-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, J0zCVEacXjeVrfTViXh1wYKCgV9rADa1Rk+7giHn9vDsegcpwNCnCZ+jHMwXu72D KoB5Y51NVAJS7HGVrtpjVw== 0001062993-09-001989.txt : 20090601 0001062993-09-001989.hdr.sgml : 20090601 20090601133236 ACCESSION NUMBER: 0001062993-09-001989 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 8 CONFORMED PERIOD OF REPORT: 20090331 FILED AS OF DATE: 20090601 DATE AS OF CHANGE: 20090601 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEOVASC INC CENTRAL INDEX KEY: 0001399708 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-53363 FILM NUMBER: 09864426 BUSINESS ADDRESS: STREET 1: 2135 13700 Mayfield place CITY: RICHMOND STATE: A1 ZIP: 00000 BUSINESS PHONE: 604-270-4344 MAIL ADDRESS: STREET 1: 2135 13700 Mayfield place CITY: RICHMOND STATE: A1 ZIP: 00000 FORMER COMPANY: FORMER CONFORMED NAME: Medical Ventures Corp DATE OF NAME CHANGE: 20070516 6-K 1 form6k.htm REPORT OF FOREIGN PRIVATE ISSUER Filed by sedaredgar.com - NEOVASC INC. - Form 6-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of June, 2009

Commission File Number: 000-53363

NEOVASC INC.
(Exact name of Registrant as specified in its charter)

Suite 2135 - 13700 Mayfield Place
Richmond, British Columbia, Canada, V6V 2E4

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

[ x ] Form 20-F   [           ] Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): [           ]

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): [           ]

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes [           ] No [ x ]

If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _________


SUBMITTED HEREWITH

Exhibits

  99.1 Interim Financial Statements for the Period ended March 31, 2009
     
  99.2 Management's Discussion and Analysis for the Period ended March 31, 2009
     
  99.3 Form 52-109FV1 - Certification of interim filings - venture issuer basic certificate - CEO
     
  99.4 Form 52-109FV1 - Certification of interim filings - venture issuer basic certificate - CFO
     
  99.5 News Release Dated June 1, 2009

 


SIGNATURES

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

  NEOVASC INC.
  (Registrant)
     
Date: June 1, 2009 By: /s/ Alexei Marko
    Alexei Marko
     
  Title: Chief Executive Officer

 


EX-99.1 2 exhibit99-1.htm INTERIM FINANCIAL STATEMENTS FOR THE PERIOD ENDED MARCH 31, 2009 Filed by sedaredgar.com - Neovasc Inc. - Exhibit 99.1


Neovasc Inc.
(Formerly Medical Ventures Corp.)
UNAUDITED CONSOLIDATED
FINANCIAL STATEMENTS

FOR THE THREE MONTHS ENDED
MARCH 31, 2009 AND 2008

(Expressed in Canadian Dollars)


CONTENTS

 

  Page
   
Notice of No Auditor Review of Interim Financial Statements 1
   
Interim Consolidated Balance Sheets 2
   
Interim Consolidated Statements of Operations, Comprehensive Loss and Deficit 3
   
Interim Consolidated Statements of Cash Flows 4
   
Notes to the Consolidated Financial Statements 5 – 14


NEOVASC INC. (Formerly Medical Ventures Corp.)

 

Notice of No Auditor Review of Interim Financial Statements

Under National Instrument 51-102, Part 4, subsection 4.3(3)(a), if an auditor has not performed a review of the Interim Financial Statements, they must be accompanied by a notice that the financial statements had not been reviewed by an auditor.

The accompanying Unaudited Interim Consolidated Financial Statements of the Company have been prepared by management and approved by the Audit Committee and Board of Directors of the Company.

The Company’s independent auditors have not performed a review of these Interim Consolidated Financial Statements in accordance with the standards established by the Canadian Institute of Chartered Accountants for a review of Interim Financial Statements by an entity’s auditors.

