Calibra Medical Inc. Receives 510(k) Clearance for the Finesse Insulin Patch-Pen, a Novel Way to Deliver Insulin
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Calibra Medical announced today 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,” said 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,” said 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.”
About Calibra:
Calibra Medical Inc. is a medical device company developing small, simple, cost-effective drug delivery systems. The company’s first product, Finesse, is designed to improve mealtime insulin therapy delivery. Calibra is seeking to improve care for people with diabetes by simplifying insulin delivery, thereby improving patient adherence to their physician’s treatment recommendations.
About Diabetes:
Diabetes is a chronic, life-threatening disease caused by the body’s failure to produce sufficient insulin or to utilize insulin correctly to control blood glucose levels.1 A progressive disease that often can be initially controlled by lifestyle changes and/or oral medications, many diabetic patients ultimately rely on insulin therapies. Insulin is a powerful hormone which requires dosage adjustments based on weight and food intake, among other things.2 Simple, reliable insulin delivery facilitates patient adherence with their doctors prescribed insulin therapy. Proper insulin therapy can reduce complications and hospital visits.3
In the U.S. there are 23.6 million diabetics and 57 million adults who are considered to be pre-diabetic or approaching clinical diabetes status. Among diagnosed diabetics, nearly 30 percent require insulin in some form. Diabetes is increasingly being diagnosed in children and adolescents.4
1 American Diabetes Association http://www.diabetes.org/for-media/2009/even-in-this-economy-2009.html
2 American Diabetes Association http://www.diabetes.org/living-with-diabetes/treatment-and-care/medication/insulin/
3 American Diabetes Association http://www.diabetes.org/living-with-diabetes/treatment-and-care/medication/insulin/insulin-routines.html
4 National Diabetes Educational Program http://www.ndep.nih.gov/diabetes-facts/index.aspx#howmany
Contact:
Calibra Medical Inc. Press, contact Abi Basu, 650-298-4710 V.P. Marketing abasu@calibra.com Investor Relations, contact William Albright, 650-298-4726 Chief Financial Officer walbright@calibra.com