Galvanize Therapeutics' endoscopic, pulsed-field needle scores FDA clearance in cancer, soft tissue ablation

Pulsed field ablation has been making waves in cardiac procedures in the past few months following a series of green lights among major devicemakers looking to offer treatments for atrial fibrillation and irregular heart rhythms with fewer side effects. Now, Galvanize Therapeutics is jumping in with its system that broadens the use of the tech to patients with cancer.

The company collected an FDA 510(k) clearance for its INUMI Flex endoscopic needle ablation system, a part of its Aliya pulsed field energy portfolio, for use against soft-tissue lesions including lung nodules that can harbor tumor cells.

Compared to traditional surgical ablation approaches that deliver heat or cold energy to a broader area, pulsed field ablation aims to be more selective by using tuned electricity to break down the membranes of troublesome cells.

According to Galvanize—which billed its forthcoming system as the first commercial product to combine pulsed field ablation with an endoscope—clinical trials have shown reductions in malignant tissue among patients with early-stage non-small cell lung cancer, with the energy being delivered immediately after a biopsy.

In addition, the company said that opening up those tumor cells and releasing certain proteins could pave the way for stronger responses from the body’s wider immune system—as seen in preliminary data from a clinical trial of the Aliya system, which was previously cleared for needle-based procedures conducted through the skin.

“The ability to diagnose and treat in a single non-invasive endoscopic procedure represents a major advancement,” said Michael Pritchett, director of the FirstHealth Chest Center of the Carolinas and an investigator in the company’s ongoing clinical trial of Aliya’s first-line use among metastatic lung cancer patients.

“The potential to stimulate the patient's immune system to create a systemic response beyond the focal ablation could be a game changer and may provide new hope for patients with metastatic disease,” Pritchett said in a statement.

Today’s Galvanize Therapeutics was born in late 2022 from a three-way merger of portfolio companies incubated under Apple Tree Partners, including separate developers of pulsed field ablation tech for solid tumors, chronic bronchitis and arrhythmias. 

A coinciding series B funding round netted the outfit $100 million, led by Fidelity Management and joined by Intuitive Surgical, which has a robotic bronchoscopy system that is being used with the Aliya system in its clinical trial.

“In a patient with two suspected oligometastatic lesions in the lung, we used the Intuitive Ion robotic platform to navigate to a 10 mm lesion on the left and biopsy,” explained Pritchett late last year as the company’s study got underway. “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. After this we moved to a 5 mm lesion on the right and completed treatment of this lesion as well, using cone beam CT to confirm accurate positioning within the small lesion,” he said.

“It's exciting to be able to diagnose and treat in a single procedure, but we have the added prospect of creating a systemic response in a patient with metastatic disease which is a game changer,” Pritchett added. “Best of all, the patient went home the same day with a recovery equivalent to a biopsy alone.”

Last year also saw Galvanize conduct layoffs; the company did not disclose how many people or departments were affected at the time. Its cardiac electrophysiology division was later acquired by CardioFocus.

Galvanize’s other product, the CE marked RheOx system, targets patients with chronic obstructive pulmonary disease, or COPD, to disrupt the mucus-producing cells in the airway that are linked with long-term bronchitis. Aliya, meanwhile, is also being explored for liver, kidney and breast cancers.

“As physicians increasingly shift from percutaneous to endoscopic access of target lesions, our team developed INUMI Flex to meet their needs,” Galvanize CEO Jonathan Waldstreicher, M.D., said in a statement. “Having demonstrated the effects of Aliya beyond focal ablation in early studies, we continue to invest in understanding the full potential of biologic activation and its unique immune response in clinical trials.”