Autonomix Medical Inc (NASDAQ: AMIX) is a pre-revenue medical device company developing a catheter-based system that uses radio frequency energy to ablate neural tissue for the treatment of pain. The company has no approved products and generates no revenue as of its fiscal year ended March 31, 2025. Its primary planned revenue model is the sale of single-use disposable catheters to hospital catheter labs, with procedure volume driving revenue. The initial target indication is pain associated with pancreatic cancer. The company carried an accumulated deficit of $50.4 million and negative operating cash flows of $8.3 million as of March 31, 2025, and its auditors have raised substantial doubt about its ability to continue as a going concern. It estimates needing $32 to $40 million in additional financing to reach initial commercial launch. Research and development expenses were $4.7 million for FY2025, up 112% from $2.2 million in FY2024. The company holds 86 issued patents across 18 patent families, with filings dating from 2012 through 2025, originated by co-founders Mr. Toth and Dr. Schwartz. AMIX completed its IPO on January 29, 2024, on the Nasdaq Capital Market.

Revenue model

No revenue generated as of FY2025. Planned model is transactional sales of single-use disposable catheters to hospital catheter labs, with revenue tied directly to procedure volume. Device software expected to be provided at no or nominal charge.

Products and services

A radio frequency catheter-based ablation system targeting nerve tissue, in proof-of-concept stage as of the 10-K filed May 29, 2025. Initial proposed indication is pain management in pancreatic cancer patients. The system is designed for use in existing hospital catheter labs.

Customers and end markets

Target customers are hospital catheter labs. End market is pain treatment for pancreatic cancer patients. No commercial customers as of FY2025. The American Cancer Society estimated approximately 64,000 new U.S. pancreatic cancer diagnoses annually as of 2023.

Value-chain role

Medical device developer and intellectual property holder. Relies on contract engineering firms and contract manufacturers for design and production. Requires FDA clearance or approval before commercialization. No manufacturing or distribution infrastructure disclosed as of the filing.

Geographic exposure

Primarily U.S.-focused for regulatory strategy and initial commercialization. Patent protection pursued on a country-by-country basis internationally. No commercial operations in any geography as of FY2025.

Source: SEC 10-K, filed 2025-05-29

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