Intuity Medical Receives FDA Clearance to Market POGO® Automatic™ Blood Glucose Monitoring System
POGO is the first glucose meter and multi-test cartridge that combines lancing, sample collection and analysis into easy, one-step testing without the need for separate strips and lancets
Apr 26, 2016, 04:00 ET
SUNNYVALE, Calif., April 26, 2016 /PRNewswire/ -- Intuity Medical, Inc., a privately-held company developing innovative technologies for diabetes management, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the POGO® Automatic™ Blood Glucose Monitoring System. The POGO System is the first blood glucose meter and multi-test cartridge to provide automatic testing with lancing, blood collection and analysis in one easy step. By combining all of the necessary blood glucose testing supplies into a convenient, self-contained 10-test cartridge, POGO provides ease of use and discretion for millions of patients who need to regularly test their blood glucose in the management of their diabetes.
The number of adults with diabetes is a staggering 422 million worldwide, with the disease being the 7th leading cause of death in the U.S. According to the American Diabetes Association, nearly half of the 29 million U.S. patients are not achieving glycemic control in the management of their diabetes. The burdens associated with blood glucose testing are among the reasons for poor glycemic control; for many patients, managing the number of supplies needed to perform glucose testing can be challenging. POGO eliminates the need to carry and use separate test supplies, including a lancing device, lancets and test strips. This means patients can perform a quick and discreet glucose test while on the go.
To perform a test, a patient simply presses the POGO test port, and POGO automatically lances the finger, collects a blood sample and displays a result after a four-second countdown. The meter only requires a tiny blood sample of 0.25 microliters to analyze the glucose value. After all ten tests are complete, the patient disposes of the self-contained cartridge, eliminating the need to handle used test strips or lancets since they remain inside the cartridge. This reduces the biohazards of used lancets and used test strips in public places.
"POGO brings new and unique features to home glucose monitoring," commented Steve Edelman, MD, Clinical Professor of Medicine at the University of San Diego and Founding Director of Taking Control of Your Diabetes (TCOYD). "By reducing the number of steps and supplies needed to test, POGO addresses some of the common barriers to testing and gives patients a new way to test their glucose. As clinicians, making testing more convenient for the patient is essential to their diabetes care."
When combined with Intuity Medical's proprietary Patterns® Diabetes Management application, a secure cloud-based system for managing glucose information, POGO provides both healthcare professionals and patients a comprehensive shared platform to detect and manage important patterns and trends that impact overall glucose control.
"POGO's unique and patented technology has the potential to change the lives of millions of patients who see glucose testing as burdensome. More than half of the 287 patients in our pivotal clinical study reported that they would better adhere to their healthcare professional's recommended testing schedule using POGO as compared to their current meter," commented Emory V. Anderson, President and Chief Executive Officer, Intuity Medical. "With this FDA clearance milestone, the Intuity team will be focused on raising capital and building the company's infrastructure for POGO's commercial launch."
Intuity Medical is focused on providing solutions to lessen the everyday struggles for people living with diabetes. POGO's technology provides patients with easy, one-step glucose testing.
About Intuity Medical
Intuity Medical is committed to simplifying diabetes management by developing proprietary and innovative technologies to address common barriers of glucose testing. Intuity Medical's POGO is the first blood glucose meter and multi-test cartridge designed to automate testing into one easy step, without the need for separate test supplies. POGO's unique integrated design gives patients the flexibility to test as often as recommended by their healthcare professional to help in their daily diabetes management. The Company's current investors are Accuitive Medical Ventures, Emergent Medical Partners, Investor Growth Capital, U.S. Venture Partners, Venrock and Versant Ventures.
For more information about POGO and Intuity Medical, visit www.presspogo.com.
About Intuity Medical's Investors
For more information about Intuity Medical's investors, visit:
Accuitive Medical Ventures www.amvpartners.com
Emergent Medical Partners www.emvllp.com
Investor Growth Capital www.investorgrowthcapital.com
U.S. Venture Partners www.usvp.com
Venrock www.venrock.com
Versant Ventures www.versantventures.com
SOURCE Intuity Medical, Inc.