10-K: Catheter Precision Faces Going Concern Doubt Amid Losses, Pursues New Capital & Aviation Venture

Sentiment:

Annual Report


Catheter Precision, a medical device company, reported recurring losses and substantial doubt about its ability to continue as a going concern, while actively raising capital and diversifying into private aviation.

Delay expectedThe Series B Preferred Stock conversion was subject to stockholder approval, which was obtained on July 25, 2025, indicating a potential delay in full conversion until that date.The Series M Warrants are not exercisable until stockholder approval is obtained, and as of the filing date (March 31, 2026), such approval has not yet occurred, representing an ongoing delay in their exercisability.The February 2026 and March 2026 private placements for Series C-2 and Series C-3 Convertible Preferred Stock are subject to stockholder approval for issuing common stock in excess of 19.99% and, for Series C-3, effectiveness of a registration statement, indicating potential future delays in capital infusion.The issuance of Series D Convertible Preferred Stock for the FLYTE acquisition is subject to stockholder approval, which could delay the full realization of this transaction.The VIVO EU Registry study required a 12-month follow-up, with data collection completed in late 2024, and publication submission planned for early Q2 2025, indicating a lag between data collection and public dissemination.The company's plan to expand VIVO's indications for use to include ischemic hearts will require additional FDA clearances, which can be a lengthy process.
Capital raiseThe company raised approximately $4.9 million in net proceeds from securities transactions during 2025.A May 2025 PIPE Financing raised $1.5 million in cash and $864 thousand in QHSLab Notes for Series B Convertible Preferred Stock and Series L Warrants.An At-the-Market (ATM) Offering sold 887,852 shares of common stock for gross proceeds of $4.0 million ($3.7 million net) in 2025.In December 2025, unsecured convertible notes payable totaling $300 thousand were issued to Boot Capital LLC and Vanquish Funding Group Inc.Subsequent to year-end, in February 2026, a private placement raised $2.2 million from common stock and Series C-1 Convertible Preferred Stock.In February 2026, an inducement offer for warrant exercise and Series B Preferred Stock conversion generated $0.4 million in proceeds.In March 2026, an additional private placement raised $1.9 million from Series C-1 Convertible Preferred Stock.Investors in the February and March 2026 private placements agreed to purchase additional Series C-2 and C-3 Convertible Preferred Stock for $1.6 million and $1.9 million per closing, respectively, subject to stockholder approval and registration statement effectiveness.Investors also have the right, but not the obligation, to purchase up to an aggregate of $39.2 million (February) and $35.6 million (March) of Series C-4 Convertible Preferred Stock.The FLYTE acquisition involved the issuance of 5,250 shares of Series D Convertible Preferred Stock ($5.3 million stated value) to SEG Jets LLC and 5,778 shares of Series D Convertible Preferred Stock ($5.8 million stated value) to Creatd, Inc., both subject to stockholder approval.The company explicitly states it "will be required to raise additional funds to finance its operations" and "expects the need to complete an additional financing sometime in the next 1 to 2 months."
Worse than expectedThe company reported a net loss of $17.7 million in 2025, an increase from $16.6 million in 2024, indicating worsening financial performance.Cash and cash equivalents significantly decreased to $0.1 million as of December 31, 2025, from $2.873 million in 2024, reflecting a substantial decline in liquidity.Operating activities continued to consume significant cash, with $8.3 million used in 2025, highlighting ongoing operational cash burn.The auditors expressed "substantial doubt about the company's ability to continue as a going concern," which is a critical negative indicator.A $7.0 million impairment charge on VIVO intangible assets in 2025 suggests a reduction in the expected future value or performance of a key product line.The company expects to need additional financing within the next 1-2 months, indicating an urgent and precarious financial position.

