Navigation Links
Calibra Gains FDA Clearance to Market Finesse™ Insulin Patch-Pen for Three-Day Use With Novolog®
Date:7/26/2010

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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Profil Institute Teams Up With American Diabetes Association to Step Out Against Diabetes
2. DOAR Provides Trial Consulting Services in Victory for 5,600 Women in Gender Discrimination Class Action Trial Against Pharmaceutical Giant
3. Drug in New Class of Targeted Therapies Shows Early Promise Against Blood-Related Cancers
4. Assegai Wins Big Settlement Against ABBOTTs Subsidiary
5. Roche Announces Joint Initiative to Train Healthcare Workers in Africas Fight Against Cancer
6. Catalyst Pharmaceutical Partners Regains Compliance with NASDAQ Minimum Bid Price Rule
7. OnBase Gains Ground as Part of Healthcares Electronic Health Record
8. Whistleblower Kickback Case Against Alpharma Results In $42.5 Million Recovery for U.S. and States
9. Atherotech Recruits Top Experts in Fight Against Heart Disease
10. Adamas Pharmaceuticals TCAD Therapy Demonstrates Broad Spectrum Activity Against Susceptible and Resistant Strains of Influenza in Animal Models
11. Jury Verdict Against Novartis Pharmaceuticals For Retaliating Against Drug Sales Rep Who Took Maternity Leave
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 2016 Dehaier Medical Systems Ltd. (NASDAQ: ... markets and sells medical devices and wearable sleep respiratory ... strategic cooperation agreement with Hongyuan Supply Chain Management Co., ... June 20, 2016, to develop Dehaier,s new Internet medical ... Dehaier will leverage Hongyuan Supply Chain,s sales platform to ...
(Date:6/24/2016)... , June 24, 2016 ... Market by Type (Standard Pen Needles, Safety Pen Needles), ... (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) ... MarketsandMarkets, This report studies the market for the forecast ... to reach USD 2.81 Billion by 2021 from USD ...
(Date:6/24/2016)...  Arkis BioSciences, a leading innovator in the ... cerebrospinal fluid treatments, today announced it has secured ... led by Innova Memphis, followed by Angel Capital ... Arkis, new financing will accelerate the commercialization of ... of its in-licensed Endexo® technology. ...
Breaking Medicine Technology:
(Date:6/25/2016)... , ... June 25, 2016 , ... Conventional wisdom preaches ... success. In terms of the latter, setting the bar too high can result in ... than just slow progress toward their goal. , Research from PsychTests.com ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute ... Dr. Barry M. Weintraub as a prominent plastic surgeon and the network’s newest ... world, and the most handsome men, look naturally attractive. Plastic surgery should be ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) ... held on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, ... dedicated to helping service members that have been wounded in battle and their families. ...
Breaking Medicine News(10 mins):