Autonomix Medical, Inc. Finalizes Design of ASIC Microchip for Sensing Technology Catheter for Use in Humans, Continuing Progress Toward a U.S. Pivotal Trial in 2025
Autonomix Medical (NASDAQ: AMIX) has achieved a important milestone by finalizing the design ('design lock') of its Application Specific Integrated Circuits (ASIC) microchip following successful in vivo preclinical and bench testing. The company has initiated manufacturing of the ASIC microchip for human use and is progressing toward submitting an Investigational Device Exemption (IDE).
The ASIC microchip is central to Autonomix's intellectual property portfolio, enabling the detection of nerve signals through vasculature. The company plans to commence a pivotal clinical trial in 2025 to support a De Novo application for FDA approval. The technology aims to commercialize the Autonomix Sensing and RF Ablation System for treating pancreatic cancer pain in the United States.
Autonomix Medical (NASDAQ: AMIX) ha raggiunto un'importante pietra miliare completando il design ('design lock') del suo microchip Application Specific Integrated Circuits (ASIC), dopo aver effettuato con successo test preclinici in vivo e test di laboratorio. L'azienda ha avviato la produzione del microchip ASIC per uso umano ed è in fase di avanzamento verso la presentazione di un Investigational Device Exemption (IDE).
Il microchip ASIC è centrale nel portafoglio di proprietà intellettuale di Autonomix, consentendo la rilevazione dei segnali nervosi attraverso i vasi sanguigni. L'azienda prevede di avviare un trial clinico fondamentale nel 2025 per supportare una domanda De Novo per l'approvazione della FDA. La tecnologia mira a commercializzare il Autonomix Sensing and RF Ablation System per il trattamento del dolore oncologico pancreatico negli Stati Uniti.
Autonomix Medical (NASDAQ: AMIX) ha alcanzado un importante hito al finalizar el diseño ('design lock') de su microchip Application Specific Integrated Circuits (ASIC) tras exitosas pruebas preclínicas in vivo y en banco. La compañía ha iniciado la fabricación del microchip ASIC para uso humano y avanza hacia la presentación de un Investigational Device Exemption (IDE).
El microchip ASIC es fundamental para el portafolio de propiedad intelectual de Autonomix, permitiendo la detección de señales nerviosas a través de los vasos sanguíneos. La empresa planea comenzar un ensayo clínico pivotal en 2025 para respaldar una solicitud De Novo para la aprobación de la FDA. La tecnología tiene como objetivo comercializar el Autonomix Sensing and RF Ablation System para tratar el dolor por cáncer pancreático en los Estados Unidos.
Autonomix Medical (NASDAQ: AMIX)는 성공적인 생체 전임상 및 실험실 테스트를 통해 어플리케이션 특수 집적 회로(ASIC) 마이크로칩 디자인(‘디자인 잠금’)을 완료하여 중요한 이정표에 도달했습니다. 이 회사는 인간 사용을 위한 ASIC 마이크로칩 생산을 시작했으며 Investigational Device Exemption (IDE) 제출을 진행하고 있습니다.
ASIC 마이크로칩은 Autonomix의 지적 재산 포트폴리오의 핵심으로, 혈관을 통한 신경 신호 탐지를 가능하게 합니다. 회사는 FDA 승인을 위한 De Novo 신청을 지원하기 위해 2025년에 중추적인 임상 시험을 시작할 계획입니다. 이 기술은 미국 내 췌장암 통증 치료를 위한 Autonomix Sensing and RF Ablation System을 상용화하는 것을 목표로 하고 있습니다.
Autonomix Medical (NASDAQ: AMIX) a atteint une étape importante en finalisant le design ('design lock') de son circuit intégré spécifique à une application (ASIC) suite à des tests précliniques in vivo et en laboratoire réussis. L'entreprise a lancé la fabrication du microchip ASIC pour un usage humain et progresse vers la soumission d'une Investigational Device Exemption (IDE).
Le microchip ASIC est au cœur du portefeuille de propriété intellectuelle d'Autonomix, permettant la détection des signaux nerveux à travers la vascularisation. L'entreprise prévoit de commencer un essai clinique pivotal en 2025 pour soutenir une demande De Novo d'approbation de la FDA. La technologie vise à commercialiser le Autonomix Sensing and RF Ablation System pour traiter la douleur due au cancer du pancréas aux États-Unis.