Summary

  • Catheter Precision, Inc. (VTAK) is primarily focused on cardiac electrophysiology (EP) medical technologies, including the VIVO System for 3D cardiac mapping and LockeT, a suture retention device.
  • The company reported a net loss of $17.7 million for the year ended December 31, 2025, compared to $16.6 million in 2024.
  • Cash and cash equivalents stood at $0.1 million as of December 31, 2025, down from $2.873 million in 2024.
  • Operating activities used $8.3 million in cash in 2025, following $9.3 million used in 2024.
  • The company has an accumulated deficit of $309.5 million as of December 31, 2025.
  • Management has concluded there is substantial doubt about the company's ability to continue as a going concern for the next 12 months.
  • Total revenues increased to $819 thousand in 2025 from $420 thousand in 2024, driven by LockeT sales.
  • LockeT sales increased by $408 thousand in 2025, while VIVO System sales decreased by $12 thousand.
  • The company acquired PeriKard, LLC's pericardial access technology for $119 thousand in January 2025, which was expensed as in-process research and development (IPR&D). This asset was later sold to CEO David Jenkins for de minimis proceeds in December 2025.
  • Cardionomix, a new subsidiary (82% owned), acquired the Cardiac Pulmonary Nerve Stimulation (CPNS) System for $0.3 million in stock and a $1.3 million promissory note in May 2025, also expensed as IPR&D.
  • KardioNav, another new subsidiary (57% owned), was formed in June 2025 to integrate VIVO mapping IP with Chelak's patents for improved pre-ablation mapping. KardioNav secured its own financing.
  • The company raised $4.9 million in net proceeds from securities transactions in 2025, including a $1.5 million cash PIPE financing and $4.0 million gross from an At-the-Market (ATM) offering.
  • In December 2025, $2.7 million in future and accrued royalty rights were exchanged for 9,490 shares of Series J Convertible Preferred Stock (fair value $5.3 million), resulting in a $2.6 million loss on debt extinguishment.
  • Subsequent to year-end, in February and March 2026, the company raised an additional $2.2 million and $1.9 million, respectively, through private placements of common and Series C-1 Preferred Stock.
  • In February/March 2026, the company acquired 100% of FLYTE, a private aviation charter business, and its subsidiary Ponderosa Air, LLC, for $0.8 million cash, a $5.0 million promissory note, and 5,778 shares of Series D Convertible Preferred Stock ($5.8 million stated value).
  • An impairment charge of $7.0 million was recorded for VIVO intangible assets in 2025 due to a sustained decrease in stock price and negative cash flows.
  • Federal net operating loss (NOL) carryforwards of $112.7 million and state NOLs of $56.0 million as of December 31, 2025, were reduced to $66.3 million and $15.4 million, respectively, due to Section 382 ownership changes in 2024 and 2025.
  • Material weaknesses in internal control over financial reporting identified in 2024 were remediated as of December 31, 2025.

Sentiment

Score: 3

Explanation: StockSavvy.ai views this filing with low sentiment due to the explicit 'substantial doubt about going concern' warning, recurring net losses, significant cash burn, and the need for immediate additional financing. While there are positive product developments and strategic diversification, the severe financial distress overshadows these efforts.

Positives

  • LockeT sales increased by $408 thousand in 2025, indicating growing market acceptance for the suture retention device.
  • LockeT received CE Mark approval in April 2025, enabling international distribution in the European Union, Switzerland, and Turkey, and leading to new distributor agreements.
  • VIVO System has been used in over 1,000 procedures by more than 30 physicians in 11 countries, demonstrating clinical adoption.
  • Clinical studies for VIVO showed 100% accuracy in matching predicted arrhythmia origin in 44/44 patients (primary endpoint) and 99.56% accuracy in matching paced sites in 225/226 locations (secondary endpoint).
  • The VIVO EU Registry data demonstrated 94.33% accuracy and improved procedural workflow when used pre-procedurally.
  • LockeT clinical studies showed improved hemostasis and time to ambulation (TTA) without major complications compared to manual compression, and a strong safety profile in large bore access EP procedures.
  • The company successfully remediated previously identified material weaknesses in internal control over financial reporting as of December 31, 2025.
  • Diversification into the FLYTE private aviation charter business offers potential for quick growth and profitability, aiming to attract capital to fund operating losses in the life sciences segment.
  • KardioNav, a new subsidiary, obtained its own financing in 2025, reducing the parent company's financial support burden for this new venture.

