Autonomix Highlights Compelling Patient Testimonial Showing Rapid Pain Relief from First-in-Human Proof-of-Concept Trial in Pancreatic Cancer Pain
Autonomix Medical (NASDAQ: AMIX) has released compelling patient testimonial results from its first-in-human proof-of-concept trial evaluating transvascular nerve ablation for pancreatic cancer pain. The study, which enrolled 20 patients, demonstrated statistically significant pain relief within 24 hours of the procedure.
Key results include: 53.3% pain improvement at 7 days post-procedure (mean pain reduction from 7.81 to 3.65 on VAS scale) and 59.2% improvement at 4-6 weeks (reduction from 7.89 to 3.22). Notably, 100% of responding patients eliminated opioid use at 7 days post-procedure, with 73% remaining opioid-free at 4-6 weeks. The procedure showed a strong safety profile with no serious adverse events.
Based on these positive outcomes, Autonomix is expanding its protocol into PoC 2 phase, including pain management for additional visceral cancers and earlier-stage pancreatic cancer patients.
Autonomix Medical (NASDAQ: AMIX) ha pubblicato risultati convincenti basati su testimonianze di pazienti nel suo primo studio di prova sull'uomo che valuta l'ablazione nervosa transvascolare per il dolore da cancro al pancreas. Lo studio, che ha coinvolto 20 pazienti, ha mostrato un significativo sollievo dal dolore entro 24 ore dalla procedura.
I risultati principali includono: un miglioramento del dolore del 53,3% a 7 giorni dalla procedura (riduzione media del dolore da 7,81 a 3,65 sulla scala VAS) e un miglioramento del 59,2% a 4-6 settimane (riduzione da 7,89 a 3,22). È importante sottolineare che il 100% dei pazienti che hanno risposto ha eliminato l'uso di oppioidi a 7 giorni dalla procedura, con il 73% che è rimasto senza oppioidi a 4-6 settimane. La procedura ha dimostrato un profilo di sicurezza solido senza eventi avversi gravi.
Grazie a questi risultati positivi, Autonomix sta ampliando il protocollo nella fase PoC 2, includendo la gestione del dolore per altri tumori viscerali e per pazienti con cancro al pancreas in stadio precoce.
Autonomix Medical (NASDAQ: AMIX) ha publicado resultados convincentes basados en testimonios de pacientes en su primer ensayo de prueba de concepto en humanos que evalúa la ablación nerviosa transvascular para el dolor del cáncer de páncreas. El estudio, que incluyó a 20 pacientes, demostró un alivio estadísticamente significativo del dolor dentro de las 24 horas posteriores al procedimiento.
Los resultados clave incluyen: una mejora del dolor del 53,3% a los 7 días después del procedimiento (reducción media del dolor de 7,81 a 3,65 en la escala VAS) y una mejora del 59,2% a las 4-6 semanas (reducción de 7,89 a 3,22). Cabe destacar que el 100% de los pacientes que respondieron eliminaron el uso de opioides a los 7 días después del procedimiento, y el 73% permaneció libre de opioides a las 4-6 semanas. El procedimiento mostró un perfil de seguridad sólido sin eventos adversos graves.
Basándose en estos resultados positivos, Autonomix está ampliando su protocolo a la fase PoC 2, incluyendo el manejo del dolor para otros cánceres viscerales y pacientes con cáncer de páncreas en etapas tempranas.
Autonomix Medical (NASDAQ: AMIX)는 췌장암 통증을 위한 혈관 내 신경 소작술을 평가하는 최초의 인간 대상 개념 증명 시험에서 환자들의 강력한 증언 결과를 발표했습니다. 20명의 환자가 참여한 이 연구는 시술 후 24시간 내에 통계적으로 유의미한 통증 완화를 보여주었습니다.
주요 결과로는 시술 7일 후 통증 개선율 53.3%(VAS 척도에서 평균 통증 점수가 7.81에서 3.65로 감소)과 4-6주 후 59.2% 개선(7.89에서 3.22로 감소)이 포함됩니다. 특히, 반응한 환자 전원이 시술 7일 후 오피오이드 사용을 중단했으며, 4-6주 후에도 73%가 오피오이드 없이 지냈습니다. 시술은 심각한 부작용 없이 안전한 프로파일을 나타냈습니다.
이러한 긍정적 결과를 바탕으로 Autonomix는 프로토콜을 PoC 2 단계로 확장하여 추가 내장암 및 초기 췌장암 환자의 통증 관리도 포함할 예정입니다.
