BioSig Technologies Stock

BioSig Technologies, Inc. (BioSig Technologies or BioSig) operates as a medical device company.

The company is commercializing an advanced digital signal processing technology platform to deliver insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), the company is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives.

The company’s first product, the PURE EP System, is an FDA 510(k) cleared non-invasive class II device consisting of a unique combination of hardware and software designed to provide unprecedented signal clarity and precision for real-time visualization of intracardiac signals paving the way for personalized patient care. Integrating with existing systems in the EP lab, PURE EP is designed to accurately pinpoint even the most complex signals to maximize procedural success and efficiency.

PURE EP Software Version 6 with ACCUVIZ Module released late 2022, is the first to be designed and launched by the company’s new commercial and operations team and represents the most advanced iteration of the company’s digital signal processing technology. Software Version 6 delivers a new level of efficiency enabling unlimited, real-time analysis of intracardiac signals. In addition, the new ACCUVIZ Module introduces advanced signal processing automation, elevated visualization of clear cardiac signal information, and even smarter workflows.

PURE EP System’s software includes the company’s proprietary High Frequency Algorithm (HFA); a novel feature that identifies the key frequency components of cardiac data that can be difficult to identify within the traditional waveform presentation. A limitation of traditional systems is that they only display data as voltage over time. PURE EP adds visibility to cardiac frequency data. By focusing on signals above 200Hz, HFA aims to eliminate RF frequencies to retain clear focus on the signals targeted for ablation.

Other unique software functionalities—including Automatic Tachycardia Characterization (ATC) and TRUSOURCE Analysis & Report—aim to improve clinical workflow and deliver clear, actionable insights to electrophysiologist during cardiac catheter procedures.

By capturing critical cardiac signals—even the most complex, the PURE EP System is designed to enhance clinical decision-making and improve clinical workflow for all types of arrhythmias - even the most challenging procedures for cardiac arrhythmias, like ventricular tachycardia (VT) and atrial fibrillation (AF).

The PURE EP System is in a national commercial launch and in regular use at healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating.

In July 2022, the company entered into its first national purchasing agreement with HCA Management Services, L.P. whereby Kansas City Heart Rhythm Institute at Overland Park Regional Medical Center in Kansas City, Missouri acquired the company’s PURE EP System under the terms of the new agreement with a 30-month lease of the system. Following Overland Park, the San Antonio Methodist Hospital purchased the PURE EP System under the same terms in October 2022.

In August 2022, the company installed a second evaluation system at the Cleveland Clinic - both Main and Fairview campuses of Cleveland Clinic’s Heart, Vascular & Thoracic Institute are now evaluating PURE EP. The additional installation will support the medical center’s clinical evaluation of the PURE EP System and expand physician access to the company’s signal processing technology. Additionally, the company recently expanded its clinical footprint in the Midwest with evaluation agreements at leading medical centers in Illinois and Wisconsin.

On January 10, 2023, the company announced that Bellin Health entered into an agreement to acquire a PURE EP System. Through a formal evaluation, Bellin reported that clear cardiac signals positively impacted procedural efficiency resulting in cost savings per procedure.

In addition to clinical evaluation, the company has conducted pre-clinical evaluation with the PURE EP System under several protocols at Mayo Clinic in Rochester, Minnesota (including novel research programs such as Artificial Intelligence, or AI, and repolarization), the company also conducted studies at Mount Sinai Hospital in New York, New York, the University of Pennsylvania, and Cleveland Clinic. The company intends to continue additional research and development studies with the company’s technology at institutions including Mayo Clinic and Cleveland Clinic – a Research Agreement was signed with the Cleveland Clinic to explore expanded applications for the company’s digital signal processing technology.

Over 3,000 procedures have been performed using the PURE EP System with more than 80 physicians at 21 hospitals across the United States.

The company’s patent portfolio includes 25 (issued/allowed) issued utility patents (18 utility patents where BioSig is at least one of the applicants). Thirty four additional U.S. and foreign utility patent applications are pending covering various aspects of the company’s PURE EP System for recording, measuring, calculating and displaying of electrocardiograms during cardiac ablation procedures (thirty four U.S. and foreign utility patent applications where either BioSig, Mayo, or both is at least one of the applicants). Two of these pending U.S. patent applications are directed to artificial intelligence (AI). The company also has 30 issued worldwide design patents, which cover various features of the company’s display screens and graphical user interface for enhanced visualization of biomedical signals (30 design patents where BioSig is at least one of the applicants). Finally, of the 34 patent applications mentioned above, the company has licenses to 7 patents and 13 additional worldwide utility patent applications from Mayo Foundation for Medical Education and Research that are pending (7 patents and 13 applications where only Mayo is the applicant). These patents and applications are generally directed to electroporation and stimulation.

