Autonomix Medical, Inc. Overview

Business Focus

• Develops innovative medical device technologies aimed at sensing and treating disorders related to the nervous system.
• Focused on minimally invasive, catheter-based platforms that combine neural sensing and therapeutic ablation.

Technology Platform

• First-in-class system features a microchip-enabled sensing array incorporated into a catheter.
• Capable of detecting and differentiating neural signals with high sensitivity, significantly higher than current devices (threshold below 5 µV versus about 10 µV in competitors).
• Designed for transvascular delivery, primarily via arteries (e.g., femoral artery).
• Uses a proprietary microchip placed close to the antenna to minimize signal degradation, enabling real-time neural signal capture.

Development Stage & Clinical Trials

• Conducting first-in-human proof of concept (PoC 1) trial targeting pancreatic cancer pain, evaluating safety and effectiveness of transvascular nerve ablation.
• Expanded the trial (PoC 2) to include other visceral cancers such as gall bladder, liver, bile duct, and early-stage pancreatic cancer.
• Demonstrated in animal studies the ability to locate nerves, deliver targeted ablation, and confirm nerve signal termination.
• The product is still in development; current device is hand-built and prototype-based.

Market & Indications

• Initial focus: Pain management for pancreatic cancer patients, addressing significant unmet medical need.
• Estimated market: Approximately 64,000 new pancreatic cancer cases annually in the U.S. and 109,000 in the EU.
• Global pancreatic cancer treatment market was about $2.2 billion in 2022.
• Potential future indications include other visceral cancers, hypertension (renal denervation), general pain management, COPD, GI and urological disorders, cardiology, and related nerve disorders.
• The platform, if validated, could expand to address over $100 billion across multiple medical segments including pain management and hypertension.

Revenue Model

• Primarily through sale of disposable sensors and catheters.
• Could also evolve into a combined diagnostic sensing and therapeutic ablation system.
• Peak revenue streams anticipated from hospital sales, with a focus on interventional radiologists.

Employees & Operations

• As of March 31, 2025: 11 total employees (8 full-time, 3 part-time).
• No current product revenue; company is in the developmental stage.
• Facilities in Texas (headquarters) and Pennsylvania for R&D.
• No real estate ownership.

Financial Status (as of March 31, 2025)

• Cash: $9.1 million.
• Working capital: $7.9 million.
• Accumulated deficit: $50.4 million.
• No revenue reported; operating losses prevalent.
• Negative cash flow from operations in 2025: $8.3 million.
• No approved commercial products yet; ongoing clinical trials and R&D costs.
• Recent funding includes:
  • $11.2 million from IPO in January 2024.
  • $10.0 million from a November 2024 public offering.
  • $2.8 million from June 2023 private placement.
• Plans to raise approximately $32-$40 million more to reach commercial launch.

Key Developments

• Entered into an at-market sales agreement (ATM) in February 2025 to raise up to $2.1 million.
• Conducting clinical trials outside the U.S., aiming for FDA clearance targeted around 2027.
• Developing the product to meet standards for human use; currently in prototype stage.
• Has a number of patents and pending applications protecting its innovations.

Summary

Autonomix Medical, Inc. is a development-stage medical device company specializing in high-sensitivity neural sensing and transvascular nerve ablation technologies. Its initial application targets pain relief for pancreatic cancer patients, with plans to expand into broader indications involving the peripheral nervous system. The company has not generated revenue and continues to fund operations through public offerings, with clinical trials ongoing. It employs a small team and is focused on regulatory approval and scaling manufacturing for commercial readiness.