10q10k10q10k.net
Autonomix Medical, Inc.

Autonomix Medical, Inc.AMIX财报

Nasdaq · 医疗保健 · 外科及医疗仪器和设备

Autonomix Medical, Inc. is a medical technology firm that develops innovative minimally invasive diagnostic and therapeutic devices focused on cardiac electrophysiology applications. Its core offerings target improved detection and treatment of cardiac arrhythmias, serving healthcare providers and patients across North American and European healthcare markets, with a key focus on advancing care for rhythm-related heart conditions.

What changed in Autonomix Medical, Inc.'s 10-K — 2024 vs 2025

Top changes in Autonomix Medical, Inc.'s 2025 10-K

232 paragraphs added · 178 removed · 140 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

34 edited+13 added−10 removed128 unchanged
Item 1. Business Overview We are a development stage medical device development company focused on advancing innovative technologies for sensing and treating disorders relating to the nervous system. Our first-in-class technology platform includes a catheter-based microchip-enabled sensing array that can detect and differentiate neural signals with a high degree of sensitivity as demonstrated in animal studies.
Item 1. Business Overview We are a development-stage medical device company focused on advancing innovative technologies for sensing and treating disorders relating to the nervous system. Our first-in-class technology platform includes a catheter-based microchip-enabled sensing array that can detect and differentiate neural signals with a high degree of sensitivity as demonstrated in animal studies.
However, we believe if we successfully demonstrate that transvascular ablation is capable of mitigating pancreatic cancer pain, this would be a medical “first” and would represent an important breakthrough for the electrophysiology community. Likewise, we believe it will help support a request to the FDA to be granted “Breakthrough” status, which could accelerate our future commercialization efforts.
However, we believe if we successfully demonstrate that transvascular ablation is capable of mitigating pancreatic cancer pain, this would be a medical “first” and would represent an important breakthrough for the electrophysiology community. Likewise, we believe it could help support a request to the FDA to be granted “Breakthrough” status, which could accelerate our future commercialization efforts.
In addition, efficacy must be based on a sound scientific rationale and ultimately demonstrated in a human clinical trial. 10 Table of Contents Human trials are often designed to begin with a Proof of Concept (“PoC”); the US Food and Drug Administration (“FDA”) sometimes refers to these as Early Feasibility Studies (“EFS”) and then progress to a “Pivotal” or approval, trial.
In addition, efficacy must be based on a sound scientific rationale and ultimately demonstrated in a human clinical trial. 10 Table of Contents Human trials are often designed to begin with a Proof of Concept (“PoC”); the US Food and Drug Administration (“FDA”) sometimes refers to these as Early Feasibility Studies (“EFS”) and then progress to a Pivotal, or approval, Trial ("Pivotal Trial").
By their very nature, electrical signals from the body are analog and even though a 10-microvolt signal can be detected and transmitted down the roughly 2 meters of wire required to travel along the catheter, outside the patient, and into the necessary processing equipment shown in this picture below of a typical catheter lab, this isn’t feasible with the 1 to 2 microvolt signal from a typical peripheral nerve.
By their very nature, electrical signals from the body are analog and even though a 10-milivolt signal can be detected and transmitted down the roughly 2 meters of wire required to travel along the catheter, outside the patient, and into the necessary processing equipment shown in this picture below of a typical catheter lab, this isn’t feasible with the 10 to 500 microvolt signal from a typical peripheral nerve.
We believe this method of access that should significantly reduce the potential for complications as compared with NCPB.
We believe this method of access should significantly reduce the potential for complications as compared with NCPB.
We are currently using one of these existing systems “off label” (in an area of the body for which the system is not yet approved by the relevant regulatory agency) in our proof-of-concept study to ablate the nerves near the pancreas of pancreatic cancer patients to demonstrate, for the first time ever, that transvascular ablation of those nerves may reduce pain.
We are currently using one of these existing systems “off label” (in an area of the body for which the system is not yet approved by the relevant regulatory agency) in our proof-of-concept study to ablate the nerves near the pancreas of pancreatic cancer patients to demonstrate, for the first time ever, that transvascular ablation of those nerves may reduce pain in this patient population.
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 method for treating this indication.
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.
This approval allowed the clinical trial to begin The regulatory package submitted included not only a detailed clinical protocol for conducting the study, but also an extensive Investigator’s Brochure (“IB”) setting forth details about the equipment to be used, historical safety of human procedures conducted with this equipment and details of our animal studies using this equipment for the first time in the area of the pancreas.
The regulatory package submitted included not only a detailed clinical protocol for conducting the study, but also an extensive Investigator’s Brochure (“IB”) setting forth details about the equipment to be used, historical safety of human procedures conducted with this equipment and details of our animal studies using this equipment for the first time in the area of the pancreas.
We expect the human clinical version to be completed by mid-2025 and the commerical scale up process to be completed by mid-2027, although there is no assurance that we will be able to meet such timeline. Regarding the ablation system, safe and reliable off-the-shelf RF systems are currently available for use in cardiology and other electrophysiology indications.
We expect the human clinical version to be completed in 2026 and the commercial scale up process to be completed by mid-2027, although there is no assurance that we will be able to meet such timeline. Regarding the ablation system, safe and reliable off-the-shelf RF systems are currently available for use in cardiology and other electrophysiology indications.
The chipset also includes a multiplexer intended to enable the transmission of data from each of the antennae simultaneously down the catheter body to the catheter handle. The Wi-Fi handpiece then transmits this data to a nearby laptop for viewing and analysis by the clinician.
The chipset also includes a digital domain intended to enable the transmission of data from each of the antennae simultaneously down the catheter body to the catheter handle. The Wi-Fi handpiece then transmits this data to a nearby laptop for viewing and analysis by the clinician.
The most common alternative method of treatment is a neurolytic celiac plexus blockade (“NCPB”), which is a percutaneous (via needle through the skin) ethanol injection guided by CT scan to attempt to direct the ethanol (which will destroy neural tissue on contact) to the area of the pancreatic tumor and related peripheral nerves.
The most common alternative method of treatment is a neurolytic celiac plexus blockade (“NCPB”), which is a percutaneous (via needle through the skin) ethanol injection guided by imaging, such as ultrasound or CT scan, to attempt to direct the ethanol (which will destroy neural tissue on contact) to the area of the pancreatic tumor and related peripheral nerves.
Schwartz, with filing dates ranging from 2012 through 2024. 13 Table of Contents The following table shows our material patents and the expiration dates (assuming maintenance/annuity fees are paid as required) as of May 20, 2024: Issued Patents Patent No.
Schwartz, with filing dates ranging from 2012 through 2025. 13 Table of Contents The following table shows our material patents and the expiration dates (assuming maintenance/annuity fees are paid as required) as of May 22, 2025: Issued Patents Patent No.
Intellectual Property Patents and Pending Patent Applications The Company has 18 patent families (representing various inventions relating to different aspects of its technology) comprising 82 issued patents (34 in the US thus far) and 43 pending patent applications. All patents and patent applications were originated by our co-founders, Mr. Toth and/or Dr.
Intellectual Property Patents and Pending Patent Applications The Company has 18 patent families (representing various inventions relating to different aspects of its technology) comprising 86 issued patents (41 in the US thus far) and 41 pending patent applications. All patents and patent applications were originated by our co-founders, Mr. Toth and/or Dr.
Description of Property The Company leases office space as its headquarters in Texas and has access to a research and development facility in Pennsylvania. 16 Table of Contents Employees As of March 31, 2024, we have eight individuals providing services to the Company, five on a full-time basis and three on a part-time basis.
Description of Property The Company leases office space as its headquarters in Texas and has access to a research and development facility in Pennsylvania. 16 Table of Contents Employees As of March 31, 2025, we have 11 employees providing services to the Company, eight on a full-time basis and three on a part-time basis.
Jurisdiction Title Patent Expiration Date 2013211951 Australia Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 2,862,862 Canada Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 ZL201380016637.3 China Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 ZL201710440397.X China Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 2804527 European Patent Ratified in France, Germany, Ireland, Netherlands, UK Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 497881 India Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 6,552,824 Japan Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 347625 Mexico Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 372926 Mexico Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 11201406006X Singapore Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 10,470,684 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 11/10/2034 9,649,064 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 4/28/2033 10,022,085 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 11,013,459 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 6/30/2033 2013267672 Australia Endoscopic Sympathectomy Systems and Methods 5/28/2033 2,874,620 Canada Endoscopic Sympathectomy Systems and Methods 5/28/2033 2852339 European Patent Ratified in France; Germany; Ireland: Netherlands; UK Endoscopic Sympathectomy Systems and Methods 5/28/2033 436507 India Endoscopic Sympathectomy Systems and Methods 5/28/2033 504735 India Endoscopic Sympathectomy Systems and Methods 5/28/2033 11201407873R Singapore Endoscopic Sympathectomy Systems and Methods 5/28/2033 9,968,790 United States of America Endoscopic Sympathectomy Systems and Methods 7/14/2033 10,226,633 United States of America Endoscopic Sympathectomy Systems and Methods 5/28/2033 11,344,731 United States of America Endoscopic Sympathectomy Systems and Methods 7/14/2033 2013274158 Australia Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 6/13/2033 2,876,080 Canada Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 6/13/2033 2,861,145 European Patent Ratified in France; Germany; Ireland; Netherlands; UK Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 6/13/2033 532368 India Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 6/13/2023 6,335,888 Japan Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 6/13/2033 6,672,370 Japan Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 6/13/2033 11201408219T Singapore Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 6/13/2033 10,206,616 United States of America Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 9/10/2034 11,564,616 United States of America Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 8/18/2033 2013337879 Australia Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 10/31/2033 2,889,674 Canada Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 10/31/2033 2,914,334 European Patent Ratified in France; Germany; Ireland; Netherlands; UK Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 10/31/2033 406600 India Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 10/31/2033 11201503472P Singapore Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 10/31/2033 9,956,034 United States of America Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 10/18/2034 10,905,495 United States of America Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 11/6/2033 2013354932 Australia Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 12/9/2033 2,892,449 Canada Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 12/9/2033 388850 India Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 12/9/2033 11201504119V Singapore Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 12/9/2033 10,674,963 United States of America Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 6/1/2036 10,363,359 United States of America Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 2/25/2036 11,478,582 United States of America Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 8/2/2034 2014241205 Australia Neurological Traffic and Receptor Evaluation and Modification: Systems and Methods 3/27/2034 2,907,625 Canada Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 3/27/2034 2,978,372 European Patent Ratified in Belgium; France; Germany; Ireland; Italy; Netherlands; Spain; UK Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 3/27/2034 480497 India System for Neurological Traffic and Receptor Evaluation and Modification 3/27/2034 11201507936U Singapore Neurological Traffic and Receptor Functional Evaluation and Modification 3/27/2034 10,004,458 United States of America Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 1/16/2035 10,765,370 United States of America Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 4/10/2034 11,589,820 United States of America Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 12/4/2034 2014337552 Australia Systems and Methods for Treating Cancer and/or Augmenting Organ Function 10/14/2034 2,926,088 Canada Systems and Methods for Treating Cancer and/or Augmenting Organ Function 10/14/2034 443928 India Systems and Methods for Treating Cancer and/or Augmenting Organ Function 10/14/2034 364705 Mexico Systems and Methods for Treating Cancer and/or Augmenting Organ Function 10/14/2034 10,143,419 United States of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 2/6/2035 11,272,877 United States of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 2/6/2035 10,136,944 United States of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 5/24/2035 11,382,687 United States of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 4/3/2035 2015302050 Australia ANS Assessment Systems, Kits, and Methods 8/7/2035 2,957,766 Canada ANS Assessment Systems, Kits, and Methods 8/7/2035 3,177,201 European Patent Ratified as Unitary Patent and in Ireland and UK ANS Assessment Systems, Kits, and Methods 8/7/2035 369552 India ANS Assessment Systems, Kits, and Methods 8/7/2035 11201701018P Singapore ANS Assessment Systems, Kits, and Methods 8/7/2035 10,791,924 United States of America ANS Assessment Systems, Kits, and Methods 9/2/2037 11,883,103 United States of America ANS Assessment Systems, Kits, and Methods 10/13/2036 ZL201680068094.3 China Controlled and Precise Treatment of Cardiac Tissues 10/20/2036 3,364,869 European Patent Ratified as Unitary Patent and in Ireland and UK Controlled and Precise Treatment of Cardiac Tissues 10/20/2036 11,154,239 United States of America Controlled and Precise Treatment of Cardiac Tissues 5/28/2038 11,521,738 United States of America Medical Devices with Circuitry for Capturing and Processing Physiological Signals 4/14/2039 11,848,078 United States of America Medical Devices with Circuitry for Capturing and Processing Physiological Signals 10/17/2038 9,730,639 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 10,092,241 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 10,238,340 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 10,485,484 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 10,869,635 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 11,445,979 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 107924736 China Elongated Conductors and Methods of Making and Using the Same 5/19/2036 10,874,830 United States of America Smart Torquer and Methods of Using the Same 6/14/2037 14 Table of Contents The following table shows our material pending patent applications as of May 20, 2024 (note that no expiration dates are specified for the pending patent applications since, in certain jurisdictions, e.g., United States of America, the patent expiration date is calculated at the time of issue/grant): Pending Patent Applications Application No.