Product

The patented PURE EP System is designed to address long-standing limitations that slow and disrupt cardiac catheter ablation procedures, such as environmental lab noise from other equipment, signal saturation, slow signal recovery, and inaccurate display of fractionated potentials. PURE EP is a signal processing platform that combines advanced hardware and software to address known challenges associated to signal acquisition, to enable electrophysiologists to see more signals and analyze them in real-time. The device aims to minimize noise and artifacts from cardiac recordings and acquire high-fidelity cardiac signals. Improving fidelity of acquired cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and ablation procedures.

Cardiac catheter ablation is a procedure that involves delivery of energy through the tip of a catheter that scars or destroys heart tissue to correct heart rhythm disturbances. In August 2018, the company received 510(k) clearance from the FDA to market its PURE EP System.

The company’s PURE EP System can record raw (unaltered) cardiac signals with multiple display options, low noise, and a large input signal dynamic range. This is achieved using a low-noise amplifier topology with minimal filtering to band-limit the signal and a high-resolution A/D converter. In addition, the PURE EP System can provide large-signal (e.g., from a defibrillator) input protection and radio frequency (RF) signal (e.g., from ablation) noise suppression. There is no need for gain switching in this architecture, and the full range of input signals is digitized with high resolution.

The company’s PURE EP System was designed to be useful in arrhythmia diagnosis. For example, in atrioventricular reentrant tachycardia (AVRT) & AV nodal reentrant tachycardia (AVNRT), EP physicians often look for a slow pathway potential or accessory pathway potentials that are not easy to detect. Furthermore, during pacing maneuvers, important diagnostic signals may be buried inside the saturation artifact from the pacing electrode. The wide dynamic range of the PURE EP System may allow for better differentiation of those signals, as there is no system saturation and a quicker recovery to baseline.

The company is focused on improving intracardiac signal acquisition and enhancing diagnostic information for catheter ablation procedures for all arrhythmias, especially complex types like ventricular tachycardia, VT and atrial fibrillation, AF. VT is a fast, abnormal heart rate in the heart’s lower chambers. VT does not give your heart enough time to fill with blood before it contracts again. This can affect blood flow to the rest of your body and is potentially life-threatening. AF is the most common cardiac arrhythmia associated with a fivefold risk of stroke. AF occurs when the upper chambers of the heartbeat irregularly, and do not pump all of the blood to the lower chambers, causing some blood to pool and potentially form clots. If a clot breaks loose, it can travel through the bloodstream to the brain and lead to a stroke. Strokes related to AF are often more severe compared to strokes with other underlying causes.

PURE EP Software Version 6 with ACCUVIZ Module released late 2022, is the first to be designed and launched by the company’s new commercial and operations team and represents the most advanced iteration of the company’s digital signal processing technology. Software Version 6 delivers a new level of efficiency enabling unlimited, real-time analysis of intracardiac signals. In addition, the new ACCUVIZ Module introduces advanced signal processing automation, elevated visualization of clear cardiac signal information, and even smarter workflows.

PURE EP’s features may allow physicians to better determine precise ablation targets, strategy, and end point of procedures with the objective of reducing the need for patients to undergo multiple procedures, and to allow for less experienced EP physicians to perform more complex procedures. The PURE EP System is intended to operate in conjunction with the existing EP lab equipment.

Initial Analysis

To determine and validate the state of present electrophysiology recording technology in the field, the company completed a detailed analysis of the effect of filters used by existing EP recorders to reduce noise on spaciotemporal characteristics of electrocardiograms and intracardiac electrograms. The company evaluated the signal quality (amplitude, morphology and duration) of the different recorders, along with the ability of the recorders to reduce noise level and remove baseline wander, which are the cardiac signals that have shifted from the isoelectric line (the base line of the signal tracing). The electrocardiogram and intracardiac signals subjected to the PURE EP System’s signal processing showed less baseline wander, noise and artifacts compared to the conventional electrophysiology recorders. Further, spaciotemporal characteristics of signals were greatly distorted by the conventional electrophysiology system, particularly when a notch filter was used, as compared to the recording of the same spaciotemporal characteristics by the PURE EP System.

