Kind Words for the FDA / Dexcom Earning Call

Dexcom’s earning call has become my goto source for a glimpse behind the curtain of diabetes devices. Yesterday's call was no different. I will share what I found interesting here. I may have missed some key stuff so I encourage you not to take my word for it and listen for yourself.  Unless you find earnings calls boring which I guess is understandable.

Shout-outs for the FDA
Maybe the most interesting part of the call is near exuberance with which Dexcom executives spoke of their relationship with the FDA in the Gen 4 review. They certainly were leaning that was last quarter and this time around they were practically fanboys.

The Dexcom Gen 4 was submitted at the end of the first quarter. In the last earnings call the noted that the FDA was very responsive in the review process. That seems to continue to be the case. At one point in the call (around 9:40) Dexcom says, “We couldn’t be more pleased with the progress we are seeing out of FDA on our Gen 4 submission.”

I am confident that the FDA is in no way rolling over. We all know that is not in the FDA’s DNA. That they are being responsive and communicative while filling their regulatory responsibility is what we all expect and hope for. I have been know to question the alacrity of the FDA. Based on the comments made on this call I may need to change my tune.

On the call Dexcom reported that in July, as part of the Gen 4 PMA, the FDA preformed an audit of Dexcom’s production facilities. Dexcom reports no findings or formal observations resulted from that audit. I think maybe you need to hear the intonation on the call to make “no findings or formal observations” sound like it is exciting and not the results of proctological exam (2:30.)

In Q and A Terry Gregg comments that this has been the fastest review his team have seen their decades of experience with the FDA process. That the agency has been very interactive in the execution of their responsibilities. It is still both a clinical and manufacturing process running 17 thousand pages. Towards the end of the call (41:30) Dexcom says that nothing the FDA is doing can be considered delaying, “quite the contrary.”

Of course I need to not get my hopes too high, this is not assurance of anything being approved - the product is still under review and Your Diabetes May Vary. It is however great to hear positive things about a process that so often we have only heard negative impressions.

Dexcom Gen 4 Photo care of
my friends at DiabetesMine.
Is it just me or is that an unrealistically flat 'curve?'

R and D
Dexcom talked about their research and development priorities for the rest of the year. Naturally commercialization of Gen 4 is on the list. Interestingly for many parents is a pediatric study. Dexcom and the FDA have worked out protocols. Dexcom says the FDA “encouraged” them to get a pediatric process started for Gen 4 “as soon as possible.” Dexcom reports (9:40) that the FDA protocols are more comprehensive than Dexcom initially expected in terms of number of patients and days in clinic.  The expectation non the less remains that these trials will be completed in 2012. There is a little more “color” (analyst speak for comments on) the pediatric process (26:20) including that the trial has been through institutional review boards at pediatric centers and that patients have already started being enrolled in the pediatric trials.

Pediatric approval has an impact on pediatric use and in some cases how insurance views reimbursement. So as a parent of a pediatric PWD I see this a s good news.

Also on the R and D front is a new algorithm that is hoped to go into trials in 2013 that will support an claim for extended wear. Also under consideration but didn't sound foreseen going into trials yet is a reduced calibration study. Again on this call Dexcom stated the long term goal is eliminating finger sticks.

My editorial comments on no finger sticks is that it would be super cool and I am not holding my breath.

Partnerships
This is always my favorite part because Dexcom sometimes (often) says stuff their partners don’t. I think the world knows that the Animas Dexcom Vibe is approved and in the market in Europe. (Somewhere in the financial stuff they mentioned that CE mark triggered a four million dollar payment from Animas.) A US filing for Vibe is a function of the Gen 4 sensor. The hope is to have the Gen 4 approved and the Vibe device into the FDA this year.

Animas Vibe More at SixUntilMe

That will make for some interesting upgrade decisions. Hopefully there will be clear viable paths to get Gen 4 and then the integrated pump without buying the Dexcom twice.

Dexcom mentioned that the Tandem and Roche integration was behind the Animas product. This is constant with what has been said before. In fact last time they were saying Gen 5 form both but they didn't repeat that this call. Sadly there was not a lot more “color” on these two products.

Notable absent was any mention of Insulet. In Q and A there is specific question about that. Pod people may want to listen for themselves (28:00.) Dexcom does not currently have any development work ongoing with Insulet. Dexcom knows that Insulet is very focused on the next generation of the Ominipod and thinks that development work will resume after that effort is complete.

All very diplomatic. Given the colorful way Dexcom calls typically go I don’t have any idea what to think of diplomatic - so I’ll take it at face value and maybe try to find an Insulet earning call.


