Company Quick10K Filing
Vycor Medical
Price0.14 EPS-0
Shares25 P/E-6
MCap3 P/FCF41
Net Debt-0 EBIT-1
TEV3 TEV/EBIT-6
TTM 2019-09-30, in MM, except price, ratios
10-Q 2020-09-30 Filed 2020-11-13
10-Q 2020-06-30 Filed 2020-08-17
10-Q 2020-03-31 Filed 2020-05-12
10-K 2019-12-31 Filed 2020-03-27
10-Q 2019-09-30 Filed 2019-11-12
10-Q 2019-06-30 Filed 2019-08-09
10-Q 2019-03-31 Filed 2019-05-13
10-K 2018-12-31 Filed 2019-03-29
10-Q 2018-09-30 Filed 2018-11-13
10-Q 2018-06-30 Filed 2018-08-10
10-Q 2018-03-31 Filed 2018-05-11
10-K 2017-12-31 Filed 2018-03-30
10-Q 2017-09-30 Filed 2017-11-13
10-Q 2017-06-30 Filed 2017-08-11
10-Q 2017-03-31 Filed 2017-05-11
10-K 2016-12-31 Filed 2017-03-31
10-Q 2016-09-30 Filed 2016-11-14
10-Q 2016-06-30 Filed 2016-08-09
10-Q 2016-03-31 Filed 2016-04-28
10-K 2015-12-31 Filed 2016-03-30
10-Q 2015-09-30 Filed 2015-11-13
10-Q 2015-06-30 Filed 2015-08-14
10-Q 2015-03-31 Filed 2015-05-15
10-K 2014-12-31 Filed 2015-03-31
10-Q 2014-09-30 Filed 2014-11-12
10-Q 2014-06-30 Filed 2014-08-12
10-Q 2014-03-31 Filed 2014-05-15
10-K 2013-12-31 Filed 2014-04-07
10-Q 2013-09-30 Filed 2013-11-15
10-Q 2013-06-30 Filed 2013-08-14
10-Q 2013-03-31 Filed 2013-05-15
10-K 2012-12-31 Filed 2013-04-01
10-Q 2012-09-30 Filed 2012-11-14
10-Q 2012-06-30 Filed 2012-08-14
10-Q 2012-03-31 Filed 2012-05-15
10-K 2011-12-31 Filed 2012-03-30
10-Q 2011-09-30 Filed 2011-11-14
10-Q 2011-06-30 Filed 2011-08-22
10-Q 2011-03-31 Filed 2011-05-13
10-K 2010-12-31 Filed 2011-03-31
10-Q 2010-09-30 Filed 2010-11-15
10-Q 2010-06-30 Filed 2010-08-16
10-Q 2010-03-31 Filed 2010-05-12
10-K 2009-12-31 Filed 2010-03-31
8-K 2020-06-30
8-K 2020-03-23
8-K 2019-03-29
8-K 2018-10-09
8-K 2018-03-30

VYCO 10Q Quarterly Report

Part I
Item 1. Financial Statements
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Item 4. Controls and Procedures
Part II
Item 1. Legal Proceedings
Item 1A. Risk Factors.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Item 3. Defaults Upon Senior Securities
Item 4. Mine Safety Disclosures
Item 5. Other Information
EX-31.1 d31746_ex31-1.htm
EX-31.2 d31746_ex31-2.htm
EX-32.1 d31746_ex32-1.htm
EX-32.2 d31746_ex32-2.htm

Vycor Medical Earnings 2014-09-30

Balance SheetIncome StatementCash Flow
4.93.21.6-0.1-1.7-3.42012201420172020
Assets, Equity
0.50.1-0.2-0.6-0.9-1.32012201420172020
Rev, G Profit, Net Income
3.92.91.90.8-0.2-1.22012201420172020
Ops, Inv, Fin

10-Q 1 d31746.htm 10-Q UNITED STATES

U.S. SECURITIES AND EXCHANGE COMMISSION


Washington, D. C. 20549


FORM 10-Q


(Mark One)

T

QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal quarter ended                     September 30, 2014                    


o

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

 

333-149782

 

20-3369218

(State of Incorporation)

 

(Commission File Number)

 

(IRS Employer Identification No.)


6401 Congress Ave., Suite 140, Boca Raton, FL 33487
(Address of principal executive offices) (Zip code)


Issuer’s telephone number: (561) 558-2000


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 T    No o


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 o    No o


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 o  

Accelerated filer o  

Non-accelerated filer o   (Do not check if a smaller reporting company)

Smaller reporting company T


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


There were 10,861,053 shares outstanding of registrant’s common stock, par value $0.0001 per share, as of November 10, 2014.


Transitional Small Business Disclosure Format (check one): Yes o   No T




TABLE OF CONTENTS


PART I

Item 1.

Financial Statements

 

2

 

Consolidated Balance Sheets as of September 30, 2014 (unaudited) and December 31, 2013

2

 

Unaudited Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2014 and September 30, 2013

3

 

Unaudited Consolidated Statements of Cash Flows for the nine months ended September 30, 2014 and September 30, 2013

4

 

Notes to Unaudited Consolidated Financial Statements

5

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operation

18

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

32

Item 4.

Controls and Procedures

 

32

PART II

Item 1.

Legal Proceedings

 

33

Item 1A.

Risk Factors

 

33

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

33

Item 3.

Defaults Upon Senior Securities

 

34

Item 4.

Mine Safety Disclosures

 

34

Item 5.

Other Information

 

34

Item 6.

Exhibits

 

34

 

 

 

 

SIGNATURES

 

35




1



PART I


ITEM 1. FINANCIAL STATEMENTS


VYCOR MEDICAL, INC.
Consolidated Balance Sheets

(unaudited)

       
   September 30,
2014
  December 31,
2013
ASSETS          
           
Current Assets          
Cash  $2,447,147   $31,303 
Trade accounts receivable, net of allowance for doubtful accounts of $6,152 and $6,474   151,899    212,660 
Inventory   261,549    206,926 
Prepaid expenses and other current assets   295,676    208,063 
Total Current Assets   3,156,271    658,952 
           
Fixed assets, net of accumulated depreciation of $1,010,225 and $830,291   623,006    706,197 
           
Intangible and Other assets:          
Trademarks   251,157    251,157 
Patents, net of accumulated amortization of $434,459 and $328,319   358,532    444,095 
Website, net of accumulated amortization of $19,309 and $17,228   13,441    1,680 
Security deposits   53,169    53,169 
Total Intangible and Other assets   676,299    750,101 
           
TOTAL ASSETS  $4,455,576   $2,115,250 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)          
           
Current Liabilities          
Accounts payable  $145,696   $254,024 
Accrued interest: Related Party   46,542    238,299 
Accrued interest: Other   30,783    147,985 
Accrued liabilities   352,755    1,776,867 
Other current liabilities   67,130    61,576 
Derivative liability    28,820     
Notes payable: Related Party       2,373,556 
Notes payable: Other   352,997    578,186 
TOTAL CURRENT AND TOTAL LIABILITIES   1,024,723    5,430,493 
           
STOCKHOLDERS’ EQUITY ( DEFICIENCY)          
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 235,560 and 16.2 issued and outstanding as at September 30, 2014 and December 31, 2013 respectively  $24   $1 
Common Stock, $0.0001 par value, 25,000,000 shares authorized, 10,851,263 and 6,757,225 shares issued and outstanding at September 30, 2014 and December 31, 2013 respectively   1,085    675 
Additional Paid-in Capital   23,846,183    13,762,689 
Treasury Stock (103,334 shares of Common Stock as of September 30, 2014 and December 31, 2013 respectively, at cost)   (1,033)   (1,033)
Accumulated Deficit   (20,443,931)   (17,032,405)
Accumulated Other Comprehensive Income   28,525    (45,170)
           
Total Stockholders’ Equity (Deficiency)   3,430,853    (3,315,243)
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)  $4,455,576   $2,115,250 


See accompanying notes to financial statements


2



VYCOR MEDICAL, INC.
Consolidated Statements of Comprehensive Loss
(unaudited)


             
   For the three months ended
September 30,
  For the nine months ended
September 30,
   2014  2013  2014  2013
             
             
Revenue  $334,339   $321,630   $991,001   $788,258 
                     
Cost of Goods Sold   47,340    41,806    125,980    99,718 
                     
Gross Profit   286,999    279,824    865,021    688,540 
                     
Operating expenses:                    
Research and development   6,933        59,684    52,635 
Depreciation and Amortization   93,860    90,561    286,955    266,106 
General and administrative   623,993    673,464    2,652,393    2,063,232 
                     
Total Operating expenses   724,786    764,025    2,999,032    2,381,973 
                     
Operating loss   (437,787)   (484,201)   (2,134,011)   (1,693,433)
                     
Other expense                    
Interest expense – Related Party   (13,706)   (34,081)   (80,093)   (95,859)
Interest expense -  Other   (11,169)   (14,492)   (38,844)   (42,546)
Loss on extinguishment of debt   (682,039)       (682,039)    
Loss on extension of warrants   (146,488)       (146,488)    
Change in fair value derivative liability   8,332        (261,661)    

Total Other expense

   (845,070)   (48,573)   (1,209,125)   (138,405)
                     
                     
Net Loss  $(1,282,857)  $(532,774)  $(3,343,136)  $(1,831,838)
                     
Comprehensive Income (Loss)                    

Foreign Currency Translation Adjustment

   (62,273)   25,865    (68,390)   14,431 
                     
Net Comprehensive Loss                    
   $(1,345,130)  $(506,909)  $(3,411,526)  $(1,817,407)
Loss Per Share                    
Basic and diluted  $(0.12)  $(0.08)  $(0.33)  $(0.29)
                     
Weighted Average Number of Shares Outstanding   10,735,884    6,481,138    10,106,903    6,231,218 


See accompanying notes to financial statements


3



VYCOR MEDICAL, INC.
Consolidated Statement of Cash Flows
(unaudited)


       
   For the nine months ended
September 30,
   2014  2013
Cash flows from operating activities:          
Net loss  $(3,343,136)  $(1,831,838)
Adjustments to reconcile net loss to cash used in operating activities:          
Amortization expense   107,833    97,553 
Depreciation expense   190,057    188,602 
Share based compensation expense   319,051    316,003 
Change in fair value of derivative liability   261,661     
 Loss on extinguishment of debt   682,039     
 Loss on extension of warrants   146,488     
           
Changes in assets and liabilities:          
Accounts receivable   60,761    (129,920)
Inventory   (54,623)   36,457 
Prepaid expenses   (166,576)   27,718 
Accounts payable   (108,189)   169,283 
Accrued interest: Related Party   (206,244)   95,859 
Accrued interest: Other   (102,715)   42,461 
Accrued liabilities   3,743    346,094 
Other current liabilities   5,554    (12,281)
           
Cash used in operating activities  $(2,204,296)   (654,009)
Cash flows used in investing activities:          
Purchase of fixed assets   (107,648)   (88,813)
Acquisition of subsidiary       (163,201)
Website costs   (13,842)    
Patent costs   (20,191)   (68,747)
Cash used in investing activities   (141,681)   (320,761)
Cash flows from financing activities:          
Proceeds from issuance of Common Stock   5,000,000    332,832 
Proceeds from issuance of Notes Payable: Related Party       550,744 
Proceeds from issuance of Notes Payable: Other   81,913    87,044 
Repayment of Notes Payable: Related Party   (126,519)    
Repayment of Notes Payable: Other   (198,551)   (53,035)
Cash provided by financing activities   4,756,843    917,585 
Effect of exchange rate changes on cash   4,978    (1,692)
Net increase (decrease) in cash   2,415,844    (58,877)
Cash at beginning of period   31,303    59,821 
Cash at end of period  $2,447,147   $944 
           
Supplemental Disclosures of Cash Flow information:          
Interest paid:  $430,208   $88 
           
Non-Cash Transactions:          
           
Common stock issued on conversion of Preferred C shares       $1,100,000 
           
Acquisition of subsidiary: Deferred consideration payable      $161,530 
Foreign exchange difference on deferred consideration        1,671 
        $163,201 


See accompanying notes to financial statements


4



VYCOR MEDICAL, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2014
(unaudited)


1.

BASIS OF PRESENTATION


The consolidated financial statements of the Company present the financial position, results of operations, and cash flows of Vycor Medical, Inc. and its wholly owned subsidiaries (the “Company”). All significant intercompany accounts and transactions have been eliminated. The accompanying unaudited condensed consolidated financial statements 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 10 of Regulation S-X of the Securities Exchange Commission. In accordance with those rules and regulations certain information and footnote disclosures normally included in comprehensive financial statements have been condensed or omitted pursuant to such rules and regulations. The consolidated balance sheet as of December 31, 2013 derives from the audited financial statements at that date, but does not include all the information and footnotes required by GAAP. These 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, 2013.