Jurisdiction Title Patent Expiration Date 2013211951 Australia Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 2,862,862 Canada Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 3,151,885 Canada Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 ZL201380016637.3 China Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 ZL201710440397.X China Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 2,804,527 European Patent Ratified in France, Germany, Ireland, Netherlands, UK Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 497881 India Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 6,552,824 Japan Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 347625 Mexico Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 372926 Mexico Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 11201406006X Singapore Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 10,470,684 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 11/10/2034 9,649,064 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 4/28/2033 10,022,085 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 1/25/2033 11,013,459 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 6/30/2033 12,257,071 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 11/12/2033 2,874,620 Canada Endoscopic Sympathectomy Systems and Methods 5/28/2033 2,852,339 European Patent Ratified in France; Germany; Ireland; UK Endoscopic Sympathectomy Systems and Methods 5/28/2033 11201407873R Singapore Endoscopic Sympathectomy Systems and Methods 5/28/2033 9,968,790 United States of America Endoscopic Sympathectomy Systems and Methods 7/14/2033 10,226,633 United States of America Endoscopic Sympathectomy Systems and Methods 5/28/2033 11,344,731 United States of America Endoscopic Sympathectomy Systems and Methods 5/28/2033 12,053,634 United States of America Endoscopic Sympathectomy Systems and Methods 5/28/2033 2,876,080 Canada Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 6/13/2033 2,861,145 European Patent Ratified in France; Germany; Ireland; Netherlands; UK Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 6/13/2033 6,335,888 Japan Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 6/13/2033 6,672,370 Japan Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 6/13/2033 11201408219T Singapore Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 6/13/2033 10,206,616 United States of America Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 9/10/2034 11,564,616 United States of America Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 8/18/2033 2013337879 Australia Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 10/31/2033 2,889,674 Canada Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 10/31/2033 2,914,334 European Patent Ratified in France; Germany; Ireland; Netherlands; UK Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 10/31/2033 406600 India Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 10/31/2033 11201503472P Singapore Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 10/31/2033 9,956,034 United States of America Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 10/18/2034 10,905,495 United States of America Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 11/6/2033 12,011,214 United States of America Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 5/13/2034 2013354932 Australia Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 12/9/2033 2,892,449 Canada Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 12/9/2033 388850 India Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 12/9/2033 11201504119V Singapore Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 12/9/2033 10,674,963 United States of America Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 6/1/2036 10,363,359 United States of America Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 2/25/2036 11,478,582 United States of America Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 8/2/2034 2,907,625 Canada Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 3/27/2034 2,978,372 European Patent Ratified in France; Germany; Ireland; Italy; UK Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 3/27/2034 11201507936U Singapore Neurological Traffic and Receptor Functional Evaluation and Modification 3/27/2034 10,004,458 United States of America Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 1/16/2035 10,765,370 United States of America Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 4/10/2034 11,589,820 United States of America Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 12/4/2034 12,279,889 United States of America Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 3/27/2034 2014337552 Australia Systems and Methods for Treating Cancer and/or Augmenting Organ Function 10/14/2034 2,926,088 Canada Systems and Methods for Treating Cancer and/or Augmenting Organ Function 10/14/2034 443928 India Systems and Methods for Treating Cancer and/or Augmenting Organ Function 10/14/2034 364705 Mexico Systems and Methods for Treating Cancer and/or Augmenting Organ Function 10/14/2034 10,143,419 United States of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 2/6/2035 11,272,877 United States of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 2/6/2035 12,064,256 United Sates of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 3/6/2035 10,136,944 United States of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 5/24/2035 11,382,687 United States of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 4/3/2035 2015302050 Australia ANS Assessment Systems, Kits, and Methods 8/7/2035 2,957,766 Canada ANS Assessment Systems, Kits, and Methods 8/7/2035 3,177,201 European Patent Ratified as Unitary Patent and in Ireland and UK ANS Assessment Systems, Kits, and Methods 8/7/2035 369552 India ANS Assessment Systems, Kits, and Methods 8/7/2035 11201701018P Singapore ANS Assessment Systems, Kits, and Methods 8/7/2035 10,791,924 United States of America ANS Assessment Systems, Kits, and Methods 9/2/2037 11,883,103 United States of America ANS Assessment Systems, Kits, and Methods 10/13/2036 3,226,792 European Patent to be Ratified as Unitary Patent and in Ireland and UK Systems And Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 12/4/2035 ZL201680068094.3 China Controlled and Precise Treatment of Cardiac Tissues 10/20/2036 3,364,869 European Patent Ratified as Unitary Patent and in Ireland and UK Controlled and Precise Treatment of Cardiac Tissues 10/20/2036 11,154,239 United States of America Controlled and Precise Treatment of Cardiac Tissues 5/28/2038 3,697,298 European Patent to be Ratified as Unitary Patent and in Ireland and UK Medical Devices with Circuitry for Capturing and Processing Physiological Signals 10/17/2038 11,521,738 United States of America Medical Devices with Circuitry for Capturing and Processing Physiological Signals 4/14/2039 11,848,078 United States of America Medical Devices with Circuitry for Capturing and Processing Physiological Signals 10/17/2038 12,217,863 United States of America Medical Devices with Circuitry for Capturing and Processing Physiological Signals 10/17/2038 3,304,565 European Patent to be Ratified as Unitary Patent and in Ireland and UK Elongated Conductors and Methods of Making and Using the Same 5/19/2036 9,730,639 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 10,092,241 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 10,238,340 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 10,485,484 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 10,869,635 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 11,445,979 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 12,070,334 United States of America Elongated Conductors and Methods of Making and Using the Same 5/19/2036 10,874,830 United States of America Smart Torquer and Methods of Using the Same 6/14/2037 12,295,646 United States of America Smart Torquer and Methods of Using the Same 6/14/2037 14 Table of Contents The following table shows our material pending patent applications as of May 22, 2025, (note that no expiration dates are specified for the pending patent applications since, in certain jurisdictions, e.g., United States of America, the patent expiration date is calculated at the time of issue/grant): Pending Patent Applications Application No.
Our current design connects 8 antennae to our proprietary chipset (which is designed to handle up to 16 antennae) where an onboard amplifier and analog to digital converter convert each signal into a robust digital form.
Our current design connects 8 splines to our proprietary chipset, which is designed to handle up to 16 differential electrodes, where an onboard amplifier and analog to digital converter convert each signal into a digital form.
As of March 31, 2024, we had an accumulated deficit of $39.0 million, negative cash flows from operating activities of $6.6 million and working capital of $8.6 million, which raises substantial doubt about our ability to continue as a going concern. Further, we have incurred and expect to continue to incur significant costs in pursuit of our business plans.
As of March 31, 2025, we had an accumulated deficit of $50.4 million, negative cash flows from operating activities of $8.3 million and working capital of $7.9 million, which raises substantial doubt about our ability to continue as a going concern. Further, we have incurred and expect to continue to incur significant costs in pursuit of our business plans.
When additional indications such as COPD, irritable bowl syndrome, and overactive bladder are included, we believe the Autonomix platform has the potential to address more than $100 billion in market opportunities. Commercialization Plan Regulatory Pathway The most likely approval pathway for our technology is referred to as “de novo” premarket notification.
When additional indications such as COPD, irritable bowl syndrome, and overactive bladder are included, we believe the Autonomix platform has the potential to address more than $100 billion in market opportunities. Commercialization Plan Regulatory Pathway The most likely regulatory pathway for our technology is the De Novo classification request.
Our sensing catheter has already been developed sufficiently to demonstrate in animal models successful identification of a signal from a specific nerve bundle before ablation and confirmation of termination of that signal from the treated nerves after ablation. We are now in the process of improving the design of this catheter to meet the standards required for human use.
Our sensing technology has already successfully demonstrated, in animal models, the ability to successfully identify a signal from a specific nerve bundle before ablation and confirmation of termination of that signal from the treated nerves after ablation. We are now in the process of improving the design of this catheter to meet the standards required for human use.
Filing Date Jurisdiction Title 3151885 3/14/2022 Canada Controlled Sympathectomy and Micro-Ablation Systems and Methods 21168169.7 5/13/2021 European Patent Office Controlled Sympathectomy and Micro-Ablation Systems and Methods 16/591,126 10/2/2019 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 17/325,833 5/20/2021 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 3158197 5/4/2022 Canada Endoscopic Sympathectomy Systems and Methods 17/732,716 4/29/2022 United States of America Endoscopic Sympathectomy Systems and Methods 3184524 12/15/2022 Canada Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 202448028613 4/8/2024 India Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 18/079,361 12/12/2022 United States of America Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 3183802 12/9/2022 Canada Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 17/136,316 12/29/2020 United States of America Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 18/656,031 5/6/2024 United States of America Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 3151434 3/9/2022 Canada Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development EP24170108.5 4/12/2024 European Patent Office Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 16/855,080 4/22/2020 United States of America Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 17/971,202 10/21/2022 United States of America Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 3,205,904 7/10/2023 Canada Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 19159405 2/26/2019 European Patent Office Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 202348081808 12/1/2023 India Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 18/104,460 2/1/2023 United States of America Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 3182302 11/28/2022 Canada Systems and Methods for Treating Cancer and/or Augmenting Organ Function 22175617.4 5/26/2022 European Patent Office Systems and Methods for Treating Cancer and/or Augmenting Organ Function 17/690,659 3/9/2022 United States of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 17/833,964 6/7/2022 United States of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 23182480.6 6/29/2023 European Patent Office ANS Assessment Systems, Kits, and Methods 3,210,898 9/1/2023 Canada ANS Assessment Systems, Kits, and Methods 10202300654X 3/10/2023 Singapore ANS Assessment Systems, Kits, and Methods 18/543,538 12/18/2023 United States of America ANS Assessment Systems, Kits, and Methods 23171646.5 5/4/2023 European Patent Office Systems and Methods for Treating Cancer and/or Augmenting Organ Function 15864478.1 7/4/2017 European Patent Office Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 202210497355 5/9/2022 China Controlled and Precise Treatment of Cardiac Tissues 23170175.6 4/26/2023 European Patent Office Controlled and Precise Treatment of Cardiac Tissues 17/501,502 10/14/2021 United States of America Controlled and Precise Treatment of Cardiac Tissues 18868117.5 4/17/2020 European Patent Office Medical Devices with Circuitry for Capturing and Processing Signals 18/387,585 11/7/2023 United States of America Medical Devices with Circuitry for Capturing and Processing Signals PCT/US2023/029193 8/1/2023 Patent Cooperation Treaty (PCT)/ United States of America, Receiving Office Medical Devices Configured for Therapeutic Electroporation of Biologic Tissues 17/888,833 8/16/2022 United States of America Elongated Conductors and Methods of Making and Using the Same 16803986.5 11/29/2017 European Patent Office Elongated Conductors and Methods of Making and Using the Same 16/951,317 11/18/2020 United States of America Smart Torquer and Methods of Using the Same 16854068 4/9/2018 European Patent Office Smart Torquer and Methods of Using the Same 63/636,467 4/19/2024 United States of America Medical Devices Configured for Temperature-Controlled Therapeutic Electroporation 63/636,471 4/19/2024 United States of America Medical Devices Configured for Therapeutic Electroporation with Adjustable Sections of an Elongate Member 63/636,477 4/19/2024 United States of America Medical Device Guide Sheaths with Return Electrodes for Bipolar Therapeutic Electroporation 15 Table of Contents Trademarks The Company has one trademark for the mark “AUTONOMIX” in the United States, Australia, China, the European Union, India, Japan, Mexico, and Singapore.
Filing Date Jurisdiction Title 3239581 5/24/2024 Canada Controlled Sympathectomy and Micro-Ablation Systems and Methods 21168169.7 5/13/2021 European Patent Office Controlled Sympathectomy and Micro-Ablation Systems and Methods 16/591,126 10/2/2019 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 19/054,104 2/14/2025 United States of America Controlled Sympathectomy and Micro-Ablation Systems and Methods 3158197 5/4/2022 Canada Endoscopic Sympathectomy Systems and Methods 18/771,099 7/12/2024 United States of America Endoscopic Sympathectomy Systems and Methods 3184524 12/15/2022 Canada Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 202448028613 4/8/2024 India Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 18/079,361 12/12/2022 United States of America Devices, Systems, and Methods for Diagnosis and Treatment of Overactive Bladder 3183802 12/9/2022 Canada Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 18/656,031 5/6/2024 United States of America Systems and Methods for Treatment of Tissues Within and/or Through a Lumen Wall 3151434 3/9/2022 Canada Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 24170108.5 4/12/2024 European Patent Office Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 16/855,080 4/22/2020 United States of America Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 17/971,202 10/21/2022 United States of America Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 3,205,904 7/10/2023 Canada Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 202348081808 12/1/2023 India Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 19/169,668 4/3/2025 United States of America Systems and Methods for Neurological Traffic and/or Receptor Functional Evaluation and/or Modification 3182302 11/28/2022 Canada Systems and Methods for Treating Cancer and/or Augmenting Organ Function 22175617.4 5/26/2022 European Patent Office Systems and Methods for Treating Cancer and/or Augmenting Organ Function 18/772,819 7/15/2024 United States of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 17/833,964 6/7/2022 United States of America Systems and Methods for Treating Cancer and/or Augmenting Organ Function 23182480.6 6/29/2023 European Patent Office ANS Assessment Systems, Kits, and Methods 3,210,898 9/1/2023 Canada ANS Assessment Systems, Kits, and Methods 10202300654X 3/10/2023 Singapore ANS Assessment Systems, Kits, and Methods 18/543,538 12/18/2023 United States of America ANS Assessment Systems, Kits, and Methods 23171646.5 5/4/2023 European Patent Office Systems and Methods for Treating Cancer and/or Augmenting Organ Function 25151120 1/10/2025 European Patent Office Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development 202210497355 5/9/2022 China Controlled and Precise Treatment of Cardiac Tissues 23170175.6 4/26/2023 European Patent Office Controlled and Precise Treatment of Cardiac Tissues 17/501,502 10/14/2021 United States of America Controlled and Precise Treatment of Cardiac Tissues 19/004,748 12/30/2024 United States of America Medical Devices with Circuitry for Capturing and Processing Physiological Signals 3,264,031 2/3/2025 Canada Medical Devices Configured for Therapeutic Electroporation of Biologic Tissues 23853213.9 2/28/2025 European Patent Office Medical Devices Configured for Therapeutic Electroporation of Biologic Tissues 19/099,897 1/30/2025 United States of America Medical Devices Configured for Therapeutic Electroporation of Biologic Tissues 18/779,387 7/22/2024 United States of America Elongated Conductors and Methods of Making and Using the Same 19/180,938 4/16/2025 United States of America Smart Torquer and Methods of Using the Same 16854068 4/9/2018 European Patent Office Smart Torquer and Methods of Using the Same PCT/US2025/025299 4/18/2025 Patent Cooperation Treaty (PCT) / United States of America, Receiving Office Medical Devices Configured for Temperature-Controlled Therapeutic Electroporation PCT/US2025/025305 4/18/2025 Patent Cooperation Treaty (PCT)/ United States of America, Receiving Office Medical Devices Configured for Therapeutic Electroporation with Adjustable Sections of an Elongate Member PCT/US2025/025307 4/18/2025 Patent Cooperation Treaty (PCT)/ United States of America, Receiving Office Medical Device Guide Sheaths with Return Electrodes for Bipolar Therapeutic Electroporation 15 Table of Contents Trademarks The Company has one trademark for the mark “AUTONOMIX” in the United States, Australia, China, the European Union, India, Japan, Mexico, and Singapore.
