What changed in this filing

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Item 1. Business

2025-03-31 compared with 2024-04-01 · 114 added, 173 removed, 329 unchanged (47% of the section changed)

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Accordingly, our current activities primarily relate to Old Catheter’s historical business which comprises the design, manufacture and sale of new and innovative medical technologies focused in the field of cardiac electrophysiology, or “EP.”

Our primary product is the VIVO System which is an anacronym for View into Ventricular Onset System(“VIVO” or “VIVO System”) which is a non-invasive imaging system that offers 3D cardiac mapping to help with localizing the sites of origin of idiopathic ventricular arrhythmias in patients with structurally normal hearts prior to EP procedures.

Our two primary products include the VIVO System and LockeT.

The VIVO System, which is an anacronym for View into Ventricular Onset System(“VIVO” or “VIVO System”) is a non-invasive imaging system that offers 3D cardiac mapping to help with localizing the sites of origin of idiopathic ventricular arrhythmias in patients with structurally normal hearts prior to EP procedures.

Our newest product, LockeT, is a suture retention device indicated for wound healing by distributing suture tension over a larger area in the patient in conjunction with a figure of eight suture closure.

LockeT is intended to temporarily secure sutures and aid clinicians in locating and removing sutures efficiently.

On January 24, 2025, we acquired PeriKard, LLC., a development stage company developing a kit of tools to enable physicians to more easily gain access to the pericardial space of the heart.

It is intended that the kit will have both a better needle system and a better drainage system than current alternatives.

The pericardium is the thin, fluid filled, sac that surrounds the heart.

The pericardium is made up of an outer layer of tissue that holds the heart in place within the chest, protects it from inflammation, and acts as a barrier to infection.

It also prevents the heart from stretching out and filling with too much blood which could constrict the heart and impede normal heart function in which case, access to the pericardium is needed to drain the excess fluid.

Access is also desirable for ablation to treat arrhythmias outside the heart wall.

PeriKard is currently in the product development phase.

Additional future royalty cash payments may be due to the seller equal to 10% of aggregate future net sales activity of PeiKard’s pericardial access kits, to the extent the product is successfully commercialized, for five years from the acquisition’s closing date.

Our product portfolio also includes the Amigo® Remote Catheter System, or Amigo, a robotic arm that serves as a catheter control device.

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We own the intellectual property related to Amigo, and this product is under consideration for future research and development of a generation 2 product.

We continue to evaluate potential product acquisitions from time to time that might prove complementary to our current portfolio.

Electrophysiology Market Overview

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The EP market includes large medical device companies such as Medtronic, Plc., Abbott Laboratories, Biosense-Webster (J&J) and Boston Scientific Corp.

and is estimated to be $15.1 billion by 2028 (CAGR of 13.0%).

Population growth, increasing rates of heart disease and the rising cost of healthcare are driving growth in the EP markets.

Within the EP market, we focus our products on the catheter ablation market.

The catheter ablation market was $3.2 billion in 2020 and estimated to grow to $6.4 billion in 2026.

The catheter ablation market is growing at a faster rate (12.4% CAGR) than the EP market as a whole.

Within the last 10 years, ventricular ablation has become a fast-growing treatment option.

Currently, there are about 80,000 ventricular ablations annually and VT ablations represent approximately 16% of ablations in the U.S.

Currently, the market is underserved, and this number is expected to increase to over 250,000 procedures by 2026.

The ventricular ablation market is expected to grow at a 21% CAGR through 2026, which is a faster rate than the global EP market and the catheter ablation market as a whole.

The growth in the ventricular ablation market is driven by an aging population, advances in EP technology as well as updated physician guidelines.

In September 2024, the Heart Failure Society of America ("HFSA") reported in the Journal of Cardiac Health that approximately 6.7 million Americans over the age of 20 currently live with heart failure, forecast to rise to 8.7 million by 2030.

The proportion of younger patients (aged 35-64) is rising faster than that of older patients driven in part by increasing obesity and hypertension rates amount younger patients, and the overall lifetime risk of heart failure for Americans has risen to 24%.

Within the EP market, we focus our products that address the catheter ablation market.

The catheter ablation market was $3.5 billion in 2022 and is estimated by Global Market Insights to grow to $14.5 billion in 2032.

This market includes medical devices used for atrial and ventricular ablation procedures.

Within the last 10 years, ventricular ablation has become a fast-growing treatment option due to updated treatment guidelines, improved technology and raising incidence rates.

However, the exact number of ventricular ablations performed is not well documented.

The ventricular ablation market is estimated by Global Market Insights to grow at a rate of 14.5% CAGR through 2032.

Over a ten-year period, one study in Australia demonstrated a growth of 18% for ventricular tachycardia.

Of note, this surpassed the growth rate of atrial fibrillation (12.7%) which has historically been the largest incidence of cardiac arrhythmias.

The Heart Rhythm Society, or HRS, Expert Consensus Statement on Catheter Ablation of Ventricular Arrhythmias, published in May 2019 recommends catheter ablation in preference to anti arrhythmic drugs or in the situation where anti arrhythmic therapy has failed or is not tolerated.

