UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

 

FORM 10-Q

 

(Mark One)

 

[X]QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
  
 For the fiscal quarter endedSeptemberJune 30, 20192020
  
[  ]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 of (Commission (IRS Employer
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 under Section 12(g) of the Exchange Act:

Common Stock par value $0.0001

 

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 [X] 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 [  ][X]

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large Accelerated Filer [  ] Accelerated Filer [  ]
Non-accelerated Filer [  ] (Do not check if a smaller reporting company) Smaller Reporting Company [X]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). [  ] Yes [  ][X] No

 

There were 24,752,83626,359,978 shares outstanding of registrant’s common stock, par value $0.0001 per share, as of November 8, 2019.August 12, 2020.

 

Transitional Small Business Disclosure Format (check one): Yes [  ] No [X]

 

 

 

 
 

 

TABLE OF CONTENTS

 

  Page
PART I
 
Item 1.Financial Statements3
   
 Unaudited Consolidated Balance Sheets as of SeptemberJune 30, 20192020 and December 31, 201820193
   
 Unaudited Consolidated Statements of Comprehensive Loss for the three and ninesix months ended SeptemberJune 30, 20192020 and 2018.2019.4
   
 Unaudited Consolidated Statement of Stockholders’ Deficiency for the three and ninesix months ended SeptemberJune 30, 20192020 and 2018.2019.5
   
 Unaudited Consolidated Statements of Cash Flows for the ninesix months ended SeptemberJune 30, 20192020 and 2018.2019.6
   
 Notes to Unaudited Consolidated Financial Statements7
   
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operation1618
   
Item 3.Quantitative and Qualitative Disclosures About Market Risk2224
   
Item 4.Controls and Procedures2225
   
PART II
 
Item 1.Legal Proceedings2326
   
Item 1A.Risk Factors2326
   
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds2326
   
Item 3.Defaults Upon Senior Securities2326
   
Item 4.Mine Safety Disclosures2326
   
Item 5.Other Information2326
   
Item 6.Exhibits2326
   
SIGNATURES2427

PART 1

 

ITEM 1. FINANCIAL STATEMENTS

VYCOR MEDICAL, INC.

Consolidated Balance Sheets

(Unaudited)

 

 September 30, December 31, 
 2019 2018  June 30, 2020  December 31, 2019 
ASSETS                
Current Assets                
Cash $98,502  $86,481  $70,994  $60,717 
Accounts receivable  214,807   257,468 
Trade accounts receivable  96,965   274,551 
Inventory  226,618   203,122   193,620   208,353 
Prepaid expenses and other current assets  116,046   82,575   75,883   92,694 
Current assets of discontinued operations  7,056   20,117 
Total Current Assets  655,973   629,646   444,518   656,432 
                
Fixed assets, net  353,746   372,641 
Fixed assets, net of accumulated depreciation  390,563   364,953 
                
Intangible and Other assets:                
Patents, net of accumulated amortization  26,320   35,303   17,338   23,326 
Website, net of accumulated amortization  -   187 
Other Assets - Long Term  6,100   6,000 
Operating lease right-of-use assets  43,586     
Security deposits  6,000   6,000 
Operating lease - right of use assets  145,691   31,658 
Long term assets of discontinued operations  6,989   9,574 
Total Intangible and Other assets  76,006   41,490   176,018   70,558 
TOTAL ASSETS $1,085,725  $1,043,777  $1,011,099  $1,091,943 
                
LIABILITIES AND STOCKHOLDERS’ DEFICIENCY                
Current Liabilities                
Accounts payable $198,219  $92,955  $170,574  $245,412 
Accrued interest: Other  268,666   232,765   304,699   280,765 
Accrued interest: Related party  39,606   24,274   58,932   44,921 
Accrued liabilities - Other  267,573   295,056 
Accrued liabilities – Other  107,146   233,067 
Accrued liabilities - Related Party  973,110   648,740   1,135,295   973,110 
Notes payable: Other  351,058   325,814   387,804   328,032 
Notes payable: Related Party  210,873   193,000   310,873   230,873 
Current operating lease  43,586   - 
Operating lease liabilities - current  42,450   28,010 
Current liabilities of discontinued operations  66,667   82,216 
Total Current Liabilities  2,352,691   1,812,604   2,584,440   2,446,406 
                
Operating lease liability - Long term  100,141   - 
        
STOCKHOLDERS’ DEFICIENCY                
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 270,307 and 270,307 issued and outstanding as at September 30, 2019 and December 31, 2018 respectively  27   27 
Common Stock, $0.0001 par value, 55,000,000 shares authorized at September 30, 2019 and December 31, 2018, 24,856,170 and 23,244,028 shares issued and 24,752,836 and 23,140,694 outstanding at September 30, 2019 and December 31, 2018 respectively  2,486   2,324 
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 270,307 and 270,307 issued and outstanding as at June 30, 2020 and December 31, 2019 respectively  27   27 
Common Stock, $0.0001 par value, 55,000,000 shares authorized at June 30, 2020 and December 31, 2019, 26,463,312 and 25,391,884 shares issued and 26,359,978 and 25,288,550 outstanding at June 30, 2020 and December 31, 2019 respectively  2,646   2,539 
Additional Paid-in Capital  28,173,146   27,771,868   28,573,484   28,306,592 
Treasury Stock (103,334 shares of Common Stock as at September 30, 2019 and December 31, 2018 respectively, at cost)  (1,033)  (1,033)
Treasury Stock (103,334 shares of Common Stock as at June 30, 2020 and December 31, 2019 respectively, at cost)  (1,033)  (1,033)
Accumulated Deficit  (29,569,267)  (28,669,686)  (30,376,278)  (29,790,258)
Accumulated Other Comprehensive Income (Loss)  127,675   127,673 
Accumulated Other Comprehensive Income  127,672   127,670 
Total Stockholders’ Deficiency  (1,266,966)  (768,827)  (1,673,482)  (1,354,463)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIENCY $1,085,725  $1,043,777  $1,011,099  $1,091,943 

 

See accompanying notes to consolidated financial statements

VYCOR MEDICAL, INC.

Consolidated Statements of Comprehensive Loss

(Unaudited)

 

 For the three months ended September 30,  For the nine months ended September 30,  For the three months ended
June 30,
  For the six months ended
June 30,
 
 2019  2018  2019  2018  2020  2019  2020  2019 
                  
Revenue $346,308  $456,213  $1,126,864  $1,082,979  $244,266  $411,902  $574,505  $738,509 
Cost of Goods Sold  31,527   46,800   106,634   123,130   20,493   36,120   57,787   68,484 
Gross Profit  314,781   409,413   1,020,230   959,849   223,773   375,782   516,718   670,025 
                                
Operating expenses:                                
Depreciation and Amortization  15,115   42,994   45,011   128,326   14,643   14,771   29,285   29,637 
Selling, general and administrative  491,339   499,143   1,497,016   1,684,445   408,488   491,556   833,492   900,482 
Total Operating expenses  506,454   542,137   1,542,027   1,812,771   423,131   506,327   862,777   930,119 
Operating loss  (191,673)  (132,724)  (521,797)  (852,922)  (199,358)  (130,545)  (346,059)  (260,094)
                                
Other income (expense)                                
Interest expense: Related Party  (7,586)  (5,257)  (14,010)  (10,016)
Interest expense: Other  (12,109)  (12,280)  (36,074)  (36,505)  (11,967)  (12,012)  (23,934)  (23,965)
Interest expense: Related Party  (5,315)  (5,924)  (15,331)  (6,570)
Loss on foreign currency exchange  (512)  (1,251)  (2,009)  (1,402)  (224)  (194)  (345)  (204)
Total Other Income (expense)  (17,936)  (19,455)  (53,414)  (44,477)  (19,777)  (17,463)  (38,289)  (34,185)
                                
Loss Before Credit for Income Taxes  (209,609)  (152,179)  (575,211)  (897,399)  (219,135)  (148,008)  (384,348)  (294,279)
Credit for income taxes  -   -   -   -   -   -   -   - 
Net Loss  (209,609)  (152,179)  (575,211)  (897,399)
Net Loss from continuing operations  (219,135)  (148,008)  (384,348)  (294,279)
Loss from discontinued operations, net of tax  (29,752)  (37,296)  (39,487)  (71,323)
Net loss  (248,887)  (185,304)  (423,835)  (365,602)
                
Preferred stock dividends  (162,185)  (162,185)  (324,370)  (324,370)  -   -   (162,185)  (162,185)
Net Loss available to common shareholders  (371,794)  (314,364)  (899,581)  (1,221,769)
Comprehensive Loss                
Net Loss available to common stockholders (248,887) (185,304) (586,020) (527,787)
Other Comprehensive Loss                
Foreign Currency Translation Adjustment  7   810   2   33,515   -   1   2   (5)
Comprehensive Loss $(371,787) $(313,554) $(899,579) $(1,188,254) 

$

(248,887) 

$

(185,303) 

$

(423,833) 

$

(365,607)
                                
Net Loss Per Share                                
Basic and diluted $(0.02) $(0.01) $(0.04) $(0.06)
                
Loss from continuing operations - basic and diluted $(0.01) $(0.01) $(0.02) $(0.01)
Loss from discontinued operations - basic and diluted $(0.00) $(0.00) $(0.00) $(0.00)
Loss from operations - basic and diluted $(0.01) $(0.01) $(0.02) $(0.02)
Weighted Average Number of Shares Outstanding – Basic and Diluted  24,222,946   22,221,266   23,689,516   21,258,184   25,830,151   23,687,130   25,562,295   23,418,381 

 

See accompanying notes to consolidated financial statements

VYCOR MEDICAL, INC.