Proof of Concept Testing

In the second and third quarters of 2013, the company performed and finalized testing of its proof of concept unit by initially using an electrocardiogram/intracardiac simulator at the company’s lab, and subsequently by obtaining pre-clinical recordings from the lab at the University of California at Los Angeles. The company’s proof of concept unit performed well as compared to GE’s CardioLab recording system, in that the electrocardiogram and intracardiac signals displayed on the company’s proof of concept unit showed less baseline wander, noise and artifacts compared to signals displayed on GE’s CardioLab recording system. Subsequently, the company determined the final design of the PURE EP System prototype to use for end-user preference studies, additional pre-clinical studies and research studies.

Prototype Testing

The company has performed pre-clinical studies at Mayo Clinic since 2015 to validate technology within the PURE EP System prototype. These studies have been designed to determine clinical effectiveness for features within the PURE EP System. Since March 2016, the company has published nine manuscripts in collaboration with the physicians from Mayo Clinic evidencing the company’s pre-clinical findings. As of December 31, 2022, the company conducted a total of twenty-four pre-clinical studies with the PURE EP System, twenty-one of which were conducted at Mayo Clinic in Rochester, Minnesota. The company also conducted a pre-clinical study at the Mount Sinai Hospital in New York, NY with emphasis on the VT model; and two pre-clinical studies at the University of Pennsylvania in preparation for clinical studies to be conducted there.

Clinical Evaluations

In February 2019, the company conducted the first clinical cases with the company’s PURE EP System. The observational patient cases were performed by Andrea Natale, M.D., F.A.C.C., F.H.R.S., F.E.S.C., Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas. In April 2019, the company announced the completion of its second set of observational patient cases, which were performed at Prisma Health at Greenville Health System in South Carolina by Andrew Brenyo, MD, FHRS. Dr. Brenyo used the PURE EP System during procedures on patients with ischemic ventricular tachycardias, AF, PVC, and atypical flutters.

In May 2019, the company announced the completion of its third set of observational patient cases at Indiana University under the leadership of Prof. John M. Miller, M.D., and Dr. Mithilesh K. Das, MBBS. Drs. Miller and Das used the PURE EP System during procedures on patients with atypical flutter, atrioventricular nodal reentry tachycardia (AVNRT), AF, supraventricular tachycardia, premature ventricular contractions, and a rare case of dual septal pathway. In August 2019, observational patient cases at Santa Barbara Cottage Hospital in California were performed by Brett Andrew Gidney, M.D. The initial experience across these early evaluation centers showed the PURE EP System functions as designed with positive feedback from EP users about the improved signal detection and fidelity.

In November 2019, the company commenced its first clinical study for the PURE EP System titled, ‘Novel Cardiac Signal Processing System for Electrophysiology Procedures (PURE EP 2.0 Study).’ The PURE EP 2.0 Study was conducted at three U.S. hospitals: Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas, Mayo Clinic in Jacksonville, Florida and Massachusetts General Hospital in Boston, Massachusetts.

In April 2021, the company announced the completion of the enrollment in the PURE EP 2.0 Study. Intracardiac signal data of clinical interest were collected during 51 cardiac ablation procedures using the PURE EP System, the signal recording system, and the 3D mapping system at the same time stamps. The samples were randomized and subjected to blinded, head-to-head evaluation by three independent electrophysiologists to determine the overall quality and clinical utility of PURE EP signals when compared to conventional sources. Each reviewer responded to the same 235 signal comparisons using a 10-point rating scale.

In July 2022, the company entered into its first national purchasing agreement with HCA Management Services, L.P. whereby Kansas City Heart Rhythm Institute at Overland Park Regional Medical Center in Kansas City, Missouri acquired the company’s PURE EP System under the terms of the new agreement with a 30-month lease of the system. Following Overland Park, the San Antonio Methodist Hospital purchased the PURE EP System under the same terms in October 2022.

In August 2022, the company installed a second evaluation system at the Cleveland Clinic - both Main and Fairview campuses of Cleveland Clinic’s Heart, Vascular & Thoracic Institute are evaluating PURE EP. The additional installation will support the medical center’s clinical evaluation of the PURE EP System and expand physician access to the company’s signal processing technology. The PURE EP System was highlighted in a peer-reviewed case report by the Journal of Atrial Fibrillation & Electrophysiology (JAFIB-EP). This clinical abstract detailed the value of PURE EP and the company’s High Frequency Algorithm (HFA) during pulmonary vein isolation procedures at Cleveland Clinic.