Autonomix Medical (NASDAQ: AMIX) hat einen wichtigen Meilenstein erreicht, indem es das Design ('design lock') seines Application Specific Integrated Circuits (ASIC) Mikrochips nach erfolgreichen präklinischen In-vivo- und Labortests abgeschlossen hat. Das Unternehmen hat mit der Herstellung des ASIC-Mikrochips für den menschlichen Gebrauch begonnen und arbeitet daran, einen Investigational Device Exemption (IDE) zu beantragen.
Der ASIC-Mikrochip ist zentral für das geistige Eigentum von Autonomix, da er die Erkennung von Nervensignalen durch Blutgefäße ermöglicht. Das Unternehmen plant, im Jahr 2025 eine entscheidende klinische Studie zu starten, um einen De Novo-Antrag auf FDA-Zulassung zu unterstützen. Die Technologie zielt darauf ab, das Autonomix Sensing and RF Ablation System zur Behandlung von Schmerzen bei Bauchspeicheldrüsenkrebs in den USA zu kommerzialisieren.
- Achieved design lock for ASIC microchip following successful preclinical testing
- Initiated manufacturing of ASIC microchip for human use
- On track for pivotal clinical trial in 2025
- Technology addresses unmet medical need in pancreatic cancer pain management
- Still requires FDA IDE approval before clinical trials can begin
- No immediate revenue generation as product is still in development phase
Insights
The finalization of the ASIC microchip design marks a important technical advancement in Autonomix's nerve-sensing catheter development. The proprietary chip enables detection of minute nerve signals through blood vessels - a significant technical challenge that has historically intravascular neuromodulation approaches. The successful completion of both in vivo preclinical testing and bench testing validates the chip's fundamental capabilities.
For the general public: Think of this microchip as an ultra-sensitive 'nerve detector' that can pick up tiny electrical signals from nerves through blood vessel walls - similar to how a highly sensitive microphone can pick up whispers through a wall. This capability is essential for precisely targeting nerve tissue for pain treatment.
The progression toward an IDE submission and planned pivotal trial for pancreatic cancer pain represents a strategic focus on a high-value initial indication. Pancreatic cancer patients experience severe pain that's often poorly managed with current treatments. A minimally invasive approach to directly target and ablate pain-causing nerves could provide meaningful relief while avoiding systemic opioid side effects.
The company's regulatory strategy appears well-structured, pursuing a De Novo pathway rather than a 510(k), which is appropriate given the novel nature of the technology. The completion of design verification and validation testing is a prerequisite for IDE submission, making the design lock a critical milestone. The focus on pancreatic cancer pain provides a clear and specific labeling indication that could facilitate FDA review.
For the general public: Before any new medical device can be tested in humans, the FDA requires extensive proof that it's designed properly and works safely. This announcement shows Autonomix has completed the necessary technical groundwork and is ready to ask the FDA for permission to start human trials.
Design lock for ASIC microchip follows successful completion of in vivo preclinical and extensive bench testing
Manufacturing of ASIC microchip for targeted use in humans has been initiated
Company advancing toward submitting 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, Jan. 17, 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 finalized the design, achieving “design lock”, for its Application Specific Integrated Circuits (ASIC) microchip following the successful completion of in vivo preclinical testing and extensive bench testing, continuing progress toward its U.S. pivotal trial.
“This design lock represents a significant milestone in the advancement of our innovative technology, placing us another step closer to commencing a pivotal clinical trial in the United States, planned in 2025. The ASIC microchip is at the core of our intellectual property portfolio and enables and differentiates our ability to sense the small amplitude of nerve signals through the vasculature. These continued technical achievements should 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.
Mr. Hauser added, “Pain has a significant impact on the lives of patients with pancreatic cancer and there continues to be a much-needed shift in the treatment paradigm for pancreatic cancer patients. Our technology has continued to demonstrate the potential to address this unmet need and offer a reduction of pain and improvement in quality of life for these patients.”
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 the pain associated with pancreatic cancer and the timing of the commencement of a pivotal clinical trial in the United States. 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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