What changed in this filing

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Item 1. Business

2026-03-31 compared with 2025-03-31 · 51 added, 56 removed, 387 unchanged (22% of the section changed)

12 unchanged sentences

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.

On February 17, 2025, we formed a new subsidiary, Cardionomix, Inc.

("Cardionomix"), to acquire certain assets previously held by Cardionomic, Inc.

("Cardionomic"), a third-party entity that had ceased operations.

We own 82% of Cardionomix’s issued and outstanding common stock.

Our Chief Executive Officer and Chairman of the Board and certain of his affiliates own 12%, while the remaining 6% of the outstanding common stock was issued to certain third parties as finder's fees for the asset acquisition (see Note 2, Summary of Significant Accounting Policies in the audited consolidated financial statements included elsewhere in this Annual Report).

On May 5, 2025, Cardionomix acquired certain assets primarily related to the Cardiac Pulmonary Nerve Stimulation ("CPNS") System previously held by Cardionomic (see Note 14, Asset Acquisition in the audited consolidated financial statements included elsewhere in this Annual Report).

The CPNS System is a novel technology for the late-stage treatment of acute decompensated heart failure by stimulating the autonomic cardiac nerves to restore autonomic balance.

Unless Cardionomix can obtain its own dedicated financing, the Company does not intend to allocate capital to fund the clinical development of the acquired assets.

On June 20, 2025, we formed a new subsidiary, KardioNav, Inc.

("KardioNav"), to pursue the advancement, development, and commercialization of certain intellectual property assigned to KardioNav.

We transferred certain intellectual property related to the View into Ventricular Onset System ("VIVO" or "VIVO System") to KardioNav, while Chelak iECG, Inc.

("Chelak"), an unrelated third party, transferred certain patents related to a medical device designed to interface with implanted cardiac devices to KardioNav.

KardioNav intends to integrate the VIVO mapping intellectual property with Chelak's assigned patents to develop a system that interfaces with implanted cardiac devices to enable improved pre-ablation mapping and more precise localization of arrhythmogenic tissue.

Research and development activities in animals and humans have begun.

We own 57% of the subsidiary's issued and outstanding common stock, while Chelak owns 33% of the subsidiary’s issued and outstanding common stock.

Our Chief Executive Officer and Chairman of the Board of Directors and certain of his affiliates own the remaining 10% of the subsidiary’s issued and outstanding common stock.

KardioNav obtained its own financing in 2025.

The Company does not intend to provide additional financial support to KardioNav.

See Note 2, Summary of Significant Accounting Policies in the audited consolidated financial statements included elsewhere in this Annual Report.

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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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.

Initial 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.

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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 first half of 2025, at which time initial international shipments to distributors will begin.

LockeT, a suture retention device, is a sterile, Class I product that was registered with the FDA in February 2023.

CE Mark approval was received in April 2025, at which time initial international shipments to distributors began.

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 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.

The studies are planned to show the product’s effectiveness and benefits, including faster wound closure, earlier ambulation (than manual compression), potentially leading to faster hospital discharge, fewer complications than traditional vascular closure devices 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 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.

The initial studies in 2023 demonstrated that the device works for its intended purpose and that the product is safe.

This data was provided at several conferences in 2024 including the Western Atrial Fibrillation Symposium and the American Heart Association’s annual meeting.

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

In 2024 a direct comparison of LockeT to manual compression (standard of care) was completed.

This study concluded that LockeT appears to improve hemostasis and time to ambulation (TTA) without major complications, while limiting post-procedural time for groin management.

The data was submitted to and accepted in 2025 at the annual American College of Cardiology conference.

In 2025, retrospective data was submitted and accepted at the annual Heart Rhythm Society (HRS) conference.

This study evaluated the safety and efficacy of LockeT in large bore access for electrophysiology data.

The data concluded LockeT showed a strong safety profile, low complication rates, and was effective hemostasis in large-bore access EP procedures, while offering a viable alternative to traditional closure devices.

This same data was recently accepted in the Journal of Cardiac Electrophysiology and is anticipated to be published in early Q2 2026.

Additional LockeT studies are ongoing and Catheter Precision continues to evaluate new study opportunities that support marketing needs.

Our Solutions

Adoption of our VIVO System by electrophysiologists is expected to enhance their ability to diagnose and treat cardiac arrhythmias.

Adoption of our VIVO System by electrophysiologists is expected to enhance their ability to identify arrhythmia locations and streamline procedures.

Non- invasive mapping prior to the ablation procedure provides a solution for patients that could not be ablated previously.

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In these situations, the patients are often brought in for ablation procedures only to have no arrhythmia and sent home time and time again.

In these instances, the physicians can monitor the patient prior to hospitalization and obtain information about the arrythmia.

In these instances, the physicians can monitor the patient prior to hospitalization and, with VIVO, obtain information about the arrythmia.

In this way, the patient can still proceed to an ablation procedure without having PVCs on the day of surgery.

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This enables the physicians to better understand where they are targeting, which enables them to make advanced decisions about where they are navigating the catheter and which catheter(s) they are using, reducing both procedure time and cost.

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 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.

The LockeT device is expected to provide patients with more comfort and faster ambulation than manual compression and reduce hospital cost while allowing for same day discharge.

The goal of our life sciences business 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 and also reduce the time and cost per procedure.

We also intend to further establish LockeT as a standard for wound closure, shortening time to achieve hemostasis while improving patient comfort at a lower cost per procedure than our competitors.

However, in order to attract capital to fund our operating losses while we pursue this strategy, we have also adopted a holding company structure within which we house and operate our FLYTE private aviation charter business which has the potential to quickly grow into a profitable subsidiary.

Our primary customers are hospitals providing cardiac electrophysiology lab procedures.

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Sales and Marketing

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.

We market and sell our products domestically with direct salespeople and internationally with both direct and indirect sales through distributors.

Our salespeople average 10 years of electrophysiology sales experience and sell 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.

and certain international markets using a combination of a direct sales force and independent distributors.

This may require us to make a significant investment building our U.S.

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

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.

Following initial training, our sales representatives typically require lead time in the field to grow their network of accounts, coordinate their sales efforts with each hospital’s capital budgeting and acquisition cycle and produce sales results.

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

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

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

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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.

Manufacturing and Availability of Raw Materials

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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 of VIVO and LockeT, and commercialization opportunities for the acquired PeriKard technology.

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

On December 31, 2025, we entered into the Series J Exchange Agreement ("Royalty Right Exchange") with Mr.

Jenkins and certain of his affiliates to exchange future and accrued royalty rights of $2.7 million for an aggregate of 9,490 shares of the Company's newly designated Series J Convertible Preferred Stock, par value $0.0001 per share and stated value of $1,000 per share.

We derecognized $2.7 million of royalties payable due to related parties and recognized the fair value of the Series J Convertible Preferred Stock of $5.3 million in additional paid-in capital in the accompanying consolidated balance sheets included elsewhere in this Annual Report.

The difference between the fair value of the Series J Convertible Preferred Stock and the fair value of the royalties payable due to related parties of $2.6 million was recorded as loss on debt extinguishment in the accompanying consolidated statements of operations included elsewhere in this Annual Report.

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

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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 the first half of 2025.

LockeT underwent MDR review and approval via the Notified Body.

CE Mark was received in April 2025.

Other Healthcare Laws

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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