PODD Earnings Call Info for Patients.

The PODD earrings call is  on Seeking Alpha. Here are a few points I thought patients may like to know.

New PODDs in weeks 

For our existing customers, we will begin the transition from the original product to the new OmniPod in the next few weeks. 

Verio PDM 

... we expect to file in the coming months a submission requesting 510(k) clearance for a PDM integrated with LifeScan Verio blood glucose meter. We are hopeful that this new PDM will be commercially available in 2013  

IOB 

... one of the blocking things that was out there was our whole insulin on-board calculation and not to bore everybody with the kind of arcane way we did it, but we thought we had kind of a better mouse trap. It wasn't the way the market leader did it. So this product basically put it in line with the way the market leader did it

CGM 

.... Finally, in January, we signed an agreement with a new continuous glucose monitoring partner. The agreement calls for both parties to continue development work already underway towards the ultimate goal of an OmniPod integrated with a CGM sensor. 

In Q& A re the name of the sensor partner, 

... we have with the company until we get to the point where we think we have a final version, a commercial version, we agreed not to give involved in disclosing that 

.... we tested on pigs, so far so good. Sometime next year we'd like to be doing it on people. And we'd like to be doing it on people not as a stand-alone sensor, but in our integrated format. So the big engineering hurdles/opportunities for us is how do we insert this within the framework of the product we have? And how close can it be to the insulin delivery? And the third one is -- and we've tested this a lot now, but we still have to go through in testing it in final is can the sensor withstand ETO sterilization. 

There is more on the CGM partnership in the Q&A part the call. Hop over to Seeking Alpha if you are interested.

OmniPod 2.0 Approved.

This just in:
Insulet's (PODD) Next-Gen OmniPod Receives FDA 510(k) Clearance

http://www.streetinsider.com/related.php?id=7949280&type=pr

Press Release:


BEDFORD, MA -- (Marketwire) -- 12/14/12 -- Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology, today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the next-generation OmniPod Insulin Management System. The new OmniPod insulin pump is more than one-third smaller and one-quarter lighter than the original model, while maintaining the same 200-unit insulin reservoir capacity and easy-to-use features. In addition to the smaller, lighter Pod, the new OmniPod System includes an updated Personal Diabetes Manager (PDM) that also features a series of enhancements.

"The OmniPod revolutionized insulin delivery with its tubeless and wireless design when it was introduced in 2005 and today, the next-generation OmniPod raises the bar for insulin pump therapy again," said Duane DeSisto, President and Chief Executive Officer of Insulet. "We are thrilled to have received FDA approval and it is my hope that our new Omnipod insulin pump will continue to make living with diabetes easier for our customers across the United States."

"When technology can make diabetes management easier for my patients, they have better clinical outcomes," said Steve Edelman, MD, Clinical Professor of Medicine at the University of California at San Diego and founder of Taking Control of Your Diabetes (TCOYD), a not-for-profit organization with the goal of teaching and motivating patients in diabetes self-care. "As an OmniPod wearer myself, I love its ease of use and no tubing! Now with its smaller and sleeker design, it will make it even easier for more people to take control of their diabetes."

"Preparations are underway to launch the new OmniPod, including training of healthcare professionals and transitioning the rest of our manufacturing production," said Mr. DeSisto. "We expect that these initiatives will take approximately two to three months to complete and anticipate our first shipments in the U.S. to occur in late Q1 2013. Like the System itself, converting our current OmniPod users to the new system has been designed to be extremely easy as to ensure a seamless transition."

Customers are encouraged to keep informed via http://www.MyOmniPod.com/NewOmniPod where the Company will publish its latest information about the exact timing and availability of the new OmniPod System, including details on how current users will be converted. Additionally, current users will receive direct notification from the Company when the conversion process is commencing.

While performing its launch preparation initiatives, Insulet continues to collaborate closely with healthcare providers and patients so they can enjoy the many benefits of the current OmniPod today.

About the OmniPod Insulin Management System The OmniPod Insulin Management System is the world's first tubeless insulin pump. The OmniPod offers people living with insulin-requiring diabetes all the benefits of insulin pump therapy, with freedom and ease. The tubing-free OmniPod insulin pump has just two easy-to-use parts: the discreet, waterproof Pod, which automatically inserts and can be worn on many parts of the body to hold and deliver insulin; and the Personal Diabetes Manager (PDM), a hand-held device that wirelessly programs the Pod, calculates suggested doses and has a built-in blood glucose meter. For more information on the OmniPod insulin pump, please visit: http://www.myomnipod.com.

