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Autonomix Medical, Inc. Treats First Patient in Follow-On Market Expansion Phase (“PoC 2”) of Proof-of-Concept Human Clinical Study
Globenewswire· 2025-06-30 12:30
Core Insights - Autonomix Medical, Inc. is expanding its clinical trials to include additional visceral cancer indications, effectively doubling its potential addressable market beyond pancreatic cancer pain [1][2] - The initiation of the PoC 2 phase follows positive results from the PoC 1 trial, which focused on patients with severe pancreatic cancer pain, indicating a strong foundation for multi-indication growth [2][3] - The company's technology platform has the potential to address a wide range of medical conditions, including cardiology, hypertension, and chronic pain management, with a concentrated focus on interventional cancer pain management applications [3][5] Company Overview - Autonomix Medical, Inc. is dedicated to advancing innovative technologies for diagnosing and treating diseases related to the nervous system [4] - The company's first-in-class platform includes a catheter-based microchip sensing array designed to detect and differentiate neural signals with greater sensitivity than existing technologies [4][5] - The technology is currently investigational and has not yet received marketing clearance in the United States [5]
Autonomix Medical, Inc. Granted New U.S. Patent for Innovative Catheter-Based Platform Technology
Globenewswire· 2025-06-27 12:00
Core Viewpoint - Autonomix Medical, Inc. has received a significant patent that enhances its position in the nerve-focused therapeutics market, supporting its mission to provide minimally invasive treatments for various nerve-related conditions [1][2]. Group 1: Patent and Technology - The newly issued U.S. Patent No. 12,279,889 B2 ('889 patent) relates to advanced systems for evaluating and modifying neurological functions, including tools for accessing small vessels and treating cancerous tumors [1][3]. - The technology includes integrated sensors in microneedles for deep tissue access, multiband optical sensors for tissue viability, and control systems that adjust treatment based on feedback signals [3][4]. - Autonomix's platform utilizes a catheter-based microchip sensing array that can detect neural signals with greater sensitivity than existing technologies, enabling a precision-guided approach to treat chronic pain and other conditions [4][6]. Group 2: Market Opportunity and Clinical Trials - The patent strengthens Autonomix's intellectual property portfolio, which now includes over 80 issued patents, positioning the company in a multi-billion-dollar market opportunity [1][2]. - The company plans to submit an Investigational Device Exemption (IDE) and begin U.S. clinical trials in 2025 for its Sensing and RF Ablation System, targeting pancreatic cancer pain [5][7]. - The technology aims to address a wide range of conditions influenced by sympathetic nerve activity, including hypertension and chronic pain syndromes, with the potential for numerous applications across various medical fields [1][7].
Autonomix Medical, Inc. Granted Approval to Expand Proof-of-Concept Human Clinical Study, Doubling Potential Addressable Market Beyond Pancreatic Cancer Pain
Globenewswire· 2025-06-05 12:45
Core Insights - Autonomix Medical, Inc. has received Ethics Committee authorization to expand its clinical trials for a proprietary ablation technology aimed at treating visceral cancer pain, building on initial success in pancreatic cancer pain [2][3] - The follow-on phase of the clinical program (PoC 2) is set to begin patient enrollment in June 2025, with the potential to double the addressable market by including additional visceral cancers [2][3][4] Group 1: Clinical Development - The PoC 2 phase will evaluate the safety and effectiveness of delivering transvascular energy to ablate problematic nerves, with a focus on interventional cancer pain management applications [2][4] - Initial trials in late-stage pancreatic cancer patients showed promising results, including significant pain reduction and decreased opioid use, indicating the technology's potential to transform cancer pain management [3][4] Group 2: Market Expansion - The expansion into visceral cancer pain aligns with Autonomix's strategy to create long-term value through multi-indication growth, addressing significant unmet needs in cancer treatment [3][4] - The technology platform has the potential to address various indications beyond cancer, including cardiology and chronic pain management, indicating a broad market opportunity [4][6][7] Group 3: Technology Overview - Autonomix's technology includes a catheter-based microchip sensing array designed to detect and differentiate neural signals with greater sensitivity than existing technologies [6][7] - The investigational nature of the technology means it has not yet been cleared for marketing in the United States, highlighting its developmental stage [7]
AMIX Stock May Climb Following Key U.S. Patent for Nerve-Sensing Tech
ZACKS· 2025-05-22 16:41
