UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM
(Mark One)
| QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
| For
the fiscal quarter ended | |
| TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT | |
| For the transition period from to |
(Exact name of small business issuer as specified in its charter)
| (State of | (Commission | (IRS Employer | ||
| Incorporation) | File Number) | Identification No.) |
(Address of principal executive offices) (Zip code)
Issuer’s
telephone number:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||
| OTCQB |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Indicate
by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data
File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files). Yes ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
| Large Accelerated Filer ☐ | Accelerated Filer ☐ |
| Smaller
Reporting Company | |
| Emerging
Growth Company |
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes
There were shares outstanding of registrant’s common stock, par value $ per share, as of August 8, 2025.
Transitional Small Business Disclosure Format (check one): Yes ☐ No ☒
TABLE OF CONTENTS
| 2 |
PART 1
ITEM 1. FINANCIAL STATEMENTS
VYCOR MEDICAL, INC.
Consolidated Balance Sheets
(Unaudited)
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash | $ | $ | ||||||
| Trade accounts receivable | ||||||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Current assets of discontinued operations | ||||||||
| Total Current Assets | ||||||||
| Fixed assets, net | ||||||||
| Other assets | ||||||||
| Non-current inventory | ||||||||
| Security deposits | ||||||||
| Operating lease - right of use assets | ||||||||
| Total Other Assets | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ DEFICIENCY | ||||||||
| Current Liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued interest | ||||||||
| Accrued interest - Related party | ||||||||
| Accrued liabilities | ||||||||
| Dividends payable - Related Party | ||||||||
| Notes payable | ||||||||
| Notes payable - Related Party | ||||||||
| Current operating lease liabilities | ||||||||
| Current liabilities of discontinued operations | ( | ) | ( | ) | ||||
| Total Current Liabilities | ||||||||
| Operating lease liability - long term | ||||||||
| Loan payable - SBA EIDL | ||||||||
| Total Liabilities | ||||||||
| STOCKHOLDERS’ DEFICIENCY | ||||||||
| Preferred stock, $ par value, shares authorized | ||||||||
| Preferred C Stock, and share issued and outstanding as at June 30, 2025 and December 31, 2024 respectively | ||||||||
| Preferred D Stock, and shares issued and outstanding as at June 30, 2025 and December 31, 2024 respectively | ||||||||
| Common Stock, $ par value, shares authorized at June 30, 2025 and December 31, 2024; shares issued and shares outstanding at June 30, 2025 and December 31, 2024, respectively | ||||||||
| Additional Paid-in Capital | ||||||||
| Treasury Stock ( shares of Common Stock as at June 30, 2025 and December 31, 2024, at cost) | ( | ) | ( | ) | ||||
| Accumulated Deficit | ( | ) | ( | ) | ||||
| Accumulated Other Comprehensive Income | ||||||||
| Total Stockholders’ Deficiency | ( | ) | ( | ) | ||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIENCY | $ | $ | ||||||
See accompanying notes to consolidated financial statements
| 3 |
VYCOR MEDICAL, INC.
Consolidated Statements of Comprehensive Income (Loss)
(Unaudited)
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Cost of Goods Sold | ||||||||||||||||
| Gross Profit | ||||||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | ||||||||||||||||
| Depreciation and amortization | ||||||||||||||||
| Selling, general and administrative | ||||||||||||||||
| Total Operating Expenses | ||||||||||||||||
| Operating income | ||||||||||||||||
| Other Income (Expense) | ||||||||||||||||
| Interest expense: Related Party | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Interest expense: Other | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income | ||||||||||||||||
| Gain (loss) on foreign currency exchange | ( | ) | ||||||||||||||
| Total Other Income (Expense) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Income (Loss) Before Provision for Income Taxes | ( | ) | ( | ) | ( | ) | ||||||||||
| Provision for income taxes | ||||||||||||||||
| Net Income (Loss) from continuing operations | ( | ) | ( | ) | ( | ) | ||||||||||
| Loss from discontinued operations, net of tax | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net Income (Loss) | ( | ) | ( | ) | ( | ) | ||||||||||
| Preferred stock dividends | ( | ) | ( | ) | ||||||||||||
| Net Income (Loss) Available to Common Stockholders | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||
| Other Comprehensive Income (Loss) | ||||||||||||||||
| Foreign Currency Translation Adjustment | ||||||||||||||||
| Comprehensive Income (Loss) | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||
| Income (Loss) Per Share - basic and diluted | ||||||||||||||||
| Income (Loss) from continuing operations | $ | $ | ) | $ | ) | $ | ) | |||||||||
| Loss from discontinued operations | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Income (Loss) available to common stockholders | $ | $ | ) | $ | ) | $ | ) | |||||||||
| Weighted Average Number of Shares Outstanding – Basic | ||||||||||||||||
| Weighted Average Number of Shares Outstanding –Diluted | ||||||||||||||||
See accompanying notes to consolidated financial statements
| 4 |
VYCOR MEDICAL, INC.
Consolidated Statements of Stockholders’ Deficiency
(Unaudited)
| Common Stock | Preferred C | Preferred D | Treasury Stock | Additional Paid-in | Accumulated | Accum OCI | ||||||||||||||||||||||||||||||||||||||||||
| Number | Amount | Number | Amount | Number | Amount | Number | Amount | Capital | Deficit | (Loss) | Total | |||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||||||||||||
| Net income for the three months ended June 30, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||||||||||||
| Balance at March 31, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||||||||||||
| Net loss for the three months ended June 30, 2024 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||||||||||||
| Common Stock | Preferred C | Preferred D | Treasury Stock | Additional Paid-in | Accumulated | Accum OCI | ||||||||||||||||||||||||||||||||||||||||||
| Number | Amount | Number | Amount | Number | Amount | Number | Amount | Capital | Deficit | (Loss) | Total | |||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | | $ | | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||||||||||
| Net loss for the six months ended June 30, 2025 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||
| Preferred stock dividends | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||||||||||||
| Net loss for the six months ended June 30, 2024 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||
| Preferred stock dividends | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||||||||||||
See accompanying notes to consolidated financial statements
| 5 |
VYCOR MEDICAL, INC.