The condensed consolidated financial statements for the three and nine months ended September 30, 2014 and 2013, 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 and results of operations. The results of operations for the three and nine months ended September 30, 2014 and 2013 are not necessarily indicative of the results to be expected for any other interim period or for the entire year. Certain prior period amounts have been reclassified to conform to the current presentation.


2.

SIGNIFICANT ACCOUNTING POLICIES


Principles of Consolidation

The 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.


Recent Accounting Pronouncements

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 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.


Derivative Liability

The Company accounts for the 34,723 Series A Warrants issued in connection with the Offering (all as defined in Note 5), the holders of which have not waived their anti-dilution rights (as detailed further in Note 5) in accordance with the guidance contained in ASC 815-40-15-7D, whereby under that provision, because they have anti-dilution rights, they do not meet the criteria for equity treatment and must be recorded as a liability. Accordingly, the Company classifies the warrant instrument as a liability at its fair value and adjusts the instrument to fair value at each reporting period. This liability is subject to re-measurement at each balance sheet date until exercised or until the anti-dilution provisions contained within the warrant agreements expire, and is classified in the balance sheet as a current liability. Any change in fair value of the warrant liability is recognized in the Company’s statement of operations as other income (loss).


Software Development Costs

The authoritative accounting guidance requires software development costs to be capitalized upon completion of the preliminary project stage. Accordingly, direct internal and external costs associated with the development of the features and functionality of the Company’s software, incurred during the application development stage, are capitalized and amortized using the straight-line method of the estimated life of five years once the software has been brought into service. Capitalized software development costs for the nine months ended September 30, 2014 and 2013 were $100,487 and $0, respectively. During the period the Company’s VRT 7.0 program completed the preliminary project stage, following which there was a capitalization of $56,434 of software development costs. Additional costs of $21,463 were capitalized for the Company’s NeuroEyeCoach program (prior to being brought into service in March 2014 with a total capitalized value of $119,106), and $22,590 for a NeuroEyeCoach retail/physician model.


5



Net Loss Per Share

Basic net loss per share is computed by dividing net loss 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,
   2014  2013
Stock options outstanding   5,557    5,557 
Warrants to purchase common stock   5,911,715    1,413,491 
Debentures convertible into common stock   171,138    368,726 
Preferred shares convertible into common stock   1,110,438    239,265 
Total   7,198,848    2,027,039 


3.

NOTES PAYABLE


Related Party Notes Payable


As of September 30, 2014 and December 31, 2013 Related Party Notes Payable consists of:


 

 

September 30, 2014

December 31, 2013

On December 29, 2009 and February 3, 2010, the Company issued convertible debentures in the amount of $371,362 and $70,000, respectively, payable to Fountainhead Capital Management (“Fountainhead”), the beneficial owner of more than 50% of the Company’s common stock. These debentures accrue interest at a rate of 6% per annum. The Holder is entitled to convert all or any amount of the principal face amount of the debentures then outstanding into shares of common stock of the Company at the conversion price of $1.88 per share, subject to adjustment, and does not require bifurcation. These debentures were originally due August 31, 2010 and the due date was extended to January 2, 2017, subject to certain early repayment provisions. On August 5, 2014 the holder exchanged the note into Series D Convertible Preferred Stock of Vycor, see below.

  

441,362

 

 

 

 

On March 31, 2010 and October 14, 2010, the Company issued convertible debentures payable to Fountainhead in the amount of $85,000 and $90,000, respectively. These debentures accrue interest at a rate of 6%. The Holder is entitled to convert all or any amount of the principal face amount of the debentures then outstanding into shares of common stock of the Company at the conversion price of $2.63 per share, subject to adjustment and does not require bifurcation. The debentures were originally due August 31, 2011, and the due date was extended to January 2, 2017, subject to certain early repayment provisions. On August 5, 2014 the holder exchanged the note into Series D Convertible Preferred Stock of Vycor, see below.

  

175,000

 

 

 

 

On October 26, 2010 and November 15, 2010, the Company issued debentures payable to Fountainhead in the amount of $77,500 and $322,500, respectively. These debentures accrue interest at a rate of 6% per annum. These debentures were originally due August 31, 2011 and the due date was extended to January 2, 2017, subject to certain early repayment provisions. On August 5, 2014 the holder exchanged the note into Series D Convertible Preferred Stock of Vycor, see below

  

400,000

 

 

 

 





6



On November 15, 2010, the Company issued a convertible debenture in the amount of $350,000 payable to Peter Zachariou, a Director of the Company. This debenture accrues interest rate of 6% per annum. The Holder is entitled to convert all or any amount of the principal face amount of the debenture then outstanding into shares of common stock of the Company at the conversion price of $2.85 per share, subject to adjustment and does not require bifurcation. On December 20, 2010, the Company repaid $50,000 of this debenture and removed the convertible rights. The debentures were originally due December 31, 2012 and the due date was extended to January 2, 2017, subject to certain early repayment provisions. On August 5, 2014 the holder exchanged the note into Series D Convertible Preferred Stock of Vycor, see below.

  

300,000

 

 

 

 

In the period July to December 2012 the Company issued short term, unsecured notes payable to Fountainhead in the aggregate amount of $300,900. The notes accrue interest at a rate of 6% per annum, are due on demand or one year after the issue date and are junior to the secured debentures and Preferred C Stock of the Company. The due date was extended to January 2, 2017, subject to certain early repayment provisions. On August 5, 2014 the holder exchanged the note into Series D Convertible Preferred Stock of Vycor, see below.

 

300,900

 

 

 

 

In the period August to December 2012 the Company issued short term, unsecured notes payable to Peter Zachariou in the aggregate amount of $115,550. The notes accrue interest at a rate of 6% per annum, are due on demand or one year after the issue date and are junior to the secured debentures and Preferred C Stock of the Company. The due date was extended to January 2, 2017, subject to certain early repayment provisions. On August 5, 2014 the holder exchanged the note into series D convertible preferred stock of Vycor, see below.

 

115,550

 

 

 

 

In the period January to September 2013 the Company issued short term, unsecured notes payable to Fountainhead in the aggregate amount of $325,744. The notes accrue interest at a rate of 6% per annum, are due on demand or one year after the issue date and are junior to the secured debentures and Preferred C Stock of the Company. The due date was extended to January 2, 2017, subject to certain early repayment provisions. On August 5, 2014 the holder exchanged the note into Series D Convertible Preferred Stock of Vycor, see below.

 

324,225

 

 

 

 

In the period August 9 to December 2013 the Company issued short term, unsecured notes payable to Fountainhead in the aggregate amount of $91,519. The notes accrue interest at a rate of 6% per annum, are due on demand or one year after the issue date and are junior to the secured debentures and Preferred C Stock of the Company. These notes were repaid in January and February 2014.

 

91,519

 

 

 

 

In the period January to September 2013 the Company issued short term, unsecured notes payable to Peter Zachariou in the aggregate amount of $210,000. The notes accrue interest at a rate of 6% per annum, are due on demand or one year after the issue date and are junior to the secured debentures and Preferred C Stock of the Company. The due date was extended to January 2, 2017, subject to certain early repayment provisions. On August 5, 2014 the holder exchanged the note into Series D Convertible Preferred Stock of Vycor, see below.

 

190,000





7




In the period August 9 to December 2013 the Company issued short term, unsecured notes payable to Peter Zachariou in the aggregate amount of $20,000. The notes accrue interest at a rate of 6% per annum, are due on demand or one year after the issue date and are junior to the secured debentures and Preferred C Stock of the Company. This note was repaid in February 2014.

 

20,000

 

 

 

 

In the period August 9 to December 2013 the Company issued short term, unsecured notes payable to David Cantor, in the aggregate amount of $15,000. The notes accrue interest at a rate of 6% per annum, are due on demand or one year after the issue date and are junior to the secured debentures and Preferred C Stock of the Company. This note was repaid in February 2014.

 

15,000

 

 

 

 

Total Related Party Notes Payable:

 

$2,373,556


Other Notes Payable


As of September 30, 2014 and December 31, 2013 Other Notes Payable consists of:


 

 

September 30, 2014

December 31, 2013

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. In connection with the loan the Company also issued EuroAmerican warrants to purchase 400,000 shares of the Company’s common stock at an exercise price of $4.50 per share for a period of three (3) years. On June 25, 2011 the due date for this note was extended to September 25, 2011 and the Holder was granted the right to convert all or any amount of the principal face amount of the debenture then outstanding and accrued interest into shares of common stock of the Company an adjusted conversion price of $1.80 per share, subject to adjustment and does not require bifurcation. The due date for this note has been extended to January 2, 2015, subject to certain early repayment provisions.

 

300,000

300,000

 

 

 

 

In the period August to December 2012 the Company issued short term, unsecured notes payable to Craig Kirsch in the aggregate amount of $98,550. The notes accrue interest at a rate of 6% per annum, are due on demand or one year after the issue date and are junior to the secured debentures and Preferred C Stock of the Company. The due date for this note was extended to January 2, 2017, subject to certain early repayment provisions. On August 5, 2014 the holder exchanged the note into Series D Convertible Preferred Stock of Vycor, see below.

 

98,550

 

 

 

 

In September 2012 the Company issued short term, unsecured notes payable to Osbaldo Trading Limited in the amount of $42,900. The notes accrue interest at a rate of 6% per annum, are due on demand or one year after the issue date and are junior to the secured debentures and Preferred C Stock of the Company. This note was repaid in June 2014.

 

42,900

 

 

 

 

In the period September to September 2013 the Company issued short term, unsecured notes payable to Craig Kirsch in the aggregate amount of $10,000. The notes accrue interest at a rate of 6% per annum, are due on demand or one year after the issue date and are junior to the secured debentures and Preferred C Stock of the Company. The due date for this note was extended to January 2, 2017, subject to certain early repayment provisions. On August 5, 2014 the holder exchanged the note into Series D Convertible Preferred Stock of Vycor, see below.

 

10,000





8



In the period August 9 to December 2013 the Company issued short term, unsecured notes payable to Craig Kirsch in the aggregate amount of $3,000. The notes accrue interest at a rate of 6% per annum, are due on demand or one year after the issue date and are junior to the secured debentures and Preferred C Stock of the Company. These notes were repaid in February 2014.

 

3,000

 

 

 

 

On October 22, 2013 the Company issued a term note for $100,000 to EuroAmerican Investment Corp. (“EuroAmerican”). The term note bears interest at 16% per annum and was due November 30, 2013. This note was repaid in January 2014.

 

100,000

 

 

 

 

Insurance policy finance agreements. During the nine months ended September 30, 2014 the Company received proceeds from Insurance policy finance agreements of $81,913 and made repayments of $52,652

 

52,997

23,736

 

 

 

 

Total Other Notes Payable:

 

$352,997

$578,186


On August 5, 2014, the Company entered into a series of agreements with Fountainhead, along with certain other related and non-related parties (together, the “Fountainhead Parties”), to exchange all of the parties’ $2,355,587 of debt into Company Series D Convertible Preferred (“Series D”) shares of an equivalent value that are convertible into Company Common Shares at a price of $2.15. The Fountainhead Parties also received a number of warrants equivalent to 75% of the Company Common Shares issuable on conversion of the Series D, exercisable at $3.08 per share for a period of three (3) years from the date of issuance. Under Applicable Accounting Guidance ASC 405 and 470, the exchange is accounted for as an extinguishment of debt. The Company is required to compare the carrying value of the securities being extinguished with the fair value of the securities being issued in exchange. The fair values of the securities issued were determined using a variety of techniques including Black-Scholes at an aggregate of $3,037,626. The securities issued in exchange were recorded on the balance sheet at this aggregate fair value and the difference of $682,039 between fair value of the new securities and the carrying value of the extinguished securities was recognized in the income statement as a loss on extinguishment of debt.


4.

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. Set out below are the revenues, gross profits and total assets for each segment.


             
   Three Months Ended September 30,  Nine months Ended September 30,
   2014  2013  2014  2013
Revenue:                    
Vycor Medical  $243,841   $225,823   $710,743   $502,847 
NovaVision   90,498    95,807    280,258    285,411 
Total Revenue  $334,339   $321,630   $991,001   $788,258 
Gross Profit:                    
Vycor Medical  $207,827   $197,873   $618,952   $449,304 
NovaVision   79,172    81,951    246,069    239,236 
Total Gross Profit  $286,999   $279,824   $865,021   $688,540 


9



       
   September 30,
2014
  December 31,
2013
Total Assets:          
Vycor Medical  $3,236,376   $799,120 
NovaVision   1,219,200    1,316,130 
Total Assets  $4,455,576   $2,115,250 


(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,
   2014  2013  2014  2013
Revenue:                    
United States  $288,063   $257,123   $819,699   $671,430 
Europe   46,276    64,507    171,302    170,828 
Total Revenue  $334,339   $321,630   $991,001   $788,258 
Gross Profit:                    
United States  $246,755   $221,541   $712,572   $538,869 
Europe   40,244    58,283    152,449    149,671 
Total Gross Profit  $286,999   $279,824   $865,021   $688,540 



       
   September 30,
2014
  December 31,
2013
Total Assets:          
United States  $3,993,530   $1,604,142 
Europe   462,046    511,108 
Total Assets  $4,455,576   $2,115,250 


5.