Autonomix Medical (NASDAQ : AMIX) a publié des résultats convaincants basés sur des témoignages de patients issus de son premier essai de preuve de concept chez l'humain évaluant l'ablation nerveuse transvasculaire pour la douleur liée au cancer du pancréas. L'étude, qui a inclus 20 patients, a démontré un soulagement statistiquement significatif de la douleur en moins de 24 heures après la procédure.
Les résultats clés comprennent : une amélioration de la douleur de 53,3 % à 7 jours post-procédure (réduction moyenne de la douleur de 7,81 à 3,65 sur l'échelle EVA) et une amélioration de 59,2 % à 4-6 semaines (réduction de 7,89 à 3,22). Notamment, 100 % des patients répondeurs ont arrêté l'utilisation d'opioïdes à 7 jours, avec 73 % restant sans opioïdes à 4-6 semaines. La procédure a présenté un profil de sécurité solide sans événements indésirables graves.
Fort de ces résultats positifs, Autonomix étend son protocole à la phase PoC 2, incluant la gestion de la douleur pour d'autres cancers viscéraux et les patients atteints d'un cancer du pancréas à un stade précoce.
Autonomix Medical (NASDAQ: AMIX) hat überzeugende Patientenberichte aus seiner ersten klinischen Machbarkeitsstudie zur transvasalen Nervenablation bei Pankreaskrebs-Schmerzen veröffentlicht. Die Studie mit 20 Patienten zeigte eine statistisch signifikante Schmerzlinderung innerhalb von 24 Stunden nach dem Eingriff.
Wichtige Ergebnisse sind: eine 53,3%ige Schmerzverbesserung 7 Tage nach dem Eingriff (durchschnittliche Schmerzminderung von 7,81 auf 3,65 auf der VAS-Skala) und eine 59,2%ige Verbesserung nach 4-6 Wochen (Reduktion von 7,89 auf 3,22). Bemerkenswert ist, dass 100% der ansprechenden Patienten den Opioidgebrauch 7 Tage nach dem Eingriff einstellten, wobei 73% auch nach 4-6 Wochen opioidfrei blieben. Das Verfahren zeigte ein starkes Sicherheitsprofil ohne schwerwiegende Nebenwirkungen.
Aufgrund dieser positiven Ergebnisse erweitert Autonomix sein Protokoll in die PoC-Phase 2, einschließlich Schmerzmanagement für weitere viszerale Krebserkrankungen und Patienten mit Pankreaskrebs im Frühstadium.
- Statistically significant pain relief achieved within 24 hours post-procedure
- 53.3% pain improvement at 7 days and 59.2% at 4-6 weeks post-procedure
- 100% of responding patients achieved zero opioid use at 7 days post-procedure
- 73% of responders remained opioid-free at 4-6 week follow-up
- Strong safety profile with no device or procedure-related serious adverse events
- Protocol expansion to include additional cancer types and earlier-stage patients
- Limited initial trial size of only 20 patients
- Results only reported for 'responding' patients, suggesting some patients may not have responded to treatment
Insights
Autonomix's nerve ablation technique shows promising early results in reducing pancreatic cancer pain and opioid use with rapid onset effects.
The proof-of-concept trial data from Autonomix presents encouraging preliminary results for their transvascular nerve ablation technology in pancreatic cancer pain management. Pain control represents a critical challenge in pancreatic cancer care, with patients often suffering debilitating pain resistant to conventional treatments.
The reported 53.3% pain reduction at 7 days and 59.2% improvement at 4-6 weeks post-procedure exceeds the minimum clinically meaningful threshold for cancer pain intervention (typically 30%). Most compelling is the reported rapid onset of relief - statistically significant as early as 24 hours post-procedure - addressing the urgent need for timely intervention in these patients.
Perhaps most significant clinically is the dramatic reduction in opioid requirements. The company reports all responding patients achieved zero opioid use at 7 days post-procedure, with 73% remaining opioid-free at 4-6 weeks. This represents a substantial quality-of-life improvement, as opioid reduction minimizes sedation, constipation, and cognitive impairment often accompanying high-dose narcotics.
The absence of serious device or procedure-related adverse events suggests a favorable preliminary safety profile, though evaluation in larger populations remains necessary. The company's expansion to include earlier-stage pancreatic cancer patients and other visceral cancers in PoC 2 indicates confidence in their approach while potentially broadening clinical applications.
