Calibra Gains FDA Clearance to Market Finesse™ Insulin Patch-Pen for Three-Day Use With Novolog®

REDWOOD CITY, Calif., July 26 /PRNewswire/ -- Calibra Medical announced today it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Finesse™ insulin patch-pen for up to three-day use with Novo Nordisk's Novolog® rapid acting insulin. Combining the mealtime therapy-adherence benefits of insulin pumps with the simplicity and affordability of syringes and pens, Calibra's novel bolus-only patch-pen is a small, adhesively attached, flat device that can be operated discretely through clothing to deliver mealtime, snack time, and correction bolus insulin in seconds.

Designed so people with diabetes can avoid the inconvenience and the occasional social challenges of daily mealtime injections with needles, Finesse represents a new category of simple mechanical devices making insulin therapy adherence easier to achieve at an affordable price.

In January, Calibra Medical received FDA clearance for the device for use with Eli Lilly's Humalog® rapid acting insulin. The company is pursuing marketing clearance for Finesse to deliver other manufacturers' insulin and diabetes drugs, and is planning to develop next-generation models, including devices pre-filled with insulin.

"With this device people will find daily self-administration of multiple doses of insulin is far easier, with less disruption and increased potential for better diabetes control," said Nancy J. V. Bohannon, M.D., a practicing endocrinologist and Director of Clinical Research at the Cardiovascular Risk Reduction Program, St. Luke's Hospital, San Francisco. Dr. Bohannon was the principal investigator for the recently completed feasibility clinical trial of the Finesse patch-pen at five leading diabetes clinics in the country.

Diabetes is a chronic, life-threatening disease caused by the body's failure to produce sufficient insulin or to utilize it correctly to control blood glucose levels. More than 98% of the 30 million people in the world who self-administer insulin use syringes and pens. However, many are challenged to overcome the difficulties and social stigma associated with delivering mealtime insulin multiple times every day with these devices. As a result, many fail to adhere to their dosing regimen, which can lead to adverse medical complications such as nerve damage, blindness, heart disease and kidney disease.

"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."

Finesse Delivers Insulin Quickly, Accurately, Affordably and Discreetly

Measuring roughly two inches long, one-inch wide and one-quarter inch thick, Finesse is a small, plastic device designed to be worn on the skin like a bandage. Patients fill the device with up to three days of insulin using a standard syringe. Finesse is operated discreetly through a user's clothing by squeezing together two buttons on the device. From start to finish, each dose takes seconds to complete. The device delivers insulin through a tiny, flexible plastic tube painlessly inserted into the skin after the device is filled. Finesse remains securely adhered to the body during typical daily activities such as showering, exercising and sleeping for up to three days.

In order for insulin to have a clinical effect, it must be administered in the amounts and at the times prescribed by a physician. Patients often find syringes, insulin pens and other insulin delivery devices inconvenient and socially challenging, making it difficult for them to take insulin when they should. In a recent study led by researchers at Loyola University Maryland, 20% of patients with diabetes admitted to regularly skipping doses of insulin, 60% admitted to occasionally skipping doses, and 33% admitted to feeling "dread" before dosing.

About Calibra Medical Inc.

Calibra Medical Inc., based in Redwood City, Calif., is a privately held medical device company developing small, cost-effective drug delivery systems. The company's first product, Finesse, is an insulin patch-pen designed to improve care for people with diabetes by simplifying insulin delivery, thereby improving patient adherence to their physician's treatment recommendations.

Novolog® is a registered trademark of Novo Nordisk. Humolog® is a registered trademark of Eli Lilly and Company.

SOURCE Calibra Medical Inc.