Negatives

  • The company incurred a net loss of $17.7 million in 2025, an increase from $16.6 million in 2024.
  • Cash and cash equivalents significantly decreased to $0.1 million as of December 31, 2025, from $2.873 million in 2024.
  • Operating activities resulted in negative cash flow of $8.3 million in 2025.
  • The accumulated deficit reached $309.5 million as of December 31, 2025, indicating a history of unprofitability.
  • Auditors expressed "substantial doubt about the company's ability to continue as a going concern."
  • The company expects to need additional financing within the next 1 to 2 months to fund operations and pay debts.
  • VIVO System sales decreased by $12 thousand in 2025, primarily due to reduced sales efforts and a key EU-based sales consultant's prolonged medical leave.
  • An impairment charge of $7.0 million was recorded for VIVO intangible assets in 2025, reflecting a decrease in their recoverable value.
  • The exchange of royalty rights for Series J Convertible Preferred Stock resulted in a $2.6 million loss on debt extinguishment.
  • The company's ability to use its federal and state net operating loss (NOL) carryforwards was significantly limited by Section 382 ownership changes, reducing federal NOLs from $112.7 million to $66.3 million and state NOLs from $56.0 million to $15.4 million.
  • Over 70% of 2025 revenues were derived from four customers, with two customers accounting for over half, indicating significant customer concentration risk.
  • The PeriKard membership interests, acquired in January 2025, were sold to CEO David Jenkins for de minimis proceeds in December 2025, after being fully expensed as IPR&D.

Risks

  • The company will be required to raise additional funds to finance operations and continue as a going concern, with no assurance of timely or advantageous financing terms.
  • The business has a history of losses, will incur additional losses, and may never achieve profitability, with an accumulated deficit of $309.5 million as of December 31, 2025.
  • Profitability depends on establishing VIVO as an integral tool, developing new products like LockeT and PeriKard, and building out U.S. commercial infrastructure and sales force, which may not be achieved.
  • Research and development and commercialization efforts may depend on collaborations, which may not fully support the company's interests or commit sufficient resources.
  • Economic downturns, inflation, and tariffs could adversely affect business, increase costs, disrupt supply chains, and limit customer spending.
  • AI technologies may exacerbate existing risks (data privacy, cybersecurity, IP, fraud) and introduce new risks due to autonomous nature, potential for bias, unreliability, and regulatory changes.
  • Future joint marketing agreements could reduce revenues from product sales.
  • Royalty agreements for LockeT (5% on first $1M net sales, then 2% up to $10M after patent, plus 12% of net sales to Noteholders through Dec 31, 2035) will reduce future profits.
  • Significant disruptions in information technology systems (viruses, hackers, failures) could adversely affect operations, including shipping, inventory, and customer service.
  • The rate of technological innovation might not keep pace with the market, making it difficult to maintain competitive status or ensure product compatibility.
  • Involvement in legal proceedings (patent, product liability, employee claims, regulatory investigations) could adversely affect reputation, financial condition, and divert management attention.
  • Acquisitions or divestitures could lead to difficulties in integrating personnel, financials, operations, products, or technologies, and may dilute earnings or increase expenses.
  • Failure to attract and retain sufficient qualified personnel, especially key individuals like the Executive Chairman and CEO, could impede growth.
  • Revenues may depend on customers' receipt of adequate reimbursement from private insurers and government healthcare programs, which are subject to change and may not be adequate.
  • The medical device industry is highly competitive, with larger competitors having greater resources, broader product lines, and established customer relationships.
  • Dependence on limited sources for certain components, industry-wide shortages, and pricing fluctuations could result in production delays and adversely affect operating results.
  • Even with regulatory approval, products may not gain market acceptance among hospitals, physicians, patients, and third-party payers due to various factors including cost-effectiveness and competition.
  • Operating in foreign countries exposes the company to differing regulatory requirements, reimbursement regimes, economic instability, compliance with foreign laws, currency fluctuations, and geopolitical risks.
  • Military conflicts (Ukraine, Israel-Gaza, Iran) and related sanctions could disrupt supply chains, increase costs, and adversely affect business and results of operations.
  • Reliance on third parties for clinical trials means their failure to comply with good clinical practices could delay or prevent regulatory approval and commercialization.
  • Exposure to product liability risks could result in substantial damages or legal expenses exceeding insurance coverage.
  • The ability to use net operating loss carryforwards is significantly limited by Section 382 of the Internal Revenue Code due to ownership changes.
  • Potential future milestone payments under the Settlement Agreement with the Department of Justice.
  • Subject to extensive and continuing regulation by the FDA and other regulatory agencies, with potential for recalls, revocations, suspensions, and enforcement actions.
  • Changes in trade policies, including new or higher tariffs, could pressure selling prices and adversely affect revenues and operating results.
  • Product clearances and approvals can be denied or significantly delayed, impacting market entry and expansion.
  • Even after clearance, products remain subject to extensive regulatory scrutiny, including limitations on marketing and potential for withdrawal or sanctions for non-compliance.
  • Inability to obtain and maintain patent protection for products could allow competitors to commercialize similar products, adversely affecting the company's competitive position.
  • Risk of third parties asserting infringement of their intellectual property rights, leading to expensive and time-consuming litigation.
  • The price of common stock has been and may continue to be highly volatile, potentially resulting in substantial losses for investors.
  • Future sales and issuances of substantial numbers of common stock or rights to purchase common stock could result in additional dilution and cause the stock price to fall.
  • Charter documents and Delaware law contain anti-takeover provisions that could delay or prevent a change of control, limiting the market price of common stock.
  • Exclusive forum provisions in the certificate of incorporation could limit stockholders' ability to obtain a favorable judicial forum for disputes.
  • Failure to comply with continued listing requirements could lead to delisting, limiting investor ability to trade and subjecting the company to additional restrictions.
  • No immediate plans to pay dividends, as earnings will be reinvested.