The guidelines also recommend ablation for reducing recurrent VT and implantable cardioverter-defibrillator shocks.

The guidelines also recommend ablation for reducing recurrent ventricular tachycardia, or VT, and implantable cardioverter-defibrillator shocks.

Existing Treatments and Methods for Catheter Ablations

Traditionally, the first line of treatment for cardiac arrhythmias is medication.

Unfortunately, this is not a permanent fix and most patients eventually need a catheter ablation.

However, this is often not a permanent fix and many patients eventually need a catheter ablation.

In September 2024, the New England Journal of Medicine published clinical trial results which compared the number of adverse events in patients treated with catheter ablation versus patients treated with drug therapy.

The trial found that patients treated with catheter ablation had suffered 50% fewer adverse events at the median follow-up period of 4.3 years than patients treated with drug therapy.

Catheter Ablation Procedure Overview

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Treatment Challenges for Ventricular Arrhythmias

Treatment of ventricular ablations with cardiac ablations is a relatively new treatment option.

As a result, we believe that the patient population is underserved and is not as well understood, and the available techniques and technologies are limited when compared to the atrial ablation options.

Treatment of ventricular arrhythmias with cardiac ablations is a relatively new treatment option.

As a result, we believe that the patient population is underserved, the condition is not as well understood, and the available techniques and technologies are limited when compared to the atrial ablation options.

Ablation locations within the ventricle are very difficult to identify.

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Even when a patient has frequent ventricular arrhythmias, the process of pace-mapping often takes 4 – 5 hours to identify the location for ablation, which can increase the likelihood of patient complications due to the extended time under anesthesia.

Lastly, many patients with untreated ventricular arrhythmias cannot tolerate anesthesia well, thus invasive mapping that takes a long time is not an option for them.

Lastly, many patients with untreated ventricular arrhythmias cannot tolerate anesthesia well, thus invasive mapping may not be an option for them.

Treatment Challenges for Atrial Arrhythmias

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According to a study entitled “ Long Term Outcomes of Catheter Ablation of Atrial Fibrillation:

A Systematic Review and Meta- Analysis” published in the Journal of American Heart Association on March 18, 2013, which looked at multiple individual studies covering over 6,000 patients, “single procedure freedom from atrial fibrillation at long term follow up was 53.1%.” The same study found “with multiple procedures performed, the long-term success rate was 79.8%.” Ineffective treatment may result in patients undergoing two or more EP procedures to achieve relief from atrial fibrillation at an estimated cost in the range of $20,000 or more per procedure.

A Systematic Review and Meta- Analysis ” published in the Journal of the American Heart Association on March 18, 2013, which looked at multiple individual studies covering over 6,000 patients, “single procedure freedom from atrial fibrillation at long term follow up was 53.1%.” The same study found “with multiple procedures performed, the long-term success rate was 79.8%.” Ineffective treatment may result in patients undergoing two or more EP procedures to achieve relief from atrial fibrillation at an estimated cost in the range of $20,000 or more per procedure.

Specific reasons have not been proven for the lower success rate of initial ablation procedures.

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Our Vivo System is focused on the controlled delivery of these catheter technologies to enhance both the performance of ablation procedures and the ease and safety for the physicians who perform them.

A recent peer-reviewed multicenter study sponsored by Biosense Webster, entitled “Paroxysmal AF Catheter Ablation with a Contact Force Sensing Catheter” published in 2014 found that catheter ablation success rates can be as high as 80% when the physician is able to maintain stable contact force within investigator selected working ranges.

“When the CF (contact force) employed was between investigator selected working ranges > 80% of the time during therapy, outcomes were 4.25 times more likely to be successful.” Further, “stable CF during radiofrequency application increases the likelihood of twelve-month success.” However, it should be noted that, using manually controlled methods, the physicians in the study could only maintain optimal tissue contact in less than 30% of the patients studied.

In addition, another study, sponsored by St.

Jude Medical, Inc.

and published in 2015 showed similar findings using their recently FDA-approved contact-force sensing catheter, TOCCASTAR.

In the TOCCASTAR study, 85.5% of ablation procedure patients were free of atrial fibrillation at one year after the procedure when optimal catheter tip contact force was maintained, versus only 67.7% when non-optimal contact force was achieved.

VIVO ™ System

Our lead product, VIVO, is an FDA-cleared and CE marked product that utilizes non-invasive inputs to locate the origin of ventricular arrhythmias.

VIVO has been used in more than 1,000 procedures in leading U.S.

and European hospitals.

VIVO is a non-invasive imaging system that offers 3D cardiac mapping to help with localizing the sites of origin of idiopathic ventricular arrhythmias in patients with structurally normal hearts prior to electrophysiology procedures.

The VIVO system has achieved a CE Mark allowing it to be sold in the European Union and has been placed at several hospitals in Europe.

FDA 510(k) Clearance in the United States was received in June 2019.

The VIVO software is provided on an off-the-shelf laptop, and the system includes a 3D camera.

In addition, the system can only be used with a disposable component, the VIVO Positioning Patches, which are required for each procedure.

The VIVO software contains proprietary algorithms that are based on standard EP principles.