There was more interesting stuff but I am a finance geek and what I find interesting the rest of the world call stupefyingly boring. They may be onto something.

As I have written before I own shares in Dexcom, I still do and I have an obligation to disclose that.

Ping or not to Ping that is the Question.

When our internet goes down, I ping a known address. When I get a reply back, I know everything is OK.

Hoping for a analogs response, I figured I would put out some queries for Ping the new Animas One Touch Pump (or is it a system?)


The Big Questions
(by big I mean without answers there is no point in even considering a 4 year commitment to Ping.)

• When do you expect Dexcom integration?
• Will Ping need an upgrade to talk with Dexcom, if an upgrade is required for a Dexcom why should I buy a Ping now?

It is public information that Dexcom integration is in the works. Asking for answers about how it will be handled is only a fair and proper action for an informed consumer.

Further it sadly appears that since the Johnson and Johnson acquisition of Animas the upgrade policy has changed to a practice of increasingly substantially fees. The more so the longer a user has been loyal to the Animas brand. It seems that the policy now is to create incremental product cycles to insure users pay out of pocket upgrade fees. Given that appearance, one can logically assume that Dexcom integration is at least as far down the road as to generate upgrade fees for Johnson and Johnson. Given this appearance of a J&J policy of maximizing out of pocket fees by users, why would anyone consider Ping without a commitment to know pricing for the Dexcom integration?

Here are some suggested fair and honestly acceptable answers.

At Animas we are working diligently to integrate the Dexcom CGM capability into our Ping product. We can not speculate on FDA actions and can not comment on time frames.
(That is a fair an honest answer and I would take it as such.)

Since we do not know what the FDA may require we can not commit to not needing and upgrade.
(again fair and honest answer.)

We at Animas / One Touch / Johnson and Johnson recognize that continuous glucose monitoring is of the highest importance to our pumping clients. We commit to every Ping client that if upgrades are needed to integrate CGM into the Ping system that we will make those upgrades free of charge during the normal warranty period. Users can take advantage of the wireless benefits of the Ping system now knowing they will be able to take advantage of the additional benefit of integrating the Dexcom CGM capability into the ping system with no out of pocket costs.
(That would be a fair and honest answer too.)

Now when they get those first question answered here are some more about the rest of the Ping product.

Wireless Hand Held BG meter questions:
Does hand held meter communicate BG to Dex for calibration as it communicates BG to the pump?

Can multi user households have more than one meter in house w/o confusing pumps.

How will Ping work with Dexcom?
Will Ping communicate directly with the Dexcom transmitter?
Or will users need to carry a Dexcom receiver around also?
Or will hand held meter be the intermediary or we need to carry all three?


About the Ping Pump
Can pump alarm setting be adjusted by time of day and set real loud at night?

Do menus allow for scrolling “around the horn” that is loop from top to bottom and visa versa?

Does Ping still allow for custom music on alarms so that multi pump households can tell which kid’s pump is alarming from the tone?

Has the food database interface been updated to allow for user customization or are Baby food & Beans still in the high priority spots?

Has the food database been given iPod like “Play List” user control?

Is food database customizable for user defined foods in categories?

Is food database exportable to smart phone?

How does Ping communicate to computer? – Still the IR dongle in the serial port?

How does Ping communicate with the remote meter - Infrared, rf, Bluetooth…

How will Ping communicate with Dexcom? - Infrared, rf, Bluetooth…

How Ping wireless communication effect battery life?

How much is a replacement hand held Meter?

How many events does the Ping system record?

Where are those events recorded? In the pump or in the hand held meter.

What events are recorded and is there a provision for recording memos on exercise activity.

Can the Ping talk to multiple wireless meters, for example a separate one at school?

What if you use another meter can Ping work with manual BG entry and does Ping remember the BG you enter into it for down loading?

Why is it bigger?

Does the meter come in colors so families with more than one T1 can tell whose meter is whose?

About Max
Is the ezManager Max software all new?

Is ezManager Max software stable?

Is ezManager Max built on Access?

Does ezManager Max follow win and Mac conventions?

Can users access their data and make custom reports?

Are the ezManager Max data files open source?

Do Ping / Johnson and Johnson support the idea of and commit to open source user diabetes data files?

Does Ping / ezManager Max allow users to plan changes to basal w/o connecting pump?

How does the ezManager Max software get information from the CGM?

Does ezManager Max download data from other meters and CGMs?

Does ezManager Max software anticipate families with multi pump users?

How does ezManager Max report basals rates?

