Good Morning-
I was wondering about the status of the development of the home dialysis product. I noticed that their stock is currently at 3 cents a share. Are they moving forward with development?
Re Xcorporeal (and others)
While I am aware of some of the information you seek, there is much activity in the home dialysis equipment arena right now - indeed there has been for some time: Fresenius/RSI, Baxter, Xcorporeal, the Quanta, the C-Pak, the Awak, the Pd-sorb, the Dutch consortium, and others, just to name some.
All (understandably) play their commercial cards close to their chests and there are a range of commercial-in-confidence ‘bindings’ that prevent a great deal of free-to-air Internet of other platform discussion. Excorporeal is within that mix.
Are they (all) moving forward with development? … essentially the answer is ‘yes’ though the speed and strength of that movement is dictated by capital - often venture - the access to which has significantly changed since finance unhinged in the US in 2008. That changed a lot of things, with R&D and regulation both being part of those changes, both within the US and outside it.
While I have been involved and/or in touch with some of these - to a greater or lesser extent - it remains a ‘watch this space’ response on all of them. While some are moving forward, others are held up at various points along the chain from concept, through design and testing to commercial reality. However, you should see some positive outcomes in 2012.
John,
I am most interested in the concept that Renal Solutions has with the sorbent technology. However, the old REDY system had issues with long term use, but was fine as short term travel arrangement. From a technological and clinical point of view, do you believe that Renal Solutions has a viable long term day after day treatment or do we need to wait for the clinical trials and after market experience when and if they ever come on line.
Thank you,
Peter
Dear Peter
As you know, I am on the MAB at RSI and I can’t say a great deal under in-confidence agreements, but while there were some issues in the 70’s-80s with the REDY system … cartridge saturation and spill-over, aluminium release, and sodium accumulation … I believe that these issues/criticisms of the old REDY system have been fully appreciated and appropriate steps taken to ensure the newly-designed and scripted system is suited to long term treatment.
Clearly, as with all new or redesigned systems … and the same will apply to Baxters redesigned and re-tooled Aksys process when their desktop is released … clinical trials will be needed and long-term follow-up data accumulated to ensure predicted models perform without issue longer term. This was also the case with NxStage when it was first released and when ‘concerns’ re its different dialysate/blood transfer and flow interface(s) were still being discussed and documented.
In short, I beleive the issues that dogged the REDY are resolved. Some of those were, it should be said, overplayed by REDY competitors and opponents though clearly some were real issues. I believe RSI have addressed these and it will be seen that they have found satisfactory solutions.
Thanks for the info John, I understand your constraints as MAB. The RSI machine is the most intriguing one to me because of the supply issue with only 6 L of potable water needed. From what I have read, it produces a near ultra-pure dialysate. Does this exceed the European standards for dialysate purity and lower endotoxins? If the water purity is in the range of ultra-pure with only 6 L of potable water, then that opens a lot more doors as far as ease of use and storage issues. In addition, it is my understanding that the clearances with this machine will be equivalent to in-center machines. From the point of view of portability and travel as well as optimal settings, it seems that this is the best fit in many ways if they can pull off all that they are promising at this time.
Dear Peter
I would agree with all your assessments. The water quailty will far surpass AAMI standards (as do the European and our own standards) with 6L or less tap water as the starting pint and with no additional intra-dialytic water needed. The clearances, as you say, appear exceptionally good and are a match for those of the single-pass systems we currently use. It promises to be a very nice, truly portable system. That’s about all I can say at the moment, except to say that I think it promises to add much to the potentials (and potency) of home dialysis.
Thanks John, I hope we have something tangible soon to evaluate. Just by coincidence, my son and I are watching Australia, the movie at the moment. Thank you for keeping the fires of optimal dialysis on the burners.
I liked that movie!
How much time passed between the release of NxStage and the determination/documentation that it was safe for home use?
Re a new machine from RSI using this sorbent technology, what kind of time frame are we looking at? When do you all think we will have a nifty new portable, easy to use, home hemodialysis machine that will rival NxStage? Is there really reason to be hopeful?