However, the accuracy of the algorithms is improved because it does not use generalized assumptions and instead uses patient specific information.

VIVO uses standard clinical inputs such as a CT or MRI and a 12 lead ECG, both of which are routinely gathered for most EP procedures, allowing VIVO to seamlessly integrate into the workflow.

A 3D photograph is obtained of the patient’s torso after the ECG leads are in place and all of these clinical inputs are combined to generate a 3D map of the patient’s heart with a location of the earliest onset of the ventricular arrhythmia.

VIVO Workflow

VIVO Clinical Use and Studies

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If accepted for wide-spread treatment, this would allow for previously un-ablatable patients to receive lifesaving treatments.

In February 2023, a study from the Royal Brompton Hospital was published.

This study enrolled 15 patients with 24 VTs (ventricular contractions) and PVCs (premature ventricular contractions).

VIVO accurately identified VT and PVC origin in 23/24 (96%) and sub-localized in 100% of subjects.

Acute success was achieved in 100% of cases.

Standard ECG algorithms, conducted by 3 physicians in blind trials, only identified the correct chamber in 50-88% of the patients and sub-localized within the right ventricular outflow tract (septum v free wall) in 37 – 58% of subjects.

Of note, six patients had previously attended for nine attempted ablations collectively, which were either unsuccessful or aborted owing to lack of spontaneously occurring clinical PVCs.

One patient had previously reported for four separate attempts without PVCs and ablations were aborted, but collection of a single beat allowed VIVO to create an analysis map and provide the physician with information to complete the ablation for all these patients.

In addition, this study showed a 27% reduction in procedure time when using VIVO as compared to a historical cohort.

This study concluded that VIVO can accurately identify arrhythmia origin with an accuracy that is superior to that of established ECG algorithms.

In April 2022, one physician from the Netherlands presented an abstract at EHRA (European Heart Rhythm Association), focused on using VIVO as a way to screen patients prior to the ablation procedure.

This study of 15 patients concludes that using VIVO pre-procedurally may enable the physician to determine procedure success rates and prevent unnecessary ablation procedures.

This data will need to be further studied in larger numbers but determining success in advance of the procedure would improve ablation therapy, which has a high failure rate and thus requires additional ablation procedures.

In October 2021 the first patient was enrolled in the VIVO EU Registry.

This registry aims to gather data about how VIVO is used in real-world settings, outside of a rigorous clinical study.

The registry will enroll 125 patients across Europe and the UK and collect information about different workflows and applications for VIVO.

The registry enrolled 125 patients across Europe and the UK and collected information about different workflows and applications for VIVO.

Enrollment of 125 patients was completed in June 2023.

The study requires 12 month follow-up and data collection is planned for completion in Q3 2024.This data serves multiple purposes including fulfilling European regulatory requirements for on-going data collection, publication of multi-center data, and future development of studies and improvements to the VIVO technology.

Currently, there is an ongoing physician initiated study at Coventry hospital in the UK.

This study will enroll 50 patients with Re-entrant Ventricular Tachycardia.

These patients have hearts that are not structurally normal and scarred tissue is present in the ventricle.

This data will be used for publication and to support an FDA submission to expand the current labeling of the existing product.

Our lead product, VIVO, is an FDA-cleared and CE marked product that utilizes non-invasive inputs to locate the origin of ventricular arrhythmias.

VIVO has been used in more than 1,000 procedures in leading U.S.

and European hospitals under a limited commercial launch that commenced in the third quarter of 2021.

A full scale commercial launch commenced in Q1 2023 in conjunction with the expansion of a direct sales force in the US.

The VIVO system has achieved a CE Mark allowing it to be commercialized in the European Union and has been placed at several hospitals in Europe.

FDA 510(k) Clearance in the United States was received in June 2019.

The VIVO software is provided on an off the shelf laptop, and the system includes a 3D camera.

In addition, the system can only be used with a disposable component, the VIVO Positioning Patches, which are required for each procedure.

The VIVO software contains proprietary algorithms that are based on standard EP principles.

However, the accuracy of the algorithms is improved because it does not use generalized assumptions and instead, uses patient specific information.

VIVO uses standard clinical inputs such as a CT or MRI and a 12 lead ECG, both of which are routinely gathered for most EP procedures, allowing VIVO to seamlessly integrate into the workflow.

VIVO Workflow

The study required a 12-month follow-up and data collection was completed in late 2024.This data serves multiple purposes including fulfilling European regulatory requirements for on-going data collection, publication of multi-center data, and future development of studies and improvements to the VIVO technology.

The EU registry data demonstrated that approximately 60% of physicians used VIVO pre-procedurally to improve procedural workflow and that VIVO is 94.33% accurate.

This data is planned for publication submission in early Q2 2025.

The physician-initiated study at Coventry Hospital in the UK completed enrollment and follow-up of 50 patients in Q4 2024.

This study focused on outcomes of re-entrant ventricular tachycardia procedures when using VIVO pre-procedurally.

These patients have hearts that are not structurally normal and have scarred tissue present in the ventricle.