1


NEOVASC INC. (Formerly Medical Ventures Corp.)
Interim Consolidated Balance Sheets

    March 31,     December 31,  
    2009     2008  
    (Unaudited)        
 ASSETS            
             
 CURRENT            
       Cash and cash equivalents $  972,510   $  2,498,439  
       Accounts receivable   335,694     470,200  
       Inventory (Note 6)   490,176     341,564  
       Prepaid expenses   58,635     52,356  
    1,857,015     3,362,559  
 RESTRICTED CASH AND CASH EQUIVALENTS (Note 9)   50,000     50,000  
 RETIREMENT ASSETS (Note 7)   8,320     8,320  
 PROPERTY AND EQUIPMENT (Note 8)   1,375,259     1,399,644  
  $  3,290,594   $  4,820,523  
             
 LIABILITIES            
             
 CURRENT            
       Accounts payable and accrued liabilities $  1,352,140   $  1,218,405  
       Current portion of long-term debt   20,979     20,635  
       Current portion of repayable contribution agreement   -     -  
    1,373,119     1,239,040  
 LONG-TERM DEBT (Note 9)   413,237     418,612  
 RETIREMENT LIABILITIES (Note 7)   8,964     8,964  
    1,795,320     1,666,616  
             
 SHAREHOLDERS’ EQUITY            
             
 Share capital (Note 11)   58,608,621     58,607,066  
 Contributed surplus (Note 11)   4,522,856     4,436,804  
 Deficit   (61,636,203 )   (59,889,963 )
    1,495,274     3,153,907  
  $  3,290,594   $  4,820,523  
             
CONTINUING OPERATIONS (Note 2)            
SUBSEQUENT EVENTS (Note 15)            

APPROVED BY THE DIRECTORS:

(Signed) Alexei Marko  
Alexei Marko, Director  
   
(Signed) Steven Rubin  
Steven Rubin, Director  

See accompanying Notes to the Audited Consolidated Financial Statements

2


NEOVASC INC. (Formerly Medical Ventures Corp.)
Interim Consolidated Statements of Operations, Comprehensive Loss and Deficit
For the three months ended March 31

    2009     2008  
    (Unaudited)     (Unaudited)  
SALES (Note 13)            
   Product sales $  298,630   $  404,863  
   Consulting services   56,854     28,622  
    355,484     433,485  
COST OF GOODS SOLD            
   including underutilized capacity of $13,958 (2008: $12,579)   149,760     208,260  
GROSS PROFIT   205,724     225,225  
             
EXPENSES            
   Selling   302,885     749,504  
   General and administration   750,829     538,285  
   Product development and clinical trials   876,780     621,745  
   Amortization   32,356     45,766  
    1,962,850     1,955,300  
LOSS BEFORE OTHER            
   INCOME (EXPENSES)   (1,757,126 )   (1,730,075 )
OTHER INCOME (EXPENSES)            
   Interest income   9,621     9,095  
   Interest on long-term debt   (7,253 )   (7,514 )
   Accreted interest on repayable contibution agreement (Note 10)   -     (3,839 )
   Gain (Loss) on foreign exchange   8,518     (9,242 )
    10,886     (11,500 )
NET LOSS AND COMPREHENSIVE            
   LOSS FOR THE YEAR   (1,746,240 )   (1,741,575 )
DEFICIT, BEGINNING OF YEAR   (59,889,963 )   (25,630,398 )
DEFICIT, END OF YEAR $  (61,636,203 ) $  (27,371,973 )
             
BASIC AND DILUTED            
LOSS PER SHARE $  (0.10 ) $  (0.31 )
             
WEIGHTED AVERAGE NUMBER OF            
   COMMON SHARES OUTSTANDING   17,756,951     5,560,477  
WEIGHTED AVERAGE NUMBER OF            
   FULLY DILUTED SHARES OUTSTANDING   18,132,559     5,560,477  

See accompanying Notes to the Audited Consolidated Financial Statements

3


NEOVASC INC. (Formerly Medical Ventures Corp.)
Interim Consolidated Statements of Cash Flows
For the three months ended March 31

