What's on the horizon?

Can anyone give me an idea of what kind of new technology for home hemo is on the horizon? New machines? I’ve heard of the new “wearable” kidney they’re developing in Asia, but that’s some years down the line. Is there anything new that might be available to us within the next, oh, two years?

Hi Moosemom,

There are at least a couple of options that may come out in the next year or two. Baxter is the closest, with the “son of the Aksys PHD”. The Aksys PHD was the first machine on the market that was built from the ground up just for home HD. Folks who used it (like Bill Peckham) really loved it, and it gave a great treatment. (I thought it was VERY noisy, myself). Unfortunately, it was quite prone to breakdowns, and techs had to come out to the home to fix it. The company limited the areas it could serve, and finally gave up. I have not seen what Baxter is up to with the second generation machine, but would guess that it will be smaller and more portable than the original. Baxter has been advertising for staff and spending money on prelaunch activities, so they must be fairly close.

Home Dialysis Plus (HD+) is based in Portland, OR. They are using Hewlett Packard inkjet technology, and possibly nanotechnology as well to shrink the dialyzer to a small size. HD+ won the largest innovation grant ever in Oregon. I don’t have a time update of when to expect their machine out. As far as I know, they are not yet doing human tests, but I don’t know.

I have to suspect that NxStage must be working on a generation 2 machine, because they’ve always been very strategic and great planners. But I haven’t heard even a whisper of what it might be! (It’s true that even if I did hear, I wouldn’tbe able to say–but I haven’t heard).

Fresenius bought the RenalSolutions machine, which uses sorbent technology. Only about 6 liters of water are needed to make dialysate for a whole treatment, because a sorbent cartridge (with multiple chemical layers) regenerates the dialysate so it can be used over and over. (This technology was first developed in the '70s). But, their initial plan was to retire the machine and use the cartridge in their standard machines. I suspect that they are also working on a small, portable machine, but don’t have any details about what it might be like or when it might come out.

There are other players in this pond, too, both in the US and in other parts of the world. So, there’s a lot of activity, but, as always with new technology, it’s anyone’s guess when it will actually come to market. Baxter has my bet for first one out.

I have no direct knowledge of what is coming but it is a good question. If you had asked this question in 2009 I think everyone’s answer would be exactly what they would say today, I know my answer would be the same … pretty much what Dori said. So to me the interesting question to ask is: What happened? Why have we lost two years? Why has there been no innovation in HHD delivery since 2005 (when, correct me if I’m wrong, NxStage rolled out).

The Aksys was available to the public in 2002. I was the first to use it and was the only person using it for months, but it’s now been six years since the last new HHD device, what happened?

I’d say a contributing, if not leading, factor in this delay is dialysis provider consolidation. In the last 7 years the market has become very consolidated and one of the providers - Fresenius- is a verticly intergrated manufacturer of their own machines. So really the market is DaVita followed by DCI and an alphabet soup of smaller providers. And then you look a little closelr and the business challenge increases.

If you can pick up the July issue of Nephrology News & Issues take a look at their 17th Annual ranking of dialysis providers by size. The top 10 providers in the US represent about 82% of the census (330K out of 400K). The 10 largest provider have, it is reported, about two thirds of the home hemo census (NN&I reports 3,921 using HHD, while I would guess that the total nationally is ~6,000). What this means is that the small dialysis providers, with 18% of the census are over preforming at getting people to use HHD - about a third of all HHD dialyzors. The other detail is that among the big 10, DaVita has well over half those using HHD - 2,200.

So where’s the market? The over preforming small provider sector might be willing to offer both a new device and NxStage but how much training capacity will they really be able to deploy over the mid term - the next 1 to 4 years? They’re small providers. They’re generally being besieged by financial and regulatory forces, are they really ready to invest in innovation?

Is FMC finally going to go outside the FMC family of products for a nonFMC HHD device? Possible. With the newly acquired Liberty/Renal Advantage they’ve nearly doubled their HHD program and I assume the nearly 600 newly acquired dialyzors using HHD were using NxStage. And there are report of FMC units starting their own NxStage programs. FMC has a lot of room to increase their HHD program. Before buying Liberty/RA they had only 698 HHD patients out of a total census of 137,325. Now they’ll have about 1,300 HHD patients out of a total census of over 150,000. So maybe NxStage has cracked the German monolith but would FMC add another nonFMC machine? I don’t think you could count on that.

Would DaVita offer a second HHD option? Possible. But I have to believe they would have to be given very favorable terms and they would probably only be using you for leverage in negotiations with NxStage. I don’t think you could count on them fulfilling your business plan.