Future Outlook

The company's strategy involves establishing VIVO as an integral tool for cardiac electrophysiologists and LockeT as a standard for wound closure, while also pursuing commercialization opportunities for acquired Cardionomix and KardioNav technologies. It plans to develop a generation 3 of VIVO with expanded indications and improved usability. To fund operating losses during this period, the company has diversified into the FLYTE private aviation charter business, which is expected to grow quickly into a profitable subsidiary. However, the company anticipates continued operating losses and negative cash flows, requiring additional financing within the next 1-2 months.

Management Comments

  • We believe that Mr. Jenkins is qualified to serve as a director because of his extensive experience in the medical device industry.
  • We believe that Mr. Colombatto is qualified to serve as a member of our board of directors due to his extensive management experience and familiarity with our business and strategy.
  • We believe that Mr. Caruso is qualified to serve as a director because of his senior level financial experience with public and private companies.
  • We believe Mr. Arno is qualified to serve on our Board of Directors because of his financial expertise and his experience as a director on other public company boards.
  • Management plans to raise additional capital through public or private equity, debt financing, or other innovative and specialty financing strategies in order to fulfill its operating and capital requirements for at least 12 months from the date of issuance of the consolidated financial statements.
  • Management has concluded that there is substantial doubt about our ability to continue as a going concern for a period of one year after the date of issuance of the consolidated financial statements for the year ended December 31, 2025 are issued.
  • We expect operating losses and negative cash flows to continue for the foreseeable future unless our sales and gross profit increase sufficiently to cover our operating expenses.
  • We expect our current operating expenses to remain relatively fixed for the near term, absent entering into a transformative strategic transaction.
  • We expect the need to complete an additional financing sometime in the next 1 to 2 months.
  • In managements opinion, any potential loss resulting from the resolution of these matters will not have a material effect on our results of operations, financial position or cash flows.

Industry Context

StockSavvy.ai notes that Catheter Precision operates in the highly competitive and rapidly growing cardiac electrophysiology (EP) market, which was valued at $3.5 billion in 2022 and is projected to reach $14.5 billion by 2032. The company's focus on ventricular ablation aligns with a fast-growing segment, with one study showing an 18% growth for ventricular tachycardia, surpassing atrial fibrillation (12.7%). The industry is dominated by large medical device companies like Medtronic, Abbott Laboratories, Biosense-Webster (J&J), and Boston Scientific Corp., which possess significantly greater resources. Catheter Precision's strategy to develop non-invasive solutions like VIVO and suture retention devices like LockeT addresses existing treatment challenges, such as the difficulty in identifying ablation locations for ventricular arrhythmias and the need for improved wound closure. The diversification into private aviation with FLYTE is an unusual move for a medical device company, potentially reflecting a strategy to generate alternative revenue streams to fund its core, capital-intensive life sciences R&D in a challenging funding environment.