Does ezManager Max have 24 hour basal, bolus, carb, insulin report? Does it correctly report basal rates in the times they were given or does it incorrectly report basals as ezManager does.

Does ezManager Max calculate and report on standard deviation.

Does ezManager Max have a multi day average basal BG report?

Does ezManager Max have a multi day graphical representation of BG like Cosmo’s.

Does ezManager Max have a report report of blood glucose vs. carbs and bolus for evaluation of meal spikes and insulin on board.

Is there a portable version of ezManager Max? Is it in the wireless meter? Can it be put in a smart phone?

Counting CGMS Before they Hatch

For OmniPod and Animas users looking for CGMs integration the news is more FDA reviews. Dexcom’s Earnings call of Nov 4 was released on Seeking Alpha on Sunday Nov 7. It is a long and nuanced call. I am sure a fair amount of that nuance sailed over my head. I recommend folks have a look for themselves if only to get a glimpse at the magnitude of the complexity of the regulatory process.

Here is a way over simplified overview of what I get: The FDA came back to Dexcom and is requesting more data. There is quite a bit of candid conversation in that call. About CGM pump integration and about the FDA looking at insulin pumps with a more heightened scrutiny.

Attempting to translate the call into the simple what does it mean for my pumper language for families living diabetes it comes down to this; CGM integration into OminPod and Animas pumping systems is at pushed back. Taking a SWAG maybe a half year, probably more. This looks to be in part about CGMs and part about tighter regulation of insulin pumps.

Insulin pump companies today are faced with the likely prospect of having their pump products regulated under a new subset of class two devices where approval standards are in a state of flux and human clinical data requirements are unclear.

the FDA is undergoing sweeping changes to its review and approval policies and procedures, and has set forth as a priority an effort to improve the level of regulatory science the agency applies to all medical devices to better assess, evaluate, and review products.

With regard to Generation 4 of the Dexcom system which is what Animas is looking to work with:

we (Dexcom) expect to complete a small additional clinical trial with the Gen4 sensor paired with our next-generation receiver and transmitter, and file an amendment to our Gen4 PMA supplement during the first half of next year. Although we cannot predict the ultimate decision or timing for a decision by the FDA, we believe this amended Gen4 submission will be incorporated into the current Gen4 180-day review cycle, give or take a few months.

OmniPod has some decisions to make about how to proceed. They were expected to launch before Animas based on using the current generation 3 Dexcom product. However the FDA seeking more information means OmniPod may want to look to Gen 4

Insulet, as you'll recall, is paired with the SEVEN Plus. The Animas product, when complete and filed, will be paired the Gen4 sensor.

The Insulet situation's a bit more difficult to describe, only from the standpoint that Insulet's got to make some decisions as to what they want to do going forward, either to move forward with the SEVEN Plus, or if they make the decision to go to Gen4

While there is additional scrutiny in the USA the EU combined Animas/Dexcom system continues to be expected in the first half of 2011.

we remain committed to filing for CE mark approval before the end of this year and expect to be in a position to launch the combination product in Europe during the first half of next year.

In closing my post, I thought this was a particularly telling comment in that I think every patient, parent and partner of a pumper is accurately aware of the seriousness of this statement:

I've long said it amazed me that the pumps were 510(k) products that carry around anywhere from 180 to 300 units of insulin, which is a potentially lethal amount of insulin.

As a parent of type 1 kids I don't take that lightly at all. We accept that as a means to a living more normal, better manages lives. The point of all this technology is to make diabetes secondary to living pseudo normal lifes and pursuing dreams.

Full disclosure: I own shares in Dexcom. I think CGM is a good idea. Dexom is a pure CGM play. Your Investments May Vary, mine sure do.

From The News Wire: DexCom on Animas and Edwards

DexCom is in the news today.

The stock is getting whacked, we hold these truths to be self evident since everything is getting whacked. Some press is about DexCom and not making earnings this quarter. That is par for financial press.

I find more interesting the news that they are entering into an agreement with Edwards Lifesciences Corporation, "to develop products for continuously monitoring blood glucose levels in patients hospitalized for a variety of conditions." The deal brings cash to DexCom and helps get the product into institutional markets. I would think that a wider market for DexCom products is a good thing. Of course your interpetation of how this all shakes out is up to you. I like the idea of a vote of confidence and capital in the CGM feild.

More interesting persoanlly, since we use Animas pumps, are the comments about DexCom and Animas. They are still expecting a product out in the summer of '09. See Seeking Alpha for the full call transcript

"A quick update on our insulin pump partnership with Animas Corporation. We continue to make substantial progress on the joint development of an integrated insulin pump CGM System with Animas Corporation. Our continued goal is to complete all development, clinical and regulatory efforts with Animas and be positioned to launch our first product during the summer of 2009. But, as you are well aware, the timing of regulatory process is uncertain."