Consolidated Statements of Cash Flows
(Unaudited)
| For the six months ended | ||||||||
| June 30, | June 30, | |||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to cash provided by operating activities: | ||||||||
| Depreciation of fixed assets | ||||||||
| Allowance for doubtful accounts - accounts receivable | ||||||||
| Stock based compensation | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ( | ) | ||||||
| Inventory | ( | ) | ||||||
| Prepaid expenses | ( | ) | ||||||
| Accrued interest - Related Party | ||||||||
| Accrued interest | ||||||||
| Accounts payable | ( | ) | ||||||
| Accrued liabilities | ( | ) | ||||||
| Changes in discontinued operations, net | ||||||||
| Cash provided by operating activities | ||||||||
| Cash flows from investing activities: | ||||||||
| Purchase of fixed assets | ( | ) | ||||||
| Sale of fixed assets | ||||||||
| Cash (used in) provided by investing activities | ( | ) | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds - Notes Payable Other | ||||||||
| Repayments - Notes Payable Other | ( | ) | ( | ) | ||||
| Cash used in financing activities | ( | ) | ( | ) | ||||
| Effect of exchange rate changes on cash | ||||||||
| Net (decrease) increase in cash | ( | ) | ||||||
| Cash at beginning of period | ||||||||
| Cash at end of period | $ | $ | ||||||
| Supplemental Disclosures of Cash Flow information: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Cash paid for income tax | $ | $ | ||||||
| Non-Cash Activities: | ||||||||
| Non-cash accrued dividends | $ | $ | ||||||
| Unamortized stock compensation | $ | $ | ||||||
See accompanying notes to consolidated financial statements
| 6 |
VYCOR MEDICAL, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2025
(Unaudited)
1. BASIS OF PRESENTATION
The accompanying unaudited consolidated financial statements of Vycor Medical, Inc. (the “Company” or “Vycor”) have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities Exchange Commission. In accordance with those rules and regulations certain information and footnote disclosures normally included in consolidated financial statements have been omitted pursuant to such rules and regulations. The consolidated balance sheet as of December 31, 2024 derives from the audited financial statements at that date but does not include all the information and footnotes required by GAAP. These unaudited consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
The unaudited consolidated financial statements as of and for the three and six months ended June 30, 2025 and 2024, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the Company’s financial condition, results of operations and cash flows. The results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results to be expected for any other interim period or for the entire year.
Ability to continue as a Going Concern
The
accompanying unaudited consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
The Company has incurred losses since its inception, including a net loss of $
The
Company is executing on a plan to achieve a reduction in cash operating losses. Included within the working capital deficiency above
is a term note for $
2. SIGNIFICANT ACCOUNTING POLICIES
Principles of Consolidation
The unaudited consolidated financial statements include the accounts of Vycor Medical, Inc., and its wholly-owned subsidiaries, NovaVision, Inc. (a Delaware corporation), NovaVision GmbH (a German corporation) and Sight Science Limited (a UK corporation), both wholly owned subsidiaries of NovaVision, Inc. The Company is headquartered in Boca Raton, FL. All material inter-company account balances, transactions, and profits have been eliminated in consolidation. Following the decision in April 2020 to close the German office of NovaVision, the activities of NovaVision GmbH have been accounted for as discontinued operations.
Recent Accounting Pronouncements
From time-to-time new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that may have an impact on the Company’s accounting and reporting. Unless otherwise discussed, the Company believes that other recently issued accounting pronouncements and other authoritative guidance for which the effective date is in the future will not have an impact on its accounting or reporting or that such impact will not be material to its financial position, results of operations and cash flows when implemented.
| 7 |
Recently adopted accounting pronouncements
Segment Reporting
In November 2023, the FASB issued Accounting Standards Update (ASU) No. 2023-07, Improvements to Reportable Segment Disclosures (Topic 280). This ASU updates reportable segment disclosure requirements by requiring disclosures of significant reportable segment expenses that are regularly provided to the Company’s Chief Operating Decision Maker (“CODM”), who is our Chief Executive officer, and included within each reported measure of a segment’s profit or loss. This ASU also requires disclosure of the title and position of the individual identified as the CODM and an explanation of how the CODM uses the reported measures of a segment’s profit or loss in assessing segment performance and deciding how to allocate resources. The ASU is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. We adopted this ASU retrospectively on December 31, 2024. The adoption of ASU 2023-07 did not have a significant impact on the Company’s consolidated financial statements and related disclosures. Refer to Note 7 for the inclusion of the new required disclosures.
Recently issued accounting pronouncements not yet adopted
Income Taxes
In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures (“ASU 2023-09”). ASU 2023-09 is intended to improve income tax disclosures primarily through enhanced disclosure of income tax rate reconciliation items, and disaggregation of income (loss) from continuing operations, income tax expense (benefit) and income taxes paid, net disclosures by federal, state and foreign jurisdictions, among others. ASU 2023-09 is effective for annual reporting periods beginning after December 15, 2024, and early adoption is permitted. The Company is evaluating the impact that ASU 2023-09 will have on the consolidated financial statements and its plan for adoption, including the adoption date and transition method.
