Galvanize Launches PROPEL Registry to Study Aliya® PEF Ablation for Soft Tissue Lesions
Galvanize Therapeutics has officially initiated the PROPEL Registry, marking a pivotal moment in the evaluation of its innovative Aliya Pulsed Electric Field (PEF) ablation technology. This multicenter observational study focuses on the clinical safety and effectiveness of Aliya® in treating soft tissue lesions, particularly those found in complex regions such as the lung and liver.
The first patient was successfully enrolled by Dr. Kamran Mahmood, who is not only the Director of Interventional Pulmonology at Duke University Medical Center but an Associate Professor of Medicine as well. This enrollment signifies the commencement of a broader investigation into the clinical applications of Aliya. Dr. Mahmood noted that interventional pulmonology has traditionally concentrated on diagnosing lung malignancies; however, the focus is now shifting towards the effective ablation of such lesions.
The methodology behind the Aliya PEF technology is particularly noteworthy. Unlike conventional thermal ablation methods, which can damage surrounding tissue, Aliya employs short-duration high-voltage electrical pulses. This technology effectively induces cell death while safeguarding surrounding delicate structures, including airways and blood vessels. By not harming these critical areas, Aliya offers a promising new avenue for patients situated in anatomically challenging regions or those affected by previous radiation treatments.
As noted by Dr. Bill Krimsky, the Chief Medical Officer at Galvanize, the PROPEL Registry will provide invaluable insights into the performance of Aliya within diverse patient demographics outside of strictly controlled clinical trials. By meticulously gathering data regarding procedural techniques, clinical outcomes, and physician feedback, the study aims to contribute to the evidence-based integration of the PEF ablation system in standard clinical procedures.
The registry is designed to enroll as many as 1,000 patients across up to 50 medical centers throughout the United States. Participants will be monitored over a period extending up to 24 months, with a focus on collecting comprehensive data related to procedural approaches, immediate surgical outcomes, and any radiographic changes observed post-treatment.
For medical professionals or clinical institutions interested in taking part in the PROPEL Registry, further information regarding the Aliya PEF system is available on Galvanize’s official website. Notably, the Aliya® PEF System and the associated INUMI® Flex needle have received 510(k) clearance from the FDA for surgical soft tissue ablation within the United States, though they are not yet available commercially in other regions.
Galvanize is dedicated to becoming a leading force in the realm of medical technology, aiming to deliver remarkable innovations that enhance the treatment of various ailments, including solid tumors and chronic bronchitis symptoms. Situated in Redwood City, California, the company continues to drive forward with its groundbreaking Aliya® PEF energy platform. This technology holds great potential in reshaping current medical practices for treating soft tissue lesions, thereby contributing to more effective patient outcomes and expanded treatment options.
Overall, the launch of the PROPEL Registry signifies a major advancement in the clinical exploration of Aliya, symbolizing a proactive shift towards understanding its capabilities and applications in real-world medical settings.