The system is intended to treat patients with stage IV NSCLC or metastasis to the lung who are not surgical candidates. Credit: Africa Studio / Shutterstock.com.

Galvanize Therapeutics has commenced the AFFINITY clinical study in the US to assess the safety and technical success of the Aliya Pulsed Electric Field (PEF) system.

The system is intended to treat patients with stage IV non-small cell lung cancer (NSCLC) or metastasis to the lung who are not surgical candidates.

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It provides high-voltage, short-duration electrical energy locally for altering the transmembrane potential of a cell and inducing non-thermal programmed cell death without damaging the extracellular matrix or cellular proteins.

FirstHealth’s Chest Center of the Carolinas director and Pinehurst Medical Clinic pulmonology specialist Dr Michael Pritchett treated the first patient using the Aliya Endobronchial Needle through robotic-assisted bronchoscopy.

This needle is currently an investigational device in the US.

Pritchett said: “Today’s procedure was a glimpse into the future. In a patient with two suspected oligometastatic lesions in the lung, we used the Intuitive Ion robotic platform to navigate to a 10mm lesion on the left and biopsy.

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“Onsite pathologic evaluation confirmed malignancy, mostly likely secondary to metastatic renal cell carcinoma. We then maintained our position at the lesion and treated it with Aliya.”

The prospective, open-label, multi-centre, non-randomised, single-arm and early feasibility study is carried out at three centres in the country.

It will enrol up to ten non-surgical subjects with stage IV NSCLC or lung metastasis who are indicated for first-line standard-of-care therapy.

It will assess the safety of adding Aliya PEF treatment to the care pathway for these patients with advanced disease and evaluate the potential immune modulation and treatment effects further.

The company received 510(k) clearance from the US Food and Drug Administration for this device for the surgical ablation of soft tissue. It is currently not for sale in any other geography.