kirkland, WA-based medical device maker says demand for its first marketed product—a tool for cleaning out clogged leg arteries—is climbing, and it appears to be on its way to becoming a hit.

Pathway is a private company, so chairman Tom Clement doesn’t have to disclose his company’s sales figures, but when pressed, he disclosed quite a bit in an interview about how the company’s Jetstream device is performing in its first few months on the market. Pathway introduced the device to the U.S. market in September, and has sold it to almost 100 physician customers, even while hospital purchasing committee budgets have been tightening up. The machine, at a cost of about $4,000 per patient, has been used on about 500 patients to date, he says.

Sales have been climbing every month, even as the economy has grown progressively worse. The performance has encouraged Pathway to boost its sales force from 23, at the end of the year, to about 35 by the end of this month, giving the company a total staff of 200, Clement says. Pathway is announcing today it started marketing a modified version of the tool, called Jetstream G2, which is supposed to vacuum out all sorts of hard and soft blockages in a slightly more efficient way than the original, Clement says. The company is pushing the newer device in response to demand from doctors, who have put it to the test on patients with much longer and gnarlier leg blockages than the ones in clinical trials. Even so, the device is still doing the job without causing an increase in adverse events, such as the big worry—artery perforations.

“I’m biased, of course, but I think we have a real winner,” Clement says. “We’re set up to do things none of our competitors can do.”

Pathway is trying to capture a growing part of the market for patients with what is known as peripheral artery disease. An estimated 2 million people in the U.S. have sought treatment for fatty blockages in the legs, complaining of pain when they walk.

Pathway’s device uses a tiny stainless-steel drill mounted on a catheter that snakes inside clogged arteries, where it both cuts up and vacuums out fatty buildups. It has shown in clinical trials that it has “differential cutting” ability, meaning it can slice through squishy clots known as thrombus just as easily as rock-hard calcium deposits—and the stuff that’s in-between.

The 172 patients in the company’s clinical trials typically had minor blockages, about 4 centimeters long.But now, in commercial use, physicians are pushing the envelope, using the Jetstream on patients with more severe disease, usually 10 centimeters or more, and sometimes on horrific blockages that can run most of the length of a thigh, or as much as 57 centimeters long, Clement says.

This is one way that Pathway hopes its tool will stand out versus the competition, Clement says. Plymouth, MN-based ev3 (NASDAQ: EVVV) markets tools known as the SilverHawk and the RockHawk, which work by slicing through and scraping out blockages in the legs. Colorado Springs, CO-based Spectranetics uses a laser-based system, while St. Paul, MN-based Cardiovascular Systems Inc. has a high-speed diamond-tipped cutting tool.

Pathway’s device is the only one that offers the vacuuming feature, which is important because it’s faster and easier than other processes that require doctors to manually remove the fatty buildups, Clement says. The Jetstream is also supposed to be more versatile, because it can cut through all forms of blockages, unlike the others, which tend to be good at one kind of blockage, but not all.

Clement wouldn’t reveal his company’s sales goals for 2009, but he said expectations “are more than modest.” Back in July, when the device won approval, Pathway director David Auth said it could “easily top $200 million” a year. Of course, that was before the economy went seriously downhill and hospitals started tightening their budgets for 2009.

Still, Pathway was able to attract Paul Buckman, a veteran of medical device commercial strategy at Boston Scientific and ev3, to be its new CEO back in October. Buckman, in a speech to investors last month in San Francisco, told an anecdote about how one doctor used the Pathway device on a 91-year-old woman. This fragile patient had her leg arteries cleared out in less than an hour, and the doctor said that job previously would have taken seven different devices, 14 onerous insertions of catheters, and $20,000 in equipment.

“We have physicians out there who are trying this on patients with incredibly complex disease,” Clement says. “Our value proposition to them is that we have a single product for a wide variety of states of diseases.”