Autonomix Medical, Inc. Initiates Good Laboratory Practice (GLP) Study for Sensing and RF Ablation System
Autonomix Medical (NASDAQ: AMIX) has initiated a crucial Good Laboratory Practice (GLP) preclinical study for its Sensing and RF Ablation System, targeting pancreatic cancer pain treatment. The study, conducted at CBSET research institute, represents a significant step toward FDA regulatory approvals.
The company remains on track to submit its Investigational Device Exemption (IDE) and, pending approval, begin U.S. clinical trials in 2026 to support a De Novo FDA application. CEO Brad Hauser highlighted this as a critical milestone in their regulatory pathway.
Autonomix's first-in-class technology platform shows potential applications across multiple therapeutic areas, including cardiology, resistant hypertension, interventional pain management, and pulmonary and gastrointestinal disorders.
Autonomix Medical (NASDAQ: AMIX) ha avviato uno studio preclinico GLP cruciale per il suo Sensing and RF Ablation System, mirato al trattamento del dolore nel cancro al pancreas. Lo studio, condotto presso l'istituto di ricerca CBSET, rappresenta un passo significativo verso l'approvazione regolatoria FDA. L'azienda rimane in linea per presentare la Investigational Device Exemption (IDE) e, in caso di approvazione, iniziare prove cliniche negli Stati Uniti nel 2026 per supportare una domanda De Novo alla FDA. Il CEO Brad Hauser ha definito questo traguardo come una tappa critica del loro percorso regolatorio. La piattaforma tecnologica di Autonomix, prima nel suo genere, mostra potenziali applicazioni in diverse aree terapeutiche, tra cui cardiologia, ipertensione resistente, gestione del dolore interventivo e disturbi polmonari e gastrointestinali.
Autonomix Medical (NASDAQ: AMIX) ha iniciado un estudio preclínico GLP crucial para su Sensing and RF Ablation System, dirigido al tratamiento del dolor por cáncer de páncreas. El estudio, realizado en el instituto de investigación CBSET, representa un paso importante hacia las aprobaciones regulatorias de la FDA. La empresa continúa en camino de presentar su Exención de Dispositivo Investigacional (IDE) y, si recibe la aprobación, empezar ensayos clínicos en Estados Unidos en 2026 para apoyar una solicitud De Novo ante la FDA. El director ejecutivo Brad Hauser destacó esto como un hito crítico en su ruta regulatoria. La plataforma tecnológica de Autonomix, de nueva generación, muestra potencial en múltiples áreas terapéuticas, incluyendo cardiología, hipertensión resistente, manejo del dolor intervencionista y trastornos pulmonares y gastrointestinales.
Autonomix Medical (NASDAQ: AMIX)가 췌장암 통증 치료를 목표로 하는 Sensing and RF Ablation System에 대한 중요한 GLP 전임상 연구를 시작했습니다. CBSET 연구소에서 수행된 이 연구는 FDA 규제 승인을 향한 중요한 단계입니다. 회사는 IDE(Investigational Device Exemption) 제출에 계획대로 진행 중이며, 승인을 받으면 2026년 미국에서 임상시험을 시작하여 De Novo FDA 신청을 지원합니다. CEO Brad Hauser는 이것을 규제 경로의 중요한 이정표로 강조했습니다. Autonomix의 차세대 기술 플랫폼은 심장학, 저항성 고혈압, 중재적 통증 관리, 그리고 폐와 위장 질환 등 여러 치료 영역에서의 적용 가능성을 보여줍니다.
Autonomix Medical (NASDAQ: AMIX) a lancé une étude préclinique GLP cruciale pour son Sensing and RF Ablation System, visant le traitement de la douleur due au cancer du pancréas. L’étude, réalisée dans l’institut de recherche CBSET, représente une étape importante vers les approbations réglementaires de la FDA. L’entreprise reste en bonne voie pour soumettre son Investigational Device Exemption (IDE) et, sous réserve d’approbation, débuter des essais cliniques américains en 2026 pour soutenir une demande De Novo auprès de la FDA. Le PDG Brad Hauser a souligné que cela constitue une étape critique de leur parcours réglementaire. La plateforme technologique de premier ordre d’Autonomix montre un potentiel d’applications dans plusieurs domaines thérapeutiques, incluant la cardiologie, l’hypertension résistante, la gestion de la douleur interventionnelle et les troubles pulmonaires et gastro-intestinaux.
Autonomix Medical (NASDAQ: AMIX) hat eine wichtige GLP-Präklinik-Studie für sein Sensing and RF Ablation System eingeleitet, das auf die Schmerzbehandlung bei Bauchspeicheldrüsenkrebs abzielt. Die Studie wurde am CBSET-Forschungsinstitut durchgeführt und stellt einen bedeutenden Schritt in Richtung FDA-Regulierungsfreigaben dar. Das Unternehmen bleibt auf dem Weg, seinen Investigational Device Exemption (IDE) einzureichen und, vorbehaltlich der Genehmigung, im Jahr 2026 mit US-Klinischen Studien zu beginnen, um eine De Novo FDA-Anwendung zu unterstützen. CEO Brad Hauser hob dies als entscheidenden Meilenstein auf ihrem regulatorischen Weg hervor. Die erstklassige Technologielplattform von Autonomix zeigt Potenzial in mehreren Therapiebereichen, darunter Kardiologie, resistente Hypertonie, interventionelle Schmerztherapie sowie Lungen- und Magen-Darm-Erkrankungen.