Consolidated Statement of Stockholders’ Deficiency

(Unaudited)

 

                          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 December 31, 2018  23,244,028   2,324   1   0   270,306   27   (103,334) $(1,033)  27,771,868  $(28,669,686)  127,673  $(768,827)
Issuance of stock for board and consulting fees  535,714   54                           112,446           112,500 
Directors deferred compensation granted  -                               21,000           21,000 
Accumulated Comprehensive Loss                                          (6)  (6)
Net loss for period ended March 31, 2019                                      (342,483)      (342,483)
Balance at March 31, 2019  23,779,742  $2,378   1  $0   270,306  $27   (103,334) $(1,033) $27,905,314  $(29,012,169) $127,667  $(977,816)
Issuance of stock for board and consulting fees  540,714   54                           113,385           113,439 
Directors deferred compensation granted  -                               21,000           21,000 
Foreign currency translation adjustment                                          1   1 
Net loss for period ended June 30, 2019                                      (185,304)      (185,304)
Balance at June 30, 2019  24,320,456  $2,432   1  $0   270,306  $27   (103,334) $(1,033) $28,039,699  $(29,197,473) $127,668  $(1,028,680)
Issuance of stock for board and consulting fees  535,714   54                           112,447           112,501 
Directors deferred compensation granted  -                               21,000           21,000 
Foreign currency translation adjustment                                          7   7 
Net loss for period ended September 30, 2019                                      (371,794)      (371,794)
Balance at September 30, 2019  24,856,170  $2,486   1  $0   270,306  $27   (103,334) $(1,033) $28,173,146  $(29,569,267) $127,675  $(1,266,966)
                                                 
Balance at December 31, 2017  19,925,322   1,993   1   0   270,306   27   (103,334)  (1,033)  26,921,574  $(26,965,960)  124,841   81,442 
Issuance of stock for board and consulting fees  250,000   25                           92,475           92,500 
Directors deferred compensation granted                                  21,000           21,000 
Share based compensation issued to management/employees                                  4,871           4,871 
Accumulated Comprehensive Loss                                          (1,162)  (1,162)
Net loss for period ended March 31, 2018                                      (488,821)      (488,821)
Balance at March 31, 2018  20,175,322  $2,018   1  $0   270,306  $27   (103,334) $(1,033) $27,039,920  $(27,454,781) $123,679  $(290,172)
Issuance of stock for board and consulting fees  1,031,125   103                           357,397           357,500 
Directors deferred compensation granted  -                               21,000           21,000 
Issuance of shares and warrants pursuant to offering, net  1,113,936   111                           (111)          - 
Share based compensation issued to management/employees                                  86,754           86,754 
Foreign currency translation adjustment                                          3,667   3,667 
Net loss for period ended June 30, 2018                                      (418,584)      (418,584)
Balance at June 30, 2018  22,320,383  $2,232   1  $0   270,306  $27   (103,334) $(1,033) $27,504,960  $(27,873,365) $127,346  $(239,833)
Issuance of stock for board and consulting fees  387,931   39                           112,461           112,500 
Directors deferred compensation granted  -                               21,000           21,000 
Foreign currency translation adjustment                                          810   810 
Net loss for period ended September 30, 2018                                      (314,364)      (314,364)
Balance at September 30, 2018  22,708,314  $2,272   1  $0   270,306  $27   (103,334) $(1,033) $27,638,421  $(28,187,729) $128,156  $(419,887)
                          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, 2020  25,927,598  $2,593      1  $     0   270,307  $  27   (103,334) $(1,033) $28,440,038  $(30,127,391) $127,672  $(1,558,094)
Issuance of stock for board and consulting fees  535,714   53                           112,446           112,499 
Directors deferred compensation granted  -                               21,000           21,000 
Issuance of shares pursuant to exercise of warrants                                              - 
Accumulated Comprehensive Loss                                          -   - 
Net loss available to common stockholders                                      (248,887)      (248,887)
Balance at June 30, 2020  26,463,312  $2,646   1  $0   270,307  $27   (103,334) $(1,033) $28,573,484  $(30,376,278) $127,672  $(1,673,482)

                          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 December 31, 2019  25,391,884  $2,539      1  $    0   270,307  $  27   (103,334) $(1,033) $28,306,592  $(29,790,258) $127,670  $(1,354,463)
Issuance of stock for board and consulting fees  1,071,428   107                           224,892           224,999 
Directors deferred compensation granted  -                               42,000           42,000 
Issuance of shares pursuant to exercise of warrants                                              - 
Accumulated Comprehensive Loss                                          2   2 
Net loss available to common stockholders                                      (586,020)      (586,020)
Balance at June 30, 2020  26,463,312  $2,646   1  $0   270,307  $27   (103,334) $(1,033) $28,573,484  $(30,376,278) $127,672  $(1,673,482)

                          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, 2019  23,779,742  $2,378      1  $   0   270,307  $   27   (103,334) $(1,033) $27,905,314  $(29,012,169) $127,667  $(977,816)
Issuance of stock for board and consulting fees  540,714   54                           113,385           113,439 
Directors deferred compensation granted  -                               21,000           21,000 
Issuance of shares pursuant to exercise of warrants                                              - 
Accumulated Comprehensive Loss                                          1   1 
Net loss available to common stockholders                                      (185,304)      (185,304)
Balance at June 30, 2019  24,320,456  $2,432   1  $0   270,307  $27   (103,334) $(1,033) $28,039,699  $(29,197,473) $127,668  $(1,028,680)

                          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 December 31, 2018  23,244,028  $2,324      1  $    0   270,307  $    27   (103,334) $(1,033) $27,771,868  $(28,669,686) $127,673  $(768,827)
Issuance of stock for board and consulting fees  1,076,428   108                           225,831           225,939 
Directors deferred compensation granted  -                               42,000           42,000 
Issuance of shares pursuant to exercise of warrants                                              - 
Accumulated Comprehensive Loss                                          (5)  (5)
Net loss available to common stockholders                                      (527,787)      (527,787)
Balance at June 30, 2019  24,320,456  $2,432   1  $0   270,307  $27   (103,334) $(1,033) $28,039,699  $(29,197,473) $127,668  $(1,028,680)

 

See accompanying notes to consolidated financial statements

VYCOR MEDICAL, INC.

