The ingredients work together to transform tissue metabolites into products that protect cells. In the heart, for example, Somah converts ammonia–a toxic byproduct of tissue metabolism–into a metabolite that augments the nitric-oxide pathway. “That opens up the vasculature of the heart, which helps to preserve its function,” says Alison Williams, a scientist at Harvard’s School of Public Health, who is serving as Hibergenica’s chief scientific officer. Specifically, nitric oxide inhibits vasoconstriction, clotting, and inflammation.
Hibergenica’s plan is to build on Thatte’s initial research by transplanting Somah-preserved organs from pigs into other pigs, so they can measure post-transplant survival rates. If their expectations are met, they’ll need about a year of human trials before they can apply for FDA approval. They’ll start with kidneys and other abdominal organs, “because that’s where the volume is,” Elhawary says. If all goes well, they’ll test the solution in heart and lung transplants.
There haven’t been any significant advances in organ preservation in over 20 years, though other companies are certainly trying. In March, Andover, MA-based TransMedics raised $36 million to develop a technology that uses blood perfusion to preserve organs in a system designed to mimic the conditions of the human body.
Proving that Somah reduces organ damage will be critical for convincing transplant surgeons to embrace the solution, says Luca Cicalese, director of the Texas Transplant Center and John Sealy Distinguished Chair in Transplantation Surgery at the University of Texas Medical Branch in Galveston, TX. “Organs get wasted not because of time factors, but because of quality issues,” Cicalese says. “If this solution reduces damage to cells, that would be a major help.”
Other surgeons argue that extending the time window for transplantation could, in fact, offer significant advantages. Michael Marvin, chief of transplant surgery at the University of Louisville, points out that many donated organs have to be flown on chartered airplanes and transplanted in the middle of the night. “Surgeons are working on very little sleep, which may not be optimal,” he says. And if organs could be flown on commercial airlines instead of chartered jets, “I imagine there would be a dramatic reduction in costs,” he adds.
Much of Hibergenica’s pitch to investors hinges on the idea that Somah will save health-care costs over the long run, despite its hefty price. “If the organs we’re offering are in a much better state, that will reduce postoperative complications and morbidity,” says Elhawary, who has spent the last several months on the road with his three teammates, pitching the idea to venture capitalists and angel investors. “Ultimately that will save money for hospitals and insurance companies.”