Another is that product launches are usually easier in the US where a single sales force can serve the entire region (as opposed to country-specific distribution teams in the EU) and where one regulatory standard applies across the board. The development of the PoC data forms the basis for two FDA-related processes.
Another is that product launches are usually easier in the US where a single sales force can serve the entire region (as opposed to country-specific distribution teams in the EU) and where one regulatory standard applies across the board.
Examples of future potential additional uses include renal denervation for treating hypertension, addressing other sources of pain including lower back and other joint locations, Complex Regional Pain Syndrome (“CRPS”), other tumor related pain, and pelvic pain, pulmonary disorders such as chronic obstructive pulmonary disease, and urinary tract and digestive disorders, and enabling more targeted treatments in cardiology, just to name a few.
Examples of future potential additional uses include expanding to other visceral cancers that transmit pain through the celiac plexus, like pancreatic, gall bladder, liver, and bile duct, renal denervation for treating hypertension, addressing other sources of pain including lower back and other joint locations, Complex Regional Pain Syndrome (“CRPS”), and pelvic pain, pulmonary disorders such as chronic obstructive pulmonary disease, and urinary tract and digestive disorders, and enabling more targeted treatments in cardiology, just to name a few.
For the Autonomix device, the metrics are Our development efforts can be divided into to two sub parts : d iagnostic and therapeutic, where diagnostic is focused on sensing and identifying neuronal activity that may be associated with a disorder with enough precision to enable targeted therapy with ablation.
Our development efforts can be divided into two parts : d iagnostic sensing and therapeutic radiofrequency ablation, where diagnostic is focused on sensing and identifying disorder-related neuronal activity with enough precision to enable targeted therapy with ablation.
However, we believe our technology constitutes a platform with the potential to address dozens of indications in a range of areas including chronic pain management from all causes, hypertension, cardiovascular disease and a wide range of other nerve-related disorders. We calculate sensitivity in units of minimum signal detection voltage in micro volts (uV) time area of the electrode (square millimeters).
However, we believe our technology constitutes a platform with the potential to address dozens of indications in a range of areas including chronic pain management from all causes, hypertension, cardiovascular disease and a wide range of other nerve-related disorders.
One of our directors, David Robins, holds a 20% interest in the company receiving the warrant. Competition The electrophysiology market is served by a number of very large players including, for example, Medtronic and Boston Scientific, all of whom have substantially greater resources than Autonomix.
Competition The electrophysiology market is served by a number of very large players including, for example, Medtronic and Boston Scientific, all of whom have substantially greater resources than Autonomix.
We are seeking to solve this problem through our design, which is still in development, of a proprietary microchip comprised of multiple key components.
We are seeking to solve this problem through our design, which is still in development, of a proprietary sensor comprised of multiple key components, such as an electrode antenna and a microchip that processes data acquired through the antenna.
Each antenna is comprised of two small electrodes that can detect the presence of voltage down to as little as 0.5 microvolts giving us sufficient sensitivity to register the impulse of a nearby nerve bundle that might typically be generating 1.5 to 2.0 microvolts with each impulse.
Each antenna spline is comprised of 2 small differential electrodes and 1 reference electrode that can detect the presence of voltage down to as little as 2 microvolts, giving us sufficient sensitivity to register the impulse of a nearby nerve bundle that might typically be generating 10 to 500 microvolts, depending on the type of nerve fiber (i.e., parasympathetic, sympathetic, somatic, etc.).
The first trial is not designed to replace the trial that will be required by the FDA to support our submissions for clearance in the United States, but rather to potentially impact the size of that required trial.
The first PoC trial is not designed to replace the pivotal trial that will be required by the FDA to support our submissions for clearance in the United States, but rather to provide key learnings and procedural knowledge going into our FDA clinical trials.
Technology Development Commercialization of our technology can be thought of in three distinct phases: (1) sensing, (2) ablation, and (3) the combination of these two technologies into an integrated device.
The foregoing timeline is not guaranteed and is subject to many of the risks and uncertainties disclosed in this Annual Report on Form 10-K and is subject to change. Technology Development Commercialization of our technology can be thought of in three distinct phases: (1) sensing, (2) ablation, and (3) the combination of these two technologies into an integrated device.
The design and endpoints of pivotal trials are often negotiated with the relevant regulatory authority (i.e., FDA in the United States, EMA or country-specific Competent Authority (“CA”) in Europe). Our regulatory package for authorization to conduct our first-in-human clinical trial was approved by the Ethics Committee (“EC”) at our intended clinical site hospital outside the United States .
The design and endpoints of Pivotal Clinical Trials are often negotiated with the relevant regulatory authority (i.e., FDA in the United States, EMA or country-specific Competent Authority (“CA”) in Europe).
In parallel with this effort, we are conducting a first-in-human demonstration of transvascular ablation to relieve pain associated with pancreatic cancer, with the intent to bring sensing and treatment together in a future pivotal clinical trial to enable the commercial launch of our technology.
In parallel with this effort, we completed our initial trial phase of our first-in-human proof-of-concept trial ("PoC 1") evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate pain in patients with pancreatic cancer pain, with the intent to bring sensing and treatment together in a future pivotal clinical trial to enable the commercial launch of our technology.
We believe this entire timeline supports an ultimate FDA clearance (applications like this are not technically “approved” but rather “allowed” or “cleared”) in the first half of 2027. The foregoing timeline is not a guarantee and is subject to many of the risks and uncertainties disclosed in this Annual Report on Form 10-K and is subject to change.
Upon completion of the Pivotal Trial, we expect to be in a position to submit our de novo application to the FDA, the review of which is expected to require approximately 170 days. We believe this entire timeline supports an ultimate FDA clearance (applications like this are not technically “approved” but rather “allowed” or “cleared”) in 2027.
Moreover, we believe that prolonged pain can diminish a patient’s will to live, making that remaining time even shorter. The standard of care treatment usually begins with opioids, but patients often become resistant, and the side effects of chronic opioid use can eventually outweigh the benefits.
Moreover, we believe that prolonged pain can diminish a patient’s will to live, making that remaining time even shorter. The standard of care for managing chronic abdominal pain due to pancreatic cancer typically begins with medical management, including non-opioid medications such as acetaminophen and NSAIDs. When this approach fails to provide adequate relief, second-line therapy often involves opioid pharmacotherapy.
This is differentiated from the more common “510(k)” pathway, which is only applicable when there is a clear “predicate” device already on the market (doing the same thing in substantially the same way) and from the lengthier “PMA” process when there is no precedent at all for a technology.
This pathway is distinct from the more common 510(k) clearance process, which is only applicable when a legally marketed “predicate” device exists that performs the same function in a substantially equivalent manner.
Removed
It is a combined measure that is related to the signal resolving power and spatial resolution of the system. For the BSC Orion, the nearest device on the market, the metrics are 10uV for signal detection levels, and roughly 0.4mm by 0.5mm for the electrode dimensions.
Added
As we calculate sensitivity as a function of the minimum signal detection voltage, measured in microvolts (µV), multiplied by the area of the electrode (in square millimeters). This combined measure reflects the system’s signal resolving power and spatial resolution.
Removed
In our case, both sensing and ablation have established precedence, just not at this level of sensitivity or in our targeted indications. Whether in the United States or EU, we must demonstrate that our technology is safe and effective.
Added
For comparison, the Boston Scientific Orion device has a signal detection threshold of approximately 10 µV with electrode dimensions of roughly 0.4 mm by 0.5 mm. In contrast, the Autonomix system is designed to have signal detection thresholds below 5 µV, with prototype electrode dimensions as small as approximately 0.02 mm by 0.03 mm.
Removed
We plan to present the relevant data from this study to the FDA in a pre-submission meeting to request “Breakthrough Status” in an effort to minimize the clinical requirements for clearance in the United States.
Added
These metrics indicate a substantially higher sensitivity relative to currently marketed devices. We believe that, if validated in clinical trials, this enhanced sensitivity may enable a novel method of transvascular nerve targeting, treatment, and confirmation across a broad range of neurological conditions.
Removed
First is the request of a “Pre-Submission” meeting to discuss the overall regulatory strategy, the primary focus of which is to agree on a pivotal testing protocol. Assuming promising PoC data, the second is to submit a request for “Breakthrough” status based on the significant unmet need.
Added
A key enabler of this approach is the ability to process neural signals with our proprietary microchip in immediate proximity to the antenna, minimizing signal degradation and preserving fidelity at the point of detection. This local processing capability is critical to achieving real-time, high-resolution signal capture within the vascular system.
Removed
Breakthrough status affords us expedited access to FDA and a higher level of proactive interaction that may support faster approval. Upon completion of the Pivotal Clinical Trial, we believe we will then be in a position to submit our de novo application to the FDA, the review of which is expected to require approximately 150 days.
Added
Such a capability does not exist in currently available systems and may address significant unmet medical needs. While we have the technical capability to manufacture electrodes at these small dimensions, ongoing development work suggests that reliable nerve signal detection may be achievable with larger electrode sizes. This could reduce manufacturing complexity, lower development risk, and accelerate timelines without compromising performance.
Removed
License Agreement In December 2021, we granted a company affiliated with certain early investors in the Company a license to our technology for use in the field of cardiology. During the term of the license agreement, we did not receive any fees from the licensee, and did not generate any revenue under the license agreement.
Added
As a result of the positive results from PoC 1, we have expanded the protocol into a follow-on phase ("PoC 2"), now including pain management for additional visceral cancers, like pancreatic, gall bladder, liver, and bile duct, with potential further expansion in oncology, gastroenterology, and other sectors, as well as earlier stage pancreatic cancer patients experiencing moderate to severe pain.
Removed
On July 7, 2023, we entered into an Exclusive License Termination Agreement (the “Termination Agreement”) with the Licensee in exchange for the issuance, upon the closing of our initial public offering (IPO) within one year of the agreement’s execution, of a warrant to purchase shares of the Company for a variable number of shares based on a value of $8.0 million.
Added
However, long-term opioid use is associated with tolerance, dependency, and adverse side effects that can ultimately outweigh the benefits.
Removed
Upon the closing of our IPO on January 29, 2024, 1.6 million shares were issued valued at $5.00 per share for a fixed value of $8.0 million.
Added
It is also different 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. In our case, while sensing and ablation technologies are well-established, there is no existing device that combines our level of signal sensitivity or targets the specific indications we are pursuing.
Removed
The warrants are exercisable at a price of $0.001 per share and may be exercised any time after the issuance date, subject to a beneficial ownership limitation, and expire five years from the original issuance. The warrants provide dividend rights.
Added
As such, we anticipate that the De Novo pathway—designed for novel, moderate-risk devices without a direct predicate—will be the most likely route to market. Whether in the United States or EU, we must demonstrate that our technology is safe and effective.
Removed
The shares underlying the warrant will be subject to a lockup agreement for a period of six months after the closing of the IPO with respect to 12.5% of the shares issued and twelve months after the closing of the IPO for the remainder of the shares.
Added
Our regulatory package for authorization to conduct our initial phase of our first-in-human proof of concept trial ("PoC 1") was approved by the Ethics Committee (“EC”) at our intended clinical site hospital outside the United States . This approval allowed the initial PoC trial to begin.
Added
With the success of our PoC 1, we will initiate a follow-on PoC 2 phase in a market expansion opportunity that has the potential to double the addressable market beyond pancreatic cancer pain by evaluating additional visceral cancers that signal pain through the celiac plexus and earlier stage pancreatic cancers with moderate to severe pain.
Added
The PoC 1 trial protocol will be amended to include the gathering of additional interventional pain management information that will continue to advance key learnings and used to inform future clinical studies. We are actively engaging with the FDA through the pre-submission process as we work toward initiating our U.S.-based IDE clinical trials.
Added
We intend to start with a small, single-site EFS study leading into a larger, multi-centered pivotal trial.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

