Pathway Medical, With FDA Clearance in Hand, Starts Selling Device for Wiping Out Blockages in Leg Arteries

9/5/08Follow @xconomy

Pathway Medical Technologies is in the marketing game for real now. The Kirkland, WA-based company has started selling its Jetstream device for clearing out fatty blockages in leg arteries, after winning FDA clearance for a modified version of the device, hiring its initial sales team, and stocking up on inventory for what it expects will be an early wave of demand.

We broke the news first here in July when Pathway won FDA clearance for the Jetstream. The company said then it would take some time before it could hit the market because it wanted to go back to the agency with minor modifications that would make the device easier to manufacture, simpler for doctors to use, and, frankly, look snazzier, says Tom Clement, Pathway’s CEO. The FDA said yes to all the tweaks, Pathway hired a sales staff of 18 to fill out its roster of 150 employees, and it stocked up on several months of inventory.

“We’ve been working feverishly,” Clement says. “We see a very, very bright future for this product and the world of endovascular care.”

Pathway’s Jetstream is a tiny stainless-steel drill mounted on a catheter that snakes inside clogged arteries, where it cuts up and vacuums out fatty buildups. The company is pitching it as the first device capable of drilling into and vacuuming out rock-hard calcium deposits in leg arteries, just as easily as its slices through squishier clots and lesions.

The condition, known formally as peripheral artery disease, affects an estimated 8 million to 12 million people in the U.S., although most go undiagnosed. Besides trying to drum up more demand, Pathway will be competing with Plymouth, MN-based ev3 (NASDAQ: EVVV), maker of a device called the SilverHawk, which cuts and scrapes out buildups. Apparently, the competition is well aware of the threat from Jetstream, and sounds worried. Six sales reps from ev3 have quit their jobs there to come work for Pathway, Clement says. Other ev3 reps are being given bonuses to resist the urge to jump ship to come work at Pathway, he says. “People know this device is coming down the pike,” Clement says.

Despite the excitement at Pathway, Clement says the company is trying to be careful not to commit the sin of getting overzealous. Sales reps will initially focus on prestigious medical centers that treat large volumes of patients with leg blockages. The company plans to have a sales rep spend three weeks at each site, training doctors, answering questions, making sure they are comfortable with the product, listening. He wants to juxtapose that approach with plans taken by competitors, whose goals are to “book big orders and move on,” Clement says. “One of the things I’m going to look at is the re-order rate.” He adds, “We want to listen to the physicians. They have tremendous experience in the field, yet no experience yet with our device.”

Physicians here in the U.S. will all need training, and some artful persuasion to overcome skepticism about the drilling approach, known as atherectomy, Clement says. None of them have first-hand experience with the device in clinical trials for leg blockages. Jetstream was cleared by the FDA based on a study of 172 patients in Europe. Pathway’s reps will be sure to fill them in on the data, though. Arteries of patients went from 89 percent blocked on average at the beginning of the study to 39 percent clogged after the Jetstream was used. The arteries apparently stay open, too. After six months of follow-up, only about 14 percent of patients required a second procedure, Clement says, compared with about half of patients after traditional balloon angioplasty.

So far, the early read on demand is strong. The company sent 14 of what it considers the leading physicians specializing in peripheral artery disease in the U.S. on individual tours to meet with the clinical trial investigators in Germany. All 14 of those physicians have expressed interest in securing the first order, Clement says, and the company is now going through the processing of winning over purchasing agents and committees at the hospitals where those doctors work.

One of those 14 doctors is William Gray, director of endovascular services in the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital. “Clinical data suggests that Jetstream is quite effective at debulking and treating vascular disease in the peripheral vasculature,” Gray said in a company statement.

One of the lessons Clement learned from his previous experience as a co-founder of Redmond,WA-based Heart Technology can be seen in today’s game plan at Pathway. He wants to make sure the Jetstream is easy to use. Heart Technology developed the Rotablator, an earlier-generation drill to clear out arteries, which was supplanted by stents in the late 1990s, because it was cumbersome, Clement says. “You had to wheel in an air tank, it had to be charged, a technician had to adjust the speed,” he says.

The Jetstream, by comparison, only takes about an hour to learn how to use. It can be activated and ready to use in a little more than three minutes. It has a simple ergonomic design, Clement says.

Pathway isn’t saying what the device will cost exactly. It will command a higher price than ev3′s SilverHawk, which sells for about $2,600, although exact prices will vary depend on high-volume discounts some hospitals will get, says Pathway marketing head Stephanie Amoss. “We’ve found that customers aren’t price-sensitive,” Clement adds.

The company expects it will raise another round of equity funding to support the Jetstream introduction before it expects to turn cash-flow positive in 18 to 24 months, Clement says. Whether Pathway gets there depends a lot on the future performance of the sales team, but also how shrewd its engineers were over the last several years in anticipating the needs of doctors and patients.

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  • DR U GOVIND

    What is the smallest calibre of artery that the devise has been used for and what are the results. Is there a centre in South Africa that uses your device?