NASDAQ: AMIX

We are initially developing our technology for the treatment of pain associated with pancreatic cancer, a disease where existing therapies, including opioid pharmacotherapy and neurolytic injections, may provide inconsistent relief and are associated with meaningful risks and undesirable side effects. We believe our platform may also have the potential to support additional applications, including other visceral pain conditions, hypertension, cardiovascular disease, and other nerve-related disorders. These potential applications remain under evaluation and will require further development and clinical validation.

Our Technology

Targeting the Peripheral Nervous System

The peripheral nervous system consists of an extensive network of nerve fibers that extend throughout the body and interact with virtually every organ. These nerves can be broadly categorized into autonomic (regulating involuntary functions such as heart rate, blood pressure, and organ control) and somatosensory (transmitting sensory information such as pain). Whether as a root cause or as part of disease manifestation, the peripheral nervous system plays a role in nearly all major disease states.

We believe there are currently very few tools capable of effectively sensing and targeting nerve fibers within the peripheral nervous system. While our Company name reflects the autonomic subgroup of the peripheral nervous system, our technology is intended to address both autonomic and somatosensory pathways, with potential future applications in the central nervous system.

The Vascular Pathway Approach

Our system is catheter-based, enabling delivery of sensing and therapeutic components through the vascular system. Because many peripheral nerves run in close proximity to blood vessels, effectively creating a "vascular superhighway" of access to neural structures throughout the body, our system can reach nerve targets via arteries and is typically introduced through the femoral or brachial artery using standard interventional techniques.

We believe this transvascular approach may offer meaningful advantages over existing percutaneous techniques such as neurolytic celiac plexus blockade ("NCPB"), including improved access, procedural safety, and greater control over therapeutic targeting. Once positioned adjacent to target nerve fibers, the system is intended to detect neural signals through the vessel wall and enable objective confirmation of successful denervation.

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The Sensing Problem

While catheter-based approaches have long been used in cardiovascular procedures, their broader application to the peripheral nervous system has been limited by the lack of sufficiently sensitive sensing technologies. Existing electrophysiology systems can detect cardiac signals in the range of 10 to 15 microvolts, which is sufficient for cardiology applications where signals are relatively strong (approximately 100 microvolts). However, peripheral nerve signals are significantly weaker, typically in the range of 1 to 2 microvolts, making them difficult or impossible to detect with current systems.

Additionally, electrical signals from the body are analog, and even though a 10-millivolt signal can be detected and transmitted the roughly seven feet to processing equipment outside the body, this is not feasible with the typical 10 to 500 microvolt signal from a peripheral nerve. Given noise from other signals and equipment in the catheter lab, as well as signal degradation over the distance traveled, these faint signals become lost before reaching conventional processing equipment. As a result, transvascular nerve ablation procedures, including renal denervation for hypertension, are currently being performed "blind" without direct visualization of the target nerve and rely on indirect methods and anatomical assumptions that can lead to inconsistent outcomes and increased risk of unintended tissue damage.

The Autonomix Solution

We believe this challenge requires a fundamentally different technological approach. Autonomix is developing a system that incorporates a proprietary sensing architecture combining a micro-scale electrode antenna with a 1x2 mm microchip positioned directly at the site of signal detection and immediately adjacent to the sensing electrodes. This "at-source" processing enables amplification and digitization of neural signals before they can degrade over distance.

The catheter architecture consists of 8-splines, each carrying five electrodes that are mounted on an expandable balloon. When the balloon is inflated, the 8-splines deploy radially and press the electrode array against the inner vessel wall, achieving circumferential contact across all 16-channels simultaneously. This geometry is specifically designed to maximize the electrode surface area in contact with the vessel wall, ensuring the signals from structures surrounding the vessel are captured from all positions. The expanded electrode count and expandable spline-based geometry provide spatial coverage, higher sensitivity, and 360-degree multichannel signaling.

We believe this architecture may enable clinicians to precisely localize target nerves, improve procedural accuracy and consistency, reduce unintended tissue damage, and objectively confirm treatment success in a way that is not currently achievable.