Consolidated Statement of Cash Flows

(Unaudited)

 

 For the six months ended 
 

For the nine months ended

September 30,

  June 30, 
 2019  2018  2020  2019 
Cash flows from operating activities:                
Net loss $(575,211) $(897,399) $(423,835) $(365,602)
Adjustments to reconcile net loss to cash provided by (used in) operating activities:        
Adjustments to reconcile net loss to cash used in operating activities:        
Amortization of intangible assets  8,983   37,748   5,988   5,989 
Depreciation of fixed assets  43,376   98,455   24,381   24,890 
Inventory provision  9,418   3,139   6,279   6,279 
Stock based compensation  401,440   492,125   266,999   267,940 
                
Changes in assets and liabilities:                
Accounts receivable  42,661   (134,732)  177,587   (36,347)
Inventory  (32,914)  (7,565)  8,454   (57.473)
Prepaid expenses  58,714   (21,913)  17,359   5,801 
Security Deposits  -   3,169 
Accrued interest - Related Party  15,332   6,570   14,011   10,017 
Accrued interest Other  35,901   35,901 
Accrued interest - Other  23,934   23,803 
Accounts payable  105,205   (45,575)  (74,838)  63,165 
Accrued liabilities Other  (27,483)  143,945 
Cash provided by /(used in) operating activities  85,422   (286,132)
Accrued liabilities - Other  (125,921)  15,418 
Changes in discontinued operations, net  473  5,746 
Cash used in operating activities  (79,129)  (30,374)
Cash flows from investing activities:                
Purchase of fixed assets  (25,057)  (56,604)  (49,991)  (5,654)
Changes in investing activities of discontinued operations, net  

(376

  (2,529

Cash used in investing activities  (25,057)  (56,604)  (50,367)  (8,183)
Cash flows from financing activities:                
Proceeds from Notes Payable - Related Party  17,873   193,000   80,000   17,873 
Proceeds from and (repayments of) Notes Payable - Other  (66,941)  28,473 
Cash provided by/(used in) financing activities  (49,068)  221,473 
Proceeds net of repayments Notes Payable - Other  59,772   (246)
Cash provided by financing activities  139,772   17,627 
Effect of exchange rate changes on cash  724   5,180   1   663 
Net increase (decrease) in cash  12,021   (116,083)  10,277   (20,267)
Cash at beginning of period  86,481   206,213   60,717   78,011 
Cash at end of period $98,502  $90,130  $70,994  $57,744 
                
Supplemental Disclosures of Cash Flow Information:     
Supplemental Disclosures of Cash Flow information:        
Cash paid for interest $0 $0  $-  $- 
Cash paid for income tax $0 $0  $-  $- 
Non-Cash Transactions:        
Common stock issued to related party for payment of accrued liabilities $0  $225,000 

 

See accompanying notes to consolidated financial statements

VYCOR MEDICAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

SeptemberJune 30, 20192020

(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, 20182019 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, 2018.2019.

 

The unaudited consolidated financial statements as of and for the three and ninesix months ended SeptemberJune 30, 20192020 and 2018,2019, 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 ninesix months ended SeptemberJune 30, 20192020 and 20182019 are not necessarily indicative of the results to be expected for any other interim period or for the entire year.

 

Ability to continue as a Going Concern

 

The accompanying unaudited consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred losses since its inception, including a net loss of $575,211$586,020 for the ninesix months ended SeptemberJune 30, 20192020 and has not generated sufficient positive cash flows from operations. As of SeptemberJune 30, 20192020 the Company had a working capital deficiency of $473,129,$634,822, excluding related party liabilities of $1,223,589. As a result these$1,505,100. 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 revenue growth and 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 $268,666,$304,699, which has a maturity date of December 31, 2019,2020, having been extended on a number of occasions from its initial due date of June 11, 2011. The Company will seek an extension to the note, althoughAt this time, it is not known whether any further extension of the note beyond December 31, 2020 will be extended or the terms of any extension.available. However, the Company believes it may not have sufficient cash to meet its various cash needs through November 30, 2020August 31, 2021 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.

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 accounts, transactions, and profits have been eliminated in consolidation. Following the decision in April 2020 to close the German office of NovaVision, the activities of NovaVision GmbH have been accounted for as discontinued operations.

 

Recent Accounting Pronouncements

The Company adopted Accounting Standards Codification 842, Leases (“ASC 842”) in the first quarter of 2019. As a result the Company updated its significant accounting policies for leases below. Refer to Note 4 for additional information related to the Company’s lease arrangements and the impact of the adoption of ASC 842 on the Company’s unaudited consolidated financial statements.

 

From time 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, other than as disclosed above, such 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.

 

Discontinued Operations

In accordance 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 required to be reported as discontinued operations if 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 all of the criteria to 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.

Leases

 

The Company has one leased buildingsbuilding in Boca Raton, Florida that is classified as operating lease right-of use (“ROU”) assets and operating lease liabilities in the Company’s unaudited consolidated balance sheet.sheet as per ASC 842. ROU assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date for leases exceeding 12 months. Minimum lease payments include only the fixed lease component of the agreement. Operating lease expense is recognized on a straight-line basis over the lease term and is included in cost of Selling, General and Administrative expenses.

 

The standard was effective for us beginning January 1, 2019. The Company elected the available practical expedients on adoption. The adoption had a material impact on our unaudited consolidated balance sheets, but did not have a material impact on our unaudited consolidated statements of comprehensive loss. The most significant impact was the recognition of ROU assets and lease liabilities for operating leases.

 

Net Loss Per Share

 

Basic net loss per share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period. Diluted net 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.

The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share:

 

 September 30, September 30, 
 2019  2018  June 30, 2020  June 30, 2019 
Stock options outstanding  700,000   1,380,000   680,000   700,000 
Warrants to purchase common stock  3,717,826   3,717,826   -   3,717,826 
Debentures convertible into common stock  2,707,933   2,479,364   2,879,521   2,650,324 
Preferred shares convertible into common stock  1,272,052   1,272,052   1,272,052   1,272,052 
Directors Deferred Compensation Plan  1,075,908   685,107   1,375,905   975,909 
Total  9,473,719   9,534,349   6,207,478   9,316,111 

Covid-19

In December 2019, an outbreak of a novel strain of coronavirus (COVID-19) originated in Wuhan, China, and has since spread to a number of other countries, including the United States. On March 11, 2020, the World Health Organization characterized COVID-19 as a pandemic. In addition, as of the time of the filing of this Form 10-Q, several states in the United States remain in states of emergency, and travel restrictions continue to be applied in several countries around the world, including the United States. Vycor Medical experienced a reduction in demand during the six months ended June 30, 2020 in the US and Internationally. Although neurosurgery is not considered an elective procedure, general hospital dislocation and diversion of resources away from non-emergency surgeries, or surgeries that can be postponed for a short period without harm, has impacted our revenues during the six months ended June 30, 2020 and could continue to do so. In addition, sales and marketing efforts by Vycor’s representatives have been disrupted or curtailed due to lockdown and social distancing, and this has and may continue to hinder the recovery of revenues. While our operations are principally located in the United States, and our sub-contract manufacturers are located in the United States, we participate in a global supply chain, and the existence of a worldwide pandemic, the fear associated with COVID-19, or any, pandemic, and the reactions of governments around the world in response to COVID-19, or any, pandemic, to regulate the flow of labor and products and impede the travel of personnel, may impact our ability to conduct normal business operations, which could adversely affect our results of operations and liquidity. Disruptions to our supply chain and business operations, or to our suppliers’ or customers’ supply chains and business operations, could include disruptions from the closure of supplier and manufacturer facilities, interruptions in the supply of raw materials and components, personnel absences, or restrictions on the shipment of our or our suppliers’ or customers’ products, any of which could have adverse ripple effects on our manufacturing output and delivery schedule. Although we have implemented business continuity plans for our offices and personnel to enable continuity of service remotely, if a critical number of our employees become too ill to work, or we are not able to access a sufficient quantity of our inventory for shipment due to enforced office closures, our production ability could be materially adversely affected in a rapid manner. Similarly, if our customers experience adverse business consequences due to COVID-19, or any other, pandemic, demand for our products could also be materially adversely affected in a rapid manner. Global health concerns, such as COVID-19, could also result in social, economic, and labor instability in the countries and localities in which we or our suppliers and customers operate. Any of these uncertainties could have a material adverse effect on our business, financial condition or results of operations.

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 June 2020 Vycor announced that it would be entering into a license agreement and transition agreement (the “Agreements”) with HelferApp GmbH, a cognitive therapy specialist. Under the Agreements, HelferApp will be licensed to provide NovaVision’s products and therapies in Germany, Austria and Switzerland to patients and professionals; and will assume responsibility for the current patients of NovaVision in the territory. The NovaVision German office was closed effective June 30, 2020. The Company will continue to fund the remaining expenses of the German operations, which are non-material, until such a time as NovaVision GmbH will be formally wound up.