Autonomix Medical (NASDAQ: AMIX) قد أطلقت دراسة حيوية GLP ما قبل السريرية لنظام الاستشعار والتحفيز بالتردد اللاسلكي RF Ablation System، لاستهداف علاج ألم سرطان البنكرياس. الدراسة، التي أُجريت في معهد CBSET للأبحاث، تمثل خطوة مهمة نحو موافقات FDA التنظيمية. ما تزال الشركة على المسار لتقديم استثناء جهاز تجريبي (IDE)، وبناءً على الموافقات، لبدء التجارب السريرية في الولايات المتحدة في 2026 لدعم طلب De Novo FDA. أشار الرئيس التنفيذي براد هاوزر إلى أن ذلك يمثل محطة رئيسية في مسارهم التنظيمي. تُظهر منصة Autonomix التكنولوجية من الجيل الأول تطبيقات محتملة في مجالات علاجية متعددة، بما في ذلك طب القلب، ارتفاع ضغط الدم المقاوم، إدارة الألم التدخلي، واضطرابات الرئة والجهاز الهضمي.
Autonomix Medical (NASDAQ: AMIX) 已启动针对胰腺癌疼痛治疗的 Sensing and RF Ablation System 的关键 GLP 预临床研究。该研究在 CBSET 研究所进行，标志着向 FDA 监管批准迈出的重要一步。公司仍然在按计划提交 Investigational Device Exemption (IDE)，如获批，预计于 2026 年在美国启动临床试验，以支持 De Novo FDA 申请。CEO Brad Hauser 将此视为其监管路径上的关键里程碑。Autonomix 的首创科技平台在多种治疗领域显示出潜在应用，包括 心脏病学、难治性高血压、介入性疼痛管理，以及肺部和胃肠道疾病。
- Initiation of FDA-required GLP study marks progress toward regulatory approval
- Company on schedule for IDE submission and potential 2026 clinical trials
- Technology platform has potential applications across multiple therapeutic areas
- Product still in pre-clinical phase with no guaranteed timeline for FDA approval
- Clinical trials have not yet begun
Insights
Autonomix hits key regulatory milestone with GLP study for nerve treatment device, keeping 2026 clinical trial timeline on track.
Autonomix's announcement of commencing a Good Laboratory Practice (GLP) study represents a significant regulatory milestone in the company's development pathway. GLP studies are mandated by the FDA to verify the safety and reliability of medical devices before human clinical trials can begin, making this an essential step toward their Investigational Device Exemption (IDE) submission.
The company's Sensing and RF Ablation System targets pancreatic cancer pain through precision nerve-targeted treatments. This technology appears to use radiofrequency ablation combined with sensing capabilities to potentially provide more precise nerve modulation than current standards. The GLP study being conducted at CBSET, a respected translational research institute, will generate the preclinical data package required for regulatory submissions.
The timeline confirmation that Autonomix remains on track for a 2026 IDE submission and potential clinical trials provides investors with concrete developmental goalposts. Their regulatory strategy appears to be following the De Novo pathway, which is appropriate for novel devices without predicate comparisons on the market.
What's particularly notable is management's characterization of their technology as a platform with multiple potential applications beyond pancreatic cancer pain, including cardiology (resistant hypertension), interventional pain management, and pulmonary/gastrointestinal disorders. This suggests a broader market strategy than might be initially apparent, with the current indication potentially serving as their regulatory entry point for a wider therapeutic platform.
GLP study marks a key milestone in Autonomix's path to achieve regulatory approvals
Company remains on track to submit Investigational Device Exemption (“IDE”), and if approved, commence U.S. clinical trials in 2026 to support a De Novo FDA application
THE WOODLANDS, TX, Sept. 29, 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 that it has commenced a Good Laboratory Practice (GLP) preclinical study required by the FDA at CBSET, a state-of-the-art pre-clinical translational research institute, for its Sensing and RF Ablation System as a treatment for pancreatic cancer pain.
This GLP study is a set of quality standards that Autonomix is following to ensure the reliability and integrity of its devices in order to meet regulatory requirements for submitting data to the FDA for IDE clinical trials and product approval.
“The initiation of this study marks a critical milestone in our regulatory pathway towards potential approval. I am incredibly pleased with the progress made to date and with the continued solid execution of our plan. We remain on track to file our IDE and, if approved, commence clinical studies next year,” commented Brad Hauser, CEO of Autonomix.
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. For more information about the Company’s technology, please visit autonomix.com.
About CBSET
CBSET is a state-of-the-art translational research institute located in the greater Boston area of MA. Its mission is to advance biomedical research, through innovative, high-quality services. CBSET combines top-tier research with operational expertise. Since its inception, CBSET has continued to develop technical and scientific acumen through collaborative projects in the medical device, pharmaceutical and academic communities. CBSET’s 40,000 square foot, GLP-compliant, AAALAC- accredited facility includes vivaria, procedure rooms, catheterization / imaging labs, surgical and necropsy suites, histopathology, SEM, and a range of other technologies.
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 submission of its IDE and, if approved, the timing of the commencement of clinical studies. 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, 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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