There is other good stuff like talking about working with insurance for reimbursement, demand for the product, the JDRF study and lots of geeky finance talk. If that stuff floats you boat enjoy the call transcript.

Your Diabetes May Vary and so does the value of stocks I own including DexCom. Hopefully your A1C is more stable than portfolio. LOL.

From The News Wire: DexCom and Animas

3-Aug-2009 - Entry into a Material Definitive Agreement, Results of Operations and Financial Condit

ITEM 1.01. ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT
On July 30, 2009, DexCom, Inc. ("DexCom"), entered into (i) a Letter of Amendment, amending the Amended and Restated Joint Development Agreement dated January 12, 2009, and (ii) Amendment No. 1 to the Commercialization Agreements, amending the OUS Commercialization Agreement dated January 12, 2009 (collectively, the "Amendments"), each with Animas Corporation ("Animas"). Pursuant to the Amendments, DexCom will collaborate with Animas to develop a modified version of DexCom's transmitter to support a single, global CGM-enabled insulin pump launch by Animas. DexCom is entitled to receive a one-time $1 million milestone payment upon the achievement of performance qualification of a manufacturing line for the modified transmitter and is also entitled to receive an additional one-time $4 million payment upon the first regulatory body approval outside the United States for the new system. The Letter of Amendment modifies the original $5.0 million milestone payment that DexCom was entitled to receive upon receipt of a CE Mark for the first commercializable OUS product. Pursuant to Amendment No. 1 to the Commercialization Agreements the initial term of the OUS Commercialization Agreement is three years from the first commercial product launch, but no later than three years after December 31, 2010.

YDMV Full Disclosure: I own shares of Dexcom. I am also trying to get the things for my kids passed insurance approval.

FTNW: Animas/Dexcom Vibe gets CE Mark

From the News Wire: Animas Dexcom CGM combo get approved in Europe. Here are the highlights and a link:

Animas® Vibe™, the First Integrated Offering from Animas Corporation and Dexcom, Inc., Receives European CE Mark Approval:

WEST CHESTER, PA, June 2, 2011 /PRNewswire/ — Animas Corporation announced today the receipt of CE Mark approval for Animas® Vibe™, the first and only continuous glucose monitoring (CGM)-enabled insulin pump system with Dexcom G4™ CGM technology.  Animas® Vibe™ brings together the unique features of an Animas® insulin pump and the convenience of Dexcom CGM, which is the only sensor approved for up to seven days of wear. More here.

 

Editorializing Conjecture on CGM Pump Intergration

Europe is going to see Dexcom integration into insulin pumps before those of us on the left side of the pond, or so it seems from Dexcom’s earning call. We have to deal with Zombies first. Oh and it is going to named after a Pontiac.

Dexcom’s earrings call is online. You are welcome to go give it a click. I did. It's here: http://biz.yahoo.com/cc/0/121120.html

I listened for news on the integration of CGM into insulin pumps. Dexcom is working on that with both the Pod People and Animas. (I wish I had as good a nick name for Animas as Pod People is for Insulet with visions of the classic 1956 movie Invasion of the Body Snatchers, if you think of one post it as a comment - must be a 50s B movie.)

Where was I other than Zombie Invasions?

Oh Yeah! Earnings calls, the bit on the next generation of Dexcom sensor and combination Dexcom/pump products starts at about 11 minutes into the call. The good news: Dexcom received a CE mark for the 4th generation sensor. That is the one that will be integrated into the pumps. Dexcom expects it to launch in Europe with a Animas pump in the first half of 2011. The call even mentioned the combo pump thing has a name, “The Vibe.” Well, if you are going to name something after a Pontiac, Vibe is better than Aztec but it is no GTO.

Meanwhile the zombie invasion continues within the FDA or at least as far as getting pump/sensor approvals is concerned. Oops, that was a forward looking editorial statement based on conjecture. What I mean to say is that Dexcom publicly reported actual “constructive discussions” with the FDA on what it may take to get a gen. 4 sensor approved here in these United States.

The bit that confused the heck out of me (not that it is all that difficult to confuse me) is apparently in trials the FDA now considers glucose level manipulation a significant risk.

Really?

