Autonomix Medical, Inc. Engages Leading Medical Experts to Guide U.S. Clinical and Regulatory Path in Pancreatic Cancer Pain
Autonomix Medical (NASDAQ: AMIX) has announced the engagement of leading medical experts to guide its U.S. clinical and regulatory pathway for pancreatic cancer pain treatment. The advisory team includes former Society of Interventional Radiology Past Presidents Dr. Michael Brunner and Dr. Katharine Krol, along with Dr. Patricio Polanco and Dr. Nikola Cesarovic.
The company is preparing for FDA De Novo submission in 2026, with plans to initiate U.S. clinical studies in 2025. This strategic move aims to ensure their pre-clinical and clinical studies align with FDA requirements for their first-in-class technology in nervous system disease diagnosis and treatment.
Autonomix Medical (NASDAQ: AMIX) ha annunciato l'ingaggio di esperti medici di spicco per guidare il suo percorso clinico e normativo negli Stati Uniti per il trattamento del dolore da cancro pancreatico. Il team consultivo include gli ex Presidenti della Society of Interventional Radiology, Dr. Michael Brunner e Dr. Katharine Krol, insieme al Dr. Patricio Polanco e al Dr. Nikola Cesarovic.
L'azienda si sta preparando per la presentazione De Novo alla FDA nel 2026, con l'intenzione di avviare studi clinici negli Stati Uniti nel 2025. Questa mossa strategica mira a garantire che i loro studi pre-clinici e clinici siano in linea con i requisiti della FDA per la loro tecnologia innovativa nella diagnosi e nel trattamento delle malattie del sistema nervoso.
Autonomix Medical (NASDAQ: AMIX) ha anunciado el compromiso de destacados expertos médicos para guiar su camino clínico y regulatorio en EE. UU. para el tratamiento del dolor por cáncer de páncreas. El equipo asesor incluye a los ex presidentes de la Society of Interventional Radiology, Dr. Michael Brunner y Dr. Katharine Krol, junto con el Dr. Patricio Polanco y el Dr. Nikola Cesarovic.
La empresa se está preparando para la presentación De Novo ante la FDA en 2026, con planes de iniciar estudios clínicos en EE. UU. en 2025. Este movimiento estratégico tiene como objetivo asegurar que sus estudios preclínicos y clínicos estén alineados con los requisitos de la FDA para su tecnología de primera clase en el diagnóstico y tratamiento de enfermedades del sistema nervioso.
Autonomix Medical (NASDAQ: AMIX)는 췌장암 통증 치료를 위한 미국의 임상 및 규제 경로를 안내할 주요 의료 전문가들을 영입했다고 발표했습니다. 자문 팀에는 전 미국 중재 방사선학회 회장인 Dr. Michael Brunner와 Dr. Katharine Krol, 그리고 Dr. Patricio Polanco와 Dr. Nikola Cesarovic가 포함되어 있습니다.
회사는 2026년 FDA De Novo 제출을 준비하고 있으며, 2025년에는 미국에서 임상 연구를 시작할 계획입니다. 이 전략적 움직임은 그들의 전임상 및 임상 연구가 신경계 질환 진단 및 치료를 위한 FDA 요구 사항에 부합하도록 보장하는 것을 목표로 하고 있습니다.
Autonomix Medical (NASDAQ: AMIX) a annoncé l'engagement d'experts médicaux de premier plan pour guider son parcours clinique et réglementaire aux États-Unis pour le traitement de la douleur liée au cancer du pancréas. L'équipe consultative comprend d'anciens présidents de la Society of Interventional Radiology, le Dr Michael Brunner et le Dr Katharine Krol, ainsi que le Dr Patricio Polanco et le Dr Nikola Cesarovic.
L'entreprise se prépare à une soumission De Novo à la FDA en 2026, avec des plans pour initier des études cliniques aux États-Unis en 2025. Ce mouvement stratégique vise à garantir que leurs études précliniques et cliniques soient conformes aux exigences de la FDA pour leur technologie de première classe dans le diagnostic et le traitement des maladies du système nerveux.
Autonomix Medical (NASDAQ: AMIX) hat die Engagements führender medizinischer Experten angekündigt, um den klinischen und regulatorischen Weg in den USA zur Behandlung von Schmerzen bei Bauchspeicheldrüsenkrebs zu leiten. Das Beratungsteam umfasst die ehemaligen Präsidenten der Society of Interventional Radiology, Dr. Michael Brunner und Dr. Katharine Krol, sowie Dr. Patricio Polanco und Dr. Nikola Cesarovic.
Das Unternehmen bereitet sich auf die FDA De Novo-Einreichung im Jahr 2026 vor und plant, 2025 klinische Studien in den USA zu beginnen. Dieser strategische Schritt zielt darauf ab, sicherzustellen, dass ihre präklinischen und klinischen Studien mit den Anforderungen der FDA für ihre bahnbrechende Technologie zur Diagnose und Behandlung von Erkrankungen des Nervensystems übereinstimmen.
- Strategic appointment of experienced medical advisory team strengthens regulatory pathway
- On track for planned clinical trials in 2025
- Clear regulatory timeline with FDA De Novo submission targeted for 2026
- No immediate revenue generation as product is still in pre-clinical phase
- Extended timeline to potential commercialization with FDA approval not expected before 2026
Company on track to commence U.S. clinical studies in 2025 to support a De Novo application for FDA approval
THE WOODLANDS, TX, April 08, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced it has engaged U.S. and international-based medical experts in interventional radiology and cancer pain to guide the Company’s U.S. clinical and regulatory path to ensure pre-clinical and clinical studies meet the needs of the Company’s expected FDA De Novo submission in 2026.
The Company’s medical advisors include former Society of Interventional Radiology Past Presidents, Dr. Michael Brunner and Dr. Katharine Krol of Health Tech Guidance, Dr. Patricio Polanco of UT Southwestern and Dr. Nikola Cesarovic of ETH Zürich.
“We are actively building the team and infrastructure necessary to support our clinical and regulatory initiatives in preparation for the potential FDA approval of our first-in-class technology. The establishment of a team of medical experts to guide the U.S. clinical and regulatory path is an important step in this process, and we are thrilled to be working with highly skilled and accomplished medical professionals,” commented Brad Hauser, CEO of Autonomix. “I am encouraged by the continued progress our team is making. With a growing body of positive data, we are on track to initiate clinical studies in the U.S. in 2025. We believe this step will provide valuable insight and guidance as we continue to progress.”
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 up to 3,000 times 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 potential of the technology to treat cancerous tumors and the pain associated with pancreatic cancer. 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 31, 2024. Forward-looking statements speak only as of the date of the document in which they are contained 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
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