Galvanize Receives FDA Clearance for the INUMI Flex Endoscopic Needle, Expanding its Aliya® Pulsed Electric Field (PEF) Portfolio for Soft Tissue Ablation

First Commercially Available Endoscopic Pulsed Electric Field Ablation System for Soft Tissue Lesions

REDWOOD CITY, Calif., May 28, 2024 /PRNewswire/ -- Galvanize today announced that it received U.S. Food and Drug Administration 510(k) regulatory clearance for the INUMI Flex endoscopic needle for use with the Aliya^® PEF System for soft tissue ablation. The INUMI Flex needle expands the Aliya Pulsed Electric Field ablation portfolio, enabling minimally invasive endoscopic delivery to complement the previously cleared percutaneous Needle. Galvanize will soon initiate commercial release in the United States.

Aliya, with the INUMI Flex needle, is the first commercially available system to deliver PEF energy through an endoscope, enabling physicians to reach and non-thermally ablate soft tissue lesions. In the ongoing Galvanize AFFINITY clinical trial, clinicians deliver energy immediately after an initial biopsy. 

Aliya delivers high voltage, short duration electrical energy locally to alter the transmembrane potential of cells, which results in loss of homeostasis, inducing non-thermal programmed cell death without denaturing cellular proteins and the extracellular matrix. In addition to focal ablation, preclinical and prior clinical feasibility studies suggest this process may release antigens from the dying tumor cells that may stimulate an immune response for a potential systemic effect beyond focal ablation. Aliya can now be delivered using either an endoscopic or percutaneous approach. 

"As physicians increasingly shift from percutaneous to endoscopic access of target lesions, our team developed INUMI Flex to meet their needs," commented Jonathan Waldstreicher, MD, CEO of Galvanize. "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."

Endoscopic delivery of Aliya has been evaluated in two clinical feasibility studies in patients with Non-Small Cell Lung Cancer (NSCLC), one with robotic-assisted bronchoscopy and the other with navigation bronchoscopy. INCITE-ES was a treat-and-resect study conducted outside of the U.S. and was designed to assess safety and feasibility of Aliya while examining immune activation in patients with early stage IA2‐IB NSCLC (NCT04732520). Outcomes demonstrated no device-related adverse events, a significant reduction in malignant tissue in the treated region, and an increase in formation of tertiary lymphoid structures (TLS) in treated patients. This early data suggests Aliya may stimulate a systemic immune effect beyond focal ablation. The AFFINITY study (NCT05890872) which is currently enrolling, is a prospective, single-arm, non-randomized, multi-center, feasibility study in patients with stage IV NSCLC or lung metastases who are indicated for first line standard of care therapy. This study is examining the safety of adding Aliya to the care pathway for these advanced disease patients and further assesses the potential immune modulation and treatment effect.

"The ability to diagnose and treat in a single non-invasive endoscopic procedure represents a major advancement", said Michael Pritchett, DO, MPH, Pulmonary Specialist and Director of the Chest Center of the Carolinas at FirstHealth in Pinehurst, North Carolina, and investigator in the AFFINITY trial. "I'm encouraged by early results we are seeing in patients enrolled in the study. 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. I'm excited to now have this option available to offer patients outside of a clinical trial."

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. 

About Galvanize™

Galvanize aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, including solid tumors, and chronic bronchitis symptoms. Formed by ATP (Apple Tree Partners), Galvanize is based in Redwood City, Calif., and is developing and commercializing its revolutionary Aliya^® PEF energy platform in the United States. For more information, please visit www.galvanizetx.com.

SOURCE Galvanize Therapeutics, Inc.