Houston, TX (July 30, 2019) – Procyrion, Inc., a medical device company developing percutaneous circulatory support devices for the treatment of heart failure, announced today that it has secured Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its Aortix™ System. Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) with worsening renal function.
Breakthrough Designation is granted to certain medical devices and device-led combination products that provide a more effective treatment of life-threatening or irreversibly debilitating diseases. It enables manufacturers to provide patients and healthcare providers with timely access to medical devices by expediting their development, assessment, and review. Benefits of this designation include frequent interactions and feedback from FDA during the premarket review phase.Through this program, Procyrion can expect prioritized review of its FDA submissions for the Aortix System. In addition, the Centers for Medicare and Medicaid Services (CMS) recently proposed a new rule¹ that would provide coverage and increase payments for medical devices designated by the FDA as breakthrough devices, so Medicare beneficiaries do not have to wait for access to the latest innovations.
“With Aortix, we have a device innovation that truly warrants breakthrough designation for the treatment of ADHF patients with worsening renal function, a particularly challenging group of patients for whom outcomes are generally poor and treatment options limited,” commented Keith Aaronson, MD, MS, Pitt Collegiate Professor of Cardiovascular Medicine and Medical Director of the Center for Circulatory Support at the University of Michigan.
Heart failure (HF) is common, affecting more than 6 million adults and resulting in over 1 million annual hospitalizations in the United States alone.² HF costs the nation an estimated $30.7 billion each year.³ HF is a chronic, progressive condition, marked by episodes of acute decompensation typically requiring hospitalization for stabilization and improvement in symptoms. Unfortunately, outcomes after a hospitalization for decompensated heart failure are poor. The 1-year mortality rate after a heart failure hospitalization has remained high at 20-30%,⁴ and there is additive risk with each subsequent hospitalization⁵⁻⁶. In addition, at least moderate renal dysfunction (Stage III) is present in up to 64% of ADHF admissions⁷ and it is estimated that over 325,000 admissions per year in the U.S. are for patients with ADHF who also have worsening renal function.⁸ These patients represent a particularly high-risk population as they are frequently non-responders to available medical therapy and have poor outcomes.
“We believe Aortix addresses an important unmet clinical need and can fill a major gap ineffective therapy options that are available for heart failure patients. This is particularly critical as this large patient population has high rates of rehospitalization and death, long lengths of stay in the hospital and high healthcare costs,” commented Eric S. Fain, MD, president and chief executive officer of Procyrion. “We plan to fully leverage the benefits of FDA Breakthrough Device designation as we seek to accelerate the U.S. clinical and regulatory process with the goal of providing physicians and patients with the benefits of our novel device.”
The Aortix System is a percutaneous circulatory support device for the treatment of heart failure. The initial version of the Aortix device provides up to seven days of circulatory support for chronic heart failure patients who have been hospitalized for ADHF, have worsening renal function and are unresponsive to medical management. As demonstrated in animal studies⁹ and a six-patient First-in-Human study¹⁰, Aortix benefits both the heart and the kidneys based on its unique design and placement in the descending thoracic aorta. Aortix can disrupt the harmful cardiorenal cycle in two ways: above the pump, it rests the heart by reducing aortic root pressure (afterload) resulting in increased cardiac output and decreased cardiac work; downstream, it provides increased blood flow to the kidneys resulting in increased urine output and a reduction in fluid overload. The device is placed via a minimally invasive catheter-based procedure that takes less than 10 minutes.
Procyrion Inc., headquartered in Houston, Texas, is developing catheter-based circulatory support technologies to address the significant unmet clinical need in the large chronic heart failure population. This groundbreaking cardiology tool, conceived by cardiologist Dr. Reynolds M. Delgado, III, medical director of Mechanical Support Devices in Heart Failure at the Texas Heart Institute, and launched at Fannin Innovation Studio, is being developed to provide a minimally invasive treatment option for millions of chronic heart failure patients. Aortix is not approved for sale in any geography. Please visit www.procyrion.com for more information.
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
2 Benjamin,E. J. et al. Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association. Circulation CIR.0000000000000485(2017). doi:10.1161/cir.0000000000000485
3 Heidenreich,P. A. et al. Forecasting the Future of Cardiovascular Disease in theUnited States. Circulation 123, 933–944 (2011).
4 Chen,J., Normand, S.-L. T., Wang, Y. & Krumholz, H. M. National and Regional Trends in Heart Failure Hospitalization and Mortality Rates for Medicare Beneficiaries, 1998-2008. JAMA 306, 1669–1678 (2011).
5 Solomon,S. D. et al. Influence of nonfatal hospitalization for heart failure on subsequent mortality in patients with chronic heart failure. Circulation 116, 1482–7 (2007).
6 Setoguchi,S., Stevenson, L. & Schneeweiss, S. Repeated hospitalizations predict mortality in the community population with heart failure. American Heart Journal 154, 260–266 (2007).
7 Heywood,J. et al. High prevalence of renal dysfunction and its impact on outcome in 118,465 patients hospitalized with acute decompensated heart failure: a report from the ADHERE database. Journal of cardiac failure 13,422–30 (2007).
8 Adams,K. F. et al. Characteristics and outcomes of patients hospitalized for heart failure in the United States: Rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J 149, 209–216(2005).
9 Shabari,F. et al. Improved Hemodynamics With a Novel Miniaturized Intra-aortic Axial Flow Pump in a Porcine Model of Acute Left Ventricular Dysfunction. ASAIO Journal 59, 240 (2013).
10 Vora, A. N. et al. First‐in‐human experience with Aortix intraaortic pump. Catheter Cardio Inte (2018). doi:10.1002/ccd.27857