Comparison to Industry Standards

  • The catheter ablation market was $3.5 billion in 2022 and is estimated to grow to $14.5 billion in 2032, indicating a robust growth trajectory for the industry segment Catheter Precision operates in.
  • Ventricular ablation, a focus area for Catheter Precision's VIVO system, is growing at a CAGR of 14.5% through 2032, with one study showing an 18% growth for ventricular tachycardia, surpassing atrial fibrillation (12.7%).
  • Clinical trial results published in the New England Journal of Medicine in September 2024 found that patients treated with catheter ablation suffered 50% fewer adverse events at a median follow-up of 4.3 years compared to drug therapy, supporting the efficacy of the company's core treatment area.
  • The VIVO system's 100% accuracy in matching predicted arrhythmia origin in a U.S. multi-center study (44/44 patients) and 99.56% accuracy in matching paced sites (225/226 locations) demonstrates strong performance compared to invasive mapping systems.
  • The VIVO EU registry data showing 94.33% accuracy and improved procedural workflow aligns with the industry's drive for more effective and efficient EP procedures, where large companies like Medtronic and Boston Scientific are investing in force-sensing catheters to improve outcomes.
  • LockeT's direct competitors include established devices like Abbott's Perclose, Haemonetics' VASCADE, and Inari Medical's FlowStasis, indicating a competitive landscape for suture retention devices.

Management Changes

RolePrevious PersonNew PersonEffective DateReason
Chief Financial OfficerMargrit Thomassen (Former Interim CFO and Secretary)Philip Anderson2025-01-06Appointment to permanent role, filling a vacancy.
Chief Commercial OfficerMarie-Claude JacquesNA2025-06-02Employment terminated.

Corporate Governance

Change TypeDescriptionEffective DateImpact Assessment
Board CompositionBoard consists of four members, three of whom are independent under NYSE American listing standards.NAMaintains a majority of independent directors, aligning with good governance practices.
Board ClassificationBoard of directors is divided into three classes with staggered three-year terms.NADiscourages hostile takeovers by making it more difficult for stockholders to replace a majority of directors at once.
Stockholder Action LimitationsStockholders may not act by written consent; special meetings can only be called by the chairperson, CEO, or a majority of the board.NALimits stockholders' ability to initiate actions or remove directors without board approval, potentially entrenching current management.
Advance Notice ProceduresBylaws establish advance notice procedures for stockholder proposals and director nominations.NAMay preclude certain business at meetings if procedures are not followed and can deter proxy solicitations for control.
Director Election and RemovalVacancies and newly created directorships filled only by majority of existing directors; directors removed only for cause by affirmative vote of majority of voting shares.NAStrengthens board's control over its composition and makes director removal more challenging for stockholders.
No Cumulative VotingCertificate of incorporation and bylaws do not expressly provide for cumulative voting.NAMakes it more difficult for minority stockholders to gain board seats and influence takeover decisions.
Charter Amendment RequirementsAmendment of certain anti-takeover provisions in the certificate of incorporation requires approval by holders of at least 66 2/3% of outstanding capital stock.NAProvides a high threshold for changing key governance provisions, further deterring unsolicited takeovers.
Delaware Anti-Takeover Statute (Section 203)Subject to Section 203 of the Delaware General Corporation Law, prohibiting certain business combinations with interested stockholders for three years unless specific conditions are met.NADiscourages hostile takeovers and may prevent transactions that stockholders might otherwise deem in their best interests.
Choice of ForumDelaware Court of Chancery is the exclusive forum for certain corporate actions; federal district courts are exclusive for Securities Act claims.NALimits stockholders' ability to choose a favorable judicial forum, potentially discouraging certain lawsuits.
Audit Committee Financial ExpertJames Caruso qualifies as an audit committee financial expert.NAEnsures specialized financial expertise on the audit committee, enhancing oversight of financial reporting.
Insider Trading PolicyAdopted an Insider Trading Policy and procedures governing securities transactions by directors, officers, and employees.2025-03-21Designed to promote compliance with insider trading laws and regulations, enhancing corporate integrity.
Remediation of Material WeaknessesRemediated previously identified material weaknesses in internal control over financial reporting by adding a new CFO, designing a control framework for service providers, and enhancing management review controls.2025-12-31Improved the reliability of financial reporting and internal controls, reducing financial risk.

Legal Proceedings

  • The company is at times subject to pending and threatened legal actions in the normal course of business.
  • Management believes any potential loss from these matters will not have a material effect on results of operations, financial position, or cash flows.
  • As of December 31, 2025, the company had no outstanding litigation.
  • The company previously settled a civil False Claims Act investigation with the Department of Justice (DOJ) on December 28, 2020, related to its previously marketed DABRA product, requiring payments of $2.5 million (initial) and $5.0 million (in Jan 2023 due to merger).