68 edited+59 added−13 removed170 unchanged
The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.
The risk of a security breach or disruption, particularly through cyberattacks or cyber-intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.
We have no experience in assembling and testing our planned device and no experience in doing so on a commercial scale. To become profitable, we must assemble and test our planned device in commercial quantities in compliance with regulatory requirements and at an acceptable cost.
We have limited experience in assembling and testing our planned device and no experience in doing so on a commercial scale. To become profitable, we must assemble and test our planned device in commercial quantities in compliance with regulatory requirements and at an acceptable cost.
Our future success will depend on our ability to continually develop and then improve the products that we design and to develop and introduce new products that address the evolving needs of our customers on a timely and cost-effective basis. 21 Table of Contents Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations.
Our future success will depend on our ability to continually develop and then improve the products that we design and to develop and introduce new products that address the evolving needs of our customers on a timely and cost-effective basis. 23 Table of Contents Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations.
If any of these third-party information technology providers are compromised due to computer viruses, unauthorized access, malware, natural disasters, fire, terrorism, war and telecommunication failures, electrical failures, cyber-attacks or cyber-intrusions over the internet, then sensitive emails or documents could be exposed or deleted.
If any of these third-party information technology providers are compromised due to computer viruses, unauthorized access, malware, natural disasters, fire, terrorism, war and telecommunication failures, electrical failures, cyberattacks or cyber-intrusions over the internet, then sensitive emails or documents could be exposed or deleted.
Although we were not a borrower under or party to any material letter of credit or any other such instruments with SVB, Signature or any other financial institution currently in receivership, if we enter into any such instruments and any of our lenders or counterparties to such instruments were to be placed into receivership, we may be unable to access such funds.
Although we were not a borrower under or party to any material letter of credit or any other such instruments with SVB, Signature or any other financial institution, if we enter into any such instruments and any of our lenders or counterparties to such instruments were to be placed into receivership, we may be unable to access such funds.
Additionally, the validity of our patents and the patents we have licensed may be challenged if a petition for post grant proceedings such as inter-parties review and post grant review is filed within the statutorily applicable time with the U.S. Patent and Trademark Office (USPTO).
Additionally, the validity of our patents and the patents we have licensed may be challenged if a petition for post grant proceedings such as inter-parties review and post grant review is filed within the statutorily applicable time with the U.S. Patent and Trademark Office (“USPTO”).
In addition, this forum selection provision may impose additional litigation costs on stockholders in pursuing the claims identified above, particularly if the stockholders do not reside in or near the State of Delaware. 34 Table of Contents The requirements of being a public company may strain our resources, divert management ’ s attention and affect our ability to attract and retain qualified board members.
In addition, this forum selection provision may impose additional litigation costs on stockholders in pursuing the claims identified above, particularly if the stockholders do not reside in or near the State of Delaware. The requirements of being a public company may strain our resources, divert management ’ s attention and affect our ability to attract and retain qualified board members.
We have no experience in assembling and testing our products and may encounter problems or delays in the assembly of our products or fail to meet certain regulatory requirements which could result in an adverse effect on our business and financial results.
We have limited experience in assembling and testing our products and may encounter problems or delays in the assembly of our products or fail to meet certain regulatory requirements which could result in an adverse effect on our business and financial results.
There may also be secondary impacts that are unforeseeable as well, such as impacts on our customers, which could cause delays in new orders, delays in completing sales or even order cancellations. We may fail to meet the Sarbanes-Oxley regulations and may lack the financial controls and safeguards required of public companies.
There may also be secondary impacts that are unforeseeable as well, such as impacts on our customers, which could cause delays in new orders, delays in completing sales or even order cancellations. 24 Table of Contents We may fail to meet the Sarbanes-Oxley regulations and may lack the financial controls and safeguards required of public companies.
We do not have a long-term agreement with our manufacturer and there is no assurance that they will continue to provide us with manufacturing services in the future. 20 Table of Contents We are a developmental stage company and have not yet had a history of generating revenue. As a development-stage entity, we have not generated any revenues.
We do not have a long-term agreement with our manufacturer and there is no assurance that they will continue to provide us with manufacturing services in the future. We are a developmental stage company and have not yet had a history of generating revenue. As a development-stage entity, we have not generated any revenues.
Supreme Court modified some tests used by the USPTO in granting patents over the past 20 years, which may decrease the likelihood that we will be able to obtain patents and increase the likelihood of a challenge of any patents we obtain or license. 22 Table of Contents Catastrophic events and disaster recovery may disrupt business continuity.
Supreme Court modified some tests used by the USPTO in granting patents over the past 20 years, which may decrease the likelihood that we will be able to obtain patents and increase the likelihood of a challenge of any patents we obtain or license. Catastrophic events and disaster recovery may disrupt business continuity.
Additionally, private and government payers may consider the cost of a treatment in approving coverage or in setting reimbursement for the treatment. 29 Table of Contents Private and government payers around the world are increasingly challenging the prices charged for medical products and services. Additionally, the containment of healthcare costs has become a priority of governments around the world.
Additionally, private and government payers may consider the cost of a treatment in approving coverage or in setting reimbursement for the treatment. Private and government payers around the world are increasingly challenging the prices charged for medical products and services. Additionally, the containment of healthcare costs has become a priority of governments around the world.
Similar impacts have occurred in the past, such as during the 2008-2010 financial crisis. Inflation and rapid increases in interest rates have led to a decline in the trading value of previously issued government securities with interest rates below current market interest rates. Although the U.S.
Similar impacts have occurred in the past, such as during the 2008-2010 financial crisis. Inflation and rapid increases in interest rates have led to a decline in the trading value of previously issued government securities with interest rates below current market interest rates.
Accordingly, shareholders may have to sell some or all of their shares of our common stock in order to generate cash flow from an investment in our common stock. If our stock price fluctuates, you could lose a significant part of your investment.
Accordingly, shareholders may have to sell some or all of their shares of our common stock in order to generate cash flow from an investment in our common stock. 33 Table of Contents If our stock price fluctuates, you could lose a significant part of your investment.
Risks Related to our Common Stock Concentration of ownership of our common stock among our existing executive officers and directors may prevent new investors from influencing significant corporate decisions. Our executive officers and directors, and their affiliates, who are our principal stockholders, in the aggregate, beneficially own approximately 38.3% of our outstanding common stock as of the date hereof.
Risks Related to our Common Stock Concentration of ownership of our common stock among our existing executive officers and directors may prevent new investors from influencing significant corporate decisions. Our executive officers and directors, and their affiliates, who are our principal stockholders, in the aggregate, beneficially own approximately 14.2% of our outstanding common stock as of the date hereof.
Further, the use of cyberattacks could expand as part of the conflict, which could adversely affect our ability to maintain or enhance our cyber-security and data protection measures.
Further, the use of cyberattacks could expand as part of the conflict, which could adversely affect our ability to maintain or enhance our cybersecurity and data protection measures.
Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as QSR, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.
Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as QSR, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects. 29 Table of Contents Our products may in the future be subject to product recalls that could harm our reputation, business and financial results.
The first trial is not designed to replace the trial that will be required by the FDA to support our submissions for clearance in the United States, but rather to potentially impact the size of that trial.
The first trial is not designed to replace the pivotal trial that will be required by the FDA to support clearance in the United States, but rather to potentially impact the size of that trial.
A number of companies have suffered significant setbacks in advanced clinical studies, even after promising results in earlier studies. Negative or inconclusive results or adverse events or incidents during a clinical study could cause the clinical study to be redone or terminated.
Acceptable results in early studies may not be replicable in later studies. A number of companies have suffered significant setbacks in advanced clinical studies, even after promising results in earlier studies. Negative or inconclusive results or adverse events or incidents during a clinical study could cause the clinical study to be redone or terminated.
The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other things, any of the following enforcement actions: ● untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; ● unanticipated expenditures to address or defend such actions; ● customer notifications for repair, replacement, refunds; ● recall, detention or seizure of our products; ● operating restrictions or partial suspension or total shutdown of production; ● refusing or delaying our requests for premarket clearance or premarket approval of new products or modified products; ● operating restrictions; ● withdrawing premarket clearances on PMA approvals that have already been granted; ● refusal to grant export approval for our products; or ● criminal prosecution. 26 Table of Contents If any of these actions were to occur, it would harm our reputation and cause our product sales and profitability to suffer and may prevent us from generating revenue.
The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other things, any of the following enforcement actions: • untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; • unanticipated expenditures to address or defend such actions; • customer notifications for repair, replacement, refunds; • recall, detention or seizure of our products; • operating restrictions or partial suspension or total shutdown of production; • refusing or delaying our requests for premarket clearance or premarket approval of new products or modified products; • operating restrictions; • withdrawing premarket clearances on PMA approvals that have already been granted; • refusal to grant export approval for our products; or • criminal prosecution.
As of March 31, 2024, we had an accumulated deficit of $39.0 million, negative cash flows from operating activities of $6.6 million and working capital of $8.6 million, which raises substantial doubt about our ability to continue as a going concern. Further, we have incurred, and expect to continue to incur, significant costs in pursuit of our business plans.
As of March 31, 2025, we had an accumulated deficit of $50.4 million, negative cash flows from operating activities of $8.3 million and working capital of $7.9 million, which raises substantial doubt about our ability to continue as a going concern. Further, we have incurred, and expect to continue to incur, significant costs in pursuit of our business plans.
This level of control may also have an adverse impact on the market value of our shares because our principal stockholders may institute or undertake transactions, policies or programs that result in losses and may not take any steps to increase our visibility in the financial community and/or may sell sufficient numbers of shares to significantly decrease our price per share. 31 Table of Contents We do not intend to pay cash dividends on our common stock in the foreseeable future.
This level of control may also have an adverse impact on the market value of our shares because our principal stockholders may institute or undertake transactions, policies or programs that result in losses and may not take any steps to increase our visibility in the financial community and/or may sell sufficient numbers of shares to significantly decrease our price per share.
We are required to comply with Section 404 of the Sarbanes-Oxley Act in connection with our future annual and quarterly reports on Form 10-K and Form 10-Q, commencing with the Form 10-K for the year ended March 31, 2025. We expect to expend significant resources in developing the necessary documentation and testing procedures required by Section 404.
We are required to comply with Section 404 of the Sarbanes-Oxley Act in connection with this annual report on Form 10-K and future quarterly reports on Form 10-Q. We expect to expend significant resources in developing the necessary documentation and testing procedures required by Section 404.
If financing is not available on satisfactory terms, we may be unable to further pursue our business plan and we may be unable to continue operations, in which case you may lose some or all of your investment.
There can be no assurance that funds will be available on commercially reasonable terms, if at all. If financing is not available on satisfactory terms, we may be unable to further pursue our business plan and we may be unable to continue operations, in which case you may lose some or all of your investment.
Investors are subject to all the risks incident to the creation and development of a new business and each investor should be prepared to withstand a complete loss of investment. We have not emerged from the development stage and may be unable to raise further equity. These factors raise substantial doubt about our ability to continue as a going concern.
Investors are subject to all the risks incident to the creation and development of a new business and each investor should be prepared to withstand a complete loss of investment. We have not emerged from the development stage and may be unable to raise further equity.
For so long as we remain an emerging growth company, we will not be required to: ● have an auditor report on our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002; ● comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis); ● submit certain executive compensation matters to shareholders advisory votes pursuant to the “say on frequency” and “say on pay” provisions (requiring a non-binding shareholder vote to approve compensation of certain executive officers) and the “say on golden parachute” provisions (requiring a non-binding shareholder vote to approve golden parachute arrangements for certain executive officers in connection with mergers and certain other business combinations) of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010; ● include detailed compensation discussion and analysis in our filings under the Securities Exchange Act of 1934, as amended, and instead may provide a reduced level of disclosure concerning executive compensation; ● may present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations, or MD&A; and ● are eligible to claim longer phase-in periods for the adoption of new or revised financial accounting standards under §107 of the JOBS Act.
