ASCENSIA DIABETES CARE MARKS ONE-YEAR ANNIVERSARY OF US EVERSENSE E3 CGM LAUNCH WITH COMMERCIAL UPDATE AND INNOVATION OUTLOOK

PARSIPPANY, N.J., April 24, 2023 /PRNewswire/ -- Ascensia Diabetes Care, a global diabetes care company, maker of the CONTOUR^® Blood Glucose Monitoring (BGM) system portfolio and exclusive distributor of Eversense^® Continuous Glucose Monitoring (CGM) Systems, marks the one-year anniversary of launching Eversense^® E3 in the U.S. with a commercial update and outlook on future innovation, as discussed in the recent Eversense CGM Virtual Analyst and Investor Event.

"The last year has really seen our partnership with Senseonics go from strength to strength," said Rob Schumm, President and CEO of Ascensia Diabetes Care. "At Ascensia we've been focused on driving the uptake of this highly differentiated product, and we are encouraged to see more patients accessing its benefits. Meanwhile, Senseonics has been focused on delivering innovation based on the feedback that we both hear from patients. Together, we have an ambitious vision for what the diabetes management of tomorrow looks like, and we are increasingly excited about what the future holds."

In April 2022, Ascensia launched the Eversense^® E3 CGM System for patients in the U.S., shortly after it was approved by the U.S. Food and Drug Administration (FDA). Developed by Senseonics, the system includes the longest lasting CGM sensor available, with up to six-months of wear, compared to just one or two weeks with most CGM systems. Alongside improved longevity, this next-generation system also offers people with diabetes unique and competitive features such as a fully implantable sensor, a removable smart transmitter*, discreet on-body vibe alerts, exceptional accuracy¹ and an intuitive smartphone app. Key highlights from the past year include:

U.S. Commercial Highlights

• Significant coverage success with over 250 million covered lives, including favorable Medicare reimbursement and coverage from nearly all major national insurers
• Number of Eversense users significantly expanded since the launch of Eversense E3, providing a foundation for the strong growth that we expect in the US this year
• Continuation of PASS (Payment Assistance and Simple Savings) Program to reduce out-of-pocket expenses for Eversense users with insurance coverage
• Growing number of certified inserters, supplemented by a network of certified mobile and at-home inserters through the Nurse Practitioner Group partnership
• Increasing opportunity for people living with type 2 diabetes, with type 2 diabetes patients accounting for half of those using the system
• Majority of our new users are moving from their current CGM to Eversense
• Ongoing expansion of our dedicated CGM salesforce to help drive Eversense awareness and adoption

Innovation Outlook

• ENHANCE pivotal clinical trial for the 365-day sensor is underway, with plans to submit data to the FDA for potential approval, targeted for mid-2024
  - Pediatric cohort has started enrolling, evaluating the use of Eversense in youth
• Executing plans with a goal to achieve iCGM (integrated CGM) clearance and integration for Eversense with automated insulin delivery (AID) systems
• The Gemini development program, investigating products with both real-time CGM monitoring and on-demand intermittent scanning to provide increased flexibility for patients
• Work underway towards the Eversense Freedom system, which captures all the current features and benefits of Eversense but with no on-body components

Last year's launch was an important landmark in the global partnership between Ascensia and Senseonics, which has supported both patient access to Eversense and the development of future products, by allowing both companies to focus on their core strengths. Senseonics remains responsible for research, development, innovation, and manufacturing while Ascensia is able to leverage its market-leading position in BGM to exclusively lead worldwide marketing and commercialization.

Eversense CGM Systems and the Eversense CGM App are available across the US and select countries in Europe. Please visit www.ascensia.com/eversense for more information. To learn more, please refer to the recent Eversense CGM Virtual Analyst and Investor Event hosted by Ascensia, Senseonics Holdings (NYSE: SENS) and PHC Holdings Corporation (TSE: 6523).

¹ Garg, S. K. et al.  (2021). Evaluation of Accuracy and Safety of the NextGeneration Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study. Diabetes Technology & Therapeutics, 24(2), 1-9. DOI: 10.1089/dia.2021.0182

*There is no glucose data generated when the transmitter is removed.

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SOURCE Ascensia Diabetes Care