Thrombotic Stroke

The US-based medical device company is carrying out the A PRIORI study to assess the safety and performance of the Aortix pump to increase renal perfusion The Aortix percutaneous mechanical circulatory support device. (Credit: Procyrion) Procyrion has reported the successful first-in-human (FIH) cases in the A PRIORI pilot trial of its Aortix percutaneous mechanical circulatory support (pMCS) device in the prevention of acute kidney injury (AKI) during cardiac surgery. A PRIORI expands to Aortix therapy for Perioperative ReductIon Of Renal Injury. The US-based medical device company is conducting the A PRIORI study to assess the safety and performance of the Aortix pump to increase renal perfusion. The Aortix pMCS device is said to be a catheter-deployed pump technology that uses fluid entrainment to pump blood to address various conditions with unmet needs. According to Procyrion, the A PRIORI study will enrol up to 50 patients across four clinical sites in Australia. Procyrion president and CEO Eric Fain said: “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 pump is inserted into the descending thoracic aorta by a percutaneous catheter technique at the start of the scheduled surgical procedure, the medical device company said. This will directly boost kidney perfusion while decreasing cardiac energy requirements As per Procyrion, intra-aortic implantation eliminates the risk of device-related thrombotic stroke or injury to the heart or valves, and the pump can be installed in less than 15 minutes. The pump’s design uses fluid entrainment to provide therapy in a way that is physiologically natural while also directly increasing renal artery flow and pressure. The Aortix pump should be used for up to 48 hours following surgery to maintain increased renal perfusion, the medical device firm added. This will provide extra protection against postoperative risk factors for AKI, and lessen the strain on the recuperating heart.

A PRIORI study to evaluate safety and performance of novel Aortix percutaneous mechanical circulatory support device to increase renal perfusion Study adds to the growing body of data for the Aortix pump, which will be featured in a late-breaking presentation at the Technology and Heart Failure Therapeutics conference in March HOUSTON, Feb. 22, 2023 /PRNewswire/ -- 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. New study to prevent AKI in patients undergoing cardiac surgery adds to growing body of data for the Aortix pump. "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 for more information. Cautionary Statement Regarding Forward-Looking Statements This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