Sense, Treat, Verify Two-Catheter System

Our system is being developed to support a "sense, treat, verify" workflow. The platform currently comprises two distinct components used together in a single procedure:

● Sensing Catheter: A proprietary microchip-enabled catheter that can detect, differentiate, and geolocate peripheral nerve signals in real time from within the vasculature. Our microchip-enabled catheter incorporates a miniaturized basket antenna array connected to a proprietary microchip that amplifies, digitizes, and wirelessly transmits neural signal data for clinician review; and

● RF Ablation Catheter: A separate catheter designed to deliver targeted radiofrequency energy to ablate specific nerve tissue identified by the sensing catheter. Once sensing confirms nerve localization, the ablation catheter is used to treat the target. Sensing is then used to confirm that the intended nerve signal has been successfully interrupted.

In the near term, sensing and RF ablation will be delivered via two separate catheter systems used together in a single procedure. Our longer-term intention is to integrate these capabilities into a single device capable of identifying target nerves, delivering therapy, and confirming treatment success within a single minimally invasive procedure. We believe that commercial success can be achieved with either the standalone sensing or ablation system and is not dependent on full integration, although integration may represent the optimal long-term solution.

It is important to note that our clinical proof-of-concept studies conducted to date utilized commercially available RF generators and ablation catheters to deliver therapeutic energy, while our proprietary sensing catheter and RF ablation catheter were in parallel development. These procedures were therefore conducted without the benefit of our sensing system, which has not yet been cleared for use in humans. These studies were designed to generate clinical learnings and procedural knowledge to inform the design of our planned U.S.-based Investigational Device Exemption ("IDE") clinical trials, which will incorporate our proprietary devices.

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Focus on Pancreatic Cancer Patients

We believe our technology has the potential to meaningfully advance the precision and clinical utility of treating peripheral nervous system disorders. If validated, we believe this platform could support a wide range of applications across multiple disease states. That said, our experience suggests that the most effective way to develop and commercialize a novel technology is through a focused, indication-driven approach. For these reasons, we are initially targeting the treatment of pain associated with pancreatic cancer and have aligned our development and commercialization strategy around this as our first proposed indication for use.

Significant Unmet Need

According to a report by The Oncologist titled "Pancreas Cancer-Associated Pain Management" (April 2021), pain is highly prevalent in patients with pancreatic cancer. Approximately 90% of patients discussed pain with their health care provider and 50% reported emergency room visits related to pain symptoms. The severe, persistent pain associated with tumor progression can significantly diminish the quality of patients' remaining time and may impact their overall well-being and willingness to continue treatment.

The current standard of care begins with non-opioid medications (acetaminophen, NSAIDs) and progresses to opioid pharmacotherapy when initial approaches fail. Long-term opioid use is associated with tolerance, dependency, and systemic side effects that can ultimately outweigh the benefits. NCPB is the most common alternative interventional approach and involves percutaneous injection of ethanol guided by imaging to ablate nerve fibers associated with the pancreatic tumor. However, the complex anatomy of the abdomen creates the potential for the neurolytic agent to miss the intended target or migrate to unintended areas. A meta-analysis published in the American Journal of Gastroenterology (2007, Vol. 102, p. 430-438) suggests that NCPB benefits may be only marginally better than opioids and may not outweigh the risks, which can include bowel perforation, intra-abdominal hemorrhage, paralysis, and death.

In contrast, we believe our procedure has the potential to offer a safer, more precise, and more reliable treatment option by accessing the target anatomy via the arterial system, providing the clinician with a clear anatomical targeting window directly adjacent to the specific nerves responsible for transmitting pain signals, offering the potential for a durable, procedure-based solution rather than ongoing systemic therapy and enabling objective confirmation of denervation which substantially reduces placebo influence on pain outcomes.

Efficient Clinical Development Pathway

Despite the significant unmet need, there are relatively few clinical trials worldwide focused on improving pain management for pancreatic cancer patients and we are not aware of any proposed or currently active trials at the location of our proof-of-concept study site. We believe this limited competitive landscape may facilitate patient recruitment and support clinical execution.

Given the palliative nature of this indication, we believe regulatory authorities may be willing to consider more streamlined clinical development pathways with smaller, more focused study designs. We currently anticipate that each patient will require a single treatment followed by periodic follow-up visits and that initial indications of efficacy may be observed relatively soon after treatment. However, such determinations are solely within the discretion of the applicable regulatory authorities and there can be no assurance that our proposed trial designs will be accepted.