Hello FDA - Those living with type 1 kinda hav’ta to manipulate glucose levels 24/7. The manipulating blood glucose up is called eating. Bringing, sorry, manipulating blood sugar down is the whole insulin thing. What you are calling significant risk is what families living with type 1 diabetes call daily living. While I appreciate all the carefulness, I kinda, hav’ta, wanta call BS on the FDA for acting like a bunch of zombies pretending they don’t know there is a lot of glucose manipulation going on already.  Better tools would minimize the whole diabetes varies thing and therefor risk in actual daily lives. Doh! that was editorializing conjecture too.

So it seems commercialization of Dexcom / Pump combo is 6 moths off for Europe.  For us, just like it has been for the last few years, best case is a year here. Seems like the same time system as the cure - you know the one that has been ten years down the road for decades.

disclosure

I have two T1 teens, own a few shares of Dexcom and like movies more than earnings calls.

/disclosure

Dexcom, Magic Radars and Connectivity: Q4 Earnings Call

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.) 

Artist's Depiction
(OK not much of an artist)

The most interesting part of the call for me was Terry Gregg talking about Dexcom Share. Share was described as a docking station for a Dexcom receiver that could send information to “designated recipients.” Share would send that information to smart phones. Naturally I assume magic and 50's style radar stations are involved. At one point Dexcom suggest that Share may be the first class III device approved by the FDA to work with a smart phone. I wouldn't know. I do know the FDA mobile guidance is not light reading.

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.

Animas offers rebate on Dexcom G4

Got this email form Animas, haven't found a web version to link:

We've partnered with Dexcom to integrate glucose sensing with our insulin pumps. Find out how we can help you make a smooth transition to next generation technology as soon as it becomes available. Animas pumpers are eligible for a $200 rebate on Dexcom G4™ PLATINUM CGM today. Get the latest, greatest pump technology for just $99 when it becomes available with the ezAccess Upgrade Program.† Call 1-877-YES-PUMP to learn more, and to get all the perks that come with pump therapy from Animas and CGM from Dexcom.   *To receive the $200 rebate, Animas patients must be within their warranty period and must purchase the Dexcom G4™ PLATINUM CGM System by 04/30/2013. †The ezAccess Upgrade Program is effective 6/1/2011 to 4/30/2013. The ezAccess Upgrade Program excludes individuals with Medicare or Medicaid, or any other federal or state healthcare plans. It is not valid for patients who reside in MA. Offer not available to participants of the Animas Access Program or prior ezAccess Upgrade Program participants who have not purchased a full revenue pump since last upgrade. Other exclusions may apply.

Peeping in on Dexcom and the FDA

Dexcom released an earnings call yesterday.

Here is my voyeur's disclaimer: I listen to Dexcom’s earning calls more as Peeping Tom looking in a window into what seems to me to be strange courtship of of industry and the FDA around integrating of sensor and pumps. That is more interesting to me than the perspective of a Dexcom shareholder. I think my bias as a parent of diabetic kids is more pronounced than my vested interest in a few Dexcom shares. That said, as you read this, know I write from personal interests and make no bones about them.

This peep and tell used to be a lot easier when the call was available transcribed on Seeking Alpha. I recommend to anyone foolish enough to take my interpretation of the call as fair and balanced to re-think that and listen to the call themselves. They can find it here:
http://investor.shareholder.com/dexcom/events.cfm
While many, if not most folks may find earnings calls only slightly less dull than watching paint dry, listening for yourself will free you from my slant.

The call starts with new board members and a new president as symbols of plans to grow, whoopee. Wait I own shares that should be: Whoopee!

Somewhere in the call was a mention, in passing, of a type 2 CGM study. I opened another window to peep through and found a link and have posed an abstract of that study.

Dexcom talked about working with the FDA collaboratively to define what they need to do to get trials done for the gen 4 sensor. It sounds like Dexcom is hoping to get clarity from the FDA and have trials and the PMA for the 4th generation product started this year. This is significant because gen 4 is this product that will be paired up with pumps from Animas and Omni Pod. As I understood the call the gen 4 product studies are expected to take 60 to 90, under the heroic assumption that Dexcom has a clue about what the FDA wants. (Sorry, was that too sarcastic about FDA intent?) Dexcom is hoping to have a PMA supplement to the FDA by late summer.

Dexcom said on the call, they continue to expect the Animas / Dex integrated product to be introduced in Europe before it comes to market in the USA. In fact they said they expect the combo product to be marketed before the end of this quarter in Europe.

The Pod product is expected to be the new Pod and the gen 4 sensor. Neither of which as far as I can tell FDA blessed. So while both apparently are in works that sounds a bit further down the road. (Insert you favorite piece of FDA timing skepticism here.)

