Medical technology company Galvanize has secured the 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for its INUMI Flex endoscopic needle.
The FDA has granted clearance to INUMI Flex endoscopic needle for use with the Aliya Pulsed Electric Field (PEF) System in soft tissue ablation.
The clearance expands the Aliya Pulsed Electric Field ablation lineup. This allows for minimally invasive endoscopic delivery to complement the previously approved percutaneous needle.
Galvanize, which is based in California, is planning to commence commercial distribution in the US shortly.
The INUMI Flex needle with Aliya system will make the first commercially available system capable of delivering PEF energy via an endoscope.
The integration is expected to empower physicians to target and non-thermally ablate soft tissue lesions.
In the ongoing Galvanize AFFINITY clinical study, clinicians administer energy immediately following an initial biopsy.
Aliya operates by delivering high voltage, short duration electrical energy locally to modify the transmembrane potential of cells.
The procedure leads to the loss of homeostasis, inducing non-thermal programmed cell death without denaturing cellular proteins and the extracellular matrix, the medical technology firm said.
Aliya PEF System is now adaptable for delivery via both endoscopic and percutaneous methods.
Galvanize CEO Jonathan Waldstreicher said: “As physicians increasingly shift from percutaneous to endoscopic access of target lesions, our team developed INUMI Flex to meet their needs.
“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.”
The endoscopic delivery of Aliya was evaluated in two clinical feasibility studies of patients with non-small cell lung cancer (NSCLC).
The INCITE-ES study is designed to evaluate the safety and feasibility of Aliya in patients with early-stage IA2‐IB NSCLC.
Results indicated no device-related adverse events, a reduction in malignant tissue within the treated area, and an increase in the formation of tertiary lymphoid structures (TLS).
The ongoing AFFINITY study is currently enrolling participants with stage four NSCLC or lung metastases.
The trial will assess the safety of incorporating Aliya into the treatment pathway for these advanced disease patients. It will also assess the potential for immune modulation and treatment efficacy.