Reconciliation of the Major Line Items constituting Loss from discontinued operations, net of tax, that are presented in the Consolidated Statements of Comprehensive Loss

  For the three months ended
June 30,
  For the six months ended
June 30,
 
  2020  2019  2020  2019 
Major line items constituting loss from discontinued operations                
Revenue $17,864  $17,988  $38,676  $42,047 
Cost of Goods Sold  2,618   2,789   4,219   6,623 
Gross Profit  15,246   15,199   34,457   35,424 
                 
Operating expenses:                
Depreciation and Amortization  -   40   -   259 
Selling, general and administrative  43,780   51,900   72,682   105,195 
Total Operating expenses  43,780   51,940   72,682   105,454 
Operating loss  (28,534)  (36,741)  (38,225)  (70,030)
                 
Other income (expense)                
Loss on foreign currency exchange  (1,218)  (555)  (1,262)  (1,293)
Total Other Income (expense)  (1,218)  (555)  (1,262)  (1,293)
                 
Loss Before Credit for Income Taxes  (29,752)  (37,296)  (39,487)  (71,323)
Credit for income taxes  -   -   -   - 
Loss from discontinued operations, net of tax $(29,752) 

$

(37,296) $(39,487) 

$

(71,323)

The reduction in operating loss for the three and six months ended June 30, 2020 compared to the same periods in 2019, from $36,741 to $28, 534 and from $70,030 to $38,225, respectively, is primarily due to a reduction in Selling, general and administrative expenses as a result of the wind-down of operations in Germany.

4.NOTES PAYABLE

 

Related Parties Notes Payable

 

Related Party Notes Payable consists of:

 

  September 30, 2019  December 31, 2018 
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, 2020 or on demand by the Payee $30,000  $30,000 
In March 2019 and between March 2018 and July 2018 the Company issued various promissory notes to Fountainhead Capital Management Limited for $180,873. 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. Five notes were extended for another twelve months on their due dates which will be due between March and July 2020 or on demand by the Payee.  180,873   163,000 
Total Related Party Notes Payable $210,873  $193,000 
  June 30, 2020  December 31, 2019 
       
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, 2021 or on demand by the Payee. $30,000  $30,000 
Between March 26, 2018 and April 24, 2020 the Company issued various promissory notes to Fountainhead Capital Management Limited for $280,873. 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. Six notes were extended on their due dates for another twelve months. The Notes will be due between December 2020 and July 2021 or on demand by the Payee.  280,873   200,873 
Total Related Party Notes Payable $310,873  $230,873 

 

Other Notes Payable

 

Other Notes Payable consists of:

 

  September 30, 2019  December 31, 2018 
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 March 19, 2019, the note was extended to December 31, 2019. See further note below. $300,000  $300,000 
Insurance policy finance agreements.  51,058   25,814 
Total Notes Payable: $351,058  $325,814 

  June 30, 2020  December 31, 2019 
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 extended to December 31, 2020. The note is personally guaranteed by certain officers and directors of the Company. See further note below $300,000  $300,000 
On May 16, 2020, the Company was granted a loan from Citizens Bank N.A. in the aggregate amount of $58,600, pursuant to the Paycheck Protection Program (the “PPP”) under Division A, Title I of the CARES Act, which was enacted March 27, 2020. The Loan, which was in the form of a Note dated May 16, 2020 issued by the Borrower, matures on May 16, 2022 and bears interest at a rate of 1% per annum, payable monthly commencing on November 16, 2020. The Note may be prepaid by the Borrower at any time prior to maturity with no prepayment penalties. The Company intends to use the entire Loan amount for qualifying expenses. Under the terms of the PPP, certain amounts of the Loan may be forgiven if they are used for qualifying expenses as described in the CARES Act.  58,600   - 
Insurance policy finance agreements and other.  29,204   28,032 
Total Other Notes Payable: $387,804  $328,032 

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 until December 31, 2018 and was further extended until December 31, 2019. Thethe 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 2,707,9332,879,521 shares of Common Stock as of SeptemberJune 30, 2019.2020. 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. In addition, the Company agreed to issue warrants to purchase 2,308,405 shares of Common Stock at $0.27, the same terms as the 2018 Offering, exercisable for three years from January 1, 2018, if and when the conversion option is exercised. 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 party finance company which requires a down payment and subsequent monthly payments, the time periods vary from 10 months to 12 equal monthly payments.

4.5.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 $5,700 plus sales tax per month that will expire on September 30, 2020. Based on the original lease agreement, the Company has the one-time option to renew the lease for another three years with minimum annual rent at market price, not less than the original lease payment amount. In January 2020, the Company exercised the option to extend the original lease for another three years with the expiration date of August 31, 2023. In accordance with ASC 842-10-35, the Company considered this lease extension as the modification of the original lease and re-measured the lease liability and the right-of-use assets on the commencement date of the lease extension.

The Company recognized the following related to a lease in its unaudited consolidated balance sheet at SeptemberJune 30, 2020 and December 31, 2019:

 

  Nine Months Ended September 30, 
  2019  2018 
Operating Lease Assets        
Current portion $43,586  $- 
  $43,586  $- 
Operating Lease Liabilities        
Current portion $43,586  $- 
  $43,586  $- 

  June 30, 2020  December 31, 2019 
       
Operating Lease ROU Assets $145,691  $31,658 
  $145,691  $31,658 
         
Operating Lease Liabilities        
Current portion $42,450  

$

28,010 
Long-term portion 100,141  - 
  $142,591  $28,010 
5.6.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 all revenues were in Europe; see Note 3. Set out below are the revenues, gross profits and total assets for each segmentsegment:

 

  Three Months Ended September 30,  Nine Months Ended September 30, 
  2019  2018  2019  2018 
Revenue:                
Vycor Medical $301,053  $399,450  $988,786  $930,553 
NovaVision $45,255  $56,763  $138,078  $152,426 
  $346,308  $456,213  $1,126,864  $1,082,979 
Gross Profit                
Vycor Medical $273,146  $357,674  $895,484  $821,240 
NovaVision $41,635  $51,739  $124,746  $138,609 
  $314,781  $409,413  $1,020,230  $959,849 
  September 30, 2019  December 31, 2018 
Total Assets:        
Vycor Medical $1,022,449  $981,553 
NovaVision  63,276   62,224 
Total Assets $1,085,725  $1,043,777 
  Three Months Ended June 30,  Six Months Ended June 30, 
  2020  2019  2020  2019 
Revenue:                
Vycor Medical $218,997  $390,627  $526,284  $687,733 
NovaVision $25,269  $21,275  $48,221  $50,776 
  $244,266  $411,902  $574,505  $738,509 
Gross Profit                
Vycor Medical $201,179  $355,415  $472,036  $622,338 
NovaVision $22,594  $20,367  $44,682  $47,687 
  $223,773  $375,782  $516,718  $670,025 

  June 30, 2020  December 31, 2019 
Total Assets:        
Vycor Medical $986,757  $1,036,857 
NovaVision  10,297   25,395 
Discontinued operations  14,045   29,691 
Total Assets $1,011,099  $1,091,943 

 

(b) Geographic information

 

The Company operates in two geographic segments, the United States and Europe. Set out below are the revenues, gross profits and total assets for each segment.

 

 Three Months Ended September 30, Nine Months Ended September 30,  Three Months Ended June 30,  Six Months Ended June 30, 
 2019  2018  2019  2018  2020  2019  2020  2019 
Revenue:                                
United States $320,477  $425,800  $1,051,237  $1,002,923  $241,325  $410,145  $569,140  $730,761 
Europe $25,831  $30,413  $75,627  $80,056  $2,941  $1,757  $5,365  $7,748 
 $346,308  $456,213  $1,126,864  $1,082,979  $244,266  $411,902  $574,505  $738,509 
Gross Profit                                
United States $291,536  $382,006  $953,861  $889,190  $220,832  $374,033  $511,353  $662,325 
Europe $23,245  $27,407  $66,369  $70,659  $2,941  $1,749  $5,365  $7,700 
 $314,781  $409,413  $1,020,230  $959,849  $223,773  $375,782  $516,718  $670,025 

 

  September 30, 2019  December 31, 2018 
Total Assets:        
United States $1,051,776  $1,010,067 
Europe  33,949   33,710 
Total Assets $1,085,725  $1,043,777 

  June 30, 2020  December 31, 2019 
Total Assets:        
United States $955,208  $1,055,312 
Europe  41,846   6,940 
Discontinued operations  14,045   29,691 
Total Assets $1,011,099  $1,091,943 
6.7.EQUITY

 

Common Stock and Stock Grants

 

During January to SeptemberJune 2020 and 2019, and 2018, the Company granted 299,997 and 174,580199,998 shares respectively, of Common Stock (valued at $63,000 during each period)$42,000) to non-employee Directors. Under the terms of the Directors Deferred Compensation Plan, the receipt of these shares is deferred until the January 15thfollowing the termination of their services as a director. As of SeptemberJune 30, 20192020 these shares have yet to be issued.

During January to SeptemberJune 2020 and 2019, under the terms of the Consulting Agreement referred to in note 9,10, the Company issued 1,607,142 shares1,071,428 of Common Stock to Fountainhead for fees of $337,500. During January to September 2018, under the terms of the Consulting Agreement, the Company issued 1,669,056 shares of Common Stock to Fountainhead for fees of $562,500 of which $225,000 had been accrued at December 31, 2017.

