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Sunday, January 01, 2012

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Rich Berkowitz

Where have they gone indeed? As one would say, ‘that’s a good question”. Surely Fresenius doesn’t think the Baby K is the answer for home hemodialysis. Not when a growing number of people are demanding portability so they have the option to travel. So far NxStage is the only game in town, and with a growing following. But dialyzors have been demanding more even from the leader in home hemodialysis. Since its inception dialyzors have gotten just a taste of what a home machine can do. From the time ten NxStagers cruised together on the Freedom Cruise to dozens of dialyzors and care partners going to NxStageUsers Meet Ups and Conferences, people have learned travel and a better quality of life need not be given up from the lack of inadequate therapy. Yet, we want more. We want easier and lighter machines. We want to be able to live “normal” lives.

NxStage should certainly be credited for re-establishing home hemodialysis after it had practically disappeared from the landscape. The Aksys machine didn’t survive, although it too allowed people to go back home. The Allient from Renal Solutions was supposed to be the new entry and even got its FDA approval to be marketed. Fresenius could have and should have introduced it to the marketplace after its purchase. They certainly had the finances and a defined market since it’s the largest dialysis provider in the country. It seems like it should have been pre4tty easy with its captive patient base.

So why did Fresenius not introduce a machine that seemingly didn’t required any additional work. Peter asks a good question and I think we deserve an answer. Was Fresenius serious about home hemodialysis, or was the purchase of Renal Solutions and Xcorporeal a way to stifle the market.

Many people believe the FTC should force the breakup of both Fresenius and DaVita as both continue in their rampant consolidation of the dialysis provider arena. But perhaps a closer look is due at a company which, because of its wealth, is looking to control dialysis in other insidious ways. How can we let this continue? If other machines are available, dialysis patients should have a choice of what is better for them. And surely the RSI sorbent technology would have been able to be put into a more portable chassis.

So what are the intentions of Fresenius? We do know that Renal Solutions filed a
510K for the 2008 Sorbent Hemodialysis
machine in August 2010. It named the predicate devices as the Allient and the 2008T Hemodialysis Systems. Please don’t tell us these are the plans from a purchase that had so much promise for home hemodialysis. Fresenius, please tell us that you are trying to expand the potential for home hemodialysis.

HemoDoc Fan

Well, Fresenius actually had it's "2008 Sorbent Hemodialysis" system - basically a Fresenius version of the Allient - approved by the FDA in August 2010, but they don't seem to have started marketing it yet. Perhaps they don't plan to. I don't think it would be a big hit anyway - given its size. However, Fresenius has also told investors lately that they are set to launch a PAK - Portable Artificial Kidney - based on sorbent technology (similar to the machine Xcorporeal showed drawings of) in 2012. That could - as opposed to the bulky Allient - be a real game changer for home hemodialysis patients. So I guess, we'll just have to keep our fingers crossed and hope for an exciting launch in the new year.

MooseMom

I'd love to know who "HemoDoc Fan" is! LOL! Do you have some inside knowledge? Do you think we realistically can hope for some good news on this front in 2012?

Peter Laird, MD

HemoDoc fan? My wife is still laughing at the notion that I have a fanclub, but thank you for the sentiment and your kind comments. She still is just trying to get me to pick up my dirty clothes and make the bed so the thought of a fanclub of sorts is quite a hard concept for my wife.

As far as the PAK, it would still have to go through the proper clinical testing prior to launch. FMC and all of the new innovative dialysis machines are keeping all of their cards close to their chest so to speak. If the PAK becomes a reality soon, then NxStage and the others will counter with their upgraded machines as well. It could be a very exciting time in dialysis, at least we can only hope.

MooseMom

I think you are very deserving of a fanclub, Hemodoc. Your wife is just envious. ha. Now, pick up your socks!

HemoDoc Fan

HemoDoc, you are of course right that FDA's approval process will apply also to Fresenius coming PAK - so it would clearly be impressive if they'll be able to start marketing it in 2012. However, from what they are telling investors, they clearly seem to be aiming at least at having it approved in 2012, and my guess would be that they will be using the approved "2008 Sorbent system" as a "predicate device" to speed up the approval process.

This is the Xcorporeal machine they seem to have had as a model for the coming PAK: http://www.businesswire.com/news/home/20081112005484/en/Xcorporeal-Announces-XCR-6-Dialysis-Platform-Self-Directed-Kidney

Now, compare that picture with what Fresenius has been showing investors lately, e.g., on slides 7 and 12 in this presentation: http://www.fmc-ag.com/files/110920_SCB_Strategic_Decisions_Conf_Ldn.pdf

Also, don't forget that Baxter has a new HHD device under trial right now (started the trial in August 2011), and that NxStage claims to be working on the next generation of its machine.

The future looks bright!

Peter Laird, MD

Dear HemoDoc Fan, great links to the PAK and Xcorporeal machine. I am hopeful that indeed, market competition will finally bring to pass what the American nephrologist has ignored and abandoned since the early days of hemodialysis. We always seem to forget the dialysis originally was at home and for what would today be defined as extended dialysis.

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