AQIX® Fluid Technology.Transplant Perfusion
AQIX® RS-I solution uniquely replicates the tissue fluid present in all human organs, without adding extracts of human or animal serum.
It can be used to store organs ‘cold static’ in the simple ‘bag on ice method’ or in a machine perfusion system. AQIX® RS-I can also be used to perfuse organs over a range of temperatures from 4°C up to ‘normothermic’ body temperature.
AQIX® RS-I is in pre-clinical development ahead of CE marking as a Class 3 medical device for use in the transport, storage and/or functional evaluation of organs during transplantation.
Clinical Need
There is a severe shortage of organs for transplant and the organ transplant waiting list continues to grow worldwide, with currently 10,000 people in the UK on transplant waiting lists and 100,000 in the USA. This is despite more organs being sourced from non-heart beating or marginal donors and the criteria for 'acceptability of use' of organs continuing to be extended consequences of which:
- Organs recovered from marginal or extended criteria donors have frequently suffered reversible deterioration as a result of long ischemic periods.
- Up to 18% of all kidneys and 60% of hearts are rejected for transplant because of the risks associated with this deterioration.
- For kidney transplants alone there are an estimated 700 waiting list deaths in the UK and approximately 9,000 in the USA each year.
New approaches are needed to extend organ availability whilst improving organ quality (via tissue regeneration) and limiting ischemic damage or reperfusion injury (stabilisation and conditioning), which are considered to be the main factors in determining graft function and patient survival.
Market Size
An $80M direct market opportunity with $500M additional potential.
Conventional products used for organ preservation (e.g. UW, HTK) rely upon cold temperatures and are not regenerative. Organox Ltd is developing a normothermic liver perfusion system and Vitrolife AB has a CE marked Lung perfusion fluid. Neither is universally applicable (compared to AQIX® RS-I) or suitable for use with kidneys or hearts.
The market for therapeutics capable of regeneration of organs from non-heart beating donors is currently less than $1m per annum due to lack of uitable products, but not lack of need. A product applied to marginal organs which increased organ availability by as little as 2% is expected to have a global market of $80M at $2,000 per regeneration, once established (5-10 years).
Aqix Ltd model is based on a 25% market share but higher levels are feasible given its patents and market leadership.
Benefits with AQIX® RS-I
- Reduced 'warm’ and ‘cold’ ischemic damage, increasing the success of primary graft function.
- Increased global availability of viable organs for transplant.
- Minimising organ rejection and post-transplant care and associated costs.
- A better physiological environment to assess and potentially improve the functional capability of the organ.
- Maintaining the functionality of the organ as if it had never left the donor body and potentially restore any imbalance in basic homeostatic mechanisms.
- Speeding up and simplifying the transplant process, from donor organ procurement to preparation of the organ for transplantation.
- Providing the universal solution for preserving the functionality all types of human donor organs.
- One product capable of providing a contiguous environment for the procurement and normothermically perfusion of human organs.
Pre-clinical Research
Over the last 5 years AQIX® RS-I has been trialed in a multiple of transplant research applications as a means of regenerating organs pre/post transport, stabilising organs during storage, and regenerating or conditioning organs pre-implantation. In each case:
- AQIX® RS-I has shown its ability to stabilise and regenerate organs and demonstrate superiority over other preservation and perfusion solutions in low temperature studies.
- AQIX® RS-I restores and maintains the functional viability of isolated organs perfused at normothermic temperatures.
No other preservation solution is suitable for hypothermic or normothermic storage, transportation and perfusion of isolated organs, other than autologous blood.
If you would like to trial a sample of AQIX® RS-I for research applications or require further information, please contact us using the contact section of the web site.