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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 appointed Julie Manchester as Vice President of Regulatory Affairs and Quality, strengthening its team ahead of planned FDA approval initiatives. The company, which recently completed animal testing and design lock for its RF technology, remains on track to submit an Investigational Device Exemption (IDE) and commence a pivotal clinical trial in 2025 to support a De Novo FDA application.
Manchester brings over 15 years of quality and regulatory experience in medical devices and related industries. The company granted her an inducement stock option to purchase 19,500 shares, vesting over four years. Autonomix continues to make progress in its proof-of-concept clinical trial for treating pancreatic cancer pain, reporting positive patient outcomes.
Autonomix Medical (NASDAQ: AMIX) has achieved design lock for its radio frequency (RF) ablation catheter following successful animal testing. The company's first-in-class catheter-based technology features a microchip sensing array antenna that can detect neural signals with up to 3,000 times greater sensitivity than current technologies.
The company plans to submit an Investigational Device Exemption (IDE) and commence a pivotal clinical trial in the second half of 2025 to support a De Novo application for FDA approval. The technology aims to revolutionize chronic pain treatment, particularly for pancreatic cancer patients, by offering a precision-guided approach to sense, treat, and verify nerve ablation, potentially replacing current treatments like opioids and invasive ethanol injections.
Autonomix Medical (NASDAQ: AMIX) has closed its previously announced underwritten public offering, raising $10.0 million in gross proceeds. The offering included 615,500 common stock units and 917,596 pre-funded warrant units, priced at $6.54 and $6.539 respectively. Each unit contained one share (or pre-funded warrant) and one Series A Warrant with a five-year term and $6.54 exercise price. The offering included a partial exercise of the over-allotment option. Ladenburg Thalmann & Co. acted as sole bookrunner. Proceeds will fund clinical trials, research and development, intellectual property development, and working capital.
Autonomix Medical announced the pricing of an underwritten public offering expected to raise $9.0 million in gross proceeds. The offering consists of 1,376,287 common stock units priced at $6.54 per unit. Each unit includes one share of common stock (or pre-funded warrant) and one Series A warrant exercisable at $6.54 with a five-year term. The company granted the underwriter a 45-day option to purchase up to 15% additional shares and warrants. Proceeds will fund clinical trials, research and development, intellectual property development, and working capital. Ladenburg Thalmann & Co. is acting as sole bookrunning manager.
Autonomix Medical (NASDAQ: AMIX) reported Q2 FY2025 financial results and clinical progress. The company's ongoing proof-of-concept trial for pancreatic cancer pain showed promising results, with 83% pain reduction and 100% of lead-in patient responders achieving zero opioid use at 4-6 weeks post-procedure. Trial enrollment reached 60%, with a 79% responder rate among first 15 patients. The company reported a net loss of $2.8 million for Q2, with cash position of $5.2 million as of September 30, 2024. R&D expenses increased to $1.2 million, primarily due to clinical trial costs. Autonomix expects to complete trial enrollment by end of 2024 and aims for potential FDA clearance in 1H 2027.
Autonomix Medical (NASDAQ: AMIX) reported positive results from its proof-of-concept clinical trial for pancreatic cancer pain treatment. The trial, with 60% enrollment completed (15 patients), showed a 79% responder rate among treated patients. Key findings at 7 days post-procedure include a mean 4.96 reduction in VAS pain scale scores (63% reduction), zero opioid use after 24 hours, and 66% improvement in overall health status. Femoral access patients showed significant improvement while brachial access patients showed no improvement. The trial will enroll a total of 20 patients, using the company's catheter-based microchip sensing technology for nerve detection and RF ablation.
Autonomix Medical (NASDAQ: AMIX) announced positive 4-6 week follow-up data from the first five lead-in patients in their ongoing proof-of-concept human clinical trial. The study evaluates the safety and effectiveness of their transvascular energy delivery system for ablating problematic nerves to reduce pain in pancreatic cancer patients. Dr. Robert Schwartz, Chief Medical Officer, discussed these results in a Virtual Investor 'What This Means' segment.
Autonomix Medical (NASDAQ: AMIX) reported positive preliminary results from its ongoing proof-of-concept human clinical trial evaluating nerve ablation technology for pancreatic cancer pain. The trial's initial 'lead-in' cohort showed significant pain reduction in responding patients, with VAS scores decreasing from 8.0 pre-procedure to 1.33 at 4-6 weeks post-procedure. Notably, all responding patients completely eliminated opioid use within 4-6 weeks. The trial revealed that patients treated with femoral access responded positively, while those with brachial access showed no improvement. The company's technology uses a catheter-based microchip sensing array with enhanced neural signal detection capability, followed by RF ablation for targeted nerve treatment.
Autonomix Medical (NASDAQ: AMIX) has announced its participation in a Virtual Investor 'What This Means' segment scheduled for October 30, 2024. During this virtual event, Dr. Robert Schwartz, the company's Chief Medical Officer, will present additional findings from the 4-6 week follow-up data of the first five 'lead-in' patients from their ongoing proof-of-concept human clinical trial. The company, which specializes in precision nerve-targeted treatments, will make the segment accessible through their platform.
Autonomix Medical, Inc. (NASDAQ: AMIX), a medical device company focused on advancing innovative technologies for diagnosing and treating nervous system diseases, has announced the release of a new CEO Corner segment on its website. The segment features Brad Hauser, CEO of Autonomix, discussing Pain Awareness Month and the company's efforts to address the significant unmet need in pancreatic cancer pain.
This CEO Corner segment, now available on the Autonomix website, highlights the company's commitment to addressing critical issues in pain management, particularly in the context of pancreatic cancer. The release of this segment demonstrates Autonomix's ongoing efforts to communicate its mission and progress to stakeholders and the public.
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