Disaggregation of Income Statement Expenses
In November 2024, the FASB issued ASU No. 2024-03, “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses”, which requires disaggregated disclosure of income statement expenses for public business entities. ASU 2024-03 requires new financial statement disclosures in tabular format, disaggregating information about prescribed categories underlying any relevant income statement expense caption. The prescribed categories include, among other things, purchases of inventory, employee compensation, depreciation, and intangible asset amortization. Additionally, entities must disclose the total amount of selling expenses and, in annual reporting periods, an entity’s definition of selling expenses. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and for interim reporting periods within fiscal years beginning after December 15, 2027. The guidance can be applied prospectively with an option for retrospective application. Early adoption is also permitted. We are currently evaluating the provisions of this ASU.
Revenue Recognition
On January 1, 2018 the Company adopted ASC 606, Revenue from Contracts with Customers and all the related amendments (new revenue standard) to all contracts.
Vycor Medical generates revenue from the sale of its surgical access system to hospitals and other medical professionals. Vycor Medical records revenue from product sales when obligations under the terms of a contract with customers are satisfied. Generally, this occurs with the transfer of control of the goods to customers. Vycor Medical does not provide for product returns or warranty costs.
Vycor determines revenue recognition through the following steps:
| ● | Identification of the contract, or contracts, with a customer | |
| ● | Identification of the performance obligations in the contract | |
| ● | Determination of the transaction price | |
| ● | Allocation of the transaction price to the performance obligations in the contract | |
| ● | Recognition of revenue when Vycor satisfy a performance obligation |
| 8 |
NovaVision generates revenues from various programs, therapy services and other sources such as software license sales. Therapy services revenues represent fees from NovaVision’s vision restoration therapy software, eye movement training software, diagnostic software, clinic set up and training fees, and the professional and support services associated with the therapy. NovaVision provides vision restoration therapy directly to patients. The typical therapy program consists of NeuroEyeCoach, performed over 2-4 weeks, and six modules of Vision Restoration Therapy, performed over 6 months. A patient contract comprises set-up fees and monthly therapy fees. Set-up fees are recognized at the outset of the contract and therapy revenue is recognized ratably over the therapy period. Patient therapy is restricted to being completed by a patient within a specified time frame.
Contract liabilities (Deferred revenue) results from patients paying for the therapy in advance of receiving the therapy.
The Company disaggregates its revenue by division – Vycor and NovaVision – and by geography – United States and Europe – and presents the disaggregation in Note 7.
Basic net income (loss) per share is computed by dividing net income (loss) available to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share is computed giving effect to all dilutive potential common shares that were outstanding during the period. Dilutive potential common shares consist of incremental shares issuable upon conversion of preferred stock and convertible debt. Such potentially dilutive shares are excluded when the effect would be to increase a net income per share or reduce a net loss per share. No dilution adjustment has been made to the weighted average outstanding common shares in the periods presented of net loss because the assumed conversion of preferred stock and debt would be anti-dilutive.
| Six months ended June 30, 2025 | Three and Six months ended June 30, 2024 | |||||||
| Debentures convertible into common stock | ||||||||
| Preferred shares convertible into common stock | ||||||||
| Total | ||||||||
The following table sets forth the potential shares of common stock that are included in the calculation of diluted net income per share where a net income is reported:
| Three months ended June 30, 2025 | ||||
| Debentures convertible into common stock | ||||
| Preferred shares convertible into common stock | ||||
| Total | ||||
Reclassifications
Certain prior period amounts have been reclassified to conform with the current period presentation: on the balance sheets, inventory has been separated out in current and non-current assets.
| 9 |
3. DISCONTINUED OPERATIONS
In April 2020, the board of Vycor took the decision to close the German operations of NovaVision, including the German office and NovaVision GmbH, and instead migrate to a licensed business model; effective July 1, 2020, Vycor entered into a license agreement with a German-based partner. The NovaVision German office was closed effective June 30, 2020. The Company will continue to fund the remaining expenses of the German operations, which are non-material, until such a time as NovaVision GmbH will be formally wound up.
Reconciliation of the major line items from discontinued operations that are presented in the unaudited consolidated balance sheets and unaudited consolidated statements of comprehensive income (loss) are as follows:
Major line items constituting assets and liabilities in the unaudited consolidated balance sheets
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash | $ | $ | ||||||
| Total Current Assets | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES | ||||||||
| Current Liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Other current liabilities | ( | ) | ( | ) | ||||
| Total Current Liabilities | $ | ( | ) | $ | ( | ) | ||
Major line items constituting loss from discontinued operations
For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Cost of Goods Sold | ||||||||||||||||
| Gross Profit | ||||||||||||||||
| Operating Expenses: | ||||||||||||||||
| Selling, general and administrative | ||||||||||||||||
| Total Operating Expenses | ||||||||||||||||
| Operating Loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (Expense) | ||||||||||||||||
| Loss on foreign currency exchange | ( | ) | ( | ) | ||||||||||||
| Total Other Income (Expense) | ( | ) | ( | ) | ||||||||||||
| Loss Before Provision for Income Taxes | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Provision for income taxes | ||||||||||||||||
| Loss from discontinued operations, net of tax | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 10 |
4. NOTES PAYABLE
Related Parties Notes Payable
Related Party Notes Payable consists of:
| June 30, 2025 | December 31, 2024 | |||||||
| On June 25, 2018 the Company issued promissory notes to Peter Zachariou for $ | $ | $ | ||||||
| Between March 26, 2018 and November 17, 2022 the Company issued fifteen promissory notes to Fountainhead Capital Management Limited for $ | ||||||||
| Total Related Party Notes Payable | $ | $ | ||||||
Other Notes Payable
Other Notes Payable consists of:
| June 30, 2025 | December 31, 2024 | |||||||
| On March 25, 2011 the Company issued a term note for $ | $ | $ | ||||||
| Insurance policy finance agreements and current portion of EIDL Loan (see Long-Term Notes Payable below) | ||||||||
| Total Other Notes Payable | $ | $ | ||||||
Long-Term Notes Payable consists of:
| June 30, 2025 | December 31, 2024 | |||||||
| On July 7, 2020, the Company was advised that the Small Business Administration (SBA) had approved a $ | $ | $ | ||||||
| Total Long-term Notes Payable | $ | $ | ||||||
In
January 2018 the Company entered into an amendment agreement (the “Amendment”) with EuroAmerican Investments (“EuroAmerican”)
regarding its $
The Company routinely finances all their insurance policies through a third-party finance company which requires a down payment and subsequent monthly payments, the time periods vary from 10 months to 12 equal monthly payments.
