GLYSENS, INC. — Department of Health and Human Services SBIR Phase II: DESCRIPTION (provided by applicant): Diabetes is a major healthcare problem that is reachi

GLYSENS, INC. — SBIR Phase II award from Department of Health and Human Services.

Amount
$1,992,819
Agency
Department of Health and Human Services · National Institutes of Health
Program / Phase
SBIR · Phase II
Solicitation
PA13-088
NAICS
Place of performance
CA
Period

Description

DESCRIPTION (provided by applicant): Diabetes is a major healthcare problem that is reaching crisis proportions, and new therapies are urgently needed. We have developed a long term, fully self-contained glucose monitoring sensor with battery-operated telemetry for implantation in subcutaneous tissues. The sensor would have unique applications in type 1 diabetes for hypoglycemia warning, insulin dosing, and control of the artificial pancreas. The sensor may also have application for glucose monitoring in type 2 diabetes, caloric and activity management in obesity, and prevention of type 2 diabetes in susceptible individuals. Development of this long term implantable glucose sensor has been underway for several years. Following extensive preclinical validations in the first phase of this project, including operation in animal implants of up to 520 days, in a second phase we demonstrated operation in a 6-month, FDA-cleared, first-in-human clinical trial. In this clinical trial, sensor/telemetry unis implan