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(PODD) Insulet Announces Development Partner for the OmniPod Artificial Pancreas

Company’s Alliance with Algorithm Partner Marks Critical Step Forward in Advanced Diabetes Treatment

BILLERICA, Mass., Feb. 25, 2016  — Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System (OmniPod System), today announced a license agreement and partnership with Mode AGC (Automated Glucose Control LLC), to develop and incorporate the advanced artificial pancreas algorithm created by renowned researchers Francis Doyle PhD, Eyal Dassau PhD, and Howard Zisser MD. This alliance marks a significant step forward in Insulet’s mission to improve the quality of life for individuals with insulin-dependent diabetes. Insulet’s artificial pancreas system will use the innovative and differentiated OmniPod platform, the latest DexCom Continuous Glucose Monitoring (CGM) technology and the algorithm licensed from Mode AGC.

The algorithm was created by Drs. Doyle, Dassau and Zisser during their tenure at the University of California, Santa Barbara, and further developed by Mode AGC, a California-based early-stage medical device company founded by prominent diabetes technology specialist Thomas Peyser PhD and diabetes advocate and entrepreneur Jennifer Schneider MD. Over the last several months, Insulet has worked with Mode AGC and the inventors to optimize the performance of the algorithm for incorporation into a commercial product. Coupled with the unique tubeless OmniPod platform, this system will be poised to deliver not only improved clinical outcomes, but the greatly desired improvement in quality of life for those living with insulin-dependent diabetes.

“Insulet continues to make substantial progress toward incorporating advanced artificial pancreas functionality into the future-generation of OmniPod,” said Patrick Sullivan, Insulet President and Chief Executive Officer. “The additional expertise the algorithm inventors bring to Insulet is exceptional, as is the clinical superiority of the algorithm. We are excited to integrate the algorithm into our OmniPod System and to deliver a seamless user experience.”

Dr. Howard Zisser, Medical Director of Insulet, worked with Professor Doyle and his colleagues for over a decade conducting clinical studies at the Sansum Diabetes Research Institute in Santa Barbara, California, as part of the Juvenile Diabetes Research Foundation (JDRF) Artificial Pancreas Project.

“I have had the privilege of working closely with Frank Doyle and his colleagues for many years,” said Dr. Zisser. “The Doyle Group is unquestionably one of the leading Artificial Pancreas algorithm groups in the world. I look forward to continued collaboration with Frank and Mode AGC on developing Insulet’s OmniPod Artificial Pancreas system.”

Insulet’s clinical feasibility study involving the algorithm and prototype of its future-generation OmniPod is underway. The Company expects to begin on-body clinical trials later this year.

About the OmniPod Insulin Management System:

The OmniPod Insulin Management System is an innovative continuous insulin delivery system that provides all the proven benefits of continuous subcutaneous insulin infusion (CSII) therapy in a way no conventional insulin pump can. The OmniPod System’s innovative design and features allows people living with diabetes to live their life—and manage their diabetes—with unprecedented freedom, comfort, convenience, and ease. The OmniPod System consists of two components: (i) a Pod that stores and delivers insulin; and (ii) a Personal Diabetes Manager (PDM) that wirelessly programs the user’s personalized insulin delivery, calculates suggested doses and insulin on board, and has a convenient, built-in blood glucose meter. The small, light-weight Pod can be worn in multiple locations, including the abdomen, hip, back of upper arm, upper thigh or lower back and, because it is waterproof (IPX8), there is no need to remove when showering, swimming or performing other activities. This means that OmniPod can provide up to three days of non-stop insulin delivery, without the need to disconnect a tube set or manually inject insulin. The Pod and PDM communicate wirelessly to offer precise, personalized and continuous insulin delivery with customizable basal and bolus delivery options, as well as important safety checks. The Pod’s auto-cannula insertion is quick, simple, and virtually pain-free. Users never have to handle a needle.  The user simply pushes a button on the PDM and the Pod’s automated insertion system inserts the cannula beneath the skin and begins delivering insulin according to the user’s programmed basal rate.

The OmniPod System is the world’s first commercially available tubeless insulin delivery system that allows users to live untethered by tubing and without the stress and anxiety of multiple daily injections. By breaking down the barriers to insulin pump therapy, the OmniPod System offers freedom for users to live life on their own terms and with the ease of use they deserve.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes. The OmniPod is a revolutionary and easy-to-use tubeless insulin pump that features just two parts and a fully automated cannula insertion. Insulet’s Drug Delivery Systems business also partners with global pharmaceutical and biotechnology companies to tailor the OmniPod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas. To read inspiring stories of people with diabetes living their lives to the fullest with OmniPod, please visit the Company’s customer blog: http://suited.myomnipod.com. Founded in 2000, Insulet Corporation is based in Billerica, Massachusetts. For more information, please visit: http://www.myomnipod.com.

About Francis Doyle PhD:

Francis J. Doyle, III is Dean of the Harvard John A. Paulson School of Engineering and Applied Sciences. A distinguished scholar in chemical engineering, he previously served as Associate Dean for Research at the University of California, Santa Barbara’s College of Engineering and as Chair of the Department of Chemical Engineering. As a scholar, Professor Doyle applies systems engineering principles to the analysis of regulatory mechanisms in biological systems. In 2012, he was named Santa Barbara’s 2012 “Innovator of the Year” for the worldwide impact of his bioengineering research and development of artificial pancreas technology for treatment of type 1 diabetes. He led the development of process control software for the artificial pancreas system. Professor Doyle was named a Fellow of the American Association for the Advancement of Science (AAAS), the American Institute for Medical & Biological Engineering (AIMBE), the International Federation of Automatic Control, and the Institute of Electrical and Electronics Engineers (IEEE). He received his undergraduate degree from Princeton University, master’s degree from Cambridge University and doctoral degree in chemical engineering from the California Institute of Technology.

About Mode AGC:

Mode AGC (Automated Glucose Control LLC) is an early-stage medical device company in Palo Alto, CA developing closed-loop technology for insulin pumps. Mode AGC, was founded by Jennifer Schneider MD and Thomas Peyser PhD. Dr. Schneider is a Stanford-trained orthopedic surgeon, a noted diabetes advocate and entrepreneur. Dr. Peyser is a world-renowned expert on diabetes technology who has worked for two decades on continuous glucose monitoring. Most recently, Dr. Peyser was Vice President of Science & Technology at DexCom where he worked on the development of the G4 Platinum continuous glucose monitoring system. While at DexCom, Dr. Peyser led the company’s collaborations with artificial pancreas research groups around the world.

Forward-Looking Statement:

This press release may contain forward-looking statements concerning Insulet’s expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited, those described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 26, 2015 in the section entitled “Risk Factors,” and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

Investor Relations and Media Contact:

Deborah R. Gordon
Vice President, Investor Relations and Corporate Communications
(978) 600-7717
dgordon@insulet.com

Thursday, February 25th, 2016 Uncategorized