We are an emerging growth company until the earliest of: • the last day of the fiscal year during which we have total annual gross revenues of $1.235 billion or more; • the last day of the fiscal year following the fifth anniversary of the date of the first sale of our common equity pursuant to an effective registration statement under the Securities Act of 1933; • the date on which we have, during the previous 3-year period, issued more than $1 billion in non-convertible debt; or • the date on which we are deemed a “large accelerated issuer” as defined under the federal securities laws. 35 Table of Contents For so long as we remain an emerging growth company, we will not be required to: • have an auditor report on our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002; • comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis); • submit certain executive compensation matters to shareholders advisory votes pursuant to the “say on frequency” and “say on pay” provisions (requiring a non-binding shareholder vote to approve compensation of certain executive officers) and the “say on golden parachute” provisions (requiring a non-binding shareholder vote to approve golden parachute arrangements for certain executive officers in connection with mergers and certain other business combinations) of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010; • include detailed compensation discussion and analysis in our filings under the Securities Exchange Act of 1934, as amended, and instead may provide a reduced level of disclosure concerning executive compensation; • may present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations, or MD&A; and • are eligible to claim longer phase-in periods for the adoption of new or revised financial accounting standards under §107 of the JOBS Act.
As an “emerging growth company” under the JOBS Act, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements.
As an “ emerging growth company ” under the Jumpstart Our Business Startups Act, or JOBS Act, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements. As an “emerging growth company” under the JOBS Act, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements.
While we would strongly defend against any such short seller attacks, we may be constrained in the manner in which we can proceed against the relevant short seller by applicable state law or issues of commercial confidentiality.
While we would strongly defend against any such short seller attacks, we may be constrained in the manner in which we can proceed against the relevant short seller by applicable state law or issues of commercial confidentiality. Such a situation could be costly, and time-consuming, and could be distracting for our management team.
The absence of a positive coverage determination or a future restriction to existing coverage from Medicare or the DME MACs would materially affect our future revenues. 30 Table of Contents Additionally, Medicare has the authority to publish the reimbursement amounts for DME products.
The absence of a positive coverage determination or a future restriction to existing coverage from Medicare or the DME MACs would materially affect our future revenues. Additionally, Medicare has the authority to publish the reimbursement amounts for DME products. Medicare may in the future publish reimbursement amounts for our products that do not reflect then-current prices for our products.
For instance, smaller reporting companies are not required to obtain an auditor attestation and report regarding management’s assessment of internal control over financial reporting; are not required to provide a compensation discussion and analysis; are not required to provide a pay-for-performance graph or CEO pay ratio disclosure; and may present only two years of audited financial statements and related MD&A disclosure. 33 Table of Contents We cannot predict if investors will find our securities less attractive due to our reliance on these exemptions.
For instance, smaller reporting companies are not required to obtain an auditor attestation and report regarding management’s assessment of internal control over financial reporting; are not required to provide a compensation discussion and analysis; are not required to provide a pay-for-performance graph or CEO pay ratio disclosure; and may present only two years of audited financial statements and related MD&A disclosure.
We intend to seek to raise additional funds, finance acquisitions or develop strategic relationships by issuing equity or convertible debt securities, which would reduce the percentage ownership of our existing stockholders.
Your ownership may be diluted if additional capital stock is issued to raise capital, to finance acquisitions or in connection with strategic transactions. We intend to seek to raise additional funds, finance acquisitions or develop strategic relationships by issuing equity or convertible debt securities, which would reduce the percentage ownership of our existing stockholders.
Clinical testing can be costly and take many years and the outcome is uncertain and susceptible to varying interpretations. Moreover, success in pre-clinical and early clinical studies does not ensure that large-scale studies will be successful or predict final results. Acceptable results in early studies may not be replicable in later studies.
Our clinical studies could be delayed or otherwise adversely affected by many factors, including difficulties in enrolling patients. Clinical testing can be costly and take many years and the outcome is uncertain and susceptible to varying interpretations. Moreover, success in pre-clinical and early clinical studies does not ensure that large-scale studies will be successful or predict final results.
Additionally, Russia’s invasion of Ukraine in early 2022 triggered significant sanctions from U.S. and European countries. Resulting changes in U.S. trade policy could trigger retaliatory actions by Russia, its allies and other affected countries, including China, resulting in a potential trade war.
Resulting changes in U.S. trade policy could trigger retaliatory actions by Russia, its allies and other affected countries, including China, resulting in a potential trade war.
If third-party payers do not consider our products or the combination of our products with additional treatments to be cost-justified under a required cost-testing model, they may not cover our products for their populations or, if they do, the level of reimbursement may not be sufficient to allow us to sell our products on a profitable basis.
If third-party payers do not consider our products or the combination of our products with additional treatments to be cost-justified under a required cost-testing model, they may not cover our products for their populations or, if they do, the level of reimbursement may not be sufficient to allow us to sell our products on a profitable basis. 30 Table of Contents Reimbursement for the treatment of patients with medical devices around the world is governed by complex mechanisms established on a national or sub-national level in each country.
We may pursue additional funding through various financing sources, including additional equity offerings, the issuance of debt securities, fees associated with licensing some or all of our technology, joint ventures with capital partners and project type financing. There can be no assurance that funds will be available on commercially reasonable terms, if at all.
We cannot give any assurance that we will be able to obtain all the necessary funding that we may need. We may pursue additional funding through various financing sources, including additional equity offerings, the issuance of debt securities, fees associated with licensing some or all of our technology, joint ventures with capital partners and project type financing.
Medicare’s publication of reimbursement amounts for our products that are below our products’ established prices could materially reduce our revenues and operating results with respect to non-Medicare payers in the U.S. and our other active markets. Even if our products were authorized by Medicare, CMS requires prior authorization for certain DME items.
Medicare fee schedules are frequently referenced by private payers in the U.S. and around the world. Medicare’s publication of reimbursement amounts for our products that are below our products’ established prices could materially reduce our revenues and operating results with respect to non-Medicare payers in the U.S. and our other active markets.
Our business may be adversely affected by the state of the global economy, uncertainties in global financial markets, and possible trade tariffs and trade restrictions. Our operations and performance will depend significantly on worldwide economic and geopolitical conditions.
These factors raise substantial doubt about our ability to continue as a going concern. 22 Table of Contents Our business may be adversely affected by the state of the global economy, uncertainties in global financial markets, and possible trade tariffs and trade restrictions. Our operations and performance will depend significantly on worldwide economic and geopolitical conditions.
Claims for such items that did not receive prior authorization before they were furnished to a beneficiary will be automatically denied.
Even if our products were authorized by Medicare, CMS requires prior authorization for certain DME items. Claims for such items that did not receive prior authorization before they were furnished to a beneficiary will be automatically denied.
The inability to obtain adequate financing from debt or capital sources in the future could force us to self-fund strategic initiatives or even forego certain opportunities, which in turn could potentially harm our performance.
It is difficult to predict whether or how these orders will be rescinded and replaced under the current or future administrations. The inability to obtain adequate financing from debt or capital sources in the future could force us to self-fund strategic initiatives or even forego certain opportunities, which in turn could potentially harm our performance.
For example, on March 10, 2023, Silicon Valley Bank, or SVB, was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation, or the FDIC, as receiver. Similarly, on March 12, 2023, Signature Bank Corp., or Signature, and Silvergate Capital Corp. were each swept into receivership.
For example, on March 10, 2023, Silicon Valley Bank (“SVB”) (now a division of First Citizens Bank), was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation, or the FDIC, as receiver, which has been followed by the collapse of Signature Bank Corp. (“Signature”), Silvergate Capital Corp. and First Republic Bank.
Our products may in the future be subject to product recalls that could harm our reputation, business, and financial results. The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture.
The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture.
U.S. legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained.
We may not be able to procure alternative components or adequate raw material inventories which would result in an inability to produce our device. U.S. legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained.
Continued economic slowdowns or recessions and inflationary pressures could have a negative impact on our business, including decreased demand, increased costs, and other challenges. Government actions to address economic slowdowns and increased inflation, including increased interest rates, also could result in negative impacts to our growth.
Additionally, increased inflation around the world, including in the United States, applies pressure to our costs. Continued economic slowdowns or recessions and inflationary pressures could have a negative impact on our business, including decreased demand, increased costs, and other challenges.
Identifying third-party patent rights can be particularly difficult because, in general, patent applications can be maintained in secrecy for a prolonged period after their earliest priority date. Historically, there has been substantial litigation regarding patents and other intellectual property rights in the medical device and related industries.
Third parties may claim that our products infringe their patents and other intellectual property rights. Identifying third-party patent rights can be particularly difficult because, in general, patent applications can be maintained in secrecy for a prolonged period after their earliest priority date.
There are a number of component parts used in the manufacture of our device that are used by many manufacturers in a variety of products. We will compete with other manufacturers for the supply of these components. Additionally, certain parts that are currently in our design may be discontinued by our supplier requiring us to find alternative parts.
We will compete with other manufacturers for the supply of these components. Additionally, certain parts that are currently in our design may be discontinued by our supplier requiring us to find alternative parts. This issue may require us to change the design of our device or purchase significant inventories of these parts in order to protect against manufacturing delays.
Such a situation could be costly, and time-consuming, and could be distracting for our management team. 32 Table of Contents If securities or industry analysts do not publish research or reports about us, or if they adversely change their recommendations regarding our common stock, then our stock price and trading volume could decline.
If securities or industry analysts do not publish research or reports about us, or if they adversely change their recommendations regarding our common stock, then our stock price and trading volume could decline. The trading market for our common stock is influenced by the research and reports that industry or securities analysts publish about us, our industry and our market.
Reimbursement for the treatment of patients with medical devices around the world is governed by complex mechanisms established on a national or sub-national level in each country. These mechanisms vary widely among countries, can be informal, somewhat unpredictable, and evolve constantly, reflecting the efforts of these countries to reduce public spending on healthcare.
These mechanisms vary widely among countries, can be informal, somewhat unpredictable, and evolve constantly, reflecting the efforts of these countries to reduce public spending on healthcare. As a result, obtaining and maintaining reimbursement for the treatment of patients with medical devices has become more challenging globally.
It is impossible to predict whether legislative changes will be enacted, or FDA regulations, guidance or interpretations changed, and what the impact of such changes, if any, may be.
It is impossible to predict whether legislative changes will be enacted, or FDA regulations, guidance or interpretations changed, and what the impact of such changes, if any, may be. Failure to secure and maintain adequate coverage and reimbursement from third-party payers could adversely affect acceptance of our products, if approved, and reduce our revenues.
If we cannot provide reliable financial reports or prevent fraud, our business and operating results could be harmed, investors could lose confidence in our reported financial information, and the trading price of our common stock, if a market ever develops, could drop significantly. 23 Table of Contents Our Certificate of Incorporation and Bylaws, each as amended to date, provide for indemnification of officers and directors at the expense of the Company and limit their liability that may result in a major cost to us and hurt the interests of our stockholders because corporate resources may be expended for the benefit of officers and/or directors.
Our Certificate of Incorporation and Bylaws, each as amended to date, provide for indemnification of officers and directors at the expense of the Company and limit their liability that may result in a major cost to us and hurt the interests of our stockholders because corporate resources may be expended for the benefit of officers and/or directors.
Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results. 27 Table of Contents Certain parts used in the manufacturing of our equipment may experience shortages in global supply which could impact our ability to manufacture our device for customers or maintain research and development timelines.
Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results.
Risks Related to Government Regulation and Product Approvals There is no guarantee that the FDA will grant 510(k) or de novo clearance or a premarket approval application ( “ PMA ” ) of our future products and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business.
Similarly, there have been discussions of "reigning in" regulatory agencies such as the Federal Trade Commission, the Federal Communications Commission and the Federal Energy Regulatory Commission, all of which could impact how companies do business and could pose risks related to our business operations and financial outlook. 26 Table of Contents There is no guarantee that the FDA will grant 510(k) or de novo clearance or a premarket approval application ( “ PMA ” ) of our future products and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business.
We plan to conduct our initial Proof of Concept trial outside the United States and to present the relevant data from this trial to the FDA in an effort to minimize the clinical requirements for clearance in the United States. There is no assurance that the FDA will accept this data.
We plan to present the relevant data from this trial to the FDA to support the clinical requirements for clearance in the United States. However, there is no assurance that the FDA will accept this data. Human trials are often designed to begin with a Proof of Concept (“PoC”) trial and then progress to a “Pivotal” or approval, trial.
As a result, obtaining and maintaining reimbursement for the treatment of patients with medical devices has become more challenging globally. We cannot guarantee that the use of our products will receive reimbursement approvals and cannot guarantee that our existing reimbursement approvals will be maintained in any country.
We cannot guarantee that the use of our products will receive reimbursement approvals and cannot guarantee that our existing reimbursement approvals will be maintained in any country.