EQUITY


The Offering


On January 2, January 31, February 28, March 31, and April 25, 2014 the Company completed five separate closings (the “Closings” of an offering (the “Offering”) of Units comprising shares of common stock (“Common Stock”) (collectively, the “Shares” and individually, a “Share”) and Series A and Series B Warrants (collectively, the “Warrants”) (collectively, the “Units”) to accredited investors (the “Investors”) in a private placement. The Closings comprised the sale of an aggregate of $5,000,000 in the Units), which were issued pursuant to five separate Securities Purchase Agreements between the Company and the Investors in each of the four Closings. In the aggregate, the Company issued 2,777,808 shares of Common Stock, Series A Warrants to purchase an aggregate of 1,388,919 shares of Common Stock and Series B Warrants to purchase an aggregate of 1,388,919 shares of Common Stock.


Each Unit was priced at $1.80 and comprised of one share of Common Stock, a Series A warrant (the “Series A Warrants”) and a series B warrant (the “Series B Warrants”). The Series A Warrants were detachable and were exercisable over a three-year term and were issued with respect to the purchase of a number of shares of Common Stock equal to 50% of the number of Shares purchased by such investor at an exercise price per share of $2.05. The Series B Warrants were detachable and were exercisable over a three-year term and were issued with respect to the purchase of a number of shares of Common Stock equal to 50% of the number of Shares purchased by such investor at an exercise price per share of $3.08. The Warrants are subject to adjustment for stock splits, stock dividends or recapitalizations.


10



Also on January 2, 2014, Fountainhead exchanged an aggregate of $1,426,542 of consulting fees owed to it by the Company for the Units issued in the Offering. In the aggregate, the Company issued to Fountainhead 792,523 shares of Common Stock, Series A Warrants to purchase an aggregate of 396,262 shares of Common Stock and Series B Warrants to purchase an aggregate of 396,262 shares of Common Stock.


Based on the subscription terms applicable to the holders of the Company’s previously-issued Series C Convertible Preferred Stock, such holders were given the option of exchanging their investment in such unconverted Series C Convertible Preferred Stock and the related warrants into the securities which are the subject of the Offering, based on the amount of their investment in the Series C Convertible Preferred Stock and the related warrants. On February 24, 2014, the holders of 15.15 shares of Series C Convertible Preferred Stock (representing an aggregate investment of $757,700) exchanged their Series C Convertible Preferred Stock and related warrants for an aggregate of 420,838 shares of Common Stock, Series A Warrants to purchase an aggregate of 210,419 shares of Common Stock and Series B Warrants to purchase an aggregate of 210,419 shares of Common Stock.


Under the terms of the Placement Agent agreement with Garden State Securities, Inc. (“GSS”) (see Note 9), the Company issued an aggregate of 402,033 Placement Agent Warrants, on almost identical terms to the Series A Warrants.


The Series A Warrants and Placement Agent Warrants carried anti-dilution rights (which arose in the event the Company sold securities at a price below $2.05 within one year of the date that the initial Registration Statement has been declared effective by the SEC). Effective May 15, 2014 these anti-dilution rights were waived for all but 34,723 of the Series A Warrants and for all of the Placement Agent Warrants. Accordingly, 34,723 shares of Common Stock are subject to anti-dilution and are recorded as a derivative liability in accordance with the guidance contained in ASC 815-40-15-7D (see Note 2 and Note 7)


Other Equity Transactions


During January to September 2014, the Company issued: 6,532 shares of Common Stock (valued at $15,000) to Steven Girgenti, 6,222 shares of Common Stock (valued at $15,000) to Oscar Bronsther and 5,718 shares of Common Stock (valued at $13,750) to Lowell Rush in consideration for services provided to the Board of Directors; and 2,007 shares of Common Stock (valued at $4,688) to Alvaro Pasual-Leone, 4,014 shares of Common Stock (valued at $9,375) to Josef Zihl and 1,944 shares of Common Stock (valued at $4,688) to each of Jason Barton and Jose Romano in respect of their roles as members of the NovaVision, Inc. Scientific Advisory Board.


During January to September 2014, in accordance with the terms the Consulting Agreement, the Company issued 18,988 shares of Common Stock (valued at $45,000) to Fountainhead.


During January 2014, the Company issued 3,000 and 2,000 shares of Common Stock (valued at $5,400 and $3,600) to Del Mar Consulting Group, LLC and Alex Partners respectively under the terms of their advisory amendment agreements.


On March 11, 2014 the Company entered into an Amendment Agreement with GSS. Under the Amendment Agreement, the Company agreed to issue 30,000 shares of Common Stock (valued at $66,000) on the date of the Amendment Agreement in respect of the period January to September 2014, rather than 7,500 shares per month under the original agreement.


During March 2014, in accordance with the terms of an investor relations advisory agreement, the Company issued 2,500 shares of Common Stock (valued at $4,700) to J and M Group, LLC.


During June 2014, in accordance with the terms of an investor relations advisory agreement, the Company issued 18,000 shares of Common Stock (valued at $43,020) to Hayden IR, LLC.


In August 2014, Fountainhead entered into an agreement with the Company preventing it from selling any Vycor Shares currently held by Fountainhead below $4.50. In return, the Company agreed to extend the life of certain of Fountainhead’s existing warrants expiring in 2015 to the same 3-year term as the warrants issued under the exchange of Fountainhead debt into Company Preferred Shares (see Note 3). The fair value of the extended terms was determined, using Black-Scholes, and recorded on the balance sheet, and the difference between fair value of the extended terms and of the existing terms of $146,488 was recognized in the income statement as loss on extension of warrants.


6.

SHARE-BASED COMPENSATION


Stock Option Plan

The Company adopted the Vycor Medical, Inc Employee, Director, and Consultant Stock Plan (the “Plan”) as of February 13, 2008. The Plan provides for both incentive stock options and nonqualified stock options to be granted to employees, officers, consultants, independent contractors, directors and affiliates of the Company. The board of directors establishes the terms and conditions of all


11



stock option grants, subject to the Plan and applicable provisions of the Internal Revenue Code. Incentive stock options must be granted at an exercise price not less than the fair market value of the common stock on the grant date. The options granted to participants owning more than 10% of the Company’s outstanding voting stock must be granted at an exercise price not less than 110% of the fair market value of the common stock on the grant date. The options expire on the date determined by the board of directors, but may not extend mare than 10 years from the grant date, while incentive stock options granted to participants owning more than 10% of the Company’s outstanding voting stock expire five years from the grant date. The vesting period for employees is generally over three years. The vesting Period for non-employees is determined based on the services being provided. The maximum number of shares of stock which may be delivered under the plan shall automatically increase by a number sufficient to cause the number of shares covered by the plan to equal 10% of the total number of shares of stock then outstanding on a fully diluted basis.


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 empoyee 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. No employee stock options were granted for the three- and nine-month periods ended September 30, 2014 and 2013.


Initial grants of options to purchase 500,000 shares were issued under the Plan on February 13, 2008 to each of Kenneth T. Coviello, the Company’s then Chief Executive Officer and then Heather N. Vinas, the Company’s President at an exercise price of $0.135 per share. The options vested 33-1/3% on each of the first, second, and third anniversary of the grant and expire February 12, 2018. Following Heather Vinas’ resignation as President of the Company in May 2010, 166,667 unvested options were cancelled. These options have been fully expensed.


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 September 30, 2014 there were no awards of any stock appreciation rights.


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.


The details of the outstanding rights, options and warrants and value of such rights, options and warrants are as follows:


       

STOCK WARRANTS:

  Number of shares  Weighted average
exercise price
per share
Outstanding at December 31, 2012   1,749,874   $3.03 
           
Granted        
Exercised   (341,941)   1.49 
           
Cancelled or expired   (3,334)   10.50 
           
Outstanding at December 31, 2013   1,404,599   $3.39 
           
Granted   5,226,120    2.61 
Exercised        
Cancelled or expired   (719,004)   4.46 
           
Outstanding at September 30, 2014   5,911,715   $2.57 


12



       

STOCK OPTIONS:

  Number of shares  Weighted average
exercise price
per share
Outstanding at December 31, 2012   5,557   $20.25 
           
Granted        
Exercised        
Cancelled or expired        
           
Outstanding at December 31, 2013   5,557   $20.25 
           
Granted        
Exercised        
Cancelled or expired        
           
Outstanding at September 30, 2014   5,557   $20.25 


As of September 30, 2014, the weighted-average remaining contractual life of outstanding warrants and options is 2.33 and 3.63 years, respectively.


Non-Employee Stock Compensation


During the nine months ended September 30, 2014, the Company issued an aggregate of 6,532 shares of Common Stock (valued at $15,000) to Steven Girgenti, 6,222 shares of Common Stock (valued at $15,000) to Oscar Bronsther and 5,718 shares of Common Stock (valued at $13,750) to Lowell Rush for services rendered to the board of directors. For the nine months ended September 30, 2014, a total of $43,750 was recognized as share-based compensation for the issuance of these shares.


During nine months ended September 30, 2014 the Company issued an aggregate of 2,007, 1,944 and 1,944 shares of common stock, respectively, valued at $4,688, to each of Alvaro Pascual-Leone, Jason Barton and Jose Romano and 4,014 shares of common stock valued at $9,375 to Josef Zihl for services rendered to the Scientific Advisory Board of NovaVision. For the nine months ended September 30, 2014, an aggregate of $23,438 was recognized as share-based compensation for the issuance of these shares.


In November 2013, the Company entered into three-month extension amendments to the existing agreements with Del Mar Consulting, Inc. and Alex Partners, LLC under which 33,000 and 27,000 shares of Company Common Stock respectively were issued, valued at $66,000 and $54,000 respectively. The value of these shares was amortized over the period of the agreement, and for the nine months ended September 30, 2014 stock compensation of $78,620 was recognized as share-based compensation in connection with these agreements. Under the extension agreement, the Company has the option to pay all or part of the monthly fees in cash and for January 2014 3,000 shares valued at $5,400 were issued to Del Mar and 2,000 shares valued at $3,600 were issued to Alex Partners.


On July 2, 2013, the Company entered into an advisory agreement, amended March 11, 2014 with Garden State Securities, Inc. (“GSS”) to provide certain financial advisory services to the Company. Under the terms of the advisory agreement, the Company issued 30,000 restricted shares of Company Common Stock to GSS in March 2014 valued at $66,000, which is being amortized over the six months from January 1, 2014, being the remaining term of the agreement. For the nine months ended September 30, 2014 stock compensation of $66,000 was recognized as share-based compensation in connection with this agreement.


On January 2, 2014 the Company issued warrants to Dr. Donald O’Rourke to purchase 7,000 shares of Vycor Common Stock at an exercise price of $3.08 per share, exercisable for a period of three years. The fair value of these warrants was estimated at $5,522 using Black-Scholes and the full value was recognized immediately.


On January 2, 2014 the Company and Fountainhead amended their Consulting Agreement. Under the Amendment, 18,988 shares valued at $45,000 were issued to Fountainhead in respect of fees for the nine months ended September 30, 2014.


In March 2014, the Company entered into a one-month investor relations advisory agreement with J and M Group, LLC, under which the Company issued 2,500 shares of Common Stock valued at $4,700, which was fully expensed in March 2014.


In March 2014, the Company entered into an investor relations advisory agreement with Hayden IR, LLC, under which the Company issued 18,000 shares of Common Stock valued at $43,020, which is being amortized over the six months from April to September, 2014. For the nine months ended September 30, 2014 stock compensation of $43,020 was recognized as share-based compensation in connection with this agreement.


13



Aggregate stock-based compensation expense charged to operations for stock and warrants granted to the above non-employees for the nine months ended September 30, 2014 was $319,050. As of September 30, 2014, there was $21,510 of total unrecognized compensation costs related to warrant and stock awards and non-vested options.


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 stock options or warrants meet the criteria for equity treatment and the fair value of the stock options or warrants granted is estimated at the grant date 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, using the assumptions noted in the table below. The fair value of the common stock is determined by the then-prevailing share price. Expected volatility is based on the historical volatility of a peer group of publicly traded companies.


The following assumptions were used in calculations of the Black-Scholes option pricing model for the nine months ended September 30, 2014 and 2013:


   Nine months ended September 30,
   2014  2013
Risk-free interest rates   0.78%     
Expected life   

3 years

     
Expected dividends   0%     
Expected volatility   75%     
Vycor Common Stock fair value   $2.05     


7.

FAIR VALUE MEASUREMENTS


The Company has adopted ASC 820 for its financial assets and liabilities that are re-measured and reported at fair value at each reporting period. The adoption of ASC 820 did not have an impact on the Company’s financial position or results of operations.


