That is great news.
Choices are good!!
Here is the latest press release, sounds encouraging. I hope to find a way to join the clinical trial of the 365 day sensor (despite my current lovecrush for the G6). Seems like the 365 day sensor should come out after I’ve gone over to Medicare.
Recent Highlights & Accomplishments:
- Reinitiated Eversense® new patient sales and marketing activities in the U.S. with Ascensia Diabetes Care on October 1, 2020
- Submitted Premarket Approval (PMA) supplement application for the extension of the wearable life of the Eversense CGM System for up to 180 days to the United States Food and Drug Administration (FDA)
- Announced PROMISE study accuracy results for the 180-day Eversense product, demonstrating mean absolute relative difference (MARD) matching the performance of the current 90-day Eversense system of 8.5%-9.6%
- Continued efforts to expand patient access resulted in positive coverage decisions representing approximately 80% of covered lives in the U.S. This includes Medicare patients following the issuance of Local Coverage Determinations from all Medicare Administrative Contractors ahead of the 2021 Medicare Physician Fee Schedule Proposed Rule that will provide national coverage for implantable CGMs
“…Investment and resources are focused on the approval of the 180-day Eversense system in the U.S. and driving the development of the 365-day product where we are making great strides with configuration optimization. Following our PMA supplement submission and the early efforts with Ascensia we are excited and well positioned for a potential launch of the 180-day product in the first half of next year. We continue to drive execution across the company, including our product development and commercialization efforts with our partner Ascensia, while supporting our approximately 5,000 active patients globally. With our strategic partnership set we believe we are continuing to build a compelling value proposition for patients with diabetes.”
Anticipated Key Milestones:
Q1 2021 – Proposed Medicare National Payment Schedule
Q1 2021 – Initiation of commercial activities outside of the U.S. by Ascensia
H1 2021 – Expected decision on approval of 180-day Eversense product by FDA
H1 2021 – Planned IDE approval of 365-day Eversense clinical trial by FDA, including pediatric population
H2 2021 – Planned enrollment of 365-day Eversense clinical trial