Autonomix Medical, Inc.

Autonomix

Company overview

Autonomix is a development-stage medical device company focused on sensing and treating disorders of the nervous system. The platform integrates high-sensitivity neural signal detection with targeted radiofrequency (RF) ablation to enable a “sense, treat, verify” workflow. The initial commercial target is pain associated with pancreatic cancer, with potential expansion into other visceral pain indications, hypertension, cardiovascular and other nerve-related disorders.

Core technology and platform

• Catheter-based system with a proprietary microchip-enabled sensing architecture designed to detect low-amplitude neural signals within the vascular system.
• At-source processing: amplification and digitization are performed at the detection site, near the sensing electrodes, to reduce signal degradation.
• Catheter geometry: 8 splines with 5 electrodes per spline. An expandable balloon deploys radially to press a 16-channel electrode array against the vessel wall for 360-degree multi-channel sensing.
• Two main components:
  • Sensing catheter: proprietary catheter with microchip-enabled sensing, signal amplification, digitization, and wireless data transmission.
  • RF ablation catheter: separate catheter for delivering RF energy to ablate targeted nerve tissue identified by sensing.
• Near-term approach uses separate sensing and RF ablation catheters in a single procedure, with a long-term objective to integrate sensing, therapy, and verification into a single device.

Product status and development

• The sensing system is in prototype form and is not yet a commercial device.
• Initial clinical exploration used commercially available RF ablation equipment to gather procedural knowledge while proprietary sensing and RF ablation catheters were developed in parallel.
• Proof-of-concept (PoC) program:
  • PoC 1 (May 2025): approximately 20 subjects with pancreatic cancer-related pain; used commercially available RF equipment.
  • PoC 2 expansion: planned to enroll an additional ~20 subjects across broader visceral cancer-related pain indications and pancreatic cancer pain at various stages. Enrollment was paused to evaluate and refine clinical strategy due to variability linked to vascular access and targeting.
• Recent focus shifted to further validate the RF ablation catheter and begin initial use of the sensing catheter in patients with severe pancreatic cancer-related pain.
• U.S. IDE clinical trials are planned to commence in late 2026, subject to new financing.

Regulatory pathway

• The company intends to pursue FDA De Novo classification for the overall system.
• U.S. plan includes:
  • First-in-human feasibility study (small, single-site) for initial safety and procedural learnings.
  • Pivotal multi-center clinical trial to generate evidence for regulatory submission.
  • De Novo submission to FDA.
• First-in-human work has been conducted outside the U.S. as part of PoC activities; FDA pre-submission discussions are ongoing.

Commercialization strategy

• Controlled launch with a limited regional footprint and key opinion leader involvement to refine commercial strategy.
• Business model scenarios include standalone sensing, standalone ablation, and an integrated sensing/ablation system.
• Potential partnership or licensing arrangements with larger medtech participants are being considered; management has experience with both independent and partnered commercialization.
• Anticipated procedure-based revenue model driven by disposable catheters and related software, comprised of:
  • Disposable sensing catheter
  • RF ablation catheter
  • RF energy generator
  • Software-based user interface
• Near-term focus is on securing regulatory clearance and generating early clinical data to support U.S. trials and commercialization; the long-term vision is wider indications and broader platform deployment.

Market and opportunity

• Primary indication: pancreatic cancer-related pain in a palliative care context.
• Pancreatic cancer pain is common and often poorly managed; current treatments (opioids, neurolytic injections such as NCPB) have limitations and risks.
• The global pancreatic cancer treatment market was estimated at approximately $2.2 billion in 2022. Pain management across oncology and other indications represents a much larger opportunity, potentially in the tens of billions of dollars depending on regulatory clearance and adoption.
• Potential future applications include other visceral cancers, renal denervation for hypertension, chronic pain (e.g., CRPS, low back pain), and pulmonary, gastrointestinal, urological, and cardiovascular disorders.

Intellectual property

• Portfolio: 18 patent families with 75 issued patents and 37 pending applications.
• Patents cover nerve modulation, tissue treatment, organ function regulation, diagnostic systems, neuromodulation, microchip-enabled signal processing, catheter and sensing technologies, and related methods.
• Trademarks: AUTONOMIX registered in multiple regions (U.S., EU, Australia, etc.).
• Management views the IP portfolio as a strategic asset for competitive positioning.

Manufacturing and development

• Device production currently relies on third-party manufacturers.
• The sensing system is at prototype level and is hand-built from custom and 3D-printed components.
• The company has not yet assembled or tested a fully commercial version.
• Scaling to commercial manufacturing will require addressing supply, quality control, capacity, and program timing. Dependence on third-party suppliers is a program risk.

Financial and operating profile (as of March 31, 2026)

• No approved products and no reported revenue to date.
• Accumulated deficit: approximately $67.1 million.
• Negative cash flows from operating activities: approximately $12.3 million.
• Working capital: approximately $5.9 million.
• The company believes current capital resources are sufficient to fund operations into the fourth calendar quarter of 2026 without additional capital infusion, while additional financing will be required to complete trials, expand commercialization, and fund ongoing operations.
• Recent financing activity:
  • November 2025 private placement: Pre-Funded Warrants to purchase 4,501,666 shares and Common Warrants to purchase up to 9,003,332 shares; combined price around $1.1097 per unit.
  • December 2025 registration of resale of 13,504,998 shares underlying the warrants.
• Corporate and liquidity matters:
  • 1-for-20 reverse stock split completed October 24, 2024.
  • Potential liability related to rounding of fractional shares (271,846 post-split shares) identified November 2024; inquiry is pending.
  • Nasdaq compliance: deficiency letter dated January 14, 2026 for bid price below $1.00; a 180-day period to regain compliance runs to July 13, 2026, with potential for a second 180-day extension. Failure to regain compliance could result in delisting and a shift to OTC trading, which would affect liquidity.

Other disclosures

• The company highlights regulatory uncertainty and the need for financing to advance trials and regulatory submissions.
• It acknowledges operational and regulatory risks inherent to a first-in-class, novel medical device platform.

Key takeaways

• Autonomix is developing a transvascular neural sensing and ablation platform (two-catheter approach) intended to sense, treat, and verify denervation, with an initial focus on pancreatic cancer pain.
• The program is development-stage with prototype sensing systems, ongoing PoC studies, and planned U.S. IDE trials targeted for late 2026, contingent on financing.
• The company maintains a substantial IP portfolio and relies on third-party manufacturing for development and production.
• Financially, the company has an accumulated deficit, negative operating cash flows, and limited working capital, and expects to need additional financing to complete clinical and commercialization milestones.