$SENS FDA Approval On Worlds First Implantable 180 Day Continuous Glucose Monitor

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 Overall mean absolute relative difference (MARD) against reference value was 9.1% for the primary sensor over 49,000 paired points and 8.5% for the SBA sensor over 12,000 paired points. The percent sensor readings within 20 mg/dL or 20% of reference values (20/20% agreement rate) were as follows: Across the full 40-400 mg/dL range, the agreement rate was 92.9% for the primary sensor and 93.9% for the SBA sensor. In the hypoglycemic ranges of 40-60 mg/dL and 61-80 mg/dL, the agreement rates were 89.4% and 92.2% for the primary sensor and 96.5% and 96.8% for the SBA sensor, respectively. Confirmed hypoglycemic alert detection rate was 93% for primary sensor and 94% for the SBA sensor. There were no related serious adverse events, all sensors were removed during the initial removal procedure and 1.1% of patients had a mild infection at the procedure site. https://www.senseonics.com/investor-relations/news-releases/2021/06-03-2021-210515226 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. ​ https://preview.redd.it/4yby71jl4hz71.png?width=500&format=png&auto=webp&s=37774863a08a7a986af5d364f52a5b755629665f Institutional Investors Loading Up (Data Retrieved From Fintel) Positions sizes have increased quite drastically over the last 3 Quarters and are continuing to increase. ​ https://preview.redd.it/wpbi4ljq6hz71.jpg?width=866&format=pjpg&auto=webp&s=4fad4d5f9ac7f3a2a0cff1a0ddde15d42600e14a

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$SENS FDA Approval On Worlds First Implantable 180 Day Continuous Glucose Monitor

bullish

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

  • Overall mean absolute relative difference (MARD) against reference value was 9.1% for the primary sensor over 49,000 paired points and 8.5% for the SBA sensor over 12,000 paired points.
  • The percent sensor readings within 20 mg/dL or 20% of reference values (20/20% agreement rate) were as follows:
    • Across the full 40-400 mg/dL range, the agreement rate was 92.9% for the primary sensor and 93.9% for the SBA sensor.
    • In the hypoglycemic ranges of 40-60 mg/dL and 61-80 mg/dL, the agreement rates were 89.4% and 92.2% for the primary sensor and 96.5% and 96.8% for the SBA sensor, respectively.
  • Confirmed hypoglycemic alert detection rate was 93% for primary sensor and 94% for the SBA sensor.
  • There were no related serious adverse events, all sensors were removed during the initial removal procedure and 1.1% of patients had a mild infection at the procedure site.

https://www.senseonics.com/investor-relations/news-releases/2021/06-03-2021-210515226

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.



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