Core Insights - Autonomix Medical, Inc. (AMIX) has been granted a U.S. patent for its catheter-based platform that senses and differentiates nerve signals in real-time, marking a significant advancement in neuromodulation technology [1][4] - The patented technology aims to improve treatment precision for chronic conditions such as cancer and pain management, addressing the need for more accurate therapies in modern medicine [2][4] Company Developments - The patent approval strengthens AMIX's long-term business by securing exclusive rights to its nerve-sensing and stimulation technology, positioning the company as a first-mover in a high-demand market [4][6] - AMIX plans to submit an Investigational Device Exemption (IDE) and initiate U.S. clinical trials in 2025, with pancreatic cancer pain as its first commercial indication [10] Market Performance - Following the patent announcement, AMIX shares have remained flat, with a year-to-date decline of 52.1%, compared to the industry’s decline of 7.7% and a slight gain of 0.3% for the S&P 500 [3] - The company currently has a market capitalization of $4.4 million and a price-to-book ratio of 0.5X, significantly lower than the industry average of 2.30X [5] Technology Features - The patented technology includes advanced features such as flexible "microfingers" with built-in sensors for real-time monitoring, enabling a comprehensive approach to nerve treatment [9] - The system allows for the identification and ablation of overactive nerves using a minimally invasive method, offering a promising alternative to traditional treatments [8][9]
Autonomix Medical, Inc. Granted Key U.S. Patent for Innovative Catheter-Based Platform Technology
Globenewswire· 2025-05-15 12:30
Core Viewpoint - Autonomix Medical, Inc. has strengthened its intellectual property position in the nerve-mapping and denervation space with the issuance of U.S. Patent No. 12,257,071, which supports its mission to advance minimally invasive, nerve-focused therapeutics [1][2]. Patent and Technology - The newly issued '071 patent relates to advanced catheter-based systems that combine nerve mapping and radiofrequency (RF) ablation technologies, enhancing precision in treating nerve-related conditions [1][3]. - Key features of the '071 patent include deployable microfingers with embedded sensors for real-time physiological monitoring, the ability to map, stimulate, ablate, and assess nerve activity in a single integrated system, and feedback-driven control of multiple types of procedures [3][4]. - The technology is designed to treat conditions influenced by sympathetic nerve activity, including renal denervation for hypertension, chronic pain syndromes, and various metabolic and neurological disorders [3][4]. Clinical Development and Future Plans - The company plans to submit an Investigational Device Exemption (IDE) and commence U.S. clinical trials in 2025 to support commercialization of the Autonomix Sensing and RF Ablation System as a treatment for pancreatic cancer pain [5][7]. - Autonomix's technology platform aims to revolutionize the diagnosis and treatment of diseases involving the nervous system, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain [6][7]. Market Position and Strategy - The issuance of the patent marks a key milestone in the company's strategy to transform pain management and treat neurological disorders through minimally invasive, catheter-based denervation [2][4]. - The company currently holds over 80 issued patents and 40 pending patent applications, indicating a strong and expanding global patent portfolio [1][2].
Autonomix CEO Brad Hauser to Present at Virtual Investor's Closing Bell Event
GlobeNewswire News Room· 2025-05-14 13:20
Core Viewpoint - Autonomix Medical, Inc. is participating in the Virtual Investor Closing Bell Series to showcase its innovative medical device technology focused on precision nerve-targeted treatments [2][3]. Company Overview - Autonomix Medical, Inc. is a medical device company dedicated to advancing technologies for diagnosing and treating diseases related to the nervous system [5]. - The company's first-in-class platform system technology features a catheter-based microchip sensing array designed to detect and differentiate neural signals with greater sensitivity than existing technologies [5][6]. Technology and Applications - The initial development of the technology is aimed at treating pain, specifically targeting pancreatic cancer, which is known for causing severe pain and lacks reliable treatment options [6]. - The technology has the potential to address a wide range of indications, including cardiology, hypertension, and chronic pain management, across various diseases [6]. Event Details - The event will feature a corporate overview by Brad Hauser, President and CEO, and will include a live Q&A session for investors and interested parties [3][4]. - The live video webcast will be accessible on the company's website, with a replay available for 90 days following the event [4].
Brad Hauser, CEO of Autonomix Medical, Inc. Outlines Follow-On Expansion Study Expected to Begin in Q2 2025, Potentially Doubling Addressable Market
Globenewswire· 2025-05-13 13:20
Core Insights - Autonomix Medical, Inc. is set to initiate a follow-on phase ("PoC 2") of its proof-of-concept trial, focusing on the safety and effectiveness of transvascular energy delivery to alleviate cancer pain, with the expansion phase expected to start in Q2 2025 [2][3][4] Company Overview - Autonomix is a medical device company dedicated to advancing innovative technologies for diagnosing and treating diseases related to the nervous system [7][8] - The company's technology includes a catheter-based microchip sensing array designed to detect and differentiate neural signals with greater sensitivity than existing technologies [7] Market Expansion - The follow-on PoC 2 phase aims to evaluate additional visceral cancers, potentially doubling the addressable market beyond pancreatic cancer pain, by including gall bladder, liver, and bile duct cancers [3][4] - The initial phase (PoC 1) demonstrated significant pain reduction and decreased opioid use in patients with severe pancreatic cancer pain, leading to the decision to expand the investigation [4][5] Technology and Applications - Autonomix's technology is positioned as a platform capable of addressing various indications, including cardiology, hypertension, and chronic pain management, with a concentrated focus on interventional cancer pain management applications [5][8] - The company has established key opinion leader relationships and emerging preclinical evidence to support further expansion in oncology and gastroenterology sectors [5]
Autonomix Highlights Compelling Patient Testimonial Showing Rapid Pain Relief from First-in-Human Proof-of-Concept Trial in Pancreatic Cancer Pain
GlobeNewswire News Room· 2025-05-05 12:30
Core Viewpoint - Autonomix Medical, Inc. has released a video testimonial highlighting the effectiveness of transvascular nerve ablation in reducing pain for patients with severe pancreatic cancer, indicating a significant potential to improve quality of life in late-stage cancer care [2][3]. Company Overview - Autonomix Medical, Inc. is a medical device company focused on innovative technologies for diagnosing and treating diseases related to the nervous system [6][7]. - The company is developing a catheter-based microchip sensing array aimed at enhancing the detection and differentiation of neural signals, which may enable transvascular diagnosis and treatment of peripheral nervous system diseases [6][7]. Clinical Trial Insights - The initial phase of the first-in-human proof-of-concept trial (PoC 1) involved 20 patients with severe pancreatic cancer pain, demonstrating statistically significant pain relief as early as 24 hours post-procedure [3][5]. - Pain reduction was measured with a mean improvement of 4.16 on the Visual Analog Scale (VAS), representing a 53.3% improvement at 7 days post-procedure, and a mean reduction of 4.67 on the VAS, indicating a 59.2% improvement at 4-6 weeks post-procedure [3][5]. - 100% of responding patients achieved zero opioid use at 7 days post-procedure, with 73% remaining opioid-free at the 4-6 week follow-up [3][10]. Future Directions - Based on the positive outcomes from PoC 1, the company plans to expand the protocol into a follow-on phase (PoC 2), which will include pain management for additional visceral cancers and earlier-stage pancreatic cancer patients [3][4].
Autonomix Medical, Inc. (NASDAQ: AMIX) Participates in Virtual Investor “What This Means” Segment Highlighting Key Learnings from First-In-Human Trial and Extension into Visceral Cancer Pain
Globenewswire· 2025-05-01 13:25
Core Insights - Autonomix Medical, Inc. has successfully completed the initial phase of its first-in-human proof-of-concept trial ("PoC 1") demonstrating clinically meaningful pain reduction in patients with pancreatic cancer pain [1][2] - The company plans to initiate a market expansion study ("PoC 2") targeting additional visceral cancers and earlier stage pancreatic cancer, expected to commence in Q2 2025 [1][2] Company Overview - Autonomix is a medical device company focused on innovative technologies for diagnosing and treating diseases involving the nervous system [3] - The company's platform technology includes a catheter-based microchip sensing array designed to detect and differentiate neural signals with greater sensitivity than existing technologies [3] - The initial development of this technology is aimed at treating pain associated with pancreatic cancer, a condition currently lacking reliable treatment options [4] Future Prospects - The technology has the potential to address a wide range of indications beyond pancreatic cancer, including cardiology, hypertension, and chronic pain management [4] - The investigational technology has not yet received marketing clearance in the United States [4]
Autonomix Medical, Inc. Reports Positive Outcomes in Initial Phase of First-in-Human Proof-of-Concept Trial in Pancreatic Cancer Pain and Initiates Market Expansion Study for Visceral Cancer Pain
Globenewswire· 2025-04-30 12:15
Core Insights - Autonomix Medical, Inc. has successfully completed the initial trial phase ("PoC 1") for its innovative pain management technology, demonstrating significant pain reduction in patients with severe pancreatic cancer pain [1][2][5] - The company plans to initiate a follow-on market expansion study ("PoC 2") in Q2 2025, targeting additional visceral cancers and earlier stage pancreatic cancer, potentially doubling the addressable market [1][6][12] Group 1: Trial Results - The PoC 1 trial enrolled 20 patients, achieving clinically meaningful pain reduction with 100% of responders reporting zero opioid use at 7 days post-procedure and 73% remaining opioid-free at 4-6 week follow-up [1][2][8] - Pain relief was statistically significant, with a mean reduction of 3.32 on the Visual Analog Scale (VAS) at 7 days (baseline 7.61 to 4.29), representing a 43.6% improvement, and a mean reduction of 3.95 at 4-6 weeks (baseline 7.95 to 4.00), or 49.7% improvement [8][11] - Responding patients treated via femoral access showed a mean pain reduction of 4.16 at 7 days (baseline 7.81 to 3.65), or 53.3% improvement, and 4.67 at 4-6 weeks (baseline 7.89 to 3.22), or 59.2% improvement [8][11] Group 2: Safety and Quality of Life - The procedure demonstrated a strong safety profile, with no device or procedure-related serious adverse events reported, although there were 8 serious adverse events unrelated to the procedure [8][11] - Patients reported a 76% improvement in global quality of health at 7 days and a 42% improvement at 4-6 weeks post-procedure [8][11] Group 3: Future Directions - The follow-on PoC 2 phase will focus on interventional pain management for additional visceral cancers and earlier stage pancreatic cancer, with an amended trial protocol to gather more data on pain management [6][7][9] - Autonomix's technology platform has the potential to address a wide range of indications beyond cancer pain, including cardiology and chronic pain management [7][12][13]