Dexcom seem to think that US products are in the time frame of end of this year or beginning of next year. If I am not mistaken that has been the expected time frame on each call back over a number of years. (Insert you favorite piece of product timing skepticism here. Which is why parents shouldn’t speculate on this stuff - but hey these tools are possibly a means to better lives for our kids - I mentioned we’re parents right?)

Hold not thy breath, lest ye die.


In the ‘interesting conversation’ side bar realm one of the issues the FDA may worry about is the risk of dosing insulin based on a device that isn’t indicated for that use and may not be sufficiently accurate. {Cough: meters} Far be it from me to point out that meter accuracy has been something that advocates have been calling for an improvement in since the late 80s.  Before the DCCT - the bench mark study on tight control taht got the world chasing tight control with meters that were not designed for that.

Granted meters may be more accurate than sensing but the simple fact of living with type 1 is that it is a balancing act. Part of that balance is coping with less than perfect sources of information. Sensing can ad trend to the over all mix of information. Trend can inform urgency. More importantly studies show sensing makes for better results.

So FDA repeat after me: "Perfect is not be the enemy of better."

I feel a number of my typical rants coming on and am looking around to borrow Glen Bech chalk board. If that isn’t a sign I have carried on too long I don’t know what is.

From the News Wire: Dexcom Call on Seeking Alpha

Dexcom's earnings call transcript is on Seeking Alpha. Now I don't want to deprive anyone of the fun of reading the financial press but just in case wading though ten pages of CEO and Analyst speak isn't you idea of high times, here are the highlight with regard to CGM pump integration:

Terry Gregg Dex CEO

A quick update on our insulin pump partnerships with Animas and Insulet. In January of this year, we announced an expansion of our Animas relationship to an exclusive agreement to develop and market integrated insulin pump CGM systems in markets outside the US. In return, Animas will pay us $5 million upon receipt of a CE Mark for the first OUS commercial product that is expected either later this year or early in 2010. And in addition Animas will pay DexCom a royalty of $200 per CGM enabled pump sold in any OUS market. As parts of this agreement, Animas will also serve as a nonexclusive distributor of transmitters and sensors to purchasers of the Animas CGM enabled pumps outside the US. This exclusive arrangement has an initial term of three years.

We continue our development work on the integrated insulin pumps CGM systems with our pump partners. Our continued goal is to complete all development, clinical and regulatory efforts on these joint development projects and be positioned to launch a first product with Animas during 2009 and with Insulet sometime the following year. But as you are well aware, the timing of the regulatory process is uncertain.

There is a little more on page 9 including, "Well, I can't speak for them." Hmmm wonder if Terry got his hand slapped for saying more that the partners wanted in previous calls.

So pump fans this just ads to our what do we do about the pump that is up for a new 4 year hitch in April problem. If we re-up now we will more than likely need to pay a big fat upgrade fee in just a few months. Why sign up for a four year deal when it look like significant improvements are literally in for FDA approval?

Just to be on the up and up, I do have shares of Dexcom in my IRA. Jacques Cousteau and the team from the Calypso have sent divers looking but the portfolio is so far underwater they will need the mini sub any artifacts from it. LOL Maybe they will save the day by coming up with that huge diamond from the last scene of Titanic...

Dex on Ping / Pod

Some of the questions in To Ping or not to Ping had to do with how the integration of the Dexcom CGM will work with Animas’ future pump. While Animas is not offering up any particulars the other side of the relationship is. And they are also talking about how it will work with the Pod.

Thanks to the good folks at Thomson Financial and Voxant we can see what DexCom, Inc. had to say at the Citigroup Healthcare Conference this year.

Technology integration partnerships -- in January of this year, we announced two separate partnerships, one with Animas Corporation, a J&J subsidiary, and one with Insulet Corporation. In each of these arrangements, we would seek to develop an integrated insulin pump CGM system. What that will entail embedding our proprietary software and hardware design into the Animas pump in the case of Animas, or into the Insulet PDA in the case of Insulet. That will allow the user to display CGM data on the screen of their pump or their PDA. This results in the elimination of the patient having to carry a separate DexCom receiver, but it will retain all of the same functionality within those devices.

The full transcript is here.


Well that sort of sheds some light. Maybe what is what is in the slightly larger Ping case is the DexCom stuff.

But that was before the Ping introduced the idea of a controller like meter / remote like the Omni Pods with a traditional pump. So maybe it doesn’t shed much light other than we shouldn't expect to carry a DexCom receiver.

FTNW: Dexcom Earnings Call

The Dexcom Earnings call went up on Seeking Alpha 5/5. It sounds like they will be out with pump CGM integration with OmniPod sooner than with Animas.

