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have larger gross profit margins, Purvin says.
A lot of engineering, and intellectual property, is packed into a very small “patch” style package, Purvin says. The device is two inches long, one inch wide, and about one-quarter inch thick—it’s a tad bigger than an iPod nano. In that tiny package, Calibra has found a way to sock away three days’ worth of insulin. The device has a cannula, or a little tube on the back, which the patient has to stick into the body to anchor the device in place. It can easily go in around the beltline, like an insulin pump, or some other place on the body, Purvin says.
Once on the body, the patient has to squeeze two buttons on each side simultaneously to deliver a dose of insulin.
There are a couple of things that make this device different, Purvin says. Having a “patch” on the body means patients only have to give themselves one needle stick every three days—instead of one or more every day. They can also dose themselves discreetly, without pulling out needles in front of other people at mealtime. That’s always been one of the selling points of insulin pumps, like those marketed by Bedford, MA-based Insulet (NASDAQ: PODD) or Medtronic (NYSE: MDT).
What’s really different here is that the Calibra machine is made entirely of mechanical parts—unlike standard pumps which have electronics in them that make them bigger, more expensive, and trickier to operate, and which require recharging of batteries, Purvin says.
Going with entirely mechanical parts means the Finesse system can be made cheap enough to compete on price with pre-filled syringes, Purvin says. He wouldn’t say exactly what the device will cost, not yet anyway.
Like Alferness says, getting this far required taking on some serious engineering challenges. Giving patients too much or too little insulin can be a dangerous thing, so those basic mechanical parts had better be smart. Calibra found a way to discreetly alert patients when the device has run out of insulin, by retracting the buttons. And the engineering team found another way for the device to quietly signal to the user when the cannula is clogged up—which happens regularly with insulin pumps.
I didn’t have a lot of time to press Purvin about the body of evidence to support this tool. He did say that it has been tested in a controlled clinical trial of 38 patients, who used the Calibra device for six weeks, and then switched over for another six weeks on conventional pre-filled syringes, or “pens.”
Researchers on the study, including American Diabetes Association president Richard Bergenstal, saw positive results, Purvin says. There was significantly less fluctuation in blood sugar levels for those on the Calibra device, and what Purvin called a “strong directional improvement” in overall blood sugar control. The company also captured quality of life data … Next Page »
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