(Scanned from the Applicant?s Abstract): The goal of this proposal over Phase I and II SBIR studies and subsequent full scale development is to commercialize a noninvasive insulin infusion system that is painless, convenient, discrete, safe, efficacious and cost-effective. Such a system will bridge the gap between the tight glucose control currently recommended by the American Diabetes Association and the convenience and quality of life desired by persons with diabetes. This system will be based on a proprietary thermal microporation technology which eliminates the barrier function of the stratum corneum to percutaneous infusion. We hypothesize that a thermal microporation based infusion system can controllably deliver insulin over an extended period of time in a manner similar to insulin pumps available on the market today. Phase I efforts demonstrated the feasibility of an insulin infusion system which combines the thermal microporation method with iontophoresis. Phase II efforts will focus on patch design and insulin formulation to optimize the product as well as evaluating the capabilities, repeatability and controllability of a MicroPor(TM)-based insulin infusion system.

Proposed Commercial Applications

The goal is the development of a cost effective, needle-free, personal insulin infusion system. The entire system could be made to be worn like a pager electrically connected to a disposable infusion patch. Alternately, a small hand held unit could be briefly connected to an infusion patch to create the thermal micropores once every twenty-four hours, and then a small processor in the patch could control the insulin delevery profile.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DK057381-02
Application #
6443568
Study Section
Special Emphasis Panel (ZRG1-SSS-T (10))
Program Officer
Arreaza-Rubin, Guillermo
Project Start
1999-09-01
Project End
2004-08-31
Budget Start
2002-09-01
Budget End
2003-08-31
Support Year
2
Fiscal Year
2002
Total Cost
$391,878
Indirect Cost
Name
Altea Therapeutics Corporation
Department
Type
DUNS #
134092803
City
Atlanta
State
GA
Country
United States
Zip Code
30313