| 11 |
5. INVENTORY
| June 30, 2025 | December 31, 2024 | |||||||
| Current Inventory | ||||||||
| Raw materials and work in process | $ | $ | ||||||
| Finished goods | ||||||||
| Total Current Inventory | $ | $ | ||||||
| Non-Current Inventory | ||||||||
| Raw materials and work in process | $ | $ | ||||||
| Finished goods | ||||||||
| Less: obsolescence provision - finished goods | ( | ) | ( | ) | ||||
| Total Non-Current Inventory | $ | $ | ||||||
The Company estimates the consumption of inventories and separates the inventories that may be consumed after 12 months as non-current inventory.
6. LEASE
The Company recognized the following related to a lease in its unaudited consolidated balance sheets at June 30, 2025 and December 31, 2024:
| June 30, 2025 | December 31, 2024 | |||||||
| Operating Lease ROU Assets | $ | $ | ||||||
| Operating Lease Liabilities | ||||||||
| Current portion | $ | $ | ||||||
| Long-term portion | ||||||||
| $ | $ | |||||||
7. SEGMENT REPORTING, GEOGRAPHICAL INFORMATION
(a) Business segments
The
Company operates in
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue: | ||||||||||||||||
| Vycor Medical | $ | $ | $ | $ | ||||||||||||
| NovaVision | ||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Gross Profit | ||||||||||||||||
| Vycor Medical | $ | $ | $ | $ | ||||||||||||
| NovaVision | ||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Operating Income (Loss) | ||||||||||||||||
| Vycor Medical | $ | $ | $ | $ | ||||||||||||
| NovaVision | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Corporate | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| $ | $ | $ | $ | |||||||||||||
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Total Assets: | ||||||||
| Vycor Medical | $ | $ | ||||||
| NovaVision | ||||||||
| Discontinued operations | ||||||||
| Total Assets | $ | $ | ||||||
| 12 |
(b) Geographic segments
The
Company operates in
For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue: | ||||||||||||||||
| United States | $ | $ | $ | $ | ||||||||||||
| Europe | ||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Gross Profit | ||||||||||||||||
| United States | $ | $ | $ | $ | ||||||||||||
| Europe | ||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Operating Income (Loss) | ||||||||||||||||
| United States | $ | $ | $ | $ | ||||||||||||
| Europe | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Corporate | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| $ | $ | $ | $ | |||||||||||||
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Total Assets: | ||||||||
| United States | $ | $ | ||||||
| Europe | ||||||||
| Discontinued operations | ||||||||
| Total Assets | $ | $ | ||||||
8. EQUITY
Equity Transactions
During
each of the six months ended June 30, 2025 and 2024, the Company accrued $
Equity Classes
Our authorized capital stock consists of shares of common stock, par value $ per share, and shares of preferred stock, par value $ per share, the rights and preferences of which may be established from time to time by our board. As at June 30, 2025, there were shares of common stock, one () share of Series C Preferred Stock and shares of Series D Preferred Stock outstanding.
Holders of our common stock are entitled to one vote for each share on all matters voted upon by our stockholders, including the election of directors, and do not have cumulative voting rights. Subject to the rights of holders of any then outstanding shares of our preferred stock, our common stockholders are entitled to any dividends that may be declared by our board. Holders of our common stock are entitled to share ratably in our net assets upon our dissolution or liquidation after payment or provision for all liabilities and any preferential liquidation rights of our preferred stock then outstanding. Holders of our common stock have no preemptive rights to purchase shares of our stock. The shares of our common stock are not subject to any redemption provisions and are not convertible into any other shares of our capital stock. All outstanding shares of our common stock are, and the shares of common stock to be issued will be, upon payment therefor, fully paid and non-assessable. The rights, preferences and privileges of holders of our common stock will be subject to those of the holders of any shares of our preferred stock we may issue in the future.
Series C Convertible Preferred Stock shares (“Preferred C Stock”) are convertible (at the Holder’s option or mandatorily upon the occurrence of certain events) into shares of the Company’s Common Stock (at $ per share). The Preferred C Stock carries no dividend or other rights.
Series
D Convertible Preferred Stock shares (“Preferred D Stock”) are convertible into Company Common Shares at a price of $.
The Series D carry a cumulative preferred dividend of
| 13 |
The Company from time-to-time issues common stock, stock options or common stock warrants to acquire services or goods from non-employees. Common stock, stock options and common stock warrants issued to other than employees or directors are recorded on the basis of their fair value, which is measured as of the “measurement date” using an option pricing model, or their contractual value if different in the case of common stock. The “measurement date” for options and warrants related to contracts that have substantial disincentives to non-performance is the date of the contract, and for all other contracts is the vesting date. Expense related to the options and warrants is recognized on a straight-line basis over the shorter of the period over which services are to be received or the life of the option or warrant.
Non-Employee Stock Compensation
Aggregate stock-based compensation for shares of common stock granted to non-employees for each of the six months ended June 30, 2025 and 2024 was $ and $ respectively and for each of the three months ended June 30, 2025 and 2024 was $ and $ respectively. As of June 30, 2025 and December 31, 2024, there was $ and $ respectively of total unrecognized compensation costs related to stock awards, which were included in Prepaid expenses and other current assets on the consolidated balance sheets (see Note 11).
