MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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38 | JULY 2016 E ven though heart failure affects ap- proximately 6 million Americans, there are surprisingly few device treatments and procedures available for these patients. Left ventricular assist devices (LVADs) have received plenty of attention in recent years for their ability to help severe heart failure patients, but invasive surgery can hold little appeal for people who have less severe heart failure. Yet these patients may not be getting satisfactory results from drugs. "These are patients [ for whom] drugs aren't enough anymore, but they're not sick enough to warrant cracking their chest and doing an LVAD or a transplant," said Ben- jamin Hertzog, PhD, president and CEO of Procyrion. That's a population of more than 2 million heart failure patients. Procyrion, the Houston-based company that recently won MD+DI's 2016 Medtech Startup Showdown, is developing the Aor- tix system for chronic heart failure patients who fall into the New York Heart Association (NYHA) Class III and IVa categorization of disease severity, meaning they aren't yet sick enough for LVAD therapy. Aortix aims to offer the benefits of circulatory assistance without chest-opening surgery. Instead, the device could be delivered via a catheter and patients would be able to walk around. Cardiologist Reynolds Delgado, III, MD, FACC, medical director of mechanical sup- port devices in heart failure at the Texas Heart Institute, conceived of Aortix and founded Procyrion in 2005. Delgado is now the company's chief medical officer. In 2007, Houston's Fannin Innovation Studio offered seed funding for the company. Hertzog said that in late 2009 and early 2010, while he was working to "triage" the group's portfolio, he spotted Procyrion. "I got really excited about Procyrion and the opportunity for it, the huge clini- cal unmet need in heart failure and the commercial opportu- nity for an interventional car- diology tool for heart failure." Aortix is tiny, 6 mm wide and less than 6.5 cm long, with a micro- motor on expandable struts. The pump ac- celerates blood flow using fluid entrainment. Hertzog explained that the device is deployed by snaking a catheter into the patient's femo- ral artery and into the descending thoracic aorta. From there, the pump is designed to reduce cardiac afterload and increase blood flow to organs. The pump could be powered by a flexible power wire or possibly with a subcutaneous transcutaneous energy trans- fer system, according to information on the company's website. According to Hertzog, preclinical animal studies have shown that Aortix increased blood volume by 10–15% and reduced needed car- diac energy by almost 40%, resulting in a nearly 60% increase in ef- ficiency. Since Aortix would enhance blood flow but not fully support the heart, any unexpected failure should not en- danger the patient, unlike with VADs. The device's implant location should be a plus for active, ambulatory patients—the descending thoracic aorta is outside of the heart and downstream from the carotid ar- teries, reducing the risk of thrombotic stroke, valve damage, or blood flow problems within the heart. The location could also be a boon to other organs, including the kidneys. An- other unique design detail is the reversible anchoring technology. When the cardiologist has moved Aortix into the descending tho- racic aorta, the catheter sheath is retracted to anchor Aortix to the aortic wall using self-ex- panding nitinol struts. This anchor can also be collapsed, which should allow retrieval. Manesh Patel, MD, director of the Inter- ventional Cardiology and Catheterization Labs at Duke University Health Systems and Duke Clinical Research Institute and a mem- ber of Procyrion's scientific advisory board, wrote to MD+DI, "I think one of the ways we can return patients quality of life and reduce some of the hospital-based comorbidity is by providing therapies that allow ambula[tion] while improving their heart failure." The company has chosen two sites for first- in-human implants later this year, in Asun- ción, Paraguay, and at Duke University under FDA's Early Feasibility Study program. "The FDA is wholeheartedly encouraging the de- velopment of innovative therapies and we're glad to be participating in that," Hertzog said. Procyrion has raised a total $13.5 million from Fannin Innovation Studio, Dallas-based Scientific Health Development, and other strategic and angel investors. "We're a small team of engineer- entrepreneurs, and our real focus is innova- tion. We like to push the boundaries. I've got a team of like-minded individuals here and the most motivating thing you can say to us is, 'That'll never work.' We like nothing more than to prove that wrong," Hertzog said. —Marie Thibault 2 "These are patients [for whom] drugs aren't enough anymore, but they're not sick enough to warrant cracking their chest . . ." Benjamin Hertzog, PhD, President and CEO Keeping Heart Failure Patients on Their Feet Procyrion envisions its Aortix device as a less invasive approach that would keep heart failure patients ambulatory while under treatment. Inside Look: Procyrion The small Aortix device, under development now, is being designed for the Class III and IVa heart failure patient. Image courtesy of PROCYRION

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