This data will be used for publication and to support an FDA submission to expand the current labeling of the existing product in Q2 2025.

The Coventry data shows that the VIVO non-invasive mapping system was able to accurately map the ventricular tachycardia sight of origin in scar development dependent ventricular tachycardia and identify the relevant myocardial scar.

Procedural success was seen in 90% of patients at mean follow up of 7.3 ± 4.7 months.

LockeT, a suture retention device, is a sterile, Class I product that was registered with the FDA in February 2023, at which time we began initial shipments to distributors.

In May 2023, Catheter submitted LockeT for CE Mark approval.

CE Mark approval is expected in the second half of 2024, at which time initial international shipments to distributors will begin.

LockeT is indicated for wound healing by distributing suture tension over a larger area in the patient in conjunction with a figure of eight suture closure and is intended to temporarily secure sutures and aid clinicians in locating and removing sutures efficiently.

CE Mark approval is expected in the first half of 2025, at which time initial international shipments to distributors will begin.

LockeT is indicated for wound healing by distributing suture tension over a larger area in the patient in conjunction with a figure of eight suture closure and is intended to temporarily secure sutures, aid clinicians in locating and removing sutures efficiently and promote hemostasis.

Clinical studies for LockeT began during 2023.

The three phases of the current studies are planned to show the product’s effectiveness and benefits, including faster wound closure, earlier ambulation, potentially leading to early hospital discharge, and lower costs for the healthcare provider and/or insurance payor.

This data is intended to provide crucial data for marketing and to expand our indications for use with the FDA.

The five phases of the current studies are planned to show the product’s effectiveness and benefits, including faster wound closure, earlier ambulation, potentially leading to faster hospital discharge, and lower costs for the healthcare provider and/or insurance payor.

This data is intended to aid our marketing efforts and expand our indications for use with the FDA.

See License and Other Agreements below.

The Phase I - First in Man Feasibility Study was completed in 2023 and showed the device works for its intended purpose, that there were no safety events and gathered initial data to support Phase II submission to Institutional Review Board (IRB).

The results were submitted to the Journal of American Academy of Cardiologists in January 2024.

Phase II received IRB approval in late 2023 and is anticipated to be completed by June 2024.

This phase will compare manual compression (standard of care) to LockeT in a one-to-one randomized study of 100 patients and assess improved time to hemostasis and ambulation when using LockeT versus manual compression.

Phase III IRB approval is in process and will compare LockeT to one or more competitive products in a one-to-one randomized study of 100 patients and will include cost comparisons and assess risk of hematoma when using LockeT versus those competitive products.

We anticipate this phase to be completed in early 2025.

Our Previously Marketed DABRA Product

Prior to the Merger, we manufactured and marketed DABRA, a portable excimer laser console with proprietary, single-use catheters for the minimally invasive endovascular treatment of vascular blockages resulting from lower extremity vascular disease in both above and below the knee lesions.

The DABRA catheter transmitted energy from the laser to the vascular blockage.

The laser energy traveled through the catheter and ablated the blockage, reducing it to chemicals that were found naturally in the bloodstream.

The catheters were specifically designed for use with our excimer laser.

The DABRA catheter used a liquid-filled plastic tubing allowing for the efficient and precise delivery of the laser energy.

Subsequent to the Merger, we no longer manufactured or marketed DABRA.

The Phase I - First in Man Feasibility Study was completed in 2023 and showed that the device works for its intended purpose and that there were no safety events, and gathered initial data to support Phase II submission to Institutional Review Board (IRB).

This data has been presented as an abstract at several conferences including Western Atrial Fibrillation Symposium in February 2024 and American Heart Association in March 2024.

This data was also accepted and published in August 2024 in the Journal of Cardiovascular Electrophysiology.

Phase II completed enrollment of 97 patients in late 2024.

This phase compared manual compression (standard of care) to LockeT.

This data has been drafted into a manuscript and is currently undergoing revisions and journal submission is planned for the first half of 2025.

The journal for submission has not yet been determined.

Phase III was submitted to the IRB in December 2024.

The study was approved by the IRB in January 2025.

This study is collecting retrospective data, and as such, data collection has already been completed.

The manuscript is currently in draft form and under review for planned journal submission in the first half of 2025.

The aim of this study is to evaluate the safety profile of LockeT as compared to another vascular closure device when closing large bore access sites for left atrial appendage occlusion procedures.

Phase IV was submitted to the IRB in December 2024.

The study was approved by the IRB in January 2025.

This study aims to evaluate the effectiveness of LockeT, a novel external compression device, for large-bore venous vascular access site hemostasis following electrophysiologic pulsed field ablation procedures.

This study is planned to begin enrollment by April 2025 and take 6 months to complete.

Thus, the anticipated completion date is October 2025.

Phase V was submitted to IRB in February 2025.

The goal of this study is to compare the safety and effectiveness of LockeT for small bore vascular closure compared to Vascade, a vascular closure device.

It is anticipated that approval from the IRB will be provided by April 1, 2025, at which point enrollment will commence.

Study duration is expected to be 9 months, with enrollment conclusion by end of Q4 2025.