Meaningful Commercial Market

Although pancreatic cancer is classified as a rare disease, it represents a meaningful commercial opportunity. According to the American Cancer Society, approximately 64,000 new cases of pancreatic cancer were diagnosed annually in the United States as of 2023. Annual new cases in the European Union exceeded 100,000 in 2019 and continue to grow (International Journal of Cancer, 2021). Market analyses estimate the global pancreatic cancer treatment market was approximately $2.2 billion in 2022. Certain existing therapies, such as Abraxane, can exceed $10,000 per month in cost, which we believe highlights the magnitude of potential market size, though this should not be taken to imply future pricing for our procedure.

We also note that pancreatitis, a non-cancerous condition also associated with chronic abdominal pain, has an incidence estimated to be as much as three times that of pancreatic cancer. We believe if our technology is successfully developed and cleared for pancreatic cancer pain, it may be expanded to address pancreatitis and other related conditions.

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The Potential to Impact Cancer

Recent independent research suggests that neural pathways may play a role in cancer progression and metastasis. Published research has demonstrated that pancreatic tumors progressing to invade the liver do so by traveling along local neural pathways, leading to the hypothesis that disruption of these pathways could potentially slow or stop primary tumor progression. In collaboration with a pancreatic cancer specialist, we conducted a preclinical study in a mouse model evaluating whether ablation of nerve fibers surrounding the pancreas could impact tumor progression. Results of this study demonstrated a reduction in tumor progression. While this was a small, early-stage study and may not be indicative of results in humans, we believe these findings warrant further investigation and may represent a potential future application of our technology beyond pain management.

Platform Expansion Opportunity

We view pancreatic cancer pain management as an initial proof-of-concept for our broader platform. Potential future applications include:

● Other visceral cancers that transmit pain through the celiac plexus, such as gallbladder, liver, and bile duct cancers;

● Renal denervation for treatment-resistant hypertension;

● Chronic pain conditions, including lower back pain, joint pain, Complex Regional Pain Syndrome ("CRPS"), and pelvic pain; and

● Pulmonary, gastrointestinal, urological, and cardiovascular disorders.

A Markets and Markets report ("Electrophysiology Market Global Forecast to 2027", February 2023) estimates the global electrophysiology market at $6.8 billion in 2021 and growing to $11.6 billion by 2027, primarily driven by cardiology applications. We believe our technology has the potential to expand electrophysiology well beyond cardiology to address conditions throughout the peripheral nervous system, making the long-term opportunity substantially larger than current market projections for electrophysiology alone. We believe that enabling targeted transvascular treatment of pain may provide access to the approximately $75 billion pain management market and that our approach to renal denervation may enable access to the $23 billion hypertension market. When expanded to include indications such as COPD, irritable bowel syndrome, and overactive bladder, we believe our platform may have the potential to address more than $100 billion in aggregate market opportunities.

Clinical Development Program

During the fiscal year ended March 31, 2026, we advanced the clinical development program for our platform. In May 2025, we reported positive results from our initial proof-of-concept study ("PoC 1") in approximately 20 subjects with pancreatic cancer-related pain. As noted above, this study utilized commercially available RF generators and ablation catheters while our proprietary devices were in parallel development. Based on these findings, we initiated an expansion study ("PoC 2") designed to enroll an additional 20 subjects to evaluate the platform in a broader patient population, including other visceral cancer-related pain indications and patients with moderate or earlier-stage pancreatic cancer pain.

As the expansion study progressed, we observed that early clinical outcome signals in this broader cohort diverged from those seen inPoC 1 femoral access . In response to this variability, the decision was made to pause further enrollment under the existing study protocol to conduct a comprehensive evaluation and refine our clinical and procedural strategy. We believe differences in vascular access and anatomic targeting contributed to the observed inconsistencies in clinical outcomes. We view these findings as aligned with the objectives of a proof-of-concept program, which is designed in part to evaluate procedural approaches, optimize technique, and inform future study design.

Based on these insights, we have determined to reallocate resources toward further clinical validation of our RF ablation catheter, along with initial use of our sensing catheter technology, in patients with severe pancreatic cancer-related pain. We believe that focusing on this more targeted patient population and refined procedural approach will provide the most relevant data to support the design of our planned U.S.-based clinical trials, which are currently anticipated to commence in late 2026, subject to the receipt of sufficient new financing.