Forward-Looking Statement This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and of Section 21E of the Securities Exchange Act of 1934 concerning Insulet's expectations, anticipations, intentions, beliefs or strategies regarding the future, including those related to its planned expansion of sales of the next generation OmniPod System in the U.S. and abroad, product demand, the market acceptance of our next generation OmniPod System, regulatory matters and financial performance. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the Company's dependence on the OmniPod System; Insulet's ability to increase customer orders and manufacturing volumes; adverse changes in general economic conditions; impact of healthcare reform legislation; potential supply problems or price fluctuations with sole source or other third-party suppliers on which Insulet is dependent; international business risks; Insulet's inability to obtain adequate coverage or reimbursement from third-party payors for the OmniPod System and potential adverse changes in reimbursement rates or policies relating to the OmniPod; potential adverse effects resulting from competition with competitors; technological innovations adversely affecting the Company's business; potential termination of Insulet's license to incorporate a blood glucose meter into the OmniPod System; conflicts with the intellectual property of third parties, including claims that Insulet's current or future products infringe the proprietary rights of others; adverse regulatory or legal actions relating to the OmniPod System; failure of Insulet's contract manufacturers or component suppliers to comply with FDA's quality system regulations; product liability lawsuits that may be brought against Insulet; reduced retention rates; unfavorable results of clinical studies relating to the OmniPod System or the products of Insulet's competitors; potential future publication of articles or announcement of positions by physician associations or other organizations that are unfavorable to Insulet's products; the expansion, or attempted expansion, into foreign markets; the concentration of substantially all of Insulet's manufacturing capacity at a single location in China and substantially all of Insulet's inventory at a single location in Massachusetts; Insulet's ability to attract and retain key personnel; Insulet's ability to manage its growth; intense competition among distributors of diabetes supplies impairing Insulet's business; failure to retain key supplier and payor partners; the expansion of Insulet's distribution network; and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 28, 2012 in the section entitled "Risk Factors," and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

About Insulet Corporation Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes. The OmniPod is a revolutionary and easy-to-use tubeless insulin pump that features just two parts and fully-automated cannula insertion. Insulet's subsidiary, Neighborhood Diabetes, is a leading distributor for diabetes products and supplies, delivered through a high touch customer service model. Founded in 2000, Insulet Corporation is based in Bedford, Mass.

Contact:
Stephanie Marks for Insulet Corporation
ir@insulet.com
877-PODD-IR1 (877-763-3471)

Erich Sandoval for Insulet Corporation
pr@insulet.com
917-497-2867

Source: Insulet Corporation

PODD Call re: Dexcom

In writing about yesterday's Dexcom earnings call I noted that they left Insulet (aka stock symbol PODD) out of the Dexcom/Pump integration conversation. Today PODD had their earnings call and at about the 12:00 minute mark spoke briefly about CGM. They said that they have had conversations with Dexcom about integrating the Gen 4 into the new OmniPod product and expect to “soon commence” work on integration. They say that the integrated device is expected to also use the LifeScan Verio strip.

OmniPod fans may want to listen to the call and break out their tea leaf reading skill. Management did speak to the FDA process and the new device. They have been working through details with the agency. I sounded to me like they are woking on some final interface issues, the entry of some information and training. I will be honest I am not particularly well versed in OmniPod. A cold war Kremlinologist or and an experienced Pod user may be able to gleam more out of what was said than I can.

The PODD call is online here: http://investor.insulet.com/events.cfm

YDMV

OmniPod and One Touch to Connect

From the News Wire:

Johnson & Johnson's market-leading LifeScan blood glucose monitor will be incorporated intothe remote controller for Insulet's next-generation OmniPod insulin pump.

The next generation of Insulet's (NSDQ:PODD) OmniPod insulin pump, which is awaiting 510(k) clearance from the FDA, will be compatible with the LifeScan blood glucose monitoring technology made by Johnson & Johnson (NYSE:JNJ).

The 2 companies inked a deal for LifeScan's OneTouch technology to be incorporated into a new personal diabetes manager that patients use to control the OmniPod. Insulet's chief commercial officer, Peter Devlin, told MassDevice.com that the company is targeting a mid-2013 commercial release.

More: http://www.massdevice.com/news/diabetes-insulet-inks-deal-with-jjs-lifesscan-next-gen-omnipod

Happy New Lancet and Butterfly Pod People #TwoBits

Here is a quick #TwoBits* from around the DOC.

First Happy New Lancet form our pals across the pond at Shoot Up or Put Up who say;

"Happy New Lancet to all our readers, Please join us in cracking open a brand new shiny lancet in celebration of the new year."

Leighann has a post reporting that Butterfly strips are now approved for the OmniPod so Happy New Strips to the Pod People.

*If you see an interesting pair of posts around the Diabetes Online Community (DOC) how about sharing them with the rest of us with the hash tag #TwoBits in case others missed them?

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.

From The News Wire: Artificial Pancreas Used in T1s

Hi there YDMV fans. This one sounds interesting. Dexcom & Omni Pod used in closed loop:

NEW ORLEANS, June 8 /PRNewswire/ -- UC Santa Barbara and SansumDiabetes Research Institute scientists have demonstrated for the firsttime that an automated artificial pancreas system (APS) can safely andeffectively maintain desired blood glucose levels in patients with type1 diabetes. The clinical study results will be presented today in alate-breaking poster session(1) at the American Diabetes Association's69th Scientific Sessions in New Orleans.

