WallabyPhenox Announces First U.S. Patient Treatment in PIANO IDE Trial

Irvine, California — March 20, 2026 —WallabyPhenox announced the successful treatment of the first U.S. patient in the p48 and p64 MW HPC in Aneurysm Occlusion (PIANO) IDE trial. The trial evaluates the p48 and p64 MW HPC Flow Modulation Devices for treating intracranial aneurysms. The first two procedures were performed by Adel Malek, MD, PhD, Chief of Neurovascular Surgery at Tufts Medical Center in Boston, MA.

According to Ruilin Zhao, CEO of WallabyPhenox, initiating the PIANO IDE trial is an important milestone, demonstrating the company's commitment to bringing life-saving innovations to patients in the United States.

Flow diversion is an established therapy for intracranial aneurysms. However, limited device options remain available to U.S. physicians. The p48 and p64 MW HPC flow diverters are market leaders in Germany.

Gary Brogan, VP of Global Clinical & Regulatory Affairs, stated that the p48 and p64 MW HPC devices have been used in the treatment of more than 20,000 patients worldwide. Data from rigorous studies conducted outside the United States demonstrate consistently high aneurysm occlusion rates and low complication rates.

The p48 & p64 MW HPC devices offer multiple novel features, including the first Movable Wire (MW) technology designed for stable and controlled positioning. The Hydrophilic Polymer Coating (HPC) is designed to reduce thrombogenicity of the implant. Smaller microcatheter delivery simplifies procedural access. Lastly, the Nitinol wires with platinum core provide full radiographic visibility.

Demetrius Lopes, MD, who serves as the National Principal Investigator along with Jared Knopman, MD, and Eytan Raz, MD, PhD, stated that the U.S. physician community has been eagerly awaiting this unique flow diverter.

Dr. Malek welcomes the opportunity to offer new innovations and technologies to patients through clinical trials. According to Dr. Malek, a device that proves to be safe, effective, and efficient will enhance the ability to treat intracranial aneurysms and ensure the best-possible outcomes for patients.

Enrollment in the PIANO IDE trial is ongoing at leading U.S. centers.

The p48 and p64 MW HPC Flow Modulation Devices are investigational devices in the United States and are limited by federal law to investigational use.