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Senseonics Gets FDA Approval for First Long-Term Implantable Continuous Glucose Monitoring System

Eversense system - sensor, transmitter and mobile app - lasts up to three months with a single sensor.

Over 30 million people—9.4% of the populationhave diabetes in the US, according to the CDC’s 2017 National Diabetes Statistics Report. Over 7 million of those with diabetes are undiagnosed, and the percentage of adults with diabetes increases significantly with age. Over 25% of people aged 65 or over have diabetes, and the struggle to control blood glucose levels impacts millions more. A landmark 2015 analysis of 46 different type 2 diabetes studies revealed that hypoglycemia is particularly prevalent among those taking insulin, affecting 50% of those with diabetes with an average of 23 incidents per year.

Senseonics SENS announced it received FDA approval for its Eversense Continuous Glucose Monitoring (CGM) System—the first CGM system to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months. The system has been approved in Europe since 2016.

We’re very pleased to receive this FDA approval that allows us to make Eversense available in the United States, as it is in many European markets. With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way. More importantly, we believe the unique features Eversense offers will help open up CGM to millions of people with diabetes who, up to this point, have been hesitant to try CGM despite the clear health benefits it provides.

– Tim Goodnow, President and CEO, Senseonics.

Source: Senseonics

The Eversense CGM System consists of a fluorescence-based sensor, a smart Bluetooth transmitter worn over the sensor for data communication and a mobile app that shows glucose values, trends and alerts. The sensor lasts up to three months and is designed to be inserted subcutaneously in the upper arm by a physician in a brief in-office procedure. Traditional CGM systems require patients to self-administer the weekly or biweekly sensor insertions. Additionally, Eversense uses the only CGM transmitter that can be removed and recharged without discarding the sensor.

Research has repeatedly demonstrated the clinical benefits patients experience with regular CGM use, including improved glucose control and protection against severe hypoglycemia. Despite these benefits, a significant number of people with diabetes do not use, or have access to, continuous glucose monitoring. Furthermore, the data shows that many people who’ve tried traditional CGM in the past either don’t wear it as often as they should or don’t stick with it for a variety of reasons, including concerns surrounding sensor accuracy, sensor insertion, and sensor discomfort. So, it’s important that patients have choices and that medical device companies continue to advance the field of CGM with innovations that make it easier for the end user.

– Steven Edelman, MD, Professor of Medicine, UC San Diego, Founder & Director of Taking Control of Your Diabetes and Senseonics Board member.

Senseonics management will host a conference call today, June 22, 2018, at 4:30 p.m. ET to discuss the approval and commercial activities to support the Eversense launch in the US:

  • (877) 883-0383 for domestic callers
  • (412) 902-6506 for international callers
  • Conference ID: 5389400.
  • Live webcast at the “Investor Relations” section of the company’s website, where a replay will also be available after the call.

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