I read through the transcript of the Insulet Q3 Earnings call. There were a couple of updates on the new DASH PDM (you known - the locked down android phone that communicates via bluetooth to the pod.) so I though I would share to save you the googling. Also Horizon is the new Omnipod “automated pancreas” system.
Here are my highlights:
The DASH PDM 510 (k) will filed at the end of the year and should launch mid 2018. During the Q&A they said they were comitted to a 2018 release date.
It sounds like Insulet and Dexcom are talking. The DASH/Horizon is being developed to work with both the Dexcom G5 and the upcoming Dexcom G6 sensor/transmitters. There was a reference that DASH is able to talk to different CGM devices and may be able to talk to Libre for the European market, likely though a phone plug-in app, but I cannot be certain.
There is a focus on our data: Bluetooth will make it easier to collect and aggregate data from the PDM and other diabetes tech devices. Looks like there will be a phone app with a Dash board (pun intended) as well as other apps to send data to doctors etc. Like most data things I am happy/sad about this. Happy that my doctor and I can get access to data but sad because they are giving it to the insurance company. (I use xdrip+ so I already have all the data I can use in the same place, but I am happy to see something mainstream coming.
The Omnipod Horizon (automated pump) is being tested in a “hotel setting” and tests have been promising. Everything is “on track” and it still sounds like a 2019 (or early 2020) release. It sounds like they are learning from the Medtronic release and want to have their trainers trained and enough stock before they release.
Earnings are up. It sounds like Insulet is not going out of business any time soon.
Animas - In the Q&A there were lots of questions about people switching from Animas to Omnipod. Insulet stated that they see their biggest growth from MDI folks and not from Animas users who use tubed pumps. Although they did say they are working on Dexcom integration. I read this as, some of the Animas folks will go to Tandem and Medtronic, but for those who do not want Medtronic sensors - we will have Dexcom integration.
A couple quotes from the transcript caught my eye (These are quoted from Seeking Alpha and there are only 379 words so it meets their copyright policy of only allowing up to 400 words quoted )
“We now have more than 50,000 Omnipod customers, well over half of our U.S. installed base, using Insulet Provided Glooko. This enables incredibly rich, large population, real-world data sets to demonstrate the value of Omnipod to payers, clinicians, and to end users.”
“The most notable change is in what you can’t see, the Bluetooth connectivity. This connectivity liberates the data in our PDM and pod to provide all of our Dash customers with unique meaningful benefits. For the payer, this means access to aggregate diabetes and outcomes data on their specific membership populations through their Omnipod Dashboards. For the clinician, this means less time training patients on pump therapy and immediate access to their diabetes data for streamlined office workflow and improved interactions with their patients. And for the patients, this means insulin delivery control at their fingertips, easy access to their pod therapy information on their PDMs or on their mobile phone, and the ability to share their diabetes data with caregivers via our Dash View mobile app. Their Omnipod PDM data will be an app on their phones right where they view their CGM data or their health and fitness data.”
“We are very pleased to report that we have successfully completed our summative (18:17) human factor studies for Dash, and based on early feedback, we are confident our customers will love this new product platform, which will transform the way they manage their diabetes. We are on track to submit our 510(k) to the FDA around the end of this year and anticipate a limited market launch mid next year. This marks a very important milestone for Insulet, since Dash is the platform for our future product innovations, including concentrated insulins and our Horizon Automated Glucose Control System.”
“We continue to make great progress on our Omnipod Horizon development program. We now have 118 patients including pediatrics, adolescents, and adults monitored with our Horizon algorithm. We are currently underway with our third IDE, which is taking place under normal living conditions, in a hotel setting with the patients spending a longer time in our hybrid closed-loop phase. The study results continue to demonstrate that our Horizon algorithm performs very well, and is safe during the day and night across all age groups.”
For those who need to google it IDE = Investigation Device Exemption which means FDA allows testing of a medical device that is not approved yet.
Transcript is here:
You can listen here: