UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

 

FORM 10-Q

 

(Mark One)

 

QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
  
 For the fiscal quarter ended June 30, 20222023
  
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT
  
 For the transition period from            to           

 

VYCOR MEDICAL, INC.

(Exact name of small business issuer as specified in its charter)

 

Delaware 001-34932 20-3369218
(State (Commission (IRS Employer
of Incorporation) File Number) Identification No.)

 

951 Broken Sound Parkway, Suite 320, Boca Raton, FL 33487

(Address of principal executive offices) (Zip code)

 

Issuer’s telephone number: (561) 558-2020

 

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 (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. Yes ☒ No ☐

 

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 ☐ No

 

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”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large Accelerated Filer ☐Accelerated Filer ☐
Non-accelerated FilerSmaller 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 ☒ No

 

There were 31,991,45832,628,835 shares outstanding of registrant’s common stock, par value $0.0001 per share, as of August 15, 2022.11, 2023.

 

Transitional Small Business Disclosure Format (check one): Yes ☐ No ☒

 

 

 

 

 

 

TABLE OF CONTENTS

 

  Page
 PART I 
   
Item 1.Financial Statements3
   
 Unaudited Consolidated Balance Sheets as of June 30, 20222023 and December 31, 202120223
   
 Unaudited Consolidated Statements of Comprehensive LossIncome (Loss) for the three and six months ended June 30, 20222023 and 2021.2022.4
   
 Unaudited Consolidated Statement of Stockholders’ Deficiency for the three and six months ended June 30, 20222023 and 2021.2022.5
   
 Unaudited Consolidated Statements of Cash Flows for the six months ended June 30, 20222023 and 2021.2022.6
   
 Notes to Unaudited Consolidated Financial Statements7
   
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operation1617
   
Item 3.Quantitative and Qualitative Disclosures About Market Risk23
   
Item 4.Controls and Procedures23
   
 PART II 
   
Item 1.Legal Proceedings24
   
Item 1A.Risk Factors24
   
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds24
   
Item 3.Defaults Upon Senior Securities24
   
Item 4.Mine Safety Disclosures24
   
Item 5.Other Information24
   
Item 6.Exhibits24
   
SIGNATURES25

 

2

 

 

PART 1

 

ITEM 1. FINANCIAL STATEMENTS

 

VYCOR MEDICAL, INC.

Consolidated Balance Sheets

(Unaudited)

 

 June 30,  December 31,  June 30, December 31, 
 2022 2021  2023 2022 
ASSETS                
Current Assets                
Cash $43,619  $90,941  $53,404  $37,035 
Trade accounts receivable  212,455   126,096   282,550   156,204 
Inventory  201,717   207,521   219,490   248,874 
Prepaid expenses and other current assets  54,693   62,473   61,898   74,438 
Current assets of discontinued operations  312   380   1,026   1,212 
Total Current Assets  512,796   487,411   618,368   517,763 
        
Fixed assets, net  334,986   362,393   272,803   303,770 
                
Intangible and Other assets:                
Security deposits  6,000   6,000   6,000   6,000 
Operating lease - right of use assets  56,400   79,560   8,267   32,645 
Total Intangible and Other assets  62,400   85,560   14,267   38,645 
TOTAL ASSETS $910,182  $935,364  $905,438  $860,178 
                
LIABILITIES AND STOCKHOLDERS’ DEFICIENCY                
Current Liabilities                
Accounts payable $147,566  $227,720  $123,363  $200,044 
Accrued interest: Other  401,779   380,479   448,699   424,897 
Accrued interest: Related party  124,350   106,444   170,651   146,007 
Accrued interest  170,651   146,007 
Accrued liabilities - Other  148,322   126,959   128,087   91,352 
Accrued liabilities - Related Party  1,784,035   1,621,850   2,108,405   1,946,220 
Accrued liabilities  2,108,405   1,946,220 
Notes payable: Other  302,121   319,329   303,410   324,711 
Notes payable: Related Party  400,873   320,873   493,373   493,373 
Notes payable  493,373   493,373 
Current operating lease liabilities  48,133   46,915   4,280   29,591 
Current liabilities of discontinued operations  (1,600)  (572)  (1,094)  (1,399)
Total Current Liabilities  3,355,579   3,149,997   3,779,174   3,654,796 
                
Loan Payable - SBA EIDL $147,879  $150,000   144,596   146,253 
Operating lease liability - Long term  6,021   30,580 
Total Long-term Liabilities  153,900   180,580 
        
Total Liabilities  3,923,770   3,801,049 
                
STOCKHOLDERS’ DEFICIENCY                
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 270,307 and 270,307 issued and outstanding as at June 30, 2022 and December 31, 2021 respectively  27   27 
Common Stock, $0.0001 par value, 55,000,000 shares authorized at June 30, 2022 and December 31, 2021, 32,094,792 and 30,921,701 shares issued and 31,991,458 and 30,818,367 outstanding at June 30, 2022 and December 31, 2021 respectively  3,209   3,092 
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 270,307 and 270,307 issued and outstanding as at June 30, 2023 and December 31, 2022 respectively  27   27 
Common Stock, $0.0001 par value, 55,000,000 shares authorized at June 30, 2023 and December 31, 2022, 32,732,169 and 32,630,506 shares issued and 32,628,835 and 32,527,172 outstanding at June 30, 2023 and December 31, 2022 respectively  3,273   3,263 
Additional Paid-in Capital  29,303,715   29,172,169   29,365,070   29,355,626 
Treasury Stock (103,334 shares of Common Stock as at June 30, 2022 and December 31, 2021 respectively, at cost)  (1,033)  (1,033)
Treasury Stock (103,334 shares of Common Stock as at June 30, 2023 and December 31, 2022 respectively, at cost)  (1,033)  (1,033)
Accumulated Deficit  (32,032,889)  (31,697,142)  (32,513,346)  (32,426,429)
Accumulated Other Comprehensive Income  127,674   127,674 
Accumulated Other Comprehensive Income (Loss)  127,677   127,675 
Total Stockholders’ Deficiency  (2,599,297)  (2,395,213)  (3,018,332)  (2,940,871)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIENCY $910,182  $935,364  $905,438  S860,178 

 

See accompanying notes to consolidated financial statements

 

3

 

 

VYCOR MEDICAL, INC.

Consolidated Statements of Comprehensive LossIncome (Loss)

(Unaudited)

 

 2022  2021  2022  2021  2023 2022 2023 2022 
 

For the three months ended

June 30,

  

For the six months ended

June 30,

  

For the three months ended

June 30,

 

For the six months ended

June 30,

 
 2022  2021  2022  2021  2023 2022 2023 2022 
                  
Revenue $327,923  $491,427  $641,756  $787,176  $482,768  $327,923  $843,762  $641,756 
Cost of Goods Sold  27,885   39,328   61,294   67,805   39,797   27,885   70,596   61,294 
Gross Profit  300,038   452,099   580,462   719,371   442,971   300,038   773,166   580,462 
                                
Operating Expenses:                                
Research and development  -   3,929   -   6,629   7,550   -   13,058   - 
Depreciation and amortization  14,649   17,602   29,298   31,547   14,374   14,649   28,749   29,298 
Selling, general and administrative  359,763   407,079   678,437   864,555   324,527   359,763   601,631   678,437 
Total Operating Expenses  374,412   428,610   707,735   902,731   346,451   374,412   643,438   707,735 
Operating loss  (74,374)  23,489   (127,273)  (183,360)
Operating income (loss)  96,520   (74,374)  129,728   (127,273)
                                
Other income (Expense)                
Other Income (Expense)                
Interest expense: Related Party  (9,994)  (8,000)  (17,906)  (15,665)  (12,301)  (9,994)  (24,644)  (17,906)
Interest expense: Other  (13,370)  (13,662)  (25,684)  (29,780)  (13,359)  (13,370)  (26,593)  (25,684)
Interest expense  (13,359)  (13,370)  (26,593)  (25,684)
Loss on foreign currency exchange  12   (884)  (660)  (999)  (69)  12   (131)  (660)
Total Other Income (Expense)  (23,352)  (22,546)  (44,250)  (46,444)  (25,729)  (23,352)  (51,368)  (44,250)
                                
Loss Before Credit for Income Taxes  (97,726)  943   (171,523)  (229,804)
Credit for income taxes  -   -   -   - 
Net Loss from continuing operations  (97,726)  943   (171,523)  (229,804)
Income (Loss) Before Provision for Income Taxes  70,791   (97,726)  78,360   (171,523)
Provision for income taxes  -   -   -   - 
Net Income (Loss) from continuing operations  70,791   (97,726)  78,360   (171,523)
Loss from discontinued operations  (1,284)  (10,317)  (2,039)  (22,489)  (2,385)  (1,284)  (3,092)  (2,039)
Net Loss  (99,010)  (9,374)  (173,562)  (252,293)
Net Income (Loss)  68,406   (99,010)  75,268   (173,562)
                                
Preferred stock dividends  -   -   (162,185)  (162,185)  -   -   (162,185)  (162,185)
Net Loss Available to Common Stockholders $(99,010) $(9,374) $(335,747) $(414,478)
Other Comprehensive Loss                
Net Income (Loss) Available to Common Stockholders $68,406  $(99,010) $(86,917) $(335,747)
                
Other Comprehensive Income (Loss)                
Foreign Currency Translation Adjustment  (1)  (5)  -   2   2   (1)  2   - 
Comprehensive Loss  (99,011)  (9,379)  (173,562)  (252,291)
Comprehensive Income (Loss) $68,408  $(99,011) $75,270  $(173,562)
                                
Net Loss Per Share - basic and diluted                
Loss from continuing operations $(0.00) $0.00  $(0.01) $(0.01)
Net Income (Loss) Per Share - basic and diluted                
Net Income (Loss) from continuing operations $0.00  $(0.00) $0.00  $(0.01)
Loss from discontinued operations $(0.00) $(0.00) $(0.00) $(0.00) $(0.00) $(0.00) $(0.00) $(0.00)
Net loss available to common stockholders $(0.00) $(0.00) $(0.01) $(0.01)
Net Income (Loss) available to common stockholders $0.00  $(0.00) $(0.00) $(0.01)
                                
Weighted Average Number of Shares Outstanding – Basic and Diluted  31,461,631   29,670,235   31,444,736   28,755,966 
Weighted Average Number of Shares Outstanding – Basic  32,628,835   31,461,631   32,578,285   31,444,736 
Weighted Average Number of Shares Outstanding –Diluted  37,466,122   

31,461,631

   

37,415,572

   

31,444,736

 

 

See accompanying notes to consolidated financial statements

 

4

 

 

VYCOR MEDICAL, INC.

Consolidated Statement of Stockholders’ Deficiency

(Unaudited)

  Number  Amount  Number  Amount  Number  Amount  Number  Amount  Capital  Deficit  (Loss)  Total 
  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, 2023  32,630,506  $3,263   1  $0   270,306  $27   (103,334) $(1,033) $29,355,626  $(32,581,752) $127,675  $(3,096,194)
Issuance of stock for board and consulting fees  101,663   10   -   -                   9,444           9,454 
Comprehensive Income                                          2   2 
Net income for three months ended June 30, 2023                      -       -       68,406       68,406 
Balance at June 30, 2023  32,732,169  $3,273   1  $0   270,306  $27   (103,334) $(1,033) $29,365,070  $(32,513,346) $127,677  $(3,018,332)

  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, 2022  32,630,506  $3,263   1  $0   270,306  $27   (103,334) $(1,033) $29,355,626  $(32,426,429) $127,675  $(2,940,871)
Issuance of stock for board and consulting fees  101,663   10   -   -                   9,444           9,454 
Comprehensive Income                                          2   2 
Net loss for six months ended June 30, 2023                      -       -       (86,917)      (86,917)
Balance at June 30, 2023  32,732,169  $3,273   1  $0   270,306  $27   (103,334) $(1,033) $29,365,070  $(32,513,346) $127,677  $(3,018,332)

  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, 2022  31,457,415  $3,147   1  $0   270,306  $27   (103,334) $(1,033) $29,217,651  $(31,933,879) $127,675  $(2,586,413)
Issuance of stock for board and consulting fees  637,377   62                           86,065           86,127 
Comprehensive Loss                                          (1)  (1)
Net loss for three months ended June 30, 2022              -       -       -       (99,010)      (99,010)
Balance at June 30, 2022  32,094,792  $3,209   1  $0   270,306  $27   (103,334) $(1,033) $29,303,716  $(32,032,889) $127,674  $(2,599,297)

  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, 2021  30,921,701  $3,093   1  $0   270,306  $27   (103,334) $(1,033) $29,172,169  $(31,697,142) $127,674  $(2,395,213)
Balance, value  30,921,701  $3,093   1  $0   270,306  $27   (103,334) $(1,033) $29,172,169  $(31,697,142) $127,674  $(2,395,213)
Issuance of stock for board and consulting fees  1,173,091   116                           131,547           131,663 
Comprehensive Income                                          -   - 
Comprehensive Income (Loss)                                          -   - 
Net loss for six months ended June 30, 2022      -      -       -       -   -   (335,747)  -   (335,747)
Net income (loss)                                      (335,747)      (335,747)
Balance at June 30, 2022  32,094,792  $3,209   1  $0   270,306  $27   (103,334) $(1,033) $29,303,716  $(32,032,889) $127,674  $(2,599,297)
Balance, value  32,094,792  $3,209   1  $0   270,306  $27   (103,334) $(1,033) $29,303,716  $(32,032,889) $127,674  $(2,599,297)

 

  Number  Amount  Number  Amount  Number  Amount  Number  Amount  Capital  Deficit  (Loss)  Total 
                          Additional     Accum    
  Common Stock  Preferred C  Preferred D  Treasury Stock  Paid-in  Accumulated  OCI   
  Number  Amount  Number  Amount  Number  Amount  Number  Amount  Capital  Deficit  (Loss)  Total 
                                     
Balance at March 31, 2022  31,457,415  $3,147   1  $0   270,306  $27   (103,334) $(1,033) $29,217,651  $(31,933,879) $127,675  $(2,586,413)
Issuance of stock for board and consulting fees  637,377   62                           86,065           86,127 
Issuance of stock related to deferred compensation of directors  -   -                                         

Directors deferred compensation granted

                                                
Accumulated Comprehensive Loss                                          (1)  (1)
Net loss for period available to common stockholders      -        -        -        -        (99,010)      (99,010)
Balance at June 30, 2022  32,094,792  $3,209   1  $0   270,306  $27   (103,334) $(1,033) $29,303,716  $(32,032,889) $127,674  $(2,599,297)

                          Additional          
  Common Stock  Preferred C  Preferred D  Treasury Stock  Paid-in  Accumulated  Accum   
  Number  Amount  Number  Amount  Number  Amount  Number  Amount  Capital  Deficit  OCI  Total 
                                     
Balance at December 31, 2021  30,921,701  $3,093   1  $0   270,306  $27   (103,334) $(1,033) $29,172,169  $(31,697,142) $127,674  $(2,395,213)
Issuance of stock for board and consulting fees  1,173,091   116                           131,547           131,663 
Accumulated Comprehensive Loss                                          -   - 
Net loss for period available to common stockholders              -        -        -        (335,747)      (335,747)
Balance at June 30, 2022  32,094,792  $3,209   1  $0   270,306  $27   (103,334) $(1,033) $29,303,716  $(32,032,889) $127,674  $(2,599,297)

                          Additional          
  Common Stock  Preferred C  Preferred D  Treasury Stock  Paid-in  Accumulated  Accum   
  Number  Amount  Number  Amount  Number  Amount  Number  Amount  Capital  Deficit  OCI  Total 
                                     
Balance at March 31, 2021  28,537,248  $2,854   1  $0   270,306  $27   (103,334) $(1,033) $28,948,707  $(31,342,214) $127,676  $(2,263,983)
Issuance of stock for board and consulting fees  637,377   64                           94,530           94,594 
Issuance of stock related to deferred compensation of directors  1,142,442   114                           

(114

)           - 
Accumulated Comprehensive Loss                                          (5)  (5)
Net loss for period available to common stockholders              -        -        -        (9,374)      (9,374)
Balance at June 30, 2021  30,317,067  $3,032   1  $0   270,306  $27   (103,334) $(1,033) $29,043,123  $(31,351,588) $127,671 ��$(2,178,768)

  Common Stock  Preferred C  Preferred D  Treasury Stock  Paid-in  Accumulated  Accum OCI   
  Number  Amount  Number  Amount  Number  Amount  Number  Amount  Capital  Deficit  (Loss)  Total  
                                     
Balance at December 31, 2020  27,534,740  $2,753   1  $0   270,306  $27   (103,334) $(1,033) $28,826,378  $(30,937,110) $127,669  $(1,981,316)
Balance, value  27,534,740  $2,753   1  $0   270,306  $27   (103,334) $(1,033) $28,826,378  $(30,937,110) $127,669  $(1,981,316)
Issuance of stock for board and consulting fees  1,173,091   118                           195,906           196,024 
Issuance of stock related to deferred compensation of directors  1,609,236   161                           (161)          - 
Directors deferred compensation granted                                  21,000           21,000 
Accumulated Comprehensive Loss                                          2   2 
Net loss for period available to common stockholders              -        -        -        (414,478)      (414,478)
Balance at June 30, 2021  30,317,067  $3,032   1  $0   270,306  $27   (103,334) $(1,033) $29,043,123  $(31,351,588) $127,671  $(2,178,768)
Balance, value  30,317,067  $3,032   1  $0   270,306  $27   (103,334) $(1,033) $29,043,123  $(31,351,588) $127,671  $(2,178,768)

 

See accompanying notes to consolidated financial statements

 

5

 

 

VYCOR MEDICAL, INC.

Consolidated Statement of Cash Flows

(Unaudited)

 2022  2021  2023 2022 
 For the six months ended  For the six months ended 
 June 30,  June 30, June 30, 
 2022  2021  2023 2022 
Cash flows from operating activities:                
Net loss $(173,562) $(252,293)
Adjustments to reconcile net loss to cash used in operating activities:        
Amortization of intangible assets  -   5,988 
Net Income/(Loss) $75,268  $(173,562)
Adjustments to reconcile net income (loss) to cash provided by (used in) operating activities:        
Depreciation of fixed assets  30,605   26,267   30,425   30,605 
Inventory provision  8,660   6,180   -   8,660 
Stock based compensation  127,546   

201,927

   5,414   127,546 
                
Changes in assets and liabilities:                
Accounts receivable  (86,360)  

(45,849

)  (126,346)  (86,360)
Inventory  (2,856)  (16,642)  29,384   (2,856)
Prepaid expenses  11,716   34,766   16,581   11,716 
Accrued interest - Related Party  17,906   15,665   24,644   17,906 
Accrued interest - Other  19,179   

29,780

   22,145   19,179 
Accounts payable  (80,154)  

38,840

  (76,681)  (80,154)
Accrued liabilities - Other  21,364   11,292  35,802   21,364 
Changes in discontinued operations, net  (960)  

(3,610

)  492   (960)
Cash used in operating activities  (106,916)  

52,311

Cash provided by (used in) in operating activities  37,127   (106,916)
Cash flows from investing activities:                
Purchase of fixed assets  (3,198)  (32,242)
Cash used in investing activities  (3,198)  (32,242)
(Purchase)/Sale of fixed assets  542   (3,198)
Cash provided by (used in) investing activities  542   (3,198)
Cash flows from financing activities:                
Proceeds from Notes Payable - Related Party  80,000   10,000   -   80,000 
Proceeds from Paycheck Protection Program  -   58,600 
Proceeds net of repayments Notes Payable - Other  (17,208)  (25,987)
Cash provided by financing activities  62,792   42,613 
Repayments net of Proceeds - Notes Payable - Other  (21,301)  (17,208)
Cash provided by (used in) financing activities  (21,301)  62,792 
Effect of exchange rate changes on cash  -   3   1   - 
Net decrease in cash  (47,322)  62,685 
Net increase (decrease) in cash  16,369   (47,322)
Cash at beginning of period  90,941   46,002   37,035   90,941 
Cash at end of period $43,619  $108,687  $53,404  $43,619 
                
Supplemental Disclosures of Cash Flow information:                
Cash paid for interest $2,815  $

-

  $2,791  $2,815 
Cash paid for income tax $-  $-  $-  $- 

 

See accompanying notes to consolidated financial statements

 

6

 

VYCOR MEDICAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 20222023

(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, 20212022 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, 2021.2022.

 

The unaudited consolidated financial statements as of and for the three and six months ended June 30, 20222023 and 2021,2022, 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, 20222023 and 20212022 are not necessarily indicative of the results to be expected for any other interim period or for the entire year. Certain prior period amounts on the unaudited consolidated financial statements have been reclassified to conform to the current period presentation.

 

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 available to common stockholders of $335,74786,917 for the six months ended June 30, 20222023 and since inception has not generated sufficient positive cash flows from operations.operations, although did generate positive cash flows for the six months ended June 30, 2023. As of June 30, 20222023 the Company had a working capital deficiency of $533,525388,377, excluding related party liabilities of $2,309,2582,772,429. 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.

 

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 $300,000 to EuroAmerican Investment Corp. (“EuroAmerican”), together with accrued interest of $400,699448,699, which has a maturity date of MarchDecember 31, 2023, 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 MarchDecember 31, 2023 will be available. However, the Company believes it may not have sufficient cash to meet its various cash needs through August 31, 20232024 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.

7

 

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.

 

7

Recent Accounting Pronouncements

 

From time to timetime-to-time new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies that may have an impact on the Company’s accounting and reporting. The Company believes that 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.

 

Revenue Recognition

On January 1, 2018, the Company adopted the new accounting standard, ASC 606, Revenue from Contracts with Customers and all the related amendments (new revenue standard) to all contracts. The adoption of the new accounting standard had no impact on company’s consolidated financial statements.

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

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.

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 6.

Discontinued Operations

 

In accordanceApril 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 ASU No. 2014-08, Reporting Discontinued Operations and Disclosures of Disposals of Components of an Entity, a disposal of a component of an entity or a group of components of an entity is requiredGerman-based partner. The NovaVision German office was closed effective June 30, 2020. The Company will continue to be reported as discontinued operations iffund the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results when the components of an entity meets the criteria in paragraph 205-20-45-1E to be classified as held for sale. When allremaining expenses of the criteria toGerman operations, which are non-material, until such a time as NovaVision GmbH will be classified as held for sale are met, including management, having the authority to approve the action, commits to a plan to sell the entity, the major current assets, other assets, current liabilities, and noncurrent liabilities shall be reported as components of total assets and liabilities separate from those balances of the continuing operations. At the same time, the results of all discontinued operations (which we presented as operations to be disposed and operations disposed), less applicable income taxes (benefit), shall be reported as components of net income (loss) separate from the net income (loss) of continuing operations in accordance with ASC 205-20-45.formally wound up.

 

Accounting for forgivable loan received under the Small Business Administration Paycheck Protection ProgramNet Income (Loss) Per Share

 

During the year ended December 31, 2020 the Company received a loan of $58,600 (“First Draw Loan”), pursuant to the Paycheck Protection Program (the “PPP”) under Division A, Title I of the CARES Act. During the year ended December 31, 2021 the Company received an additional PPP loan of $58,600 (“Second Draw Loan”). Under the terms of the PPP, both the First Draw Loan and Second Draw Loan were forgiven during the year ended December 31, 2021 as they were used for qualifying expenses as described in the CARES Act.

The Company accounted for the loans as a financial liability in accordance with FASB ASC 470 and accrued interest in accordance with the interest method under FASB ASC 835-30. For purposes of derecognition of the liability, FASB ASC 470-50-15-4 refers to guidance in FASB ASC 405-20. Based on this guidance, the proceeds of the loans were recorded as a liability until either (1) the loans are, in part or wholly, forgiven and the Company has been “legally released”, or (2) the Company pays off the loans. The Company has accordingly reduced the liability by the amount forgiven and recorded a gain on the extinguishment.

Net Loss Per Share

Basic net lossincome (loss) per share is computed by dividing net lossincome (loss) available to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net lossincome (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 exercise of stock options and warrants and conversion of preferred stock and convertible debt. Such potentially dilutive shares are excluded when the effect would be to reduce a net loss per share. No dilution adjustment has been made to the weighted average outstanding common shares in the periods presented because the assumed exercise of outstanding options and warrants and the conversion of preferred stock and debt would be anti-dilutive.

8

 

The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net lossincome per share:share where a net income is reported:

 SCHEDULE OF COMMON STOCK NOT INCLUDED IN CALCULATION OF DILUTED NET LOSS PER SHARE

 June 30, 2022 June 30, 2021  June 30, 2023 June 30, 2022 
Debentures convertible into common stock  3,336,662   3,108,092   3,565,235   3,336,662 
Preferred shares convertible into common stock  1,272,052   1,272,052   1,272,052   1,272,052 
Total  4,608,714   4,380,144   4,837,287   4,608,714 
Anti-dilutive shares  4,837,287   4,608,714 

 

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; in Juneeffective July 1, 2020 Vycor announced that it would be enteringentered into a license agreement and transition agreement (the “Agreements”) with HelferApp GmbH, a cognitive therapy specialist. Under the Agreements, HelferApp is licensed to provide NovaVision’s products and therapies in Germany, Austria and Switzerland to patients and professionals; and has assumed responsibility for the current patients of NovaVision in the territory.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 iswill be formally wound up.

 

8

Reconciliation of the major line items from discontinued operations that are presented in the unaudited consolidated balance sheets and unaudited consolidated statements of comprehensive lossincome (loss) are as follows:

SCHEDULE OF DISCONTINUED OPERATIONS

Major line items constituting assets and liabilities in the unaudited consolidated balance sheets

 

  June 30,  December 31, 
  2023  2022 
ASSETS        
Current Assets        
Cash $1,026  $1,212 
Total Current Assets  1,026   1,212 
         
TOTAL ASSETS $1,026  $1,212 
         
LIABILITIES        
Current Liabilities        
Accounts payable $4  $693 
Other current liabilities  (1,098)  (2,092)
Total Current Liabilities $(1,094) $(1,399)

SCHEDULE OF LOSS FROM DISCONTINUED OPERATIONS

  June 30,  December 31, 
  2022  2021 
ASSETS        
Current Assets        
Cash $312   380 
Total Current Assets  312   380 
         
TOTAL ASSETS $312   380 
         
LIABILITIES        
Current Liabilities        
Accounts payable $4   4 
Accrued liabilities - Other  -   - 
Other current liabilities  (1,604)  (576)
Total Current Liabilities $(1,600)  (572)

9

 

Major line items constituting loss from discontinued operations

 

  2022  2021  2022  2021 
  For the three months ended
June 30,
  

For the six months ended

June 30,

 
  2022  2021  2022  2021 
Revenue $-  $- $-  $- 
Cost of Goods Sold  -   -   -   - 
Gross Profit  -   -   -   - 
                 
Operating Expenses:                
Selling, general and administrative  1,243   10,078   1,994   21,647 
Total Operating Expenses  (1,243)  (10,078)  (1,994)  (21,647)
Operating Loss  (1,243)  (10,078)  (1,994)  (21,647)
                 
Other Income (Expense)                
Loss on foreign currency exchange  (41)  (239)  (45)  (842)
Total Other Income (Expense)  (41)  (239)  (45)  (842)
                 
Loss Before Credit for Income Taxes  (1,284)  (10,317)  (2,039)  (22,489)
Credit for income taxes  -   -   -   - 
Loss from discontinued operations, net of tax $(1,284) $(10,317) $(2,039) $(22,489)

9

  2023  2022  2023  2022 
  

For the three months ended

June 30,

  

For the six months ended

June 30,

 
  2023  2022  2023  2022 
             
Revenue $-  $-  $-  $- 
Cost of Goods Sold  -   -   -   - 
Gross Profit  -   -   -   - 
                 
Operating Expenses:                
Selling, general and administrative  2,273   1,243   2,939   1,994 
Total Operating Expenses  (2,273)  (1,243)  (2,939)  (1,994)
Operating Loss  (2,273)  (1,243)  (2,939)  (1,994)
                 
Other Income (Expense)                
Loss on foreign currency exchange  (112)  (41)  (153)  (45)
Total Other Income (Expense)  (112)  (41)  (153)  (45)
                 
Loss Before Provision for Income Taxes  (2,385)  (1,284)  (3,092)  (2,039)
Provision for income taxes  -   -   -   - 
Loss from discontinued operations, net of tax $(2,385) $(1,284) $(3,092) $(2,039)

 

4. NOTES PAYABLE

 

Related Parties Notes Payable

 

Related Party Notes Payable consists of:

 SUMMARY OF NOTES PAYABLE

  June 30, 2022  December 31, 2021 
       
  30,000  30,000 
On June 25, 2018 the Company issued promissory notes to Peter Zachariou for $30,000. The notes bear interest at 10% per annum and are payable on the earlier of one year or five days following the delivery of written demand for payment by the Payee. The note was extended for another twelve months on its due date to June 25, 2023 or on demand by the Payee. $30,000  $30,000 
Between March 26, 2018 and March 25, 2022 the Company issued eleven promissory notes to Fountainhead Capital Management Limited for $370,873. The notes bear interest at 10% per annum and are payable on the earlier of one year or five days following the delivery of written demand for payment by the Payee. Ten notes were extended on their due dates for another twelve months. The Notes will be due between July 2022 and July 2023 or on demand by the Payee.  370,873   290,873 
Total Related Party Notes Payable $400,873  $320,873 
  June 30, 2023  December 31, 2022 
       
On June 25, 2018 the Company issued promissory notes to Peter Zachariou for $30,000. The notes bear interest at 10% per annum and are payable on the earlier of one year or five days following the delivery of written demand for payment by the Payee. The note was extended for another twelve months on its due date to June 25, 2024 or on demand by the Payee. $30,000  $30,000 
Between March 26, 2018 and November 17, 2022 the Company issued fifteen promissory notes to Fountainhead Capital Management Limited for $463,373. The notes bear interest at 10% per annum and are payable on the earlier of one year or five days following the delivery of written demand for payment by the Payee. Thirteen of the notes were extended on their due dates for another twelve months. The Notes will be due between October 2023 and August 2024 or on demand by the Payee.  463,373   463,373 
Total Related Party Notes Payable $493,373  $493,373 

10

 

Other Notes Payable

 

Other Notes Payable consists of:

 

 June 30, 2022 December 31, 2021  June 30, 2023 December 31, 2022 
On March 25, 2011 the Company issued a term note for $300,000 to EuroAmerican Investment Corp. (“EuroAmerican”). The term note bears interest at 16% per annum and was due June 25, 2011, and has been extended on a number of occasions. On the note’s most recent due date, the note was amended and extended to March 23, 2023. See further note below. $300,000  $300,000 
On March 25, 2011 the Company issued a term note for $300,000 to EuroAmerican Investment Corp. (“EuroAmerican”). The term note bears interest at 16% per annum and was due June 25, 2011, and has been extended on a number of occasions. On the note’s most recent due date, the note was amended and extended to December 31, 2023. See further note below. $300,000  $300,000 
Current portion of Long-Term Notes payable, see below  2,121   -   3,283   3,222 
Insurance policy finance agreements.  -   19,329   127   21,489 
Total Notes Payable: $302,121  $319,329  $303,410  $324,711 

 

Long-Term Notes Payable consists of:

 

  June 30, 2022  December 31, 2021 
On July 7, 2020, the Company was advised that the Small Business Administration (SBA) had approved a $150,000 loan under the Economic Injury Disaster Loan Program pursuant to the Coronavirus Aid, Relief and Economic Security (CARES) Act (“Loan”). The Loan, evidenced by a promissory note dated July 7, 2020, has a term of thirty (30) years, bears interest at a fixed rate of three and three-quarters percent (3.75%) per annum, with monthly payments in the amount of $731.00 per month commencing July 7, 2021 and is secured by essentially all of the assets of the Company. The proceeds of the Loan have been used for general working capital purposes to alleviate economic injury caused by disaster occurring in the month of January 2020 and continuing thereafter. $147,879  $150,000 
Total Long-Term Notes Payable: $147,879  $150,000 

10

  June 30, 2023  December 31, 2022 
On July 7, 2020, the Company was advised that the Small Business Administration (SBA) had approved a $150,000 loan under the Economic Injury Disaster Loan Program pursuant to the Coronavirus Aid, Relief and Economic Security (CARES) Act (“Loan”). The Loan, evidenced by a promissory note dated July 7, 2020, has a term of thirty (30) years, bears interest at a fixed rate of three and three-quarters percent (3.75%) per annum, with monthly payments in the amount of $731.00 per month commencing July 7, 2021 and is secured by essentially all of the assets of the Company. The proceeds of the Loan have been used for general working capital purposes to alleviate economic injury caused by disaster occurring in the month of January 2020 and continuing thereafter. $144,596  $146,253 
Total Long-Term Notes Payable: $144,596  $146,253 

 

In January 2018 the Company entered into an amendment agreement (the “Amendment”) with EuroAmerican Investments (“EuroAmerican”) regarding its $300,000 loan note (the “Note”). Under the Amendment, the Note was extended and the conversion terms of the Note were reduced to $0.21, the same as the offering price of the 2018 Offering. Conversion of the Note and accrued interest would result in the issuance of 3,336,6623,565,235 shares of Common Stock as of June 30, 2021.2023. Notwithstanding, EuroAmerican agreed that the Note could not be converted without first offering the Company the right to redeem the Note at principal and accrued interest, and secondly Fountainhead the right to purchase the Note, which cannot be converted prior to such offer and the failure of the Company and Fountainhead to exercise such option in accordance with the amendment terms. The amendment was recognized as a modification, based on the guidance in ASC 470-50.

 

The Company routinely finances all their insurance policies through a third partythird-party finance company which requires a down payment and subsequent monthly payments, the time periods vary from 10 months to 12 equal monthly payments.

 

5. LEASE

 

The Company recognized the following related to a lease in its unaudited consolidated balance sheet at June 30, 20222023 and December 31, 2021:2022:

 SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION RELATED TO LEASES

 June 30, 2022  December 31, 2021  June 30, 2023 December 31, 2022 
          
Operating Lease ROU Assets $56,400  $79,560  $8,267  $32,645 
Operating Lease ROU Assets $56,400  $79,560 
                
Operating Lease Liabilities         $4,280  $29,591 
Current portion  48,133   46,915 
Long-term portion $6,021  $30,580 
Operating Lease Liabilities $54,154  $77,495 

11

 

6. SEGMENT REPORTING, GEOGRAPHICAL INFORMATION

 

(a) Business segments

 

The Company operates in two business segments: Vycor Medical, which focuses on devices for neurosurgery; and NovaVision, which focuses on neuro stimulation therapies and diagnostic devices for the treatment and screening of vision field loss and which includes Sight Science. Discontinued operations were part of NovaVision and revenues and assets were in Europe; see Note 3. Set out below are the revenues, gross profits and total assets for each segment:

 SCHEDULE OF BUSINESS SEGMENTS INFORMATION

 2022  2021  2022  2021  2023 2022 2023 2022 
 

Three Months Ended

June 30,

 

Six Months Ended

June 30,

  Three Months Ended June 30, Six Months Ended June 30, 
 2022  2021  2022  2021  2023 2022 2023 2022 
Revenue:                         
Vycor Medical $298,723  $462,318  $586,079  $725,031  $463,335  $298,723  $800,199  $586,079 
NovaVision $29,200  $29,109  $55,677  $62,145  $19,433  $29,200  $43,563  $55,677 
Revenue $327,923  $491,427  $641,756  $787,176  $482,768  $327,923  $843,762  $641,756 
Gross Profit                                
Vycor Medical $272,485  $424,261  $528,822  $660,194  $425,228  $272,485  $732,854  $528,822 
NovaVision $27,553  $27,838  $51,640  $59,177  $17,743  $27,553  $40,312  $51,640 
Gross Profit $300,038  $452,099  $580,462  $719,371  $442,971  $300,038  $773,166  $580,462 
                
Operating Income (Loss)                
Vycor Medical $184,135  $81,773  $306,547  $173,716 
NovaVision $(55,924) $(38,304) $(105,284) $(99,501)
Corporate $(31,691) $(117,843) $(71,535) $(201,488)
Operating Income (Loss) $96,520  $(74,374) $129,728  $(127,273)

 

  June 30,  December 31,         
  2023  2022         
Total Assets:                
Vycor Medical $876,979  $822,174         
NovaVision  27,433   36,792         
Discontinued operations  1,026   1,212         
Total Assets $905,438  $860,178         

1112

 

  June 30,  December 31, 
  2022  2021 
Total Assets:        
Vycor Medical $869,746  $901,930 
NovaVision  40,124   33,054 
Discontinued operations  312   380 
Total Assets $910,182  $935,364 

 

(b) Geographic information

 

The Company operates in two geographic segments, the United States and Europe. Discontinued operations were part of NovaVision and revenues and assets were in Europe; see Note 3. Set out below are the revenues, gross profits and total assets for each segment.

 SUMMARY OF GEOGRAPHIC INFORMATION

 2022  2021  2022  2021  2023 2022 2023 2022 
 

Three Months Ended

June 30,

 

Six Months Ended

June 30,

  Three Months Ended June 30, Six Months Ended June 30, 
 2022  2021  2022  2021  2023 2022 2023 2022 
Revenue:                         
United States $325,507  $487,908  $636,112  $776,688  $481,508  $325,507  $840,125  $636,112 
Europe $2,416  $3,519  $5,644  $10,488  $1,260  $2,416  $3,637  $5,644 
Revenue $327,923  $491,427  $641,756  $787,176  $482,768  $327,923  $843,762  $641,756 
Gross Profit                                
United States $297,632  $448,610  $574,844  $708,982  $441,743  $297,632  $769,604  $574,844 
Europe $2,406  $3,489  $5,618  $10,389  $1,228  $2,406  $3,562  $5,618 
Gross Profit $300,038  $452,099  $580,462  $719,371  $442,971  $300,038  $773,166  $580,462 
Operating Income (Loss)                
United States $101,529  $(71,212) $134,847  $(120,770)
Europe $(5,009) $(3,162) $(9,119) $(6,503)
Operating Income (Loss) $96,520  $(74,374) $129,728  $(127,273)

 

 June 30, December 31,  June 30, December 31,  
 2022 2021  2023 2022  
Total Assets:                 
United States $905,661  $928,761  $900,403  $854,236         
Europe  4,209   6,223   4,009   4,730  
Discontinued operations  312   380   1,026   1,212  
Total Assets $910,182  $935,364  $905,438  $860,178  

 

7. EQUITY

 

Common Stock GrantsEquity Transactions

 

During January to June 20222023 and 2021,2022, under the terms of the Consulting Agreement referred to in noteNote 10, the Company issued 0 and 1,071,428 of Common Stock to Fountainhead valued at $119,4640 and $175,895119,464, respectively.

 

On April 1, 2023 and April 1, 2022 the Company issued 101,663 shares of Common Stock to Ricardo Komotar (RJK Consulting), a consultant, in accordance with the terms of a consulting agreement.

Equity Classes

Our authorized capital stock consists of 55,000,000 shares of common stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share, the rights and preferences of which may be established from time to time by our board. As of August 11, 2023, there were 32,628,835 shares of common stock, one (1) share of Series C Preferred Stock and 270,306 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 in the offering 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.

1213

 

Series C Convertible Preferred Stock Optionsshares (“Preferred C Stock”) are convertible (at the Holder’s option or mandatorily upon the occurrence of certain events) into 14,815

The details shares of the outstanding stock options are as follows:Company’s Common Stock (at $3.75 per share). The Preferred C Stock carries no dividend or other rights.

SCHEDULE OF STOCK OPTIONS

  

Number of

shares

  

Weighted

average

exercise price

per share

 
Outstanding at December 31, 2020  680,000  $0.28 
Granted  -   - 
Exercised  -   - 
Cancelled or expired  (680,000)  0.28 
Outstanding at December 31, 2021  -  $- 
Granted  -   - 
Exercised  -   - 
Cancelled or expired  -   - 
Outstanding at June 30, 2022  -  $- 

 

8. STOCK-BASED COMPENSATION

 

The Company from time to timetime-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 stock granted to non-employees for each of the six months ended June 30, 20222023 and 20212022 was $127,5465,414 and $201,927127,546, respectively.

 

9. 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 $4,000 per month, plus other charges of approximately $1,5003,000 per month. The lease terminated September 30, 2020terminates on August 31, 2023 and washas been extended for a further three years and four months to AugustDecember 31, 2023.2026. Rent expense for the six months ended June 30, 20222023 and 2021 for the continuing operations2022 was $38,05337,173 and $38,95438,053 respectively. See Note 5.

 

Potential German tax liability

 

In June 2012 the Company’s NovaVision German subsidiary received a preliminary assessment for Magdeburg City trade tax of €75,000 (approximately $82,000), with an additional interest charge of €12,000 (approximately $13,200). This assessment is for the 2010 fiscal year and relates to the Company’s acquisition of the assets of the former NovaVision, Inc. An initial assessment for corporate tax for the same period was preliminarily reduced to zero. The Company did not accept this trade tax assessment and appealed against it to the relevant tax authorities with a view to its reduction. The relevant tax authorities agreed to suspend the assessment pending the outcome of certain court hearings and proposed tax legislation, and the Company agreed to make monthly payments on account totaling €75,000 (approximately $82,000) which were completed in October 2016 and fully expensed. At that time the Company appealed against the interest charge of €12,000 (approximately $13,200) which the tax authorities did not accept but also agreed to suspend pending the outcome of the hearings and proposed legislation outlined above. Accordingly, the Company has made no provision for this liability in the six months ended June 30, 20222023 and the year ended December 31, 20212022 respectively. The Company is in the process of winding down the entity, as disclosed in Note 3.

 

1314

 

 

10. CONSULTING AND OTHER AGREEMENTS

 

The following agreements were entered into or remained in force during the periodperiods ended June 30, 2023 and 2022:

 

Consulting Agreement with Fountainhead

 

In March 2017 and effective April 1, 2017, the Company amended the Fountainhead Consulting Agreement. Under the Amended Agreement, fees of $450,000 arewere payable to Fountainhead with an option to receive $5,000 per month in cash and the remainder payable in Company Common Stock issued at the higher of $0.21 and the average price for the 30 days prior to issuance, and deliverable at the end of each fiscal quarter. The Consulting Agreement also contains provisions for Fountainhead to receive a higher proportion of its fees in cash subject to certain future liquidity events and Board approval.

EffectiveThis was amended slightly effective January 1, 2021 the Company made a slight amendment to the Fountainhead Consulting Agreement (“the Amended Agreement”). Under the Amended Agreement, fees are payable to Fountainhead with an option to receive $5,000 per month in cash, and the remainder payable in Company Common Stock (“Shares”) as follows: 1) 535,714 Shares on the last day of each quarter; to the extent there are cash retainer payments during the quarter, the Shares shall be reduced by a number calculated by dividing the cash amount by the average closing price of the Shares for the 30 trading days prior to issuance; or 2) if the average closing price of the Shares for the 30 trading days prior to issuance is above $0.21, a number of Shares calculated by dividing $112,500 by the average closing price of the Shares for the 30 trading days prior to issuance. The Consulting Agreement also contains provisions for Fountainhead to receive a higher proportion of its fees in cash subject to certain future liquidity events and Board approval. Under the terms of the Amended Agreement, Fountainhead continuescontinued to provide the executive management team of the Company, including the positions of CEO, President and CFO, whose employment agreements with the Company stipulate they receive no remuneration from the Company.

 

Effective October 1, 2022 the Amended Agreement was terminated by Fountainhead and the Company by mutual agreement. Effective the same date the Company entered into revised employment agreements with Peter Zachariou, David Cantor and Adrian Liddell under which they would continue as CEO, President and CFO respectively as individuals and not as representatives of Fountainhead; there is no compensation payable under the employment agreements

During the six months ended June 30, 2023 and 2022 the Company issued 0and June 30, 2021, under the terms of the Amended Agreement, Fountainhead received 1,071,428 shares of Company Common Stock, valued at $119,4640 and $175,895119,464, respectively.

 

Other Agreements

 

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. Under the Agreement, Dr. Komotar will provide general scientific advisory consultancy services, and will also provide scientific advisory services based around certain specific pre-determined milestones. In consideration of the Consultant’s services, the Company agreed to deliver to the Consultant over the course of the three-year term, a total of 304,989 shares of Company Common Stock in respect of the general consultancy, and up to 1,219,957 shares of Company Common Stock in respect of the milestones, the actual number of shares to be delivered being determined by the achievement of the pre-determined milestones. On April 1, 20212023 and 2022 101,663 shares of Company Common Stock were issued under the terms of the Agreement.

 

11. RELATED PARTY TRANSACTIONS

 

Peter Zachariou and David Cantor, directors of the Company, are investment managers of Fountainhead that owned, at June 30, 2022,2023, 61.962.3% of the Company’s Common Stock and 69.7% of the Company’s Series D Preferred Stock. Peter Zachariou owns 0.15% of the Company’s Common Stock and 25.7% of the Company’s Series D Preferred Stock. Adrian Liddell, Chairman is a consultant to Fountainhead.

 

14

During each of the six months ended June 30, 20222023 and June 30, 2021,2022, under the terms of the Amended Agreement referred to in noteNote 10, the Company issued 0 and 1,071,428 shares of Common Stock to Fountainhead valued at $119,4640 and $175,895119,464 respectively.

 

During each of the six months ended June 30, 20222023 and 2021,2022, the Company accrued an aggregate of $162,185 of Preferred D Stock dividends, of which $113,019 was regarding Fountainhead and $41,693 was regarding of Peter Zachariou. Total accrued Preferred D Stock dividends at June 30, 20222023 and 2021December 31, 2022 was $1,784,0402,108,405 and $1,459,6691,946,220, respectively, of which $1,243,2051,469,242 and $1,017,1671,356,224, respectively, was regarding Fountainhead and $458,622542,008 and $375,237500,315, respectively, was regarding of Peter Zachariou.

 

During the six months ended June 30, 20222023 and 20212022 the Company issued unsecured loan notes to Fountainhead for a total of $80,0000 and $10,00080,000, respectively. The loan notes bear interest at a rate of 10% and are due on demand or by their one-year anniversary (see Note 4).

 

There were 0 other related party transactions duringDuring the six months ended June 30, 2023 and 2022 the Company accrued interest on related party loans of $24,644and 2021.$17,906, respectively.

15

 

12. CONCENTRATION

 

Vycor Medical sells its neurosurgical devices in the US primarily direct to hospitals, and internationally through distributors who in turn sell to hospitals.

SCHEDULE OF CONCENTRATION

Sales Concentration:

 

 

Three Months Ended

June 30,

  

Three Months Ended

June 30,

 
 2022 2021  2023 2022 
          
Number of customers over 10%  -   -   1   - 
Percentage of sales  0%  0%  14%  0%

 

 

Six Months Ended

June 30,

  

Six Months Ended

June 30,

 
 2022 2021  2023 2022 
          
Number of customers over 10%  -   -   1   - 
Percentage of sales  0%  0%  11%  0%

 

Accounts Receivable Concentration

 

 At June 30, At December 31,  At June 30, At December 31, 
 2022 2021  2023 2022 
          
Number of customers over 10%  1   1   1   1 
Percentage of accounts receivable  13%  11%  14%  13%

 

The Company has three sub-contract manufacturers from which it purchases, respectively, VBAS injection molded parts, completed and sterilized VBAS units, and VBAS 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 10% of total annual purchases.

 

13. SUBSEQUENT EVENTS

 

The Company has evaluated the existence of events and transactions subsequent to the balance sheet date through the date the unaudited consolidated financial statements were issued and has determined that there were no significant subsequent events or transactions which would require recognition or disclosure in the financial statements.

 

1516

 

 

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 has 61 issued or allowed patents and a further 11 pending. The Company leverages joint resources across the divisions to operate in a cost-efficient manner.

 

16

The Company periodically engages in discussions with potential strategic partners for or purchasers of each or both of our operating divisions. 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; in June 2020 Vycor announced that it would bemodel, entering into a license agreement and transition agreement (the “Agreements”) with HelferApp GmbH, a cognitive therapy specialist.local German partner. Under the Agreements, HelferAppagreement, the partner is licensed to provide NovaVision’s products and therapies in Germany, Austria and Switzerland to patients and professionals. The NovaVision German office was closed effective June 30, 2020.

17

 

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 a number of other international markets. Vycor Medical has 30 granted and 11 pending patents.

 

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 and has 31 granted patents.

 

Strategy

 

The Company is continuing to execute on a plan to achieve revenue growth and a reduction in annual cash operating losses1, and generated a cash operating profit1 duringincome for the six months ended June 30, 2022.2023. For Vycor Medical this plan includes: increasing market penetration in the US; increasing international growth in territories where we are not represented or under-represented and continued new product development in response to market demands and demonstrating applicability in a broader range of pathologies. In the US the Company is focused on increasing market penetration through targeting neurosurgeons systematically, both through its distribution and marketing network and also directly by leveraging existing KOLkey opinion leader (“KOL”) neurosurgeon VBAS supporters to access new neurosurgeon users.

The Company continues to target key international territories including Europe where it intends to drive adoption of its VBAS product through selected key KOL neurosurgeon VBAS users in each territory to identify both new potential users and also high-quality distribution partners to bolster our existing network.

1 Operating Income or Loss before Depreciation, Amortization and non-cash Stock Compensation

 

The Company has for some time been working to better integrate its VBAS with neuronavigation. The first phase of the modification of the existing VBAS product range was completed in September 2017 and has beenwas well received by surgeons. The second phase involvesinvolved the introduction of an optional Alignment Clip accessory that will snapsnaps onto the VBAS and allowallows for a neuronavigation pointer to be fully integrated into the body of the VBAS. ThisVBAS; this new model range, known as the VBAS AC, model range has received US FDA 510(k) clearance, EU clearance and regulatory approvals elsewhere internationally; it is envisaged that it will be available during 2022.was launched in September 2022, with the international roll-out being complete by the end of 2023. The Company will continue to work with neuronavigation companies to seek ways to further integrate the VBAS with neuronavigation and with other companies with complementary technologies used in neurosurgery. We will also be exploring with neurosurgeons and focus groups additional selected development work targeted at increasing the ease and applicability of our products to additional common procedures.

 

For NovaVision, given the company’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 broad range of patient and professional products is by partnering with entities in selected geographies that have either direct access to the end users or a desire and financial wherewithal to leverage the NovaVision therapy platform, including into new areas. As a result, the Company closed the NovaVision German office and entered into a license agreement with HelferApp, a cognitive therapy specialist,local German for Germany, Austria and Switzerland, and is seeking similar partnerships in other territories with regional companies able to leverage NovaVision’s clinically supported vision therapies.Switzerland. 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.