Subsequent to the end of our latest fiscal year, we submitted a revised clinical protocol reflecting these changes, which was approved by the relevant Ethics Committee on April 9, 2026. There can be no assurance that our revised clinical strategy will result in consistent or favorable outcomes in future studies or that our technology will ultimately receive regulatory approval or achieve commercial success.

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Regulatory Strategy

We believe the most appropriate regulatory pathway for our system is the U.S. Food and Drug Administration's ("FDA's") De Novo classification process, given the novel nature of our technology and the lack of a directly comparable predicate device. This pathway differs from the more common 510(k) process, which requires a substantially equivalent predicate. It also differs from the more rigorous Premarket Approval ("PMA") pathway, which is typically reserved for high-risk devices with no prior precedent or those requiring extensive clinical validation. While sensing and ablation technologies are individually well-established, we are not aware of any existing device that combines our level of neural signal sensitivity with the specific clinical applications we are pursuing.

We elected to conduct our first-in-human study program outside of the United States, where we believe the regulatory requirements for off-label use of CE-marked devices may be less burdensome in certain jurisdictions. Our first-in-human has been established, and we believe there are compelling reasons to prioritize U.S. regulatory approval, including generally higher reimbursement levels and the ability to deploy a unified commercial strategy across a single regulatory framework.

We are engaging with the FDA through the pre-submission process as we work toward initiating our U.S.-based IDE clinical trials. Our planned regulatory pathway includes:

● First-in-Human Feasibility Study - a small, single-site study to establish initial safety and procedural learnings with our proprietary devices;

● Pivotal Clinical Trial - a larger, multi-centered study to generate the clinical evidence required to support regulatory submissions; and

● De Novo submission - to the FDA.

Our first two studies in our proof-of-concept program were designed to provide key learnings and procedural knowledge going into our FDA clinical trials and planned regulatory pathway. Based on our current expectations, regulatory clearance could potentially occur in the 2028 timeframe; however, this timeline is subject to significant uncertainty and is not guaranteed.

Commercialization Strategy

Commercial Launch Approach

We currently plan to initiate commercialization through a controlled launch, potentially targeting a limited number of regions or Key Opinion Leaders ("KOLs") to refine and optimize the commercial strategy prior to national and global deployment. Our commercialization approach may include either a standalone commercial launch or a strategic partnership or licensing arrangement with a larger industry participant. Our management team has experience executing both independent and partnered commercialization strategies.

Our system is designed to integrate into existing catheter-based workflows, utilizing techniques already familiar to interventional radiologists and cardiologists. We believe this compatibility may reduce training requirements and support clinical adoption.

Revenue Model

We envision a procedure-based revenue model primarily driven by the recurring income of single-use disposable catheters used in hospital catheter labs with revenue volume expected to closely track procedural volume. Our system is expected to consist of four primary components:

● Disposable sensing catheter;

● RF ablation catheter designed to access peripheral nerves;

● RF energy generator to power our customer RF ablation catheter; and

● Software-based user interface for data visualization and system control.

Designed to fit current hospital workflows, this modular platform is expected to minimize capital equipment needs, shorten procurement cycles, and require minimal training for interventionalists to accelerate adoption and utilization. Our selection of RF energy is based on its well-established clinical use and regulatory familiarity with the FDA. We also envision multiple additional revenue pathways, including deployment as a standalone sensing technology for diagnostic use and an integrated sensing and ablation system addressing a broad range of conditions.

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Manufacturing and Development

We currently rely on third-party manufacturers for device production and expect to continue doing so for commercial-scale manufacturing. Our sensing system is currently in prototype form and is hand-built using a combination of custom-fabricated and 3D-printed components. We have not yet assembled or tested a fully commercial version of our proposed device. Even if our proposed device receives regulatory clearance, there is no guarantee that we will be able to successfully manufacture it at scale.

We believe one of the most significant challenges in our commercialization plan will be scaling our current sensing prototype into a robust, manufacturable commercial product. We are actively developing a more robust version suitable for clinical and commercial use; however, scaling production presents significant technical and operational challenges. Our dependency on third-party supply and manufacturing partners to supply the materials and components for our research and development, preclinical, and clinical trial devices represents a risk to our development timelines.

