Autonomix Medical, Inc. Achieves Design Lock for RF Ablation Catheter Following Successful Completion of Animal Testing, Continuing Progress Toward a U.S. Pivotal Trial in 2025
Autonomix Medical (NASDAQ: AMIX) has achieved design lock for its radio frequency (RF) ablation catheter following successful animal testing. The company's first-in-class catheter-based technology features a microchip sensing array antenna that can detect neural signals with up to 3,000 times greater sensitivity than current technologies.
The company plans to submit an Investigational Device Exemption (IDE) and commence a pivotal clinical trial in the second half of 2025 to support a De Novo application for FDA approval. The technology aims to revolutionize chronic pain treatment, particularly for pancreatic cancer patients, by offering a precision-guided approach to sense, treat, and verify nerve ablation, potentially replacing current treatments like opioids and invasive ethanol injections.
Autonomix Medical (NASDAQ: AMIX) ha raggiunto la fase di design lock per il suo catetere ad ablazione a radiofrequenza (RF) dopo test animali di successo. La tecnologia del catetere, unica nel suo genere, presenta un’antenna array con microchip che può rilevare segnali neurali con una sensitivity fino a 3.000 volte superiore rispetto alle tecnologie attuali.
L’azienda prevede di presentare una Richiesta di Esenzione per Dispositivo Investigativo (IDE) e di avviare un trial clinico decisivo nella seconda metà del 2025 per supportare una richiesta De Novo di approvazione da parte della FDA. Questa tecnologia mira a rivoluzionare il trattamento del dolore cronico, in particolare per i pazienti affetti da cancro al pancreas, offrendo un approccio guidato dalla precisione per rilevare, trattare e verificare l’ablazione dei nervi, potenzialmente sostituendo i trattamenti attuali come oppioidi e iniezioni invasive di etanolo.
Autonomix Medical (NASDAQ: AMIX) ha logrado el bloqueo de diseño para su catéter de ablación por radiofrecuencia (RF) tras exitosas pruebas en animales. La tecnología de catéter de la compañía, pionera en su clase, cuenta con una antena de arreglo de microchip que puede detectar señales neuronales con una sensibilidad hasta 3.000 veces superior a la de las tecnologías actuales.
La compañía planea presentar una Exención de Dispositivo Investigacional (IDE) y comenzar un ensayo clínico pivotal en la segunda mitad de 2025 para respaldar una solicitud De Novo para la aprobación de la FDA. La tecnología tiene como objetivo revolucionar el tratamiento del dolor crónico, particularmente para pacientes con cáncer de páncreas, al ofrecer un enfoque guiado por la precisión para detectar, tratar y verificar la ablación de nervios, potencialmente reemplazando tratamientos actuales como opioides e inyecciones invasivas de etanol.
Autonomix Medical (NASDAQ: AMIX)는 동물 테스트에 성공한 후 RF(라디오 주파수) 절제 카테터의 디자인 잠금을 완료했습니다. 회사의 선도적인 카테터 기반 기술은 신경 신호를 현재 기술보다 3,000배 더 높은 감도로 감지할 수 있는 마이크로칩 센서 배열 안테나를 특징으로 합니다.
회사는 FDA 승인을 위한 De Novo 신청을 지원하기 위해 2025년 하반기에 주요 임상 시험을 시작하는 것과 함께 Investigational Device Exemption (IDE)를 제출할 계획입니다. 이 기술은 만성 통증 치료를 혁신하는 것을 목표로 하며, 특히 췌장암 환자에게 정밀하게 가이드를 제공하여 신경 절제 작업을 감지, 치료 및 검증할 수 있도록 해, 현재의 오피오이드 및 침습적 에탄올 주사와 같은 치료법을 대체할 수 있는 가능성이 있습니다.
Autonomix Medical (NASDAQ: AMIX) a atteint le verrouillage de conception de son cathéter d'ablation par radiofréquence (RF) après des tests réussis sur des animaux. La technologie de cathéter de l'entreprise, de première classe, comporte une antenne à réseau de capteurs à microchip capable de détecter des signaux neuronaux avec une sensation jusqu'à 3.000 fois supérieure à celle des technologies actuelles.