17

1 Operating Income or Loss before Depreciation, Amortization and non-cash Stock Compensation

Comparison of the Three Months Ended June 30, 20222023 to the Three Months Ended June 30, 20212022

 

Revenue and Gross Margin:

 

 Three months ended  Three months ended 
 June 30,  June 30, 
 2022  2021  % Change  2023 2022 % Change 
Revenue:              
Vycor Medical $298,723  $462,318   -35% $463,335  $298,723   55%
NovaVision $29,200  $29,109   0% $19,433  $29,200   -33%
 $327,923  $491,427   -33% $482,768  $327,923   47%
Gross Profit                        
Vycor Medical $272,485  $424,261   -36% $425,228  $272,485   56%
NovaVision $27,553  $27,838   -1% $17,743  $27,553   -36%
 $300,038  $452,099   -34% $442,971  $300,038   48%

18

 

Vycor Medical recorded revenue of $298,723$463,335 from the sale of its products for the three months ended June 30, 2022, a decrease2023, an increase of $163,595,$164,612 or 35%55%, over the same period in 2021.2022. The 2021 period hadmajority of the increase was in the U.S., reflecting the addition of new hospitals and improved utilization as the VBAS AC model has been rolled out. One international customer placed an unusually high leveladvance order of activity as Vycor’s markets, particularlywhich approximately $35,000 relates to sales that would normally have occurred in the US, recovered from Covid and hospitals re-stocked their inventories and recommenced surgeries and procedures that had been deferred or postponed. The three months ended June 30, 2022 recorded an increase in revenues over both the three months ended March 31, 2022 and the three months ended December 31, 2021, demonstrating that progress continuesJuly to be made.October 2023 period. Gross margin of 91%92% and 92%91% was recorded for the three months ended June 30, 20222023 and 2021,2022, respectively.

 

NovaVision recorded revenues of $29,200$19,433 for the three months ended June 30, 2022, approximately the same for 2021.2023, a decrease of $9,767. Gross margin was 94%91%, compared to 96%94% for the same period in 2021.2022.

 

Selling, General and Administrative Expenses:

 

Selling, general and administrative expenses decreased by $47,316$35,236 to $359,763$324,527 for the three months ended June 30, 20222023 from $407,079$359,763 for the same period in 2021.2022. Included within Selling, General and Administrative Expenses are non-cash charges for stock basedstock-based compensation as the result of amortizing employee and non-employee shares, warrants and options which have been issued by the Company over various periods. The charge for the three months ended June 30, 20222023 was $76,978,$2,364, a $2,519$74,614 decrease from the charge in 20212022 of $79,497.$76,978 following the termination of the Fountainhead Consulting Agreement effective October 1, 2022. Also included within Selling, General and Administrative Expenses are Sales Commissions, which decreasedincreased by $44,986$38,224 to $96,894 from $103,656 to $58,670 in 2021.2022.

 

The remaining Selling, General and Administrative expenses increased marginally from $223,926$224,115 to $224,115$225,269 in 2021. Patent costs2023. Regulatory fees decreased by $23,330$20,420 due to a delayed EU audit and software development costsother lower activity and accounting fees decreased by $10,274,$13,345 due to a change in accruals during 2022; this was offset by patent fees increased by $16,896 reflecting lowerhigher levels of activity compared to 2021; regulatory costs increased by $19,091 due to EU regulatory audit and other activity during the periodin Vycor, and payroll increased by $11,398 from the addition of staff.$7,004 reflecting additional staffing levels.

 

18

An analysis of the change in cash and non-cash G&A is shown in the table below:

 

 Cash G&A  Non-Cash G&A  Cash G&A Non-Cash G&A 
Commissions  38,224     
Other (premises, insurance, other)  11,020     
Payroll  7,004     
Legal, patent, audit/accounting  3,550     
Regulatory  19,091   -   (20,420)    
Payroll  11,398   - 
Board and financial  -   (2,519)  -   (74,614)
Other (travel/insurance/premises)  (5,614)  - 
Scientific, clinical and software development  (10,274)  - 
Legal, patent, audit/accounting  (14,413)    
Commissions  (44,986)  - 
Total change  (44,798)  (2,519)  39,378   (74,614)

 

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, 2023 and 2022 was $12,301 and 2021 was $9,994, and $8,000, respectively. Other Interest expense for the three months ended June 30, 2023 and 2022 was $13,359 and 2021 was $13,370, and $13,662, respectively.

 

Operating loss from Discontinued Operations:

 

Operating loss from Discontinued Operations decreasedincreased by $9,033$1,101 to $2,385 in 2023 from $1,284 in 2022 from $10,317 in 2021;2022; the Company has some ongoing costs related to the wind-down of the discontinued operations in Germany but no revenues.

 

19

Comparison of the Six Months Ended June 30, 20222023 to the Six Months Ended June 30, 20212022

 

Revenue and Gross Margin:

 

 Six months ended  Six months ended 
 June 30,  June 30, 
 2022  2021  % Change  2023 2022 % Change 
Revenue:              
Vycor Medical $586,079  $725,031   -19% $800,199  $586,079   37%
NovaVision $55,677  $62,145   -10% $43,563  $55,677   -22%
 $641,756  $787,176   -18% $843,762  $641,756   31%
Gross Profit                        
Vycor Medical $528,822  $660,194   -20% $732,854  $528,822   39%
NovaVision $51,640  $59,177   -13% $40,312  $51,640   -22%
 $580,462  $719,371   -19% $773,166  $580,462   33%

 

Vycor Medical recorded revenue of $586,079$800,199 from the sale of its products for the six months ended June 30, 2022, a decrease2023, an increase of $138,952,$214,120, or 19%37%, over the same period in 2021.2022. The 2021 period had an unusually high levelmajority of activity as Vycor’s markets, particularly the US, recovered from Covid and hospitals re-stocked their inventories and recommenced surgeries and procedures that had been deferred or postponed, particularlyincrease was in the three months ended June 30, 2022. The three months ended June 30, 2022 recordedU.S., reflecting the addition of new hospitals and improved utilization as the VBAS AC model has been rolled out. One international customer placed an increaseadvance order of which approximately $35,000 relates to sales that would normally have occurred in revenues over both the three months ended March 31, 2022 and the three months ended December 31, 2021, demonstrating that progress continuesJuly to be made.October 2023 period. Gross margin of 90%92% and 91%90% was recorded for the six months ended June 30, 20222023 and for the same period in 2021.

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2022.

 

NovaVision recorded revenues of $55,677$43,563 for the six months ended June 30, 2022,2023, a decrease of $6,468$12,114 over the same period in 2021,2022, and gross margin of 93%, compared to 95% for was the same period in 2021.for both periods.

 

Selling, General and Administrative Expenses:

 

Selling, general and administrative expenses increaseddecreased by $186,118$76,806 to $678,437$601,631 for the six months ended June 30, 20222023 from $864,555$678,437 for the same period in 2021.2022. Included within Selling, General and Administrative Expenses are non-cash charges for share basedstock-based compensation as the result of amortizing employee and non-employee shares, warrants and options which have been issued by the Company over various periods. The charge for the six months ended June 30, 20222023 was $127,546,$5,414, a decrease of $74,381 over $201,927$122,132 from $127,546 in 2021.2022 following the termination of the Fountainhead Consulting Agreement effective October 1, 2022. Also included within Selling, General and Administrative Expenses are Sales Commissions, which decreasedincreased by $35,330$42,474 from $151,326$115,996 to $115,996.$158,470.

 

The remaining Selling, General and Administrative expenses decreasedincreased by $76,407$2,852 from $511,302$434,895 to $434,895.$437,747. Patent costs decreased by $39,329 and$10,551 due lower costs of NovaVision patents during the period offset by higher levels of activity in Vycor, software development costs decreased by $9,269, reflecting lower levels$9,472 and accounting fees decreased by $13,345 due to a change in accruals during 2022; this was offset by increases in payroll of activity compared to 2021; payroll increased by $10,773 from the addition of staff.$16,551 and other expenses.

20

 

An analysis of the change in cash and non-cash G&A is shown in the table below:

 

 Cash G&A  Non-Cash G&A  Cash G&A Non-Cash G&A 
Commissions  42,474     
Other (travel/regulatory/premises)  36,237   - 
Payroll  10,773   -   16,551   - 
Scientific, clinical and software development  (7,572)  - 
Regulatory  487   -   (20,894)  - 
Scientific, clinical and software development  (18,231)    
Other (travel/insurance/premises)  (34,061)  - 
Commissions  (35,330)  - 
Legal, patent, audit/accounting  (35,375)  -   (21,470)  - 
Board and financial  -   (74,381)  -   (122,132)
Total change  (111,737)  (74,381)  45,326   (122,132)

 

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, 20222023 was $17,906$24,644 compared to $15,665$17,906 for 2021.2022. Other Interest expense for the six months ended June 30, 20222023 was $25,684$26,593 compared to $29,780$25,684 for 20212022 following the forgiveness of PPP loans.

