Calibra Gains FDA Clearance to Market Finesse
Calibra Medical has announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its FinesseTM insulin patch-pen for up to three-day use with Novo Nordisk's Novolog® rapid-acting insulin. This much-anticipated step closer to market release follows the announcement in January that Calibra received FDA clearance for the device for use with Eli Lilly's Humalog® rapid-acting insulin.
Described as a great alternative to expensive insulin pumps and inconvenient syringes, the Finesse is a bolus-only patch-pen. A small, plastic device designed to be worn on the skin like a bandage, it measures roughly two inches long, one inch wide, and one-quarter inch thick. It is entirely mechanical, with no batteries, no electronics, and no separate infusion sets. After it's been filled with up to three days worth of insulin using a standard syringe, it can be used to dose insulin during mealtimes and snack times, or for correction boluses.
The Finesse delivers insulin through a tiny, flexible plastic tube (the cannula) inserted into the skin after the device is filled. The inserter needle for the cannula is 27 gauge, which is fairly large, but Calibra Medical claims that the design is such that it's almost painless. The Finesse remains securely adhered to the body during typical daily activities such as showering, exercising, and sleeping.
The Finesse is operated discreetly through a user's clothing, thereby eliminating the need to carry syringes and insulin or administer shots in public. When it is time to administer insulin, the user simply presses the two buttons on either side of the device at the same time, and the insulin is dispensed in one or two units, depending on the device. Calibra Medical is currently developing devices that can dispense five units, as well as 0.5 units for children. It's a bolus-only device, so users still need shots of long-acting insulin.
"Finesse will be easy for physicians and diabetes educators to explain to patients. Most patients want to eliminate the social embarrassment, elaborate preparation before each dose, and the many daily needle sticks required by syringes and insulin pens," said Jeffrey L. Purvin, Calibra Medical's chairman and CEO. "Like expensive insulin pumps, Finesse provides fast, discreet, needle-free dosing. Yet, it accomplishes this with the simplicity, safety and affordability of syringes or insulin pens."
Calibra Medical has talked with most of the major insurance companies and believes that they'll get coverage for this almost immediately and that it won't be counted as durable medical equipment.
Calibra Medical Inc., based in Redwood City, Calif., is a privately held medical device company developing small, cost-effective drug delivery systems. Finesse is the company's first product.
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