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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D) OF

THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): November 14, 2025

 

Vycor Medical, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware   001-34932   20-3369218

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File No.)

 

(I.R.S. Employer

Identification No.)

 

951 Broken Sound Parkway, Suite 320, Boca Raton, FL   33487
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (561) 558-2020

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol   Name of each exchange on which registered
Common Stock   VYCO   OTCQB

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

 

 

TABLE OF CONTENTS

 

Item 2.02. Results of Operations and Financial Conditions
Item 9.01 Financial Statements and Exhibits
SIGNATURES

 

 

 

 

Item 2.02. Results of Operations and Financial Conditions

 

The information in this report and the exhibit attached hereto are being furnished pursuant to Item 2.02 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall they be deemed incorporated by reference in any filing with the Securities and Exchange Commission under the Securities Act of 1934 or the Securities Act of 1933, except as shall be expressly set forth by specific reference to such filing.

 

On November 14, 2025, we issued a press release regarding our financial results for the three and nine months ended September 30, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

 

Non-GAAP Measures

 

We make reference to non-GAAP financial information in this press release together with a reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures. Specifically, we have provided non-GAAP Cash Operating Expenses and non-GAAP Cash Operating Loss measures that exclude Depreciation and non-cash Stock Compensation.

 

We believe that these non-GAAP financial measures provide investors with insight into what is used by management to conduct a more meaningful and consistent comparison of our ongoing operating results and trends, compared with historical results. This presentation is also consistent with the measures management uses to measure the performance of ongoing operating results against prior periods and against our internally developed targets. There are limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. These non-GAAP financial measures should not be considered in isolation or as a substitute for GAAP financial measures. Investors and potential investors should consider non-GAAP financial measures only in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP and the reconciliation of non-GAAP financial measures in this press release.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit 99.1.   Vycor Medical, Inc. Press Release dated November 14, 2025.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Vycor Medical, Inc.  
     
By: /s/ Peter C. Zachariou  
Name: Peter C. Zachariou  
Title: Chief Executive Officer  
     
Dated: November 14, 2025  

 

 

 

 

Exhibit 99.1

 

 

Vycor Medical Releases Financial Results for the Three and Nine Months Ended September 30, 2025

 

BOCA RATON, FL (November 14, 2025) – Vycor Medical, Inc. (“Vycor” or the “Company”) (OTCQB—VYCO), today announced financial results for the three and nine months ended September 30, 2025.

 

The Company operates through two business units: Vycor Medical, which produces the ViewSite™ Brain Access System (VBAS) for neurosurgery; and NovaVision®, a business in development which offers therapy programs to help patients recover from visual disorders after stroke or brain injury.

 

Company Highlights

 

  The Vycor Medical division revenues for the three and nine months ended September 30, 2025 increased by 32% and 29%, respectively; most of the increase for the three months was in the US, with the majority of the nine-month growth being from international markets, a key strategic objective.

 

  Operating profit for the three and nine months ended September 30, 2025 was $32,085 and $70,425, respectively, and non-GAAP operating profit for the three and nine months ended September 30, 2025 was $60,162 and $166,262, respectively, all substantial increases over the 2024 periods.

 

  Three new clinical papers were published involving Vycor’s VBAS during the three months ended September 30, 2025 in addition to the six papers already published during the year, bringing the total published peer reviewed clinical papers to 50, with an additional 14 other clinical papers. One of the studies was a multi-center study on using VBAS for the evacuation of deep intracerebral hemorrhage, an important developing clinical area, in which the authors commented: “These findings suggest that our use of Vycor tubular retractors for minimally invasive ICH evacuation is promising”, and with a shorter length of stay for patients’ post-surgery than for existing methods. The second peer review paper reported on a novel pediatric surgical procedure for which VBAS was fundamentally important.

 

  A new clinical study on NovaVision’s NeuroEyeCoach was published, comparing results from using the program at home or in a clinic. The study concluded that both home-based and clinic-based patients showed meaningful improvements with no significant differences between the two settings in activities of daily living improvements, validating NeuroEyeCoach as an effective tool, whether used clinically or accessed remotely. This is an important study for the company given the significant drive in healthcare systems worldwide to access digital technologies in home settings.