Under the terms of the Offering, during the period January 2 to April 25, 2014, in five separate closings, a total of 2,397,631 Series A Warrants and Placement Agent Warrants were issued as part of the Offering, which carried anti-dilution rights. Effective May 15, 2014 these anti-dilution rights were waived for all but 34,723 of the Series A Warrants and for all of the Placement Agent Warrants. The Company accounts for the Series A Warrants in accordance with the guidance contained in ASC 815-40-15-7D, whereby under that provision, because they have anti-dilution rights, they do not meet the criteria for equity treatment and must be recorded as a liability. Accordingly, the Company classifies the warrant instrument as a liability at its fair value and adjusts the instrument to fair value at each reporting period.


The following table presents information about the Company’s liabilities that are measured at fair value on a recurring basis (the Series A Warrants described above) as of September 30, 2014 and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical liabilities. Fair values determined by Level 2 inputs utilize data points that are observable such as quoted prices, interest rates and yield curves. Fair values determined by Level 3 inputs are unobservable data points for the liability, and includes situations where there is little, if any, market activity for the liability:


Description

September 30, 2014

 

Level 1

 

Level 2

 

Level 3

 

 

 

 

 

 

 

 

Warrant Liability

$28,820

 

$—

 

$—

 

$28,820


14



The table below provides a reconciliation of the beginning and ending balances for the liabilities measured using fair significant unobservable inputs (Level 3):


Balance at December 31, 2013  $ 
Issuance of Series A Warrants and Placement Agent Warrants as part of Offering Units on January 2, January 31, February 24, February 28 and March 31, April 25, 2014   2,103,195 
Change in fair value during period   261,661 
Reduction in liability from waiver of anti-dilution May 15, 2014   (2,336,036)
      
Balance at September 30, 2014  $28,820 


The fair value of the Series A Warrants and Placement Agent Warrants was determined using a Monte Carlo Simulation. This model requires the input of highly subjective assumptions, including the expected price volatility, which is based on the historical volatility of a peer group of publicly traded companies. Changes in the subjective input assumptions can materially affect the estimate of fair value of the warrants and the Company’s results of operations could be impacted.


The following assumptions were used in calculations of the Monte Carlo Simulation model for the nine months ended September 30, 2014 and 2013:


 

Nine months ended September 30,

 

2014

2013

Risk-free interest rates

0.58-0.93%

Expected life

3 years

Expected dividends

0%

Expected volatility

71–97%

Vycor Common Stock fair value

$1.88–$2.70


8.

COMMITMENTS AND CONTINGENCIES


Lease

The Company leases approximately 10,000 sq. ft located at 6401 Congress Ave., Suite 140, Boca Raton, FL 33487 from Catexor Limited Partnership for a gross rent of $14,630 plus sales tax per month. The term of the lease is 5 years and 6 months terminating July, 2017. The Company’s subsidiaries in Germany and the UK occupy properties on short term lease agreements. Rent expense for the nine months ended September 30, 2014 and 2013 were $150,300 and $146,014 respectively.


Potential German tax liability

In June 2012 the Company's German subsidiary received a preliminary assessment for Magdeburg City trade tax of approximately €75,000 (approximately $94,000). This assessment is for the 2010 fiscal year and relates to the Company's acquisition of the assets of the former NovaVision, Inc. An initial assessment for corporate tax for the same period has been preliminarily reduced to zero. The Company has not accepted this trade tax assessment and is in discussion with the relevant tax authorities with a view to its reduction. The tax authorities have agreed to suspend the assessment pending the outcome of certain court hearings, and the Company has agreed to make limited monthly payments on account. To the extent that this assessment, a higher or a reduced amount, is ultimately confirmed by the tax authorities, the Company believes it has a very strong claim against certain professional advisors which would offset the liability in full. Accordingly, the Company has made no provision for this liability for the nine months ending September 30, 2014, other than recording the monthly payments as an expense.


Potential Patent Infringement

The Company was made aware in 2012 that a competitor had been granted a patent for related technology, and appeared to be entering the market with products that infringe the Company’s own issued patent. Following investigation, the Company has taken steps to initiate an invalidation of the competitor’s patent and enforce its patent rights; in March 2014 the Patent Re-examination Board issued an Examination Decision invalidating all the claims of the competitor’s patent. The competitor has appealed but the Company is contesting the appeal and believes it has a strong case. The Company is now preparing for possible enforcement of the Company’s patent against this competitor. The Company has also been made aware that a second competitor has filed a patent application for related technology and also may be producing a product that potentially infringes the Company’s patent. The company has filed comments at the Chinese Patent Office opposing grant of this competitor’s patent application, and will continue to evaluate whether what further additional actions to take in this instance. As a general rule the Company intends to take all necessary action to protect its patent portfolio. As with all patent infringement actions, there is some risk that the accused infringer will not be found to infringe the claims, and an additional risk that the accused infringer will successfully challenge the validity of the asserted claims.


15



9.

CONSULTING AND OTHER AGREEMENTS


The Company has entered into no new consulting or other agreements during the nine months ended September 30, 2014, other than amendments to existing agreements outlined below. The following agreements remained in force during the period:


Consulting Agreement with Fountainhead


Effective as of January 2, 2014, the Company and Fountainhead amended their Consulting Agreement to extend the term of the Consulting Agreement to January 2, 2015. As of January 2014, the monthly retainer payable to Fountainhead was reduced to $10,000 per month, payable $5,000 in cash and the remainder payable in Company Common Stock at the end of each quarter until the occurrence of specified milestones.


Consulting Agreement with Del Mar Consulting Group, Inc and Alex Partners, LLC.


In November 2013, the Company entered into three-month extension amendments to the existing agreements with Del Mar Consulting, Inc. and Alex Partners, LLC under which 33,000 and 27,000 shares of Company Common Stock respectively were issued, valued at $66,000 and $54,000 respectively. These agreements expired at the end of February 2014.


Garden State Securites, Inc. (“GSS”) Advisory and Placement Agent Agreements


On July 2, 2013, the Company entered into two agreements with GSS one to provide certain financial advisory services to the Company (“Advisory Agreement”) and the other to act as placement agent for the Company (“Placement Agent Agreement”).


Under the terms of the Advisory Agreement, GSS was engaged on a non-exclusive basis to provide financial advisory services to the Company for at least ninety (90) days and thereafter until either party terminates the arrangement. Under the terms of the Advisory Agreement, as amended on March 14, 2014, the Company issued 45,000 restricted shares of Company Common Stock to the broker-dealer, 15,000 of which were issuable on the date of the execution of the Agreement and 30,000 additional shares were issued on March 11, 2014. The Agreement also called for the Company to reimburse certain out-of-pocket expenses.


Under the terms of the Placement Agent Agreement, the Company engaged GSS as its exclusive placement agent until the later of (i) 90 days from the date of execution of the Agreement or (ii) the end of the offering period of any securities financing undertaken by the Company in connection with the Placement Agent Agreement. Normal placement agents fees and expense reimbursement were payable.


Hayden IR, LLC. Investor Relations Agreement


In March 2014, the Company entered into a twelve (12) month investor relations advisory agreement, as amended (“Hayden Agreements”) in June 2014, with Hayden IR, LLC. Under the terms of Hayden Agreements, Hayden receives $8,500 in cash per month and 36,000 shares of Common Stock; 18,000 issued in June 2014 and 3,000 shares issued monthly from October 2014 of which 9,000 were issued in November 2014.


10.

RELATED PARTY TRANSACTIONS


Under the terms of the Offering, there were certain agreements with Related Parties:

(a)

Debt Amendment and Repayment. Fountainhead and Peter Zachariou agreed to extend the maturity of all of the Company’s debt obligations due to them due to as of August 9, 2013 (aggregating $2,247,037) to January 2, 2017, subject to the earlier repayment of such debt upon the occurrence of certain specified conditions. Fountainhead and Peter Zachariou further released all security interests associated with any of the obligations and agreed to forebear declaring any event of default under the obligations for a period of 24 months following the date of the Initial Closing. During January and February 2014, also under the terms of the Offering, debt obligations arising since August 9, 2013 were repaid as follows: Fountainhead - $91,519; Peter Zachariou - $20,000; David Cantor - $15,000.

(b)

Employment of Chief Executive Officer and Employment Agreements. Effective as of January 2, 2014, our board of directors appointed Peter C. Zachariou, our Executive Vice President, to the additional role as the Company’s Chief Executive Officer. Also effective as of the January 2, 2014 the Company entered into separate, but largely identical Employment Agreements with Mr. Zachariou, Adrian Liddell and David Cantor. Mr. Zachariou’s Employment Agreement commences on the Effective Date and terminates six months following the appointment of a successor Chief Executive Officer; Mr. Liddell’s Employment Agreement commences on the Effective Date and terminates upon the appointment of a successor Chief Financial Officer; and Mr. Cantor’s Employment Agreement commences on the Effective Date and terminates upon the appointment of a successor. The aforementioned Employment Agreements provide for annual compensation of $110,000, payment of which is deferred for 12 months from the


16



Effective Date and is subject to the achievement of certain enumerated milestone conditions. Each of these Employment Agreements supersede any prior employment agreements or arrangements between the respective parties.

(c)

Amendment to Consulting Agreement. Effective as of January 2, 2014, the Company and Fountainhead amended their Consulting Agreement to extend the term of the Consulting Agreement to January 2, 2015. As of January 2014, the monthly retainer payable to Fountainhead was reduced to $10,000 per month, payable $5,000 in cash and the remainder payable in Company Common Stock at the end of each quarter until the occurrence of specified milestones.

(d)

Conversion Agreement. Effective as of January 2, 2014, the Company and Fountainhead entered into a Conversion Agreement whereby Fountainhead agreed to convert all amounts accrued as of the date of the Initial Closing into an investment in that amount in the Offering. Pursuant to the terms of this agreement, Fountainhead converted $1,426,542 of accrued consulting fees into the Units.


During January to September 2014, in accordance with the terms the Consulting Agreement, the Company issued 18,988 shares of Common Stock (valued at $45,000) to Fountainhead.


During June 2014 related party accrued interest due payments were made to: Fountainhead ($202,683); Peter Zachariou, a director of the Company ($69,198); and David Cantor, a director of the Company ($247).


On August 5, 2014, the Company entered into a series of agreements with Fountainhead, along with certain other related and non-related parties (together, the “Fountainhead Parties”), to exchange all of the parties’ $2,355,587 of debt into an equivalent amount of Company preferred equity. This equity exchange will result in the Company’s Shareholders’ Equity being increased by $2,355,587, equivalent to the face amount of the exchanged debt. Under the terms of the exchange, the Fountainhead Parties received $2,355,587 of newly-issued Company Series D Convertible Preferred shares (“Series D”) that are convertible into Company Common Shares at a price of $2.15. The Series D carry a cumulative preferred dividend of 7% per annum, payable in cash or Series D at the Company’s option. On the second (2nd) anniversary of the date of issuance of the Series D, the dividend rate is increased to 12% per annum. The Company is able to redeem the Series D at par at any time, at its sole option. The Fountainhead Parties will received a number of warrants equivalent to 75% of the Company Common Shares issuable on conversion of the Series D, exercisable at $3.08 per share for a period of three (3) years from the date of issuance. If the Series D has not then been redeemed or converted within three years from date of issuance, the Fountainhead Parties will receive additional warrants equivalent to 50% of the shares of the Company Common Shares issuable on conversion of the Series D that they then hold, exercisable at the then market price.


At the same time, in a transaction not related to the aforementioned exchange of securities, Fountainhead entered into an agreement with the Company preventing Fountainhead from selling any Company Common Shares currently held by Fountainhead below $4.50 per share. In return, the Company agreed to extend the life of certain of Fountainhead’s existing warrants expiring in 2015 to the expiration date as the warrants being issued under the exchange.


During October 2014 related party accrued interest due payments were made to: Fountainhead ($34,269); and Peter Zachariou, a director of the Company ($12,642).


There were no other related party transactions during the nine months ended September 30, 2014 other than the payment or accrual of fees under the Fountainhead Consulting agreement described in Note 10 of the financial statements.


11.    SUBSEQUENT EVENTS


The Company evaluated subsequent events through the date the financial statements were issued:


During October 2014, the Company issued 1,984 shares of Common Stock (valued at $5,000) to Steven Girgenti, in consideration for services provided to the Board of Directors; and 713 and 1,427 shares of Common Stock respectively (valued at $1,563 and $3,125 respectively) to Alvaro Pascual-Leone and Josef Zihl in respect of their roles as members of the NovaVision, Inc. Scientific Advisory Board.


During October 2014, the Company entered into consulting agreements with JLS Ventures, LLC (“JLS”) and JDR Capital Partners (“JDR”) relating to implementation of the Company’s global Investor Relations and Public Relations Strategy (“IR/PR Strategy”).


