THE WOODLANDS, TX - Autonomix Medical, Inc. (NASDAQ: AMIX), a medical device company, announced preliminary results from an ongoing clinical trial indicating significant pain reduction in pancreatic cancer patients. The trial, focused on a transvascular nerve ablation procedure, has shown promising outcomes in its early stages.
The initial phase involved five "lead-in" patients, who, according to Autonomix CEO Brad Hauser, have experienced a substantial decrease in pain from a score of 8 to 1.33 on the Visual Analog Scale (VAS) at 4-6 weeks post-procedure. This group of patients, previously reliant on opioids for pain management, reported an 83% reduction in pain.
The study's preliminary data revealed that all patients who underwent the procedure through femoral access responded positively, while those treated with brachial access did not show improvement in pain scores. The responder group, comprising 60% of the patients, experienced clinically meaningful pain relief, with 66% reporting a VAS score of 0 or 1.
Despite the growth of their pancreatic cancer tumors, the patients in the responder group felt pain relief as early as one day post-procedure. The total treated population, including non-responders, reported a 65% mean reduction in pain scores.
Autonomix has amended the trial protocol to collect additional data and has redefined severe pain for inclusion criteria. The company aims to enroll 20 more patients by the end of the year, with patient screening under the revised protocol commencing in May 2024.
The company's technology utilizes a catheter-based microchip sensing array antenna for nerve detection, which is touted to be significantly more sensitive than existing technologies. This innovation is part of Autonomix's broader goal to revolutionize treatments for conditions involving the nervous system.
The trial's primary objective is to evaluate the success rate of nerve ablation for pain mitigation in pancreatic cancer patients. Secondary objectives include assessing adverse events and changes in pain levels and quality of life post-procedure.
The information in this article is based on a press release statement from Autonomix Medical, Inc. The company's technology is investigational and has not yet been cleared for marketing in the United States.
In other recent news, Autonomix Medical, Inc. has licensed RF Innovations' Apex 6 Radiofrequency Generator technology. The deal, completed for an undisclosed sum, provides Autonomix with a perpetual, worldwide license to this FDA-cleared technology aimed at pain management. This technology will be integrated into Autonomix's system, which is being developed to address pancreatic cancer-related pain.
Furthermore, Autonomix has announced leadership changes with Brad Hauser stepping in as the new CEO, and former CEO Lori Bisson transitioning to Executive Vice Chairman of the Board. This shift is expected to drive the next phase of growth for the company.
The company also received Ethics Committee approval for a protocol amendment in its human clinical trial, which seeks to alleviate pancreatic cancer pain through transvascular nerve ablation. In addition, Autonomix has partnered with NoiseFigure Research, Inc. to enhance its ASIC microchip, a key component of its technology for diagnosing and treating neural-related conditions.
Autonomix also announced preliminary results from its clinical trial focused on treating pancreatic cancer pain through radiofrequency ablation. The early findings showed a significant reduction in pain and improvement in quality of life for the initial patients. These are recent developments in Autonomix's constant commitment to advancing its technology and improving treatments for neurological disorders.
InvestingPro Insights
As Autonomix Medical, Inc. (NASDAQ: AMIX) reports promising clinical trial results, the company's financial health and stock performance provide additional context for investors. According to InvestingPro data, AMIX currently has a market capitalization of $18.38 million. Despite the potential of their medical technology, the company has not been profitable over the last twelve months, with an operating income of approximately -$9.36 million. This is reflected in a negative P/E ratio of -0.59, indicating that the company is yet to generate positive earnings per share.
InvestingPro Tips highlight that while AMIX holds more cash than debt, suggesting some financial resilience, the company is quickly burning through its cash reserves. This could be a concern for investors as the company continues to fund its clinical trials and research. Additionally, the stock has experienced significant price volatility, with a notable 19.1% return over the last week, yet a 73.39% decline over the last six months. This level of volatility may attract some investors looking for short-term gains, but it also indicates a higher risk profile.
For those considering an investment in Autonomix Medical, it's worth noting that the company does not currently pay a dividend to shareholders, which may influence the decision-making of income-focused investors. However, for those interested in the long-term potential of Autonomix's nerve ablation technology for pain mitigation, the InvestingPro platform offers additional insights, with a total of 12 InvestingPro Tips available to help assess the company's prospects. The current fair value estimations from InvestingPro analysts stand at $1.4 USD, while the InvestingPro Fair Value is slightly lower at $0.89 USD, providing a range of perspectives on the stock's potential value.
As the company continues to advance its clinical trials and refine its innovative medical technology, the financial metrics and market performance of AMIX will remain key factors for investors to monitor.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.