Our Solutions

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Surgery patients who are offered the LockeT device are expected to benefit from faster wound closure, more comfort than manual compression and earlier ambulation, potentially leading to early hospital discharge and lower costs for the healthcare provider and/or insurance payor.

Our goal is to become a leading medical imaging company in the field of cardiac electrophysiology, and we are dedicated to developing and delivering electrophysiology products to provide patients, hospitals, and physicians with novel technologies and solutions to improve the lives of patients with cardiac arrhythmias.

We aim to establish VIVO as an integral tool used by cardiac electrophysiologists during ablation treatment of ventricular arrhythmias by reducing procedure time and patient complications and increasing procedural success.

Our goal is to become a leading developer and marketer of electrophysiology products which provide patients, hospitals, and physicians with novel technologies and solutions to improve procedural outcomes and the lives of patients with cardiac arrhythmia.

We intend to establish VIVO as an integral tool for cardiac electrophysiologists to reduce procedure time during ablation treatment of ventricular arrhythmias, patient complications and increasing procedural success.

We further intend to establish LockeT as a standard for wound closure, shortening time to achieve hemostasis while improving patient comfort.

Our primary customers are hospitals providing cardiac electrophysiology lab procedures.

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performing approximately 600,000 ablation procedures annually.

During fiscal 2023, we had two individual customers that represented approximately 32% and 20% of our total revenues, respectively, and four customers (including the two just described) that in the aggregate represented approximately 72% of our total revenues.

During fiscal 2024, we had two individual customers that represented approximately 37% and 15% of our total revenues, respectively, and three customers (including the two just described) that in the aggregate represented approximately 62% of our total revenues.

Sales and Marketing

Today, we use a mix of distribution partners (Europe), independent sales agents (U.S.) specializing in EP products, and direct employees providing clinical support and product specialization.

In the U.S., the VIVO System and patches are currently sold by direct employees and independent sales agents who call on electrophysiologists, lab staff and hospital administrators.

This sales team qualifies appropriate prospective customers, and with support from our direct clinical specialists they conduct product demonstrations, and support customer training and case usage.

In Europe, our products are sold through distributors, supported by three full time contracted employees.

In addition, in both the U.S.

and Europe, we have entered into a co-marketing agreement with Stereotaxis, or STX.

The goal is to leverage the compatibility of VIVO with their robotic system.

STX customers are the same customers for VIVO, and VIVO provides their customers with an added tool to reduce procedure time.

Pursuant to the agreement, STX can perform promotional activity at any hospital globally that has a Stereotaxis Robotic Magnetic Navigation System, referred to herein as a robotic hospital, and where VIVO has appropriate regulatory clearances.

In addition, STX will act as a spot distributor for us at mutually agreed upon hospitals where the VIVO System is included as a line item within an STX quote.

In exchange for its marketing, distribution and support activity, Stereotaxis receives a payment equal to 45% of the revenue generated from VIVO at robotic hospitals.

After the initial sale of VIVO products to customers by Stereotaxis, we will be responsible for selling additional VIVO-related products to the customers but will continue to owe the 45% payment to Stereotaxis with respect to any such sales.

The agreement has a term that runs through December 31, 2025, provided however, that the agreement will automatically extend for successive two-year terms unless either party provides the other written notice of termination at least one year prior to the next-scheduled termination date.

Stereotaxis will continue to be entitled to receive the 45% payments described above for a period of six months following termination of the agreement.

We continue to hire additional clinical support and direct sales representation as we continue the full VIVO product launch that began in 2023.

They are experienced in the electrophysiology field and will identify and target prospective customers to educate, and demonstrate our products, leading to adoption and purchase of our technology.

We will continue to use direct clinical specialists to provide training and ongoing clinical support.

During 2024 we hired a new Chief Commercial Officer, two regional directors, eight territory managers and four clinical support specialists, replacing our entire sales team.

Our new salespeople average 10 years of electrophysiology sales experience.

Our sales team sells both VIVO and LockeT.

The sales team qualifies appropriate prospective customers, and with support from our direct clinical specialists they conduct product demonstrations, and support customer training and case usage.

In Europe, our products are sold through distributors, supported by one full-time contracted sales consultant.

In the future, we intend to market our products in the U.S.

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commercial infrastructure and sales force and in recruiting and training our sales representatives and clinical specialists for U.S.

commercialization of VIVO.

commercialization of VIVO and LockeT.

This is a lengthy process that requires recruiting appropriate sales representatives, establishing a commercial infrastructure in the United States, and training our sales representatives, and will require significant ongoing investment by us.

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Successfully recruiting and training a sufficient number of productive sales representatives is required to achieve growth at the rate we desire.

Marketing and market development activities will target increasing our product usage and expanding the applications of VIVO into the physician clinic and not just hospitals by employing a reimbursement specialist to provide reimbursement for VIVO in different settings.

Outside the U.S., we will continue to foster additional key partner relationships with distributors who will market, sell and support its products.

We previously entered into a joint marketing agreement with Stereotaxis, Inc.

The parties agreed to terminate the agreement in December 2024.

Outside the U.S., we will continue to foster additional key partner relationships with distributors who will market, sell and support our products.