 

 

 

 

Financial Results

 

For the three months ended September 30, 2025, the Company reported revenue of $513,792, an increase of $122,940 (or 31%) over the same period in 2024. The Vycor Medical division (VBAS) generated revenue of $492,102, an increase of $119,265 (or 32%) over the same period in 2024, most of the increase being from growth in the US. The gross profit margin for 2025 was 88% versus 90% in 2024, with the lower gross margin in 2025 attributable to validation and shipping costs of new production runs. The NovaVision division, which remains in development, generated revenues of $21,690 for the three months ended September 30, 2025, versus $18,015 in 2024, and gross margin of 95%, compared to 92% for 2024.

 

For the nine months ended September 30, 2025, the Company reported revenue of $1,446,523, an increase of $312,425 (or 28%) over the same period in 2024. The Vycor Medical division (VBAS) generated revenue of $1,392,410, an increase of $313,766 (or 29%) over the same period in 2024, most of the increase being from growth in international markets. The gross profit margin for 2025 was 84% versus 90% in 2024, with the lower gross margin in 2025 attributable to validation and shipping costs of new production as well as higher international sales mix. The NovaVision division, which remains in development, generated revenues of $54,113 for the nine months ended September 30, 2025, versus $55,454 in 2024, and gross margin of 94%, compared to 93% for 2024.

 

  

For the three months ended

September 30,

  

For the nine months ended

September 30,

 
   2025   2024   2025   2024 
Revenue:                
Vycor Medical  $492,102   $372,837   $1,392,410   $1,078,644 
NovaVision   21,690    18,015    54,113    55,454 
   $513,792   $390,852   $1,446,523   $1,134,098 
Gross Profit                    
Vycor Medical  $431,227   $337,404   $1,174,808   $973,443 
NovaVision   20,705    16,652    50,929    51,690 
   $451,932   $354,056   $1,225,737   $1,025,133 

 

For the three months ended September 30, 2025 the Company reported non-GAAP Cash Operating Expenses of $391,770 compared to $367,346 in 2024 and non-GAAP Operating Profit of $60,162 compared to a non-GAAP Operating Loss of $(13,290) in 2024.

 

For the nine months ended September 30, 2025 the Company reported non-GAAP Cash Operating Expenses of $1,059,475 compared to $998,112 in 2024 and non-GAAP Operating Profit of $166,262 compared to $27,021 in 2024.

 

 

 

 

Reconciliation of Non-GAAP Information

 

Non-GAAP Reconciliation

 

Management uses certain non-GAAP financial measures (including non-GAAP operating expenses and non-GAAP net loss and loss per share), which exclude non-cash depreciation of purchased assets and non-cash stock-based compensation. Management does not consider these costs in evaluating the continuing operations of the Company. Therefore, management calculates the non-GAAP financial measures provided in this earnings release excluding these costs and uses these non-GAAP financial measures to enable it to analyze further, and more consistently, the period-to-period financial performance of its core business operations. Management believes that providing investors with these non-GAAP measures gives them additional important information to enable them to assess, in the same way management assesses, the Company’s current and future continuing operations. There are limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. These non-GAAP financial measures should not be considered in isolation or as a substitute for GAAP financial measures. Investors and potential investors should consider non-GAAP financial measures only in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP. Set forth below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measures.

 

Three months ended September 30, 2025

 

On a GAAP basis the Company reported Operating Expenses of $419,847, an operating profit of $32,085, a net loss of $(157,249) and net loss of $(0.00) per share.

 

Vycor’s GAAP operating costs include non-cash depreciation of purchased assets ($15,868) and non-cash stock compensation charges ($12,209). The Company is providing additional non-GAAP financial measures that exclude these charges and expenses, and reconciliation of GAAP to non-GAAP results is provided in the tables included in this release.

 

On a non-GAAP basis, taking into account these adjustments, operating expenses were $391,770, non-GAAP operating profit was $60,162, and non-GAAP net loss was $(129,172) or $(0.00) per share.

 

Nine months ended September 30, 2025

 

On a GAAP basis the Company reported Operating Expenses of $1,155,312, an operating profit of $70,425, a net loss of $(334,110) and a loss of $(0.01) per share.

 

Vycor’s GAAP operating costs include non-cash depreciation of purchased assets ($46,999) and non-cash stock compensation charges ($48,838). The Company is providing additional non-GAAP financial measures that exclude these charges and expenses, and reconciliation of GAAP to non-GAAP results is provided in the tables included in this release.

