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minimize the number of false positives, Clement says. That algorithm hasn’t been published in a peer-reviewed journal, and the company has sought to keep that under wraps while it has put together its strategy for intellectual property protection, Clement says.
Since Holter devices have been around for a long time, and the FDA knows them well, Cardiac Insight is seeking to go through the 510k regulatory pathway, which is supposed to allow for quicker and easier market approval of devices that are basic iterations on existing technologies. The company is looking to file a couple of applications to the FDA, for the hardware and software in its device, starting in the first quarter of 2012, Clement says. Being optimistic, he says he’s hoping the company can get FDA clearance to start selling the product in the second quarter of 2012.
Cardiac Insight has been operating as a virtual company with a core group of five contractors, and will continue to do so with the new financing, Clement says. Over time, the company will look to run clinical trials of its own to see how well it performs at picking up afib in various kinds of patients, over different periods of time. The company has gotten a $150,000 award from the state Life Sciences Discovery Fund, which it plans to use to help gather that kind of data for doctors, Clement says.
If all goes according to plan, Cardiac Insight should be able to get low-cost parts for its device that would make it feasible to reach millions of patients with high-blood pressure and a family risk of heart disease, Clement says. It’s possible someday that a primary care physician, not necessarily a cardiologist or neuroradiologist, could prescribe this as a seven-day patch, and then get data that tells whether something’s wrong.
While insurers may want a low-cost device, that’s often not what VCs are looking for. And it’s possible Cardiac Insight will be able to bring its device to large numbers of patients without VCs. So far, the company has raised its money from the Wings angel network and other angels, along with the state Life Sciences Discovery Fund grant. It’s possible that “this could be a $2 million-in-and-$20 million-out kind of deal,” Clement says. That’s quite different from his last company, Pathway Medical, which took 10 years to develop an FDA-approved product, raised more than $130 million in investment capital, and was acquired in August for $125 million.
This time, Clement is taking a different tack.
“I really enjoy important new technologies, and I judge this to be an important new technology,” Clement says. “It’s a different model than anything I’ve used in the past. Most things have required a lot of money, long clinical trials, and long regulatory paths. This has appearance of something that could be a good product to get out with low dollars.”
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