The UCSB and Sansum researchers, working with the Schneider Children'sMedical Center of Israel, tested an automated insulin delivery systemcomprising the OmniPod(R) System and the DexCom STS7(R) continuousglucose monitor, linked and controlled through UCSB's artificialpancreas software. The software's insulin delivery algorithm, optimizedfor each patient, includes a unique safety feature, based on clinicalparameters, which prevents insulin-induced low blood glucose levels(hypoglycemia).

Read the full story here:

http://www.itnewsonline.com/showprnstory.php?storyid=50113

Clearly there is a lot of work going on and lots more to come. PWD are not going to see these at there next endo visit. It does get me wondering, how would you feel about using a closed loop?

There are so many non-insulin delivery variables in the YDMV equation that I am kinda sceptical. (I know me being skeptical who would have thought it?) How does it know there is exercise coming up? How does it account for stress?

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

Why Buy into Pumping

Not the idea of pumping Better is Better makes that case brilliantly. (5/16 editor note: Better is Better link has gone dead see the book.)

Why buy them?

In the next 4 years there will be a wholesale change in the insulin pump world. We have to be excited that the rate of change is accelerating. (See calculus geeks, we can love that second derivative too.) There is a lot of talk of more pod like products coming down the road. Amy has written about two, the nano pump and the behind the glass (you can't take a picture of it Amy!) MiniMed wearable pump prototype. MM would like us to believe that it is coming by 2010. NIH is sponsoring talks on the closed loop. The CGM market is expected by some to exceed the pump market in the coming years.

OK! OK! I know it isn't all roses, there were those who thought the Bong was a good idea too. Cool as it all may be it isn't Really Cool.

So why do we buy the actual pump? Is ownership the best financial model and if so who is it best for, patients, vendors or insurance companies?

Maybe we should lease them. It works for cars and office equipment.

Maybe we should rent pumps or as in the Omni Pod model throw them out with every set change. In the current buy-for-a-four-year-commitment we get stuck in a technological time-warp for 4 years. Unless we upgrade and upgrades are not typically covered by insurance. Even with insurance diabetes isn't cheap.

Anyone keep a cell phone for four years? I didn't think so. And no matter what any teen says, a cell phone isn't life saving technology.

About that insurance, the insurance company pays a large up front fee for a product it is betting will work for the patient. It may it may not. If the pump doesn’t work in a patients life style, it sits on a shelf un-used for years. The insurance company has already paid for all 4 years.

Renting or leasing would get rid of that big bump up front for the insurance company (OMG I just made a suggestion to save an insurance company money - hell must have frozen over.) If the lease term was less than 4 years pump patients could benefit from advancing technology faster.

The Pod people have an interesting model going. Every time you toss out a pod it is an opportunity to upgrade the functionality of the product. They have a lower up front cost but as I understand it have higher cost of consumables. This lowers the cost of entry that is good for expanding the market even with insurance. (Can you say lower co-pay?)

Lowering the barrier for entry also raises the need for customer service because changing becomes cheaper. If you read their conversations with the financial press (I do - so I must have no life) you will see that the Pod People are very aware of the importance of customer service. I have to think that people with diabetes can only benefit from increasing the priority of service.

Don't get me wrong, I am not saying service is bad in the pump business. Animas has provided great service from day 1. Yet regular YDMV readers know I still beat the heck out of them. We're talking about two of my kids' lives here - no good deed goes unpunished, sorry Audrey.

New business models would give the traditional pump users the opportunity to take advantage of new products faster. I would expect that there would higher consumable cost or possibly recognition (a word that here means benefit to the consumer) of the annuity value of consumables as part of the user / manufacturer relationship.

Hello? Insurance dudes? You can innovate and be creative - life isn't all actuarial calculations and denial letters.You can be part of a brave new world! Step up and create a pump rental payment plan.

If we are moving to more pod-like experiences where the technology is the consumable, why root the traditional pump in a different, traditional 4 year user cycle? In a YDMV world some folks are gonna like traditional pumps. Why can't they benefit from innovative business models as well as innovative technology too? Why do we have to wait for more pod people to land before overhauling the sales and service space?

So my YDMV friends, which is more innovative, the wear the pod pump or the business model that shortens the technology cycle for pump patients?

ps. Amy had a post on renting here. Thanks for pointing that out Amy.

Software that Works?

Animas apparently the only pump company with crapware. Amy at Diabetes Mine writes about new and improved Omini pod software today. (And has nothing good to say about their software V 1.0.) In that piece, Amy make the point that new pumpers don't want to loose data.

Neither do old pumpers.

I look forward to better software from Animas. I will be sure to look at the Pod People's at Friends For Life next month.

All the more reason for an industry standard data structure. (Calling Bernard) This is our information and we need to press our service providers to serve us.

If we are lucky making it ours vs theirs is v 3.0. I am not holding my breath.