So that leaves the 8 top US dialysis providers who are not DaVita or FMC. Among them the number one potential customer would be the third largest largest provider DCI, who, NN&I reports, have just 88 HHD patients out of a total census of 13,487. As I’ve told senior DCI management there are well over 500 people in their units who should be home. Beyond that its open to anyone’s guess but certainly there are 500. I’ve personally shown them what a person who uses HHD can do - we can do a four day three night raft trip - that makes it important to offer to all who will or want to do it. So maybe that’s where you start. But 500 is not a market.

I’d be interested in Dr Agar’s thoughts too. What happened? Why have we lost two years?

Remember the time slippage with the Aksys PHD? It finally launched about 4 years after it was promised. I suspect that difficulties conducting the human trials that are needed to get through the FDA–and then actually getting through the FDA are a big stumbling block…

Thank you for your great analysis of the #s of home dialyzors Fresenius will have with Liberty & RAI on board! It’s very helpful.

Would the son of Aksys have the same FDA hurdle as Aksys did initially?

Industry consolidation has made this a much harder market to enter. I also think people are rethinking the potnetial size of the market. Not how big it should be but how big it can be.

[QUOTE=Bill Peckham;21466]I have no direct knowledge of what is coming but it is a good question. If you had asked this question in 2009 I think everyone’s answer would be exactly what they would say today, I know my answer would be the same … pretty much what Dori said. So to me the interesting question to ask is: What happened? Why have we lost two years? Why has there been no innovation in HHD delivery since 2005 (when, correct me if I’m wrong, NxStage rolled out).

The Aksys was available to the public in 2002. I was the first to use it and was the only person using it for months, but it’s now been six years since the last new HHD device, what happened?

I’d say a contributing, if not leading, factor in this delay is dialysis provider consolidation. In the last 7 years the market has become very consolidated and one of the providers - Fresenius- is a verticly intergrated manufacturer of their own machines. So really the market is DaVita followed by DCI and an alphabet soup of smaller providers. And then you look a little closelr and the business challenge increases.

If you can pick up the July issue of Nephrology News & Issues take a look at their 17th Annual ranking of dialysis providers by size. The top 10 providers in the US represent about 82% of the census (330K out of 400K). The 10 largest provider have, it is reported, about two thirds of the home hemo census (NN&I reports 3,921 using HHD, while I would guess that the total nationally is ~6,000). What this means is that the small dialysis providers, with 18% of the census are over preforming at getting people to use HHD - about a third of all HHD dialyzors. The other detail is that among the big 10, DaVita has well over half those using HHD - 2,200.

So where’s the market? The over preforming small provider sector might be willing to offer both a new device and NxStage but how much training capacity will they really be able to deploy over the mid term - the next 1 to 4 years? They’re small providers. They’re generally being besieged by financial and regulatory forces, are they really ready to invest in innovation?

Is FMC finally going to go outside the FMC family of products for a nonFMC HHD device? Possible. With the newly acquired Liberty/Renal Advantage they’ve nearly doubled their HHD program and I assume the nearly 600 newly acquired dialyzors using HHD were using NxStage. And there are report of FMC units starting their own NxStage programs. FMC has a lot of room to increase their HHD program. Before buying Liberty/RA they had only 698 HHD patients out of a total census of 137,325. Now they’ll have about 1,300 HHD patients out of a total census of over 150,000. So maybe NxStage has cracked the German monolith but would FMC add another nonFMC machine? I don’t think you could count on that.

Would DaVita offer a second HHD option? Possible. But I have to believe they would have to be given very favorable terms and they would probably only be using you for leverage in negotiations with NxStage. I don’t think you could count on them fulfilling your business plan.

So that leaves the 8 top US dialysis providers who are not DaVita or FMC. Among them the number one potential customer would be the third largest largest provider DCI, who, NN&I reports, have just 88 HHD patients out of a total census of 13,487. As I’ve told senior DCI management there are well over 500 people in their units who should be home. Beyond that its open to anyone’s guess but certainly there are 500. I’ve personally shown them what a person who uses HHD can do - we can do a four day three night raft trip - that makes it important to offer to all who will or want to do it. So maybe that’s where you start. But 500 is not a market.

I’d be interested in Dr Agar’s thoughts too. What happened? Why have we lost two years?[/QUOTE]

I have heard from one of the DaVita big shots that they will pick up HD+ when it rolls out into the market. The launch date for HD+ is supposed to be sometime in 2012.

Mark

What’s HD+ ? Sounds like better television.lol

Home Dialysis Plus, a 32 pound dialysis machine which runs at 85%-90% efficiency level.

Here’s the website for HD+…not much there, just like there wasn’t much on the NxStage website until it got FDA approval.

http://www.homedialysisplus.com/index.php