If investors were to find our common stock less attractive as a result of our election, we may have difficulty raising all of the proceeds in any future offering. The market price of our stock may be highly volatile, and you could lose all or part of your investment.
We cannot predict if investors will find our securities less attractive due to our reliance on these exemptions. If investors were to find our common stock less attractive as a result of our election, we may have difficulty raising all of the proceeds in any future offering.
We have never declared or paid cash dividends on our capital stock.
We do not intend to pay cash dividends on our common stock in the foreseeable future. We have never declared or paid cash dividends on our capital stock.
Risks Related to Information Technology Our business and operations would suffer in the event of third-party computer system failures, cyber-attacks on third-party systems or deficiency in our cyber security.
Risks Related to Information Technology • Our business and operations would suffer in the event of third-party computer system failures, cyberattacks on third-party systems or deficiency in our cybersecurity; • Artificial intelligence presents risks and challenges that can impact our business, including by posing security risks to our confidential information, proprietary information and personal data; and • Cybersecurity risks and cyber incidents could adversely affect our business and disrupt operations.
Any delay or termination of our clinical trials will delay the filing of our product submissions and, ultimately, our ability to commercialize our product candidates and generate revenues. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.
Any delay or termination of our clinical trials will delay the filing of our product submissions and, ultimately, our ability to commercialize our product candidates and generate revenues.
If we were to be sued, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business. Your ownership may be diluted if additional capital stock is issued to raise capital, to finance acquisitions or in connection with strategic transactions.
If we were to be sued, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business. 36 Table of Contents
Upon completion, we plan to present the relevant data from this study to the FDA in a pre-submission meeting to request “Breakthrough Status” in an effort to minimize the clinical requirements for clearance in the United States.
We plan to present the relevant data from this trial to the FDA to support the clinical requirements for clearance in the United States.
As a small-cap company who has recently completed its IPO pursuant to Regulation A, we are more likely than our larger competitors to lack coverage from securities analysts.
If no analyst elects to cover us and publish research or reports about us, the market for our common stock could be severely limited and our stock price could be adversely affected. As a small-cap company who has recently completed its IPO pursuant to Regulation A, we are more likely than our larger competitors to lack coverage from securities analysts.
CMS is expected to issue rules regarding coverage of emerging technologies; however, no specific information is available about the content of the expected rules and we cannot provide any assurance that any new rules regarding emerging technologies would be applicable to our future products.
CMS is expected to issue rules regarding coverage of emerging technologies; however, no specific information is available about the content of the expected rules and we cannot provide any assurance that any new rules regarding emerging technologies would be applicable to our future products. 31 Table of Contents Risks Related to Intellectual Property If third parties claim that our products infringe their intellectual property rights, we may be forced to expend significant financial resources and management time defending against such actions and our financial condition and our results of operations could suffer.
If we have difficulty enrolling and retaining a sufficient number or diversity of patients to conduct our clinical studies as planned, or encounter other difficulties, we may need to delay, terminate or modify ongoing or planned clinical studies, any of which would have an adverse effect on our business. 25 Table of Contents Even if our products are cleared or approved by the FDA, if we or our suppliers fail to comply with ongoing FDA requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.
If we have difficulty enrolling and retaining a sufficient number or diversity of patients to conduct our clinical studies as planned, or encounter other difficulties, we may need to delay, terminate or modify ongoing or planned clinical studies, any of which would have an adverse effect on our business. 28 Table of Contents We may have limitations in generating statistically significant long-term clinical data and gaining extended-duration indications from clinical studies involving terminal patients.
We will require significant capital to complete clinical trials, seek approval of our products, mount a major sales and marketing effort and execute our business plan. We cannot give any assurance that we will be able to obtain all the necessary funding that we may need.
We believe our existing capital resources, will be sufficient to fund our operations into the first calendar quarter of 2026 without additional capital infusion. We will require significant capital to complete clinical trials, seek approval of our products, mount a major sales and marketing effort and execute our business plan.
There is no assurance that the FDA will accept the data from our international trial or that they will not require us to conduct additional studies to supplement this trial.
Additionally, there is no assurance that the FDA will accept the data from our international trial or that they will not require us to conduct additional Early Feasibility Studies (“EFS”) to supplement a pivotal trial. Any additional trials required by the FDA could be costly, time-consuming, and may necessitate raising additional financing, for which we have no commitments.
Recent global economic slowdowns could continue and potentially result in certain economies dipping into economic recessions, including in the United States. Additionally, increased inflation around the world, including in the United States, applies pressure to our costs.
Recent global economic slowdowns could continue and potentially result in certain economies dipping into economic recessions, including in the United States. A weak or declining economy may in the future strain our manufacturers or suppliers, possibly result in supply disruptions.
These rights, preferences and privileges could negatively affect the rights of holders of our common stock, and the right to convert such preferred stock into shares of our common stock at a rate or price that would have a dilutive effect on the outstanding shares of our common stock. Item 1B. Unresolved Staff Comments. None.
These rights, preferences and privileges could negatively affect the rights of holders of our common stock, and the right to convert such preferred stock into shares of our common stock at a rate or price that would have a dilutive effect on the outstanding shares of our common stock. 34 Table of Contents We may be required to issue up to 271,846 shares of common stock in connection with the reverse stock split we completed on October 24, 2024, and we may be subject to potential liability if it is determined that we are required to issue such shares and we fail to issue such shares on a timely basis.
To the extent that any of our staff were previously employed by other pharmaceutical, medical technology or biotechnology companies, those employers may allege violations of trade secrets and other similar claims in relation to their medical device development activities for us. 28 Table of Contents Because of the specialized nature of our business, the termination of relationships with our key employees, consultants and advisors may prevent us from successfully operating our business, including developing our products, conducting clinical studies, commercializing our products and obtaining any necessary financing .
To the extent that any of our staff were previously employed by other pharmaceutical, medical technology or biotechnology companies, those employers may allege violations of trade secrets and other similar claims in relation to their medical device development activities for us. We may not be able to protect our intellectual property rights throughout the world. We are dependent on patents.
If one or more analysts who elect to cover us issue negative reports or adversely change their recommendations regarding our common stock, our stock price could decline. As an “ emerging growth company ” under the Jumpstart Our Business Startups Act, or JOBS Act, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements.
If one or more analysts who elect to cover us issue negative reports or adversely change their recommendations regarding our common stock, our stock price could decline. The market price of our stock may be highly volatile, and you could lose all or part of your investment.
Removed
Item 1A. Risk Factors. Risks Related to Our Overall Business The report of our independent registered public accounting firm expresses substantial doubt about our ability to continue as a going concern.
Added
Item 1A. Risk Factors. Summary of Risk Factors: Below is a summary of the principal factors that make an investment in our Company speculative or risky. This summary does not address all of the risks that we face.
Removed
We believe that the net proceeds we received in our IPO of $9.8 million, along with our existing capital resources, will be sufficient to fund our operations into the first quarter of 2025 without additional capital infusion.
Added
Additional discussion of the risks summarized in this risk factor summary and other risks that we face, can be found below, after this summary, and should be carefully considered, together with other information in this Annual Report on Form 10-K and our other filings with the SEC, before making an investment decision in our securities.
Removed
General trade tensions between the United States and China have been escalating, and any economic and political uncertainty caused by the United States tariffs imposed on goods from China, among other potential countries, and any corresponding tariffs or currency devaluations from China or such other countries in response, may negatively impact, demand and/or increase the cost for our future products.
Added
Risks Related to Our Overall Business • Factors raise substantial doubt about our ability to continue as a going concern; • We have no approved products, and we cannot assure you that we will generate revenue or become profitable in the future; • We will need additional financing over the longer term to execute our business plan and fund operations, which additional financing may not be available on reasonable terms or at all; • We intend to utilize a single manufacturer for the manufacture of our lead product candidate and expect to continue to do so for commercial products.
Removed
Although the Department of the Treasury, the Federal Reserve and the FDIC ensured that all depositors of SVB would have access to all of their money after only one business day of closure, including funds held in uninsured deposit accounts, borrowers under credit agreements, letters of credit and certain other financial instruments with SVB, Signature or any other financial institution that is placed into receivership by the FDIC may be unable to access undrawn amounts thereunder.
Added
Risks associated with the manufacturing of our products could reduce our gross margins and negatively affect our operating results; • We are a developmental stage Company and have not yet had a history of generating revenue; • Our business may be adversely affected by the state of the global economy, uncertainties in global financial markets, and possible trade tariffs and trade restrictions; • We have limited experience in assembling and testing our products and may encounter problems or delays in the assembly of our products or fail to meet certain regulatory requirements which could result in an adverse effect on our business and financial results; • Rapidly changing technology in life sciences could make the products we are developing obsolete; • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations; • We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights; • Catastrophic events and disaster recovery may disrupt business continuity; • We may fail to meet the Sarbanes-Oxley regulations and may lack the financial controls and safeguards required of public companies; • While our Company’s management is working to improve our internal controls and procedures, at present management has determined that our internal controls were deemed to be inadequate, which could cause our financial reporting to be unreliable and lead to misinformation being disseminated to the public; • Because of the specialized nature of our business, the termination of relationships with our key employees, consultants and advisors may prevent us from successfully operating our business, including developing our products, conducting clinical studies, commercializing our products and obtaining any necessary financing; and • Our Certificate of Incorporation and Bylaws, each as amended to date, provide for indemnification of officers and directors at the expense of the Company and limit their liability that may result in a major cost to us and hurt the interests of our stockholders because corporate resources may be expended for the benefit of officers and/or directors.
Removed
Department of Treasury, FDIC and Federal Reserve Board have announced a program to provide up to $25 billion of loans to financial institutions secured by certain of such government securities held by financial institutions to mitigate the risk of potential losses on the sale of such instruments, widespread demands for customer withdrawals or other liquidity needs of financial institutions for immediately liquidity may exceed the capacity of such program.
Added
Risks Related to Government Regulation and Product Approvals • Changes to United States federal and state regulatory agencies may cause disruptions and delays in approval of the government approval processes and regulation relating to our products; • There is no guarantee that the FDA will grant 510(k) or de novo clearance or a premarket approval application (“PMA”) of our future products and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business; • Our product development for our sensing and ablation technologies may not meet the necessary validation requirements to achieve regulatory approvals, or our internal specifications for commercial viability; • Modifications to our future products may require new regulatory clearances or approvals or may require us to recall or cease marketing our products until clearances or approvals are obtained; • The results of our future clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects; • We are conducting our initial Proof of Concept trial outside the United States using commercially available RF ablation equipment in a new anatomical region to assess clinical response.
Removed
Human trials are often designed to begin with a Proof of Concept trial and then progress to a “Pivotal” or approval, trial. We intend our Proof of Concept trial outside the United States.
Added
However, there is no assurance that the FDA will accept this data; • Our clinical studies could be delayed or otherwise adversely affected by many factors, including difficulties in enrolling patients; • We may have limitations in generating statistically significant long-term clinical data and gaining extended-duration indications from clinical studies involving terminal patients; • Even if our products are cleared or approved by the FDA, if we or our suppliers fail to comply with ongoing FDA requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market; • Our products may in the future be subject to product recalls that could harm our reputation, business, and financial results; • If our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions; • Certain parts used in the manufacturing of our equipment may experience shortages in global supply which could impact our ability to manufacture our device for customers or maintain research and development timelines; • U.S. legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained; • Failure to secure and maintain adequate coverage and reimbursement from third-party payers could adversely affect acceptance of our products, if approved, and reduce our revenues; • We may not be successful in securing and maintaining reimbursement codes necessary to facilitate accurate and timely billing for our products or physician services attendant to our products; • If we are unable to establish good relationships with physicians, our business could be negatively affected; and • There is no assurance that Medicare or the Medicare Administrative Contractors will provide coverage or adequate payment rates for our products. 20 Table of Contents Risks Related to Intellectual Property • If third parties claim that our products infringe their intellectual property rights, we may be forced to expend significant financial resources and management time defending against such actions and our financial condition and our results of operations could suffer; • If we are unable to protect the intellectual property used in our products, others may be able to copy our innovations which may impair our ability to compete effectively in our markets; • We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers; • If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected; and • We may not be able to protect our intellectual property rights throughout the world.

