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.