20

Liquidity

 

The following table shows cash flow and liquidity data for the periods ended June 30, 20222023 and December 31, 2021:2022:

 

 June 30, 2022 December 31, 2021 $ Change  June 30, 2023 December 31, 2022 $ Change 
Cash $43,619  $90,941  $(47,322) $53,404  $37,035  $16,369 
Accounts receivable, inventory and other current assets $469,177  $396,470  $72,707  $564,964  $480,728  $84,236 
Total current liabilities $(3,355,579) $(3,149,997) $(205,582) $(3,779,174) $(3,654,796) $(124,378)
Working capital $(2,842,783) $(2,662,586) $(180,197) $(3,160,806) $(3,137,033) $(23,773)
Cash provided by financing activities $62,792  $42,613  $20,179)
Cash (used in) provided by financing activities $(21,301) $165,889  $(187,190)

 

Operating Activities. Cash used inprovided by (used in) operating activities comprises net lossincome (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 principleprincipal components of cash provided by (used in) operating activities during the six months ended June 30, 20222023 and 2021,2022, with a commentary of changes during the periods and known or anticipated future changes:

 

  June 30, 2022  June 30, 2021  $ Change 
Net loss $(173,562) $(252,293) $78,731 
             
Adjustments to reconcile net loss to cash used in operating activities:            
Amortization and depreciation of assets $30,605  $32,255  $(1,650)
Share based compensation $127,546  $201,927  $(74,381)
Other $8,660  $6,180  $2,480 
  $166,811  $240,362  $(73,551)
             
Net loss adjusted for non-cash items $(6,751) $(11,931) $5,180 
Changes in working capital            
Accounts receivable $(86,360) $(45,849) $(40,511)
Accounts payable and accrued liabilities $(58,790) $50,132  $(108,922)
Inventory $(2,856) $(16,642) $13,786 
Prepaid expenses and net insurance financing repayments $(5,492) $8,779  $(14,271)
Accrued interest (not paid in cash) $37,085  $45,445  $(8,360)
Changes in discontinued operations, net $(960) $(3,610) $2,650 
  $(117,373) $38,255  $(155,628)
             
Cash used in operating activities, adjusted for net insurance repayments $(124,124) $26,324  $(150,448)

  June 30, 2023  June 30, 2022  $ Change 
Net Income (Loss) $75,268  $(173,562) $248,830 
             
Adjustments to reconcile net income (loss) to cash provided by (used in) operating activities:            
Depreciation $30,425  $30,605  $(180)
Stock based compensation $5,414  $127,546  $(122,132)
Other $-  $8,660  $(8,660)
  $35,839  $166,811  $(130,972)
             
Net Income (Loss) adjusted for non-cash items $111,107  $(6,751) $117,678 
Changes in working capital            
Accounts receivable $(126,346) $(86,360) $(39,986)
Accounts payable and accrued liabilities $(40,879) $(58,790) $17,911 
Inventory $29,384  $(2,856) $32,240 
Prepaid expenses and net insurance financing repayments $(4,720) $(5,492) $772 
Accrued interest (not paid in cash) $46,789  $37,085  $9,704 
Changes in discontinued operations, net $491  $(960) $1,451 
  $(95,281) $(117,373) $22,092 
             
Cash provided by (used in) operating activities, adjusted for net insurance repayments $15,826  $(124,124) $139,950 

 

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The adjustments to reconcile net lossincome (loss) to cash of $166,811$35,839 in the period have no impact on liquidity, and the change in net lossincome (loss) of $5,180$117,678 is not material. Thedue to the increase in Vycor sales, as is the change in accounts payable and accrued liabilitiesreceivable of $108,922 between the 2022 and 2021 periods was mainly due to the settlement of expenses during the 2021 period incurred during the final quarter of 2020.

$39,986.

 

Additional inventory of $46,357$28,512 was purchased during the six months ended June 30, 20222023 as part of normal production, and the Company anticipates purchasing additional new inventory of approximately $100,000$60,000 during the next twelve months for VBAS and VBAS AC.months.

 

Investing Activities. Cash used inprovided by (used in) investing activities of continuing operations for the six months ended June 30, 20222023 was $3,198.$542 and consisted of the sale of chin rests to patients in NovaVision.

 

Financing Activities. During the six months ended June 30, 20222023 the Company received fundspaid down insurance of $80,000 in respect of loans from Fountainhead.

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$21,301.

 

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 $335,747$86,917 for the six months ended June 30, 20222023 and has not generated sufficient positive cash flows from operations. As of June 30, 20222023 the Company had a working capital deficiency of $533,525,$388,377, excluding related party liabilities of $2,309,258.$2,772,429. 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 21Strategy”, the Company is continuing to executeexecuting on a plan to achieve revenue growth and a reduction in annual cash operating losses12, and generated a small cash operating profit1 duringincome for the six months ended June 30, 2022. For Vycor Medical this plan includes: increasing market penetration in the US; increasing international growth in territories where we are not represented or under-represented and continued new product development in response to market demands and demonstrating applicability in a broader range of pathologies. In the US the Company is focused on increasing market penetration through targeting neurosurgeons systematically, both through its distribution network and also directly by leveraging existing KOL neurosurgeon VBAS supporters to access new neurosurgeon users. The Company continues to target key international territories including Europe where it intends to drive adoption of its VBAS product through selected key KOL neurosurgeon VBAS users in each territory to identify both new potential users and also high-quality distribution partners to bolster our existing network. The Company has for some time been working to better integrate its VBAS with neuronavigation. The first phase of the modification of the existing VBAS product range was completed in September 2017 and has been well received by surgeons. The second phase involves the introduction of an optional Alignment Clip accessory that will snap onto the VBAS and allow for a neuronavigation pointer to be fully integrated into the body of the VBAS. This VBAS AC model range has received US FDA 510(k) clearance, EU clearance and is going through the regulatory process elsewhere internationally; it is envisaged that it will be available during 2022. The Company will continue to work with neuronavigation companies to seek ways to further integrate the VBAS with neuronavigation and with other companies with complementary technologies used in neurosurgery. We will also be exploring with neurosurgeons and focus groups additional selected development work targeted at increasing the ease and applicability of our products to additional common procedures. For NovaVision, given the company’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 broad range of patient and professional products is by partnering with entities in selected geographies that have either direct access to the end users or a desire and financial wherewithal to leverage the NovaVision therapy platform, including into new areas. As a result, the Company closed the NovaVision German office and entered into a license agreement with HelferApp, a cognitive therapy specialist, for Germany, Austria and Switzerland, and is seeking similar partnerships in other territories with regional companies able to leverage NovaVision’s clinically supported vision therapies. 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.

2 Operating Income or Loss before Depreciation, Amortization and non-cash Stock Compensation

However, the Company believes it may not have sufficient cash to meet its various cash needs through August 31, 2023 unless the Company is able to obtain additional cash from the issuance of debt or equity securities.2023. Included within the working capital deficiency above is a term note for $300,000 to EuroAmerican Investment Corp. (“EuroAmerican”), together with accrued interest of $400,699,$448,699, which has a maturity date of MarchDecember 31, 2023, 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 MarchDecember 31, 2023 will be available. However, the Company believes it may not have sufficient cash to meet its various cash needs through August 31, 2024 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.

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2 Operating Income or Loss before Depreciation, Amortization and non-cash Stock Compensation

 

Critical Accounting Policies and Estimates

 

A detailed description of our significant accounting policies can be found in our most recent Annual Report on Form 10-K for the year ended December 31, 2021.2022.

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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.

 

The Company’s management, including our Chief Executive Officer (“CEO”) and our Chief Financial Officer (“CFO”), have evaluated the effectiveness of our “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, or 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.

 

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 material weakness set forth did not have an effect on our financial results. However, 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.

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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 15, 2022,11, 2023, 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

 

Issuance TypeSecurityShares
FHC Management FeesCommon1,071,428
Consulting agreement fees: Ricardo KomotarCommon101,663

 

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.INSInline XBRL Instance Document
101.SCHInline XBRL Taxonomy Extension Schema Document
101.CALInline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEFInline XBRL Taxonomy Extension Definition Linkbase Document
101.LABInline XBRL Taxonomy Extension Label Linkbase Document
101.PREInline XBRL Taxonomy Extension Presentation Linkbase Document
104Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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 15, 202211, 2023

 

 Vycor Medical, Inc.
 (Registrant)
   
 By:/s/ Peter C. Zachariou
  Peter C. Zachariou
  Chief Executive Officer and Director (Principal Executive Officer)
   
 DateAugust 15, 202211, 2023
   
 By:/s/ Adrian Liddell
  Adrian Liddell
  Chairman of the Board and Director
  (Principal Financial and Accounting Officer)
   
 DateAugust 15, 202211, 2023

 

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