Vycor Medical Inc.

11/14/2025 | Press release | Distributed by Public on 11/14/2025 09:11

Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

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 (MDD Class III) for brain and spine surgeries, and regulatory approvals in 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.

Comparison of the Three Months Ended September 30, 2025 to the Three Months Ended September 30, 2024

Revenue and Gross Margin:

Three months ended
September 30,
2025 2024 % Change
Revenue:
Vycor Medical $ 492,102 $ 372,837 32 %
NovaVision 21,690 18,015 20 %
$ 513,792 $ 390,852 31 %
Gross Profit
Vycor Medical $ 431,227 $ 337,404 28 %
NovaVision 20,705 16,652 24 %
$ 451,932 $ 354,056 28 %

Vycor Medical recorded revenue of $492,102 from the sale of its products for the three months ended September 30, 2025, an increase of $119,265, or 32%, over the same period in 2024, most of the increase being from growth in the US. Gross margin of 88% and 90% was recorded for the three months ended September 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 $21,690 for the three months ended September 30, 2025, an increase of $3,675, or 20%, over the same period in 2024. Gross margin was 95% for the three months ended September 30, 2025, compared to 92% for the same period in 2024.

Research & Development:

Research & Development expenses were $0 for the three months ended September 30, 2025 compared to $6,425 for the same period in 2024.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses increased by $37,081 to $404,967 for the three months ended September 30, 2025 from $367,886 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 September 30, 2025 was $12,209, a $6,104 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 increased by $24,789 from $76,701 in 2024 to $101,490 in 2025 reflecting higher US sales during the 2025 period.

The remaining Selling, General and Administrative expenses increased by $6,188 from $285,080 in 2024 to $291,268 in 2025, as set out in the table below. Investor relations expense relates to an ongoing investor and public awareness campaign being run by the company and the reduced regulatory cost relates to the high regulatory costs in 2024 of the European medical device regulatory transition.

Investor Relations $ 22,691
Premises and IT 14,305
Regulatory (27,382 )
Other (3,426 )
Total change $ 6,188

Interest Expense:

Interest comprises expense on the Company's debt and insurance policy financing. Related Party Interest expense for the three months ended September 30, 2025 and 2024 was $12,571. Other Interest expense for the three months ended September 30, 2025 was $13,884 compared to $13,419 for 2024.

Other Income:

Other income comprises the historic customer credits of $1,458 written off during the three months ended September 30, 2024.

Operating loss from Discontinued Operations:

Operating loss from Discontinued Operations in the three months ended September 30, 2025 was $54 compared to $47 in 2024; the Company has some minor ongoing costs related to the wind-down of the discontinued operations in Germany but no revenues.

Comparison of the Nine months Ended September 30, 2025 to the Nine months Ended September 30, 2024

Revenue and Gross Margin:

Nine months ended
September 30,
2025 2024 % Change
Revenue:
Vycor Medical $ 1,392,410 $ 1,078,644 29 %
NovaVision 54,113 55,454 -2 %
$ 1,446,523 $ 1,134,098 28 %
Gross Profit
Vycor Medical $ 1,174,808 $ 973,443 21 %
NovaVision 50,929 51,690 -1 %
$ 1,225,737 $ 1,025,133 20 %

Vycor Medical recorded revenue of $1,392,410 from the sale of its products for the nine months ended September 30, 2025, an increase of $313,766, or 29%, over the same period in 2024, most of the increase being from growth in international markets. Gross margin of 84% and 90% was recorded for the nine months ended September 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 $54,113 for the nine months ended September 30, 2025, a decrease of $1,341 over the same period in 2024. Gross margin was 94% for the nine months ended September 30, 2025, compared to 93% for the same period in 2024.

Research & Development:

Research & Development expenses were $9,963 for the nine months ended September 30, 2025 compared to $8,688 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 $100,415 to $1,100,708 for the nine months ended September 30, 2025 from $1,000,293 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 nine months ended September 30, 2025 was $48,838, an increase of $40,369 from $8,469 in 2024 primarily due to amortization of the Maxim financial advisory agreement. Also included within Selling, General and Administrative Expenses are Sales Commissions, which increased by $2,593 from $223,072 in 2024 to $225,665 in 2025.

The remaining Selling, General and Administrative expenses increased by $57,453 from $768,752 in 2024 to $826,205 in 2025 set out in the table below. Investor relations expense relates to an ongoing investor and public awareness campaign being run by the company and the increased payroll cost is a result of Vycor increasing its resources. The reduced regulatory cost relates to the high regulatory costs in 2024 of the European medical device regulatory transition.

