August 12, 2010

FTNW: Dexcom Earnings Call Aug '10

Dexcom's Q2 2010 Earnings Call Transcript is up on Seeking Alpha. Feel free to surf over and read the whole thing or not. My quick read was looking for information about pump integration and there was confirmation the the OmniPod/Dexcom product was into the FDA for review and that the Animas supplemental FDA filing was expected by year end.
Shifting to our insulin pump partnerships, as we mentioned on our last earning call, we have filed a PMA supplement with the Food & Drug Administration for our first generation integrated system with Insulet Corporation and we are currently awaiting feedback from the agency. Additionally, we have completed development and are in final testing with respect to a modified transmitter for use in our integrated system with Animas and we remain committed to filing a PMA supplement for the combined DexCom Animas system before the end of the year.
They also shared the information the next generation (Gen 4) was into the FDA and some of the possible features of Gen 4 that are of interest patients. May being  the operative word, these are forward looking statements:

I'm pleased to report that we have filed a PMA supplement Gen4 with the Food and Drug Administration.

... our goal with Gen4 is to bring to market a next generation sensor which will offer an unmatched level of performance and ease of use for our patients. Our Gen4 Sensor is more accurate than any of our previous sensor systems particularly in the hypoglycemia range. Gen4 will also have a one hour warm up time... We believe that performance of Gen4 may in the future allow us to submit through the FDA for an expansion of our labeled indications for use.
For example, the Gen4 sensor may permit a reduction in required calibrations points during a sensor session it may also enable us to obtain an indicated sensor light of longer than seven days. We expect to explore the requirements for obtaining these expanded indications with FDA and conduct clinical trial work later this year. Additionally, we are in the final stages of development of a new receiver form factor and a new transmitter, and we expect to file with the FDA later this year to incorporate those components into the Gen4 system.

2 comments:

Leighann of D-Mom Blog said...

We aren't thinking about a CGM yet, but I am so pleased that integration with OmniPod is on the horizon.

When choosing a pump, the only negative of the OmniPod was that if we decided to get a CGM, then it would be a separate system.

Not that our insurance covers it. They don't approve CGM for anyone under 20. Have absolutely no idea what their logic is on that one!

Reyna said...

We are using the Dexcom 7+ with my son Joe (he is 7) and LOVE,LOVE,LOVE it. We are looking forward to when it will be integrated with the Animas Ping. Who knows when that will happen. We did try the Medtronic CGM (Guardian) a few years ago and did not find it to be nearly as accurate nor as easy to use as the Dexcom, not to mention the large introducer needle. I know medtronic is changing their system up...but boy I am a HUGE DEXCOM FAN!!! Thanks for the post.