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TransMedics - Improving transplant sucess rates
Thanks to the wonders of modern science, the skill of a number of leading transplant surgeons and a state-of-the-art device developed by 3i portfolio company TransMedics, a British man now has a second chance at life.
In May 2006 the 58-year old, who was close to death and not expected to live for more than six months, received the UK’s first beating heart transplant. The successful transplant was part of an extensive European trial for the Organ Care System, developed by medical device company TransMedics – a system that surgeons believe has the potential to quadruple the number of transplants carried out across the world.
This innovative system is a radical departure from the existing practice of packing an organ in ice to preserve it prior to a transplant operation. Instead, the Organ Care System keeps the organ alive and functioning by keeping it at body temperature and connecting it to its own blood supply from the donor. This extends the transplant window
from as little as four hours to up to 24 hours, and means the organ reaches the recipient in a much better condition.
Identified early by 3i as a breakthrough technology, the system will support more transplants and better outcomes in the face of growing demand – both in the US and Europe. “We have the only system that can deliver healthier organs, potentially better outcomes and bring more organs into the field of transplantation,” says TransMedics
founder and CEO Dr Waleed Hassanein.
Since forming TransMedics in August 1998 after completing a cardiac surgery research fellowship, Dr Hassanein has taken the Andover, Massachusetts-based company through three successful rounds of funding and an extensive programme of pre-clinical trials, culminating in the first beating heart transplants this year. Considerable interest in the system from all quarters of the healthcare market has helped the company raise more than $65 million since its first round of funding in 2000, a process through which 3i has become the lead investor with a stake of close to 25%.
“The goal,” says Hassanein “is to work not only with the clinical part of the market but also with payers, regulators and transplant associations. We are taking a holistic approach which takes us from the primary customer through to the government officials who will help determine how the market takes shape.”.jpg)
In addition to providing funding for what is seen to be one of the most exciting medical technology prospects, 3i has also been able to offer TransMedics a much needed dual
perspective into the US and European markets, each of which accounts for around 25,000 organ transplants a year but where transplant waiting lists and healthcare costs are continuing to grow. “We advised them to go to Europe for their early pre-clinical trials because Europe is more aggressive in transplantation than the US,” says 3i partner Allan Ferguson who also serves on the board of TransMedics. “In fact, there was such a good response from the main transplant centres in the UK, Germany and France that there were also requests from Spain and Italy for trials to begin in those countries.”
Dr Hassanein developed his living organ concept while studying to be a cardiac surgeon. “I came up with a research project to develop a better way for heart preservation for transplants that utilises oxygenated blood,” he says. The results of his early research went a long way towards persuading Hassanein that he had a business proposition on his hands. “The proof of concept data was very compelling and resulted in publication, numerous presentations and abstracts. It became clear that this was an idea that a lot of people were focused on and if I didn’t get on and commercialise the technology, someone else would soon do so.”
Raising money was always on the agenda – even at that stage, he says. “All my work was supported by my ability to raise mainly equipment funds from medical device companies as well as research grants. This is when it became clear to me just how many people were interested in the concept and I decided to take up the challenge to build a company.”
Since then Hassanein and his team have established a business which is continuing to expand from its R&D origins to include fully fledged manufacturing and marketing operations. The 70 strong company’s immediate target is to complete its current PROTECT trial by the fourth quarter of this year before tackling the European market for real at the start of 2007.
As things stand, TransMedics has every reason to believe that it is in the right place at the right time. With an estimated 12,000 people waiting for a donor organ in Germany alone, demand in both Europe and the US continues to outstrip supply by a factor of three or more to one. “The technology offers the opportunity to use a lot of the organs that are not being considered at the moment because it takes too long to get them to a recipient,” says Ferguson. “This greater flexibility will probably quadruple the number of organs that are available and useable for transplant.”
The cost versus benefit equation is more complicated but equally compelling, says Hassanein. “A healthy organ transplant has significant value by reducing complication costs that are currently at about 75% incidence in the cold environment. From an economic standpoint, one element of our value proposition is to provide a healthier organ, reduce complications and improve post transplant outcomes. That way you can save healthcare payers a great deal of money.”
The cost of caring for patients on the waiting list is cited as another factor in the system’s favour. By making more organs available for transplant you reduce waiting lists and cut costs – at a time when virtually all developed economies are puzzling how to keep healthcare budgets under control. Hassanein notes, “if you expand the pool by just one additional organ you can potentially save hundreds of thousands of dollars when you put this against the cost of caring for an end stage heart failure patient.”
The distribution of the target customer base is another factor working in the company’sfavour, he believes. In the UK, for example, Papworth and Harefield Hospital in Greater London, both of which are taking part in the PROTECT trial, account for more than 40% of UK transplants. “Our market is very concentrated,” says Hassanein. “The UK, Germany, France, Spain and Italy account for 75% plus of the European transplant market. We are actively enrolling patients in the top one or two centres in these geographies.”
All of which should leave the company very well placed to pick up high spending customers should the trial produce the set of results that Hassanein is anticipating. “Once the clinical data is published our target customers will know what to do next regarding the purchasing decision. The fact that we’re talking to a handful of top call points puts us in a unique position.”
3i’s Ferguson agrees. “There has been a very good response from the main centres involved in the trial,” he says. “As a result of the early evidence, albeit on a limited number of patients, the surgeons are ecstatic. They are seeing results that they had not anticipated and nor had we.”
All of which bodes well for a company which is currently focusing its efforts on heart transplants but has also got its sights set on other organs. Later this year the company plans to start additional organ programmes with lungs, liver and kidney – more breakthrough technology which it hopes will fuel growth and deliver its own dramatic impact on a receptive healthcare market.
And the British recipient of the first beating heart transplant? He returned home just a month after the surgery, suffered fewer post-operative complications, and is looking forward to returning to a normal life..jpg)
Healthy organs need a constant blood supply and this is exactly what they get when they are hooked up to the Organ Care System.
The system works by mimicking the human body in terms of oxygenated blood, heat and humidity. This is done via the system’s core Perfusion Module, a transparent, sterile chamber designed to protect the organ and maintain a body-like warm temperature and humidity. In the case of heart transplant surgery, for example, the organ is placed in the module and revived to a beating state.
Once the organ is in place, the module also allows it to be assessed using sterile ultrasound and blood-sampling for off-line analysis.
The Organ Care System also includes two further modules, a portable platform with wireless monitor for supplying an organ with oxygen and blood during transport, and a solution set for delivering nutrients and other substances to keep it healthy during this period.