510(k) for Finesse Insulin Patch-Pen

Calibra Medical announced that the U.S. Food and Drug Administration (FDA) has cleared Finesse, the company’s insulin patch-pen. Finesse represents a new category of simple mechanical devices intended to make insulin therapy adherence easier for patients to achieve at an affordable price point. 93% of type 1 and type 2 diabetes patients on insulin in the U.S. and E.U., estimated at over 10 million patients, use syringes and pens and are challenged to overcome the difficulty, and often the social stigma, associated with delivering bolus, or mealtime, insulin. Calibra’s Finesse is the first of several non-electronic devices under development by the company that simplify mealtime insulin delivery.

About Finesse: A New Way to Deliver Insulin Accurately, Affordably and Discretely
Measuring roughly 2” long, 1” wide and ¼” thick, Finesse is a small plastic device designed to adhere comfortably to a patient’s skin. Finesse is able to hold and deliver prescribed amounts of insulin over multiple days while remaining firmly in place throughout a patient’s daily activities, including showering, exercising and sleeping. Finesse is operated discreetly through a patient’s clothing and is designed to quickly deliver many common dose amounts.

“Finesse combines the fast, discreet, needle-free features of wearable insulin pumps with the non-electronic simplicity, safety and affordability of insulin pens,” says Calibra’s Chairman and CEO, Jeffrey Purvin. “Most syringe and pen users wish their insulin delivery devices didn’t require so many daily needle sticks and were faster and easier to use. Finesse addresses each of those desires.”

The company has already initiated a clinical trial involving 6 major sites in the U.S.

“The Finesse insulin delivery patch device is so flat and unobtrusive that it's easily worn under almost any clothing and insulin can be discreetly dosed any time,” says Nancy Bohannon, M.D., an Endocrinologist from San Francisco, CA. “Because of this, people will find that delivering multiple doses of insulin every day is far easier than before, which means less disruption of their lives and increased potential for better control.”