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THE WOODLANDS, TX - Autonomix Medical, Inc. (NASDAQ: AMIX), a medical device company with a market capitalization of $6.23 million, has announced the successful completion of its initial proof-of-concept (PoC 1) trial phase, which focused on treating severe pancreatic cancer pain through transvascular energy delivery. The trial met all its objectives, with significant pain reduction and a decrease in opioid use among patients. According to InvestingPro data, the company has shown strong momentum with a 24.63% return over the past week, despite its overall weak financial health score of 1.5.
The study enrolled 20 patients with severe abdominal pain due to unresectable pancreatic cancer. Of these, 19 were treated with the company’s catheter-based approach aimed at ablating nerves responsible for pain transmission. The results showed a statistically significant pain relief within 24 hours post-procedure, which was maintained at the 7-day and 4-6 week follow-ups.
Following the positive outcomes, Autonomix is set to begin a market expansion study (PoC 2) in the second quarter of 2025, targeting additional visceral cancers and earlier-stage pancreatic cancer. This phase aims to potentially double the addressable market beyond pancreatic cancer pain management. While the company maintains a healthy current ratio of 5.31, InvestingPro analysis indicates the company is quickly burning through cash, with negative EBITDA of $10.57 million in the last twelve months. Subscribers to InvestingPro can access 9 additional key financial insights about AMIX’s growth potential and market position.
The PoC 1 phase revealed that 100% of the patients who responded to the treatment had ceased opioid use at 7 days post-procedure, and 73% remained opioid-free at the 4-6 week follow-up. The procedure also demonstrated a strong safety profile, with no serious device or procedure-related adverse events reported.
Autonomix’s technology, which has not yet been cleared for marketing in the United States, is seen as a platform with potential applications across a range of diseases involving the nervous system, including cardiology, hypertension, and chronic pain management.
The company’s CEO, Brad Hauser, expressed optimism about the technology’s potential to improve quality of life and reduce pain in patients with various types of visceral cancers. The PoC 2 phase will continue to gather data to inform future clinical studies, with a focus on interventional cancer pain management applications.
This update is based on a press release statement from Autonomix Medical, Inc. The company cautions that some statements in the release are forward-looking and subject to risks and uncertainties. Autonomix does not undertake any duty to update any forward-looking statements except as required by law. For comprehensive analysis of AMIX’s financial health, valuation metrics, and growth prospects, investors can explore detailed reports and real-time updates available on InvestingPro.
In other recent news, Autonomix Medical, Inc. has made significant strides in its development of neuromodulation technologies. The company has been granted a new European patent for its systems that regulate organ and tumor growth, expanding its patent portfolio to over 80 issued patents. This development underlines Autonomix’s commitment to addressing conditions related to peripheral nerve bundles and pain management. The company is preparing to submit an Investigational Device Exemption (IDE) and initiate U.S. clinical trials in 2025 for its Sensing and RF Ablation System, targeting pancreatic cancer pain. Additionally, Autonomix has completed a key milestone in integrating the Apex 6 Radiofrequency Generator into its system, marking progress toward FDA approval. The company plans to start U.S. clinical studies in 2025 to secure a De Novo application for FDA approval, anticipated in 2026. Autonomix’s platform technology, featuring a catheter-based microchip sensing array, aims to enhance neural signal detection. While the technology remains investigational, early clinical results have shown promise in providing pain relief for pancreatic cancer patients.
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