In addition, we believe there are opportunities to offer additional complementary products through our sales and marketing channels that would enhance the productivity of our sales force and provide additional scale to revenue, better covering fixed operating costs.

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Disposable VIVO Positioning Patches are also required for use of the system, and the manufacture of the patches is outsourced.

We also outsource updating and troubleshooting of the software, as needed, to a third party software engineering company from time to time.

LockeT manufacturing, inventory and product fulfillment has been subcontracted to the company who is also providing research and development of the product.

The medical device industry is highly competitive, subject to rapid change and significantly affected by new product introductions and other activities of industry participants.

In January 2025, we hired an in-house full-time software engineer for research and development activities related to VIVO.

This includes updates to the existing VIVO version and development and product release of VIVO 3.

LockeT manufacturing, inventory and product fulfillment has been subcontracted to the company that provided research and development of the product.

The medical device industry is highly competitive, subject to rapid change and is significantly affected by new product introductions and other activities of industry participants.

We face potential competition from major medical device companies worldwide, many of which have longer, more established operating histories, and significantly greater financial, technical, marketing, sales, distribution, and other resources.

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LockeT’s direct competitors include Abbott’s Perclose device, Haemonetic’s VASCADE device and Inari Medical’s FlowStasis device.

Reimbursement

At this time, there is no reimbursement for VIVO.

Ablation procedures are reimbursed using one current procedural technology, or CPT, code, which varies depending on the type and complexity of the procedure.

The range of reimbursement for ablations varies within regions but can be as much as $20,000 or more.

We currently intend, in the future, to hire a reimbursement specialist to guide us through the process of obtaining a CPT code specifically for VIVO.

Although a new Category III CPT codes is approved and available starting July 1, 2024, Category III codes, which are temporary, do not have a payment rate established, and payment is at the discretion of payors;

further, payors generally require a high level of clinical data through long-term patient studies to demonstrate that a treatment produces favorable results in a cost-effective manner relative to other treatments, in order to be willing to provide reimbursement based on Category III codes.

Successful execution of our current commercialization and build out for VIVO will be needed in order to move Category III codes to permanent Category I codes.

Research and Development

The major focus of our research and development team is to leverage our existing technology platform for new applications and improvements to our existing applications, including multiple engineering efforts to improve our current products.

Future research and development efforts will involve continued enhancements to and cost reductions for VIVO and LockeT.

Future research and development efforts will involve continued enhancements to and cost reductions of VIVO and LockeT, and commercialization opportunities for the acquired PeriKard technology.

We will also explore the development of other products that can be derived from our core technology platform and intellectual property.

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The feedback received from our customers is reviewed and evaluated for incorporation into new products.

In the future we intend to develop a generation 3 of VIVO.

This version would have expanded indications to include ischemic heart disease and improve usability by the hospital staff.

With the hiring of an in-house full-time software engineer, we have begun the development of a generation 3 of VIVO.

If successful, this version will have expanded indications to include ischemic heart disease and improve usability by the hospital staff.

It would also contain more automaticity, potentially reducing our need for clinical support.

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Any foreign filings are merely replicates of the U.S.

For the U.S., we have the following patent positions for the different product areas:

For the U.S., our key patents include:

VIVO – We have two U.S.

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These cover the basic concept, methods of use and the design of the conceived device.

AMIGO – We have twenty issued U.S.

The first patent, filed in 2006 and expiring in 2031, covers the basic idea, with a three way motor, a remote control, a sled device, and a docking station for a catheter.

The more detailed ideas behind the original concept were covered in three patents filed between 2011 and 2013 and expiring in 2026.

Additional concepts and methods were filed with six patents between 2010 and 2013, with expirations between 2029 and 2031.

We consider the most relevant of the intellectual property to be the guiding track with opposing flexible guides to hold the catheter stable as it is advanced, the form and function of the controller handle, and the introducer interface of the arm to the introducer.

An additional ten patents, filed between 2013 and 2017, and expiring in 2034 to 2037, are patents covering ideas not used in the original commercial device, but potential ideas for future embodiments.

License and Other Agreements

PEACS, NV Software and Technology License Agreement

On May 1, 2016, we entered into a certain Software and Technology License Agreement with PEACS, NV, a Netherlands company, or the License Agreement, for the exclusive worldwide license of the underlying technology to its VIVO product, including intellectual property rights and patent applications pertaining thereto.

On May 1, 2016, we entered into a certain Software and Technology License Agreement with PEACS, NV, a Netherlands company, or the License Agreement, for the exclusive worldwide license of the underlying technology to the VIVO product, including intellectual property rights and patent applications pertaining thereto.

The license was for use of the technology for the field of use defined as “the localization of the origin of cardiac activation for the electrophysiology treatment and/or detection of cardiac arrhythmias.” The License Agreement called for us to pay for the prosecution and maintenance of patents to protect the technology.

In May 2021, the License Agreement was modified to modify the field of use to specifically exclude the use of clinical applications for the implanting of atrial or ventricular pacemakers, including bi-ventricular pacemakers.