The OCEANIC program will investigate the efficacy and safety of asundexian (BAY2433334) in the prevention of stroke in patients with atrial fibrillation and also patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA)1,2 OCEANIC-AF and OCEANIC-STROKE are expected to enroll more than 27,000 patients in over 40 countries 3 WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer today announced the first patients have been enrolled in the initial trials for its OCEANIC clinical trial program, designed to explore the use of asundexian (BAY2433334), an investigational oral Factor XIa (FXIa) inhibitor, in patients with atrial fibrillation (AF) and in patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), a temporary period of symptoms similar to those of a stroke.1-2 Asundexian belongs to a potential new class of drugs being studied for thrombosis prevention.1-2 OCEANIC is one of the largest Phase III endeavors Bayer has ever undertaken.3 OCEANIC-AF (Oral faCtor Eleven A iNhibitor asundexIan as novel antithrombotic - Atrial Fibrillation study) is a multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, two-arm study that will investigate asundexian compared to apixaban in patients with atrial fibrillation at risk for stroke.1 The primary objectives of OCEANIC-AF are to determine the effects of asundexian on prevention of stroke and systemic embolism as well as compare the incidence of International Society on Thrombosis and Hemostatis (ISTH) major bleeding.1 Its first patient was enrolled in December 2022.1 “Despite advances in anticoagulation, potential bleeding risk may be a reason why some patients go untreated and underscores the need for alternative treatments to prevent thrombosis,”4 said Manesh Patel, M.D., Richard S. Stack Distinguished Professor, Chief of the Division of Cardiology and Co-Director of the Heart Center at Duke University, and Principal Investigator for the OCEANIC-AF trial. “The Phase III OCEANIC program will generate more data to advance our understanding of the safety and efficacy of asundexian across a large patient population.”1-2 OCEANIC-STROKE (Oral faCtor Eleven A iNhibitor asundexIan as novel anti-thrombotiC - STROKE study) is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study on top of standard-of-care antiplatelet therapy in patients after a non-cardioembolic ischemic stroke or high-risk TIA.2 The primary objectives are to investigate asundexian for prevention of ischemic stroke compared to placebo as well as compare the incidence of ISTH major bleeding.2 Its first patient was enrolled in late January 2023.2 “Patients with acute non-cardioembolic stroke or transient ischemic attack have a high early risk of stroke that continues in the long term,”5 said Mike Sharma, M.D., MSc., FRCPC, Michael G. DeGroote Chair in Stroke Prevention and Medical Director of Stroke Program at McMaster University and Principal Investigator for the OCEANIC-STROKE trial. “Additional research into the combination of FXI inhibition and antiplatelet agents is needed to explore potential treatment options for the future.” Combined, the trials are expected to enroll more than 27,000 patients in over 40 countries.1-2 “Through our OCEANIC clinical trial program, Bayer leverages decades of cardiovascular expertise to investigate a potential new class of antithrombotics and explore the potential of asundexian as an additional antithrombotic treatment option across multiple patient populations,” 1-2 said Maria Borentain, M.D., Vice President and Head of Thrombosis and Vascular Disease Clinical Development, Bayer. “The initiation of the OCEANIC program is based on insights from the PACIFIC Phase II program,3 which included PACIFIC-AF and PACIFIC-STROKE, and guided our decision to further explore the potential of asundexian in thrombosis management.” The following abstracts on secondary analysis from the PACIFIC-STROKE study were selected for presentation at the International Stroke Conference, being held from February 8-10 in Dallas, Texas: Smith EE, Shoamanesh A, Mundl H, et al. Effect of factor XIa inhibition with asundexian on recurrent ischemic stroke according to baseline patterns of infarction on brain MRI: PACIFIC-Stroke.6 Khatri P, Shoamanesh A, Mundl H, et al. Effects of the oral factor XIa inhibitor asundexian on intracranial bleeding among patients with acute non-cardioembolic ischemic stroke: PACIFIC-Stroke randomized trial. 7 About the FXIa Clinical Trial Program The PACIFIC clinical trials form part of the broadest Phase IIb FXIa program in the world, involving more than 4,000 patients to date. 3 The OCEANIC Phase III clinical development program, currently underway, starts with two large multinational studies, OCEANIC-AF and OCEANIC-STROKE, expected to enroll more than 27,000 patients in over 40 countries. 1-2 The program, one of the largest Phase III endeavors Bayer has ever undertaken, is part of Bayer’s commitment to address unmet needs in a growing range of underserved cardiovascular patient communities. More information about these trials is available at . About Asundexian Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential once-daily oral Factor XIa (FXIa) inhibitor in thrombosis prevention. 1-2 Factor XI is a protein in the blood that is converted into its active enzyme form (Factor XIa) as part of the blood coagulation cascade. 3 About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to . Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References ClinicalTrials.gov. A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke (OCEANIC-AF). Accessed Jan 31 2023. ClinicalTrials.gov. A Study to Learn More About Asundexian (Also Called BAY2433334) for Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older Who Already Had Such a Stroke Due to a Blood Clot That Formed Outside the Heart and Travelled to the Brain, or Temporary Stroke-like Symptoms (OCEANIC-STROKE). Accessed Jan 24 2022. Bayer Initiates Phase III Study Program for Investigational Oral fxia ... (no date). Available at: . Accessed: January 31, 2023. Maier, O. (2022). Asundexian Investor Webinar. Bhatia, K., Jain, V., Aggarwal, D., Vaduganathan, M., Arora, S., Hussain, Z., Uberoi, G., Tafur, A., Zhang, C., Ricciardi, M., & Qamar, A. (2021). Dual Antiplatelet Therapy Versus Aspirin in Patients With Stroke or Transient Ischemic Attack: Meta-Analysis of Randomized Controlled Trials. Stroke, 52(6). . Data on file. Data on file.