    2009     2008  
    (Unaudited)     (Unaudited)  
OPERATING ACTIVITIES            
   Net loss for the period   (1,746,240 )   (1,741,575 )
   Items not affecting cash            
         Amortization   32,356     45,766  
         Accreted Interest on repayable contribution agreement (Note 10)   -     3,839  
         Stock-based compensation   86,052     13,283  
    (1,627,832 )   (1,678,687 )
   Change in non-cash operating assets and liabilities            
         Accounts receivable   134,506     190,081  
         Inventory   (148,612 )   (169,160 )
         Prepaid expenses and other assets   (6,279 )   (129,145 )
         Retirement assets   -     -  
         Accounts payable and accrued liabilities   133,735     (12,900 )
         Retirement liabilities   -     -  
    (1,514,482 )   (1,799,811 )
INVESTING ACTIVITY            
   Purchase of property and equipment   (7,971 )   (7,182 )
    (7,971 )   (7,182 )
FINANCING ACTIVITIES            
   Repayment of long-term debt   (5,031 )   (4,770 )
   Repayment of repayable contribution agreement   -     (1,728 )
   Proceeds from exercise of stock options   1,555     -  
    (3,476 )   (6,498 )
(DECREASE)/INCREASE IN CASH   (1,525,929 )   (1,813,491 )
CASH AND CASH EQUIVALENTS,            
   BEGINNING OF YEAR   2,498,439     3,242,404  
   END OF YEAR $  972,510   $  1,428,913  
             
REPRESENTED BY:            
 (Bank overdraft)/cash   (33,120 )   (72,753 )
 Cashable guaranteed investment certificates   1,005,630     1,501,666  
  $  972,510   $  1,428,913  
SUPPLEMENTAL CASH FLOW INFORMATION            
   Interest paid   7,253   $  7,514  

See accompanying Notes to the Audited Consolidated Financial Statements

4



NEOVASC INC. (Formerly Medical Ventures Corp.)
Notes to the Consolidated Financial Statements
For the three months ended March 31, 2009 and 2008

1.

INCORPORATION AND NATURE OF BUSINESS

   

The Company was incorporated as Medical Ventures Corp. under the Company Act (British Columbia) on November 2, 2000 and was continued under the Canada Business Corporations Act on April 19, 2002. On July 1, 2008, the Company changed its name to Neovasc Inc. (“Neovasc” or the “Company”). Neovasc develops, manufactures and distributes medical devices.

   

The Company’s commercialized products include products using a pericardial tissue processing technology to produce a number of patch products used in cardiac reconstruction and repair, as well as a catheter- based technology called the Metricath System.

   
2.

CONTINUING OPERATIONS

   

These interim unaudited consolidated financial statements have been prepared in accordance with Canadian generally accepted accounting principles on a basis consistent with the Company’s financial statements for the year ended December 31, 2008. These interim unaudited consolidated financial statements should be read together with the audited consolidated financial statements of the Company as at December 31, 2008 and the accompanying notes included in those financial statements. For a full description of accounting policies, refer to the Company’s Annual Report for the year ended December 31, 2008. As permitted by Canadian generally accepted accounting principles certain information and footnote disclosure normally included in annual consolidated financial statements has been condensed or omitted. In the opinion of management, all adjustments necessary to present fairly the financial condition, results of operations and cash flows at March 31, 2009 and for all periods presented, have been made. Interim results are not necessarily indicative of results that may occur for a full year.

   

These interim unaudited consolidated financial statements have been prepared on a going concern basis that contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has incurred net losses of $1,746,240 for the three months ended March 31, 2009 (2008: $1,741,575) and has a deficit of $61,636,203 as at March 31, 2009 compared to a deficit of $59,889,963 as at December 31, 2008. The Company’s ability to continue as a going concern is dependent on the profitable commercialization of its products and/or obtaining additional debt or equity financing to fund ongoing operations until profitability is achieved.

   

If the going concern basis was not appropriate for these interim unaudited consolidated financial statements, significant adjustments would be necessary to the carrying values of the Company’s assets and liabilities, reported expenses and balance sheet classifications.

   
3.

CHANGES IN ACCOUNTING POLICIES

   

During the first quarter ended March 31, 2009, the Company adopted the Canadian Institute of Chartered Accountants (“CICA”) Handbook Section 3064, Goodwill and intangible assets,

   

CICA 3064 – Goodwill and Intangible Assets

   

CICA 3064 replaces CICA 3062 and establishes standards for the recognition, measurement and disclosure of goodwill and intangible assets. The provisions relating to the definition and initial recognition of intangible assets are equivalent to the corresponding provisions of IAS 38, Intangible Assets. The Section applies to interim and annual financial statements relating to fiscal years beginning on or after October 1, 2008.

   

The adoption of Handbook Section 3062 did not have an impact on the Company’s consolidated financial condition, results of operations or cash flows during the current period and is not expected to have an effect in the future.

