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Autonomix Medical, Inc. Granted U.S. Patent Covering Sensing Data Collection and Processing with Company’s Proprietary Catheter-Based Technology

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Autonomix Medical (NASDAQ: AMIX) has been granted U.S. patent 12,217,863 by the USPTO for its medical devices with circuitry for capturing and processing physiological signals. The patent protects the company's proprietary technology for real-time physiological monitoring across various applications including heart mapping, arterial mapping, and nervous system monitoring.

The company's innovative platform features a catheter-based microchip sensing array antenna that can detect neural signals with up to 3,000 times greater sensitivity than current technologies. Combined with proprietary RF ablation technology, it enables precise targeting and elimination of overactive nerves.

Autonomix plans to submit an IDE and begin U.S. clinical trials in 2025 to commercialize their Sensing and RF Ablation System for treating pancreatic cancer pain. The company's patent portfolio now includes over 80 issued patents and 40 pending applications.

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Positive

  • Secured new U.S. patent protection for core technology
  • Technology demonstrates 3,000x greater sensitivity in neural signal detection
  • Extensive IP portfolio with 80+ issued patents
  • Early clinical results showing promise in pancreatic cancer pain reduction
  • Multiple potential commercial applications across different medical fields

Negative

  • Product still requires FDA approval with clinical trials not yet started
  • Commercialization timeline extends into 2025 and beyond
  • Faces competition from established pain management treatments

Insights

Autonomix Medical's newly granted U.S. patent (12,217,863) strengthens the company's intellectual property foundation for its neural sensing and processing technology. This patent specifically protects the company's methods for collecting and processing sensing data for real-time physiological monitoring across multiple applications including heart mapping and neural monitoring.

With this addition, Autonomix has built a substantial IP portfolio of over 80 issued patents and 40 pending applications, creating significant barriers to entry in their specialized field. For a micro-cap company with a $4.7 million market valuation, robust patent protection is an essential asset that could drive future partnership opportunities or acquisition interest.

The company's planned IDE submission and clinical trials in 2025 for pancreatic cancer pain treatment establishes a concrete development pathway, though investors should recognize that revenue remains years away. The technology's potential applications across multiple high-value indications including cancer pain management and hypertension suggests substantial addressable markets if successfully developed.

While patent grants don't guarantee commercial success, this intellectual property protection is strategically important as the company progresses toward clinical validation of its technology that reportedly offers 3,000 times greater sensitivity than existing alternatives.

The technological capabilities protected in Autonomix's newly patented system represent a potentially significant advancement in neural intervention precision. Current technologies for neural signal detection lack the sensitivity necessary for many therapeutic applications, particularly in areas with complex innervation.

The company's catheter-based microchip sensing array technology claims 3,000-fold greater sensitivity in neural signal detection compared to existing technologies. This enhanced precision could fundamentally change how physicians target overactive nerves in multiple conditions.

Particularly noteworthy is the integrated approach combining both sensing and ablation capabilities in a single platform. This enables a "sense, treat, and verify" methodology that could significantly improve procedural outcomes compared to current less-targeted approaches.

The initial focus on pancreatic cancer pain addresses a significant unmet need. Pancreatic cancer patients often suffer from severe pain poorly managed by current options, which primarily rely on opioids with their associated limitations and side effects, or invasive ethanol injections.

The expansion potential into hypertension and broader cardiovascular applications represents substantial market opportunities beyond oncology. The ability to precisely target specific neural pathways involved in blood pressure regulation could potentially address a condition affecting hundreds of millions worldwide that often requires lifetime medication.

Continued progress with growing global patent portfolio to over 80 issued patents and 40 pending patent applications 

Proprietary sensing and ablation technology has demonstrated potential to more precisely target and eliminate overactive nerves, improving response rates and enhancing patient outcomes across multiple indications

THE WOODLANDS, TX, March 20, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. patent 12,217,863 (‘863 patent) titled, Medical Devices with Circuitry for Capturing and Processing Physiological Signals. The issued ‘863 patent gives Autonomix protection of proprietary technology used to collect and process sensing data for real-time physiological monitoring with broad application use that includes, e.g., heart mapping, arterial mapping, parenchymal monitoring, central nervous system monitoring and implant, robotic and wearable precision applications.

“We are pleased to strengthen our patent protection for this potential groundbreaking technology. The continued positive data on its application, efficacy, and safety reinforce our confidence in its potential. We remain committed to advancing this innovation to address critical areas of unmet medical need. To date, our early clinical results have been highly encouraging for reducing pancreatic cancer pain. Beyond cancer pain, our technology holds promise for a broad range of conditions where nerve activity plays a key role, including hypertension within the cardiovascular space,” commented Brad Hauser, CEO of Autonomix.

Autonomix’s first-in-class technology platform utilizes a catheter-based microchip sensing array antenna that may have the ability to detect and differentiate neural signals with up to 3,000 times greater sensitivity than currently available technologies. Once target nerves are identified, Autonomix uses its proprietary RF ablation technology to kill targeted nerves, enabling a precision guided sense, treat and verify approach to addressing a number of disease categories from chronic pain management to hypertension and cardiology. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects.

The Company expects to submit an IDE and commence U.S. clinical trials in 2025 to support a labeling indication to commercialize the Autonomix Sensing and RF Ablation System in the U.S. as a treatment for pancreatic cancer pain.

For more information about the Company’s technology, please visit autonomix.com.

About Autonomix Medical, Inc.

Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with up to 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.

We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.

For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.

Forward Looking Statements

Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential of the technology to treat cancerous tumors and the pain associated with pancreatic cancer, to submit and receive approval of an IDE, and to file a De Novo application. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.”

Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 31, 2024, and from time to time, our other filings with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.

Investor and Media Contact

JTC Team, LLC
Jenene Thomas
908.824.0775
autonomix@jtcir.com


FAQ

What is the significance of Autonomix Medical's (AMIX) new U.S. patent 12,217,863?

The patent protects Autonomix's proprietary technology for collecting and processing sensing data in real-time physiological monitoring, applicable to heart mapping, arterial mapping, and nervous system monitoring.

How much more sensitive is AMIX's neural signal detection technology compared to existing solutions?

Autonomix's catheter-based microchip sensing array antenna can detect neural signals with up to 3,000 times greater sensitivity than currently available technologies.

When will AMIX begin clinical trials for their pancreatic cancer pain treatment system?

Autonomix plans to submit an IDE and commence U.S. clinical trials in 2025 for their Sensing and RF Ablation System.

What are the potential applications of AMIX's sensing and ablation technology?

The technology can be used for chronic pain management, hypertension treatment, cardiology applications, and various conditions where nerve activity plays a key role.

How many patents does Autonomix Medical currently hold in their portfolio?

Autonomix has over 80 issued patents and 40 pending patent applications in their global patent portfolio.
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