Dexcom CEO to be replaced
Dexcom has
just announced that their current CEO, Andy Rasdal, is being replaced by Terrance H. Gregg formerly of Minimed and Medtronic.
I have to believe this is a good move for
Dexcom, maybe it's part of the reason their shares have been up a lot in the last 2 days. Terrance will bring a lot of business expertise appropriate to that specific market to Dexcom.
And according to their
recent webcast, Dexcom is set to publicly launch the Dexcom SEVEN on June 23rd. That seems to be when people will start to get hold of it.
These are exciting times for Dexcom. I just hope that the Dexcom SEVEN has enough improvements over the Dexcom STS to actually justify the hype.
Note: I currently own some shares in Dexcom, I work not to let this ownership influence what I say about the company or its products.
Labels: announcements, CEO, Dexcom
Dexcom conference call on Monday - Updated
This Monday at 1:30 PM (PDT)
Dexcom management will be having a conference call to discuss the approval and launch of the Dexcom SEVEN CGMS. Hopefully this will answer some of the questions raised during the
earlier announcement about the FDA approval for this system.
The number and codes have changed for this call. The new numbers are given below.
The number for the call is (866) 290-0920 (US/Canada) or (913) 312-6670 (International). And the participant code is "7146581". You should dial in about 1:25 PM (PDT). This seems to be a listen-only line. Does anyone know what number to call so you can ask questions?
The conference call will also be webcast. You can find the link to the webcast on the
Dexcom webcast page. You can go there today and pre-register for this call.
I'd like to know the answers to the following questions:
- When will the Dexcom SEVEN system be available to consumers?
- Will the new software be available on the same date? If not, when will the software ship?
- What's the pricing for the system and sensors?
- What's the upgrade pricing for the new system?
- I hear the transmitter and sensors are waterproof. Is the receiver also waterproof?
- I'd like more details about the software. Does it provide statistics, including the the average, and standard deviation for blood glucose values? Does is allow access to the data?
- If this is such great news, how come the stock price is still depressed?
I'll be camping at the time. So I'll wait and listen to the archive later in the week.
The updated Dexcom
press release doesn't give much more details than I reproduced here.
What questions would you ask Dexcom, if you could? Perhaps you'd like to e-mail them to Jessica Ching, Marketing VP for Dexcom. Her e-mail address is
jching@dexcom.com.
Note: I currently own some shares in Dexcom, I work not to let this ownership influence what I say about the company or its products.
Labels: announcements, CGM, Dexcom, news
Dexcom gets FDA Approval
Finally (because I've been waiting for it), Dexcom received FDA approval for both it's 7-Day continuous glucose monitoring system
and it's next generation software to go with it. Though it will be a while longer before most of us see it.
The
company press release doesn't provide much additional details besides the fact that the new sensors are approved for seven days of use.
But there's also a
product announcement webcast from Las Vegas. It's over 39 minutes long, and does not come with any additional slides, though there were slides shown during the presentation.
In the remainder of this long blog post, I've summarized what I picked up from listening to the webcast.
Webcast Summary
In the webcast Andy Rasdal, CEO of Dexcom says that there were no conditions from the FDA on the approval. Dexcom plans to have a limited launch of the new product offerings (presumably both hardware
and software) at the end of this quarter with a full launch in the 3rd quarter.
He says that Dexcom has eliminated the use of a shower patch. The needle size has also been reduced, so it should be more comfortable to insert (yay!). Mr. Rasdal claims that Dexcom has listened to their users so features we have asked for will be included. He mentioned that the price is likely to be increased, though the price per day is effectively reduced. (For those of us already getting more than 7 days out of a sensor, it just may end up being more expensive.)
Andy Rasdal also talked about studies that show improved outcomes (over 7 day periods) when using the Dexcom system. This shows a 40% reduction in time spent hypoglycemia, a 33% reduction in hyperglycemia, and a 24% increase in the time spent euglycemic (normal blood sugar levels, also called
normoglycemia).
The study looked at folks with less control and found that within a few days they could effectively double the time they spent in euglycemia. These were people for whom it was believed that CGM would not provide any benefits.
The new Dexcom data manager supports downloads of data to the PC for more analysis and for communicating to doctors. I guess we'll see what this means when I can get my hands on it. I still haven't succeeded in cracking the
Dexcom data format, and this alone would be a big improvement
Dexcom has 3 peer-reviewed studies published in various journals. During the webcast he referenced a new study on long term outcomes to be published in the June issue of
Diabetes Technology and TherapeuticsDexcom emphasized that this is the second generation of the Dexcom technology with more coming in the future.
Towards the end of the presentation (31 minutes in) he mentioned the new
CMS codes for CGM, and the importance of working hard on better insurance reimbursement. He mentioned five letters from Congress that endorsed CGM and looking for better coverage (I wonder whether these could be obtained under Freedom of Information). And that Dexcom has a dedicated reimbursement team, but that reimbursement is still spotty.
Interestingly Andy also talked about the needs of intensive patient monitoring post surgery. This is to move the use of Dexcom technology from just ambulatory to in-hospital use. There is 'compelling clinical evidence' to show intensive management reduced mortality and morbidity by 50%, and not all of these folks (only 13%) had diabetes. I think he mentioned a Dr. Vandenburg who had done these studies.
Dexcom sees this as a large market opportunity. There are over 110,000 critical care beds and Dexcom estimates that over 25% of hospitals have implemented intensive regimes with 12-24 finger sticks per day.And that at $3-$5 per stick, the CGM systems might be more cost effective, as well as less stressful to the patient.
This is also a more focused and effective distribution channel instead of selling to individual patients. That would clearly reduce the cost of sales for Dexcom and presumably increase profitability. Dexcom is also building in the capabilities to interface with any monitoring systems.
They see partnering with other devices makers as being significant in the future. He mentioned not just combining with an insulin pump, but perhaps also with an insulin pen. This would mean several million new users, over the several thousand already using insulin pumps.
My Final Thoughts
I think this will put more competitive pressure on Medtronic Minimed, and may also have implication for the (as yet unapproved) FreeStyle Navigator. I'm excited for the folks at Dexcom, but I'll reserve judgment on the new system until I get one in my hands.
Note: I currently own some shares in Dexcom, I work not to let this ownership influence what I'll say about the company or its products.
Labels: announcements, CGM, Dexcom, diabetes