Intellectual Property

Patents and Patent Applications

We hold an extensive and diverse patent portfolio with 18 patent families covering various proprietary medical device systems, methods, and technologies related to nerve modulation, tissue treatment, organ function regulation, cancer therapy, and diagnostic systems. The portfolio is comprised of 75 issued patents and 37 pending patent applications, which were originated by our co-founders, Mr. Landy Toth and/or Dr. Robert Schwartz, with original filing dates ranging from 2012 through 2024 and expiration dates ranging from 2033-2039. Patent coverage spans major medical technology markets to ensure commercial protection with patents issued in the United States, Europe (multiple national ratifications including Unitary Patent), Canada, Australia, China, India, Japan, Mexico, and Singapore.

Our patent families cover distinct inventive areas including the following:

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Controlled Sympathectomy and Micro-Ablation Systems and Methods - the foundational patent family; issued in the U.S., Europe (France, Germany, Ireland, Netherlands and UK), Canada and Mexico; expirations from 2033–2035;

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Endoscopic Sympathectomy Systems and Methods - issued in the U.S., Europe (France, Germany and UK) and Canada; expiring 2033;

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Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder - issued in the U.S., Europe (France, Germany, Ireland, Netherlands and UK), Canada, Japan, and Singapore; expirations from 2033–2034;

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Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall - issued in the U.S., Europe (France, Germany and UK) and Canada; expirations from 2033–2034;

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Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development - issued in the U.S. and Canada; expirations from 2034–2036;

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Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification - issued in the U.S., Europe (France, Germany and UK) and Canada; expirations from 2034–2035;

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Systems and Methods for Treating Cancer and/or Augmenting Organ Function - issued in the U.S. and Canada; expirations from 2034–2035;

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ANS Assessment Systems, Kits, and Methods - issued in the U.S., Europe (Unitary Patent, Ireland and UK) and Canada; expirations from 2035–2037;

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Controlled and Precise Treatment of Cardiac Tissues - issued in the U.S. and Europe (Unitary Patent); covers systems and methods for feedback-driven neuromodulation, denervation, and ablation of cardiac tissues; expirations from 2036–2039;

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Medical Devices with Circuitry for Capturing and Processing Physiological Signals - issued in the U.S. and Europe (Unitary Patent, Ireland and UK); covering microchip-enabled signal capture architectures; expirations from 2038–2039;

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Elongated Conductors and Methods of Making and Using the Same - issued in the U.S. and Europe (Unitary Patent and UK); covering catheter conductor design; expirations 2036; and

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Smart Torquer and Methods of Using the Same - issued in the U.S. and Europe (Unitary Patent, Ireland and UK); covering catheter navigation components; expirations from 2036–2037.

Management views the IP portfolio as a key strategic asset supporting our competitive positioning and long-term platform value.

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Trademarks

We have one registered trademark for the mark “AUTONOMIX” in the United States, Australia, China, the European Union, India, Japan, Mexico, and Singapore. The registrations of these trademarks are effective for varying periods of time and may be renewed periodically provided we comply with all applicable renewal requirements, including, where necessary, the continued use of the trademarks in the applicable jurisdictions in connection with certain goods and services.

Competition

We operate in highly competitive, innovation-driven markets: electrophysiology and interventional pain management, both dominated by large medtech players with sophisticated portfolios, substantially greater resources and challenged by emerging innovators. These industry leaders include Medtronic, Johnson & Johnson, Abbott and Boston Scientific.

While the current standards of care for treating pancreatic cancer pain are comprised largely of generic drugs and injections, we are not aware of any person or company working on a transvascular sensing and ablation method for treating this indication. Although competitors like Medtronic are expanding the use of transvascular ablation techniques, we are not aware of anyone developing a sensing technology similar in capability to ours.

Recent tests using Endoscopic Ultrasound-Guided Ablation to treat pancreatic cancer pain have claimed outcomes that may be better than NCPB; however, this is still a percutaneous technique that we believe involves similar inherent risks of infection and internal damage. We believe these risks are significantly reduced using a transvascular approach such as our technology.

Regulation of our Business

Our products are subject to extensive regulation by the FDA under the Federal Food, Drug, and Cosmetic Act ("FDCA") and its implementing regulations, guidance documentation, and standards. Our sensing and RF ablation systems are regulated by the FDA as medical devices. The FDA regulates the design, development, research, testing, manufacturing, safety, labeling, storage, record-keeping, promotion, distribution, sale, and advertising of medical devices in the United States. The FDA also regulates the export of medical devices manufactured in the United States to international markets. Any violations of these laws and regulations could result in a material adverse effect on our business.