The terms of the License Agreement are incorporated herein by reference to Exhibits 10.32 and 10.32.1 hereto.

LockeT Royalty Agreement

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Patent and Trademark Office, we will pay a royalty fee of 2% of net sales up to a total of $10 million in royalties.

In addition, at the time of the Merger, additional royalty rights with respect to LockeT device were granted to certain holders, or the Noteholders, of Old Catheter’s outstanding convertible promissory notes in exchange for forgiveness of the interest that had accrued under those notes but remained unpaid, pursuant to the terms of certain Debt Settlement Agreements.

In addition, at the time of the Merger, additional royalty rights with respect to LockeT device were granted to certain holders, or the Noteholders, of Old Catheter’s outstanding convertible promissory notes, including our Chief Executive Officer, David Jenkins, and certain of his affiliates, in exchange for forgiveness of the interest that had accrued under those notes but remained unpaid, pursuant to the terms of certain Debt Settlement Agreements.

The Debt Settlement Agreements provided for the Noteholders to receive, in the aggregate, approximately 12% of the net sales, if any, of the LockeT device, commencing upon the first commercial sale through December 31, 2035.

We own or have rights to trademarks that we use in connection with the operation of our business.

We own or have rights to trademarks for Ra Medical Systems and Catheter Precision and their logos, as well as other trademarks such as AMIGO.

In February 2024 we filed a trademark for LockeT.

We own or have rights to trademarks for Catheter Precision, LockeT and Ra Medical Systems and their logos, as well as other trademarks such as AMIGO.

Trade Secrets

We also have relied upon trade secrets, know-how and technological innovation, and may in the future rely upon licensing opportunities, to develop and maintain its competitive position.

We also have relied upon trade secrets, know-how and technological innovation, and may in the future rely upon licensing opportunities to develop and maintain our competitive position.

We have protected our proprietary rights through a variety of methods, including confidentiality agreements and proprietary information agreements with suppliers, employees, consultants and others who may have access to proprietary information.

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VIVO is an FDA-cleared Class II product.

Establishments that manufacture devices are required to register their establishments with the FDA and provide the FDA a list of the devices that they handle at their facilities.

We are currently evaluating the regulatory path for any potential PeriKard products.

Establishments that manufacture devices are required to register their establishments with the FDA and provide the FDA with a list of the devices that they handle at their facilities.

The FDA conducts market surveillance and periodic visits, both announced and unannounced, to inspect or re-inspect equipment, facilities, laboratories and processes to confirm regulatory compliance.

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Pre-Market Authorization and Notification

While most Class I and some Class II devices can be marketed without prior FDA authorization, most medical devices can be legally sold within the U.S.

While some Class I and some Class II devices can be marketed without prior FDA authorization, most medical devices can be legally sold within the U.S.

only if the FDA has:

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and (c) gather and compile information and conduct investigations relating to the organization, business, practices, and management of entities engaged in commerce.

In the context of performance claims for products such as our devices and services, compliance with the FTC Act includes ensuring that there is scientific data to substantiate the claims being made, that the advertising is neither false nor misleading, and that any user testimonials or endorsements we or our agents disseminate related to the devices or services comply with disclosure and other regulatory requirements.

In the context of performance claims for products such as our devices and services, compliance with the FTCA includes ensuring that there is scientific data to substantiate the claims being made, that the advertising is neither false nor misleading, and that any user testimonials or endorsements we or our agents disseminate related to the devices or services comply with disclosure and other regulatory requirements.

Violations of the FDCA or FTCA relating to the inappropriate promotion of approved products may lead to investigations alleging violations of federal and state healthcare fraud and abuse and other laws, including state consumer protection laws.

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We are currently collecting data via a multi-center (and country) European Registry.

This registry concluded enrollment in June 2023 and is anticipated to complete data collection and study activities in September 2024.

This registry concluded enrollment in June 2023.

The required 12-month follow-up and data collection was completed in late 2024.

LockeT is currently undergoing MDR review and approval via the Notified Body.

CE Mark is anticipated in August 2024.

CE Mark is anticipated in the first half of 2025.

Other Healthcare Laws

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laws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

In particular, activities and arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, waste and other abusive practices.

These laws and regulations may restrict or prohibit a wide range of activities or other arrangements related to the development, marketing or promotion of products, including pricing and discounting of products, provision of customer incentives, provision of reimbursement support, other customer support services, provision of sales commissions or other incentives to employees and independent contractors and other interactions with healthcare practitioners, other healthcare providers and patients.

Because of the breadth of these laws and the narrow scope of the statutory or regulatory exceptions and safe harbors available, our business activities could be challenged under one or more of these laws.

Relationships between medical product manufacturers and health care providers are an area of heightened scrutiny by the government.

Government expectations and industry best practices for compliance continue to evolve and past activities may not always be consistent with current industry best practices.

Further, there is a lack of government guidance as to whether various industry practices comply with these laws, and government interpretations of these laws continue to evolve, all of which creates compliance uncertainties.

Any non-compliance could result in regulatory sanctions, criminal or civil liability and serious harm to our reputation.

It is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in preventing such conduct, mitigating risks, or reducing the chance of governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.

