but the benefit over the control group after 36 hours wasn’t statistically significant. That’s at least partly because the sample was so small that it’s difficult to prove the finding wasn’t a fluke. Plus, three patients on the higher dose suffered brain hemorrhages, although none were reported at the lower dose. (ImaRx says the three bleeders also had uncontrolled high blood pressure, which can be a contributing factor.)
Still, the treatment appeared to offer a long-lasting benefit. After 90 days of follow-up from their stroke treatment, about 75 percent of patients on the low dose of the ImaRx therapy had improvement in their disability scores, compared with 36 percent in the control group—a difference that did reach the threshold of statistical significance.
ImaRx, as we described in a company profile last month, suffered through a pair of critical setbacks last year, when news broke about the brain bleeds in the Tucson study, and its one commercial product was forced off the market because it needed to pass stability tests.
Even so, the company’s technology has a decade of research behind it, and some persistent backers in the stroke research community. It is designed to work by using fatty nanospheres which are small enough to penetrate blood clots. Once embedded, they are gently jostled by a low therapeutic dose of ultrasound waves to the brain. These waves are supposed to help the clot gently expand and contract so it dissolves more quickly. If it works too fast, then it could open up the flow of blood too fast and cause hemorrhaging, says CEO Bradford Zakes.
ImaRx had just $2.4 million left in the bank at the end of September, and has cut down to just two employees in an attempt to line up funding to carry its work forward, Zakes said last month. The company is continuing “to evaluate strategic alternatives,” Zakes said in today’s statement.