10. COMMITMENTS AND CONTINGENCIES
Lease
The
Company leases office space located at 951 Broken Sound Parkway, Suite 320, Boca Raton, FL 33487 from WPT Land 2 L.P., for a gross
rent of approximately $
Potential German tax liability
In
June 2012 the Company’s NovaVision German subsidiary received a preliminary assessment for Magdeburg City trade tax of €
11. CONSULTING AND OTHER AGREEMENTS
The following agreements were entered into or remained in force during the periods ended June 30, 2025 and 2024:
On
August 27, 2024 Vycor entered into a financial advisory and investment banking services agreement (“Agreement”) with
Maxim. Under the terms of the Agreement, Maxim will assist Vycor in its strategy to grow the Company through strategic acquisitions
and assist the Company with efforts to position itself for a potential uplisting to a US exchange. Vycor issued
shares of Company Common Stock (valued at $
On
March 30, 2021, Vycor entered into a Consulting Agreement with Ricardo J. Komotar, M.D. (the “Agreement”) to provide
certain specified services over the three-year term of the Agreement. On April 1, 2023,
shares of Company Common Stock (valued at $
12. RELATED PARTY TRANSACTIONS AND BALANCES
Peter
Zachariou and David Cantor, directors of the Company, are investment managers of Fountainhead which owned, at June 30, 2025,
During
each of the six months ended June 30, 2025 and 2024, the Company accrued an aggregate of $
During
the three months ended June 30, 2025 and 2024 the Company accrued interest on related party loans of $
During
the six months ended June 30, 2025 and 2024 the Company accrued interest on related party loans of $
| 14 |
13. CONCENTRATION
Vycor Medical sells its neurosurgical devices in the US primarily direct to hospitals, and internationally through distributors who in turn sell to hospitals.
Sales Concentration:
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Number of customers over 10% | ||||||||||||||||
| Percentage of sales | % | % | % | % | ||||||||||||
Accounts Receivable Concentration
At June 30, 2025 | At December 31, | |||||||
| Number of customers over 10% | ||||||||
| Percentage of accounts receivable | % | % | ||||||
The
Company has three sub-contract manufacturers from which it purchases, respectively, VBAS injection molded parts, completed and sterilized
VBAS units, and extension arms. Purchases from these manufacturers vary from quarter to quarter, with no purchases in some quarters,
however on an annual basis, purchases from each manufacturer represent over
| 15 |
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Forward Looking Statements
This Interim Report on Form 10-Q contains, in addition to historical information, certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PLSRA”), Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) regarding Vycor Medical, Inc. (the “Company” or “Vycor,” also referred to as “us”, “we” or “our”). Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Forward-looking statements involve risks and uncertainties. Forward-looking statements include statements regarding, among other things, (a) our projected sales, profitability, and cash flows, (b) our growth strategies, (c) anticipated trends in our industries, (d) our future financing plans and (e) our anticipated needs for working capital. They are generally identifiable by use of the words “may,” “will,” “should,” “anticipate,” “estimate,” “plans,” “potential,” “projects,” “continuing,” “ongoing,” “expects,” “management believes,” “we believe,” “we intend” or the negative of these words or other variations on these words or comparable terminology. These statements may be found under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Description of Business,” as well as in this Form 10-Q generally. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.
Any or all of our forward-looking statements in this report may turn out to be inaccurate. They can be affected by inaccurate assumptions we might make or by known or unknown risks or uncertainties. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially as a result of various factors, including, without limitation, the risks outlined under “Risk Factors” and matters described in this Form 10-Q generally. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements contained in this filing will in fact occur. You should not place undue reliance on these forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and, except to the extent required by federal securities laws, we undertake no obligation to publicly update any forward-looking statements, whether as the result of new information, future events, or otherwise. We intend that all forward-looking statements be subject to the safe harbor provisions of the PSLRA.
1. Organizational History
The Company was formed as a limited liability company under the laws of the State of New York on June 17, 2005 as “Vycor Medical LLC”. On August 14, 2007, we converted into a Delaware corporation and changed our name to “Vycor Medical, Inc.” (“Vycor”). The Company’s listing went effective on February 2009 and on November 29, 2010 Vycor completed the acquisition of substantially all of the assets of NovaVision, Inc. (“NovaVision”) and on January 4, 2012 Vycor, through its wholly-owned NovaVision subsidiary, completed the acquisition of all the shares of Sight Science Limited (“Sight Science”), a previous competitor to NovaVision.
2. Overview of Business
Vycor is dedicated to providing the medical community with innovative and superior surgical and therapeutic solutions and operates two distinct business units within the medical device industry. Vycor Medical designs, develops and markets medical devices for use in neurosurgery. NovaVision provides non-invasive rehabilitation therapies for those who have vision disorders resulting from neurological brain damage such as that caused by a stroke. Both businesses adopt a minimally or non-invasive approach. The Company leverages joint resources across the divisions to operate in a cost-efficient manner.
Vycor Medical
Vycor Medical designs, develops and markets medical devices for use in neurosurgery. Vycor Medical’s ViewSite Brain Access System (“VBAS”) is a next generation retraction and access system. Vycor Medical is ISO 13485:2016 and MDSAP (Medical Device Single Audit Program) certified, and VBAS has U.S. FDA 510(k) clearance and CE Marking for Europe (Class III) for brain and spine surgeries, and regulatory approvals in several other international markets.
NovaVision
NovaVision provides non-invasive, computer-based rehabilitation therapies targeted at people who have impaired vision as a result of stroke or other brain injury.
Strategy
The Company is continuing to execute on a plan to achieve revenue growth. The strategy for Vycor Medical includes: increasing market penetration in the US; increasing international growth in territories where we are not represented or under-represented; continued new product development in response to market demands and demonstrating applicability in a broader range of pathologies; and adding products complementary to VBAS where the Company is able to leverage its existing distribution network.
