Galvanize Therapeutics Inc., a leading marketing pro medical technology company featuring pulsed electric field (PEF) therapies for chronic lung disease and oncology, opted for the online platform to post its positive six-month results from its robust AFFINITY clinical trial in the medical journal Cancers. The AFFINITY trial is an intentional, open-label, prospective one-line study examining the feasibility and safety of Aliya PEF.
The publication demonstrates six-month results for 28 28-examinable patient group receiving lung tumor ablation related to the extra dose of standard-of-care treatment when accurately reduced by the multidisciplinary team members and treating physician.
AFFINITY elaborates that Aliya® PEF ablation during the diagnostic biopsy is safe and does not preclude administration of consecutive therapies. The superior local control volume of ablated tumors was achieved in a group of patients on concurrent therapy, capturing 94% in 16 patients, and those with no such extra therapy showed a 100% rate in 12 patients.
The data advice that Aliya PEF might persuade systemic immune activation in the patient group having metastasis or stage 4 non-small cell lung cancer (NSCLC) to the lung, having no surgical candidates. Furthermore, the six-month AFFINITY study shows high local control, a favorable safety profile, and systemic immune activation. Around 96% of the patient group have gained control over local tumor, justifying as local partial response, stable disease and complete response of ablated lesions in the lungs.
The Aliya PEF ablation process has completed its target of reaching 100% of patients. The procedures were bilateral ablated, tolerated, avoiding delay to standard-of-care therapy with only one percutaneous procedure-based serious negative event (pneumothorax), which was fixed without sequelae. Alongside, patients receiving only Aliya PEF ablation without consecutive therapy showed the best comprehensive activation of innate and adaptive immunity. This is regular with immunogenic therapies such as vaccination or cancer immunotherapy.
Aliya PEF is beyond traditional thermal ablation techniques as it takes a short timeframe, high-voltage electrical pulses to actuate cell death without harming the other sensitive areas. This creative idea can be served endoscopically or percutaneously with the INUMI™ Flex needle. By now, above 2,000 patient groups have openly received Aliya ablation in both clinical trials and commercial settings in the United States.
In the United States, the INUMI Flex needle and Aliya PEF System are 510 (k) cleared and confirmed for the surgical ablation of soft tissue. As of now, they are not commercially available in other regions.
Mansi Kadam is a market research writer with over 3 years of experience analyzing trends in the healthcare industry. At Towards Healthcare, she covers innovations in medical sector, sustainability initiatives, and the evolving regulatory landscape.