On January 10, 2023, the company announced that Bellin Health entered into an agreement to acquire a PURE EP System. Through a formal evaluation, Bellin reported that clear cardiac signals positively impacted procedural efficiency resulting in cost savings per procedure.

In addition to clinical evaluation, the company has conducted pre-clinical evaluation with the PURE EP System under several protocols at Mayo Clinic in Rochester, Minnesota (including novel research programs, such as Artificial Intelligence, or AI, and repolarization). The company also conducted studies at Mount Sinai Hospital in New York, New York, the University of Pennsylvania, and Cleveland Clinic. The company intends to continue additional research and development studies with the company’s technology at institutions, including Mayo Clinic and Cleveland Clinic. A Research Agreement was signed with the Cleveland Clinic to explore expanded applications for the company’s digital signal processing technology.

Over 3,000 procedures have been performed using the PURE EP System with more than 80 physicians at 21 hospitals across the United States.

Commercialization of the PURE EP System

The company has developed a marketing strategy to introduce and support the company’s PURE EP System. The strategy includes the company’s presence (in-person and virtually) at leading industry events and scientific sessions, both nationally and internationally, for the purposes of physician education, PURE EP System’s demonstrations and select presentations of advanced R&D product pipeline.

The company has begun implementing a market development program to commercially launch the company’s PURE EP System. The company has installed PURE EP Systems at several medical centers of excellence throughout the U.S. during 2021 and 2022 (and will continue to do so in 2023) for clinical evaluation - whereby these systems are installed on a trial basis for system evaluations; data collection for the company’s clinical trials; to gather and publish data in peer-reviewed journals and for presentations at cardiology conferences; and for potential demonstrations to other physicians to observe the technology.

Health systems, facilities, and physicians that have conducted or observed cases performed with the company’s technology may potentially acquire the system. Sales of the company’s systems consist of hardware, software, and a recurring revenue feature through a technical service contract, including software upgrades, and down the line, include the AI-driven algorithms and applications. The company intends to support its commercial activities by growing clinical validation and educational and training programs, including establishing training hubs at the company’s early hospital partners’ facilities. With the increased commercialization activity planned, the company also plans to continue to grow its clinical account management team to support the initial use of the system and assist with ongoing product training and education, and have begun hiring a regional sales team to escalate the company’s commercialization efforts along with a technical support team.

The company will have ample inventory to meet planned commercial placement requirements in 2023. The company has made progress towards obtaining a European CE marking certificate for medical devices. In Q1 2022, the company completed the quality management system audit for the International Organization for Standardization (‘ISO’) 13485:2016.

Customers

In December 2020, the company announced that three PURE EP Systems were contracted for purchase by St. David’s Healthcare in Austin, Texas and were subsequently sold in February 2021. These units were the company’s first commercial sales. The company also sold three PURE EP Systems to Mayo Foundation for Medical Education and Research in 2021 and leased two PURE EP Systems in 2022, one in July 2022 to Overland Park Regional Medical Center and one in October 2022 to Methodist Hospital in San Antonio. In January 2023, the company entered into an agreement with Bellin Health in Wisconsin to acquire a PURE EP System. The company is in active discussions with several accounts about the acquisition of the PURE EP System. The company anticipates its following customers will be medical centers of excellence and other healthcare facilities that operate EP labs within the company’s targeted commercial launch markets in the Northeast, Florida, and Texas.

ViralClear Business

ViralClear Pharmaceuticals, Inc.

As of March 30, 2023, the company retained 69.08% ownership of ViralClear Pharmaceuticals, Inc. (‘ViralClear’).

ViralClear is an early stage medical device company that is developing N-SENSE, a novel sensing technology platform for high-speed electroneurogram (ENG) recordings. The specifications for this new product were based on the core competencies of the PURE EP signal processing technology, such as broad dynamic range of recorded signals and low signal-to-noise ratio and adapted to address disorders of the autonomic nervous systems through recordings and analysis of action potentials, the impulses along the membrane of a muscle cell or a nerve cell. These impulses are considered to carry valuable clinical information but may be difficult to detect through conventional recording platforms.

ViralClear aims to address the two main challenges of bioelectronic medicine devices: achieving accurate and targeted stimulation of specific nerves in a nerve bundle and implementing an effective feedback loop that can self-adjust for the optimal amount and timing of stimulation.