Investor Relations $ 53,074
Payroll 36,946
Accounting and Audit 10,256
Software development (9,215 )
Regulatory (37,866 )
Other 4,258
Total change $ 57,453

Interest Expense:

Interest comprises expense on the Company's debt and insurance policy financing. Related Party Interest expense for the nine months ended September 30, 2025 was $37,713 compared to $37,443 for 2024. Other Interest expense for the nine months ended September 30, 2025 was $39,885 compared to $40,084 for 2024.

Other Income:

Other income comprises the historic customer credits of $6,002 written off during the nine months ended September 30, 2024.

Operating loss from Discontinued Operations:

Operating loss from Discontinued Operations increased by $1,732 to $1,929 in 2025 from $197 in 2024; the Company has some minor ongoing costs related to the wind-down of the discontinued operations in Germany but no revenues.

Liquidity

The following table shows liquidity data as of September 30, 2025 and December 31, 2024:

September 30, 2025 December 31, 2024 $ Change
Cash $ 64,230 $ 105,648 $ (41,418 )
Accounts receivable, inventory and other current assets $ 598,366 $ 527,334 $ 71,032
Total current liabilities $ (4,815,077 ) $ (4,496,543 ) $ (318,534 )
Working capital deficit $ (4,152,481 ) $ (3,863,561 ) $ (288,920 )

The following table shows cash flow for the periods ended September 30, 2025 and 2024:

September 30, 2025 September 30, 2024 $ Change
Cash (used in) provided by operating activities $ (52,703 ) $ 98,391 $ (151,094 )
Cash used in investing activities $ (2,777 ) $ (4,369 ) $ 1,592
Cash provided by financing activities $ 14,062 $ 6,320 $ 7,742
Net increase (decrease) in cash $ (41,418 ) $ 100,342 $ (141,760 )

Operating Activities. Cash provided by (used in) 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 (used in) operating activities.

The following table shows the principal components of cash (used in) provided by operating activities during the nine months ended September 30, 2025 and 2024, with a commentary of changes during the periods and known or anticipated future changes:

September 30, 2025 September 30, 2024 $ Change
Net loss $ (9,740 ) $ (100,463 ) $ 90,723
Adjustments to reconcile net loss to cash (used in) provided by operating activities:
Depreciation of fixed assets $ 46,999 $ 47,041 $ (42 )
Allowance for doubtful accounts - accounts receivable $ 2,690 $ 3,375 $ (685 )
Stock based compensation $ 48,838 $ 8,469 $ 40,369
$ 98,527 $ 58,885 $ 39,642
Changes in operating assets and liabilities
Accounts receivable $ (83,483 ) $ (26,844 ) $ (56,639 )
Accounts payable and accrued liabilities $ (84,606 ) $ 69,358 $ (153,964 )
Inventory $ (1,736 ) $ 46,518 $ (48,254 )
Prepaid expenses $ (30,607 ) $ (22,737 ) $ (7,870 )
Accrued interest (not paid in cash) $ 58,614 $ 73,477 $ (14,863 )
Changes in discontinued operations, net $ 328 $ 197 $ 131
$ (141,490 ) $ 139,969 $ (281,459 )
Cash (used in) provided by operating activities $ (52,703 ) $ 98,391 $ (151,094 )

Additional inventory of $168,347 was purchased during the nine months ended September 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 nine months ended September 30, 2025 due to purchase of chin rests of $3,619, offset by sales of fixed assets (chinrests) of $842. Cash used in investing activities during the nine months ended September 30, 2024 was $4,369 due to purchase of chin rests of $5,368, offset by sales of fixed assets (chinrests) of $999. The Company anticipates limited investing activities during the next twelve months.

Financing Activities. During the nine months ended September 30, 2025, the Company repaid loans primarily related to insurance of $44,962 and received insurance financing proceeds of $59,024. During the nine months ended September 30, 2024 the Company received insurance financing proceeds of $60,980 and made repayments of $54,660.

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 $9,740 for the nine months ended September 30, 2025 and has not generated sufficient positive cash flows from operations. As of September 30, 2025 the Company had a working capital deficiency of $4,152,481, which includes related party liabilities of $3,645,811. 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.

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 $556,932 which has a maturity date of March 31, 2026, 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 March 31, 2026 will be available. However, the Company believes it may not have sufficient cash to meet its various cash needs through November 30, 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

During 2025 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 nine months ended September 30, 2025.

Vycor Medical Inc. published this content on November 14, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 14, 2025 at 15:11 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]