 

On a non-GAAP basis, taking into account these adjustments, operating expenses were $1,059,475, non-GAAP operating profit was $166,262, and non-GAAP net loss was $(238,273) or $(0.01) per share.

 

 

 

 

VYCOR MEDICAL, INC.

Consolidated Statements of Comprehensive Loss

(unaudited)

 

  

For the three months ended

September 30,

  

For the nine months ended

September 30,

 
   2025   2024   2025   2024 
                 
Revenue  $513,792   $390,852   $1,446,523   $1,134,098 
Cost of Goods Sold   61,860    36,796    220,786    108,965 
Gross Profit   451,932    354,056    1,225,737    1,025,133 
                     
Operating Expenses:                    
Research and development   -    6,425    9,963    8,688 
Depreciation and amortization   14,880    14,880    44,641    44,641 
Selling, general and administrative   404,967    367,886    1,100,708    1,000,293 
Total Operating Expenses   419,847    389,191    1,155,312    1,053,622 
Operating income (loss)   32,085    (35,135)   70,425    (28,489)
                     
Other Income (Expense)                    
Interest expense: Related Party   (12,571)   (12,571)   (37,713)   (37,443)
Interest expense: Other   (13,884)   (13,419)   (39,885)   (40,084)
Other income   -    1,458    -    6,002 
Gain (loss) on foreign currency exchange   (640)   (103)   (638)   (252)
Total Other Income (Expense)   (27,095)   (24,635)   (78,236)   (71,777)
                     
Income (Loss) Before Provision for Income Taxes   4,990    (59,770)   (7,811)   (100,266)
Provision for income taxes   -    -    -    - 
Net Income (Loss) from continuing operations   4,990    (59,770)   (7,811)   (100,266)
Loss from discontinued operations, net of tax   (54)   (47)   (1,929)   (197)
Net Income (Loss)   4,936    (59,817)   (9,740)   (100,463)
                     
Preferred stock dividends   (162,185)   (162,185)   (324,370)   (324,370)
Net Income (Loss) Available to Common Stockholders  $(157,249)  $(222,002)  $(334,110)  $(424,833)
                     
Other Comprehensive Income (Loss)                    
Foreign Currency Translation Adjustment   -    -    -    - 
Comprehensive Income (Loss)  $4,936   $(59,817)  ($(9,740)  $(100,463)
                     
Income (Loss) Per Share - basic and diluted                    
Income (Loss) from continuing operations  $(0.00)  $(0.01)  $(0.01)  $(0.01)
Loss from discontinued operations  $(0.00)  $(0.00)  $(0.00)  $(0.00)
Income (Loss) available to common stockholders  $(0.00)  $(0.01)  $(0.01)  $(0.01)
                     
Weighted Average Number of Shares Outstanding – Basic and Diluted   33,372,796    32,903,493    33,372,796    32,721,056 

 

 

 

 

VYCOR MEDICAL, INC.

Non-GAAP Reconciliation of Operating Loss and Net Loss

(unaudited)

 

   For the three months ended   For the nine months ended 
   September 30,   September 30, 
   2025   2024   2025   2024 
                 
GAAP Operating Expenses   419,847    389,191    1,155,312    1,053,622 
                     
Non-cash depreciation of purchased assets (1)   (15,868)   (15,740)   (46,999)   (47,041)
Non-cash stock-based compensation (2)   (12,209)   (6,105)   (48,838)   (8,469)
Total Non-GAAP Operating Expense Adjustments   (28,077)   (21,845)   (95,837)   (55,510)
                     
Non GAAP Cash Operating Expenses  $391,770   $367,346   $1,059,475   $998,112 
                     
GAAP Operating Profit (Loss)   32,085    (35,135)   70,425    (28,489)
                     
Non-GAAP Operating Expense Adjustments, as above   28,077    21,845    95,837    55,510 
                     
Non-GAAP Operating Profit  $60,162   $(13,290)  $166,262   $27,021 
                     
GAAP Net Income (Loss) available to common shareholders  $(157,249)  $(222,002)  $(334,110)  $(424,833)
                     
Non-GAAP Operating Expense Adjustments, as above   28,077    21,845    95,837    55,510 
                     
Non-GAAP Net Income (Loss) available to common stockholders  $(129,172)  $(200,157)  $(238,273)  $(369,323)
                     
Non-GAAP Income (Loss) Per Share basic and diluted  $(0.00)  $(0.01)  $(0.01)  $(0.01)
                     
Weighted Average Number of Shares Outstanding – Basic   33,372,796    32,903,493    33,372,796    32,721,056 

 

(1) Non-Cash depreciation of purchased assets. These are non-cash charges related to assets which can be impacted by the timing and magnitude of acquisitions. We consider our operating results without these charges when evaluating our ongoing costs and performance and therefore exclude such charges when presenting non-GAAP financial measures.