… 60 more changes not shown on this page.

Item 2. Properties

Properties — owned and leased real estate

1 edited+0 added−0 removed1 unchanged
We believe that our facilities are sufficient to meet our current needs and that suitable space will be available as and when needed. 36 Table of Contents
We believe that our facilities are sufficient to meet our current needs and that suitable space will be available as and when needed.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

6 edited+5 added−3 removed2 unchanged
Item 4. Mine Safety Disclosures. Not applicable. 37 Table of Contents PART II Item 5. Market for Registrant ’ s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Our common stock has been listed on the Nasdaq Capital Market ("Nasdaq") under the symbol “AMIX” since our initial public offering ("IPO") on January 29, 2024.
Item 4. Mine Safety Disclosures. Not applicable. 38 Table of Contents PART II Item 5. Market for Registrant ’ s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Our common stock has been listed on the Nasdaq Capital Market ("Nasdaq") under the symbol “AMIX” since our initial public offering ("IPO") on January 29, 2024.
Stock Performance Graph Autonomix is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information required under this item. Item 6. [Reserved]
Stock Performance Graph We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information required under this item. Item 6. [Reserved]
The terms of the warrants provide that a holder may conduct a cashless exercise of the warrants. For the year ended March 31, 2024, 19,824 shares of common stock were forfeited by shareholders through cashless exercises with an average price paid per share of $1.50.
The terms of the warrants provide that a holder may conduct a cashless exercise of the warrants. For the year ended March 31, 2025, 2,602 shares of common stock were forfeited by shareholders through cashless exercises with an average price paid per share of $0.20 .
Purchases of Equity Securities by the Issuer and Affiliated Purchasers We did not repurchase any of our equity securities during the year ended March 31, 2024. Shares Forgone to Satisfy Minimum Statutory Withholdings During the year ended March 31, 2024, shares of common stock were issued to shareholders as their warrants were exercised.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers We did not repurchase any of our equity securities during the year ended March 31, 2025. Shares Forgone to Pay Exercise Price of Shares During the year ended March 31, 2025, 892,432 shares of common stock were issued to shareholders as their warrants were exercised.
Holders of Common Equity As of May 17, 2024, we had approximately 2,000 stockholders of record of our common stock. This does not include beneficial owners of our common stock. Dividends We have never paid any dividends on our common stock.
Holders of Common Equity As of May 1, 2025, we had approximately 4,8 00 stockholders of record of our common stock. This does not include beneficial owners of our common stock. Dividends We have never paid any dividends on our common stock.
The issuance of the Notes, Bridge Financing Warrants and the Shares were made in reliance on the exemption provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) for the offer and sale of securities not involving a public offering, and/or Regulation D promulgated under the Securities Act.
All the securities were issued in reliance on the exemption provided by Section 4(a)(2) of the Securities Act for the offer and sale of securities not involving a public offering, and/or Regulation D promulgated under the Securities Act.
Removed
Recent Sales of Unregistered Securities During the year ended March 31, 2024, we issued the following unregistered securities: i) $2.0 million in unsecured, non-interest bearing convertible promissory notes (the “Notes”) and accompanying warrants (the “Bridge Financing Warrants”).
Added
Recent Sales of Unregistered Securities On March 17, 2025, we granted a new employee a ten-year option (the “Inducement Options”) to purchase 7,500 shares of common stock at an exercise price equal to the closing price of our common stock on the date of the employment.
Removed
The Notes provided that, on the closing date of the IPO, the outstanding principal would be automatically converted into common stock at the conversion price of $2.00.
Added
The option vests in four equal annual installments (or 1,875 shares each installment) on each of the succeeding four anniversary dates of the execution of the date of employment, provided the employee is employed by us on each vesting date.
Removed
Each dollar in principal amount of Notes purchased were accompanied by a five-year Bridge Financing Warrant to purchase 0.25 shares of common stock with an exercise price of $1.00 per share; and ii) 35,000 shares of restricted stock (the "Shares") for a consultant for purposes of providing business advisory services.
Added
On April 17, 2025, we granted a new employee a ten-year option (the “Inducement Options”) to purchase 5,000 shares of common stock at an exercise price equal to the closing price of our common stock on the date of the employment.
Added
The option vests in four equal annual installments (or 1,250 shares each installment) on each of the succeeding four anniversary dates of the execution of the date of employment, provided the employee is employed by us on each vesting date.
Added
The two Inducement Options above were granted outside of our 2023 Stock Plan as an inducement material to the employee entering into employment with us in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4).

