Memorandum

Medtronic announces FDA approval and market launch of mySentry, a remote CGM/pump monitor for parents and caregivers – January 5, 2012

Executive Highlights

  • Medtronic announced FDA approval and market launch of mySentry, which allows parents and caregivers to see real-time insulin pump and glucose trend information from another room.

Yesterday morning, Medtronic announced that FDA has approved mySentry, a remote monitoring system that enables a parent or caregiver to see real-time insulin pump and CGM information from another room – we think this could be a terrific tool for parents of children with diabetes who worry about severe nocturnal hypoglycemia. We could also see uses for caregivers of elderly patients or other patients who are less aware of hypoglycemia. The device is approved for the MiniMed Paradigm Real- Time Revel insulin pump and has two principal components: a monitor that displays CGM and insulin pump information (e.g., at the bedside of a parent or caregiver) and the ‘outpost’ that sends and receives information from the insulin pump to the monitor (e.g., in a child’s bedroom). The monitor has a sharp- looking color screen that displays the most recent sensor glucose value in large font, trend arrows, and status information (insulin pump status, battery life, insulin remaining, and time until next sensor calibration or change). We like that the icons on the display are color coded green, yellow, and red, which should give sleepy parents and time-pressed caregivers a quick and easy way to interpret a patient’s status. In a 35-family user evaluation study (2011), user feedback was very strong, and virtually all families found the device to be quite valuable. A quote from highly-respected Medtronic engineer and type 1 parent Lane Desborough’s after his experience with the device said it all: “The two worst days of my life have been (1) when my son Hayden was diagnosed and (2) when we had to return the mySentry from my personal testing of the device.”

The $3,000 mySentry does not have reimbursement at this time, which will limit sales early on, although we can imagine “exceptions” granted with documentation. Medtronic is offering it at a 20% discounted launch price of $2,400, with a further $500 discount for new Real-Time Revel pump/CGM users. Reimbursement should improve over time; Medtronic is speaking with payers and evaluating studies of the device to support clinical claims. ER visits for severe hypoglycemia or DKA are very costly for payers, so we would expect them to see the benefits of this device. From a business standpoint, we think this product could further bolster Medtronic’s share of the pediatric CGM marketplace, especially as accuracy of its CGM at hypoglycemic levels improves and when its new sensor (Enlite) is approved; that sensor is widely perceived as less painful. The Dexcom Seven Plus is not currently FDA-approved for children, though off-label use and reimbursement are common. Medtronic could see an increase in sensor use as parents using mySentry may be more likely to put their children or patients on CGM, especially, as noted, when Enlite is approved. Overall, we think mySentry is an exciting and useful product that addresses an increasingly important market need as patients strive for tighter glycemic control. We believe the current market for mySentry is likely around 5,000 - 10,000 families, although we believe the market could expand to 30,000 - 60,000 families with better CGM technology, HCP awareness of CGM, reimbursement for HCP time associated with CGM, and CGM reimbursement.

  • mySentry has a robust array of alarms and fairly extensive wireless range. The device’s volume can be adjusted (up to 55 decibels at one meter, comparable to a loud conversation) and mySentry will sound an alert when the Revel pump does so (for CGM, the alarm sounds for predictive alerts, rate of change alerts, and threshold alerts; for the pump, the alarm sounds when the insulin reservoir is empty and when there is no insulin delivery). These alarms can also be customized, which we see as an important feature to avoid alarm fatigue. The remote monitor does not have the ability to clear an alarm or control the pump – from what we have heard, this was a deliberate safety feature so that parents must physically clear the alarm on the pump rather than doing so remotely. We note that the outpost must be within six feet of the pump to wirelessly receive data, which is then sent to the monitor at a distance of up to 50 feet or greater (100 feet if there is a direct line of sight). According to Medtronic, no families reported problems with the device’s range in the user evaluation study.
  • In the user evaluation (n=35 families), feedback was very strong. A reported 100% of parents surveyed believed that the mySentry alarms and alerts were loud enough to hear while sleeping at night, over 90% of mySentry users surveyed would recommend mySentry to other parents or caregivers, and 100% of parents surveyed reported that mySentry was easy to use. While such surveys typically yield enthusiastic responses and don’t necessarily represent who would buy and use the device, we certainly believe that most parents of intensively-managed kids would like and use the device if they could afford it, assuming that they could deal with the alarms.
  • mySentry is immediately available to US customers who have a prescription, and Medtronic is marketing to both patients and healthcare providers alike. Since the European version of the Veo operates on a different frequency (860 Mhz) than the US Revel (916 Mhz), we understand that a European version of the mySentry would require a slight modification. We do not have information on when this will be submitted in the EU or elsewhere globally.
  • We believe the market for mySentry is likely around 5,000 – 10,000 families currently, although we believe this could easily expand to 30,000-60,000 families as CGM improves. According to Medtronic, most of the company’s US customers are on the Revel, eligible to be upgraded, or ready to repurchase; our estimates assume about half of Medtronic pumpers are currently on Revel and that the vast majority will upgrade. Given that the mySentry is for Revel users on CGM, we used the following assumptions in this calculation:​ ~400,000 pumpers in the US, 55-70% pump market share among children for Medtronic, ~ 50% current Revel penetration, and 10-20% current CGM penetration. Although mySentry is targeted at families with young children, we believe parents and caregivers of older children and older type 1 patients would also be interested. Notably, as quality and reliability of CGM improves on the Revel, especially at hypoglycemic levels, and as HCP awareness and support improves, we believe there is significant expansion potential for CGM and for mySentry. While CGM reimbursement as a barrier has improved substantially over time, HCP awareness is still sub-optimal; additionally, reimbursement for HCP time to teach patients about valuable tools like CGM is still low. Some patients also still perceive CGM as not patient-friendly enough; this will change as new products are approved in the US. For example, the Enlite sensor is perceived as a much-improved sensor over the current Medtronic sensor used in the US (see the diaTribe review of the Enlite at http://www.diatribe.us/issues/32/test-drive.php), and we believe approval of the Enlite in the US could expand the market substantially – as a reminder, the current clinical study for the Enlite is expected to end in April 2012 according to Clinicaltrials.gov (NCT01464346). Assuming a standard 180-day review for the PMA, this puts Enlite on track for approval in late 2012 (for more information, see our Medtronic F2Q12 report at bit.ly/z3TJqM). We also believe the market could​ expand with the approval of Dexcom’s next-gen sensor, on track for a late 2012/early 2013 approval (for more information, see our Dexcom 3Q11 report at bit.ly/roGR9k).
  • This is the first launch of what Medtronic is calling ‘Connected Care Solutions.’ With these products, Medtronic aims to provide people with diabetes and their caregivers more convenient options to access their diabetes information. We recently saw another example of such a solution in a live remote monitoring demonstration of the artificial pancreas (for more information, see Medtronic’s demonstration at DTM 2011 report at bit.ly/uh3qXd). Exciting movement all around.

--by Adam Brown and Kelly Close