During thein each period ended September 30, 2019 the Company issued 5,000 shares of Common Stock to Robert Anderson for fees of $940 for consultancy.

On April 20, 2018, the Company issued an aggregate of 1,113,936 shares of Company Common Stock on the cashless exercise of an aggregate of Warrants to purchase 3,111,560 shares of Common Stock.respectively.

 

Warrants and Options

 

The details of the outstanding warrants and options are as follows:

 

STOCK WARRANTS:

 

   

Weighted

average

     Weighted average 
 

Number of

shares

  exercise price
per share
  Number of shares  exercise price
per share
 
Outstanding at December 31, 2018  3,717,826  $0.27 
Outstanding at December 31, 2019  3,717,826  $0.27 
Granted  -   -   -   - 
Exercised  -   -   -   - 
Cancelled or expired  -   -   (3,717,826) $0.27 
Outstanding at September 30, 2019  3,717,826  $0.27 
Outstanding at June 30, 2020  -  $0.00 

 

STOCK OPTIONS:

 

   

Weighted

average

     Weighted average 
 

Number of

shares

  exercise price
per share
  Number of shares  exercise price
per share
 
Outstanding at December 31, 2018  1,380,000  $0.53 
Outstanding at December 31, 2019  700,000  $0.28 
Granted  -   -   -   - 
Exercised  -   -   -   - 
Cancelled or expired  (680,000)  (0.79)  (20,000)  (0.27)
Outstanding at September 30, 2019  700,000  $0.28 
Outstanding at June 30, 2020  680,000  $0.28 

 

As of SeptemberJune 30, 2019,2020, the weighted-average remaining contractual life of outstanding warrants and options is 0.360 and 1.710.99 years, respectively.

7.8.SHARE-BASED COMPENSATION

 

Stock Option Plan

 

Under ASC Topic 718, the Company estimates the fair value of option awards on the date of grant using an option pricing model. The grant date fair value is recognized over the option-vesting period, the period during which an employee is required to provide service in exchange for the award. No compensation cost is recognized for equity instruments for which employees do not render the requisite service. Under these standards, compensation cost for employee cost for employee stock-based awards is based on the estimated grant-date fair value and recognized over the vesting period of the applicable award on a straight-line basis.

 

For each of the ninesix months ended SeptemberJune 30, 20192020 and 2018,2019, the Company recognized share-based compensation of $0 and $4,871 respectively, for employee stock options.

 

Stock appreciation rights may be granted either on a stand-alone basis or in conjunction with all or part of any other stock options granted under the plan. As of SeptemberJune 30, 20192020 there were no awards of any stock appreciation rights.

 

Non-Employee Stock Compensation

 

The Company from time to time issues common stock, stock options or common stock warrants to acquire services or goods from non-employees. Common stock, stock options and common stock warrants issued to other than employees or directors are recorded on the basis of their fair value, which is measured as of the “measurement date” using an option pricing model.. 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.

 

Aggregate stock-based compensation for stock and warrants granted to non-employees for each of the ninesix months ended SeptemberJune 30, 2020 and 2019 and 2018 was $401,440 and $487,254.$266,699. The expense related to stock not issued during each of the periods ended SeptemberJune 30, 2020 and 2019 and 2018 comprise: $63,000, respectively for both periods,comprises $42,000, related to stock granted but not issued to directors under the Directors Deferred Compensation Plan. As of SeptemberJune 30, 2019,2020, there was $0 of total unrecognized compensation costs related to warrant and stock awards and non-vested options.

During the nine months ended September 30, 2019 and 2018, options with a value of $0 and $216,582, respectively, were granted to Fountainhead with performance vesting conditions, (see Note 9). The performance conditions of the options granted during 2018 were not met and these options were cancelled.

 

Stock-based Compensation Valuation Methodology

 

Stock-based compensation resulting from the issuance of Common Stock is calculated by reference to the valuation of the Stock on the date of issuance, the expense being recognized as the compensation is earned. Stock-based compensation expenses related to employee options and warrants granted to non-employees are recognized as the stock options and warrants are earned. The fair value of the stock options or warrants granted is estimated at the grant date, using the Black-Scholes option pricing model, and the expense 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. The grant date fair value of employee share options and similar instruments is estimated using the Black-Scholes option pricing model on the basis of the fair value of the underlying common stock on the measurement date, adjusted for the unique characteristics of those equity instruments, using the assumptions noted in the table below. Expected volatility is based on the historical volatility of a peer group of publicly traded companies. The expected term of options and warrants was based upon the expected life of the option or warrant, and the risk-free rate is based on the U.S. Treasury Constant Maturity rate.

 

The following assumptionsThere were used in calculationsno options or warrants issued during either of the Black-Scholes option pricing model for the nine months ended Septemberperiods ending June 30, 20192020 and 2018:2019.

 

  Nine Months Ended September 30, 
  2019  2018 
Risk-free interest rates  -%  1.72-2.41%
Expected life  -   1.5-4.0 years 
Expected dividends  -%  0%
Expected volatility  -%  102-107%
Vycor Common Stock fair value $-  $0.20-0.49 
8.9.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 $5,700 plus sales tax per month. The lease terminates September 30, 2020.2020 and has been extended for a further three years to August 31, 2023. The Company’s subsidiary in Germany occupiesoccupied premises on a short-termrolling 12 month lease agreement with a 3 month notice period of EUR1,963EUR1,650 per month (approximately $2,200).$1,815), which was terminated effective June 30, 2020. Rent expense for the ninesix months ended SeptemberJune 30, 2020 and 2019 for the continuing operations was $39,349 and 2018 was $73,925 and $74,784$38,139 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 a maximum of approximately €630,000 preliminarily reduced to €75,000 (approximately $82,000), with an additional interest charge of €12,000.€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 of the same 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 ninesix months ended SeptemberJune 30, 20192020 and the year ended December 31, 20182019 respectively.

 

9.10.CONSULTING AND OTHER AGREEMENTS

 

The following agreements were entered into or remained in force during the period ended SeptemberJune 30, 2019:2020:

 

Consulting Agreement with Fountainhead

 

In March 2017 and effective April 1, 2017, the Company amended the Fountainhead Consulting Agreement (“the Amended Agreement”). Under the Amended Agreement, fees of $450,000 are 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. Under the terms of the Amended Agreement, Fountainhead provides 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.

 

During the ninesix months ended SeptemberJune 30, 2020 and June 30, 2019, under the terms of the Amended Agreement, Fountainhead received total fees of $337,500,$225,000, which were paid through the issuance of 1,607,1421,071,428 shares of Company Common Stock. During the nine months ended September 30, 2018, under the terms of the Consulting Agreement, the Company issued 1,669,056 shares of Common Stock to Fountainhead for fees of $562,500 of which $225,000 had been accrued as at December 31, 2017.

 

During the nine months ended September 30, 2019 and 2018, options pursuant to the Vycor Medical, Inc. 2018 Stock Option Plan with a value of $0 and $216,582, respectively, were granted to Fountainhead with performance vesting conditions. The performance conditions of the options granted during 2018 were not met and these options were cancelled.

10.11.RELATED PARTY TRANSACTIONS

 

Peter Zachariou and David Cantor, directors of the Company, are investment managers of Fountainhead which owned, at SeptemberJune 30, 2019, 56%2020, 59% of the Company’s Common Stock and 70% of the Company’s Preferred D Stock. Peter Zachariou owns 26% of the Company’s Preferred D Stock. Adrian Liddell, Chairman, is a consultant for Fountainhead.

 

During each of the ninesix months ended SeptemberJune 30, 2020 and June 30, 2019, under the terms of the Consulting Agreement referred to in note 9,10, the Company issued 1,607,1421,071,428 shares of Common Stock to Fountainhead for fees of $337,500. During the nine months ended September 30, 2018, under the terms of the Consulting Agreement, the Company issued 1,669,056 shares of Common Stock to Fountainhead for fees of $562,500 of which $225,000 had been accrued as at December 31, 2017.$225,000.

 

During each of the ninesix months ended SeptemberJune 30, 20192020 and 2018,2019, the Company accrued an aggregate of $324,370$162,185 of Preferred D Stock dividends, of which $226,037$113,019 was in respect of Fountainhead and $83,386$41,693 was in respect of Peter Zachariou.

