Autonomix Medical (Nasdaq:AMIX) announced today that it advanced its proprietary sensing catheter through a final design review.
This marks the latest step for the Texas-based company in preparation for human clinical trials. Previous versions used in animal models demonstrated the ability to detect nerve signals. Now, the company believes it’s moving closer to initiating U.S. clinical studies.
Autonomix designed its sensing catheter as the first intravascular device of its kind engineered to detect and differentiate nerve signals in real time from inside the vasculature. It utilizes a proprietary microchip-based sensing antenna array.
The company hopes to offer a powerful new “sense, treat and verify” approach to targeting the nerve. This uniquely gives physicians the ability to detect nerve activity, precisely guide energy delivery, optimize ablation patterns and confirm that nerve signaling has stopped immediately during the procedure.
Autonomix hopes to bring its platform to a number of indications. Those could include cardiology and resistant hypertension, interventional pain management, and pulmonary and gastrointestinal disorders. The company currently plans to submit for FDA investigational device exemption (IDE) to use its ablation system for pancreatic cancer pain.
Said Brad Houser, CEO of Autonomix:
“What sets Autonomix’s approach apart is the potential of our device to sense and process neural signals directly at the source, enabled by our proprietary microchip array. This sensing catheter is a cornerstone of our platform, designed to help physicians precisely locate target nerves, tailor ablation, and confirm efficacy in real time. Completing this design review milestone reinforces the strength of our development program and brings us closer to delivering safer, more effective treatment options for patients, while advancing value-creating milestones for our shareholders. The ability to map nerve activity in real time has the potential to transform the field of neuromodulation and pain treatment. We believe this represents a paradigm shift in therapeutic electrophysiology, and we look forward to building momentum towards the launch of our clinical trial to support a De Novo FDA submission.”
