The clinical study, designated C-1101-101, utilizes a randomized, double-blinded approach to evaluate the safety and efficacy of the treatment. Researchers are enrolling patients across three sequential dose-escalation cohorts, with each participant receiving a single epidural injection. Andrew Hall, CEO of Consano Bio, noted that the clearance validates the company’s scientific and manufacturing standards, marking a pivotal shift in their transition toward U.S. clinical development.

Unlike traditional interventions that focus on temporary pain management or surgical procedures, C-1101 functions as a disease-modifying, platelet-derived multi-protein biologic. It aims to modulate inflammation and promote cellular repair at the site of spinal nerve root irritation. Given that no pharmaceutical treatments are currently FDA-approved for chronic lumbosacral radiculopathy, the company expects to begin dosing American patients within the coming months.