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a piece of plaque buildup breaks off from a blood vessel wall, and causes a blockage that cuts off oxygen to the brain. Those patients get clot-busting drugs like t-PA as well, but they need to get the drug in a matter of a few hours to restore blood flow to the brain. Clot-busters have traditionally been avoided in hemorrhagic patients, Newell says, because of the fear it would accelerate the dangerous bleeding. A new school of thought has emerged which says that hemorrhagic patients can become stable enough after a few days to actually benefit from the clot-buster, Newell says.
So here’s what Newell did in his clinical trial at Swedish. A total of nine patients agreed to have the experimental procedure done. They had a burr hole drilled in their skull, and doctors used a GPS-style system to precisely locate the best place to thread the probes into the brain’s blood clot. Then they combined an early-generation model of a thin Ekos ultrasound-emitting catheter alongside another catheter that was supposed to drain the blood. The ultrasound waves did their thing, while the patient received a steady dose of t-PA clot-buster for 24 hours.
The results were striking. Eight of the nine patients were alive after 30 days, even though the death rate for people with their prognosis is around 50 percent, Newell says. Importantly, there were no cases of increased bleeding episodes, no treatment-related deaths, and no infections that can sometimes crop up with invasive procedures. The ultrasound appeared to make the t-PA work in one day, instead of two or three days that doctors might expect when the clot-buster is given alone, Newell says. CT image scans showed that patients with intracerebral hemorrhages had their clots shrink by 59 percent, while those with a different form of hemorrhage saw 45 percent shrinkage. Seven of the nine patients reported improvements in quality of life, as measured by the National Institutes of Health Stroke Score.
One individual, Port of Seattle police officer Ray Blackwell, recovered well enough to go back to work after getting this treatment. It’s an anecdote that Gov. Chris Gregoire has started talking about publicly when she tries to persuade citizens and lawmakers to support her Life Sciences Discovery Fund.
Of course, Newell is the first to admit it is way too early to start talking about miracle cures. This study enrolled a small number of patients, was primarily designed to assess safety, and didn’t have a control group to see if the Ekos treatment is truly any better than t-PA on its own.
That’s where the next steps get interesting. Bob Hubert, the CEO of Ekos, told me he’s in active talks with big corporate partners who have the resources to run the rigorous kind of trials that could prove this idea works, and lay the groundwork for FDA approval. Ekos’ R&D team is working to develop a new ultrasound probe that incorporates some of its latest technology, and shortens the probe so it’s designed to work in the short anatomical distance the probe needs to travel in the brain—as opposed to the longer probes that Ekos currently makes to travel in leg arteries.
There’s no lack of interest among partners, Hubert says. Hemorrhagic stroke has all the hallmarks of a lucrative medical device opportunity—a big patient population that’s terminally ill, with no other legitimate treatment options, and no real competition in clinical trials. Ekos figures about three-fourths of all hemorrhagic stroke patients in the U.S., Europe, and Japan—150,000 people each year—could be candidates for this kind of therapy. At $6,000 to $10,000 per patient for the ultrasound procedure, sales could add up in a hurry. (Hubert didn’t offer a market size figure, but my math says if you assume Ekos captures 10 percent of the patients Ekos says are out there, and sets a price in the middle of this range, it would generate $120 million a year in annual sales).
All those business calculations are probably years away from becoming reality, if ever. A rigorous clinical trial that’s designed to compare how well patients perform after the treatment is the next step, Newell says. He sounds very hopeful that trial will get done, and deliver a promising answer.
“If this approach is successful, it will have worldwide impact,” Newell says.