Senseonics investors are still betting on FDA approval of the 180 Day Device which was submitted on October 5th 2020. (https://www.senseonics.com/investor-relations/news-releases/2020/10-05-2020-123008373) A reviewer from the FDA finally picked up the submission.
According to Q3 Earnings
"..the FDA clearance of our 180 day sensor, which we believe remains on track to occur later this quarter. In the third quarter, we have been actively engaging with and responding to requests for clarifying Information from the agency. We are pleased to be nearing the completion of the interactive review process and are excited about the potential and bringing this transformative product to people with diabetes. The FDA has been a great partner in these difficult times and they are highly engaged and focused on completing this review in its final stages, if there are no other unexpected additional impacts as a result of COVID delays or any other factor at the agency, we continue to expect approval by the end of this year" (Tim Goodnow, CEO).
They have used their PROMISE Study results as a supplement for their submission. The results from the Promise Study proves the CGMS accuracy to be robust.
PROMISE Study Results
Comparison Between Senseonics Eversense and Dexcoms G6/G7 (MARD Value Comparison)
|Senseonics Eversense||Dexcom G7||Dexcom G6|
|MARD||9.1% Primary Sensor||9.0%||8.7%|
|8.5% SBA Sensor|
Short Interest Data Retrieved From Ortex:
Short Squeeze potential is apparent with 23.97% SI. Any SI% value above 20% is considered to be "extremely high". FDA clearance for the worlds first implantable 180 day Continuous Glucose Monitor could potentially induce a short squeeze.
Institutional Investors Loading Up (Data Retrieved From Fintel)
Positions sizes have increased quite drastically over the last 3 Quarters and are continuing to increase.