A pre-clinical feasibility study for the application of AQIX®RS-I as a prime and fluid management solution during cardiopulmonary bypass surgery

Cardiac surgery utilising cardiopulmonary bypass and existing blood volume expanders, e.g.
Hartmann’s /Gelofusine, is often associated with organ injury, prolonged hospitalisation and
even mortality. As a consequence there is a clear clinical need for a blood volume
replacement solution that has a demonstrated organ protective (or restorative) effect. AQIX®
RS-I has been shown in pre-clinical studies of hypovolaemia to restore or re-establish normal
physiological function producing superior outcomes in clinically relevant measures, e.g.
reduce kidney injury, compared to the current gold standard clinical practice of Doppler
guided intra-operative fluid management. Aqix Ltd has recently agreed, through scientific
advice with the MHRA, a regulatory development programme for AQIX® RS-I. With further
Technology Strategy Board support of £100k, this project would be first step in the clinical
realisation of this programme by confirming feasibility using the only UK based non-clinical
survival model of cardiopulmonary bypass operated at the University of Bristol.
In the US and EU combined there are approximately 626,000 cardiopulmonary bypass
procedures each year, each using 6 units (3L) of fluid, 1.5L as a prime solution and 1.5L for
the maintenance of cardiac output during the procedure. The competing products can be
crudely divided into three categories: crystalloid solutions, artificial colloid solutions, and
albumin solutions. And although not used in cardiopulmonary bypass in the EU, as the US
market leader, the premium product price point for human albumin is equivalent to £50 per
unit. The benefits of AQIX® RS-I, in terms of improved patient recovery and reduced kidney
injury, are expected to exceed those of albumin solution, therefore at a potential unit price of
£60 for AQIX® RS-I, this represents a £225m market. The first product is modelled at a 25%
market share resulting in exports of approximately £50m to the US and EU. The wider £2.5bn
market for fluid therapies is shared among four global players; Fresenius Kabi, Baxter, B
Braun and Hospira who represent the target client base and distribution route for Aqix Ltd.
Based on the cumulative investment from the Technology Strategy Board over two projects of
£500k of public money, excluding the current grant application of 100k, and private
investment of a further £5m, Aqix Ltd’s value could be expected to be more than £150m on
successful completion of a Phase II study.