Given NovaVision’s resources, and the large size and diversity of its end markets, we believe that the most efficient way to tackle the distribution of its patient and professional products is by partnering with entities that have either direct access to the end users or the technological capability to leverage the NovaVision therapy platform, particularly in digital health and into non-medical areas. Management is also open to a broad range of alternatives for NovaVision as a whole, which could comprise distribution and marketing partnerships, licensing, merger or sale.
In August 2024 the Company engaged the services of Maxim Group LLC to assist in its strategy to accelerate the growth of the Company through strategic acquisitions and partnerships.
| 16 |
Comparison of the Three Months Ended June 30, 2025 to the Three Months Ended June 30, 2024
Revenue and Gross Margin:
| Three months ended | ||||||||||||
| June 30, | ||||||||||||
| 2025 | 2024 | % Change | ||||||||||
| Revenue: | ||||||||||||
| Vycor Medical | $ | 481,788 | $ | 387,249 | 24 | % | ||||||
| NovaVision | 14,565 | 19,029 | -23 | % | ||||||||
| $ | 496,353 | $ | 406,278 | 22 | % | |||||||
| Gross Profit | ||||||||||||
| Vycor Medical | $ | 401,783 | $ | 352,963 | 14 | % | ||||||
| NovaVision | 13,488 | 18,152 | -26 | % | ||||||||
| $ | 415,271 | $ | 371,115 | 12 | % | |||||||
Vycor Medical recorded revenue of $481,788 from the sale of its products for the three months ended June 30, 2025, an increase of $94,539, or 24%, over the same period in 2024, most of the increase being from growth in international markets. Gross margin of 83% and 91% was recorded for the three months ended June 30, 2025 and 2024, respectively, with the lower gross margin in 2025 due to validation and shipping costs of new production as well as sales mix.
NovaVision recorded revenues of $14,565 for the three months ended June 30, 2025, a decrease of $4,464, or 23%, over the same period in 2024. Gross margin was 93%, compared to 95% for the same period in 2024.
Research & Development:
Research & Development expenses were $4,201 for the three months ended June 30, 2025 compared to $2,263 for the same period in 2024, reflected new product development in the Vycor Medical division.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses increased by $7,250 to $345,043 for the three months ended June 30, 2025 from $337,793 for the same period in 2024. Included within Selling, General and Administrative Expenses are non-cash charges for stock-based compensation as the result of amortizing non-employee shares which have been issued by the Company. The charge for the three months ended June 30, 2025 was $18,314, a $18,314 increase from the charge in 2024 due to amortization of the Maxim financial advisory agreement. Also included within Selling, General and Administrative Expenses are Sales Commissions, which decreased by $44,409 from $83,057 in 2024 to $38,648 in 2025 partly reflecting lower US sales during the current period of 2025 and also due to the write off of historical balances of $23,593.
The remaining Selling, General and Administrative expenses increased by $33,345 from $254,736 in 2024 to $288,081 in 2025, as follows:
| Investor Relations | $ | 25,883 | ||
| Other | 7,462 | |||
| $ | 33,345 |
Interest Expense:
Interest comprises expense on the Company’s debt and insurance policy financing. Related Party Interest expense for the three months ended June 30, 2025 was $12,572 compared to $12,841 for 2024. Other Interest expense for the three months ended June 30, 2025 was $12,862 compared to $13,327 for 2024.
Operating loss from Discontinued Operations:
Operating loss from Discontinued Operations increased by $1,777 to $1,826 in 2025 from $49 in 2024; the Company has some minor ongoing costs related to the wind-down of the discontinued operations in Germany but no revenues.
| 17 |
Comparison of the Six Months Ended June 30, 2025 to the Six Months Ended June 30, 2024
Revenue and Gross Margin:
| Six months ended | ||||||||||||
| June 30, | ||||||||||||
| 2025 | 2024 | % Change | ||||||||||
| Revenue: | ||||||||||||
| Vycor Medical | $ | 900,308 | $ | 705,807 | 28 | % | ||||||
| NovaVision | 32,423 | 37,439 | -13 | % | ||||||||
| $ | 932,731 | $ | 743,246 | 25 | % | |||||||
| Gross Profit | ||||||||||||
| Vycor Medical | $ | 743,581 | $ | 636,039 | 17 | % | ||||||
| NovaVision | 30,224 | 35,038 | -14 | % | ||||||||
| $ | 773,805 | $ | 671,077 | 15 | % | |||||||
Vycor Medical recorded revenue of $900,308 from the sale of its products for the six months ended June 30, 2025, an increase of $194,501, or 28%, over the same period in 2024, most of the increase being from growth in international markets. Gross margin of 83% and 90% was recorded for the six months ended June 30, 2025 and 2024, respectively, with the lower gross margin in 2025 due to validation and shipping costs of new production as well as geographic sales mix.
NovaVision recorded revenues of $32,423 for the six months ended June 30, 2025, a decrease of $5,016 over the same period in 2024. Gross margin was 93%, compared to 94% for the same period in 2024.
Research & Development:
Research & Development expenses were $9,963 for the six months ended June 30, 2025 compared to $2,263 for the same period in 2024, reflected new product development in the Vycor Medical division.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses increased by $63,334 to $695,741 for the six months ended June 30, 2025 from $632,407 for the same period in 2024. Included within Selling, General and Administrative Expenses are non-cash charges for stock-based compensation as the result of amortizing non-employee shares which have been issued by the Company. The charge for the six months ended June 30, 2025 was $36,629, an increase of $34,265 from $2,364 in 2024 primarily due to amortization of the Maxim financial advisory agreement. Also included within Selling, General and Administrative Expenses are Sales Commissions, which decreased by $22,196 from $146,371 in 2024 to $124,175 in 2025 due to the write off of historical balances of $23,593.