Our current products are Class II device candidates and will require submission of a premarket notification or De Novo request prior to commercial distribution in the United States. We must also comply with applicable foreign regulatory requirements for distribution outside the United States.

Unless an exemption applies, before we can commercially distribute medical devices in the United States, we must obtain, depending on the type of device, either prior premarket clearance or DeNovo submission from the FDA. The FDA classifies medical devices into one of three classes:

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Class I devices, which are subject to only general controls (e.g., labeling, medical devices reporting, and prohibitions against adulteration and misbranding) and, in some cases, to the premarket clearance requirements;

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Class II devices, generally requiring premarket clearance before they may be commercially marketed in the United States; and

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Class III devices, consisting of devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed not substantially equivalent to a predicate device, generally requiring submission of a PMA supported by clinical trial data.

510(k) Clearance Pathway

When a 510(k) clearance is required, we must submit a premarket notification demonstrating that our proposed device is substantially equivalent to a previously cleared 510(k) device or a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of PMAs. By regulation, the FDA is required to clear or deny a 510(k) premarket notification within 90 days of submission of the application. As a practical matter, clearance may take longer. The FDA may require further information, including clinical data, to make a determination regarding substantial equivalence.

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Any modification to a 510(k)-cleared device that would constitute a major change in its intended use, or any change that could significantly affect the safety or effectiveness of the device, requires a new 510(k) clearance and may even, in some circumstances, require a PMA, if the change raises complex or novel scientific issues or the product has a new intended use. The FDA requires every manufacturer to make the determination regarding the need for a new 510(k) submission in the first instance, but the FDA may review any manufacturer's decision.

PMA Pathway

A PMA must be submitted to the FDA if the device cannot be cleared through the 510(k) process. A PMA must be supported by extensive data, including but not limited to, technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the FDA's satisfaction the safety and effectiveness of the device for its intended use. During the review period, the FDA will typically request additional information or clarification of the information already provided. Also, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. The FDA may or may not accept the panel's recommendation. In addition, the FDA will generally conduct a pre-approval inspection of the manufacturing facility or facilities to ensure compliance with the QSRs.

New PMAs or PMA supplements are required for modifications that affect the safety or effectiveness of the device, including, for example, certain types of modifications to the device's indication for use, manufacturing process, labeling and design. PMA supplements often require submission of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel.

DeNovo Classification

Medical device types that the FDA has not previously classified as Class I, II or III are automatically classified into Class III regardless of the level of risk they pose. The FDA Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo classification procedure. This procedure allows a manufacturer whose novel device is automatically classified into Class III to request down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA application. Prior to the enactment of the FDA Safety and Innovation Act of 2012, or the FDASIA, a medical device could only be eligible for de novo classification if the manufacturer first submitted a 510(k) premarket notification and received a determination from the FDA that the device was not substantially equivalent. FDASIA streamlined the de novo classification pathway by permitting manufacturers to request de novo classification directly without first submitting a 510(k) premarket notification to the FDA and receiving a not substantially equivalent determination. Under FDASIA, the FDA is required to classify the device within 120 days following receipt of the de novo application. If the manufacturer seeks reclassification into Class II, the manufacturer must include a draft proposal for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device. In addition, the FDA may reject the reclassification petition if it identifies a legally marketed predicate device that would be appropriate for a 510(k) or determines that the device is not low to moderate risk or that general controls would be inadequate to control the risks and special controls cannot be developed.

Clinical Trials

Clinical trials are generally required to support a PMA application and are sometimes required for 510(k) or DeNovo clearance. Such trials generally require an investigational device exemption application, or IDE, approved in advance by the FDA for a specified number of patients and study sites, unless the product is deemed a nonsignificant risk device eligible for more abbreviated IDE requirements. Clinical trials are subject to extensive monitoring, record keeping and reporting requirements. Clinical trials must be conducted under the oversight of an institutional review board, or IRB, for the relevant clinical trial sites and must comply with FDA regulations, including but not limited to those relating to good clinical practices. To conduct a clinical trial, we also are required to obtain the patients' informed consent in form and substance that complies with both FDA requirements and state and federal privacy and human subject protection regulations. We, the FDA or the IRB could suspend a clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits. Even if a trial is completed, the results of clinical testing may not adequately demonstrate the safety and efficacy of the device or may otherwise not be sufficient to obtain FDA approval to market the product in the U.S. Similarly, in Europe the clinical study must be approved by a local ethics committee (EC) and in some cases, including studies with high-risk devices, by the ministry of health in the applicable country.

