“I said I think this will make more lungs more available than anything [else] we could do. And I said I’d like to build a lung hospital,” recalls Keshavjee, who says he and Rothblatt walked onto the office’s balcony, where she pointed to the two-story building across the street. “She said, ‘How about we do that over there?’ ”
A few months later, in the summer of 2013, renovations on the building began, transforming the nondescript former home of private medical and dental offices into a state-of-the-art facility dedicated to EVLP. Keshavjee’s Toronto team remains involved as consultants to Lung Bioengineering, available around the clock for questions during procedures; many of Lung Bioengineering’s staff traveled to Toronto to learn EVLP techniques from the specialists there. Unlike the handful of hospitals around the world that perform EVLP, Lung Bioengineering does nothing else: Once a set of lungs is delivered, the procedure begins and, if all goes well, the lungs are then placed back on ice for delivery to a surgical team for immediate transplant.
The first transplant of a lung that had been treated at Lung Bioengineering occurred in the fall of 2014. Although EVLP has been performed at hospitals around the country for more than a decade, Lung Bioengineering’s unique setup outside of a hospital required approval from the Food and Drug Administration (FDA). The work it is performing now is part of a clinical trial, but Lung Bioengineering has received permission from the Centers for Medicare and Medicaid Services to be reimbursed, according to company officials. Lung Bioengineering says it charges $30,000 to $40,000 for EVLP per transplant; the cost of a single lung transplant can average around $600,000 for the procurement, transplant and recovery in the hospital, with double lung transplants averaging nearly $200,000 more, according to a 2017 report by Milliman, an international actuarial and consulting firm based in Seattle. Lung Bioengineering’s goal is to eventually perform hundreds of procedures each year if the concept is approved by the FDA once the trial is completed, according to the company. Lung Bioengineering is in the process of opening a second facility in Jacksonville, Florida, and plans to operate at least four centers nationally.
“With a vision and the mind and the resources and the experience in commercializing biotech, [Rothblatt] was able to make it happen,” Keshavjee says of the idea the two shared in her office seven years ago. “It’s going to transform the entire field of transplantation.”
On a Monday morning last September, Popa stood in a hallway at Lung Bioengineering’s headquarters in front of a screen displaying the number “101.” The figure represented the number of people who had received a lung or lungs that had undergone EVLP in the building—No. 101 had received his lung early that morning after Lung Bioengineering specialists had performed EVLP on it the night before. As of mid-January, the number of recipients stood at 118.
Popa, 38, joined the company in 2013 to help create policies and procedures before the first lungs arrived; he also trained as an EVLP specialist. Although he had little clinical health care experience, he did have extensive knowledge of the organ transplant process, having spent eight years coordinating transplants for the Indiana Donor Network, one of 58 organ procurement organizations (OPO) in the U.S. officially designated by the federal government to manage the organ donation process.
When doctors decide a patient needs a lung transplant, often due to conditions such as cystic fibrosis or severe emphysema, they place the patient’s name on a list maintained by the United Network for Organ Sharing (UNOS). The list contains information about the potential recipient, including details about their condition. When an OPO is informed of a potential donor in its region, it enters information about the donor into the UNOS database. A computerized algorithm then determines the best recipient based on a number of factors, including blood type, height and weight, medical urgency, distance from the donor hospital, and how long the recipients have been on the waiting list. The OPO then uses the list to contact the selected recipient’s medical team.
Ultimately, the decision on whether to accept the donated lung or lungs is up to the transplant surgeons. If the donor isn’t located near the recipient, his or her surgeon might make that determination based on a review of the donor’s information and conversations with the surgeons who are removing the organs. In other cases, the transplant team will travel to the location of the donor and harvest the lungs themselves. If the doctors decide the lungs can be transplanted, they are packed in ice and must be implanted in the recipient within four to six hours if EVLP is not performed.
Working for the Indiana Donor Network, Popa found that lungs and other organs often were rejected as too damaged or diseased for transplant, a disappointment even though he knew that sick lungs could be worse for a recipient than getting none at all. According to UNOS, more than 2,700 people in the United States received donated lungs in 2019. Of all the organs used for transplant, lungs are among the most difficult to harvest—the American Lung Association says that only about 28% of donor lungs are deemed suitable for transplant. The lungs are susceptible to injury both before and after a donor’s brain death, and they are often rejected by transplant surgeons looking to avoid giving damaged lungs to a recipient who’s already gravely ill. Many of the rejected lungs—some research has indicated up to 40%—may be healthy enough for transplant, surgeons say, but it can be difficult to determine the exact health of the lungs while they’re still inside the donor.