TMC PULSE

t m c » p u l s e | s e p t e m b e r 2 0 1 7 17 t m c » p u l s e | s e p t e m b e r 2 0 1 7 17 Benjamin Hertzog, Ph.D., president and CEO of Procyrion, displays the Aortix device. "There is an impeller in there that spins, so it pumps blood in from top, and out of the bottom," Hertzog said. "The blood comes out in these little high-velocity jets pointed downstream, and it's those little jets that transfer energy to the native blood. So, it's like the lazy river you take your kids to—that whole body of water is moved by these little bitty jets of water on the side." Moving the blood in this manner is known as fluid entrainment, a process also used in industries such as fracking. Aortix represents the first time this process has been applied to the human body, Delgado said. 'We will decrease the need for transplants' Heart failure is a progressive disease, which means that people experience different levels of failure. There are 6 million people in the U.S. with heart failure, Hertzog said, but few trans- plants are done because few organs are available. And transplants are risky and expensive. A heart transplant and one year of care can cost close to $1 million per patient, according to some estimates. That's why left ventricular assist devices (LVADs) and heart pumps, some of which were invented in the medical center, are being utilized. But implanting these devices is invasive surgery, Hertzog said, and reserved for those who are the sickest, because it is also risky and expensive—more than $700,000 for implantation and therapy, according to studies. Procyrion is going after 2 million of the 6 million patients with heart disease—those who need more than medication to treat their heart problems yet are not sick enough to need LVAD surgery. "If we can get to those patients before you need to crack their chest, maybe we can turn around their heart failure and prevent them from ever needing that," Hertzog said. "There's never been a device that can treat those patients. … We can put this tool in the hands of the cardiologist, and all of a sudden, you have a device that's low- risk, low-cost. It's a simple procedure, and now we can get to those patients." Procyrion's plan isn't to replace the LVAD and BiVACOR artificial heart, which Delgado's boss at the Texas Heart Institute, O.H. "Bud" Frazier, M.D., is refining, but instead to expand heart care into a different area. "We will decrease the need for trans- plants, and that's good because there are only 2,000 donors available yearly," Delgado said. Reducing the workload Aortix is designed to do some of the work the heart would normally do. "Heart failure develops one heart- beat at a time, over months and years," said Jace Heuring, Ph.D., chief scientific officer at Procyrion. "This device would help it resolve the same way, one heart- beat at a time." Patients with heart failure typically end up in the hospital, short of breath and retaining fluid. That's because when the heart weakens, the kidneys don't get enough blood to do the job they need to do. The fluid weeps into the lungs and leaves patients unable to breathe, Hertzog said. During the human trials for Aortix, patients were fitted with the pump, while undergoing a percutaneous coronary intervention—having a stent inserted to open up blood vessels in the heart. Aortix was put in first, reducing the workload of the heart, then the stent was put in and Aortix removed a few days later. "Our pump was in periprocedurally, while they were placing the stent, and we had a perfect safety record," Hertzog said. "All the patients did great. We were able to show that we reduced the workload of the heart, we increased blood flow and we got the kidneys working in these patients." Procyrion's next steps include performing trials in patients with acutely decompensated heart fail- ure; Aortix would be left in for up to seven days. Hertzog expects that to begin next year. If the trial goes well, a following trial is expected to move Aortix toward U.S. Food and Drug Administration approval, a pivotal step for mainstream use of the product. Procyrion recently kicked off its third round of funding and is looking to raise $25 million to carry the com- pany through its first approval. There is interest in what Procyrion is doing, Hertzog said, and Aortix has already gained attention from a major medical device company. "When we put this device in, it does some of the workload that the heart would have to do otherwise," he said. "The heart gets to rest. It gets stronger and then we imagine taking this out, and hopefully, it would change the trajectory of the disease for that patient. Hopefully, they never need a device again. They never need a transplant." DATA SCIENCE CONFERENCE DATA SCIENCE CONFERENCE RICE 2017 RICE 2017 Rice 2017 | Data Science Conference Oct. 9-10, 2017 BioScience Research Collaborative Houston, Texas dsconference.rice.edu k2i.rice.edu

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