Related Party Transactions

  • On December 31, 2025, David A. Jenkins (Executive Chairman and CEO) and FatBoy Capital, L.P. (an entity controlled by Mr. Jenkins) exchanged $2.7 million in future and accrued LockeT royalty rights for 9,490 shares of Series J Convertible Preferred Stock (fair value $5.3 million).
  • On December 31, 2025, the maturity dates of promissory notes payable to the Jenkins Family Charitable Institute (where Mr. Jenkins' adult daughter is trustee), FatBoy Capital, L.P., and Mr. Jenkins were extended to January 31, 2028, and January 31, 2029, respectively.
  • As part of the Related Party Notes modification, 340,000 Series M Warrants (fair value $509 thousand) were issued to FatBoy Capital, L.P. and Mr. Jenkins.
  • In connection with the Related Party Notes modification, the PeriKard membership interests (acquired in January 2025 and expensed as IPR&D) were transferred to Mr. Jenkins for de minimis proceeds on December 31, 2025.
  • On July 11, 2025, KardioNav issued two short-term promissory notes, each for $150 thousand, to David A. Jenkins and Lifestim, Inc. (a company controlled by Mr. Jenkins).
  • David A. Jenkins and certain of his affiliates own 12% of Cardionomix's issued and outstanding common stock.
  • David A. Jenkins and certain of his affiliates own 10% of KardioNav's issued and outstanding common stock.
  • On September 3, 2024, the Jenkins Family Charitable Institute invested approximately $500,000 in a public offering, receiving common stock and various warrants.
  • On December 31, 2024, the Jenkins Family Charitable Institute distributed 23,684 Series J warrants to its trustee and two advisors, who are daughters of Mr. Jenkins.
  • Mr. Jenkins' adult daughter, the non-executive Chief Operating Officer, holds options to purchase 740 shares of common stock (after expiration of 17 options).

Stakeholder Impact

  • Shareholders face significant dilution risk from ongoing capital raises (common stock, preferred stock, warrants) and potential future sales by existing large stockholders. The "substantial doubt about going concern" raises significant risk to investment value. Anti-takeover provisions may limit opportunities for premium acquisitions.
  • Employees: The company plans to increase its sales force, indicating potential job growth in that area. However, the overall financial instability and need for capital raises could create job insecurity if financing efforts fail.
  • Customers (Hospitals/Physicians): Continued product development (VIVO Gen 3, KardioNav integration) aims to improve procedural outcomes and efficiency, offering better solutions for cardiac electrophysiology. However, financial instability could impact product availability or support.
  • Suppliers: The company's ability to obtain components on commercially reasonable terms is critical, and financial instability could affect its ability to pay suppliers, potentially disrupting the supply chain.
  • Creditors: The company has outstanding short-term notes and related party notes, and its "going concern" doubt indicates heightened risk for creditors, with claims against subsidiaries like Cardionomix and KardioNav limited solely to those subsidiaries' assets.
  • Regulatory Bodies: The company's ongoing compliance with FDA and other regulations is crucial, and any failures could lead to enforcement actions, impacting product availability and public trust.

Next Steps

  • Obtain stockholder approval for the issuance of additional common stock underlying Series B Preferred Stock due to conversion price reduction.
  • Obtain stockholder approval for the issuance of shares of common stock underlying Series C-1, C-2, C-3, and C-4 Preferred Stock.
  • Obtain stockholder approval for the exercise of Series M Warrants.
  • Obtain stockholder approval for the issuance of Series D Convertible Preferred Stock related to the FLYTE acquisition.
  • File registration statements for the resale of common stock underlying Series C-1, C-2, C-3, and Series D Convertible Preferred Stock.
  • Continue clinical development of the CPNS System by Cardionomix, contingent on dedicated financing for the subsidiary.
  • Advance, develop, and commercialize intellectual property by KardioNav, integrating VIVO mapping IP with Chelak's patents.
  • Evaluate potential product acquisitions complementary to the current portfolio.
  • Develop initial users for VIVO and LockeT that demonstrate clinical and economic benefits.
  • Collaborate with clinical thought leaders to establish clinical techniques and evolve product features for VIVO and LockeT.
  • Acquire data and expand FDA clearance for VIVO to market products for additional procedure types, including ischemic hearts, using data from the Coventry study.
  • Enhance the design, user utility, and clinical capability of VIVO and LockeT through further product development.
  • Seek collaboration with larger market participants for sales synergy and fixed cost coverage.
  • Seek to obtain permanent CPT codes for Medicare reimbursement for VIVO.
  • Develop a generation 3 of VIVO with expanded indications and improved usability.
  • Continue to evaluate new study opportunities that support LockeT marketing needs.
  • Raise additional capital through public or private equity, debt financing, or other strategic transactions within the next 1-2 months.
  • Increase the sales force in support of product launches.