JLS will perform a broad range of investor relations services for an initial term of 12 months. As consideration for the services, the Company issued 100,000 shares of Company Common Stock (valued at $196,000) on execution of the agreement; and will issue an additional 100,000 shares of Company Common Stock on each of December 31, 2014, March 31, 2015 and June 30, 2015 (the “Additional Issuances”). Each of the Additional Issuances will be made at the sole and absolute discretion of the Company, based upon the Company’s reasonable determination that it is satisfied with the performance of JLS under the agreement with respect to the IR/PR Strategy.


JDR will provide on-going services related to traditional Media and Investor Relations, development of a new media program, institutional relationships and targeted media for a term of 12 months. As consideration for the services, the Company paid JDR


17



$15,000 upon execution of the agreement and will pay JDR additional payments of $15,000 per month. The agreement may be terminated by either party on thirty (30) days notice and the Company shall only be required to make payments under the agreement through the effective date of any termination.


Pursuant to the IR/PR Strategy Statement, JLS and JDR will seek to (1) improve upon existing communication channels and (2) identify and deliver new channels for communicating with potential investors, the financial community and customers, and (3) build and disseminate the Company’s IR/PR messages.


During October 2014 accrued interest due payments were made to: Fountainhead ($34,269); and Peter Zachariou, a director of the Company ($12,642).


In November 2014, the Company issued 9.000 shares of Common Stock (valued at $19,800) to Hayden IR, under the terms of their agreement.


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”), a previous competitor to NovaVision.


2.

Overview of Business


Vycor is dedicated to providing the medical community with innovative and superior neurosurgical and neurotherapeutic solutions and operates two distinct business units within the medical industry. Vycor Medical designs, develops and markets medical devices for use in neurosurgery. NovaVision develops non-invasive, computer-based therapies for those suffering from vision loss resulting from neurological trauma.


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 42 granted patents and a further 13 pending. The Company leverages joint resources across the divisions to operate in a cost-efficient manner.


In addition to our existing products and products in development we actively seek acquisition, joint venture and in-licensing opportunities in the medical device field which we believe are complementary, can benefit from our existing infrastructure and will add shareholder value.





18



Vycor Medical


Introduction


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 13485:2003 compliant, and VBAS has U.S. FDA 510(k) clearance and CE Marking for Europe (Class III) for brain and spine surgeries, full regulatory approvals in Australia, Canada, China, Korea and Japan and is seeking or has partial regulatory approvals in Brazil, India, Russia, Taiwan and Vietnam.


Vycor Medical’s Products


VBAS


To access a surgical site in the brain, a surgeon usually needs to remove part of the skull (craniotomy) and then make an entry incision in the outer protective brain tissue (corticotomy); the soft brain tissue is then parted (retracted) to access the targeted site. The current standard of care, known as blade or ribbon retractors, utilizes a metal blade retractor to pull the tissue apart; to maintain the opening the blades are attached to a head frame and parting tension is applied to the tissue. In a typical procedure 2 or more blades are used.


Many clinical studies have shown that retractors can cause excessive pressure on brain tissues, resulting in damage and a prolonged patient recovery. The incidence of contusions (tissue injuries) or infarctions (blockage of blood supply) from brain retraction is as great as 5-10% in cranial surgeries.


Vycor’s VBAS is a significant improvement over current technologies for accessing regions within the brain. A disposable product that can be used with both endoscopic and neuro-navigation systems (IGS), the VBAS includes an introducer and working channel. Available in multiple sizes, the current series consists of 12 disposable products, offered in four different port (working channel) diameters of 12mm, 17mm, 21mm, and 28 mm and a choice of three lengths: 3cm, 5cm, and 7cm. The surgeon makes a smaller corticotomy, inserts the clear, elliptical-shaped VBAS introducer through the brain tissue, removes the introducer and is left with a clear hollow working channel to provide access to the precise location desired for surgery.


VBAS’ clinical advantages are supported by a number of leading peer-reviewed articles (see Peer Review and Other Clinical Studies). Clinical benefits cited include: minimally invasive shape and less invasive procedure; resultant reduction of pressure on the brain; improved visual field; improved working channel; and more accurate target access. Management also believes, from anecdotal surgeon feedback, that although a disposable product VBAS offers potential cost savings from shorter operating theater time and reduced post-operative recovery time.


The Market For Vycor Medical’s VBAS Product


VBAS is used for craniotomy procedures. Based on statistics from the American Association of Neurological Surgeons (AANS), management estimates 700,000 such procedures were performed in the US in 2012. Of this, management believe approximately 200,000 (28 percent) are addressable by the VBAS range currently, with another 125,000 (total of 325,000 or 46 percent) addressable by an expanded future range. Management estimates, for the global market, there exists a current addressable market of approximately 1,000,000 procedures with another 600,000 addressable by an expanded VBAS range.


Competition


The VBAS device is both a brain access system and a retractor and is therefore unique with no direct competitors. Competitive manufacturers of brain retractors include Cardinal Health (V. Mueller line), Aesculap, Integra Life Science and Codman (Division of Johnson & Johnson). Nico Corporation has a brain access device specifically designed to work with its Myriad resection and suction product.


Sales and Marketing


Domestic


According to the American Board of Neorological Surgery (ABNS), there are approximately 3,500 neurosurgeons in the US,





19



providing a well-defined target audience. Vycor Medical’s sales channels are to stocking regional distributors and direct to hospitals through independent representatives, all of whom have existing relationships with neurosurgeons and provide an experienced and efficient distribution infrastructure without the need for a large and costly dedicated Vycor regional sales team. The distributors and representatives are supported by Vycor Medical Sales, Marketing and Customer Service.


Vycor Medical has found that the learning curve is only 1-2 cases for surgeons, who like the simplicity of design and ease of use after trialing the product. However, Hospital Administration is required to approve the purchase of a new product and sometimes even a trial or evaluation of the product in the hospital by the neurosurgeon and this is one of the key barriers to the speed of adoption as this process can take between 3-6 months.


International Sales


Vycor Medical utilizes select medical device distributors with experience in neurosurgical devices in their countries or regions. Vycor Medical has regulatory approvals for VBAS in Australia, Canada, China, Europe (Class III), Korea and Japan and is seeking or has partial regulatory approvals in Russia, India, Vietnam and Taiwan with distribution agreements in place or being sought.


Peer Review and Other Clinical Studies


The publication of clinical papers in neurosurgery journals by surgeon-users of VBAS regarding their experiences with the products (peer review papers), and the publication of other clinical data, is important for the Company as it continues to evidence the clinical superiority of VBAS which in turn drives its adoption and accelerates the hospital approval process. During the last 3 years the following papers were published:


     

•     

“Usage of a Minimally Invasive Tubular Retraction System for Deep-Seated Tumors in Pediatric Patients” in Journal of Neurosurgery in May 2011: Pediatrics. Co-authors Pablo Recinos, M.D., of the Cleveland Clinic and George Jallo, M.D., of Johns Hopkins University conclude that while access to deep-seated, intra-axial tumors is challenging, the ViewSite™ tubular retractor and frameless neuro navigation facilitated the surgical approach and the combination of these technologies adds to the surgeon’s armamentarium to safely approach tumors in deep locations.

 

 

 

 

“Vycor Viewsite TC: Endoscope-guided Intraparenchimal Brain Tumor Resection,” by Daniel Prevedello, M.D., Director of the Minimally Invasive Cranial Surgery Program at the Ohio State University. Dr Prevedello reported on a case with a patient taking Avastin®, which delays surgical wound healing. He said the Viewsite TC was essential to the surgery; otherwise, no procedure could have been performed on the patient.

 

 

 

 

“Minimally Invasive Trans-Portal Resection of Deep Intracranial Lesions” in Minimally Invasive Neurosurgery, February 2011 a Johns Hopkins University paper by lead author A. Quinones Hinojosa. The authors reported a case series of 9 adult and pediatric patients with a variety of pathologies, including colloid cyst, DNET, papillary pineal tumor, anaplastic astrocytoma, toxoplasmosis and lymphoma. The locations of the lesions approached included: lateral ventricle, basal ganglia, pulvinar/posterior thalamus and insular cortex. Post-operative imaging was assessed to determine extent of resection and extent of white matter damage along the surgical trajectory. Satisfactory resection or biopsy was obtained in all patients. “VBAS lends itself well to minimally invasive microsurgical approaches and can be used in combination with modern navigational systems. The use of navigation permits not only the creation of a smaller craniotomy but also facilitates the creation of a trajectory that provides efficient and safe means for splitting white fiber tracts,” said the authors.

 

 

 

 

“Minitubular Transcortical Microsurgical Approach for Gross Total Resection of Third Ventricular Colloid Cysts: Technique and Assessment” World Neurosurgery, January 2013 Author Aaron A. Cohen-Gadol, M.D., M.Sc. Goodman Campbell Brain and Spine, Indiana University Department of Neurological Surgery, Indianapolis. The author investigated microsurgical use of tubular retractor in the resection of colloid cysts in the third ventricle. The article stated that endoscopic techniques do not allow for ambidextrous microsurgical techniques and routine gross total removal of the cysts. To facilitate the use of microsurgical techniques for complete colloid cyst removal and to simultaneously minimize the violation of healthy brain tissue when reaching these deep-seated cysts the author used a VBAS tubular retractor. A retractor with a 12mm diameter was used to access and resect colloid cysts using microsurgical techniques while preserving stereoscopic vision as an alternative to open and endoscopic surgical routes. This technique was adopted in five patients with larger than 10mm colloid cysts to allow for gross total resection of the cysts in every case without any complication. The author concluded that smaller retractor tubes may be used for resection of colloid cysts while minimizing brain retraction injury and potentially improving outcomes.

 

 

 

 

“3D Endoscope-Assisted Transcallosal Approach to the Third Ventricle Using a Minimally Invasive Tubular Retractor System – A Feasibility Study” by Alireza Shoakazemi, Alexander I. Evins, Philip E. Stieg, Antonio Bernardo Published in J Neurol Surg B 2014; 75 - A047. Weill Cornell Medical Center. Conclusion. Though some authors have advocated the benefits of retractorless microsurgical techniques in approaching the third ventricle, the use of routine retractors and their potential complications, in some





20



     

 

cases, cannot be avoided. An increased incidence of cortical damage has been reported in a rat model, wherein retractors were held in place for more than 15 minutes at a pressure of 20 mmHg. We found the interhemispheric 3D endoscope-assisted trancallosal approach through tubular retractors to be feasible for the management of pathologies of the third ventricle.

 

 

 

 

•     

“3D Endoscopic Transtubular Anterior Petrosectomy for Petroclival Meningiomas: Assessment of Resection in Varying Tumor Volumes Utilizing a Synthetic Tumor Model” Alexander I. Evins, Alireza Shoakazemi, Justin C. Burrell, Rahul Kapoor, Philip E. Stieg, Antonio Bernardo Published J Neurol Surg B 2014; 75 - A036. Weill Cornell Medical Center. Conclusion. The application of 3D endoscopic transtubular anterior transpetrosal approaches in the treatment of medium and large petroclival meningiomas is both feasible and effective. Despite the demonstrated efficacy on those tumor types, resection of specific giant petroclival meningiomas still necessitate the use of traditional skull base microsurgical techniques. Further clinical studies are necessary to determine potential clinical complications.


Manufacturing


Vycor Medical uses sub-contract manufacturers to manufacture, package, label and sterilize its products. Lacey Manufacturing Company of Bridgeport, Connecticut manufactures 6 of the VBAS 12 different sizes, is FDA-registered and meets ISO standards and certifications. C&J Industries, Meadville PA (“C&J”) manufactured the remaining 6 of the VBAS 12 different sizes. The sub-contract agreement with C&J formally expired in 2014; Vycor Medical holds sufficient inventory for its foreseeable needs and is in final discussions with a selected qualified sub-contract manufacturer to replace C&J.


Intellectual Property


Patents


Vycor Medical maintains a portfolio of patent protection on its methods and apparatus for its Brain and Spine products and technology in the form of issued patents and applications, both domestically and internationally, with a total of 9 granted and 8 pending patents.


Vycor Medical’s 9 granted patents are in the China (Brain), Hong Kong (Brain), Russia (Brain), Japan (Brain and Spine), Canada (Brain) and US (Brain (2) and Spine).


Vycor Medical’s 8 pending patents are in: Canada (Spine), Europe (Brain, Spine), India (Brain, Spine), Hong Kong (Spine), US (2 IGS Navigation).


Trademarks


VYCOR MEDICAL is a registered trademark and VIEWSITE is a common law trademark.


Vycor Growth Strategy


Vycor Medical’s growth strategy is centered around:


1.

Increasing U.S. market penetration through broader hospital coverage and targeted direct physician marketing.