Many of us here cringe at the movie! But, as long as you realize it is ‘stylized’ … in the vein of a movie like Moulin Rouge … and enjoy it as such and not as any real representation of Australia, I will try to cope!
No machine has an easy birth.
Much testing, returning to the drawing board, and in the US, slow and sometimes complex assessments from and questions by the FDA which in turn require further research and/or modifications … all these and more lead to frustrating delays and timeline stretching that can turn weeks or months into months or years. Such is the gestation and birth of complex technology like dialysis machines.
Then there are the clinical trials … with their resulting reassessments, redesigning and resubmissions … and so it goes …
I believe NxStage took a good 5 years or more of R&D before it got to any level clinical use … and the same (or longer) will be the case with the other new technology that is emerging.
Patience is a virtue, it is said, but I think patience is more a trial of the saintly!
The new stuff will come … and I am afraid all our urging and discussion and hopefulness won’t make it come a day earlier.
But, it will come.
And as with all new ‘stuff’, none will be the panacea … the ‘cure’ or the ‘solution’ … for our current perceived defects in technical care. Rather, each will likely turn out, after clinical application, to have incredible strengths and disappointing deficiencies … but each an advance and another missing piece to the technical patina that serves our flawed but ever-improving clinical efforts.
None will be THE answer, rather, each will fill gaps and provide niche answers … and all will expand the choices we will have as we search for optimal dialysis care …
Is there reason to be hopeful? … Utterly!
Is the reason to expect a single solution from any one new device? … No!
I can live with the notion that one machine will not provide the solution to every obstacle posed by dialysis, but hearing that “Australia” is merely a stylized vision of your country is almost too much for me to bear. hehe.
One vital additional comment
Having spent this thread parrying real answers to probing questions re new technology - and there are reasons for that evasiveness that are required of me, but also unlike me - it MUST be said that this ‘new technology’ is, broadly, aimed (at least initially) at expanding the potentials for home and/or self care.
True … there are eco-potentials imbedded in the new technology that thrill me … and me, in particular … as I have an driving ambition to open the eyes of the nephrology and dialysis community to the current ecological rape being exacted by our sector on our natural resources and our waste-strewn environment … see my two eco-focused papers (in press), one in the next edition of HDI (Jan 2012) and the other in CJASN (February or March 2012) …
But, that said, our current technology - the single-pass machines (some may call them leviathans) that have served and continue to serve us incredibly well. The machines we use in facilities are superb. It is not the machines that are at fault as we under-dialyse, under-serve our patients … it is simply a fact that we just don’t use them correctly. The machines are fine … it is we who are at fault.
The new technology is aimed at expanding home options … of making home dialysis:
(1) easier for those who can access it (vastly more than do at the moment … again, here, 30% of my units’ HD is self-dialysis at home)
(2) containing costs (home HD is the cheapest form of dialytic care), conserving resources (water use by NxStage is a fraction of that used by facility-based machines and some of the newer machines coming will use a fraction of the water currently drawn by NxStage - as Peter Laird alluded to in his earlier post in this series)
(3) containing and reducing the carbon footprint (NxStage has been shown (Andy Connor’s work in the UK) to tread 1/4 the footprint trod by single-pass, facility-based equipment)
(4) provide portability (though I am not convinced the NxStage does so except for the true devotee)
and a range of other benefits already or yet to be appreciated.
But … it will be a long time before facility-based dialysis changes. We should use the superb equipment we already have in facilities more wisely, more effectively and more efficiently … absolutely … but the equipment in units (facilities) will not change any time soon - and nor should it.
The new stuff has - at east at present - a different target: the home.
But … if we could but learn, at the same time, to use the great stuff we already have in our facilities with more wisdom than we currently do, we would be taking two large steps forward at the same time.
I had just assumed that this new technology was targeted at home dialysis, anyway, but thanks for the clarification. Being able to reduce the waste and the water usage that comes from dialysis, whether in-clinic or at home, would be terrific. I sure hope we see some new advances in the New Year!