Hannover, Germany – December 3, 2025 – Angiolutions today announced that the first patient has been successfully treated with its investigational A3-Shield® System in the PRINCIPIIS FIH Trial, a first-in-human (FIH) study evaluating the device’s safety and effectiveness. The trial is being conducted at several centers in Tashkent, Uzbekistan, and is designed to evaluate the device as an early interventional option for patients with small abdominal aortic aneurysms (AAAs).

Photo caption: The PRINCIPIIS-FIH trial team after the successful implantation. From left to right: Prof. Mansur Duran, MD (Head of Vascular and Endovascular Surgery, Marienhospital Gelsenkirchen), Marcus Wenzel (Senior R&D Engineer), Dr. Isabel N. Schellinger, MD (Co-Founder & CEO Angiolutions), Marius Rummel (Chief Business Officer Angiolutions), Dr. Sandra Düsing, MD (Senior Physician, Department of Angiology, University Hospital Leipzig), Prof. Hubert Schelzig, MD (Director of the Clinic for Vascular and Endovascular Surgery at the University Hospital Düsseldorf and Medical Board Member Angiolutions), Prof. Markus Wagenhäuser, MD (Senior Attending Surgeon, Clinic for Vascular and Endovascular Surgery at the University Hospital Düsseldorf), Dr. Uwe Raaz, MD (Co-Founder & CEO Angiolutions).

“The first procedure in PRINCIPIIS-FIH is a major milestone for Angiolutions and for patients living with small AAAs,” said Dr. Uwe Raaz, CEO of Angiolutions. “For too long, these patients have had to accept a ‘watch and wait’ approach in a progressive, life-threatening disease. With the A3-Shield® system, we aim to open a new therapeutic window where we can intervene earlier and intercept the disease in a relatively benign state.”

“Treating the first patient in PRINCIPIIS-FIH is an important step toward offering an earlier, less invasive option to patients with AAAs who are currently managed by surveillance alone,” said Prof. Hubert Schelzig, Director of the Clinic for Vascular and Endovascular Surgery at the University Hospital Düsseldorf and member of the Medical Board at Angiolutions. “By targeting a root biomechanical driver of AAA progression, the A3 Shield system aims to reduce the risk of future rupture and limit the need for complex aortic repair. The data from PRINCIPIIS-FIH will help us determine how this concept can be translated into routine clinical practice.”

About Abdominal Aortic Aneurysm (AAA)

AAA is a prevalent, progressive dilation of the abdominal aorta, affecting roughly 1 in 20 individuals aged 60 years and older. Although the majority of AAAs are detected at a small size, current interventional treatments are generally reserved for large, advanced aneurysms due to their inherent risk profile. As a result, patients with small AAAs often face years of “watch and wait” follow up without an active treatment option. Angiolutions’ A3-Shield® system is intended to address this unmet need by introducing pulse wave modulation as new treatment modality aiming to halt disease progression at an early stage.

Short animation demonstrating how the Angiolutions A3-Shield® implant works:

About Angiolutions

Angiolutions is a medical technology company pioneering a new treatment for abdominal aortic aneurysms (AAAs), a major vascular disease. Its A3-Shield® System is a first-of-its-kind implant that stops AAA growth by locally modulating aortic pulse waves. The company is currently conducting its first-in-human clinical trial. Angiolutions is headquartered in Hannover, Germany. More information can be found on https://angiolutions.com

Disclaimer

2025 All rights reserved. The Angiolutions® A3-Shield® System is an investigational device used exclusively for clinical investigation and not approved for commercial sale.