Vycor Medical’s sales and marketing strategy is to penetrate a well defined target market of 3,500 neurosurgeons by trade shows, significantly increased direct marketing with VBAS samples and existing clinical data, and through its existing distributors which it is continually evaluating and upgrading as well as adding additional distributors in regions where it has little to no presence. In marketing to these hospitals and surgeons, Vycor Medical leads with those neurosurgical procedures where VBAS’ competitive advantages are most easily understood – deep seated tumors and other complicated deep procedures. The focus is both on adding new hospitals and expanding to additional surgeons in hospitals where VBAS is already approved and to expand usage to a broader range of procedures. Vycor Medical prioritizes its attention on teaching hospitals, which not only carry out more relevant procedures but also provide a natural way to drive adoption through the conversion of new surgeons.


2.

Provision of more Clinical and Scientific Data supporting the products superiority over the current standard of care blade retractors and to demonstrate the products potential for cost savings.


Clinical and scientific data (in the form of peer reviewed articles, clinical studies and other reports and case studies) are critical in driving adoption further and faster by demonstrating VBAS' superiority as a minimally invasive access system which helps VBAS move further up the hospital cost/benefit curve. To this end an animal comparative study is currently underway. This study is intended to demonstrate greater ease of access, faster surgery time and reduced tissue damage. The second area Vycor Medical will address is





21



MRI compatibility. Increasingly, intra operative MRI is increasingly being used in neurosurgery, further playing to VBAS' competitive edge over the traditional non MRI-compatible metal blade retractor. Vycor Medical intends to commission a brief technical study so that VBAS can be formally certified as MRI compatible. Vycor Medical is also aware of additional studies anticipated to be published over the next few months by the Weill Cornell Medical Center and Ohio State University, and additional studies are also anticipated to be published during 2015.


3. International Market Growth


Vycor Medical utilizes select medical device distributors with experience in neurosurgical devices in their countries or regions. In Europe, the Company currently only has a limited number of distributors and is only now turning its focus to this geographic region. VBAS has full regulatory approvals in Australia, Canada, China, Europe (EU – Class III), Korea and Japan and is seeking or has partial regulatory approvals in Brazil, India, Russia, Taiwan and Vietnam. Vycor Medical plans on focusing on the international markets and is actively pursuing new distribution agreements.


4. New Product Development


New Product Development is targeted at both driving the use of its existing VBAS product range through ancillaries that will facilitate the product’s use and through new product extensions to broaden VBAS applicability to procedures currently not addressed by the existing product line.


Vycor Medical has launched in the US a universal non-disposable extension arm to VBAS, as a result of surgeon feedback, which further increases the ease of use of its disposable VBAS product and, management believes, will augment VBAS adoption.


Vycor Medical has prototyped and is now implementing manufacturing of two new smaller VBAS devices that will facilitate endoscopic work within the ventricles including the placement of catheters. Vycor Medical developed this with a leading neurosurgeon and anticipates the product being available during 2015.


Vycor Medical is also working on a new set of VBAS devices that will be targeted at being completely compatible with selected Image Guided System pointers. Management strongly believes that the existing VBAS rigid structure lends itself well to being incorporated into the increasing trend of IGS surgery.


NovaVision, Inc.


Introduction


NovaVision provides non-invasive, computer-based vision solutions targeted at a substantial and largely un-addressed market of people who have lost their sight as a result of Stroke or Traumatic Brain Injury (neurological brain damage). NovaVision addresses a significant target market, estimated at approximately $2 billion in the U.S. and over $13 billion globally.


NovaVision has a family of therapies that both restore lost vision and address other neurologically-induced vision issues:


 

•     

Restoration of vision: NovaVision’s VRT and Sight Science’s Neuro-Eye Therapy (NeET), aim to improve visual sensitivity. VRT delivers a series of light stimuli along the border of the patient’s visual field loss. These programmed light sequences stimulate the border zone between the “seeing” and “blind” visual fields, repetitively challenging the visual cortex in the border zone with multiple stimuli over the course of time. NeET targets deep within the blind area by repeated stimulation, allowing patients to detect objects within the blind field, and is only available in the EU.

 

 

 

 

•     

Compensation and Re-training: NeuroEyeCoach™ provides a complementary therapy to VRT and NeET, which re-trains ability of a patient to move their eyes, re-integrate left and right vision and to make the most of their remaining visual field.


NovaVision operates in the US through our wholly-owned subsidiary, NovaVision, Inc., in Germany through our wholly-owned subsidiary, NovaVision GmbH and in the UK through our wholly-owned subsidiary, Sight Science Limited.


NovaVision’s VRT is the only medical device aimed at the restoration of vision for neurologically induced vision loss which has FDA 510(k) clearance to be marketed in the U.S; VRT and NeET both have CE Marking for the EU and NeuroEyeCoach™ is registered in the US as a Class I 510(k) exempt device. NovaVision has 33 granted and 5 pending patents worldwide.


22



NovaVision’s Products


VRT and NeET


VRT and NeET are aimed at those suffering from vision loss resulting from neurological trauma such as stroke and traumatic brain injury (TBI). It is estimated that approximately 20% of these patients experience a visual field deficit, reducing mobility and other activities of daily living. NovaVision’s VRT and NeET target market is this subset of patients who have suffered a visual field deficit.


Both VRT and NeET work on the basis that repeated stimulation of the blind or transition areas by either bright patches of light (VRT) or the specific spatial patterns (NeET) which can lead to increases in sensitivity of the blind areas. Patients progress after VRT appears to be initiated at the blind and sighted borders whereas NeET results in changes deep within the blind field. Both therapies are able to demonstrate improvements in both visual sensitivity and activities of daily living. The Company believes that these therapies are complementary.


VRT and NeET are patient-specific diagnostic and therapeutic platforms with extensive clinical data supporting their ability to increase a patient’s visual field. The diagnostic algorithm first maps the visual field and defines the areas of defect in patients suffering vision loss. The therapeutic algorithm is then specifically designed for each patient based upon the results of the diagnostic program and it repetitively challenges the visual cortex with thousands of stimuli over the course of time. The therapies are delivered through a computer device in the patient’s home and are generally performed over a four to six month period, twice a day for approximately an hour total, six days a week.


With VRT therapy, the patient first focuses on a fixation point on a display screen. Then, a series of light stimuli are presented along the border of the patient’s visual field loss. These programmed light sequences stimulate the border zone between the “seeing” and “blind” visual fields, repetitively challenging the visual cortex in the border zone with thousands of stimuli over the course of time. With NeET, the patient responds to the images that appear on the screen, initially in the border area of the patient’s visual field loss and over time deeper within the damaged field of vision.


Vycor acquired NovaVision at the end of 2010. While its VRT was clinically supported to be effective, was underpinned by 15 years of clinical research and 20 studies evidencing that 70% of patients benefited from the therapy further development was required in order: to ensure that all patients received benefit; to make it cost effective and affordable; and to make it scalable. As not all patients benefit from VRT, management concluded that a new complementary eye training therapy should be introduced into the NovaVision therapy suite to provide broader benefits to patients than the delivery of VRT on its own, and has recently soft-launched NeuroEyeCoach™ in the U.S.


NeuroEyeCoach™


NovaVision’s recently soft-launched NeuroEyeCoach™ in the U.S. This is also a computer based program providing eye-movement training to those who have suffered a visual field loss as a result of neurological.


The program is supported by more than four decades of scientific findings and was developed as collaboration between NovaVision and Josef Zihl, a NovaVision Scientific Advisor who is a world thought leader in saccadic training and the pioneer of this computer based training technique. The program is designed to result in a meaningful improvement in the patients visual search performance resulting in improvements in their navigation and object finding skills. Given that NeuroEyeCoach™ addresses the patients difficulty with their eye movements and their ability to integrate visual information while VRT and NeET focuses on the restoration of lost vision the two therapy types are highly complementary.


NeuroEyeCoach™ is delivered to patients’ computers in their homes and also provided as a clinic-based version to enable healthcare professionals to provide the therapy to patients under supervision. NovaVision has commenced marketing NeuroEyeCoach™ as a standalone therapy; in addition to benefitting patients in VRT’s target market, those suffering non-permanent defects or those otherwise unsuited to VRT can benefit from NeuroEyeCoach™. Upon completion of the VRT web based development it will be marketed with NeuroEyeCoach™ in one therapy suite providing broad benefits to all patients.


The Market For NovaVision’s Therapies


The market for NovaVision’s therapies comprises those suffering from vision loss resulting from neurological trauma such as Stroke and Traumatic Brain Injury (TBI). The U.S. Centers for Disease Control (CDC) estimates there are approximately 8 million Americans who have previously had a stroke incident, with 795,000 additional strokes occurring annually, of which 610,000 are new strokes and of which 480,000 survive. Additionally, approximately 5.3 million Americans live with long-term effects of a TBI. Based on the most recent published research, it is estimated that approximately 28.5% experience some visual impediment and 20.5% of these patients experience a permanent visual field deficit, reducing mobility and other activities of daily living. The target market for NeET and VRT is this 20.5% subset of patients who have suffered a permanent visual field deficit. Management estimates that the


23



addressable target market is approximately 1.9 million people in the US, approximately 1.8 million people in Europe and approximately 8.4 million people throughout the rest of the world. The market potential is further increased by the introduction of NeuroEyeCoach™ which addresses all 28.5% of patients who experience visual impediments and therefore adds an additional 1.9m people in the US and Europe and 4.5m in the rest of the world.


Competition


NovaVision provides restitution or restoration therapies (with VRT and NeET) and compensation or saccadic therapies (with NeuroEyeCoach™) for those suffering neurologically-induced vision loss. The other therapy type for this condition is substitution (optical aids such as prisms) and is not considered by NovaVision as competition.


In restitution, competition has been reduced through NovaVision’s acquisition of Sight Science and really only leaves two small companies, Teltra and Visiontrainer in Germany. Within compensation, competitors include RevitalVision, PositScience, Rehacom and NVT Systems.


Clinical Data


VRT


NovaVision has accumulated significant amounts of clinical data as a result of company-sponsored trials as well as studies conducted by independent third parties, of which some of the key findings can be summarized as:


     

•    

Approximately 70% of patients experience positive outcome reflected by an increase in their visual field and studies have indicated an average increase of 4.9 degrees (Mueller I, Mast H, Sabel BA (2007), Romano JG 2008).

 

 

 

 

Elapsed time since injury does not seem to impact VRT and NeET therapies success. Therefore, a large historical backlog of patients can potentially be treated (Romano JG, Schulz P, Kenkel S, Todd DP (2008)).

 

 

 

 

Improvements are permanent and do not appear to be age or gender dependent.

 

 

 

 

Age at the onset of the injury is not a critical factor, allowing access to the therapy by both young and older adults with brain injuries (Romano JG, Schulz P, Kenkel S, Todd DP (2008)).


NeuroEyeCoach


The PC-based treatment approach was originally developed by Prof. Zihl (1988, 1990) and has since been used with various modifications in 14 studies on a total of 591 patients with homonymous visual field loss and persistent visual disabilities.


The main outcome is a significant improvement in visual search performance accompanied by more efficient oculomotor strategies, and a reduction in visual disability as assessed with standardized questionnaires and behavioral measures. The efficacy of this treatment approach for the improvement of visual overview and visual exploration is superior to practice with reading (Schuett et al., 2012), non-specific visual training (Roth et al., 2009), standard occupational therapy (Mödden et al., 2012) or counseling with regards to coping strategies (Zihl, 2011). Importantly, time since brain injury (Zihl, 2011) and age of hemianopic patients (Schuett & Zihl, 2012) do not play a significant role for the treatment effect. In conclusion, there is convincing scientific empirical evidence for the efficacy of the visual search treatment method. It is important to note, that visual field borders did not change after the treatment, indicating that visual search training represents a compensatory technique and not a restorative approach.


Intellectual Property


Patents


NovaVision maintains a portfolio of patent protection on its methods and apparatus in the form of issued patents and applications, both domestically and internationally, with a total of 33 granted and 5 pending patents (including Sight Science).


NovaVision’s 33 granted patents are in the U.S. (13), Canada (4), Europe (7), Australia (2), China (2), Hong Kong (1), Singapore (1), India (1) and Japan (2).


NovaVision’s 5 pending patents are in Canada (1) and Europe (4).


24



Trademarks


NovaVision maintains a portfolio of registered trademarks for NOVAVISION, NOVAVISION VRT and VRT VISION RESTORATION THERAPY amongst others, both in the US and internationally.


NovaVision’s Growth Strategy


Prior to Vycor’s acquisition in late 2010, NovaVision previous management had already invested more than $50 million largely on developing the business’s core VRT therapy, gaining significant patent protection and validating the therapy through significant clinical research.


While its VRT was clinically supported to be effective, being underpinned by 15 years of clinical research and 20 studies or clinical papers evidencing that 70% of patients benefited from the therapy, further development was required in order to: ensure that all patients received a benefit; to make it cost effective and affordable; and to make it scalable.