 

(2) Non-Cash Stock-based compensation expense consists of expense relating to stock-based compensation issued to employees, outside directors and non-employees including stock options, restricted common stock, and warrants. Because of varying available valuation methodologies, subjective assumptions and the fact that these amounts vary in size and timing, we believe that the exclusion of stock-based compensation expense allows for a more accurate comparison of our financial results to previous periods. In addition, we believe it is useful to investors to understand the specific impact of stock-based compensation expenses on our operating results.

 

 

 

 

About Vycor Medical, Inc.

 

With corporate headquarters in Boca Raton, FL, Vycor Medical, Inc. (“Vycor”) is a publicly traded company (OTCQB: VYCO) dedicated to providing the medical community with innovative and superior surgical and therapeutic solutions and has a growing portfolio of FDA cleared or registered medical solutions that are changing and improving lives every day. The Company operates two business units: Vycor Medical and NovaVision, both of which adopt a minimally or non-invasive approach.

 

Vycor Medical’s FDA-cleared ViewSite™ Brain Access System (VBAS) a minimally invasive neurosurgical device designed to improve access to brain lesions while reducing tissue damage and enhancing patient outcomes. The VBAS system has been approved and used in over 350 hospitals in the US and in numerous countries internationally. VBAS is protected by 48 issued and 9 pending patents and has been validated through 50 peer-reviewed studies. These studies demonstrate that use of VBAS results in: less brain tissue damage; less invasive procedure; improved access and better visibility; and reduced operating and recovery time. For an overview of Vycor Medical’s VBAS see VBAS Video.

 

NovaVision provides a suite of clinically supported vision rehabilitation therapies aimed at helping patients recover from visual impairments caused by stroke or other brain injury. The Visual Restoration Therapy (VRT) is the only commercialized FDA-cleared therapy for vision rehabilitation following neurological brain damage, making it a unique and important option for patients seeking to regain lost visual capabilities. The complementary NeuroEyeCoach program, clinically supported by a 296-patient study (the largest to date in the neuro visual space), enables dramatic improvements in patients’ ability to detect objects in the visual field by training them to make better eye movements with improvement in over 80% of patients. The NovaVision therapies, while showing a positive impact on these patients’ lives, still require significant development to allow them to successfully address their market potential. For an overview of NovaVision see NovaVision Video.

 

For the latest information on the company, including media and other coverage, and to learn more, please go online at www.vycormedical.com, www.vycorvbas.com or www.novavision.com.

 

Safe Harbor Statement

 

Information in this document constitute forward-looking statements or statements which may be deemed or construed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “forecast”, “anticipate”, “estimate”, “project”, “intend”, “expect”, “should”, “believe”, and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve, and are subject to known and unknown risks, uncertainties and other factors which could cause Vycor Medical’s actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. The risks, uncertainties and other factors are more fully discussed in Vycor Medical’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements attributable to Vycor Medical herein are expressly qualified in their entirety by the above-mentioned cautionary statement. Vycor Medical disclaims any obligation to update forward-looking statements contained in this estimate, except as may be required by law.

 

Investor Relations Contacts:

 

B2i Digital:

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Chief Executive Officer

B2i Digital, Inc.

https://b2idigital.com/

212.579.4844 Office

[email protected]

 

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Vycor Medical, Inc. Contacts:

 

951 Broken Sound Parkway, Suite 320

Boca Raton, FL. 33487

(561) 558-2020

[email protected]

 

LinkedIn: https://www.linkedin.com/in/vycor-medical-inc/

Instagram: https://www.instagram.com/vycormedical/

Facebook: https://www.facebook.com/Vycor.Nova/

Twitter/X: https://x.com/vycormedical

YouTube: https://www.youtube.com/@vycormedical6049

 

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