5



NEOVASC INC. (Formerly Medical Ventures Corp.)
Notes to the Consolidated Financial Statements
For the three months ended March 31, 2009 and 2008

3.

CHANGES IN ACCOUNTING POLICIES (Continued)

   

Conversion to IFRS

   

In February 2008, the Canadian Accounting Standards Board confirmed that the use of International Financial Reporting Standards (“IFRS”) would be required for Canadian publicly accountable enterprises for fiscal years beginning on or after January 1, 2011. In preparation for the conversion to IFRS, the Company has developed an IFRS changeover plan. We are currently reviewing the differences between current Canadian GAAP and IFRS and assess the impacts on the other key elements of our conversion plan in this phase. These key elements include: accounting policy changes, information technology changes, education and training requirements, internal control over financial reporting, and impacts on business activities. While the Company has begun assessing the adoption of IFRS for 2011, the financial reporting impact of the transition to IFRS cannot be reasonably estimated at this time.

   
4.

MANAGING CAPITAL

   

The Company’s objectives, when managing capital, are to safeguard cash as well as maintain financial liquidity and flexibility in order to preserve its ability to meet financial obligations and deploy capital to grow its business.

   

In the definition of capital, the Company includes, as disclosed on its balance sheet: deficit, share capital, cash and cash equivalents and long-term debt. There has been no change in the definition since the prior period.

   

The Company’s financial strategy is designed to maintain a flexible capital structure consistent with the objectives stated above and to respond to business growth opportunities and changes in economic conditions. In order to maintain or adjust its capital structure, the Company may issue new shares, issue new debt (secured, unsecured, convertible and/or other types of available debt instruments), acquire or dispose of assets, or adjust the amount of cash or short-term investment balances.

   

As at March 31, 2009, the Company was in compliance with externally imposed capital requirements.

   
5.

FINANCIAL INSTRUMENTS

   

Financial Instruments

   

The Company classifies its cash and cash equivalents and bank overdraft as held-for-trading and carries them at fair-value. Accounts receivable are classified as loans and receivables. Accounts payable and accrued liabilities, long-term debt and repayable contribution agreement are classified as other financial liabilities. The Company had neither available-for-sale, nor held-to-maturity instruments as at March 31, 2009 and at December 31, 2008. Loans and receivables and other financial liabilities have been recorded at amortized cost using the effective interest rate method.

   

Cash equivalents

   

The Company holds cashable guaranteed investment certificates (“GIC”) returning a fixed rate of interest of 3.00%. The GIC has an initial term of one year and matures on July 1, 2009 and is renewed annually.

   

Foreign exchange risk

   

The majority of the Company’s revenues are derived from product sales in the United States, primarily denominated in United States currency. Management has considered the stability of the foreign currency and the impact a change in the exchange rate may have on future earnings during the forecasting process.

   

Interest rate risk

   

The Company makes fixed repayments on its long term debt as described in Note 12. Included in the repayments is an interest payment with an interest rate floating at prime rate. Management has considered

6



NEOVASC INC. (Formerly Medical Ventures Corp.)
Notes to the Consolidated Financial Statements
For the three months ended March 31, 2009 and 2008

the risks to cash flows from this variable interest portion and considers it unlikely that the interest rates will increase sufficiently to exceed the fixed monthly payment due on the loan.

   

Liquidity risk

   

The Company has incurred operating losses since inception, as described in Note 2. The Company’s ability to continue as a going concern is dependent on the profitable commercialization of its products or obtaining additional debt or equity financing to fund ongoing operations until profitability is achieved. The Company reviews its cash flows on a quarterly basis and forecasts expected break even points and the timing of additional cash flows.

   

The maturity of the Company’s long term debt is described in Note 9. The Company has minimal risk associated with the maturity of its long term debts.

   

As at March 31, 2009 the Company had working capital of $483,896 as compared to working capital of $2,123,519 at December 31, 2008.

   
6.

INVENTORY


      March 31     December 31  
      2009     2008  
      (Unaudited)        
  Materials $  83,209   $  48,053  
  Work in progress   98,491     25,525  
  Finished goods   308,476     267,986  
    $  490,176   $  341,564  

7.