 

During the ninesix months ended SeptemberJune 30, 20192020 and 20182019 the Company issued unsecured loan notes to Fountainhead for a total of $17,873$80,000 and $133,000,$17,873, respectively. The loan notes bear interest at a rate of 10% and are due on demand or by their one-year anniversary. During

There were no other related party transactions during the ninesix months ended SeptemberJune 30, 20192020 and 2018 the Company issued unsecured loan notes to Peter Zachariou for a total of $0 and $30,000, respectively. The loan notes bear interest at a rate of 10% and are due on demand or by their one-year anniversary. (See Note 3)2019.

 

11.12.CONCENTRATION

 

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

 

Sales Concentration   
  Three months ended  Nine months ended 
  September 30,  September 30, 
  2019  2018  2019  2018 
             
Number of customers over 10%  1   1   1   3 
Percentage of sales  11%  25%  10%  10%, 11 % and 11%

Sales Concentration:

  Three Months Ended June 30,  Six Months Ended June 30, 
  2020  2019  2020  2019 
Number of customers over 10%  0   0   1   0 
Percentage of sales  0%  0%  19%  0%

 

Accounts Receivable Concentration

 

 At September 30, At December 31,  At June 30, At December 31, 
 2019 2018  2020  2019 
          
Number of customers over 10%  1   2   1   1 
Percentage of accounts receivable  48%  13% and 40%  12%  37%

 

We have twoThe Company has three sub-contract manufacturers who bothfrom 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 purchased on antotal annual basis.purchases.

 

12.13.SUBSEQUENT EVENTS

 

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 twelve (12) months from the date of the note and is secured by essentially all of the assets of the Company. The proceeds of the Loan will be used for general working capital purposes to alleviate economic injury caused by disaster occurring in the month of January 2020 and continuing thereafter.

Other than the above stated Subsequent Event, 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.

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.”. 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”).

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. Both technologies have strong sales growth potential, address large potential markets and have the requisite regulatory approvals. The Company has 6465 issued or allowed patents and a further 89 pending. The Company leverages joint resources across the divisions to operate in a cost-efficient manner.

 

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 be entering into a license agreement and transition agreement (the “Agreements”) with HelferApp GmbH, a cognitive therapy specialist. Under the Agreements, HelferApp will be licensed to provide NovaVision’s products and therapies in Germany, Austria and Switzerland to patients and professionals; and will assume responsibility for the current patients of NovaVision in the territory. The NovaVision German office was closed effective June 30, 2020.

 

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 that was fully commercialized in early 2010 and is the first significant technological change to brain tissue retraction in over 50 years in contrast to significant development in most other neuro-surgical technologies. 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 markkets.markets. Vycor Medical has 2627 granted and 89 pending patentspatents.

 

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 38 granted patents.

Strategy

 

The Company is continuing to execute on a plan to achieve revenue growth and a reduction in cash operating losses.losses1. For Vycor Medical this plan includes in particular: increasing market penetration in the US through closer cooperation with complementary product manufacturers, broadening of the distribution network and programs to increase penetration in exitingexisting hospitals; increasing international growth in territories where we are not represented or under represented; and continued new product development. The first phase of the modification of the existing VBAS product range to make it more compatible with the most common IGS systems was completed in September 2017 and has been well received by surgeons, resulting in increased hospital penetration and revenues particularly in the US. The second phase of the development of further IGS integration is in process and will then becomplete, subject to regulatory clearances and approvals. Upon regulatory approvalclearances and product release of this new VBAS AC model range the Company intends to conduct a multi-center study tpto provide additional clinical data on the product. We will also be exploring with surgeons 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 that have either direct access to the end users or a desire and financial wherewithal to leverage the NovaVision therapy platform. TheAs a result, the Company has now closed the NovaVision German office and is entering into a license agreement with HelferApp, a cognitive therapy specialist, for Germany, Austria and Switzerland, and is seeking similar partnerships in the process of identifying and talkingother territories with regional companies able to such partners.leverage NovaVision’s clinically supported vision therapies. Management is determined to reduce the losses it is incurring in this division and isalso open to a broad range of alternatives for NovaVision as a whole, which could comprise distribution and marketing partnerships, licensing, merger sale and/or sale.

The NovaVision German operation accounted for a significant restructuringvery substantial proportion of its activities.Vycor’s operating cash loss1 during the year ended December 31, 2019. This proportion has been reduced during the six months ended June 30, 2020 for two reasons: firstly, the selling, general and administrative expenses of NovaVision Germany have been reduced as the operation has been wound down; and secondly due to the impact on Vycor revenues from Covid-19 discussed below.

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

COVID-19

In December 2019, an outbreak of a novel strain of coronavirus (COVID-19) originated in Wuhan, China, and has since spread to a number of other countries, including the United States. On March 11, 2020, the World Health Organization characterized COVID-19 as a pandemic. In addition, as of the time of the filing of this Form 10-Q, several states in the United States remain in states of emergency, and travel restrictions continue to be applied in several countries around the world, including the United States. Vycor Medical experienced a reduction in demand during the three months ended June 30, 2020 in the US and Europe. Although neurosurgery is not considered an elective procedure, general hospital dislocation and diversion of resources away from non-emergency surgeries, or surgeries that can be postponed for a short period without harm, has impacted our revenues during the six months ended June 30, 2020 and could continue to do so. In addition, sales and marketing efforts by Vycor’s representatives have been disrupted or curtailed due to lockdown and social distancing, and this has and may continue to hinder the recovery of revenues. While our operations are principally located in the United States, and our sub-contract manufacturers are located in the United States, we participate in a global supply chain, and the existence of a worldwide pandemic, the fear associated with COVID-19, or any, pandemic, and the reactions of governments around the world in response to COVID-19, or any, pandemic, to regulate the flow of labor and products and impede the travel of personnel, may impact our ability to conduct normal business operations, which could adversely affect our results of operations and liquidity. Disruptions to our supply chain and business operations, or to our suppliers’ or customers’ supply chains and business operations, could include disruptions from the closure of supplier and manufacturer facilities, interruptions in the supply of raw materials and components, personnel absences, or restrictions on the shipment of our or our suppliers’ or customers’ products, any of which could have adverse ripple effects on our manufacturing output and delivery schedule. Although we have implemented business continuity plans for our offices and personnel to enable continuity of service remotely, if a critical number of our employees become too ill to work, or we are not able to access a sufficient quantity of our inventory for shipment due to enforced office closures, our production ability could be materially adversely affected in a rapid manner. Similarly, if our customers experience adverse business consequences due to COVID-19, or any other, pandemic, demand for our products could also be materially adversely affected in a rapid manner. Global health concerns, such as COVID-19, could also result in social, economic, and labor instability in the countries and localities in which we or our suppliers and customers operate. Any of these uncertainties could have a material adverse effect on our business, financial condition or results of operations.

 

Comparison of the Three Months Ended SeptemberJune 30, 20192020 to the Three Months Ended SeptemberJune 30, 20182019

 

Revenue and Gross Margin:

 

 Three months ended  Three months ended 
 September 30,  June 30, 
 2019  2018  % Change  2020  2019  % Change 
Revenue:                        
Vycor Medical $301,053  $399,450   -25% $218,997  $390,627   -44%
NovaVision $45,255  $56,763   -20% $25,269  $21,275   19%
 $346,308  $456,213   -24% $244,266  $411,902   -41%
Gross Profit                        
Vycor Medical $273,146  $357,674   -24% $201,179  $355,415   -43%
NovaVision $41,635  $51,739   -20% $22,594  $20,367   11%
 $314,781  $409,413   -23% $223,773  $375,782   -40%

 

Vycor Medical recorded revenue of $301,053$218,997 from the sale of its products for the three months ended SeptemberJune 30, 2019,2020, a decrease of $98,397$171,630 over the same period in 2018. The decrease2019. Sales of VBAS devices have been significantly disrupted during the 2020 period in revenuethe US and internationally by COVID-19. Although neurosurgery is primarilynot considered an elective procedure, general hospital dislocation and diversion of resources away from non-emergency surgeries, or surgeries that can be postponed for a short period without harm, has impacted our revenues during the three months ended June 30, 2020. In addition, sales and marketing efforts by Vycor’s representatives have been disrupted or curtailed due to a large one-time international order inlockdown and social distancing, and this has hindered the 2018 period not being repeated. The US continued to experience growth,recovery of 13% compared to the same period in 2018, and other international sales tend to be more lumpy and impacted by timing differences.revenues. Gross margin of 92% and 91% was recorded for the three months ended SeptemberJune 30, 2020 and 2019, and 2018. Gross margin is affected by the revenue mix and also by manufacturing validation charges during the 2018 period.respectively.

