Ekos, Listening to Docs, Takes Ultrasound Clot Buster From the Legs to the Lungs

1/22/10Follow @xconomy

Ekos has been hearing scuttlebutt from doctors over the past few months about a new way of using its ultrasound technology to treat dangerous blood clots in a new organ—the lungs. The company hadn’t seriously considered investing in it, but over the past few months, anecdotes from doctors kept pouring in. So now the Bothell, WA-based company is spending some serious bucks to test this idea, and see if it can generate real medical evidence that it hopes will crack open a lucrative new market.

Regular readers of this space know that Ekos has been around a long time, and it has had its ups and downs with its novel technique for ultrasound-guided therapy. The technology uses a miniature ultrasound probe that slithers inside blood vessels, and gently amplifies the effect of clot-dissolving drugs. The intent is to get rid of clots faster, which ought to help people live healthier lives after they get out of the hospital.

Ekos raised $12.5 million a year ago to commercialize this system for its first big application—blood clots in the legs, known medically as deep vein thrombosis. This is a chronic condition that affects 250,000 people in the U.S. each year, and puts them at risk for clots that break off and create blockages in the lungs. These are serious blockages, known as pulmonary embolisms, that are thought to kill 100,000 people in the U.S. each year, making it the third-leading cause of death in hospitals, according to the National Institutes of Health.

Ekos has had some modest success by trying to convince doctors they need to aggressively treat deep vein thrombosis patients—the company is on track to reach cash-flow break even later this year. But a number of doctors, including Peter Lin of Baylor Medical College in Houston, reported anecdotal success stories that convinced the company it ought to go after sicker patients who have what are known as “sub-massive” pulmonary embolisms that have already gotten to the lungs.

So after going over the anecdotes and doing the market research, Ekos has decided the doctors might be onto something. About 40 percent of all patients with pulmonary embolisms have the “sub-massive” forms, which means they have a one-in-five chance of dying within 90 days, yet they are thought to remain healthy enough for an interventional treatment like catheter-guided ultrasound, says Ekos CEO Bob Hubert.

“Deep-vein thrombosis is not life-threatening, but pulmonary embolisms are life-threatening,” Hubert says. “Deep vein thrombosis reduces quality of life, but we think we’ll get a lot more attention with a [pulmonary embolism] solution. If you have a patient with this, you need to intervene.”

While medical device companies often get flak for running clinical trials that are sketchy at best, Ekos is staking out a plan which could provide some solid medical evidence that says its treatment works.

The plan is to enroll 50 patients with the pulmonary condition who are randomly assigned to get either a standard blood-thinner, or a low-dose of a clot-busting drug that’s being gently … Next Page »

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