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 amplified by an Ekos probe that emits ultrasound waves to help dissolve the clot faster. The goal is to see whether this technique can help, after 24 hours, to reduce strain on the right side of the heart that comes from the clot. The study will follow patients’ progress for 90 days, and it will include a standard 6-minute walk test to see if patients are in any better cardiovascular shape at that point, Hubert says.
Of course, the study will measure safety, and count how many people die. This is certainly a risky population, since more than one-fifth (22 percent) of these patients are expected to die within 90 days, Hubert says. The Ekos study isn’t designed to show in a statistically significant way that it can help improve survival rates. Results should be available by about mid-2011, Hubert says.
If Ekos is successful in this study, it could be the first step toward entering a promising new market. The trial, known as Ultima, is thought be the first-ever randomized clinical trial for this patient population, who have no other real treatment options beyond blood thinners, Hubert says. He’s careful to point out, however, that this isn’t for everybody. Some patients get what are known as “massive” pulmonary embolisms, like former NBC reporter David Bloom, who died while on assignment in Iraq in 2003 from the kind of clot that typically kills people before they can even get to a hospital, Hubert says.
But what Ekos didn’t realize is that less deadly, “sub-massive” pulmonary embolisms are a big market in their own right, making up about 40 percent of the cases, Hubert says.
“We think we could have the first and only device in combination for therapy for patients with this disease,” Hubert says.
This trial, on its own, isn’t likely to create enough evidence to secure approval from the FDA to market the Ekos device for the new use beyond deep vein thrombosis in the U.S., Hubert says. But it could form the basis for further study. And while it’s against the law for companies to promote medical products for uses that aren’t approved as safe and effective by the FDA, this is the kind of evidence that could sway doctors to start prescribing the product based on their own judgment.
Ekos is careful in stating that it doesn’t want to encourage doctors to prescribe its system for unapproved uses, but it’s certainly aware that doctors may choose to go that route, with or without FDA approval. The Ekos system is now installed at 350 medical institutions, Hubert says. “If they can see there’s a better way to treat patients, they’ll order it,” Hubert says.
How does this affect the future of the company? It sounds like a classic swing for the fence. The company is already on track to break even by the end of 2010 on the deep vein thrombosis application alone. So if it has success with pulmonary embolisms, and a third application in patients with hemorrhagic strokes, those represent new opportunities for growth. The Ekos system, which is marketed as a disposable ultrasound catheter, costs $2,700 per patient.
While the initial application “hasn’t been picked up as fast as we thought,” for patients with deep vein thrombosis, Hubert says he’s confident in the new application because doctors consider pulmonary embolisms so serious that they can’t be ignored, or at least they are worth aggressive (and expensive) treatment.
“We’re not banking on [pulmonary embolism], but I think it will be enormous,” Hubert says.
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