Senseonics Leads Development Efforts Of A Long-Term “Artificial Pancreas” System For Use In The International Diabetes Closed Loop Trial

Three European Clinical Trial Sites Tapped to Test Closed Loop System

GERMANTOWN, Md.--(BUSINESS WIRE)--Senseonics Holdings, Inc. (NYSE-MKT: SENS), a medical technology company focused on the development and commercialization of transformative glucose monitoring products, today announced a collaboration with TypeZero Technologies, Inc., a personalized diabetes management company, and Roche Diabetes Care, Inc., a global leader for diabetes management systems and services, to develop a long-term automated insulin delivery system.

“The promise of automated insulin delivery systems is the ability to automatically and sustainably maintain tight glucose control while avoiding hypoglycemia. With this partnership, we are one step closer to bringing this promise to market and to significantly improve the everyday challenges of people with diabetes”

The collaboration is part of the National Institutes of Health (NIH)-funded International Diabetes Closed Loop (IDCL) Trial, which was designed to test automated insulin delivery systems. “This partnership is an example of how industry, research and clinical care work together to move innovative technologies from research to development and then to patients to minimize the burden of diabetes,” said Boris Kovatchev, PhD, Director of the Center for Diabetes Technology at the University of Virginia and principal investigator of the IDCL Trial.

This phase of the IDCL Trial will integrate Senseonics’ Eversense^® CGM System, a long-term, implantable continuous glucose monitoring (CGM) system with TypeZero’s inControl AP algorithms and Roche’s Accu-Chek® Insight Insulin Pump. The inControl software will automatically adjust and regulate insulin delivery based on the combination of data received from the CGM system and the insulin pump.

“The promise of automated insulin delivery systems is the ability to automatically and sustainably maintain tight glucose control while avoiding hypoglycemia. With this partnership, we are one step closer to bringing this promise to market and to significantly improve the everyday challenges of people with diabetes,” said Tim Goodnow, President and CEO of Senseonics.

The collaboration is the first of its kind to incorporate a CGM sensor that lasts up to 90 days with an easy and discreet insulin pump and smart algorithms for closed loop applications. The trial will include three clinical centers in Europe – the University of Amsterdam in the Netherlands, the University of Padova in Italy and University Hospital of Montpellier in France. Hans de Vries, professor of Internal Medicine at the University of Amsterdam, believes “this is the time to focus on developing life-enhancing technologies and systems to meet the needs of an increasingly-connected diabetes population. My patients are ready for these products now.”

“We have been contributing to the important research on automated insulin delivery systems for many years. This is why we are now even more excited to be able to build on our excellent partnerships and take our collaboration to the next level within the IDCL Trial. We believe this research will support us in making a true difference for people with diabetes as we aim to improve their time in range and free them of many daily routines,” said Marcel Gmuender, Global Head of Roche Diabetes Care.

“Our goal has long been to bring revolutionary artificial pancreas products to patients as quickly as possible, and our partnership with industry pioneers like Senseonics and Roche positions us to do that,” said Chad Rogers, CEO of TypeZero. “We are excited about delivering a Senseonics-Roche-TypeZero solution to the IDCL Trial and, ultimately, giving patients differentiated options for managing their type 1 diabetes.”

About Senseonics

Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics’ first generation continuous glucose monitoring (CGM) system, Eversense^®, includes a small sensor, smart transmitter and mobile application. Based on fluorescence sensing technology, the sensor is designed to be inserted subcutaneously and communicate with the smart transmitter to wirelessly transmit glucose levels to a mobile device. After insertion, the sensor is designed to continually and accurately measure glucose levels. For more information on Senseonics, please visit www.senseonics.com.

About TypeZero Technologies, Inc.

The world leader in clinically tested artificial pancreas solutions, TypeZero Technologies is a digital health and personalized diabetes management company dedicated to revolutionizing the treatment and management of diabetes. TypeZero is combining next-generation data science techniques, proven metabolic models, and modern engineering practices to develop customized analytics tools and blood glucose control solutions to help people with diabetes improve their health and lives. TypeZero’s current solutions include a smartphone-based artificial pancreas system, therapy optimization tools for health care providers, and advisory applications for smart insulin pens. To learn more, visit www.typezero.com.

Forward Looking Statements

Certain statements contained in this press release, other than statements of fact that are independently verifiable at the date hereof, may constitute “forward-looking statements.” These forward-looking statements reflect Senseonics’ current views about its plans, intentions, expectations, strategies and prospects, including statements concerning the integration of the Eversense CGM System, TypeZero’s inControl AP closed loop algorithm and Roche’s Accu-Chek Insight Insulin Pump, the clinical development of a closed loop system in the IDCL Trial and the potential benefits of a long-term pancreas system. Although Senseonics believes that its plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, Senseonics can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond Senseonics’ control. These risks and uncertainties are more fully described in the section entitled “Risk Factors” in Senseonics’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 23, 2017, Senseonics’ Quarterly Report on Form 10-Q filed with the SEC on May 4, 2017, and Senseonics’ other SEC filings. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cause Senseonics’ expectations and beliefs to change. While Senseonics may elect to update these forward-looking statements publicly at some point in the future, Senseonics specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law.