Leeds Solution

 

A new transplant organ preservation fluid 

Leeds Solution aims to increase the availability and viability of usable transplant organs, especially marginal organs, for people awaiting transplantation.

Solution

Over several decades, experts from Leeds Teaching Hospitals NHS Trust developed two novel transplantation fluids. One solution known as Leeds Solution Abdominal (LSA) is for use in transplantation of the liver and kidney and will be the first product to market. The second solution Leeds Solution Thoracic (LST) is for transplantation of the heart and heart bypass operations and will require additional funding. The solutions have been designed by a leading transplant team and physiologist to have properties superior to those currently used clinically.

The products available on the market provide only a limited therapeutic window before the organs start to degenerate beyond use. Current indications show that new solutions are likely to significantly extend the preservation time:

Organ

Current preservation time with brand leading product (hours)

Preservation time with LSA (pre-clinical – hours)

Heart

4

8

Liver

12

24

Kidney

24

48

In addition to doubling the preservation time, the solutions will ensure a greater viability of the organ compared to the currently used products, at both long and short preservation times. This will be associated with better postoperative recovery. The solutions may also allow the transplant of organs that were once classified as being marginal which will greatly reduce waiting times and help save lives.

Leeds Solutions’ products have advantages over existing solutions in terms of usability and effectiveness. The most widely used solution is now off patent and as a result the development of LSA and LST is very timely . The company is also aware of mechanical systems that are in use to further the preservation of organs. These systems are vastly more expensive (over 100 times the price of cold storage solutions) and only suitable for a narrow selection of organs; hypothermic static storage will remain the predominant method of organ preservation. Based on the current prices of available solutions the market (EU & US) for LSA is worth over £29M per annum. The potential market (EU & US) for LST is £163M per annum.

Patient and clinical benefits

The ultimate aim of organ preservation solutions is to maintain the organ in optimal condition from the time of retrieval to the time of transplantation. Preservation using the Leeds Solutions confers two critical advantages to the transplant procedure:

  • Maintenance of quality & function of the organ: Leading to better post-operative recovery, less likelihood of organ rejection, extending the pool of useable organs and significant health economic benefit.
  • An increased window of time to transplant the organ: Allowing time to tissue match and allocate the organ, prepare the surgical teams and enable national/international territory coverage

Market

The key initial market for the current technology is the transplantation and organ preservation market, particularly for transplantation of the liver, kidney and heart. The market for Leeds Solution Abdomen can be predicted from figures for the number of operations currently carried out. The WHO Global Observatory on Donation and Transplantation estimated, based on data from 95 countries in 2013, that there were 118,114 solid organ transplantations including 79,312 kidneys, 25,050 livers, 6,270 heart, 4,834 lung and 2,474 pancreas. This represents less than 10% of the global needs.

Based on current trends and improvement in health care across the world, particularly in Asia and India etc these figures are seen as being somewhat conservative. The most recent data (2008) from Organ Procurement & Transplant Network (OPTN) and UK Transplant show a 5% increase in Kidney and Liver Transplants.

The UK (UK Transplant) are forecasting a 50% increase in transplants in the next 5 years. By 2030 26% of US population will be ≥65 yrs old, compared to 17% today.

The global market for organ preservation solutions was £38m in 2012 and forecasted to reach £131 million by 2019. It is dominated by the European market in terms of revenue (49.96%), followed by the US (42.23%), Asia (5.66%) and RoW (2.15%).

Medipex impact

Medipex supported the development and IP protection of Leeds Solutions over many years, working with the original inventors to ensure appropriate protection of the technology and developing the business case needed to obtain the necessary funding for the project.

In 2015, significant investment was raised to allow formation of Organ Preservation Solutions Ltd (OPSL) to develop the novel technology into regulatory approved products. This investment is now being used to take the products through the remaining pre-clinical/clinical trials and obtain CE mark. The role of Medipex remains pivotal to the product development process via assistance with project management and expert IP advice.

For further information, please visit www.opslgroup.com