L'entreprise prévoit de soumettre une Demande d'Exemption de Dispositif Investigational (IDE) et de commencer un essai clinique décisif dans la seconde moitié de 2025 pour soutenir une demande De Novo d'approbation par la FDA. Cette technologie vise à révolutionner le traitement de la douleur chronique, en particulier pour les patients atteints de cancer du pancréas, en offrant une approche guidée par la précision pour détecter, traiter et vérifier l'ablation des nerfs, pouvant potentiellement remplacer les traitements actuels tels que les opioïdes et les injections d'éthanol invasives.
Autonomix Medical (NASDAQ: AMIX) hat das Design-Lock für seinen Radiofrequenz(RF)-Ablationskatheter nach erfolgreichen Tierversuchen erreicht. Die bahnbrechende Kathetertechnologie des Unternehmens verfügt über eine Mikrochip-Sensorarray-Antenne, die neuronale Signale mit bis zu 3.000-mal höherer Empfindlichkeit als aktuelle Technologien nachweisen kann.
Das Unternehmen plant die Einreichung eines Investigational Device Exemption (IDE) und den Beginn einer pivotalen klinischen Studie in der zweiten Hälfte des Jahres 2025, um einen De Novo-Antrag auf FDA-Zulassung zu unterstützen. Die Technologie zielt darauf ab, die Behandlung von chronischen Schmerzen zu revolutionieren, insbesondere für Patienten mit Bauchspeicheldrüsenkrebs, indem sie einen präzisionsgeleiteten Ansatz bietet, um die Nervenablation zu erkennen, zu behandeln und zu überprüfen, wodurch möglicherweise bestehende Behandlungen wie Opioide und invasive Ethanol-Injektionen ersetzt werden können.
- Successful completion of animal testing and achievement of design lock for RF ablation catheter
- Technology offers 3,000 times greater sensitivity than current solutions
- Clear regulatory pathway established with planned IDE submission and pivotal trial in 2025
- Commercial revenue still distant with pivotal trial not starting until H2 2025
- FDA approval timeline uncertain with De Novo pathway
Insights
First-in-class catheter-based sensing technology designed to sense neuronal signals that indicate pain or disease and destroy those nerves at the source
Company expects to submit an Investigational Device Exemption (“IDE”), and if approved, will commence a pivotal clinical trial to support a De Novo application for FDA approval
THE WOODLANDS, TX, Dec. 05, 2024 (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 the milestone achievement of design lock for its radio frequency (“RF”) ablation catheter specifically designed to ablate nerves transvascularly in targeted areas following the successful completion of animal testing.
“There continues to be a much-needed shift in the treatment paradigm for pancreatic cancer patients offering a reduction of pain and improvement in quality of life. Our technology has continued to demonstrate the potential to address this urgent need, and these continued technical achievements enable us to support a labeling indication to commercialize the Autonomix Sensing and RF Ablation System in the United States as a treatment for pancreatic cancer pain,” commented Brad Hauser, CEO of Autonomix. “This design lock represents a meaningful milestone in the advancement of our technology development, placing us another step closer to commencing a pivotal clinical trial, planned in the second half of 2025, and beyond to potential De Novo clearance. The preliminary data from our ongoing first-in-human proof-of-concept study continues to bolster our confidence and demonstrate the potential of our technology to treat chronic pain. We are pleased with the continued progress and look forward to further exploring the potential of our innovative technology.”
With the successful completion of animal testing and design lock for our RF technology, the Company expects to submit an IDE and commence its pivotal clinical trial in the second half of 2025 to support a De Novo application for FDA approval. Autonomix is building its team and the infrastructure required to support its clinical and regulatory initiatives in anticipation of the FDA approval process.
The Company’s first-in-class technology platform utilizes a catheter-based microchip sensing array antenna that has the ability to detect and differentiate neural signals with up to 3,000 times greater sensitivity than currently available technologies. Once target nerves are identified, Autonomix uses its proprietary RF technology to ablate nerves, enabling a precision guided sense, treat and verify approach to addressing a number of disease categories from chronic pain management to hypertension and cardiology. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects.
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 approximately 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, to submit and receive approval of an IDE, and to file a De Novo application. 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
FAQ
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