If a government entity opens an investigation into possible violations of any of these laws (which may include the issuance of subpoenas), we would have to expend significant resources to defend ourselves against the allegations.

Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources.

Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

If any of the above occur, it could adversely affect our ability to operate our business and our results of operations.

Allegations that we, our officers, or our employees violated any one of these laws can be made by individuals called “whistleblowers” who may be our employees, customers, competitors or other parties.

Government policy is to encourage individuals to become whistleblowers and file a complaint in federal court alleging wrongful conduct.

The government is required to investigate all of these complaints and decide whether to intervene.

If the government intervenes and we are required to pay money back to the government as a result of a settlement or judgement, the whistleblower, as a reward, is awarded a percentage.

If the government declines to intervene, the whistleblower may proceed on his or her own and, if successful, he or she will receive a percentage of any judgment or settlement amount the company is required to pay.

The government may also initiate an investigation on its own.

If any such actions are instituted against us, those actions could have a significant impact on our business, including the imposition of significant fines, and other sanctions that may materially impair our ability to run a profitable business.

In particular, if our operations are found to be in violation of any of the laws described above or if we agree to settle with the government without admitting to any wrongful conduct or if we are found to be in violation of any other governmental regulations that apply to us, we, our officers and employees may be subject to sanctions, including civil and criminal penalties, damages, fines, exclusion from participation in government health care programs, such as Medicare and Medicaid, imprisonment, the curtailment or restructuring of our operations and the imposition of a corporate integrity agreement, any of which could adversely affect our business, results of operations and financial condition.

Foreign Corrupt Practices Act

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If we are found to be liable for FCPA or other violations (either due to our own acts or our inadvertence, or due to the acts or inadvertence of others), we could suffer from civil and criminal penalties or other sanctions, including contract cancellations or debarment, and loss of reputation, any of which could have a material adverse impact on our business, financial condition, and results of operations.

Privacy and Data Protection Laws

HIPAA, as amended by the HITECH Act, and the regulations that have been issued under it, impose certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of protected health information.

In the U.S., certain states have additional privacy laws that also work towards the safeguarding of personal information.

HIPAA requirements and restrictions apply to “covered entities” (which include health care providers and insurers) as well as to their business associates that receive protected health information from them in order to provide services to or perform certain activities on their behalf.

The statute and regulations also impose notification obligations on covered entities and their business associates in the event of a breach of the privacy or security of protected health information.

We occasionally receive protected health information from our customers in the course of our business.

As such, we believe that we are business associates and therefore subject to HIPAA’s requirements and restrictions with respect to handling such protected health information and have executed business associate agreements with certain customers.

It is possible the data protection laws may be interpreted and applied in a manner that is inconsistent with our practices.

If so, this could result in government-imposed fines or orders requiring that we change our practices, which could adversely affect our business.

In addition, these privacy regulations may differ from country to country and state to state and may vary based on whether testing is performed in the U.S.

or in the local country.

Complying with these various laws and regulations could cause us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business.

Further, compliance with data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions.

We can provide no assurance that we are or will remain in compliance with diverse privacy and security requirements in all of the jurisdictions in which we do business.

If we fail to comply or are deemed to have failed to comply with applicable privacy protection laws and regulations such failure could result in government enforcement actions and create liability for us, which could include substantial civil and/or criminal penalties, as well as private litigation and/or adverse publicity that could negatively affect our operating results and business.

Environmental Regulation

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Federal regulations promulgated by the Occupational Safety and Health Administration impose additional requirements on us, including those protecting employees from exposure to elements such as blood-borne pathogens.

We cannot predict the frequency of compliance, monitoring, or enforcement actions to which we may be subject as those regulations are being implemented, which could adversely affect our operations.

Segment Information

We operate our business as one segment which includes all activities related to the marketing, sales and development of medical technologies focused in the field of cardiac EP.

The chief operating decision-maker reviews the operating results on an aggregate basis and manages the operations as a single operating segment.

As of March 12, 2024, we had a total of 14 employees, including 14 full-time employees, which includes finance and administrative, sales and marketing and clinical professionals.

We also have retained a total of 5 persons as independent contractors.

We cannot predict the frequency of compliance, monitoring, or enforcement actions to which we may be subject, which events and actions could adversely affect our operations.

As of March 6, 2025, we had a total of 22 employees, including 22 full-time employees, which include finance and administrative, research and development, sales and marketing and clinical professionals.

We also have retained a total of 3 people as independent contractors.

We are planning to increase our sales force in support of product launches but currently have no other plans to increase our staff.

Corporate Information

Our principal executive offices are located at 1670 Highway 160 West, Suite 205, Fort Mill, South Carolina 29708.

Our telephone number is (973) 691-2000.

Our corporate website address is www.catheterprecision.com.

Information contained on, or that can be accessed through, our website is not incorporated by reference into this document, and you should not consider information on our website to be part of this document.

You may find on our website at www.catheterprecision.com electronic copies of our Annual Report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act of 1934, or Exchange Act.

Such filings are placed on our website as soon as reasonably possible after they are filed with the Securities and Exchange Commission, or SEC.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business