AMIX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• 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”…

• 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,…

• 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. …

• 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 s…

• 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 effect…

相对上期删除的文字 · 来源:10-Q · 2026-02-11

• Autonomix Medical, Inc. is a development-stage medical device company pioneering a first-in-class technology platform designed to sense and treat disorders of the nervous system. Our lead system in development is a catheter-based solution that combines diagnostic sensing and therapeutic radiofrequen…

• A key differentiator of our technology is its ability to detect neural signals with greater sensitivity than commercially available systems. This performance advantage stems from two core innovations. First, our proprietary antenna array is engineered to capture extremely low-amplitude neural signal…

• Our product development strategy is centered around two integrated functions: diagnostic sensing to identify pathological nerve signals, and therapeutic RF ablation to treat the identified targets. In preclinical animal models, our system has demonstrated the ability to detect signals from specific …

• In parallel, we have advanced our clinical strategy. In the second quarter of 2025, we completed our initial first-in-human proof-of-concept study ("PoC 1") evaluating the safety and feasibility of transvascular RF ablation in patients with pancreatic cancer pain. Based on the positive clinical outc…

• As a development-stage company, our technology remains investigational, and there is no guarantee that our clinical trials will produce favorable outcomes or that our products will ultimately receive regulatory approval. One of the most challenging aspects of our commercialization plan will be scali…

相对上期删除的文字 · 来源:10-Q · 2026-02-11

• Evaluation of Disclosure Controls and Procedures and Changes in Internal Control over Financial Reporting

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• Nasdaq’s recently adopted minimum Market Value of Listed Securities requirement of $5 million could result in the suspension and delisting of our common stock from Nasdaq.

• On July 22, 2026, the SEC approved a new Nasdaq rule requiring companies listed on Nasdaq to maintain a minimum Market Value of Listed Securities (“MVLS”) of at least $5.0 million. Under the new rule, if a company’s MVLS remains below $5 million for 30 consecutive business days, Nasdaq will issue a …

• A delisting under this rule would have adverse consequences on our common stock, including reduced liquidity, limited market quotations, diminished analyst coverage, and impaired ability to raise capital. In addition, a delisting from Nasdaq could cause our common stock to be classified as a “penny …

相对上期删除的文字 · 来源:10-Q · 2026-02-11

• We are not in compliance with Nasdaq’s continued listing requirements and if we are unable to regain compliance with the listing requirements, our common stock will be delisted from Nasdaq which could have a material adverse effect on our financial condition and could make it more difficult for stoc…

• Our common stock is listed on Nasdaq, and we are therefore subject to its continued listing requirements, including requirements with respect to the market value of publicly held shares, market value of listed shares, minimum bid price per share, and minimum stockholder’s equity, among others, and r…

• On January 14, 2026, we received a deficiency letter from the Listing Qualifications Department (the “Staff”) of Nasdaq notifying us that for the last 30 consecutive business days the closing bid price for our common stock had closed below the minimum $1.00 per share requirement for continued inclus…

• In accordance with Nasdaq Listing Rule 5810(c)(3)(A) (the “Compliance Period Rule”), we have been provided an initial period of 180 calendar days, or until July 13, 2026 (the “Compliance Date”), to regain compliance with the Bid Price Rule. If, at any time before the Compliance Date, the closing bid…

• If we are not in compliance with the Bid Price Rule by July 13, 2026, we may be afforded a second 180 calendar day period to regain compliance. To qualify, we would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards …