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Autonomix Medical, Inc. (NASDAQ: AMIX) is a forward-thinking medical device company focused on the development of innovative technologies for diagnosing and treating nervous system disorders. As a development-stage firm, Autonomix is pioneering a first-in-class technology platform that features a catheter-based microchip-enabled array. This array is capable of detecting and differentiating neural signals with an impressive sensitivity, as evidenced in animal studies.
The company's foremost project involves a catheter-based sensing and ablation technology intended to sense neural signals associated with pain or disease and precisely target those nerves for treatment. This technology aims to offer a better alternative to existing approaches, which often rely on systemic drugs like opioids that have limited effectiveness and troubling side effects, or invasive treatments that can miss target nerves and cause collateral damage.
Initially, Autonomix is focusing on treating pancreatic cancer-related pain. Traditional treatments such as opioids or ethanol injections offer limited relief and can result in severe side effects. The company is currently conducting a proof-of-concept (PoC) human clinical trial targeting the multi-billion-dollar pancreatic cancer market through transvascular RF ablation. This trial aims to mitigate pain in patients by ablating relevant somatic nerves using a transvascular approach, and patient enrollment is expected to be completed by year-end.
Recent achievements include the successful completion of the first three patient procedures in the PoC trial, the safe completion of an animal study demonstrating the efficacy of the technology in the renal artery, and the issuance of a U.S. patent covering the catheter-based technology for cancer-related pain. Additionally, the company has entered into a clinical site agreement with AKFA MEDLINE Ltd. and selected Clinical Accelerator and Qmed to manage trial operations and data.
Future milestones include launching a combined sensing and ablation clinical trial in 2025, submitting a de novo application in 2026, and seeking FDA clearance by 2027. Autonomix also has plans for its technology to address other conditions, including renal denervation and chronic pain management, making it a versatile platform with the potential to revolutionize how diseases involving the nervous system are treated.
For more information, visit autonomix.com and follow the company on social media platforms such as X, LinkedIn, Instagram, and Facebook.
Autonomix Medical (NASDAQ: AMIX) has completed a licensing transaction with RF Innovations for the FDA-cleared Apex 6 Radiofrequency Generator. This transaction, involving 250,000 shares of common stock, grants Autonomix a perpetual non-exclusive worldwide and royalty-free license for the Apex 6 Generator intellectual property. The Apex 6 Generator will be a component of Autonomix's sensing and ablation system for FDA clearance.
The deal aligns with Autonomix's specifications for their ablation system and enhances their supply chain with RF Innovations' experienced manufacturing partner. Autonomix plans to utilize this technology in its strategic therapeutic areas, initially focusing on pancreatic cancer-related pain, with potential for follow-on indications.
Autonomix Medical (NASDAQ: AMIX), a medical device company focused on innovative technologies for diagnosing and treating nervous system diseases, has announced its participation in the Virtual Investor Closing Bell Series on Wednesday, July 24, 2024, at 4:00 PM ET. During this event, CEO Brad Hauser will provide a corporate overview and business outlook.
The event will feature a moderated discussion and allow investors to submit live questions. Autonomix will address as many questions as possible within the allotted time. A live video webcast will be available on the company's website, with a replay accessible for 90 days following the event.
Autonomix Medical, Inc. (NASDAQ: AMIX), a medical device company focused on innovative technologies for diagnosing and treating nervous system diseases, recently participated in a Virtual Investor 'What This Means' segment. CEO Brad Hauser discussed the company's recent definitive agreement with RF Innovations, Inc. to license the intellectual property for its Apex 6 Radiofrequency Generator.
The agreement is significant for Autonomix's development program, as it provides access to FDA-cleared ablation technology. This move aligns with the company's mission to revolutionize nervous system disease management. The segment, which offers insights into the implications of this licensing agreement, is now available for viewing online.
Autonomix Medical (NASDAQ: AMIX) has entered a definitive agreement with RF Innovations to license the intellectual property of the FDA-cleared Apex 6 Radiofrequency Generator. This ablation technology is designed to lesion neural tissue for pain management in the peripheral nervous system. The transaction, valued at 250,000 shares of common stock, grants Autonomix a perpetual non-exclusive worldwide and royalty-free license. Autonomix plans to utilize this technology in its strategic therapeutic areas, potentially simplifying its regulatory strategy. The company is initially developing its technology to address pancreatic cancer-related pain, with plans for follow-on indications. This agreement is expected to accelerate Autonomix's journey in revolutionizing the diagnosis and treatment of diseases involving the nervous system.
Autonomix Medical (NASDAQ: AMIX) has launched a new platform called the CEO Corner, featuring CEO Brad Hauser. The platform aims to provide additional insights on press releases, corporate updates, events, and pipeline progress. The company focuses on advancing medical technologies for diagnosing and treating nervous system diseases. CEO Brad Hauser emphasized the importance of transparency and stakeholder engagement for the company's success. The CEO Corner will deliver direct, succinct updates to current and potential investors, covering corporate developments, clinical trials, and other advancements. The CEO Corner is now available on the company's website.
Autonomix Medical (NASDAQ: AMIX) shared preliminary positive results from its proof-of-concept human clinical trial targeting pancreatic cancer pain. In a recent Virtual Investor segment, Dr. Robert Schwartz detailed the results from the first five lead-in patients and discussed the advancements in pain management techniques with fewer side effects. The trial focuses on the safety and effectiveness of transvascular energy delivery to ablate nerves causing pain. Early indications suggest significant improvements in patient quality of life. For further details, the company has made patient testimonials and the segment available online.
Autonomix announced positive results from the first five patients in its ongoing proof-of-concept human clinical trial for pain management in pancreatic cancer patients.
Key findings include: 60% of subjects experienced a mean 6.33 reduction in pain on the VAS pain scale, and 100% of responders saw clinically meaningful pain relief at 7 days post-procedure.
Responder patients reported a mean 78% improvement in quality of health and a 45% improvement in quality of life at 7 days post-procedure. The trial aims to complete enrollment by the end of 2024, and management will host a webcast to discuss the results.
Autonomix Medical (NASDAQ: AMIX) has appointed Brad Hauser as its new President and CEO, effective immediately. Hauser, who has over 20 years of experience in medical technology innovation, succeeds Lori Bisson, now the Executive Vice Chairman of the Board. Hauser's background includes key roles in companies such as Beauty Health, Soliton, ZELTIQ Aesthetics, and Allergan Aesthetics. At Autonomix, he aims to advance the company's mission of revolutionizing the diagnosis and treatment of nervous system diseases. The board has approved an inducement stock option grant of 900,000 shares to Hauser as part of his compensation package.
Autonomix will reveal preliminary topline results from the first five patients in its human clinical trial on June 18, 2024. This trial evaluates the safety and effectiveness of transvascular energy to ablate problematic nerves and reduce pain in pancreatic cancer patients. The announcement will be accompanied by a live webcast at 8:30 a.m. ET on the same day. Interested parties can register and access the webcast on the Autonomix website, which will archive the event for 90 days.
Autonomix Medical (NASDAQ: AMIX) announced the approval of a protocol amendment by the Ethics Committee for its ongoing proof-of-concept human clinical trial. The trial evaluates the safety and efficacy of delivering transvascular energy to ablate nerves and mitigate pain in pancreatic cancer patients. Following the treatment of the first five 'lead-in' patients, the protocol was amended to gather additional data on tumor encroachment and other bio-measurements, and to refine inclusion criteria based on patient-reported pain levels. Autonomix plans to release topline results from the lead-in patients soon and aims to complete trial enrollment by year-end. The company's catheter-based technology seeks to offer a targeted, effective alternative to current pain management methods.
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