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
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