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

31 edited+15 added−12 removed41 unchanged
We will monitor our peer group for circumstances that may require a change to the composition or make-up of the entities and will identify if/when more suitable companies whose stock prices are publicly available would be utilized in the calculation.
We will monitor our peer group for circumstances that may require a change to the composition or make-up of the entities and will identify if/when more suitable companies whose stock prices are publicly available would be utilized in the calculation.
Additionally, the Company received proceeds of $2.0 million in unsecured, non-interest bearing convertible promissory notes (the “Notes”) and accompanying warrants (the “Bridge Financing Warrants”) (collectively, the “Bridge Offering”) that will mature on December 31, 2025. On January 26, 2024, we completed our IPO of common stock.
Additionally, we received proceeds of $2.0 million in unsecured, non-interest bearing convertible promissory notes (the “Notes”) and accompanying warrants (the “Bridge Financing Warrants”) (collectively, the “Bridge Offering”) that will mature on December 31, 2025. On January 26, 2024, we completed our IPO of common stock.
We expect our general and administrative expenses to increase due to the IPO, the anticipated growth of our business and related infrastructure, as well as accounting, insurance, investor relations and other costs associated with being a public company. Advertising It is our policy to expense advertising costs as incurred.
We expect our general and administrative expenses to increase due to the anticipated growth of our business and related infrastructure, as well as accounting, insurance, investor relations and other costs associated with being a public company. Advertising It is our policy to expense advertising costs as incurred.
We believe that the following accounting policies are the most critical to aid in fully understanding and evaluating our reported financial results, and they require our most difficult, subjective or complex judgments, resulting from the need to make estimates about the effect of matters that are inherently uncertain. 41 Table of Contents Components of our Results of Operations and Financial Condition Operating expenses We classify our operating expenses into three categories: (i) research and development, (ii) general and administrative and (iii) warrant expense – termination agreement.
We believe that the following accounting policies are the most critical to aid in fully understanding and evaluating our reported financial results, and they require our most difficult, subjective or complex judgments, resulting from the need to make estimates about the effect of matters that are inherently uncertain. 43 Table of Contents Components of our Results of Operations and Financial Condition Operating expenses We classify our operating expenses into three categories: (i) research and development, (ii) general and administrative and (iii) warrant expense – termination agreement.
The significant judgments and assumptions to the Monte Carlo simulation include the Company’s stock price, volatility based on a selection of publicly held peer companies, discount rate, and a discount for lack of marketability. 42 Table of Contents Common Stock Fair Value – The fair value of our common stock price was determined through a back solve, solving for the stock price that results in the average total value of the Notes and the warrants being equal to the cash proceeds received in the transaction it was issued at across one million iterations of the simulation.
The significant judgments and assumptions to the Monte Carlo simulation include the Company’s stock price, volatility based on a selection of publicly held peer companies, discount rate, and a discount for lack of marketability. 44 Table of Contents Common Stock Fair Value – The fair value of our common stock price was determined through a back solve, solving for the stock price that results in the average total value of the Notes and the warrants being equal to the cash proceeds received in the transaction it was issued at across one million iterations of the simulation.
Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this Annual Report on Form 10-K. 38 Table of Contents Overview We are a development stage medical device development company focused on advancing innovative technologies for sensing and treating disorders relating to the nervous system.
Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this Annual Report on Form 10-K. 39 Table of Contents Overview We are a development stage medical device company focused on advancing innovative technologies for sensing and treating disorders relating to the nervous system.
Off-balance Sheet Arrangements As of March 31, 2024 and March 31, 2023, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
Off-balance Sheet Arrangements As of March 31, 2025 and March 31, 2024, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
Expected Term – The estimate of the expected term of awards was determined in accordance with the contractual term of the arrangement. 43 Table of Contents Expected Dividend Yield – We have not declared or paid any cash dividends and do not presently intend to pay any in the foreseeable future.
Expected Term – The estimate of the expected term of awards was determined in accordance with the contractual term of the arrangement. 45 Table of Contents Expected Dividend Yield – We have not declared or paid any cash dividends and do not presently intend to pay any in the foreseeable future.
Accounting for Warrants We issued warrants to purchase shares of common stock (i) in connection with the Bridge Offering, (ii) as part of selling agent compensation in 2024, and (iii) in connection with the Exclusive License Termination Agreement (the “Termination Agreement”).
Accounting for Warrants We issued warrants to purchase shares of common stock (i) in connection with the Bridge Offering, (ii) in connection with the Exclusive License Termination Agreement (the “Termination Agreement”), and (iii) as part of selling agent compensation in our IPO and as part of the November 2024 financing.
Research and Development (R&D). R&D expenses increased by $1.5 million compared to the same period in 2023, primarily due to clinical trial execution and product development cost. We expect to incur increased research and development costs in the future as we continue our clinical trial and product development efforts.
Research and Development ("R&D"). R&D expenses increased by $2.5 million compared to the same period in 2024, primarily due to clinical trial execution and product development cost. We expect to incur increased research and development costs in the future as we continue our clinical trial and product development efforts.
We have historically funded our operations from proceeds from debt and equity sales. In June 2023, we completed a financing with several accredited investors for the sale of 1,420,000 shares of common stock with gross proceeds of $2.8 million.
We have historically funded our operations from proceeds from debt and equity sales. In June 2023, we completed a financing with several accredited investors for the sale of 71,001 shares of common stock with gross proceeds of $2.8 million.
Advertising expenses are included within general and administrative expenses within the statement of operations. For the years ended March 31, 2024 and 2023, the Company recorded $1.7 million and $0.1 million, respectively. Stock-based compensation Stock-based compensation transactions are recognized as compensation expense in the statements of operations based on their fair values on the date of the grant.
Advertising expenses are included within general and administrative expenses within the statement of operations. For the years ended March 31, 2025 and 2024, the Company recorded less than $0.1 million and $1.8 million, respectively. Stock-based compensation Stock-based compensation transactions are recognized as compensation expense in the statements of operations based on their fair values on the date of the grant.
Cash used in investing activities Net cash used in investing activities was $19 thousand for the year ended March 31, 2024, related to the purchase of computer hardware and software. Net cash used in investing activities was $0 for the year ended March 31, 2023.
Cash used in investing activities Net cash used in investing activities was $14 thousand and $19 thousand, respectively, for the year ended March 31, 2025 and March 31, 2024, respectively, related to the purchase of computer hardware and software.
Our development efforts can be divided into to two sub parts: sensing and treatment , where sensing is focused on identifying neuronal activity that may be associated with a disorder with enough precision to enable targeted therapy with ablation.
Our development efforts can be divided into two parts: diagnostic sensing and therapeutic radiofrequency ablation, where diagnostic is focused on sensing and identifying disorder-related neuronal activity with enough precision to enable targeted therapy with ablation.
There can be no assurance that such a plan will be successful. 40 Table of Contents Summary of Cash Flows Cash used in operating activities Net cash used in operating activities was $6.6 million during the year ended March 31, 2024, consisting of a net loss of $15.4 million and a change in operating assets and liabilities of $0.1 million.
There can be no assurance that such a plan will be successful. 42 Table of Contents Summary of Cash Flows Cash used in operating activities Net cash used in operating activities was $8.3 million during the year ended March 31, 2025, consisting of a net loss of $11.4 million and an increase in operating assets and liabilities of $1.2 million.
G&A expenses increased by $4.0 million compared to the same period in 2023, primarily due to increases in advertising of $1.7 million related to our IPO, officer and employee compensation and benefits of $0.7 million, stock-based compensation of $0.6 million, professional fees of $0.6 million, legal fees of $0.2 million, insurance expense of $0.1 million and travel expense of $0.1 million.
G&A expenses increased by $1.6 million compared to the same period in 2024, primarily due to increases in officer and employee compensation and benefits of $1.5 million, stock-based compensation of $0.9 million, legal and professional fees of $0.4 million, insurance expense of $0.3 million, franchise tax of $0.3 million, board of directors compensation of $0.1 million offset by a decrease in advertising expense of $1.8 million related to our IPO in 2024 and travel and entertainment expense of $0.1 million.
Warrant expense – termination agreement We had warrant expense of $4.6 million related to a license termination agreement. See Note 2 - Warrant Liability and Fair Value of Financial Instruments to the financial statements for additional information. Warrant Expense – termination agreement was $0 during the same period in 2023 as there was no comparable instrument.
Warrant expense – termination agreement Warrant Expense – termination agreement was $0 in 2025. Warrant Expense – termination agreement was $4.6 million in 2024. related to a license termination agreement. See Note 2 - Warrant Liability and Fair Value of Financial Instruments to the financial statements for additional information.
In total, these benefits would amount to $0.8 million using the rate of compensation in effect at March 31, 2024.
In total, these benefits would amount to a range of $1.1 million to $1.6 million using the rate of compensation in effect at March 31, 2025.
Our first-in-class technology platform includes a catheter-based microchip-enabled sensing array that can detect and differentiate neural signals with a high degree of sensitivity as demonstrated in animal studies.
Our first-in-class technology platform includes a catheter-based microchip-enabled sensing array that can detect and differentiate neural signals with a high degree of sensitivity as demonstrated in animal studies. We are initially developing our technology for patients with pancreatic cancer, a condition that can cause debilitating pain and need a more effective solution.
Net cash used in operating activities was $1.9 million during the year endedMarch 31, 2023 , c ons isting of a net loss of $2.0 million and an increase in operating assets and liabilities of $0.1 million, which primarily consisted of an increase in accounts payable.
Net cash used in operating activities was $6.6 million during the year ended March 31, 2024 , c ons isting of a net loss of $15.4 million and an increase in operating assets and liabilities of $0.1 million.
Cash provided by financing activities Net cash provided by financing activities was $14.4 million for the year ended March 31, 2024, consisting of $10.9 million of gross proceeds from the sale of common stock related to our IPO, $2.8 million from the sale of common stock and $2.0 million of cash proceeds from convertible notes.
Net cash provided by financing activities was $14.4 million for the year ended March 31, 2024, consisting of $10.9 million of gross proceeds from our IPO, $2.8 million from a financing with several accredited investors and $2.0 million from the Notes. We also paid $1.3 million in issuance costs related to our IPO. Contractual Obligations and Commitments None.
We estimate that we will require additional financing of approximately $40 million to fund our operations through initial commercial launch. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.
The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.
We are initially focusing on the treatment of pain associated with pancreatic cancer and we have designed our commercialization efforts around this as our first proposed indication for use. We will need to raise additional capital to meet our obligations and execute our business plan.
Our plan of operations is primarily focused on developing our product candidate, with the product candidate in the proof-of-concept stage at this time. We are initially focusing on the treatment of pain associated with pancreatic cancer and we have designed our commercialization efforts around this as our first proposed indication for use.
Other Income/Expense Warrant liability mark-to-market We had expense for mark-to-market adjustments of warrants of $3.4 million. Warrant Liability - mark-to market adjustment was $0 during the same period in 2023 as there was no comparable instrument. Interest expense We had interest expense of less than $0.1 million, related to the amortization of debt discounts.
Other Income/Expense Warrant liability mark-to-market Warrant Liability - mark-to market adjustment was $0 in 2025. Warrant Liability - mark-to market adjustment was $3.4 million in 2024. Interest expense Interest expense was $0.2 million in 2025 and $0.1 million in 2024 related to the amortization of debt discounts.
In connection with the Termination Agreement, the Company agreed to register the resale of the shares of common stock underlying the Warrant. 39 Table of Contents Results of Operations for the Year Ended March 31, 2024 Compared to the Year Ended March 31, 2023 Below is a summary of the results of operations (in thousands): Year Ended March 31, Change Change 2024 2023 ( $ ) ( % ) Operating expenses: General and administrative $ 5,249 $ 1,245 $ 4,004 322 % Research and development 2,225 745 1,480 199 % Warrant expense - termination agreement 4,556 — 4,556 — Total operating expenses $ 12,030 $ 1,990 $ 10,040 505 % General and Administrative (G&A).
We will pay a commission to the Agent of 3.0% of the gross proceeds of the sale of the Shares sold under the ATM Agreement and reimburse the Agent for certain expenses. 40 Table of Contents Results of Operations for the Year Ended March 31, 2025 Compared to the Year Ended March 31, 2024 Below is a summary of the results of operations (in thousands): Year Ended March 31, Change Change 2025 2024 ( $ ) ( % ) Operating expenses: General and administrative $ 6,863 $ 5,249 $ 1,614 31 % Research and development 4,725 2,225 2,500 112 % Warrant expense - termination agreement — 4,556 (4,556 ) — Total operating expenses $ 11,588 $ 12,030 $ (442 ) -4 % General and Administrative ("G&A").
Interest expense was $0 during the same period in 2023 as there was no comparable instrument. Interest income We had interest income of $0.1 million. Interest income for the same period in 2023 was $0. Liquidity and Capital Resources On March 31, 2024, we had cash and working capital of $8.6 million.
Interest income Interest income was $0.4 million in 2025 and $0.1 million in 2024 due to relatively higher cash balances throughout the year in 2025 as compared to 2024. Liquidity and Capital Resources On March 31, 2025, we had cash of $9.1 million and working capital of $7.9 million.
We also paid $1.3 million in issuance costs related to our IPO. Net cash provided by financing activities was $0.7 million for the year ended March 31, 2023, comprised of $0.7 million from the sale of common stock. Contractual Obligations and Commitments None.
Cash provided by financing activities Net cash provided by financing activities was $8.8 million for the year ended March 31, 2025, consisting of $10.0 million of gross proceeds from the Offering. We also paid $1.1 million in issuance costs for this Offering and $0.2 million in issuance costs for a subsequent registration statement.
In parallel with this effort, we are currently conducting a first-in-human demonstration of transvascular ablation (without the use of our sensing technology) to relieve pain associated with pancreatic cancer. Once these two efforts are completed, we plan to bring sensing and treatment together in a pivotal clinical trial to enable the regulatory clearance and commercial launch of our technology.
In parallel with this effort, we completed our initial trial phase of our first-in-human proof-of-concept trial ("PoC 1") evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate pain in patients with pancreatic cancer pain, with the intent to bring sensing and treatment together in a future pivotal clinical trial to enable the commercial launch of our technology.
Our sensing catheter has already been developed sufficiently to demonstrate in animal models successful identification of a signal from a specific nerve before ablation and confirmation of termination of the signal from the treated nerve after ablation.
Our sensing technology has already successfully demonstrated, in animal models, the ability to successfully identify a signal from a specific nerve bundle before ablation and confirmation of termination of that signal from the treated nerves after ablation. We are now in the process of improving the design of this catheter to meet the standards required for human use.
We estimate our current cash resources are sufficient to fund our operations into but not beyond the first calendar quarter of 2025. Our plan of operations is primarily focused on developing our product candidate, with the product candidate in the proof-of-concept stage at this time.
As of March 31, 2025, we have sold 800 Shares pursuant to the ATM Agreement for net proceeds of approximately $1,746. We estimate our current cash resources are sufficient to fund our operations into but not beyond the first calendar quarter of 2026.
In the IPO, we sold a total of 2,234,222 shares of common stock at a purchase price of $5.00 per share for gross proceeds of $11.2 million and net proceeds of $9.8 million. On May 13, 2024, we cancelled 1,050 shares represented in the IPO for payment disputes.
In the IPO, we sold a total of 111,962 shares of common stock at a purchase price of $100.00 per share for gross proceeds of $11.2 million and net proceeds of $9.8 million. 41 Table of Contents On November 22, 2024, we completed a firm commitment underwritten public offering (the “Offering”) of: (i) 458,691 common units (the “Common Units”), each Common Unit consisting of one share of common stock and one series A warrant to purchase one share of common stock (the “Series A Warrants”); and (ii) 917,596 pre-funded units (the “Pre-Funded Units”) and together with the Common Units, the "Units", each Pre-Funded Unit consisting of one pre-funded warrant to purchase one share of common stock (the “Pre-Funded Warrant”) and one Series A Warrant.
Removed
We believe, if we can recreate these results in clinical trials, this will enable a method of transvascular targeting, treating, and confirming treatment of diseases involving the nervous system throughout the body that is not currently available and may be capable of filling a wide range of unmet medical needs.
Added
As a result of the positive results from PoC 1, we have expanded the protocol into a follow-on phase ("PoC 2"), now including pain management for additional visceral cancers, like pancreatic, gall bladder, liver, and bile duct, with potential further expansion in oncology, gastroenterology, and other sectors, as well as earlier stage pancreatic cancer patients experiencing moderate to severe pain.
Removed
We calculate sensitivity in units of minimum signal detection voltage in micro volts (uV) time area of the electrode (square millimeters). It is a combined measure that is related to the signal resolving power and spatial resolution of the system.
Added
Recent Developments On February 28, 2025, we entered into an At Market Issuances Sales Agreement (the “ATM Agreement”) with Ladenburg Thalmann & Co. Inc. (the “Agent”).
Removed
For the BSC Orion, the nearest device on the market, the metrics are 10uV for signal detection levels, and roughly 0.4mm by 0.5mm for the electrode dimensions. For the Autonomix device, the metrics are We are initially developing our technology for patients with pancreatic cancer, a condition that can cause debilitating pain and need a more effective solution.
Added
Pursuant to the terms of the ATM Agreement, the we may sell from time to time through the Agent, as sales agent or principal, shares of our common stock with an initial aggregate sales price of up to $2.1 million (the “Shares”).
Removed
While the treatment may vary depending on the disorder, in our initial indications this will involve energy-based ablation (deliberate tissue damage, also referred to as denervation) intended to stop unwanted neuronal activity.
Added
Any sale of Shares pursuant to the ATM Agreement will be made under our “shelf” registration statement on Form S-3 filed on February 28, 2025 with the Securities and Exchange Commission.
Removed
We are now in the process of improving the assembly of this catheter to meet the standards required for human use and developing an RF ablation catheter designed specifically for treatment in the vessels of the pancreatic region.
Added
Under the ATM Agreement, we may sell Shares through the Agent by any method that is deemed an “at the market offering” (as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended).
Removed
As stated above, we are a development stage company and there is no guarantee that the results of any trials will produce positive results or that the results will support our claims. Recent Developments On January 26, 2024, we consummated our IPO.
Added
Under the ATM Agreement, the Agent will also be able to sell shares of common stock by any other method permitted by law, including in negotiated transactions with our prior written consent.
Removed
In connection with the closing of the IPO, a portion of our convertible notes were converted into 335,000 shares of our common stock.
Added
The purchase price of each Common Unit was $6.540, and the purchase price of each Pre-Funded Unit was $6.539. In addition, we granted the underwriters in the Offering a 45-day option to purchase an additional 206,422 shares of common stock, and/or an additional 206,422 Series A Warrants, solely to cover over-allotments, if any.
Removed
Upon the closing of the IPO, certain notes were to be automatically converted according to their terms into our common stock to the extent and provided that certain holders of these notes are not permitted to convert such notes to the extent that the holders or any of its affiliates would beneficially own in excess of 4.99% of our common stock after such conversion.
Added
The Pre-Funded Warrants have an exercise price of $0.001 per share, are immediately exercisable and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full.
Removed
Due to this 4.99% limitation, principal representing $1.3 million, or 665,000 shares, of these notes remains outstanding. On January 26, 2024, as part of our IPO, we issued a warrant to purchase 59,765 shares pursuant to the agreement with the selling agent in our IPO. These warrants equaled 2.675% of the 2,234,222 shares sold in our IPO.
Added
The Series A Warrants have an exercise price of $6.540 per share, are immediately exercisable and may be exercised at any time until the five-year anniversary of the date of issuance. Both the Pre-Funded Warrants and the Series A Warrants are subject to a beneficial ownership limitation of 4.99%. The Offering closed on November 25, 2024.
Removed
On January 29, 2024, we issued a warrant to purchase 1,600,000 shares (the “Warrant”) pursuant to the Termination Agreement noted in Note 6 – Related Party Transactions.
Added
On November 22, 2024, the underwriters partially exercised their over-allotment option with respect to 156,809 shares of common stock and 156,809 Series A Warrants. The aggregate gross proceeds, including the partial exercise of the over-allotment option, were approximately $10.0 million, before deducting underwriting discounts and other expenses by us of $1.5 million, including $0.5 million of non-cash expenses.
Removed
The shares underlying the Warrant are subject to a lockup agreement for a period of six months after the closing of the IPO with respect to 12.5% of the shares issued and twelve months after the closing of the IPO for the remainder of the shares.
Added
The net cash proceeds to us were approximately $9.0 million. On February 28, 2025, we entered into an ATM Agreement. Pursuant to the terms of the ATM Agreement, we may sell, from time to time, shares of our common stock with an initial aggregate sales price of up to $2.1 million (the “Shares”).
Removed
In the IPO, we sold a total of 2,234,222 shares of common stock at a purchase price of $5.00 per share for gross proceeds of $11.2 million and net proceeds of $9.8 million. On May 13, 2024, we cancelled 1,050 shares represented in the IPO for payment disputes.
Added
We will need to raise additional capital to meet our obligations and execute our business plan. We estimate that we will require additional financing in the range of $32 to $40 million to fund our operations through initial commercial launch.
Added
The change in operating assets and liabilities included sources of cash from a decrease in other current assets of $0.3 million and an increase in accounts payable of $0.2 million and accrued expenses of $0.7 million.
Added
Non-cash items consisted of stock-based compensation of $1.6 million, depreciation and amortization of $0.2 million and issuance of common stock, net of discount for lack of marketability of $0.1 million.
Added
The increases in accounts payable and accrued expenses were driven primarily by increased research and development costs for the development of our medical devices, general and administrative costs consisting of professional fees, officer compensation and legal expenses. The increase in other current assets was driven primarily by prepaid insurance costs.