EMPLOYEE RIGHTS UPON RETIREMENT

   

Pursuant to Israeli severance pay law, the Israeli employees are entitled to severance pay upon termination of their employment. The Company's liability for employee rights upon retirement is calculated, based on the most recent salary of each employee multiplied by the number of years of employment, as of the balance sheet date. Employees are entitled to one month's salary for each year of employment, or a portion thereof. The Company makes monthly deposits to insurance policies and severance pay funds. As of March 31, 2009, the retirement liability is $8,964 (2008: $Nil).

   

The deposited funds include profits accumulated up to the balance sheet date. The deposited funds may be withdrawn upon the fulfillment of the obligation pursuant to Israeli severance pay laws or labor agreements. The value of the deposited funds is based on the cash surrender value of these policies, and includes immaterial profits. As of March 31, 2009, the retirement asset is $8,320 (2008: $Nil).

7



NEOVASC INC. (Formerly Medical Ventures Corp.)
Notes to the Consolidated Financial Statements
For the three months ended March 31, 2009 and 2008

8.

PROPERTY AND EQUIPMENT


      March 31,  
            2009        
            Accumulated     Net Book  
      Cost     Depreciation     Value  
                     
  Land $  207,347     -   $  207,347  
  Building   1,056,705     170,300     886,405  
  Production equipment   498,030     386,608     111,422  
  Field assets   131,794     131,794     -  
  Computer hardware   188,135     121,372     66,763  
  Computer software   181,511     181,076     435  
  Office equipment, furniture and fixtures   217,937     115,050     102,887  
    $  2,481,459   $  1,106,200   $  1,375,259  

      December 31,  
            2008        
            Accumulated     Net Book  
      Cost     Depreciation     Value  
                     
  Land $  207,347     -   $  207,347  
  Building   1,056,705     160,131     896,574  
  Production equipment   498,030     377,608     120,422  
  Field assets   131,794     131,794     -  
  Computer hardware   181,914     114,664     67,250  
  Computer software   181,511     180,930     581  
  Office equipment, furniture and fixtures   217,937     110,467     107,470  
    $  2,475,238   $  1,075,594   $  1,399,644  

9.

LONG-TERM DEBT


      March 31     December 31,  
      2009     2008  
      (Unaudited)        
  Bank instalment loan $  434,216   $  439,247  
  Less current portion   (20,979 )   (20,635 )
    $  413,237   $  418,612  

Repayments will consist of 180 regular blended payments of $4,095 each month, including interest and principal, commencing on September 1, 2007 and ending on August 1, 2022. The loan is collateralized by a first charge over the Company’s land and buildings, a liquid security agreement of $50,000 to be held in cash equivalent investments and a general security agreement over all personal property of the business now owned and all personal property acquired in the future. The loan bears interest at prime.

8



NEOVASC INC. (Formerly Medical Ventures Corp.)
Notes to the Consolidated Financial Statements
For the three months ended March 31, 2009 and 2008

9.

LONG-TERM DEBT (Continued)

   

Principal maturities in the next five years and thereafter are approximately as follows:


  2009 $  20,979  
  2010   22,413  
  2011   23,945  
  2012   25,582  
  2013   27,331  
  Thereafter   313,966  
    $  434,216  

10.

REPAYABLE CONTRIBUTION AGREEMENT

   

In 2003, the Company entered into an Industrial Research Assistance Program (“IRAP”) Repayable Contribution Agreement with the National Research Council of Canada (“NRC”) and received funding of $409,363. The Company agreed to repay this funding through future royalties on the gross revenues of its Metricath products at a rate of 2.1%. If the Company does not generate $409,363 in royalties before July 1, 2015, the unpaid balance of the funding contribution will be forgiven. In 2005, Management determined that it was likely that royalties in excess of $409,363 would be generated over the period to July 1, 2015 from the sales of the Company’s Metricath products and as such had recorded a liability to reflect this obligation.

   

The fair value at inception was estimated as the present value of all future expected cash receipts discounted using the prevailing market rates of interest for a similar instrument and with a similar credit rating. Subsequent measurement of the repayable contribution agreement was at amortized net cost.

   

During the last quarter of 2008 Neovasc severed its direct sales force employees who sold the Company’s Metricath products. The Metricath products do not currently have an established sales channel and Neovasc cannot predict whether or not it will be able to establish a suitable channel in the future and generate revenue from these products in 2009. As a result, the Company released the $320,445 liability for the repayable contribution agreement, and wrote down the liability of repayable contribution agreement to Nil.