On December 18, 2020, the company signed a research agreement with the University of Minnesota launching a program to develop novel therapies to treat sympathetic nervous system disease. The program studies are expected to form a foundation for developing a new platform technology to address disorders of the autonomic nervous system. The company intends to develop new intellectual properties and products, including new hardware, software, and algorithmic solutions, with the support of Plexus, a tier 1 U.S.-based manufacturing partner and take it through FDA approval, manufacturing, and commercialization.

In February 2021, the company conducted its first preclinical experiment at the University of Minnesota. Further studies to record and evaluate relevant nerve activity were conducted in April and November 2021.

The company has partnered with Plexus to design, develop, and manufacture N-SENSE, a novel sensing and stimulation platform technology.

The company’s new product pipeline will focus on improving therapies through clearer ENG recordings – methods used to visualize directly recorded electrical activities of neurons in the central nervous system (brain, spinal cord) and/or the peripheral nervous system (nerves, ganglions). ENGs are usually obtained by placing an electrode directly in the neural tissue. ENGs consist of small, high frequency, low amplitude signals, which have been proven hard to detect with conventional signal recording systems.

The company’s business strategy is to utilize its core signal processing technology to develop superior ENG recording and processing systems and includes the following:

Develop N-SENSE, a novel nerve sensing and stimulation platform technology to be used in product candidates which qualify for a nerve mapping and stimulation treatments including, but not limited to, renal denervation, deep brain stimulation and vagus nerve stimulation.

Pursue licensing opportunities and partnerships to leverage the company’s expertise in high-fidelity signal processing for feedback loop systems for the development of products for commercial success.

The following clinical areas may benefit the most through the advancements in achieving accurate and targeted stimulation and implementation of an effective self-adjusting feedback loop:

Renal denervation (‘RDN’): RDN has been shown to reduce blood pressure and can be an effective treatment for resistant hypertension sufferers who have failed drug therapy. The technique has proven to be effective, but clinical endpoints are still suboptimal.

Potential Application: A device that can measure sympathetic nerve activity will inform the need and potential benefit for performing a procedure. Additionally, a device that can stimulate and elicit a sympathetic response, such as blood pressure, will aid in the assessment of nerve denervation success, and help determine if additional ablation is necessary. Therefore, a device that can perform stimulation on a number of channels, and record nerve activity is needed.

Deep Brain Stimulation (‘DBS’): DBS is a treatment that involves implanting electrodes (leads) within certain areas of the brain to deliver electrical pulses, which has demonstrated improvements in the treatment of movement disorders, such as the Parkinson’s disease, tremors and dystonia.

Potential Application: a new high-speed board-based platform for improved accuracy in lead implantation. Precise positioning of the electrodes during the surgical procedure is important in the success of lead implantation, and highly accurate signal readers can aid in the prediction of the activation of axons surrounding the implanted lead.

DBS may also be applicable to a substantial number of neurological and psychiatric disorders correlated with dysfunctional circuitry; comparable to a heart pacemaker that uses electric pulses to ultimately regulate brain activity.

Other applications under the company’s investigation include chronic pain management, ADHD, eating disorders, Alzheimer’s, addiction, epilepsy. Alzheimer’s as an application for DBS is undergoing clinical trials at several national and international institutions that target the hippocampal outflow pathways by increasing ACh availability, influencing the limbic system, and improving lead placements.

The company may seek additional research collaborations with other academic centers active in one or more fields of clinical interests described above.

NeuroClear Business

NeuroClear Technologies, Inc.

On July 2, 2020, the company formed an additional subsidiary, NeuroClear Technologies, Inc. (‘NeuroClear’), a Delaware corporation, to pursue additional applications of the PURE EP signal processing technology outside of cardiac electrophysiology. The company owns 100% of the outstanding shares of common stock as of March 30, 2022 and the subsidiary is dormant.

The company’s intention is to move the neurotech assets from ViralClear into NeuroClear where the current and future neurotech assets would be housed. The company intends to further develop the company’s nerve recording system and ultimately bring the technology to market under NeuroClear Technologies, Inc.

Intellectual Property

Patents

In November 2017, the company engaged 3LP Advisors LLC, now Sherpa Technology Group LLC as the company’s intellectual property advisor. The company has also retained Sterne Kessler Goldstein & Fox P.L.L.C., a patent firm based in Washington DC, to help develop and execute a strategy for the development of the company’s patent portfolio.