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.

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

Later they said of the Animas trasmitter:

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.

Terry Gregg
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.

Terry's Two Bits on DexCom and Pumps

Not much has come down the information super highway about how the DexCom CGM will work with pumps. We're told it will work with pumps and to be looking next summer / fall. There were some tidbits in the DexCom presentations to wall street. So figured what the heck why not write them a letter. Here is what I wrote and their reply:

Terry Gregg
President & CEO
DexCom, Inc.
6340 Sequence Drive
San Diego, CA 92121

Hi Terry

I have a particular interest in DexCom, in a small ways as a both a little share holder on a pure CGM play and as a diabetes blogger and in a very large way as the parent of two type 1 kids who have a very real long term interest in continuously managing their glucose.

I had the pleasure of talking to some of your team at Children With Diabetes Friends for Life conference in Orlando last month. Thanks for sending them. Maybe next year you can arrange for some trials of your device like MiniMed did this year. That would be great! A two day trial of their device dramatically changed my 14 year old son’s disinterest in wearing a CGM into a tangible interest in using one.

Since then I have read over your comments on earnings calls reported on Seeking Alpha. I have some questions that you may or may not know answers to.

In the March 11 call you talked about how DexCom and the pump folks will deliver data to us, families with diabetes. You said:

“In each case, DexCom’s CGM data will be displayed on the partner’s pump. In addition to insulin dosing information, patients will have access to glucose trend information, as well as high and low alarms, all in a single display unit.”

http://seekingalpha.com/article/68139-dexcom-incorporated-q4-2007-earnings-call-transcript?page=2

That sounds like how MiniMed is doing things now. That is good except we don’t love their pump. It is an attractive approach to CGM Pump integration as it requires less belt space on my daughter’s Batgirl like utility belt of diabetes gadgets.

I have to wonder is that ‘on the pump’ approach really going to be the case? Insulet most obviously will bring the data to their PDA like controller. For their approach to pumping the PDA is the pump interface.

Animas seems to be going down a similar path with the Ping meter/remote. Given that, do you continue to see the CMG data showing up on the partner’s pump or on will it be on another device like the remote control meter? Unlike heads to solve a problem, where two is better than one, for diabetes junk for a kid to carry one device is better than two.

Further the flexibility to choose the meter that best suits the user’s lifestyle is a feature that would be limited but using a PDA Meter as an intermediary. I would hate to be required to use the Pod or Ping meter to calibrate the CGM. But then you know recognize this value by your recent effort to get approval to us any meter to ‘Open Code’ the Seven unit.

So will it be CGM data displayed on the pump, or a meter in between?

Respectfully Yours

Bennet

Terry emailed back:

Bennet,

Thank you for your letter. Insulet will indeed display our sensor readings on their PDA. With respect to Animas, our first generation combination device will display on their pump for regulatory reasons, followed by future iterations utilizing remote programming devices (i.e., Ping). It is our goal to have these remote devices utilize an "Open Choice" format for the SMBG calibration.

We are actively pursuing a pediatric claim for our device and hope to have approval sometime next year.

Regards,

Terry

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.

Dexcom and Tandem Announce CGM Development.

From the News Wire:

SAN DIEGO--(BUSINESS WIRE)-- DexCom, Inc. (NASDAQ:DXCM - News), a leader in continuous glucose monitoring systems, announced today that it has entered into a Development and Commercialization Agreement with Tandem Diabetes Care, Inc. to integrate a future generation of DexCom’s continuous glucose monitoring (CGM) technology with Tandem’s t:slim™ Insulin Delivery System, the first ever touch-screen insulin pump.

Under the terms of the Agreement, Tandem will pay DexCom a technology license fee of $3 million, reimburse DexCom’s development, clinical and regulatory expenses, and upon commercialization of the combined system, Tandem will pay DexCom a royalty of $100 for each CGM-enabled insulin pump sold. 

more here

So that is Animas, Omni Pod, Roche and Tandem all working with Dexcom to integrate DGM into their pumps. I think the Animas agreement is exclusive outside the US (see this post). So all the agreements are nice and all, I hope that we see some products in the marketplace.

