Senseonics (NYSE:SENS) announced that it anticipates the FDA to decide within weeks on approval of its new CGM system.
The company seeks a premarket approval supplement for the next-generation Eversense 180-day implantable continuous glucose monitoring (CGM) system. Data presented earlier this year demonstrated strong accuracy. The next-generation Eversense matched performance levels compared to the current 90-day sensor available in the U.S. — but with reduced calibration, down to one per day, with the duration extended to 180 days.
According to a news release, all queries raised during FDA review have been answered, with a decision over approval expected “in the coming weeks.”
“We understand that the FDA is at full capacity managing the backlog of COVID-19 related filings creating longer than expected review timelines,” Senseonics President & CEO Tim Goodnow said in the release. “We are confident a decision regarding approval of the 180-day system will be made in the coming weeks as the FDA continues to clear out the backlog.”
Senseonics also confirmed that it is designing plans with Ascensia Diabetes Care for a smooth transition to the 180-day system in the U.S., should it garner FDA approval. Those plans include marketing campaigns to promote the availability of system upgrades and engaging payors regarding reimbursement and coverage transitions.
The Germantown, Maryland-based company said the plans aim to minimize the impact to patients, providers and sales while taking into account the expected use of existing inventory in the first quarter of this year, with the transition to the new product earmarked for the second quarter of 2022. Additionally, Senseonics reiterated its 2021 financial outlook for full-year revenue to fall in the middle of its guidance range set between $12 million and $15 million.
“In 2021 we integrated operations and coordination activities with our commercial collaborator Ascensia Diabetes Care,” Goodnow said. “A thoughtful go-to-market strategy is being designed to target a smooth transition to the 180-day system while providing uninterrupted service for patients, providers and payors.
“We are excited to advance long-term solutions for people with diabetes as we continue to aim to make the new 180-day system available in the U.S..”