Has Anybody Here, Seen my Old Friend Allient? Can you Tell me Where he's Gone?

By Peter Laird, MD

In June of 2006, Renal Solutions achieved FDA approval of their new sorbent dialysis machine that uses potable tap water to generate dialysate. The REDY system came out of the NASA space program that regenerated potable drinking water from the astronauts urine. Clinical applications of this process resulted in the REDY system which many early dialysis patients used successfully for temporary travel. Renal Solutions redeveloped this process with new and updated technology ready for the market by the end of 2005. However, we are still waiting the first patient use of this new technology today.

Renal Solutions Ready for Commercial Sales

August 9, 2005

With preliminary FDA approval in hand, the Pittsburgh Business Times reports that Renal Solutions is set to receive the first of its portable kidney dialysis system this week to begin testing to ensure they were built to the company's specifications. Insitutional sales to nursing homes and hospitals will begin over the next several months. Sales to the home user market will wait until further trials are run and final FDA approval is granted. The Company expects final approval for sale to home users early in 2006.

Xcorporeal developed another sorbent based innovative dialysis machine that expected to market their product by 2009 opening the door to even more patients having access to home hemodialysis. Now, in 2012, neither Renal Solutions or Xcorporeal have been seen by any home dialysis patients to date.

New Machine Makes Home-Based Dialysis a Reality for Millions of Patients Worldwide

LOS ANGELES--(BUSINESS WIRE)--Xcorporeal, Inc. (AMEX:XCR) announced today the XCR-6 Dialysis Platform for self-directed kidney hemodialysis. The XCR-6 will be the smallest, lightest, and easiest to use dialysis machine ever conceived, using Xcorporeal’s proprietary closed loop, regenerated dialysate technology platform. The Company is currently preparing for unattended/home use clinical trials of the XCR-6 in anticipation of commercialization in the near future.

Xcorporeal's Wearable Artificial Kidney Prototype Device Featured in Los Angeles Times Article

For the RRT market, Xcorporeal is developing a portable, multifunctional renal replacement device that will offer cost effective therapy for those patients suffering from Acute Renal Failure (ARF) which causes a rapid decline in kidney function. In the U.S., the disease affects more than 200,000 patients annually, with a mortality rate of 50%. The Xcorporeal platform technology is a natural fit for the hospital market of renal replacement therapy since the technology is designed to provide cost-effective, continuous therapy without the need for expensive replacement fluids. The projected 2007 market opportunity for the U.S. is approximately $1.4 billion. The disposable market is expected to grow at 10% per year. The devices typically need to be replaced every five years. The Company intends to commercialize this device during the first half of 2009.

Where have these machines all gone? The answer is apparent when we realize that a corporate giant bought both of these companies several years ago with the alleged hope that the infusion of capital would promote more rapid development of this new technology, yet today, we are still waiting for any sign of progress. The corporation now holding the patents to these innovative machines is Fresenius Medical Care, the largest manufacturer of dialysis machines in the world.

Fresenius Medical Care acquire techology to advance home hemodialysis and create a platform for development of a wearable kidney

Dr. Ben Lipps, Chief Executive Officer of Fresenius Medical Care commented, “The acquisition of RSI is an important step to advance the technology required for strong future growth in this field. The combination offers us the long-term opportunity to extend our leadership to home and acute dialysis products. Furthermore, by combining our equipment and membrane technology with the SORB technology, we can provide innovative solutions in the future such as a possible wearable kidney. With this acquisition, Fresenius Medical Care expects to increase its annual R&D spending by approximately $10 million starting in 2008. Our mid-term financial targets for the years 2007 through 2010 remain unchanged.”

Fresenius Buys Xcorporeal for $8 million

LOS ANGELES—Fresenius has agreed to purchase Xcorporeal Inc., which is developing a wearable artificial kidney, for $8 million.

Xcorporeal is a medical device company developing an extra-corporeal platform technology to be used in devices to replace the function of various human organs. The platform includes three initial products: a Portable Artificial Kidney (PAK) for hospital-based renal replacement therapy, the XCR-6 for home hemodialysis, and a Wearable Artificial Kidney (WAK) for continuous ambulatory hemodialysis.

Month after month, year after year, the machines that had FDA approval for clinical use in 2006 still continue in shrouded mystery as to when they will actually be released. Several experts state that the technology is an improvement and a solution to many in need of home dialysis options here in the US and around the world. The fruits of the NASA space program lie dormant to date for the hope of the future of dialysis hidden within the confines of the secretive bureaucracy of the largest dialysis organization in America. The jury is still out on whether FMC bought these companies to expand home dialysis options or instead to stifle competition with their own dialysis oligarchy. The only proof of the former will be the actual release of sorbent technology for clinical testing and rapid penetration of the home dialysis market. Until then, all we can ask is where have they gone for we know that the good, they die young.

 

Comments

[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.