AQIX® Fluid Technology.Blood Volume Replacement
The successful applications of AQIX® RS-I solution in maintaining the functional viability of human cadaver tissues and organs following hypothermic storage and normothermic perfusion, indicates the potential for AQIX® RS-I as the first true therapeutic blood volume replacement solution.
Clinical Need
The initial clinical application of AQIX® RS-I will be within the field of cardiac surgery.
This patient population suffers from significant complications of undergoing surgery, specifically Acute Kidney Injury (AKI). There is an inherent logic, unique to AQIX® RS-I, in the use of a product developed for ex-vivo preservation of cellular function within organs, where the main regulatory centres of the human body (lungs, liver, kidneys etc.) are subjected to a rapid large parenteral volume exposure.
The link between organ damage during cardiac surgery (specifically kidney damage) and worse clinical outcomes (shorter life) has been well established. Acute kidney injury during cardiopulmonary bypass surgery leads to:
- A doubling of healthcare costs and hospital stay
- A 4-fold increased risk of patient death following surgery
- A mortality as high as 60% in those requiring renal replacement therapy
Cardiopulmonary bypass surgery is common procedure with approximately one million cardiac procedures taking place globally each year and there is already well established infrastructure for conducting human clinical trials in this area.
Market Size
The global market for blood volume replacement solutions is in the region of $4Bn annually ($400M directly in cardiac surgery). Acute Kidney Injury incurs significant healthcare costs, with a doubling of post operative healthcare costs and post-operative stay.
| Incurred Costs | Expected Hospital Stay |
|---|---|
| ~$35,000 without renal replacement therapy | ~10 days without renal replacement therapy |
| ~$75,000 with renal replacement therapy | ~21 days without renal replacement therapy |
| Control costs ~$18,000 | Control: 5 days |
Pre-Clinical Models
Current Data
Preclinical models of haemorrhagic shock have shown AQIX® RS-I to be capable of achieving superior cardiovascular resuscitation compared to the current clinical standard for fluid management in two independent studies of hypovolaemia.
- AQIX® RS-I confers superior cardiac performance following resuscitation from massive bleeding compared to current standard of care.
- AQIX® RS-I preserves blood pressure better following resuscitation from massive bleeding compared to current standard of care.
- AQIX® RS-I restores normal metabolism more rapidly following resuscitation from massive bleeding compared to current standard of care.
- AQIX® RS-I reduces kidney injury following resuscitation from massive bleeding compared to current standard of care.
Future Investigations
Aqix Ltd has established a new collaboration with Mr. Gavin Murphy, Consultant Cardiac Surgeon at the Bristol Royal Infirmary/University of Bristol to investigate the regenerative and protective effects of AQIX® RS-I on Acute Kidney Injury during cardiac bypass surgery.