Autonomix Medical, Inc. Finalizes Design Review of First-Ever Intravascular Nerve Sensing Catheter in Key Step Toward U.S. Clinical Studies
Autonomix Medical (NASDAQ: AMIX) has completed the final design review of its groundbreaking intravascular nerve sensing catheter, marking a significant milestone toward U.S. clinical trials. The device, featuring a proprietary microchip-based sensing antenna array, is the first of its kind capable of detecting and differentiating nerve signals in real-time from within blood vessels.
The technology enables a novel "sense, treat and verify" approach, allowing physicians to detect nerve activity, guide energy delivery precisely, and confirm treatment efficacy during procedures. The company is preparing to submit an Investigational Device Exemption (IDE) to commence clinical trials, initially focusing on treating pancreatic cancer pain, with potential applications across multiple therapeutic areas including cardiology, pain management, and pulmonary disorders.
Autonomix Medical (NASDAQ: AMIX) ha completato la revisione finale del progetto del suo innovativo catetere intravascolare per la rilevazione dei nervi, segnando un importante traguardo verso gli studi clinici negli Stati Uniti. Il dispositivo, dotato di una proprietaria matrice di antenne sensoriali basata su microchip, è il primo del suo genere in grado di rilevare e distinguere segnali nervosi in tempo reale dall'interno dei vasi sanguigni.
La tecnologia abilita un nuovo approccio «rilevare, trattare e verificare», che consente ai medici di identificare l'attività nervosa, guidare con precisione l'erogazione di energia e confermare l'efficacia del trattamento durante le procedure. L'azienda si sta preparando a presentare una Investigational Device Exemption (IDE) per avviare gli studi clinici, concentrandosi inizialmente sul trattamento del dolore da cancro del pancreas, con possibili applicazioni in diversi ambiti terapeutici quali cardiologia, gestione del dolore e patologie polmonari.
Autonomix Medical (NASDAQ: AMIX) ha completado la revisión final del diseño de su innovador catéter intravascular para la detección de nervios, marcando un hito importante de cara a los ensayos clínicos en EE. UU. El dispositivo, equipado con una matriz de antenas sensores basada en microchips patentada, es el primero de su tipo capaz de detectar y diferenciar señales nerviosas en tiempo real desde el interior de los vasos sanguíneos.
La tecnología posibilita un nuevo enfoque «detectar, tratar y verificar», que permite a los médicos identificar la actividad nerviosa, orientar con precisión la entrega de energía y confirmar la eficacia del tratamiento durante los procedimientos. La compañía se prepara para presentar una Investigational Device Exemption (IDE) para iniciar ensayos clínicos, centrando inicialmente los esfuerzos en el tratamiento del dolor por cáncer de páncreas, con potencial aplicación en cardiología, manejo del dolor y enfermedades pulmonares, entre otras áreas terapéuticas.
Autonomix Medical (NASDAQ: AMIX)가 혁신적인 혈관 내 신경 감지 카테터의 최종 설계 검토를 완료하며 미국 임상시험을 향한 중요한 이정표를 달성했습니다. 이 장치는 독자적인 마이크로칩 기반 센싱 안테나 배열을 탑재해 혈관 내부에서 실시간으로 신경 신호를 감지하고 구분할 수 있는 최초의 제품입니다.
해당 기술은 의료진이 신경 활동을 감지하고 에너지 전달을 정확히 유도하며 시술 중 치료 효과를 확인할 수 있는 새로운 ‘감지, 치료 및 검증’ 접근법을 가능하게 합니다. 회사는 임상시험을 시작하기 위해 Investigational Device Exemption(IDE) 제출을 준비 중이며, 초기에는 췌장암 통증 치료에 중점을 두고 심장학, 통증 관리, 폐 질환 등 다양한 치료 분야로의 적용 가능성을 모색하고 있습니다.
Autonomix Medical (NASDAQ: AMIX) a achevé la revue finale de conception de son cathéter intravasculaire novateur de détection nerveuse, franchissant une étape majeure en vue des essais cliniques aux États-Unis. L'appareil, doté d'un réseau d'antennes de détection à base de micro-puces propriétaire, est le premier de son genre capable de détecter et de distinguer des signaux nerveux en temps réel depuis l'intérieur des vaisseaux sanguins.
La technologie permet une nouvelle approche «détecter, traiter et vérifier», qui autorise les praticiens à repérer l'activité nerveuse, à guider avec précision l'administration d'énergie et à confirmer l'efficacité du traitement pendant les interventions. La société se prépare à déposer une Investigational Device Exemption (IDE) pour lancer des essais cliniques, en ciblant initialement le traitement de la douleur liée au cancer du pancréas, avec des applications potentielles en cardiologie, prise en charge de la douleur et pathologies pulmonaires.
Autonomix Medical (NASDAQ: AMIX) hat die abschließende Designprüfung seines bahnbrechenden intravaskulären Nervensensor-Katheters abgeschlossen und damit einen bedeutenden Meilenstein auf dem Weg zu US-Studien erreicht. Das Gerät verfügt über ein proprietäres mikrochipbasiertes Antennenarray zur Sensortechnik und ist das erste seiner Art, das Nervensignale in Echtzeit aus Blutgefäßen erfassen und unterscheiden kann.