The remaining Selling, General and Administrative expenses increased by $51,265 from $483,672 in 2024 to $534,937 in 2025 as follows:
| Investor Relations | $ | 30,383 | ||
| Payroll | 38,232 | |||
| Legal, patent, audit/accounting | 12,307 | |||
| Regulatory | (10,484 | ) | ||
| Software development | (9,215 | ) | ||
| Other | (9,958 | ) | ||
| Total change | $ | 51,265 |
Interest Expense:
Interest comprises expense on the Company’s debt and insurance policy financing. Related Party Interest expense for the six months ended June 30, 2025 was $25,142 compared to $24,872 for 2024. Other Interest expense for the six months ended June 30, 2025 was $26,001 compared to $26,665 for 2024.
Other Income:
Other income comprises the historic customer credits of $4,544 written off during the six months ended June 30, 2024.
Operating loss from Discontinued Operations:
Operating loss from Discontinued Operations increased by $1,725 to $1,875 in 2025 from $150 in 2024; the Company has some minor ongoing costs related to the wind-down of the discontinued operations in Germany but no revenues.
| 18 |
Liquidity
The following table shows liquidity data as of June 30, 2025 and December 31, 2024:
| June 30, 2025 | December 31, 2024 | $ Change | ||||||||||
| Cash | $ | 99,700 | $ | 105,648 | $ | (5,948 | ) | |||||
| Accounts receivable, inventory and other current assets | $ | 454,655 | $ | 527,334 | $ | (72,679 | ) | |||||
| Total current liabilities | $ | (4,581,539 | ) | $ | (4,496,543 | ) | $ | (84,996 | ) | |||
| Working capital deficit | $ | (4,027,184 | ) | $ | (3,863,561 | ) | $ | (163,623 | ) | |||
The following table shows cash flow for the periods ended June 30, 2025 and 2024:
| June 30, 2025 | June 30, 2024 | $ Change | ||||||||||
| Cash provided by operating activities | $ | 19,724 | $ | 87,921 | $ | (68,197 | ) | |||||
| Cash (used in) provided by investing activities | $ | (2,777 | ) | $ | 662 | $ | (3,439 | ) | ||||
| Cash used in financing activities | $ | (22,895 | ) | $ | (26,578 | ) | $ | 3,683 | ||||
| Net increase (decrease) in cash | $ | (5,948 | ) | $ | 62,005 | $ | (67,953 | ) | ||||
Operating Activities. Cash provided by operating activities comprises net loss adjusted for non-cash items and the effect of changes in working capital and other activities. The net repayment of normal insurance financing should also be taken into account when considering cash provided by operating activities.
The following table shows the principal components of cash provided by operating activities during the six months ended June 30, 2025 and 2024, with a commentary of changes during the periods and known or anticipated future changes:
| June 30, 2025 | June 30, 2024 | $ Change | ||||||||||
| Net loss | $ | (14,676 | ) | $ | (40,646 | ) | $ | 25,970 | ||||
| Adjustments to reconcile net loss to cash provided by operating activities: | ||||||||||||
| Depreciation of fixed assets | $ | 31,131 | $ | 31,301 | $ | (170 | ) | |||||
| Allowance for doubtful accounts - accounts receivable | $ | - | $ | 4,865 | $ | (4,865 | ) | |||||
| Stock based compensation | $ | 36,629 | $ | 2,364 | $ | 34,265 | ||||||
| $ | 67,760 | $ | 38,530 | $ | 29,230 | |||||||
| Changes in operating assets and liabilities | ||||||||||||
| Accounts receivable | $ | 42,591 | $ | (42,410 | ) | $ | 85,001 | |||||
| Accounts payable and accrued liabilities | $ | (106,253 | ) | $ | 45,039 | $ | (151,292 | ) | ||||
| Inventory | $ | (8,304 | ) | $ | 15,832 | $ | (24,136 | ) | ||||
| Prepaid expenses | $ | (10,614 | ) | $ | 22,618 | $ | (33,232 | ) | ||||
| Accrued interest (not paid in cash) | $ | 48,945 | $ | 48,808 | $ | 137 | ||||||
| Changes in discontinued operations, net | $ | 275 | $ | 150 | $ | 125 | ||||||
| $ | (33,360 | ) | $ | 90,037 | $ | (123,397 | ) | |||||
| Cash provided by operating activities | $ | 19,724 | $ | 87,921 | $ | (68,197 | ) | |||||
Additional inventory of $126,129 was purchased during the six months ended June 30, 2025 as part of normal production, and the Company anticipates purchasing additional new inventory of approximately $75,000 during the next twelve months for VBAS devices.
Investing Activities. There was $2,777 cash used in investing activities during the six months ended June 30, 2025 due to purchase of chin rests of $3,618, offset by sales of fixed assets (chinrests) of $842. Cash provided by investing activities during the six months ended June 30, 2024 was $662 due to sales of fixed assets (chinrests). The Company anticipates limited investing activities during the next twelve months.
Financing Activities. During the six months ended June 30, 2025, the Company repaid loans primarily related to insurance of $22,895. During the six months ended June 30, 2024 the Company made repayments of $26,578.