Following the acquisition, Vycor put in place a world class Scientific Advisory Board and acquired Sight Science in the UK, NovaVision’s only sizeable competitor, thereby also gaining a highly regarded Chief Scientific Officer. Leveraging this scientific team, NovaVision’s strategy is centered around driving the adoption of its therapies, through:


·

Reduced Cost and Greater scalability; enabled by a completely new therapy delivery mechanism moving away from hardware based to an asset light software solution allowing significant cost savings, which will be passed onto the patients. This different delivery mechanism and significant business process streamlining of currently largely manual tasks will enable NovaVision to provide an affordable and much more scalable therapy and thus be in a position to service a much larger number of patients.


·

Introduction of a new therapy module into the NovaVision’s overall visual rehabilitation therapy regime that will provide additional functional benefits to patients who undergo the regime. This new therapy program, NeuroEyeCoach™, is a saccadic training program which is highly complementary to VRT and will ensure that patients will receive greater benefit from the overall NovaVision therapy regime. NeuroEyeCoach™ is internet-delivered and is targeted at the same patients as VRT. Stroke patients, in addition to losing their sight, typically also have difficulty moving their eyes and integrating visual information. These conditions lead patients to need specific re-training to make effective use of their eyes and get the most out of their remaining vision. NeuroEyeCoach™ will be sold as a standalone therapy; in addition to benefitting VRT patients, those suffering non-permanent defects or those otherwise unsuited to VRT can benefit from NeuroEyeCoach™. Upon completion of the VRT web based development it will be marketed with NeuroEyeCoach™ in one therapy suite providing broader benefit to patients.


·

New Potential Licensing model targeted at Rehabilitation Centers. Management is also in the advanced stages of exploring a licensing model under which NovaVision would license a diagnostic-only VRT device to a rehabilitation center for a monthly fee. The center, be it in-patient or out-patient, would be able to efficiently screen its patients on their own for visual field deficits. NovaVision would receive licensing fees and benefit from incremental patient flow from center referrals.


3.

Other Matters


Product Liability Insurance


We presently have Product Liability insurance for both Vycor Medical and NovaVision.


Government Regulations


We are committed to an integrated total quality management system. We believe that we have completed the necessary procedures and Vycor Medical is certified to the ISO standards expected of medical device manufacturers as follows:


ISO 13485:2003 Medical Devices — Quality Management Systems


The certification of a quality management system to ISO 13485, specifically for medical devices, is advantageous and often essential for medical companies to export their products to the global market, as well as maintain and enter into certain agreements and business growth opportunities within the U.S. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485:2003. The certification is also required for placement of branded devices into the European Union.


Vycor Medical has the following certification/licensing:

·

Fully Quality Assurance System Directive 93/42/EEC for Medical Devices, Annex II (3)

·

EC Design-Examination Certificate Directive 93/42/EEC for Medical Devices, Annex II (4)


25



·

ISO 13485.2003

Continuing Regulatory Requirements

Vycor Medical’s products have been classified as Class II products by the FDA and cleared for marketing through the 510(k) process. NovaVision’s VRT product has been cleared as a Class U product through the 510(k) while its NeuroEyeCoach product is registered as an exempt Class 1 device.


After a device is placed on the market, numerous regulatory requirements apply. These include:

quality system regulation, which requires manufacturers to follow design, testing, control, documentation and other quality assurance procedures during the manufacturing process;

labeling regulations, which prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling; and

medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur.


Failure to comply with applicable regulatory requirements, and failure to respond to requested corrective actions on an ongoing basis, can result in enforcement action by the FDA.


Medical device laws are also in effect in many of the countries outside of the United States in which we do business. These laws range from comprehensive device approval and quality system requirements for some or all of our medical device products to simple requests for product data or certifications. The number and scope of these requirements are increasing. In June 1998, the European Union Medical Device Directive became effective, and all medical devices must meet the Medical Device Directive standards and receive CE mark certification. CE mark certification involves a comprehensive Quality System program, and submission of data on a product to the Notified Body in Europe.


Vycor Medical has obtained the CE marking approval to allow for distribution of its VBAS products in Europe as a Class III device and has received HPB licensing approval for distribution in Canada. NovaVison’s VRT and Sight Science’s NeET have CE mark registrations as Class I devices in Europe. NeuroEyeCoach does not have European regulatory clearance at this time.


Employees

We currently have 17 employees.


Websites

The Company operates websites at www.vycormedical.com, www.vycorvbas.com, www.novavision.com, www.novavisionvrt.com, www.sightscience.com and www.neuroeyecoach.com.


Comparison of the Three Months Ended September 30, 2014 to the Three Months Ended September 30, 2013



Revenue and Gross Margin:


   2014  2013  %
Change
Revenue:               
Vycor Medical  $243,841   $225,823    8%
NovaVision   90,498    95,807    (6)%
Total Revenue  $334,339   $321,630    4%
                
Gross Profit               
Vycor Medical  $207,827   $197,873    5%
NovaVision   79,172    81,951    (3)%
Total Gross Profit  $286,999   $279,824    3%


Vycor Medical recorded revenue of $243,841 from the sale of its products for the three months ended September 30, 2014, an increase of $18,108 over the same period in 2013, reflecting increased activity in the US and internationally. Gross margin of 85% compared to 88%, was achieved in 2014 for the same period in 2013. Gross margin is mostly a product of sale mix between US sales through


26



distributors, US sales direct and international sales. International sales are all indirect through distributors and end-market prices internationally tend to be lower.


NovaVision recorded revenues of $90,498 for the three months ended September 30, 2014, a decrease of $5,309 over the same period in 2013, and gross margin of 87%, compared to 86% for the same period in 2013.


Operating Expenses:


Research and Development Expense:


Research and development (“R&D”) expenses were $6,933 for the three months ended September 30, 2014, as compared to $0 for the same period in 2013. The expense increase is due to costs related product development in Vycor Medical. Capitalized software development costs for the three months ended September 30, 2014 and 2013 were $45,448 and $61,167, respectively. During the period the Company’s VRT 7.0 program had additional capitalization of $31,235 of software development costs. Additional costs of $14,213 were capitalized for the Company’s NeuroEyeCoach program Pro Physician model in the three month period ended September 2014.


General and Administrative Expenses:


General and administrative expenses decreased by $49,471 to $623,993 for the three months ended September 30, 2014 from $673,464 for the same period in 2013. Included within 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 three months ended September 30, 2014 was $59,323, a decrease of $82,616 over $141,939 in 2013. Also included within General and Administrative Expenses are Sales Commissions, which increased by $33,178 to $57,160. The remaining General and Administrative expenses decreased by $33 from $507,544 to $507,511. 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
Investor relations and road show costs   26,665    (80,116)
Board, financial and scientific advisory   (83,749)   (2,500)
Payroll   45,268     
Legal, professional and other consulting   15,447     
Sales, marketing and travel   7,106     
Other   (10,770)    
Total change   (33)  $(82,616)


Other Income and Expense:


Interest Expense:


Interest comprises expense on the Company’s debt and insurance policy financing. Related Party Interest expense for the three months ended September 30, 2014 decreased by $20,375 to $13,706 from $34,081 for 2013; other Interest expense for 2014 decreased by $3,323 to $11,169 from $14,492 for 2013; these decreases were as a result of debt repayment and debt conversion into preferred shares of the Company.


Loss on Extinguishment of Debt:


On August 5, 2014, the Company entered into a series of agreements with Fountainhead, along with certain other related and non-related parties (together, the “Fountainhead Parties”), to exchange all of the parties’ $2,355,587 of debt into an equivalent amount of Company Series D Preferred shares. The Fountainhead Parties also received a number of warrants exercisable into Company Common Shares. Under Applicable Accounting Guidance ASC 405 and 470, the exchange is accounted for as an extinguishment of debt. The Company is required to compare the carrying value of the securities being extinguished with the fair value of the securities being issued in exchange. The fair values of the securities issued were determined at an aggregate of $3,037,626. The securities issued in exchange were recorded on the balance sheet at this aggregate fair value and the difference of $682,039 between fair value of the new securities and the carrying value of the extinguished securities was recognized in the statement of comprehensive loss for the three months ended September 30, 2014 as a loss on extinguishment of debt.


27



Loss on Extension of Warrants:


In August 2014, Fountainhead entered into an agreement with the Company preventing it from selling any Vycor Shares currently held by Fountainhead below $4.50. In return, the Company agreed to extend the life of certain of Fountainhead’s existing warrants. The fair value of the extended terms was determined and recorded on the balance sheet and the difference between fair value of the extended terms and of the existing terms of $146,488 was recognized in the statement of comprehensive loss for the three months ended September 30, 2014 as a loss on extension of warrants.


Change in fair value of derivative liability:


The Company accounts for the 34,723 Series A Warrants issued in connection with the Offering in accordance with the guidance contained in ASC 815-40-15-7D, whereby under that provision, because they have anti-dilution rights, they do not meet the criteria for equity treatment and must be recorded as a liability. Accordingly, the Company classifies the warrant instrument as a liability at its fair value and adjusts the instrument to fair value at each reporting period. A gain of $8,332 was recorded for the three months ended September 30, 2014.


Comparison of the Nine months Ended September 30, 2014 to the Nine months Ended September 30, 2013


Revenue and Gross Margin:


   2014  2013  %
Change
Revenue:               
Vycor Medical  $710,743   $502,847    41%
NovaVision   280,258    285,411    (2)%
Total Revenue  $991,001   $788,258    26%
                
Gross Profit               
Vycor Medical  $618,952   $449,304    38%
NovaVision   246,069    239,236    3%
Total Gross Profit  $865,021   $688,540    26%


Vycor Medical recorded revenue of $710,743 from the sale of its products for the nine months ended September 30, 2014, an increase of $207,896, over the same period in 2013, reflecting increased activity in the US and internationally. Gross margin of 87% was achieved in 2014 compared to 89% in the same period in 2013. Gross margin is mostly a product of sale mix between US sales through distributors, US sales direct and international sales. International sales are all indirect through distributors and end-market prices internationally tend to be lower.


NovaVision recorded revenues of $280,258 for the nine months ended September 30, 2014, a decrease of $5,153 over the same period in 2013, and gross margin of 88%, compared to 84% for the same period in 2013.


Operating Expenses:


Research and Development Expense:


Research and development (“R&D”) expenses were $59,684 for the nine months ended September 30, 2014, as compared to $52,635 for the same period in 2013. The expense relates to product development in Vycor Medical. Capitalized software development costs for the nine months ended September 30, 2014 and 2013 were $100,487 and $61,167, respectively. During the period the Company’s VRT 7.0 program completed the preliminary project stage, following which there was a capitalization of $56,434 of software development costs. Costs of $44,053 were capitalized for the Company’s NeuroEyeCoach program and the NeuroEyeCoach Pro Physician Model during the period.


General and Administrative Expenses:


General and administrative expenses increased by $589,160 to $2,652,392 for the nine months ended September 30, 2014 from $2,063,232 for the same period in 2013. Included within 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


28



Company over various periods. The charge for the nine months ended September 30, 2014 was $319,050, an increase of $3,047 over $316,003 in 2013. Also included within General and Administrative Expenses are Sales Commissions, which increased by $82,830 to $162,333. The remaining General and Administrative expenses increased by $503,283 from $1,667,727 to $2,171,010, of which the Offering costs comprised $581,702.


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
Offering costs  $581,702   $ 
Investor relations and road show costs   35,020    (97,538)
Board, financial and scientific advisory   (310,750)   100,585 
Legal, professional and other consulting   70,839     
Sales, marketing and travel   22,384     
Payroll   92,750     
Other   11,338     
Total change  $503,283   $3,047 


Other Income and Expense:


Interest Expense:


Interest comprises expense on the Company’s debt and insurance policy financing. Related Party Interest expense for the nine months ended September 30, 2014 decreased by $15,766 to $80,093 from $95,859 for 2013; Other Interest expense for 2014 decreased by $3,702 to $38,844 from $42,546 for 2013; these decreases were as a result of debt repayment and debt conversion into preferred shares of the Company.


Loss on Extinguishment of Debt:


On August 5, 2014, the Company entered into a series of agreements with the Fountainhead Parties, to exchange all of the parties’ $2,355,587 of debt into an equivalent amount of Company Series D Preferred shares. The Fountainhead Parties also received a number of warrants exercisable into Company Common Shares. Under Applicable Accounting Guidance ASC 405 and 470, the exchange is accounted for as an extinguishment of debt. The Company is required to compare the carrying value of the securities being extinguished with the fair value of the securities being issued in exchange. The fair values of the securities issued were determined at an aggregate of $3,037,626. The securities issued in exchange were recorded on the balance sheet at this aggregate fair value and the difference of $682,039 between fair value of the new securities and the carrying value of the extinguished securities was recognized in the statement of comprehensive loss for the nine months ended September 30, 2014 as a loss on extinguishment of debt.


Loss on Extension of Warrants:


In August 2014, Fountainhead entered into an agreement with the Company preventing it from selling any Vycor Shares currently held by Fountainhead below $4.50. In return, the Company agreed to extend the life of certain of Fountainhead’s existing warrants. The fair value of the extended terms was determined and recorded on the balance sheet and the difference between fair value of the extended terms and of the existing terms of $146,488 was recognized in the statement of comprehensive loss for the nine months ended September 30, 2014 as a loss on extension of warrants.