Die Technologie ermöglicht einen neuartigen Ansatz „erfassen, behandeln und verifizieren“, der Ärzten erlaubt, Nervenaktivität zu erkennen, die Energieabgabe präzise zu steuern und die Wirksamkeit der Behandlung während der Eingriffe zu bestätigen. Das Unternehmen bereitet die Einreichung einer Investigational Device Exemption (IDE) zur Aufnahme klinischer Studien vor, mit anfänglichem Schwerpunkt auf der Behandlung von Schmerzen bei Bauchspeicheldrüsenkrebs und potenziellen Anwendungen in Kardiologie, Schmerztherapie und pulmonalen Erkrankungen.
- First-ever intravascular device capable of real-time nerve signal detection and differentiation
- Proprietary microchip-based technology enables precise nerve targeting and treatment verification
- Platform technology with potential applications across multiple high-value therapeutic areas
- Successfully completed final design review, advancing toward clinical trials
- Still requires IDE approval before clinical trials can begin
- No clinical data in humans yet, only animal models
Insights
AMIX's innovative nerve-sensing catheter reaches final design stage, advancing toward clinical trials for a first-in-class technology with multi-indication potential.
Autonomix has reached a critical milestone with their proprietary sensing catheter completing final design review before human clinical trials. This represents significant technical progress from earlier animal testing models that successfully demonstrated nerve signal detection capabilities. The innovation centers on a microchip-based sensing antenna array that enables intravascular nerve detection and differentiation in real-time – a capability unavailable in current medical technologies.
The core technical advantage lies in the device's ability to implement a "sense, treat and verify" approach. Current technologies force physicians to work blindly, resulting in either incomplete denervation or overtreatment. Autonomix's platform could fundamentally transform procedural accuracy by enabling physicians to precisely locate target nerves, optimize ablation patterns, and immediately confirm treatment efficacy during the procedure.
What makes this development particularly noteworthy is its potential platform versatility. The technology architecture appears designed for application across multiple therapeutic areas including cardiology (resistant hypertension), interventional pain management, and pulmonary/gastrointestinal disorders. The immediate clinical pathway focuses on pancreatic cancer pain treatment, with the company preparing for an Investigational Device Exemption (IDE) submission to commence U.S. clinical trials supporting a De Novo FDA application.
The technology represents a potential paradigm shift in therapeutic electrophysiology by enabling direct neural signal processing at the source – something existing approaches cannot accomplish. If successful in clinical trials, this would establish an entirely new category of precision-guided neuromodulation devices with improved safety and efficacy profiles.
Microchip-based platform enables real-time nerve mapping and targeted treatment from within the vascular system
Continued progress toward submitting Investigational Device Exemption (“IDE”), and if approved, the commencement of U.S. clinical trials to support a De Novo FDA application
THE WOODLANDS, TX, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced it has advanced its proprietary sensing catheter through a final design review in preparation for human clinical trials. Previous versions had been used in animal models to demonstrate the ability to detect nerve signals. This marks a major step forward on the Company’s path toward initiating U.S. clinical studies.
Autonomix’s innovative sensing catheter is the first intravascular device of its kind engineered to detect and differentiate nerve signals in real time from inside the vasculature using Autonomix’s proprietary microchip-based sensing antenna array. Current technologies require physicians to treat blindly, which can lead to incomplete denervation or overtreatment. Autonomix’s sensing catheter aims to offer a powerful new “sense, treat and verify” approach to targeting the nerve, which uniquely gives physicians the ability to detect nerve activity, precisely guide energy delivery, optimize ablation patterns, and confirm that nerve signaling has stopped immediately during the procedure.
“What sets Autonomix’s approach apart is the potential of our device to sense and process neural signals directly at the source, enabled by our proprietary microchip array. This sensing catheter is a cornerstone of our platform, designed to help physicians precisely locate target nerves, tailor ablation, and confirm efficacy in real time. Completing this design review milestone reinforces the strength of our development program and brings us closer to delivering safer, more effective treatment options for patients, while advancing value-creating milestones for our shareholders,” commented Brad Hauser, CEO of Autonomix. “The ability to map nerve activity in real time has the potential to transform the field of neuromodulation and pain treatment. We believe this represents a paradigm shift in therapeutic electrophysiology, and we look forward to building momentum towards the launch of our clinical trial to support a De Novo FDA submission.”
Autonomix’s first-in-class technology constitutes a platform with the potential to address dozens of indications in multiple high-need therapeutic areas, including cardiology and resistant hypertension or high blood pressure, interventional pain management, pulmonary and gastrointestinal disorders, and more.
Autonomix is currently executing the operational plan required to submit an IDE and commence U.S. clinical trials to support a labeling indication to commercialize the Autonomix Sensing and RF Ablation System in the U.S. as a treatment for pancreatic cancer pain.
For more information about the Company’s technology, please visit autonomix.com.
About Autonomix Medical, Inc.
Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.
We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.
For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.
Forward Looking Statements
Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the commencement of U.S. clinical trials and any FDA submission. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.”
Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 29, 2025, and from time to time, in our other filings with the SEC. Forward-looking statements speak only as of the date of this press release and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.
Investor and Media Contact
JTC Team, LLC
Jenene Thomas
908-824-0775
autonomix@jtcir.com
FAQ
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