 

NovaVision recorded revenues of $45,255$25,269 for the three months ended SeptemberJune 30, 2019, a decrease2020, an increase of $11,508$3,994 over the same period in 2018, as a result of reduced patient volumes in both the US and Europe offset by increased professional revenue in Europe.2019. Gross margin was 92%89%, compared to 91%96% for the same period in 2018.2019.

Selling, General and Administrative Expenses:

 

Selling, general and administrative expenses decreased by $7,806$83,068 to $491,339$408,488 for the three months ended SeptemberJune 30, 20192020 from $499,143$491,556 for the same period in 2018.2019. Included within Selling, General and Administrative Expenses are non-cash charges for stock 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, 2020 was $133,500, a $939 decrease from the charge in 2019 of $134,439. Also included within Selling, General and Administrative Expenses are Sales Commissions, which decreased by $28,433 from $75,035 to $46,602 in 2020, reflecting the reduced level of sales in the US due to COVID-19.

The remaining Selling, General and Administrative expenses decreased by $53,696 from $282,082 to $228,386 in 2020. Regulatory fees reduced by $17,341 reflecting the completion of the transition to a new EU Notified Body for Vycor; and patent fees reduced by $34,111 reflecting the level of patent filing activity in the 2019 period.

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 
Legal, patent, audit/accounting, regulatory $(44,971)  - 
Sales, marketing and travel  (3,985)  - 
Board, financial and scientific advisory  (5,991)  - 
Payroll  2,284  (939)
Other (premises, insurances)  (1,033)  - 
Commissions  (28,433)  - 
Total change $(82,129)  (939)

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, 2020 was $7,586 compared to $5,257 for 2019. Other Interest expense for the three months ended June 30, 2020 was $11,967 compared to $12,012 for 2019.

Comparison of the Six Months Ended June 30, 2020 to the Six Months Ended June 30, 2019

Revenue and Gross Margin:

  Six months ended 
  June 30, 
  2020  2019  % Change 
Revenue:            
Vycor Medical $526,284  $687,733   -23%
NovaVision $48,221  $50,776   -5%
  $574,505  $738,509   -22%
Gross Profit            
Vycor Medical $472,036  $622,338   -24%
NovaVision $44,682  $47,687   -6%
  $516,718  $670,025   -23%

Vycor Medical recorded revenue of $526,284 from the sale of its products for the six months ended June 30, 2020, a decrease of $161,449. Sales of VBAS devices have been significantly disrupted, particularly from March to June, in the US and internationally by COVID-19 Although neurosurgery is not considered an elective procedure, general hospital dislocation and diversion of resources away from non-emergency surgeries, or surgeries that can be postponed for a short period without harm, has impacted our revenues during the six months ended June 30, 2020. In addition, sales and marketing efforts by Vycor’s representatives have been disrupted or curtailed due to lockdown and social distancing, and this has hindered the recovery of revenues. Gross margin of 90% was recorded for the six months ended June 30, 2019 and for the same period in 2019.

NovaVision recorded revenues of $48,221 for the six months ended June 30, 2020, a decrease of $2,555 over the same period in 2019 and gross margin of 93%, compared to 94% for the same period in 2019.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses decreased by $66,990 to $833,492 for the six months ended June 30, 2020 from $900,482 for the same period in 2019. Included within Selling, General and Administrative Expenses are non-cash charges for share 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 threesix months ended SeptemberJune 30, 2019 and 20182020 was $133,500.$266,699, a decrease of $939 over $267,939 in 2019. Also included within Selling, General and Administrative Expenses are Sales Commissions, which decreased by $45,139$34,304 from $101,900$130,861 to $56,761 in 2019; this was$96,557, as a result of commissions paid to an international distributor for a large one-time orderhigher revenues in the 2018 period.US market, reflecting the reduced level of sales in the US due to COVID-19.

 

The remaining Selling, General and Administrative expenses increaseddecreased by $37,335$31,747 from $263,743$501,682 to $301,078 in 2019. The Company is in$469,935. Regulatory fees reduced by $14,596 reflecting the processcompletion of migratingthe transition to a new EU Notified Body for VBAS, with a resultant significant increase in regulatory fees for this migration during the period;Vycor; and patent fees were also higher due toreduced by $30,942 reflecting the level of patent filing of 8 new patents for VBAS.and prosecution activity in the 2019 period.

 

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

 

Cash G&ANon-Cash G&A
Regulatory56,424-
Legal, patent, audit/accounting, insurance25,947-
Sales, marketing and travel(8,524)    -
Board and Management--
Payroll(33,764)-
Other G&A, Premises(2,750)-
37,333
Commissions(45,139)-
Total change(7,806)-
  Cash G&A  Non-Cash G&A 
Legal, patent, audit/accounting, regulatory $(35,624)  - 
Sales, marketing and travel  (7,219)  - 
Board, financial and scientific advisory  (12,840)  - 
Payroll  14,615   (939)
Other (premises, insurances)  9,320   - 
Commissions  (34,303)  - 
Total change $(66,051)  (939)

 

Interest Expense:

 

Interest comprises expense on the Company’s debt and insurance policy financing. Related Party Interest expense for the threesix months ended SeptemberJune 30, 20192020 was $5,315$14,010 compared to $5,294$10,016 for 2018.2019. Other Interest income and expense for 2019 decreased by $171 to $12,109 from $12,280 for 2018.

Comparison of the Nine Months Ended September 30, 2019 to the Nine Months Ended September 30, 2018

Revenue and Gross Margin:

  Nine months ended 
  September 30, 
  2019  2018  % Change 
Revenue:            
Vycor Medical $988,786  $930,553   6%
NovaVision $138,078  $152,426   -9%
  $1,126,864  $1,082,979        4%
Gross Profit            
Vycor Medical $895,484  $821,240   9%
NovaVision $124,746  $138,609   -10%
  $1,020,230  $959,849   6%

Vycor Medical recorded revenue of $988,786 from the sale of its products for the nine months ended September 30, 2019, an increase of $58,233 over the same period in 2018. Good performance from the US (increase of 43%) and international (up 16%) was offset by two large international orders in the 2018 period which were not repeated during 2019. Gross margin of 91% was recorded for the nine months ended September 30, 2019 compared to 88% for the same period in 2018.

NovaVision recorded revenues of $138,078 for the nine months ended September 30, 2019, a decrease of $14,348 over the same period in 2018, as a result of reduced patient volumes in both the US and Europe primarily in the third quarter, offset by increased professional revenue in Europe. Gross margin of 90%, compared to 91% for the same period in 2018.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses decreased by $187,429 to $1,497,016 for the nine months ended September 30, 2019 from $1,684,445 for the same period in 2018. Included within Selling, General and Administrative Expenses are non-cash charges for share 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 nine months ended September 30, 2019 was $401,440 a decrease of $90,685 over $492,125 in 2018. Also included within Selling, General and Administrative Expenses are Sales Commissions, which decreased by $237 from $187,859 to $187,622.

The remaining Selling, General and Administrative expenses decreased by $96,507 from $1,004,461 to $907,954. The Company is in the process of migrating to a new EU Notified Body for VBAS, with a resultant significant increase in regulatory fees for this migration during the period; patent fees were also higher due to the filing of 8 new patents for VBAS.

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 
Regulatory  91,995   (4,871)
Legal, patent, audit/accounting, insurance  18,362   - 
Sales, marketing and travel  (63,664)    
Board and Management  -   (85,815)
Payroll  (138,087)    
Other G&A, Premises  (5,112)    
   (96,506)    
Commissions  (237)  - 
Total change  (96,743)  (90,686)

Interest Expense:

Interest comprises expense on the Company’s debt and insurance policy financing. Related Party Interest expense for the ninesix months ended SeptemberJune 30, 20192020 was $15,331$23,934 compared to $6,570$23,965 for 2018. Other Interest expense for 2019 decreased by $431 to $36,074 from $36,505 for 2018.2019.

