Galvanize Therapeutics has announced the enrollment of the first patient in the PROPEL Registry, a multicenter observational study designed to evaluate the clinical application, safety, and outcomes of the Aliya Pulsed Electric Field (PEF) ablation system for soft tissue lesions, including primary and metastatic lesions in the lung, liver, and other organs.
The inaugural procedure was performed by Kamran Mahmood, Director of Interventional Pulmonology and Associate Professor of Medicine at Duke University Medical Center. The study aims to investigate Aliya in clinical practice.
“Interventional pulmonology has been focused on diagnosing lung cancer over the last few decades. Now we are shifting our attention to ablating the lesion,” said Dr. Mahmood.
Unlike traditional thermal ablation techniques, Aliya PEF uses short-duration, high-voltage electrical pulses to induce cell death without damaging the surrounding sensitive structures such as airways, blood vessels, or the pleura. This innovative approach, delivered either percutaneously or endoscopically, preserves the extracellular matrix and surrounding tissue, offering an ablation modality that may expand options for patients with lesions in anatomically complex or previously irradiated regions. In addition to focal ablation, preclinical and early clinical data suggest Aliya may promote antigen release that could activate the immune system.
"The PROPEL Registry is an important step in understanding how Aliya performs in a broad, heterogeneous patient population outside of a prospective trial setting," said Dr. Bill Krimsky, Chief Medical Officer at Galvanize.
"By systematically capturing procedural data, clinical outcomes, and physician experience, we aim to inform evidence-based integration of our PEF ablation into clinical care pathways,” he added.
The study plans to enroll up to 1,000 patients across up to 50 US centers. Patients will be followed over a period of up to 24 months, with data collected on procedural techniques, perioperative outcomes, and radiographic response.
The Aliya PEF System and the INUMI Flex needle are 510(k) cleared in the United States for the surgical ablation of soft tissue. They are not currently commercially available in any other geography.
Headquartered in Redwood City, CA, Galvanize Therapeutics develops and commercializes energy-based medical device technology, with a focus on oncology, chronic bronchitis, and drug delivery.
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