FIRST PATIENT ENROLLED IN AKURA MEDICAL'S US PIVOTAL TRIAL FOR PULMONARY EMBOLISM

• Initial case with the Katana™ Thrombectomy System conducted at TriStar Centennial Medical Center
• The Katana System is an intelligent thrombectomy system designed to remove diverse clot types, optimize catheter delivery and provide interoperative feedback

LOS GATOS, Calif., Feb. 4, 2025 /PRNewswire/ -- Akura Medical, a Shifamed portfolio company focused on reshaping the landscape of venous thromboembolism (VTE) care, announced today the first patient enrollment in the QUADRA-PE study (NCT06672510) evaluating the Katana™ Thrombectomy System in patients with acute pulmonary embolism (PE). The initial procedure was successfully performed by Samuel Horr, MD, Director of Cardiovascular Research at TriStar Centennial Medical Center.

"TriStar Centennial is thrilled to be a part of research trials that hold the potential to deliver better care to patients," commented Dr. Horr. "With this trial, the hope is to provide physicians with continuous, real-time pulmonary artery pressure readings throughout the entire procedure to streamline the removal of the blood clot."

"One of the biggest challenges in thrombectomy procedures for PE is determining when you've successfully removed the thrombus entirely, as incomplete removal can may lead to suboptimal outcomes," said Sanjum Sethi, MD, Interventional Cardiologist at Columbia University Medical Center and Co-Principal Investigator for the QUADRA-PE trial. "The Katana System's display of real-time pressure data represents a significant advancement, providing physicians with clinically useful insights during the procedure."

The Katana System includes:

• A bi-directional, low-profile sheath designed to facilitate smoother navigation in complex vasculature and enable contrast injection without requiring catheter exchanges.
• High velocity saline jets that are engineered to effectively break up clots independent of morphology and prevent catheter clogging for procedural efficiency.
• Sensors that provide real-time pulmonary artery pressure data to provide insights into procedure progress.
• The Sentinel™ Console, which displays clot engagement and blood loss to inform the physician and to potentially minimize uncertainty.

"Pulmonary embolisms can be life-threatening and demand swift and effective intervention. Meaningful strides have been made in the thrombectomy landscape, but challenges remain in navigating complex vasculature and simplifying decision making," said Ann Gage, MD, Critical Care and Interventional Cardiologist at TriStar Centennial Medical Center and Co-Principal Investigator for the QUADRA-PE trial. "I am incredibly excited to be involved in this study as it represents a significant milestone in the forward trajectory of pulmonary embolism treatment."

The QUADRA-PE study is a multi-center, international trial designed to enroll up to 118 patients with clinically significant acute PE, at up to 26 sites globally. The primary effectiveness endpoint is the reduction in right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure as assessed by CT angiography. The primary safety endpoint is the composite rate of major adverse events (MAEs) within 48 hours post-procedure.

About Akura Medical, Inc.
Akura Medical, a privately held portfolio company of Shifamed LLC, is a medical technology company dedicated to addressing venous thromboembolism (VTE). Our flagship product, the Katana™ Thrombectomy System, is poised to redefine pulmonary embolism (PE) treatment standards by enabling enhanced removal of diverse clot types more efficiently. The Katana Thrombectomy System embodies our mission to reshape the landscape of VTE care and make a lasting impact on the lives of patients worldwide. To learn more about Akura Medical, visit http://www.akuramed.com/.

*The Katana System is for Investigational Use only and is not cleared for sale in the USA. Not approved for sale in any country.

About Shifamed, LLC.
Founded by serial entrepreneur Amr Salahieh, Shifamed is a highly specialized medical innovation hub focused on developing solutions that accelerate time to market, reduce risk, increase impact, and forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.

MEDIA CONTACT:
Jennie Kim
SPRIG Consulting, LLC
[email protected] 

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SOURCE Akura Medical, Inc.