Liquidity

 

The following table shows cash flow and liquidity data for the periods ended SeptemberJune 30, 20192020 and December 31, 2018:2019:

 

 September 30, 2019 December 31, 2018 $ Change  June 30, 2020  December 31, 2019  $ Change 
Cash $98,502  $86,481  $12,021  $70,994  $60,717  $10,277 
Accounts receivable, inventory and other current assets $557,471  $543,165  $14,306  $373,524  $595,715  $(222,191)
Total current liabilities $(2,352,691) $(1,812,604) $(540,087) $(2,584,440) $(2,446,406) $(138,034)
Working capital $(1,696,718) $(1,182,958) $(513,760) $(2,139,922) $(1,789,974) $(349,948)
Cash provided by/(used in) financing activities $(49,068) $221,473  $(270,541)
Cash provided by financing activities $139,772  $17,627  $122,145 

 

Operating Activities. Cash provided by/(used in)in operating activities comprises net loss adjusted for non-cash items and the effect of changes in working capital and other activities. The net repayment of normal insurance financing should also be taken into account when considering cash provided by/(used in)in operating activities.

The following table shows the principle components of cash provided by/(used in)in operating activities during the ninesix months ended SeptemberJune 30, 20192020 and 2018,2019, with a commentary of changes during the periods and known or anticipated future changes:

 

 September 30, 2019 September 30, 2018 $ Change  June 30, 2020  June 30, 2019  $ Change 
Net loss $(575,211) $(897,399) $322,188  $(423,835) $(365,602) $(58,233)
                        
Adjustments to reconcile net loss to cash used in operating activities:                        
Amortization and depreciation of assets $52,359  $136,203  $(83,844) $30,369  $30,879  $(510)
Share based compensation  401,440   492,125   (90,685)
Stock based compensation $266,999  $267,940  $(941)
Other  9,418   3,139   6,279  $6,279  $6,279  $- 
 $463,217  $631,467  $(168,250) $303,647  $305,098  $(1,451)
                        
Net loss adjusted for non-cash items $(111,994) $(265,932) $153,938  $(120,188) $(60,504) $(59,684)
Changes in working capital                        
Accounts receivable, accounts payable and accrued liabilities  120,383   (33,193)  153,576  $(23,172) $42,236  $(65,408)
Inventory  (32,914)  (7,565)  (25,349) $8,454  $(54,399) $62,853 
Prepaid expenses and net insurance financing repayments  (8,227)  6,560   (14,787) $77,131  $5,555  $71,576 
Accrued interest (not paid in cash)  51,233   42,471   8,762  $37,945  $33,820  $4,125 
Changes in discontinued operations, net $473 $5,746  $(5,273)
 $130,475  $8,273  $122,202  $100,831  $32,958  $67,873 
                        
Cash used in operating activities, adjusted for net insurance repayments $18,481  $(257,659) $276,140  $(19,357) $(27,546) $8,189 

 

The adjustments to reconcile net loss to cash of $463,217$120,187 in the period have no impact on liquidity. The decreasechange in netNet loss (as adjusted for non-cash items) by $153,938 to $111,994items of ($59,683) was primarily a resultdue to the impact of increased revenues, as well as reduced expenses. ThereCOVID-19 on the Vycor division sales. At December 31, 2019 there was a decrease in accounts receivable offset by an increase in accounts payable.payable mainly due to expenditure on regulatory and testing for the VBAS development occurring during the fourth quarter. The net change in accounts receivable, accounts payable and accrued liabilities was mainly due to the settlement of these accounts.

 

The Company is in the process of modifying the VBAS product suite to make it easier to integrate with IGS. The first phase of this project was completed in September 2017 and additionalAdditional inventory of $108,000$30,745 was purchased during the ninesix months ended SeptemberJune 30, 2019. The2020 as part of normal production, and the Company is progressing the second phase of this project and as a result anticipates purchasing additional new inventory of approximately $40,000.$80,000 during the next twelve months.

 

Investing Activities.Cash used in investing activities for the ninesix months ended SeptemberJune 30, 20192020 was $25,057,$47,406, which primarily reflected expenditure on the second phase of modifying the VBAS product suite to make it easier to integrate with IGS. The Company anticipates additional expenditures for this second phase, including work to obtain regulatory clearances and approvals, of approximately $100,000.$80,000.

Financing Activities. During the period ending Septembersix months ended June 30, 20192020 the Company received funds of $17,873$80,000 in respect of loans from Fountainhead. The Company also received a loan of $58,600 during the period, pursuant to the Paycheck Protection Program (the “PPP”) under Division A, Title I of the CARES Act,

 

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 $575,211$586,020 for the ninesix months ended SeptemberJune 30, 20192020 and has not generated sufficient positive cash flows from operations. As of SeptemberJune 30, 20192020 the Company had a working capital deficiency of $473,129,$634,822, excluding related party liabilities of $1,223,589. As a result these$1,505,100. 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 2 “Strategy”, the Company is continuing to execute on a plan to achieve revenue growth and a reduction in cash operating losses.losses2. For Vycor Medical this plan includes in particular: increasing market penetration in the US through closer cooperation with complementary product manufacturers, broadening of the distribution network and programs to increase penetration in exitingexisting hospitals; increasing international growth in territories where we are not represented or under represented; and continued new product development. The first phase of the modification of the existing VBAS product range to make it more compatible with the most common IGS systems was completed in September 2017 and has been well received by surgeons, resulting in increased hospital penetration and revenues particularly in the US. The second phase of the development of further IGS integration is in process and will then becomplete subject to regulatory clearances and approvals. Upon regulatory approvalclearances and product release of this new VBAS AC model range the Company intends to conduct a multi-center study tpto provide additional clinical data on the product. We will also be exploring with surgeons 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 that have either direct access to the end users or a desire and financial wherewithal to leverage the NovaVision therapy platform. TheAs a result, the Company has now closed the NovaVision German office and is entering into a license agreement with HelferApp, a cognitive therapy specialist, for Germany, Austria and Switzerland, and is seeking similar partnerships in the process of identifying and talkingother territories with regional companies able to such partners.leverage NovaVision’s clinically supported vision therapies. Management is determined to reduce the losses it is incurring in this division and isalso open to a broad range of alternatives for NovaVision as a whole, which could comprise distribution and marketing partnerships, licensing, merger sale and/or a significant restructuring of its activities.sale.

 

However, the Company believes it may not have sufficient cash to meet its various cash needs through November 30, 2020August 31, 2021 unless the Company is able to obtain additional cash from the issuance of debt or equity securities. Included within the working capital deficiency above is a term note for $300,000 to EuroAmerican Investment Corp. (“EuroAmerican”), together with accrued interest of $256,568,$304,699, which has a maturity date of December 31, 2019,2020, having been extended on a number of occasions from its initial due date of June 11, 2011. The Company will seek an extension to the note, althoughAt this time, it is not known whether any further extension of the note beyond December 31, 2020 will be extended or the terms of any extension.available. 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.

Critical Accounting Policies and Estimates

 

Uses of estimates in the preparation of financial statements

 

The preparation of unaudited consolidated financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the unaudited consolidated financial statements and accompanying notes. Actual results could differ from those estimated. To the extent management’s estimates prove to be incorrect, financial results for future periods may be adversely affected. Significant estimates and assumptions contained in the accompanying unaudited consolidated financial statements include management’s estimate of the allowance for uncollectible accounts receivable, amortization of intangible assets, and the fair values of options and warrant included in the determination of debt discounts and share-basedstock-based compensation.

 

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, 2018.2019.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable

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

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, as of the end of such period, the Company’s disclosure controls and procedures were effective as of that date to provide reasonable assurance that the information required to be disclosed by the Company in the reports it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC and 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. 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) and 15d-15(f) under the Exchange Act) during the fiscal quarter to which this report relates that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

(b) Changes in Internal Controls

 

There have not been any changes in the Company’s internal control over financial reporting (as such term is defined in Rules 13a-15(f) under the Exchange Act) during the fiscal period to which this report relates that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

The Company’s management, including the Company’s CEO and CFO, does not expect that the Company’s internal control over financial reporting will prevent all errors and all fraud. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree or compliance with the policies or procedures may deteriorate.

PART II

 

ITEM 1. LEGAL PROCEEDINGS

 

We are subject from time to time to litigation, claims and suits arising in the ordinary course of business. As of November 8, 2019,August 12, 2020, 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 Type Security Shares
FHC Management Fees Common 1,607,142
Robert Anderson1,071,428 Common5,000

 

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.

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 November 8, 2019.August 17, 2020.

 

 Vycor Medical, Inc.
 (Registrant)
   
 By:/s/ Peter C. Zachariou
  Peter C. Zachariou
  Chief Executive Officer and Director
(Principal Executive Officer)
   
 DateNovember 11, 2019August 17, 2020
   
 By:/s/ Adrian Liddell
  Adrian Liddell
  Chairman of the Board and Director
  (Principal Financial and Accounting Officer)
   
 DateNovember 11, 2019August 17, 2020

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