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Pervasive and Continuing Regulation

After a device is placed on the market, numerous regulatory requirements apply. These include:

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Product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action;

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Quality System Regulation, or QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;

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labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;

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clearance of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use of one of our cleared devices;

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approval of product modifications that affect the safety or effectiveness of one of our approved devices;

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medical device reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur;

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post-approval restrictions or conditions, including post-approval study commitments;

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post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device;

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the FDA's recall authority, whereby it can ask, or under certain conditions order, device manufacturers to recall from the market a product that is in violation of governing laws and regulations;

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regulations pertaining to voluntary recalls; and

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notices of corrections or removals.

Advertising and promotion of medical devices, in addition to being regulated by the FDA, are also regulated by the Federal Trade Commission and by state regulatory and enforcement authorities. Recently, promotional activities for FDA-regulated products of other companies have been the subject of enforcement action brought under healthcare reimbursement laws and consumer protection statutes. In addition, under the federal Lanham Act and similar state laws, competitors and others can initiate litigation relating to advertising claims. In addition, we are required to meet regulatory requirements in countries outside the U.S., which can change rapidly with relatively short notice. If the FDA determines that our promotional materials or training constitutes promotion of an unapproved use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions.

Furthermore, our products could be subject to voluntary recall if we or the FDA determine, for any reason, that our products pose a risk of injury or are otherwise defective. Moreover, the FDA can order a mandatory recall if there is a reasonable probability that our device would cause serious adverse health consequences or death.

The FDA has broad post-market and regulatory enforcement powers. Once we have a marketed product, we will be subject to unannounced inspections by the FDA to determine our compliance with the QSR and other regulations, and these inspections may include the manufacturing facilities of some of our subcontractors. Failure by us or by our suppliers to comply with applicable regulatory requirements can result in enforcement action by the FDA or other regulatory authorities, which may result in sanctions including, but not limited to:

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untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;

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unanticipated expenditures to address or defend such actions

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customer notifications for repair, replacement, refunds;

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recall, detention or seizure of our products;

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operating restrictions or partial suspension or total shutdown of production;

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refusing or delaying our requests for premarket clearance or premarket approval of new products or modified products;

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operating restrictions;

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withdrawing premarket clearances or PMA approvals that have already been granted;

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refusal to grant export approval for our products; or

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criminal prosecution.

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Glossary

Unless we otherwise indicate, or unless the context requires otherwise, any references in this Annual Report on Form 10-K to the following medical terms have the respective meanings set forth below:

ablation: the removal or destruction of a body part or tissue or its function. This is often conducted with energy-based devices utilizing radio frequency or pulsed electrical field energy.

catheter: a thin tube made from medical grade materials serving a broad range of functions; catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure.

celiac plexus: also known as the solar plexus because of its radiating nerve fibers, is a complex network of nerves located in the abdomen, near where the celiac trunk, and other arteries branch from the abdominal aorta.

electrophysiology: the branch of physiology that deals with the electrical phenomena associated with nervous and other bodily activity.

hypertension: high blood pressure.

microvolt: one millionth of a volt.

transvascular: across the wall of a blood vessel (or similar vessel).

Available Information

Our Internet address is www.autonomix.com. On this website, we post the following filings as soon as reasonably practicable after they are electronically filed with or furnished to the U.S. Securities and Exchange Commission (“SEC”): our Annual Reports on Form 10-K; our Quarterly Reports on Form 10-Q; our Current Reports on Form 8-K; our proxy statements related to our annual stockholders’ meetings; and any amendments to those reports or statements. All such filings are available on our Web site free of charge. The charters of our audit, nominating and governance and compensation committees and our Code of Business Conduct and Ethics Policy are also available on our Web site and in print to any stockholder who requests them. The content on our Web site is not incorporated by reference into this Annual Report on Form 10-K.