Key Dates

DateDescription
2002-09-04Predecessor company incorporated in California.
2006-01-01Old Catheter's inception and start of AMIGO System development funding.
2016-05-01Entered into Software and Technology License Agreement with PEACS, NV for VIVO technology.
2017-01-01Martin Colombatto began serving as a director.
2018-07-01Company reincorporated in Delaware in connection with initial public offering.
2018-09-01Company listed on the New York Stock Exchange.
2019-05-01Heart Rhythm Society (HRS) Expert Consensus Statement on Catheter Ablation of Ventricular Arrhythmias published.
2019-06-01Initial FDA 510(k) Clearance for VIVO System (Generation 1) received.
2019-12-01FDA unannounced facility inspection related to previously marketed DABRA product.
2020-03-01Company adopted and terminated the 2020 Inducement Equity Incentive Plan.
2020-09-25Final Form 483 report sent to FDA closing out inspection related to DABRA product.
2020-12-28Entered into Settlement Agreement with DOJ to resolve civil False Claims Act investigation.
2021-05-01License Agreement with PEACS, NV modified to exclude certain clinical applications.
2021-10-01First patient enrolled in VIVO EU Registry.
2022-02-01Agreed to assignment and royalty agreement for LockeT device.
2023-01-09Merger with Old Catheter completed; David A. Jenkins became Executive Chairman of the Board.
2023-02-01LockeT registered with the FDA as a sterile, Class I product.
2023-04-01David A. Jenkins became Interim Chief Executive Officer.
2023-06-01Enrollment of 125 patients completed in VIVO EU Registry.
2023-07-01Company's stockholders approved the 2023 Equity Incentive Plan.
2024-01-02David A. Jenkins named Chief Executive Officer.
2024-05-01Marie-Claude Jacques appointed Chief Commercial Officer.
2024-05-30David A. Jenkins loaned $500,000 to the Company in exchange for a short-term promissory note.
2024-06-25FatBoy Capital L.P. loaned $150,000 to the Company in exchange for a short-term promissory note.
2024-07-01Company entered into a short-term promissory note with FatBoy Capital L.P. for $250,000.
2024-07-18Company entered into a short-term promissory note with FatBoy Capital L.P. for $100,000.
2024-07-25Company entered into a short-term promissory note with Jenkins Family Charitable Institute for $500,000.
2024-08-23First amendment of Related Party Notes, extending maturity to Jan 31, 2026, and increasing interest rate to 12%.
2024-08-30Entered into Underwriting Agreement with Ladenburg Thalmann & Co. Inc. for public offering.
2024-09-01Heart Failure Society of America (HFSA) reported heart failure statistics in the Journal of Cardiac Health.
2024-09-03Completed public offering, selling Common Stock Units and Pre-Funded Warrant Units.
2024-09-26Purchased director and officer liability insurance coverage for $293 thousand.
2024-10-14Overallotment Option for public offering expired.
2024-10-25Executed 2024 Warrant Inducement Offer, lowering exercise price of existing warrants.
2024-10-28Jenkins Family Charitable Institute exercised pre-funded warrants.
2024-12-01VIVO EU Registry data collection completed.
2024-12-01Coventry Hospital study completed enrollment and follow-up of 50 patients.
2024-12-01Joint marketing agreement with Stereotaxis, Inc. terminated.
2024-12-04Registration statement for Series K Warrants declared effective.
2025-01-06Philip Anderson became Chief Financial Officer.
2025-01-10Registration Statement on Form S-3 (File No. 333-284217) initially filed with SEC.
2025-01-13Stockholders approved amendment to Certificate of Incorporation, increasing authorized capital stock.
2025-01-14Entered into Membership Interest Purchase Agreement with Cardiofront, LLC to purchase PeriKard, LLC.
2025-01-22Registration Statement on Form S-3 (File No. 333-284217) declared effective.
2025-01-24PeriKard, LLC acquisition closed.
2025-02-17Formed new subsidiary, Cardionomix, Inc.
2025-04-01U.S. patent for LockeT granted by the United States Patent and Trademark Office.
2025-04-01LockeT received CE Mark approval.
2025-05-05Cardionomix acquired certain assets related to the Cardiac Pulmonary Nerve Stimulation (CPNS) System.
2025-05-12Entered into Securities Purchase Agreement for May 2025 PIPE Financing.
2025-05-19Entered into At Market Offering Agreement (ATM Agreement) with Ladenburg.
2025-05-30Registration statement for resale of Series B Convertible Preferred Stock and Series L Warrants declared effective.
