Autonomix Medical, Inc. Treats First Patient in Follow-On Market Expansion Phase (“PoC 2”) of Proof-of-Concept Human Clinical Study
Autonomix Medical (NASDAQ:AMIX) has announced the enrollment and treatment of its first patient in the follow-on phase of its proof-of-concept human clinical trial (PoC 2). This expansion follows positive results from the initial PoC 1 study in patients with severe pancreatic cancer pain.
The PoC 2 phase aims to double the potential addressable market by evaluating the company's nerve ablation technology in additional visceral cancers that signal pain through the Celiac Plexus, as well as earlier stage pancreatic cancers with moderate to severe pain. The technology involves delivering transvascular energy to ablate problematic nerves for pain mitigation.
The company's platform technology has potential applications across multiple indications, including cardiology, hypertension, and chronic pain management. The current PoC 2 phase specifically focuses on interventional cancer pain management applications in areas such as pancreatic, gall bladder, liver, and bile duct cancers, with possibilities for further expansion in oncology and gastroenterology sectors.
Autonomix Medical (NASDAQ:AMIX) ha annunciato l'arruolamento e il trattamento del suo primo paziente nella fase successiva del trial clinico di prova di concetto umano (PoC 2). Questa espansione segue i risultati positivi dello studio iniziale PoC 1 su pazienti con dolore severo da cancro pancreatico.
La fase PoC 2 mira a raddoppiare il mercato potenziale indirizzabile valutando la tecnologia di ablazione nervosa dell'azienda in ulteriori tumori viscerali che trasmettono dolore attraverso il plesso celiaco, oltre a tumori pancreatici in stadio iniziale con dolore da moderato a severo. La tecnologia consiste nella somministrazione di energia transvascolare per ablare i nervi problematici al fine di alleviare il dolore.
La tecnologia piattaforma dell'azienda ha potenziali applicazioni in diverse indicazioni, tra cui cardiologia, ipertensione e gestione del dolore cronico. La fase attuale PoC 2 si concentra specificamente sulle applicazioni interventistiche per la gestione del dolore oncologico in aree come cancro pancreatico, della cistifellea, del fegato e delle vie biliari, con possibilità di ulteriori espansioni nei settori oncologico e gastroenterologico.
Autonomix Medical (NASDAQ:AMIX) ha anunciado la inscripción y tratamiento de su primer paciente en la fase de seguimiento de su ensayo clínico humano de prueba de concepto (PoC 2). Esta expansión sigue a resultados positivos del estudio inicial PoC 1 en pacientes con dolor severo por cáncer de páncreas.
La fase PoC 2 tiene como objetivo duplicar el mercado potencial direccionable evaluando la tecnología de ablación nerviosa de la compañía en otros cánceres viscerales que transmiten dolor a través del plexo celíaco, así como en cánceres pancreáticos en etapas tempranas con dolor moderado a severo. La tecnología consiste en administrar energía transvascular para ablacionar los nervios problemáticos y mitigar el dolor.
La tecnología plataforma de la compañía tiene aplicaciones potenciales en múltiples indicaciones, incluyendo cardiología, hipertensión y manejo del dolor crónico. La fase PoC 2 actual se enfoca específicamente en aplicaciones intervencionistas para el manejo del dolor oncológico en áreas como cáncer de páncreas, vesícula biliar, hígado y conductos biliares, con posibilidades de expansión adicional en los sectores de oncología y gastroenterología.
Autonomix Medical (NASDAQ:AMIX)는 개념 증명 임상시험(PoC 2) 후속 단계에서 첫 환자 등록 및 치료를 발표했습니다. 이번 확장은 중증 췌장암 통증 환자를 대상으로 한 초기 PoC 1 연구에서 긍정적인 결과를 바탕으로 합니다.
PoC 2 단계는 잠재적 대상 시장을 두 배로 확대하는 것을 목표로 하며, 회사의 신경 절제 기술을 복강 신경총을 통해 통증 신호를 전달하는 추가 내장암과 중등도에서 중증 통증을 동반한 초기 췌장암 환자에 대해 평가합니다. 이 기술은 문제 신경을 절제하기 위해 혈관 내 에너지를 전달하여 통증 완화를 도모합니다.
회사의 플랫폼 기술은 심장학, 고혈압, 만성 통증 관리 등 다양한 적응증에 적용 가능성이 있습니다. 현재 PoC 2 단계는 췌장암, 담낭암, 간암, 담관암 등 암성 통증 관리 중재적 적용에 중점을 두고 있으며, 종양학 및 위장병학 분야로의 추가 확장 가능성도 있습니다.
Autonomix Medical (NASDAQ:AMIX) a annoncé l'inscription et le traitement de son premier patient dans la phase de suivi de son essai clinique humain de preuve de concept (PoC 2). Cette extension fait suite aux résultats positifs de l'étude initiale PoC 1 chez des patients souffrant de douleurs sévères liées au cancer du pancréas.
La phase PoC 2 vise à doubler le marché adressable potentiel en évaluant la technologie d'ablation nerveuse de l'entreprise sur d'autres cancers viscéraux signalant la douleur via le plexus cœliaque, ainsi que sur des cancers du pancréas à un stade précoce avec des douleurs modérées à sévères. La technologie consiste à délivrer une énergie transvasculaire pour ablater les nerfs problématiques afin d'atténuer la douleur.