   

The company recorded accreted interest expenses of $nil and $3,839 for the three months ended March 31, 2009 and 2008, respectively.

9



NEOVASC INC. (Formerly Medical Ventures Corp.)
Notes to the Consolidated Financial Statements
For the three months ended March 31, 2009 and 2008

11.

SHARE CAPITAL

   

All share data and per share amounts have been adjusted to retroactively restate the impact of the reverse stock split on a 20 for 1 basis that took place on July 1, 2008.


  (a)

Authorized

     
 

Unlimited number of common shares without par value
Unlimited number of preferred shares without par value


      Common Shares     Contributed  
  (b) Issued and outstanding Number     Amount     Surplus  
                     
    Balance, December 31, 2007 5,560,477   $  28,835,081   $  976,637  
    Issued for repurchasing warrants (i) 175,657     38,648     (38,648 )
    Issued on acquistion of B-Balloon (ii) 5,273,800     11,602,360     1,101,923  
    Issued on acquistion of Neovasc Medical (ii) 4,610,091     10,142,200     1,767,071  
    Issued for cash pursuant to a private placement (iii) 2,081,251     8,325,004        
    Share issue costs (iii)       (93,916 )      
    Stock-based compensation             387,360  
    Expiry of agent's warrants       (242,461 )   242,461  
    Issued for cash on exercise of options 750     150        
    Balance, December 31, 2008 17,702,026   $  58,607,066   $  4,436,804  
    Issued for cash on exercise of options 158,529     1,555        
    Stock-based compensation             86,052  
    Balance, March 31, 2009 (Unaudited) 17,860,555   $  58,608,621   $  4,522,856  

  (i)

In connection with, and contingent upon the completion of the acquisition of Neovasc Medical and B-Balloon, the Company made an offer to all of the holders of warrants outstanding as at April 30, 2008 to repurchase those warrants in exchange for a lesser number of common shares in the Company. The offer to repurchase was made based on the value of the warrants ($38,648) calculated immediately prior to the exchange using a Black Scholes valuation method. 976,868 warrants were repurchased in exchange for common shares at a ratio of one common share for 5.75 warrants and 27,356 were repurchased at one common share for 4.75 warrants. An aggregate of 175,657 common shares were issued for the repurchase of the warrants. The warrant and option offer was completed immediately prior to the acquisitions on July 1, 2008.

     
  (ii)

Pursuant to the acquisition agreement, the Company issued 5,273,800 and 4,610,091 common shares to the securityholders of B-Balloon and Neovasc Medical respectively.

     
  (iii)

As a condition of the acquisitions the Company was required to complete a concurrent non- brokered private placement of units to raise minimum gross proceeds of $6,000,000. The actual proceeds raised on July 1, 2008 were $8,325,004. The units were issued at a price of $4.00 per unit and consist of one common share of the Company and 0.62 of a warrant. Each whole warrant is exercisable to purchase one additional common share of the Company at a price of $5.00 for a period of 18 months from July 1, 2008. Share issue costs related to the concurrent financing were $93,916.

10



NEOVASC INC. (Formerly Medical Ventures Corp.)
Notes to the Consolidated Financial Statements
For the three months ended March 31, 2009 and 2008

11.

SHARE CAPITAL (Continued)

     
(c)

Stock-based compensation

     

The Company adopted a stock option plan under which the directors of the Company may grant options to purchase common shares to directors, officers, employees and service providers (the “optionees”) of the Company on terms that the directors of the Company may determine within the limitations set forth in the Stock Option Plan. Effective November 22, 2005, the board of directors of the Company approved an amendment to the Company's incentive Stock Option Plan to increase the number of options available for grant under the plan to 10% of the number of common shares of the Company outstanding from time to time.

     

Options under the Company’s Stock Option Plan granted to directors may vest immediately and options granted to employees and officers vest over a four year term. The directors of the Company have discretion within the limitations set forth in the Stock Option Plan to determine other vesting terms on options granted to directors, officers, employees and others. The minimum exercise price of a stock option cannot be less than the applicable market price of the common shares on the date of the grant and the options have a maximum exercise period of five years.

