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. The products available on the market provide only a limited therapeutic window before the organs start to degenerate beyond use.

Solution

Leeds Solution has developed two novel transplantation fluids. One solution known as Leeds Solution Abdomen (LSA) is for use in transplantation of the liver and kidney. This 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 pharmacologist and have properties superior to those currently used clinically.

Current indications show that Leeds Solutions are likely to significantly extend the preservation time as shown in the table below:

Organ

Current preservation time with brand leading product

Preservation time with new Leeds Solutions

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 interest in LSA and LST is very current. The company is also aware of mechanical systems that are in use to further the preservation of organs and these systems still require solutions, such as Leeds Solutions, to flush and preserve the organs. Based on the current prices of available solutions the market (EU & US) for LSA is worth over £29 per annum. The potential market (EU & US) for LST is £163M per annum.

Patient and clinical benefits

The significant benefit of Leeds Solution is that it will double the preservation time and improves organ viability.

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 Leeds Solutions confers two critical advantages to the transplant procedure:

  • Significantly increases time available to transplant the organ
    • Increases time available to allow tissue matching.
    • Increases time available to prepare the recipient and surgical team.
    • Ensures the quality and the function of the organ leading to better postoperative recovery
    • Provides substantial health economic benefit.

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.

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 has raised investment to develop and place a Leeds Solution product on the market. The investment will be used to manufacture a GMP product and carry out stability studies and to fund a human safety & efficacy trial for the liver and kidney in order to obtain both CE mark and US FDA approval.  

To achieve this Medipex has initiated dialogue with regulatory partners and defined the regulatory strategy; placed a contract with a manufacturing partner; and initiated dialogue with licensing partners.