American Cardiac Surgeon Waleed Hassanein, M.D., Named 2017 EPO European Inventor Award Finalist

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Inventor Pioneered New Method for Preserving Donor Organs Before Reaching Transplant Recipients

The European Patent Office (EPO) today announced that Waleed Hassanein, M.D., president and CEO of TransMedics, Inc., of Andover, Mass., has been named a finalist for the European Inventor Award 2017 in the category of “Non-European countries.” The winners of the 12th edition of the EPO’s annual innovation prize will be announced at a ceremony held on June 15th at the Arsenale di Venezia in Venice, Italy.

For many decades, donor organs were preserved by storing them on ice while en route to transplant recipients. This method, known as cold ischemia, significantly limits the time span before organs suffer severe cold-related damage – only three to four hours for a human heart – and may also increase postoperative complications. A new approach changes the paradigm: U.S. Cardiac Surgeon Waleed Hassanein (48) developed a process for preserving donor organs outside the human body up to three times as long as in cold storage. Released into clinical practice in 2007 as the Organ Care System (OCS), the invention has already been used in over 800 successful organ transplants. It is covered by dozens of patents.

“Hassanein’s ‘living organ’ technology offers a new approach to preserving organs for transplantation, and fresh hope for transplant recipients,” said EPO President Benoît Battistelli announcing the European Inventor Award 2017 finalists. "The invention could replace a decades-old method in clinical practice and has already helped to launch a successful company."

Hassanein began working on his breakthrough as a young resident doctor at Georgetown University in the early 1990s. During his first heart transplant, Hassanein was shocked to see a potentially life-saving organ placed in cold storage. "When I saw a human heart, the organ I was trained to protect, being placed inside what was essentially a picnic cooler, I knew there had to be a better way," says Hassanein. He began experimenting with keeping the organs in a warm environment, surrounded by nutrient-rich blood. This provided the fundamental insights behind the Organ Care System (OCS). Originally developed for storing human hearts, the OCS platform now also supports lungs and kidneys. The system could have significant potential in transplant surgery: It allows clinicians to inspect organs during storage for damage or even treat infections outside of the body – something impossible during cold ischemia. Successful OCS heart transplants have been made after up to 11 hours of receipt of the organ.

'HEART-IN-A-BOX' TECHNOLOGY

Behind OCS technology lies a fundamentally new approach to ex vivo (out of body) organ preservation. While storing organs on ice only serves to slow down its inevitable death, Hassanein's method prolongs the organ's life while it is being transported to a recipient. "The system enables donor organs to remain in a near-physiological and functioning state outside the human body. Hearts keep beating, lungs breathing, livers producing bile and kidneys producing urine," says Hassanein. To do so, OCS replicates human functions and continuously supports donor organs with warm, oxygenated blood through a so-called "perfusion system" inside a clear, sterile, temperature-controlled chamber. Loaded with pumps, ventilation systems, and control sensors, the devices are the size of small refrigerators. They can be wheeled on board ambulance vehicles and rescue helicopters, adding crucial hours in a "race against the clock" when bringing donor organs to their destination.

A NEW HOPE FOR TRANSPLANT RECIPIENTS

Around the world, several hundred thousand patients are currently waiting for life-saving organ transplants, around 120,000 in the U.S., and roughly 86,000 patients in the EU and some neighboring countries, such as Iceland, Norway and Turkey. But due to the limitations of cold storage, only one in three donated hearts can be used for transplants. In the U.S., for example, 22 people die each day while awaiting a transplant. OCS expands the pool of available organs by allowing for prolonged out-of-body storage, which in turn means donor organs can be transported over longer distances, and by enabling doctors to evaluate and assess organs ‘suitability for transplant while in storage, which was not possible before. The system also reduces a serious post-transplant complication called Primary Graft Dysfunction (PGD) – during which the body rejects the new organ – with 50% fewer PGD cases than cold storage.

Widespread adoption of OCS could create an end-to-end live organ storage network between donors, clinics, and recipients. As a first step, the UK's National Institute for Health and Care Excellence (NICE) has issued a recommendation for clinical use of the OCS Heart system in 2016. Looking ahead, the inventor believes that OCS technology also holds the potential to unlock "out of body" chemotherapy, genetic therapy and regenerative medicine. "We are utterly convinced that the Organ Care System is going to transform organ transplantation and provide more and better organs for very sick patients in need of these transplants," says Hassanein.

REVITALIZING THE MARKET

In order to market his patented inventions, Hassanein founded Massachusetts-based start-up company TransMedics in 1998. So far, the company has received roughly EUR 280 million in venture and private equity capital and employs 70 people. As of today, the OCS technology platform – consisting of the OCS Lung, OCS Heart and OCS Liver systems – is CE-marked in the EU and approved in Australia and Canada, while FDA-approval is pending in the US. Analysts expect this invention to have a significant impact on the medical technology market, which could reach EUR 189 million as early as 2019.

PUTTING PATIENTS FIRST

Born and raised in a suburb of Cairo, Egypt, Waleed Hassanein has always set his sights on lofty goals: As a young man, he wanted to become an airplane pilot, but a family legacy of successful physicians saw him headed into medicine. After immigrating to the United States in 1990 – he is now a U.S. citizen – the inventor earned his MD in medicine from the Georgetown University School of Medicine in Washington, D.C., in 1993. It was here that the cardiac surgeon decided to improve the prospects of organ recipients with his methods.

Today, Waleed Hassanein serves as the CEO, President, and Director of TransMedics, the start-up company he created to market his entirely new concept of "living organ transplants" that he hopes will change clinical practice. "We are no longer fighting against the clock, because the organ is living outside of the human body. So theoretically speaking, this organ can stay alive in our system for a day or two, maybe even longer. Basically, we can transform a transplant from an emergency procedure into a scheduled procedure," says Hassanein, who is currently expanding the technology to accommodate even more types of organs.

ADDITIONAL RESOURCES:

Video and photo material
Read more about the inventor

View the patent: EP1768490

INNOVATIONS IN TRANSPLANTATION

Waleed Hassanein is not the only inventor nominated for an invention that increases the chances of survival for recipients of donor organs at this year's award. In the Industry category, Italian nephrologist Giuseppe Remuzzi is a finalist for inventing medications that use angiotensin-converting-enzyme (ACE) to prevent kidney failure after organ transplants.

Read more about the future of medicine.

About the European Inventor Award

About the European Patent Office (EPO)

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