     

The following table summarizes stock option activity for the respective periods as follows:


            Weighted     Average  
            Average     Remaining  
      Number of     Exercise     Contractual  
      Options     Price     Life (years)  
  Options outstanding, December 31, 2006   139,629   $  9.00     1.98  
     Granted   96,438     3.40     4.04  
     Exercised   -     -        
     Forfeited   (18,750 )   10.20     -  
  Options outstanding, December 31, 2007   217,316   $  6.40     3.29  
     Granted before June 30, 2008   2,500   $  2.00     4.73  
     Forfeited before June 30, 2008   (16,750 ) $  7.00        
     Options outstanding, June 30, 2008   203,066              
     Option amendment (i)   (96,950 ) $  -     -  
     Options assumed on acquisition of                  
                                   B-Balloon Ltd. (ii)   584,200   $  0.01     6.48  
                                   Neovasc Medical Ltd. (ii)   512,515   $  0.01     8.41  
     Granted on October 31, 2008   1,157,077   $  1.15     4.84  
     Forfeited   (181,977 ) $  0.63     -  
     Exercised   (750 )            
  Options outstanding, December 31, 2008   2,177,181   $  0.57     6.01  
     Granted on Feburary 2, 2009   487,500   $  0.40     4.85  
     Forfeited   (95,750 ) $  1.15        
     Exercised   (158,525 )            
  Options outstanding, March 31, 2009 (Unaudited)   2,410,406   $  0.47     5.48  
  Options exercisable, March 31, 2009 (Unaudited)   1,286,132   $  0.25     6.03  
                     
  Weighted average grant date fair value of stock                  
     options awarded during period $  0.27              

11



NEOVASC INC. (Formerly Medical Ventures Corp.)
Notes to the Consolidated Financial Statements
For the three months ended March 31, 2009 and 2008

11.

SHARE CAPITAL (Continued)

       
(c)

Stock-based compensation (Continued)

       
(i)

In connection with, and contingent upon the completion of the acquisition of B-Balloon and Neovasc Medical, the Company made an offer to all of the holders of options outstanding as at April 30, 2008 to amend those options for a lesser number of $0.20 options to acquire common shares of the Company. The offer to amend the options was structured so that the estimate fair value of the replacement options issued equaled that of the options they replaced, calculated on the date of the exchange using a Black Scholes valuation method. All holders of options accepted the offer and as a result all the outstanding market priced options were amended into 106,116 $0.20 options on July 1, 2008. All of these amended options vested immediately on the date of the acquisition.

       
(ii)

As part of the consideration paid to acquire B-Balloon and Neovasc Medical 1,096,715 options were assumed by Neovasc and replaced by an equal number of options of the Company. Of these, 81,039 unvested options issued to the option holders of B-Balloon and 105,231 unvested options issued to the option holders of Neovasc Medical are held by active employees or consultants and have been excluded from the purchase price to be expensed as compensation cost over their remaining vesting period. In addition, 11,058 options included as part of the calculation of total consideration have been forfeited as the employees were terminated during the period and their vesting period ceased. The options issued by Neovasc as part of the consideration are excluded from the Company’s stock option plan, and they have an exercise price of less than $0.01 and a maximum exercise period of 10 years.

During the three months ended March 31, 2009, the Company recorded $86,052 (2008 – $13,283) as compensation expense for stock-based compensation awarded to employees. The Company used the Black-Scholes option-pricing model to estimate the value of the options at each grant date using the following weighted average assumptions:

    March 31, March 31,
    2009 2008
  Dividend yield nil nil
  Annualized volatility 85% 82%
  Risk-free interest rate 2.00% 4.00%
  Expected life 5 years 5 years

12



NEOVASC INC. (Formerly Medical Ventures Corp.)
Notes to the Consolidated Financial Statements
For the three months ended March 31, 2009 and 2008

12.

RELATED PARTY TRANSACTIONS

   

Related party transactions are entered into in the normal course of operations and are recorded at amounts established and agreed on between the related parties.


