Whatever happened to the WAK?

Around 2009 there was all kinds of hype that the UCLA WAK (Wearable Artificial Kidney) was at last ready for human trials. Publications from then indicated you were involved in this research.

What happened? Whither went the WAK?

Whither the WAK …

Firstly, no, I wasn’t involved in the WAK - though I have kept in once-or-twice-a-year contact at meetings with Victor Gura, the nephrologist who worked so hard to get the WAK going and to bring it to the stage of clinical trials in the UK (as were reported in the Lancet in December 2008). On the other hand, I have been on the Medical Advisory Board of RenalSolutionsInc … the company that has been moving forward with sorbent systems and whose sorbents were used in the WAK to reconstitute the dialysate. It was also the company that developed the Allient - a sorbent based system … and if you want a relay=tively simple paper to explain sorbent dialysis, you could go to my paper in Nephrology … Agar JWM. Understanding Sorbent Dialysis Systems. Nephrology. 15(4): 406-411. June 2010.

I think the Global Financial Crisis has much to answer for … not only in world financial systems - though, almost alone, Australia has weathered all the financial storms to date without seeming too much difficulty or any noticeable change of pace … but also in the R&D departments of the major companies (including the dialysis companies). As for those smaller companies who depended on venture capital to push ahead or even just to stay afloat, the GFC was even more catastrophic.

A small ‘sunrise’ company lives, almost day-to-day, on venture capital. Venture capitalists back an idea, a concept, a hope … but when the financial markets dry up, so too does venture capital - and, all too often, so too does the idea, the concept and the hope.

Several small R&D dialysis companies - pointy, sharp, focused, single idea companies - were caught, just as they were at their most vulnerable … much invested, but as yet no marketable product … in the loss of venture capital that followed the rapaciousness of Wall Street and the unsustainable get-rich-quick programs it fostered or supported.

As I understand it, the WAK project simply ran out of funds. But, it, like the RSI Allient, the old, shelved AKSYS and, more recently, the X-Corporeal, were, fortuitously bought - mostly in time - by the bigger Fresenius and Baxter conglomerates. But then, within a year, the GFC brought anxiety and stagnation to many programs - and I suspect these were no different. The Allient and the X-Corporeal both live on, are recovering, and will (soon) re-emerge - changed but in principle the same - as the Fresenius PAK = the Allient guts and the X-Corporeal design, but “Fresenius’ized”.

The Baxter revision of the AKSYS system (let’s call it the ‘G2’ for want of a better name) also lives on. But, both it and the Fresenius ‘PAK’ are much behind their original time-lines … they were (both) due (initially) for commercial release late 2011 … but, not only due to financial constraints but due to the inevitable issues that arise as emerging technology creates a whole bunch of new problems to solve.

But, I believe both will emerge - hopefully this calendar year - as true and up-to-date challengers in the home portable market. Without doubt, they both will have a formidable home opponent in the NxStage and it will be interesting to watch the field unfold over the next 12-18 months (= my time-line). But, to be honest, I think NxStage has some functional issues to solve too - maybe in a NxStage, Mark II … though I am yet to hear that one is ‘coming’ too. I have recently communicated my thoughts to NxStage via their Oz-based representatives after a trial here at my unit - things where we felt changes might make a difference.

The WAK is still there … but while it, too, has been on-sold, as I understand it, it is hibernating while it awaits re-capitalisation. To be honest, although the WAK has already been trialed on 8 patients at the London University Hospital by Alan Davenport in 2007/8, I think it likely has a far longer time-line … indeed, far longer than I can see to the end of … before we see it as a clinically robust dialysis option.

A consortium in the Netherlands has a similar goal and have moved well along similar tracks to the WAK, while the Quanta is a realistic British option for the portable-sized market (though it still needs an RO - and that is a distinct ‘disadvantage’). The South Koreans have a seemingly nice system, still, as I understand it, in R&D - the C-PAK - which I have seen but, beyond that, I don’t know where it’s ‘at’ in development or if it has progressed. There is a YouTube promo out on the C-PAK - the origins of which I do not know - but there isn’t substantive available data on it and I am not aware of the origins (or veracity) of the YouTube clip. I would tak it with caution. Oh … and there are others, too.

Of all these, the Fresenius and Baxter machines - apart from the UK Quanta - are the ‘most likely’, as I see it. And even these are still just ‘coming’.

It would be jumping the gun to hold any up as ‘the answer’ … or even ‘an answer’ … until each or any have been tried, trialed, evaluated, assessed, and re-tooled where necessary.

I know there is much anticipation and enthusiasm ‘out there’ … but this has to be kept in its bottle until a true and tested contender for the home market emerges. And that ain’t yet! Meantime, there is the single pass equipment we use here in Australia … and it IS great equipment, for all its size … and there’s the NxStage.

But … hopefully … as venture capital begins to recover, if a little shakily, we will see systems such as the WAK (and others) rekindled and brought back as true contenders in the race to produce a truly portable and/or wearable kidney.