Business Description

Overview We are a development-stage medical device company focused on advancing technologies for sensing and treating disorders of the nervous system. Our platform is designed to integrate high-sensitivity neural signal detection with targeted radiofrequency (“RF”) ablation, enabling a “sense, treat, verify” approach intended to improve the precision and consistency of nerve-targeted therapies. The technology we have developed consists of a catheter-based system incorporating a proprietary microchip-enabled sensing architecture designed to detect low-amplitude neural signals from within the vascular system. By placing signal amplification and digitization at or near the point of detection, this approach is intended to reduce signal degradation and improve detection of neural activity compared to conventional systems. We believe this may enable more precise localization of target nerves and support targeted therapeutic intervention. Our development efforts are focused on two core components: diagnostic sensing and therapeutic RF ablation. In preclinical studies, our sensing technology has demonstrated the ability to detect signals from specific nerve bundles prior to ablation and confirm signal termination following treatment. We are currently refining the design of our catheter to meet requirements for human use in the United States. In parallel with development of our sensing system, we have conducted an early clinical proof-of-concept study evaluating the safety and feasibility of transvascular nerve ablation using commercially available RF ablation technologies. Following positive initial findings, we initiated an expansion study to evaluate a broader patient population. As the study progressed, we observed variability in early clinical outcomes, which we believe may be related to differences in vascular access and anatomical targeting. Enrollment was subsequently paused to allow for further evaluation and refinement of our clinical and procedural approach. We are initially developing our technology for the treatment of pain associated with pancreatic cancer, a disease where existing therapies, including opioid pharmacotherapy and neurolytic injections, may provide inconsistent relief and are associated with meaningful risks and undesirable side effects. We believe our platform may also have the potential to support additional applications, including other visceral pain conditions, hypertension, cardiovascular disease, and other nerve-related disorders. These potential applications remain under evaluation and will require further development and clinical validation. Our Technology Targeting the Peripheral Nervous System The peripheral nervous system consists of an extensive network of nerve fibers that extend throughout the body and interact with virtually every organ. These nerves can be broadly categorized into autonomic (regulating involuntary functions such as heart rate, blood pressure, and organ control) and somatosensory (transmitting sensory information such as pain). Whether as a root cause or as part of disease manifestation, the peripheral nervous system plays a role in nearly all major disease states. We believe there are currently very few tools capable of effectively sensing and targeting nerve fibers within the peripheral nervous system. While our Company name reflects the autonomic subgroup of the peripheral nervous system, our technology is intended to address both autonomic and somatosensory pathways, with potential future applications in the central nervous system. The Vascular Pathway Approach Our system is catheter-based, enabling delivery of sensing and therapeutic components through the vascular system. Because many peripheral nerves run in close proximity to blood vessels, effectively creating a "vascular superhighway" of access to neural structures throughout the body, our system can reach nerve targets via arteries and is typically introduced through the femoral or brachial artery using standard interventional techniques. We believe this transvascular approach may offer meaningful advantages over existing percutaneous techniques such as neurolytic celiac plexus blockade ("NCPB"), including improved access, procedural safety, and greater control over therapeutic targeting.…