2025-06-02Marie-Claude Jacques' employment terminated.
2025-06-11771 shares of Series B Convertible Preferred Stock converted into 115,913 shares of common stock.
2025-06-13Filed prospectus supplement increasing ATM offering to $3.2 million.
2025-06-20Formed new subsidiary, KardioNav, Inc.
2025-07-08Entered into second lease extension agreement for New Jersey office through Dec 31, 2027.
2025-07-11KardioNav issued two short-term promissory notes for $150 thousand each to CEO and Lifestim, Inc.
2025-07-25Stockholders approved amendment to Certificate of Incorporation to effect a 1-for-19 reverse stock split.
2025-08-07Filed prospectus supplement increasing ATM offering to $4.3 million.
2025-08-151-for-19 reverse stock split became effective.
2025-09-01Research and development activities in animals and humans commenced for KardioNav.
2025-10-01Purchased director and officer liability insurance coverage for $77 thousand.
2025-10-17Stockholders approved additional amendment to Certificate of Incorporation, increasing authorized capital stock to 510 million shares.
2025-11-21Filed Current Report on Form 8-K announcing termination of ATM Agreement.
2025-11-24ATM Agreement terminated.
2025-12-26Issued unsecured convertible notes payable totaling $300 thousand to Boot Capital LLC and Vanquish Funding Group Inc.
2025-12-31Entered into second amendment of Related Party Notes, extending maturity dates and issuing Series M Warrants.
2025-12-31Entered into Series J Exchange Agreement, exchanging royalty rights for Series J Convertible Preferred Stock.
2025-12-31Sold PeriKard membership interests to Mr. Jenkins for de minimis proceeds.
2026-01-31Purchased director and officer liability insurance coverage for $277 thousand.
2026-02-06Entered into Securities Purchase Agreement for a private placement financing, raising $2.2 million.
2026-02-06Agreed to lower exercise price of existing warrants and conversion price of Series B Preferred Stock to $1.78 per share, raising $0.4 million.
2026-02-09Conversion price of Series B Preferred Stock reduced from $6.65 to $1.78 per share.
2026-03-06Certificate of Amendment of Certificate of Designations of Series C-1 Convertible Preferred Stock dated.
2026-03-09Entered into additional Securities Purchase Agreement for a private placement financing, raising $1.9 million.
2026-03-09Acquired 100% of FLYTE and Ponderosa Air, LLC for $0.8 million cash, $5.0 million promissory note, and $5.8 million Series D Convertible Preferred Stock.
2026-03-11Certain holders of Series B Convertible Preferred Stock converted 578.916 shares into 335,346 common stock.
2026-03-18Company had 17 employees.
2026-03-20Company had 486,541,439 unreserved shares of common stock and 9,985,390.256 unreserved shares of preferred stock available for issuance.
2026-03-20Last reported sales price of common stock was $1.23.
2026-03-20Company had 2,692,473 shares of common stock outstanding.
2026-03-31Date of filing of the Annual Report on Form 10-K.

Recommendation

sell

The filing explicitly states 'substantial doubt about our ability to continue as a going concern' and highlights recurring net losses, negative cash flows, and an urgent need for additional financing within 1-2 months. This severe financial distress, coupled with significant dilution from recent and planned capital raises, a $7.0 million impairment charge on a key product (VIVO), and the substantial reduction in NOL carryforwards, presents an extremely high-risk profile. While there are some positive product developments and a diversification into private aviation, these are insufficient to offset the immediate and existential financial challenges. A seasoned investor would view the company's current financial state as highly precarious, with a high probability of further dilution or even bankruptcy, making a 'sell' recommendation appropriate to mitigate significant downside risk.

Keywords

Catheter Precision, VTAK, Medical Devices, Electrophysiology, VIVO System, LockeT, Cardiac Arrhythmias, Suture Retention Device, SEC Filing, 10-K, Financial Reporting, Going Concern, Capital Raise, Private Placement, Warrants, Convertible Preferred Stock, NOLs, Intellectual Property, FDA Clearance, CE Mark, Cybersecurity, FLYTE, Private Aviation, Heart Failure, CPNS System, KardioNav, Medical Technology

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