The company’s patent portfolio includes 25 (issued/allowed) issued utility patents (18 utility patents where BioSig is at least one of the applicants). Thirty four additional U.S. and foreign utility patent applications are pending covering various aspects of the company’s PURE EP System for recording, measuring, calculating and displaying of electrocardiograms during cardiac ablation procedures (thirty four U.S. and foreign utility patent applications where either BioSig, Mayo, or both is at least one of the applicants). Two of these pending U.S. patent applications are directed to artificial intelligence (AI). The company also has 30 issued worldwide design patents, which cover various features of the company’s display screens and graphical user interface for enhanced visualization of biomedical signals (30 design patents where BioSig is at least one of the applicants). Finally, of the 34 patent applications mentioned above, the company has licenses to 7 patents and 13 additional worldwide utility patent applications from Mayo Foundation for Medical Education and Research that are pending (7 patents and 13 applications where only Mayo is the applicant). These patents and applications are generally directed to electroporation and stimulation.

BioSig and ViralClear signed three patent and know-how license agreements with Mayo Foundation for Medical Education and Research in November 2019. Under the terms of such agreements, BioSig exclusively licensed additional patents and applications of the Mayo Clinic related to novel ways for ablation therapy and to treat autonomic nervous system disease, including hardware, software and algorithmic solutions to be integrated into the PURE EP platform technology. BioSig intends to take the licensed intellectual properties and products, which have been developed by Mayo Clinic over the last decade, through FDA approval, manufacturing, and commercialization. On March 5, 2021, the company announced that the U.S. Patent Office had allowed a utility patent that ViralClear has exclusively licensed from the Mayo Foundation for Medical Education and Research. The patent application number 16/805,017 entitled, ‘Systems and Methods for Electroporation’ was filed on February 28, 2020. The patent describes and claims methods and materials for improving the treatment of hypertension via electroporation of nerves in the renal area. Electroporation is an emerging technique that has demonstrated efficacy in treatments for several critical conditions and is being evaluated for the treatments of autonomic nervous disorders, including hyper- and hypotension / syncope.

Trademarks

The company’s trademark for ‘BIOSIG TECHNOLOGIES’ was registered on April 25, 2017. The company’s trademark for ‘PURE EP’ was registered on January 26, 2016. The company’s trademark for the standard mark, ‘BIOSIG’ was registered March 19, 2019.

On October 7, 2019, the company filed a standard mark trademark application for ‘SEE MORE, CLEARLY’ and received notice of acceptance of statement of use on February 25, 2023.

On October 22, 2020, the company filed a standard mark trademark application for ‘WCT+’ and the company filed a statement of use on November 11, 2022.

On October 22, 2020, the company filed a standard mark trademark application for ‘ACCUVIZ’ and the company filed a statement of use on November 11, 2022.

On November 5, 2018, the company filed a standard mark trademark application for ‘NEUROCLEAR’ and on January 29, 2019, NeuroClear filed a stylized/design trademark application for the NeuroClear logo; extensions for statements of use have been filed.

On October 4, 2019, the company filed a stylized/design trademark application for ‘ALLIANCE FOR ADVANCING BIOELECTRONIC MEDICINE’ and an extension for a statement of use has been filed.

On May 26, 2020, the company filed a standard mark trademark application for ‘N-SENSE’ and an extension for a statement of use has been filed.

On May 26, 2020, the company filed a standard mark trademark application for ‘N-SENSE TECHNOLOGIES’ and an extension for a statement of use has been filed.

In July 2021, the company received EU certificates of registration for the following trademarks: ACCUVIZ, WCT+, and COMBIO.

In July 2021, the company received UK certificates of registration for the following trademarks: SMARTFINDER, ACCUVIZ, WCT+, and COMBIO.

Suppliers

Plexus Corp is the company’s manufacturing partner for the complete PURE EP System.

Government Regulation

The company’s solutions include software and hardware, which will be used for patient diagnosis and, accordingly, are subject to regulation by the FDA and other regulatory agencies.

The company is subject to unannounced device inspections by the FDA, as well as other regulatory agencies overseeing the implementation of, and compliance with, applicable state public health regulations.

Research and Development Expenses

The company’s research and development expenses were $5,821,460 for the year ended December 31, 2022.

History

BioSig Technologies, Inc. was founded in 2009. The company was incorporated in 2009 under the laws of the state of Nevada. The company was subsequently re-incorporated in the state of Delaware in 2011.