Medical Device Daily Contributing Writer

Waleed Hassanein, MD, is president, CEO and a director of TransMedics (Andover, Massachusetts). He founded the company in 1998 and led it through the clinical development, market launch and commercial rollout of the breakthrough Organ Care System (OCS) technology for ex vivo physiologic preservation and assessment of transplantable organs, in both the European and U.S. markets

Hassanein has successfully raised more than $190 million of private equity capital to develop and commercialize the OCS technology and has established world-class clinical advocates for the OCS technology worldwide from the key opinion leaders in organ transplantation.

MDD: TransMedics seems to fill a much-needed niche in medicine. What led you to its founding?

Hassanein: We're addressing a growing worldwide clinical need: The need for more organ transplants, and improved patient outcomes, and that is really the key reason why I started the company. We need organ transplants to last longer and be more effective, and that really is the main reason why I started the company. I was a cardiac surgeon in training when I developed the basic concept of the OCS. I developed that concept because of the obvious clinical need.

As I was getting ready to continue on with my clinical career, I had already established a patent portfolio around the technological concept of the OCS and I presented this to many key decision leaders of medical device technologies to see if there was interest in developing this product. To my surprise, all of them came back and said the concept is scientifically sound but it is going to take time and money.

I left my medical career and established TransMedics. I knew the OCS had the potential to become the next standard of care in solid-organ preservation, starting with hearts and lungs and followed by livers and kidneys.

MDD: How does it differ from traditional organ transportation systems?

Hassanein: Let me tell you how current transportation for organ transplant works. Where are you located?

MDD: I'm in Alpharetta, outside of Atlanta.

Hassanein: For example, since you're located in Atlanta, the largest transplant center in your region is Emory. So if someone is listed on the Emory heart or lung transplant waiting list and receives a notification for a matching donor somewhere in Florida, Tennessee or Texas, Emory sends their heart and lung transplant surgical team to retrieve the organ. They bring a variety of equipment, including a large cooler filled with ice, solutions and medications that are used to stop the organ function and cool the organ down. The retrieval team goes to where the donor is, removes the organ from the donor and places it on ice in a bag filled with medications and solutions. The team then returns to Emory to complete the transplant.

The minute you stop the blood supply and remove the organ from its normal physiologic state of the human body, a decay curve begins. In the case of the current standard of care, the organ is frozen in an effort to slow the process of decay; however, the longer the organ stays on ice, the higher the risk of damage. While on ice the organ is not functioning and therefore there is no clinical ability to determine if the organ is healthy enough for transplant, nor is there an ability to optimize or recondition the organ.

In summary, the current cold storage technique for organ preservation has significant limitations: lack of optimization capabilities, lack of assessment capabilities and significant logistical time and distance limitation for organ retrieval. All these limitations are the basis for the huge clinical need we discussed earlier.

MDD: Okay then, how does the Organ Care System work?

Hassanein: The OCS is the complete opposite of cold storage. It treats the organ as if it were still in the human body. Once instrumented on the OCS, the organ is perfused with a solution that is a combination of blood and other physiologic media. The blood-based perfusion solution is oxygenated as if it were in the body, so the organ gets oxygen. The organ is kept warm, so it is not subjected to the damaging effects of ice. The organ is metabolically active. The OCS is reconditioning, optimizing and resuscitating that organ by providing it with all the needed substrates that had been depleted while still in the donor.

The organ is fully functional while on the OCS as if it's in the body. This presents a new environment for the transplant community to assess donor organ viability to maximize the yield, clinical confidence and risk. If a heart or lung fails to function after transplant, the patient has a high risk for mortality. Additionally, there is an ever-increasing cost to the hospitals and the payors upwards of $700,000 or $800,000 per occurrence.

Because the organ is now protected from the decay curve in a near-physiologic condition, the time and distance limitations that are currently imposed on organ preservation are extended. We can take a heart or lung from a further distance and transport it to the recipient site.

In summary, we are the only technology that can improve the yields from donor organs that often are wasted because of the limitations of traditional cold-storage technology. Very few technologies have the capability to deliver both good medicine and good economics. TransMedics has accomplished this cost-effectively for all stakeholders – for the patient, the provider and the payor.

MDD: Your product development efforts to date are focused on heart transplantation and lung transplantation. Could you describe the demographics of those two segments?

Hassanein: Every year in the United States, we transplant 2,000 to 2,200 hearts. But approximately 6,000 hearts are wasted annually. That number has been very steady for the last decade. In the case of the lung, we transplanted 1,800 lungs last year in the U.S., but lost 11,000 lungs that were not utilized due to the shortcomings of cold storage. This is why we are determined to make the OCS the next standard of care. We believe it can dramatically improve that severely underutilized market, and make more hearts and lungs available for transplantation thereby saving more patients who are on the waiting list.

MDD: How does that translate into costs?

Hassanein: Every patient on the waiting list for transplant costs the system and the payors somewhere between $30,000 and $40,000 per month. If we can make more organs available, patients will be on the waiting list for a shorter period of time, which can significantly impact the costs of treating those patients on the waiting lists.

The improved outcomes picture becomes clearer after the transplant procedure. A bad heart or a bad lung that doesn't function well after transplant adds significant cost, measured in tens or even hundreds of thousands of dollars per occurrence. By having the organ in a better physiologic environment, you deliver significant cost benefits to the hospital and the payors.

(In Part 2 of the MDD Interview next week, Waleed Hassanein discusses the progress of TransMedics' clinical studies, including the recent first U.S. transplantation of a breathing lung, as well how outcomes are measured through use of the Organ Care System, the company's success in a difficult finning environment, its dealings with the FDA and the status of medical innovation in the U.S.)

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