Liquidity and Plan of Operations, Ability to Continue as a Going Concern
The accompanying unaudited consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred losses since its inception, including a net loss of $14,676 for the six months ended June 30, 2025 and has not generated sufficient positive cash flows from operations. As of June 30, 2025 the Company had a working capital deficiency of $4,027,184, which includes related party liabilities of $3,486,055. These conditions, among others, raise substantial doubt regarding our ability to continue as a going concern. The unaudited consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
| 19 |
As described earlier in this ITEM 1 “Strategy”, the Company is executing on a plan to achieve a growth in revenues. Included within the working capital deficiency above is a term note for $300,000 to EuroAmerican Investment Corp. (“EuroAmerican”), together with accrued interest of $544,833 which has a maturity date of September 30, 2025, having been extended on a number of occasions from its initial due date of June 11, 2011. At this time, it is not known whether any further extension of the note beyond September 30, 2025 will be available. However, the Company believes it may not have sufficient cash to meet its various cash needs through August 31, 2026 unless the Company is able to obtain additional cash from the issuance of debt or equity securities. Fountainhead, the Company’s largest shareholder, has provided working capital funding to the Company on an as-needed basis, although there is no guarantee that this will continue to be the case. The Company may consider seeking additional equity or debt funding, although there is no assurance that this would be available on acceptable terms or at all. If adequate funds are not available, the Company may have to delay or curtail development or commercialization of products or cease some of its operations.
Imposition of trade tariffs
In recent months, following the change in the U.S. presidential administration, there has been an imposition by the U.S. of increased trade tariffs on imported goods entering the United States and the imposition by some countries of retaliatory tariffs. Vycor Medical’s products and the raw materials that are used to manufacture the products are all manufactured in the United States. The imposition of import tariffs should not, therefore, impact our costs, however raw material prices may increase, and raw material supply chains could be disrupted. Although the majority of our sales are to hospitals in the United States, we export to a number of countries, with important export territories including Canada, Japan, the UK and the EU. The imposition of additional retaliatory tariffs by these or other countries to which we export could negatively impact our international revenues. The escalation of tariffs globally could have broader economic impacts which could adversely affect our results of operations and liquidity.
Critical Accounting Policies and Estimates
The Company’s unaudited consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of its unaudited consolidated financial statements and related disclosures requires it to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and the disclosure of contingent assets and liabilities in the Company’s unaudited consolidated financial statements. The Company bases its estimates on historical experience, known trends and events and various other factors that it believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. The Company evaluates its estimates and assumptions on an ongoing basis. Actual results may differ from these estimates under different assumptions or conditions.
Our senior management has reviewed the critical accounting policies and estimates with our Board of Directors. For a description of the Company’s critical accounting policies and estimates, refer to “Part II—Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” in our most recent Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on April 15, 2025. Critical accounting policies are those that are most important to the portrayal of our financial condition, results of operations and cash flows and require management’s most difficult, subjective and complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. If actual results were to differ significantly from estimates made, the reported results could be materially affected. There were no significant changes to our critical accounting policies and estimates during the three and six months ended June 30, 2025.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable
ITEM 4. CONTROLS AND PROCEDURES
(a) Disclosure Controls and Procedures
We are required to maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our chief executive officer (also our principal executive officer) and our chief financial officer (also our principal financial and accounting officer) to allow for timely decisions regarding required disclosure.
Pursuant to Rule 13a-15(b) under the Securities Exchange Act of 1934 (“Exchange Act”), the Company’s management, including the Company’s Chief Executive Officer (“CEO”) (the Company’s principal executive officer) and Chief Financial Officer (“CFO”) (the Company’s principal financial and accounting officer), has evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined under Rule 13a-15(e) under the Exchange Act) as of the end of the period covered by this report. Based on such evaluation, our CEO and our CFO have concluded that a material weakness occurred as of April 1, 2021 with the resignation of the independent members of the Company’s Audit Committee as of that date. Effective that date, our disclosure and controls were no longer effective to ensure that information required to be disclosed by the Company in the reports its files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its CEO and its CFO, as appropriate, to allow timely decisions regarding required disclosure.
| 20 |
The matter involving internal controls and procedures that our management considered to be material weaknesses under the standards of the Public Company Accounting Oversight Board were a lack of a functioning audit committee with independent members, resulting in ineffective oversight in the establishment and monitoring of required internal controls and procedures. This weakness occurred as of April 1, 2021 due to the resignation of the independent members of the Audit Committee from the Board of Directors effective as of April 1, 2021.
Management believes that the lack of a functioning audit committee and the lack of a majority of outside directors on our board of directors, results in ineffective oversight in the establishment and monitoring of required internal controls and procedures, which could result in a material misstatement in our financial statements in future periods.
(b) Changes in Internal Controls
There have not been any changes in the Company’s internal control over financial reporting (as such term is defined in Rules 13a-15(f) under the Exchange Act) during the fiscal period to which this report relates that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
The Company’s management, including the Company’s CEO and CFO, does not expect that the Company’s internal control over financial reporting will prevent all errors and all fraud. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree or compliance with the policies or procedures may deteriorate.
PART II
ITEM 1. LEGAL PROCEEDINGS
We are subject from time to time to litigation, claims and suits arising in the ordinary course of business. As of August 8, 2025, we were not a party to any material litigation, claim or suit whose outcome could have a material effect on our financial statements.
ITEM 1A. RISK FACTORS.
As a “smaller reporting company” as defined by Item 10 of Regulation S-K, the Company is not required to provide information required by this Item.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
None
Index to Exhibits
| 31.1 | Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| 31.2 | Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| 32.1 | Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
| 32.2 | Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
| 101.INS | Inline XBRL Instance Document | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
| 21 |
SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on August 8, 2025
| Vycor Medical, Inc. | ||
| (Registrant) | ||
| By: | /s/ Peter C. Zachariou | |
| Peter C. Zachariou | ||
| Chief Executive Officer and Director | ||
| (Principal Executive Officer) | ||
| Date August 8, 2025 | ||
| By: | /s/ Adrian Liddell | |
| Adrian Liddell | ||
| Chairman of the Board and Director | ||
| (Principal Financial and Accounting Officer) | ||
| Date August 8, 2025 | ||
| 22 |