Dexcom’s Q4 / Full Year 2012 earnings call is up on their site. As usual it makes for interesting listening for those interested in sensor supported diabetes care. I may get stuff wrong so first hand (ear?) listening is available: Click here to listen to the webcast. (1 hour, 4 minutes.)
(OK not much of an artist)
For parents this sounds something like mySentry. I perviously likened mySenty to the BatSignal. Share seem like it may be similar but with connections to more phones than the red BatPhone in commissioner Gordon's office. By that I mean cell phones not just the dedicated mySentry receiver.
The device springs from market research with parents and Dexcom said they hope to submit a filing for Share to the FDA in Q3 2013. In part, Terry said that Share is not getting up at 3:00 am to do a finger stick. Share then would need pediatric approval of Dexcom sensing to thrive.
Dexcom reported they received an extension of their CE mark giving pediatric approval of the G4 system in Europe last week. Further they said they have filed a PMA supplement with the FDA for pediatric approval in the USA. That is a 180 day regulatory process. Optimist will note that the FDA has seen the G4, the adult G4 approval was less than 180 days, the FDA on pervious calls was reportedly is very interested in pediatric use. Pessimist will make comments about the FDA.
Regarding pump integration Dexcom expects that a PMA for the Animas integrated pump to be filed first quarter of 2013. In another part of the call they noted JnJ reports that in the parts of Europe where the CGM pump is on sale the demand is 30% than where it is not available. There is some detailed conversation about PMA, 510k and who files what is in the Q and A around 35:00 (+/-) mark. There was detailed conversation about pediatric integrated pump approvals in the last few minutes of the call which is another can of worms.
Tandem was reported to have agreed to move forward with G4 integration with their pump. Previously the G5 was reported to be the path for integration for Tandem and that the G4 was being studied. So apparently the study showed that integration was a good fit.
My editorializing here is the Animas sales and the Tandem study indicate what I think many people living with diabetes hold to be self evident; that an integrated CGM / pump product is more desirable and two separate devices.
Regarding the OmniPod, Dexcom cited Insulet releases that the OmniPod is moving to a relationship with an undisclosed CGM vendor to explore a single site combination Pod/CGM sensor. Dexcom’s G5 platform with mobile connectivity was cited as part of the reason that the OmniPod chose to go in a different direction with CGM. Also Dexcom is hoping to extend the time sensors can be worn. This would create a significant difference between pod like and sensor life span.
In Q and A approval for a ten day sensor approval was to said not to be a 2013 priority.
Dexcom also reported that Roche will not be moving forward with G4 integration with their pump. Costa and time to market were cited as reasons as was the G5 and mobile.
As I have written before I own shares in Dexcom, I still do and I have an obligation to disclose that.