Issuing an operational update, Senseonics Holdings Inc (NYSE:SENS) said FDA review for the PMA supplement for the next generation Eversense 180-day CGM system is nearing completion.
- All queries raised have been answered, and an approval decision is expected in the coming weeks.
- The Company expects to initiate the transition to the new product in Q2 2022
- Reiterating financial outlook expectation for FY21, the Company sees sales of $12.0 million - $15.0 million.
- "We understand that the FDA is at full capacity managing the backlog of COVID-19 related filings creating longer than expected review timelines. 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," said Tim Goodnow, President, and CEO.
- Senseonics' CGM systems, Eversense and Eversense XL include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor.
- The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.
- Price Action: SENS shares are up 18.3% at $3.17 during the premarket session on the last check Wednesday.