While these results warrant cautious optimism, important questions remain unanswered, including the definition of "responders," the total proportion of patients who responded, and durability of effect beyond 6 weeks.
Autonomix's pancreatic cancer pain treatment shows promising early data with significant pain reduction and opioid elimination in first human trial.
Autonomix's announcement represents a potentially meaningful advancement in interventional pain management for pancreatic cancer, an indication with severely limited treatment options. The company's transvascular nerve ablation approach addresses a specific, high-burden symptom in a difficult-to-treat patient population.
The preliminary data from their 20-patient proof-of-concept trial demonstrates clinically significant pain reduction, with a mean VAS improvement of 4.16 points (53.3%) at 7 days and 4.67 points (59.2%) at 4-6 weeks post-procedure. These metrics exceed standard thresholds for meaningful clinical improvement in cancer pain (typically 2 points or 30%).
The reported complete elimination of opioid use among responders at 7 days post-procedure (with 73% maintaining opioid-free status at 4-6 weeks) represents a particularly compelling outcome. Opioid reduction or elimination translates directly to improved patient function and reduced medication-related complications.
From a development perspective, the company's decision to conclude the initial phase and advance to an expanded PoC 2 study suggests confidence in their preliminary results. The protocol expansion to earlier-stage pancreatic cancer patients and additional visceral cancers strategically broadens the potential market opportunity.
While the clean safety profile (no device or procedure-related serious adverse events) is encouraging, several questions remain unanswered, including the specific definition of "responders" and what percentage of total treated patients achieved the reported benefits. The company remains in early clinical development, with substantial work required before potential commercialization.
Video testimonial demonstrates pain reduction after transvascular nerve ablation, suggesting potential for improving quality of life in late-stage cancer care
Patient testimonial now available here
THE WOODLANDS, TX, May 05, 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 release of a new video testimonial from a patient participating in the initial phase of its first-in-human proof-of-concept trial (“PoC 1”) evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant nerves and mitigate pain in patients with severe pancreatic cancer pain. Access the patient testimonial here.
“We are deeply grateful to the patients who have shared their experiences with us. Testimonials like this provide meaningful insight into the real-world impact our technology can have, particularly in improving quality of life and reducing dependence on pain medication,” said Brad Hauser, Chief Executive Officer of Autonomix. “Patients with late-stage pancreatic cancer face severe, often unrelenting pain. Data emerging from our ongoing study reinforce the significant burden this pain places on quality of life and point to a clear, unmet need for innovative interventional pain management solutions.”
As previously announced, the Company enrolled twenty (20) patients in PoC 1, including the first five (5) “lead-in” patients. Based on consistent, corresponding evidence that successfully met the trial objectives, the Company determined there was a sufficient number of patients and will conclude its initial phase of the study. Notable findings from the study include statistically significant pain relief as early as 24-hours post procedure, providing patients with rapid relief. Pain reduction across the responding* patient population remained consistently positive at 7-days and 4-6 weeks post-procedure, with a mean pain reduction of 4.16 on the Visual Analog Scale (“VAS”) (baseline 7.81 to 3.65), or
About the Proof-of-Concept Trial
The goal of the first-in-human proof-of-concept trial is to assess pain reduction via RF ablation. The Company’s catheter-based microchip sensing array used to detect and differentiate neural signaling was not used in this trial and will be evaluated in future studies.
The primary objective of the initial phase of the PoC 1 trial was to assess the success rate of ablating relevant nerves to mitigate pain in patients with pancreatic cancer pain utilizing RF ablation in a transvascular approach to the nerves in the region. Secondary objectives included assessing the incidence of device- and procedure-related adverse events up to 4-6 weeks post-procedure; estimating the change in pain levels from pre- to post-procedure; and estimating the change in quality of life from pre- to post-procedure. All patients who had a successful procedure were evaluated at 7-days, 4-6 weeks, and at 3-months post-procedure. All patients entered the study with severe abdominal pain from unresectable pancreatic cancer and had a life expectancy of 3-months or more.
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 commencement of the PoC 2 phase, the potential of the technology to treat pain associated with pancreatic cancer, and to complete its clinical study in pancreatic cancer pain. 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 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
* Responders refer to 16 of the 20 patients who were treated using femoral access responded to treatment. The three (3) patients treated using brachial access showed no improvement in pain scores, representing a key procedural learning.
FAQ
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