Asante Solutions Receives FDA Clearance for Pearlâ„¢ Insulin Pump

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Asante Solutions Receives FDA Clearance for Pearlâ„¢ Insulin Pump

The small and sleek Pearl is the only pump that uses a pre-filled 300-unit insulin cartridge. That’s right . . . no more reservoir filling. No need to handle syringes to fill our pump. No battling pesky air bubbles from filling reservoirs. It’s a simple yet elegant pump solution – Asante Solutions.

SUNNYVALE, Calif., May 17, 2011 – Asante Solutions, Inc. (Asante), a medical device

company focused on diabetes care, announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the company’s Pearl Insulin Pump. Last month, the Pearl also received the CE Mark, a European proof of conformity that certifies the product meets EU safety, health and environmental requirements.

“We are pleased to accomplish these important regulatory milestones, and we are particularly proud to be the first fully-programmable insulin pump cleared under the FDA’s new more comprehensive and stringent infusion pump guidelines,†said Phil Hopper, Asante’s CEO and president. “These milestones validate our sensible approach to solving some of the fundamental challenges faced by more than 500,000 people worldwide who use an insulin pump or are considering insulin pump therapy. These clearances now allow us to focus on establishing the capabilities necessary to provideworld class operations and customer service as the product becomes available.â€â€œThe Pearl Insulin Pump’s utilization of a pre-filled insulin cartridge is an evolutionary step forward for those on intensive insulin therapy,†said Chamberlain, MD,medical director for Diabetes Services at St. Mark’s Hospital and St. Mark’s Diabetes Center.

“The fact that the Pearl minimizes all the ‘plumbing’ issues associated with reservoir filling in other insulin pumps makes it an attractive choice as a starter pump forthose initiating insulin pump therapy as well as for those seeking greater ease of use. The Pearl is designed to reduce steps, add convenience, and save time.â€About the Pearl Insulin PumpThe Pearl Insulin Pump’s many user-friendly features are designed to make the Pearl an easy to use system for those on intensive insulin therapy. The pump features a unique modular product configuration that allows significantly lower pump therapy initiation costs through pay-as-you-pump pricing. It is the only insulin pump using glass pre-filled 300 unit insulin cartridges for use in pumps for up to seven days. More product details will be available in the near future at http://www.asantesolutions.com/. About Asante Solutions, Inc.Based in the heart of Silicon Valley, Asante Solutions, Inc. is a privately-held medical device company developing simple solutions for diabetes.http://www.asantesolutions.com/

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