Procyrion Announces Successful First-in-Human Cases With Aortix Pump to Prevent Acute Kidney Injury in Patients Undergoing Cardiac Surgery

Houston, Tx — Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac and renal impairment, announced today successful treatment of the first patients in the A PRIORI (Aortix therapy for Perioperative ReductIon Of Renal Injury) pilot trial to evaluate the performance of its Aortix™ percutaneous mechanical circulatory support (pMCS) device in preventing acute kidney injury (AKI) during cardiac surgery, a common and serious complication that impacts approximately 30% of patients.1 The A PRIORI study will enroll up to 50 patients across four clinical sites in Australia: Royal Adelaide Hospital, Monash Health, Princess Alexandra Hospital, and Macquarie University.

"We are thrilled to be the first center in the world to provide Aortix pump therapy during a cardiac surgery with the goal of reducing the risk of AKI," said Professor Stephen Worthley, Macquarie University Hospital, Sydney, Australia. "Patient history can help identify those with known risk factors for developing AKI and the Aortix pump has the potential to address major risk factors both during and after surgery by improving renal artery flow. The catheter-based pump was easy to deploy, operated in a location that did not interfere with the surgery, and greatly improved perfusion to the kidneys."

During surgery, a reduction in systemic pressure can lower renal perfusion, increasing risk of AKI. Approximately one third of high-risk patients (defined as those with poor kidney function, heart failure, or diabetes or hypertension with complications) may develop AKI following a coronary artery bypass surgery (CABG) or heart valve surgery.1 Moderate AKI after cardiac surgery can lead to a 5x increase in morbidity and mortality rates and double length of stay, hospital costs, and re-admission rates.2,3

The Aortix pump is placed in the descending thoracic aorta via a percutaneous catheter procedure at the beginning of the scheduled surgical procedure to directly increase perfusion to the kidneys while reducing cardiac energy requirements. The pump can be deployed in less than 15 minutes and the intra-aortic placement essentially eliminates risk of device-related thrombotic stroke or damage to the heart or valves. The innovative design harnesses fluid entrainment to directly increase renal artery flow and pressure and allows for physiologically natural delivery of therapy. The Aortix pump is intended to be left up to 48 hours post-surgery to maintain increased renal perfusion to provide additional protection against post-operative risk factors for AKI, as well as decrease the workload of the recovering heart.

"I would like to thank Prof. Worthley and the entire team for their collaboration in achieving this important milestone," stated Eric. S. Fain, MD, President and Chief Executive Officer, Procyrion. "The initiation of the A PRIORI study, after recently completing our pilot study in treating cardiorenal syndrome patients, is an exciting step that contributes to the growing body of evidence demonstrating the potential of the Aortix pump technology to improve outcomes for patients with cardiac and renal impairment."

The Aortix cardiorenal syndrome (CRS) pilot study will be presented by Dr. Jennifer Cowger, Henry Ford Health Heart & Vascular Institute, Detroit, MI, in the late-breaking clinical science session at 2 pm EDT on March 21, 2023 during the Technology and Heart Failure Therapeutics (THT) conference in Boston.

About Procyrion
Procyrion, Inc. is a privately held medical device company dedicated to providing effective treatment options for patients with cardiac and renal impairment. The company is developing the Aortix™ percutaneous mechanical circulatory support device, a catheter-deployed pump technology that uniquely harnesses fluid entrainment to pump blood to address multiple conditions with significant unmet needs. The platform technology is currently being evaluated for in-hospital therapy of cardiorenal syndrome (CRS) patients and prevention of acute kidney injury (AKI) associated with cardiac surgery. Aortix is limited by Federal law to investigational use only and is not approved for sale in any geography. Please visit www.procyrion.com for more information.

References:

1. Based on ICD-10 codes for acute kidney injury in specified surgical groupings in National Inpatient Survey of data through 2018

2. Dasta JF, Kane-Fill SL, Durtschi, AJ, Pathak DS, Kellum JA. Costs and outcomes of acute kidney injury (AKI) following cardiac surgery. Nephrol Dial Transplant. 2008;23:1970-1974.

3. Brown JR, Parikh CR, Ross CS, et al. Impact of Perioperative Acute Kidney Injury as a Severity Index for Thirty-Day Readmission After Cardiac Surgery. Ann Thorac Surg. 2014;97(1):111-117.3.

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