Change in fair value of derivative liability:


The Company accounts for the 34,723 Series A Warrants issued in connection with the Offering in accordance with the guidance contained in ASC 815-40-15-7D, whereby under that provision, because they have anti-dilution rights, they do not meet the criteria for equity treatment and must be recorded as a liability. Accordingly, the Company classifies the warrant instrument as a liability at its fair value and adjusts the instrument to fair value at each reporting period. A loss of $261,661 was recorded for the nine months ended September 30, 2014.


Liquidity and Capital Resources


Liquidity


The following table shows cash flow and liquidity data for the periods ended September 30, 2014 and December 31, 2013:


29



          
   September 30, 2014  December 31, 2013  $ Change
Cash  $2,447,147   $31,303   $2,415,844 
Accounts receivable, inventory and other current assets  $709,124   $627,649   $81,475 
Total current liabilities  $(1,024,723)  $(5,430,493)  $4,405,770 
Working capital/(deficit), excluding derivative liability  $2,160,368   $(4,771,541)  $6,931,908 
Cash provided by financing activities  $4,756,843   $1,089,071   $3,667,772 


In January to April 2014 the Company held five separate closings (the “Closings”) of the sale of $4,070,140 in Units (the “Units”) comprising shares of common stock (“Common Stock”) and Series A and Series B Warrants (collectively, the “Warrants”) to accredited investors (the “Investors”) in a continuing offering (the “Offering”) which allowed for maximum proceeds of $5,000,000. These Closings raised net proceeds, after expenses, of $4,472,841.


On August 5, 2014, the Company entered into a series of agreements with the Fountainhead Parties, to exchange all of the parties’ $2,355,587 of debt into Company Series D Convertible Preferred shares of equivalent value. The net impact of this transaction was to reduce debt by $2,355,587 and increase Stockholders’ Equity by the equivalent amount.


As of September 30, 2014 we had $2,447,147 cash, working capital of $2,160,368 (before taking into account the derivative liability of $28,820) and an accumulated deficit of $(20,443,931). Total Stockholders’ equity at September 30, 2014 was $3,430,853. Total current debt at September 2014, included in working capital above, was $352,997.


Critical Accounting Policies and Estimates


Uses of estimates in the preparation of financial statements


The preparation of consolidated financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the 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 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 based compensation.


Research and Development


The Company expenses all research and development costs as incurred.


Cash and cash equivalents


The Company maintains cash balances at various financial institutions. Accounts at each institution are insured by the Federal Deposit Insurance Corporation up to $250,000. Cash balances may at times exceed the FDIC insured limits. Cash also includes a US investment account in a money market backed by government securities up to 105% of the account balance. The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Included within cash are deposits paid by patients, held by the Company until the patient returns the VRT device at the end of therapy. At September 30, 2014 and December 31, 2013 patient deposits amounted to $34,217 and $25,467, respectively, and are reserved against in Other Current Liabilities


Property and equipment


Property and equipment are stated at cost less accumulated depreciation. Depreciation is provided for on a straight-line basis over the useful lives of the assets. Expenditures for additions and improvements are capitalized; repairs and maintenance are expensed as incurred.


Income taxes


The Company accounts for income taxes in accordance with the current authoritative guidance. Deferred income tax assets and liabilities are determined based upon differences between financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are established, when it is more likely than not that such benefit will not be realized.


30



Patents and Other Intangible Assets


The Company capitalizes legal and related costs associated with the establishment and enhancement of patents for its products once patents have been applied for. Costs associated with the development of the patented item or processes are charged to research and development costs and expensed as incurred. The capitalized costs are amortized over the life of the patent. The Company reviews intangible assets on an annual in accordance with the authoritative guidance. Trademarks have an indefinite life and are also reviewed annually by management for impairment in accordance with the authoritative guidance.


Revenue Recognition


Vycor Medical generates revenue from the sale of its surgical access system to hospitals and other medical professionals. Vycor Medical records revenue when a completed contract for the sale exists, the product is invoiced and shipped to the customer. Vycor Medical does provide for product returns or warranty costs.


NovaVision generates revenues from various programs, therapy services and other sources such as government grants. Therapy services revenues represent fees from NovaVision’s vision restoration therapy software, diagnostic software, medical devices, clinic set up and training fees, and the professional and support services associated with the therapy. NovaVision recognizes revenue for providing the vision restoration therapy as the Company’s work effort is expended. NovaVision provides vision restoration therapy directly to patients. The typical vision restoration therapy consists of six modules, performed on average over 6 months in the U.S. and 10 months in Germany. A patient contract comprise set-up fees and monthly therapy fees. Set-up fees are recognized at the outset of the contract and therapy revenue is recognized ratably over the therapy period. Patient therapy is restricted to being completed by a patient within a specified time frame.


Deferred revenue results from patients paying for the therapy in advance of receiving the therapy.


Accounts Receivable and Allowance for Doubtful Accounts Receivable


We have a policy of reserving for uncollectible accounts based on our best estimate of the amount of probable credit losses in our existing accounts receivable. We extend credit to our customers based on an evaluation of their financial condition and other factors. We generally do not require collateral or other security to support accounts receivable. We perform ongoing credit evaluations of our customers and maintain an allowance for potential bad debts if required. We determine whether an allowance for doubtful accounts is required by evaluating specific accounts where information indicates the customers may have an inability to meet financial obligations. In these cases, we use assumptions and judgment, based on the best available facts and circumstances, to record a specific allowance for those customers against amounts due to reduce the receivable to the amount expected to be collected. These specific allowances are re-evaluated and adjusted as additional information is received. The amounts calculated are analyzed to determine the total amount of the allowance. We may also record a general allowance as necessary. Direct write-offs are taken in the period when we have exhausted our efforts to collect overdue and unpaid receivables or otherwise evaluate other circumstances that indicate that we should abandon such efforts.


Inventory


Inventories are stated at average cost, determined by using the weighted average cost method, and net realizable value. Net realizable value is the estimated selling price, in the ordinary course of business, less estimated costs to complete and dispose of the product.


If the Company identifies excess, obsolete or unsalable items, its inventories are written down to their realizable value in the period in which the impairment is first identified. Shipping and handling costs incurred for inventory purchases and product shipments are recorded in cost of sales in the Company's consolidated statements of operations.


Foreign Currency


The Euro is the local currency of the country in which NovaVision GmbH conducts its operations and is considered the functional currency of this entity; the GB Pound is the local currency of the country in which Sight Science Limited conducts its operations and is considered the functional currency of this entity. All balance sheet amounts are translated to U.S. dollars using the U.S. exchange rate at the balance sheet date except for the equity section which is translated at historical rates. Operating statement amounts are translated using an average exchange rate for the period of operations. Foreign currency translation effects are accumulated as part of the accumulated other comprehensive income (loss) and included in shareholders’ (deficit) in the accompanying Consolidated Balance Sheet.


31



Educational marketing and advertising expenses


The Company may incur costs for the education of customers on the uses and benefits of its products. The Company will include education, marketing and advertising expense as a component of selling, general and administrative costs as such costs are incurred.


ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK


Not applicable


ITEM 4. CONTROLS AND PROCEDURES


(a)

Disclosure Controls and Procedures


We are required to maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission's rules and forms, and that such information is accumulated and communicated to our management, including our chief executive officer (also our principal executive officer) and our chief financial officer (also our principal financial and accounting officer) to allow for timely decisions regarding required disclosure.


The Company’s management, including our Chief Executive Officer (“CEO”) and our Chief Financial Officer (“CFO”), have evaluated the effectiveness of our “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, or the Exchange Act), as of the end of the period covered by this report. Based on such evaluation, our CEO and our CFO have concluded that, 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.


(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.


32



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 10, 2014, 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


The Offering

On January 2, January 31, February 28, March 31, and April 25, 2014 the Company completed five separate closings (the “Closings” of an offering (the “Offering”) of Units comprising shares of common stock (“Common Stock”) (collectively, the “Shares” and individually, a “Share”) and Series A and Series B Warrants (collectively, the “Warrants”) (collectively, the “Units”) to accredited investors (the “Investors”) in a private placement. The Closings comprised the sale of an aggregate of $5,000,000 in the Units), which were issued pursuant to five separate Securities Purchase Agreements between the Company and the Investors in each of the four Closings. In the aggregate, the Company issued 2,777,808 shares of Common Stock, Series A Warrants to purchase an aggregate of 1,388,919 shares of Common Stock and Series B Warrants to purchase an aggregate of 1,388,919 shares of Common Stock.


Each Unit was priced at $1.80 and comprised of one share of Common Stock, a Series A warrant (the “Series A Warrants”) and a series B warrant (the “Series B Warrants”). The Series A Warrants were detachable and were exercisable over a three-year term and were issued with respect to the purchase of a number of shares of Common Stock equal to 50% of the number of Shares purchased by such investor at an exercise price per share of $2.05. The Series B Warrants were detachable and were exercisable over a three-year term and were issued with respect to the purchase of a number of shares of Common Stock equal to 50% of the number of Shares purchased by such investor at an exercise price per share of $3.08. The Warrants are subject to adjustment for stock splits, stock dividends or recapitalizations.


Also on January 2, 2014, Fountainhead exchanged an aggregate of $1,426,542 of consulting fees owed to it by the Company for the Units issued in the Offering. In the aggregate, the Company issued to Fountainhead 792,523 shares of Common Stock, Series A Warrants to purchase an aggregate of 396,262 shares of Common Stock and Series B Warrants to purchase an aggregate of 396,262 shares of Common Stock.


Based on the subscription terms applicable to the holders of the Company’s previously-issued Series C Convertible Preferred Stock, such holders were given the option of exchanging their investment in such unconverted Series C Convertible Preferred Stock and the related warrants into the securities which are the subject of the Offering, based on the amount of their investment in the Series C Convertible Preferred Stock and the related warrants. On February 24, 2014, the holders of 15.15 shares of Series C Convertible Preferred Stock (representing an aggregate investment of $757,700) exchanged their Series C Convertible Preferred Stock and related warrants for an aggregate of 420,838 shares of Common Stock, Series A Warrants to purchase an aggregate of 210,419 shares of Common Stock and Series B Warrants to purchase an aggregate of 210,419 shares of Common Stock.


Under the terms of the Placement Agent agreement with Garden State Securities, Inc. (“GSS”) (see Note 10), the Company issued an aggregate of 402,033 Placement Agent Warrants, on almost identical terms to the Series A Warrants.


Other Equity Transactions

During January to September 2014, the Company issued: 6,532 shares of Common Stock (valued at $15,000) to Steven Girgenti, 6,222 shares of Common Stock (valued at $15,000) to Oscar Bronsther and 5,718 shares of Common Stock (valued at $13,750) to Lowell Rush in consideration for services provided to the Board of Directors; and 2,007 shares of Common Stock (valued at $4,688) to Alvaro Pasual-Leone, 4,014 shares of Common Stock (valued at $9,375) to Josef Zihl and 1,944 shares of Common Stock (valued at $4,688) to each of Jason Barton and Jose Romano in respect of their roles as members of the NovaVision, Inc. Scientific Advisory Board.


During January to September 2014, in accordance with the terms the Consulting Agreement, the Company issued 18,988 shares of Common Stock (valued at $45,000) to Fountainhead.


During January 2014, the Company issued 3,000 and 2,000 shares of Common Stock (valued at $5,400 and $3,600) to Del Mar Consulting Group, LLC and Alex Partners respectively under the terms of their advisory amendment agreements.


33



On March 11, 2014 the Company entered into an Amendment Agreement with GSS. Under the Amendment Agreement, the Company agreed to issue 30,000 shares of Common Stock (valued at $66,000) on the date of the Amendment Agreement in respect of the period January to September 2014, rather than 7,500 shares per month under the original agreement.


During March 2014, in accordance with the terms of an investor relations advisory agreement, the Company issued 2,500 shares of Common Stock (valued at $4,700) to J and M Group, LLC.


During June 2014, in accordance with the terms of an investor relations advisory agreement, the Company issued 18,000 shares of Common Stock (valued at $43,020) to Hayden IR, LLC.



ITEM 3. DEFAULTS UPON SENIOR SECURITIES


None.


ITEM 4. MINE SAFETY DISCLOSURES


Not applicable.


ITEM 5. OTHER INFORMATION


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.


34



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 12, 2014.


 

 

 

VYCOR MEDICAL, INC.

 

 

 

 

By:

/s/ Peter C. Zachariou

 

 

Peter C. Zachariou

 

 

Chief Executive Officer and

 

 

Director (Principal Executive Officer)

 

 

 

 

By:

/s/ Adrian C. Liddell

 

 

Adrian C. Liddell

 

 

Chairman of the Board and

 

 

Director (Principal Financial Officer)

 

 

 

 

 

 


35