La technologie plateforme de l'entreprise présente des applications potentielles dans plusieurs indications, notamment en cardiologie, hypertension et gestion de la douleur chronique. La phase PoC 2 actuelle se concentre spécifiquement sur les applications interventionnelles pour la gestion de la douleur cancéreuse dans des domaines tels que les cancers du pancréas, de la vésicule biliaire, du foie et des voies biliaires, avec des possibilités d'expansion supplémentaires dans les secteurs de l'oncologie et de la gastroentérologie.
Autonomix Medical (NASDAQ:AMIX) hat die Einschreibung und Behandlung seines ersten Patienten in der Folgephase seiner Proof-of-Concept Human-Studie (PoC 2) bekanntgegeben. Diese Erweiterung folgt auf positive Ergebnisse der initialen PoC 1-Studie bei Patienten mit starken Schmerzen durch Bauchspeicheldrüsenkrebs.
Die PoC 2-Phase zielt darauf ab, den potenziell adressierbaren Markt zu verdoppeln, indem die Nervablationstechnologie des Unternehmens bei weiteren viszeralen Krebsarten, die Schmerzen über den Plexus celiacus signalisieren, sowie bei Bauchspeicheldrüsenkrebs im Frühstadium mit mäßigen bis starken Schmerzen evaluiert wird. Die Technologie beinhaltet die transvasale Energieabgabe zur Ablation problematischer Nerven zur Schmerzlinderung.
Die Plattformtechnologie des Unternehmens hat potenzielle Anwendungen in verschiedenen Indikationen, darunter Kardiologie, Bluthochdruck und chronisches Schmerzmanagement. Die aktuelle PoC 2-Phase konzentriert sich speziell auf interventionelle Anwendungen zur Schmerzbehandlung bei Krebs in Bereichen wie Bauchspeicheldrüsen-, Gallenblasen-, Leber- und Gallengangskrebs mit Möglichkeiten zur weiteren Expansion in den Onkologie- und Gastroenterologiesektor.
- Expansion into additional cancer indications doubles the potential addressable market
- Positive results demonstrated in initial PoC 1 study for pancreatic cancer pain
- Technology platform has potential to address multiple indications beyond cancer pain
- Established relationships with key opinion leaders in target medical sectors
- None.
Insights
Autonomix's expansion into additional cancer pain indications doubles their market opportunity while building on positive early clinical results.
Autonomix's announcement represents a significant advancement in their clinical development strategy. The company has initiated their follow-on market expansion phase (PoC 2) of their proof-of-concept study, enrolling and treating the first patient for cancer pain beyond pancreatic indications. This expansion leverages the positive results already demonstrated in their initial clinical phase (PoC 1) that focused specifically on pancreatic cancer pain.
The strategic importance of this development is two-fold: First, it doubles their potential addressable market by including additional visceral cancers that signal pain through the Celiac Plexus as well as earlier-stage pancreatic cancers with moderate to severe pain. Second, it validates their platform technology approach, confirming their ability to potentially address multiple indications with the same core technology.
This expansion aligns with Autonomix's broader vision of developing their transvascular nerve ablation technology as a versatile platform that could eventually target dozens of indications across cardiology, hypertension, and chronic pain management. The company is wisely focusing initially on interventional cancer pain management applications where they've established key opinion leader relationships and have preclinical evidence.
For a medical device company at this stage, successfully expanding clinical applications demonstrates both clinical validation of their core technology and prudent commercial strategy execution. The market will be watching closely for forthcoming clinical data from both study phases to further validate the technology's efficacy and safety profile across these expanded indications.
Expansion of study into additional indications doubles the potential addressable market beyond pancreatic cancer pain
PoC 2 phase builds on early success and positive results demonstrated in PoC 1 in patients with severe pancreatic cancer pain, supporting multi-indication growth strategy
THE WOODLANDS, TX, June 30, 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 the first patient has been enrolled and treated in the follow-on phase to its proof-of-concept human clinical trial (“PoC 2”) evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate cancer pain.
“We’re executing on a bold vision to expand the reach of our technology beyond pancreatic cancer pain and into a broader range of high-need visceral cancer indications,” said Brad Hauser, CEO of Autonomix. “The start of patient treatment in our PoC 2 study represents a major milestone that reinforces our momentum and marks a critical step toward unlocking substantial clinical and commercial potential. We believe this expansion strengthens our value proposition and positions us to deliver meaningful impact for patients while creating long-term value for shareholders. We look forward to sharing further updates as clinical data become available.”
As previously announced, based on the positive results demonstrated in the initial phase of the Company’s first-in-human proof-of-concept study (“PoC 1”) in patients with severe pancreatic cancer pain, Autonomix has initiated a follow-on PoC 2 phase in a market expansion opportunity, which doubles the potential addressable market beyond pancreatic cancer pain by evaluating additional visceral cancers that signal pain through the Celiac Plexus and earlier stage pancreatic cancers with moderate to severe pain.
Autonomix’s technology constitutes a platform with the potential to address dozens of indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. The PoC 2 phase will provide a concentrated focus on interventional cancer pain management applications like pancreatic, gall bladder, liver, and bile duct, with potential further expansion in oncology, gastroenterology, and other sectors where the Company has established key opinion leader relationships and emerging preclinical evidence.
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 results of the PoC 2 phase of the trial. 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, 2025 and in other filings made by us from time to time with the SEC. 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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