With regard to Pump CGM integration Terry Greg said:
Shifting to our insulin pump partnerships, we are pleased to report that we have filed a PMA supplement with the Food and Drug Administration for our first generated integrated system with Insulet Corporation. We're extremely excited about the combination of our SEVEN PLUS system with the OmniPod Insulin Management System which will merit Insulet's unique [tubeless] insulin delivery device with our best in class CGM technology.Later they said of the Animas trasmitter:
Although we cannot predict the ultimate decision or timing for a decision by the FDA, we typically expect a PMA supplement to be subject to 180 day review cycle, give or take a few months, and we hope to be positioned to launch a first product with Insulet late this year or early next.
But as you're well aware the timing of the regulatory process is uncertain. With respect to Anima, we continue to push forward on the development of a modified transmitter capable of supporting a unified global launch by Anima*. And while the development cycle has taken slightly longer than expected, we remain committed to filing a PMA supplement with the combined DexCom Anima's* system later this year as well.
*Animas - I quote'm like they write'm
Ben Andrew - William Blair
... And then you talked about the modified transmitter for Animas to launch and filing the PMA supplement later this year. Is that kind of a year end sort of event given some of the delays you've seen Terry or can we look for it before then.
Well we're still going through the technical review of that as late as last night with their folks being here. Obviously, if we can pull that in earlier, we will since it is a brand new transmitter versus the existing transmitter with the Gen3 system. Some of those still challenge us. So I would not want to predict other than in the comments that I made by the end of the year.
On the CGM The Next Generation:
I'm pleased to report that we have successfully completed a pivotal trial for our fourth generation short-term sensor, and we expect to file a PMA supplement with the FDA before the end of the quarter. In addition to improved manufacturing ability and reduced cost, our goal with Gen4 is to bring the market a next generation sensor, which will offer an unmatched level of performance and ease of use for our patients.
I expect to give additional color on the key attributes of Gen4 during our next earnings call post PMA submission, and of course we will not stop with Gen4, and we are equally excited about the progress we've made on the development of a fifth generation sensor, which we've mentioned may have application not only as a future ambulatory sensor, but also as a subcutaneous sensor for use in the hospital outside of critical care.
Full disclosure I own shares in Dexcom. My kids use Dexcom.