Cambridge Heart (OTC:CAMH) is halting a pilot study and gearing up for a prospective trial to test its MTWA heart-attack test for detecting ischemic events.
The Tewksbury, Mass.-based company’s Microvolt T-Wave Alternans test is currently approved in the U.S. for detecting the risk of heart attack, or arrhythmia, president and CEO Ali Haghighi-Mood told MassDevice. The new trial will investigate whether the test can also predict ischemic events involving restricted blood flow to the heart.
The new trial was prompted by evidence from the pilot study that the MTWA test can not only help predict ischemia but also identify underlying heart disease that other tests miss,
"Our technology is capable of detecting ischemic events which were not detected by other standard modalities," he told us. "Last June, after we accumulated a number of these cases, we thought there was enough evidence to go and start understanding the phenomenon a little better and investigate how to formally start a trial to investigate this new application."
Discovering that evidence wasn’t completely unexpected,
"It was pleasant, but not a surprise. There have been data in the lab setting and animal setting that by inducing ischemia, basically clipping an artery, you could create alternans. The question was how relevant is it to a patient population that’s at risk for an ischemic event and how, in a clinical setting, this can be utilized," he said. "Data that we have today suggest that it can add to what the standard practice is today and uncover cases that have not been detected by other modalities."
The new trial is expected to begin in six to nine months, Haghighi-Mood said. If the new theory proves out, it could expand the patient pool from 10 to 12 million to roughly 40 million, according to a Cambridge Heart spokeswoman. That would be a boon for Cambridge Heart, which has traveled a rocky road lately.
In April, Cambridge Heart warned that it doesn’t have enough cash to stay afloat past the end of the year and registered for a stock offering worth more than $7.8 million. The company plans to sell nearly 30.2 million shares for 26 cents apiece, according to the filing. In June, Cambridge Heart landed a big win when a division of UnitedHealth Group, the largest health insurer in the U.S., made the test a covered benefit for its members.
Last year the Food & Drug Administration cleared an OEM version of the MTWA module. In September, CAMH officials said that it had begun shipping its integrated OEM MTWA module with a non-invasive diagnostic cardiac test designed to detect the risk of sudden heart attack, made by Bothell, Wash.-based Cardiac Science.
Haghighi-Mood said the acquisition of Cardiac Science by India’s Opto Circuits last year threw a temporary wrench into the deal.
"We launched the product in September last year. A few weeks later [Cardiac Science] was bought out," he told us. "The penetration and placement of the product was slower that what we expecteed. Effective in July, we launched a new marketing program. The premise of it is that the product will be included in every Q-Stress that Cardiac Science sells. The intention was to make upfor the lost time and get the program jump-started fast."