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.