FDA Clears Galvanize Therapeutics’ Endoscopic Pulsed-Field Needle for Cancer and Soft Tissue Ablation

Pulsed-field ablation (PFA) is increasingly being applied in cardiac surgery, particularly for treating atrial fibrillation and irregular heartbeats, with fewer complications. Now, Galvanize Therapeutics is adapting this technology for cancer treatment. Focusing on the Aliya pulsed field energy segment, the INUMI Flex endoscopic needle ablation system has been cleared by the FDA 510(k) for soft-tissue lesion ablation, specifically targeting lung lesions containing tumor cells.

Standard techniques for tissue ablation typically use heat or cold energy, which can affect a large portion of the tissue. PFA, on the other hand, uses precisely controlled electric energy to selectively permeabilize cell membranes, minimizing harm to the surrounding tissue. Galvanize’s INUMI Flex system is noteworthy as the first commercial product to combine PFA with endoscopy, enhancing treatment outcomes.

Clinical trials of the Aliya system, previously granted De Novo designation for percutaneous needle-based procedures, showcased promising improvements in reducing malignant tissue in subjects with early-stage non-small cell lung cancer. The system is used after a biopsy to increase the accuracy and speed of treatment. Additionally, Galvanize suggests that the PFA process may help provoke an immune response by releasing proteins from the ablated tumor cells.

Michael Pritchett, from the FirstHealth Chest Center of the Carolinas and the principal investigator in Aliya’s current clinical trial, emphasized the benefits of integrating diagnostics and therapy into one endoscopic method. He highlighted the potential for developing a systemic immune response through PFA, offering new hope for metastatic patients.

Galvanize Therapeutics was formed at the end of 2022 when three startups founded by Apple Tree Partners merged, focusing on PFA technology for various cancers, chronic bronchitis, and arrhythmias. The merger occurred during a series B funding round, which raised $100 million from Fidelity Management and Intuitive Surgical. A robotic bronchoscopy system using the Aliya system is currently in clinical trials with Intuitive.

A company representative described an interaction where the Intuitive Ion robotic platform was used to locate and biopsy a potential metastatic lung mass. The lesion was confirmed as malignant, and the Aliya system was used to treat the patient immediately. This approach enabled targeted treatment and the possibility of eliciting a systemic immunological response. The patient was discharged the same day, with a recovery period similar to a simple biopsy.

Despite challenges over the past year, such as layoffs (the exact number not disclosed) and the sale of its cardiac electrophysiology division to CardioFocus, Galvanize continues to progress. Recently, the company launched a CE-marked RheOx system intended for COPD treatment by destroying mucus-producing cells linked to chronic bronchitis. The Aliya system is also being considered for liver, kidney, and breast cancer detection.