DexCom(TM) Announces Joint Development Agreement with Animas

So Here is the answer to my question about where is Animas

Partnership Will Focus on Developing a Continuous Glucose Monitoring System
to Work with Animas(R) Insulin Pumps

SAN DIEGO--(BUSINESS WIRE)--DexCom, Inc. (NASDAQ: DXCM - News), a leading provider of
continuous glucose monitoring systems for people with diabetes, today announced
that it has entered into a joint development agreement with Animas Corporation
to integrate DexCom’s continuous glucose monitoring (CGM) technology into
Animas® insulin pumps.

http://biz.yahoo.com/bw/080110/20080110005232.html?.v=1

Dexcom as Entertainment News

I took one for the DOC team and listened to the Dexcom presentation at the 28th Annual JP Morgan Health Conference. You don’t have to.

You are welcome.


After a fair amount of opening material for the folks who not only don’t know what Dexcom does or what diabetes is, (about 15 to 16 minutes) it got a little more interesting. That is when Terry Gregg talked about coming attractions.

PREVIEWS!

Always one of my favorites at the local Multi Plex. Here is what you can expect in this summer's block busters: Lt. Uhura is on the case and she found an open COM channel. Dex will talk to pumps, Animas and Omni pod were specifically seen in the trailer. The expectation is it will be in theaters this year (2010.) YDMV. Yeah Lt Uhura! Must be the next generation hot, smart and unimpressed buy the new Kirk, Uhura. (Wait! Wasn’t Newkirk on Hogans Heros before kissing all the ladies on that game show?)

Dexcom the next generation is coming too, where in Geordi La Forge will tweak the warp drive and they will be able to have the replicator produce more and better sensors. Also in the “Mid Term” Next Gen, faster tricorder warm up and better accuracy via more groovy math. So I guess it will also feature Charlie Eppes from NUMB3RS. Also this Mid Term starts to get more interesting as Dexcom moves the glucose engine to the transmitter. The intent is open architecture on the receiver end. Think Phones. Yes Terry mentioned the 'produce' brand names of phones (apples and berries) as likely open source receivers.

Skipping out of the entertainment news and into the business section. Animas pays out big when Dexcom get the regulatory blessing of a CE mark. $5 million. They also pay Dex $200 for every non USA pump sold with the integrated CGM. That is expected this year too. Now if I was the type to speculate without any knowledge, facts, wisdom or anything else resembling a clue, I would think J&J would be looking to buy the whole company outright at that point but that would be baseless and totally irresponsible of me.

So for families dealing looking for integrated CGM options 2010 should be a good year both in and outside the US of A.

Live Long and Prosper.

(Oh and the real entertainment Buzz at Sundance is on a flick called Buried.)

Animas® Vibe™ Insulin Pump and CGM FDA Approved

The Vibe has been approved by FDA!

Integrated System Streamlines Diabetes Management for Patients 

CHESTERBROOK, Pennsylvania, Dec. 1, 2014 / PR Newswire / — Animas Corporation today announced FDA approval of the Animas® Vibe™ insulin pump and Continuous Glucose Monitoring (CGM) system for the management of insulin-requiring diabetes in adults ages 18 and older. As the first and only integrated system featuring Dexcom G4® PLATINUM sensing technology with proven accuracy, Animas® Vibe™ allows patients to view glucose data and administer insulin right from the pump; simplifying and aiding their ability to make more informed decisions to fine tune insulin delivery and manage their diabetes. 

Animas is now accepting orders for Animas® Vibe™ and anticipates shipment to patients to begin in January 2015. For more information, visit www.animas.com. 

More: http://www.multivu.com/players/English/7312951-animas-corporation-vibe-insulin-pump-continuous-glucose-monitoring-system-fda-approved/ 

From The News Wire: DexCom on Animas and Podd

From DexCom's Earnings Call as reported on Seeking Alpha - Their thoughts on CGM and Pumps and the next generations of the DexCom product.

Terry Gregg - DexCom President

..Our continued goal is to complete all development, clinical and regulatory efforts with Animas and be positioned to launch our first product during the summer of 2009. But, as you are well aware, the timing of the regulatory process is uncertain we would expect to combine product with Insulet to follow later in 2009.

We are also pleased to report that we have filed a PMA supplement for a third generation continuous glucose monitoring system with the Food and Drug Administration. Data from our approval support trial demonstrated significant improvements in system on time and improved accuracy as compared to our current product. In addition our third generation system will include twin doors to complement our turn graph and event entry capabilities such insulin intake, (inaudible) exercise as well as configurable alarms.

Keep inline with generation alliterations we continue to make progress on our fourth generation product. We expect this design to incorporate an enhanced membrane system, we have been greater accuracy and be suited for large volume production. Additionally our fifth generation sensor is now being tested in humans in connection with our in-hospital product.

http://seekingalpha.com/article/89295-dexcom-inc-q2-2008-earnings-call-transcript?source=wl_sidebar&page=3