      For the three months ended,  
      March 31,  
      2009     2008  
  Income            
       Contract Manufacturing $  -   $ 40,000  
  Expenses            
       Services of the Chairman   4,906     45,843  
       Legal Services            
       General expenses   -     5,153  
       Acquisition costs   -     24,236  
             Financing costs   -     -  
       Consulting Services   -     43,157  
               
      As at  
      March 31,     December 31,  
  Accounts Receivable   2009     2008  
       Contract Manufacturing   -     120,654  
  Accounts Payable            
       Service of the Chairman   -     2,730  
       Legal Services   -     338  
       Consulting Services   -     -  

  (i)

Contract Manufacturing

     
 

The Company performs contract manufacturing services for a related corporation. One of the directors of this corporation is a significant shareholder in the Company. On July 1, 2008 the shareholder ceased to be a significant shareholder of the Company.

     
  (ii)

Services of the Chairman

     
 

The services of the Chairman are provided to the Company by a corporation controlled by the Chairman. The Company and the corporation have a director in common. These fees are included in general and administration expenses. The Chairman resigned as CEO on July 1, 2008, but remains Chairman of the board of Directors.

     
  (iii)

Legal Services

     
 

Legal and corporate secretarial services were provided by a legal firm. A partner of that firm is a director of the Company. The director resigned as a director of the Company on July 1, 2008.

     
  (iv)

Consulting Services

     
 

Sales and marketing consulting services are provided by a director of the Company. The director resigned as a director of the Company on July 1, 2008.

The carrying amounts of the accounts receivable and accounts payable approximate fair values due to their short term nature.

13



NEOVASC INC. (Formerly Medical Ventures Corp.)
Notes to the Consolidated Financial Statements
For the three months ended March 31, 2009 and 2008

13.

SEGMENT INFORMATION

   

The Company’s operations are in one business segment; the development, manufacture and marketing of medical devices. Each of the Company’s product lines has similar characteristics, customers, distribution and marketing strategies, and are subject to similar regulatory requirements.

   

Substantially all of the Company’s long-lived assets are located in Canada. The Company carries on business in Canada and to a lesser extent in Israel. It earns revenue from sales to customers in the following geographic locations:


      For the three months ended  
      March 31,  
      2009     2008  
  SALES            
       Canada $  23,211   $  67,437  
       United States   187,384     275,331  
       Other   144,889     90,717  
    $  355,484   $  433,485  

53% and 64% of the Company’s revenues for the three months ended March 31, 2009 and 2008, respectively, were derived from customers located in the United States. Sales to the Company’s largest customer in each period accounted for approximately 34% of the Company’s sales for the three months ended March 31, 2009 and 2008, respectively.

   
14.

CONTINGENCIES

   

On November 14, 2008, the Company received a claim from an ex-employee claiming wrongful dismissal on October 22, 2008. The employee was made redundant as part of the rationalization process undertaken by the Company. The maximum amount of the claim is $25,000.

   
15.

SUBSEQUENT EVENTS

   

On April 23, 2009, the Company completed a non-brokered private placement of 9,523,810 units at the price of $0.21 per unit for aggregate gross proceeds of $2.0 million. Each unit consists of one common share of Neovasc stock and one-half of one common share purchase warrant of Neovasc stock. Each whole warrant will entitle the holder thereof to purchase one common share of Neovasc stock at the exercise price of $0.30 per share for a period of one year after the closing date of the offering.

14


EX-99.2 3 exhibit99-2.htm MD&A FOR THE PERIOD ENDED MARCH 31, 2009 Filed by sedaredgar.com - Neovasc Inc. - Exhibit 99.2


Neovasc Inc.
Management’s Discussion
and Analysis
Form 51-102F2

For the Three Months ended
March 31, 2009 and 2008

 

 

Q1
2009

Neovasc Management’s Discussion & Analysis 1 of 11


FORM 51-102F1: MANAGEMENT’S DISCUSSION AND ANALYSIS

This discussion and analysis covers the unaudited interim consolidated financial statements for the three months ended March 31, 2009 and 2008.

The Management’s Discussion and Analysis (“MD&A”) of Financial Condition and Results of Operations should be read in conjunction with the unaudited interim consolidated financial statements and notes thereto for the three months ended March 31, 2009 (included as part of Neovasc Inc.’s quarterly filing) as well as the audited consolidated financial statements and notes thereto and the MD&A for the fiscal year ended December 31, 2008 (collectively known as the “Financial Statements”).

FORWARD-LOOKING STATEMENTS

This discussion and analysis, contains forward-looking statements that are not based on historical fact, including without limitation statements containing the words “believes”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipates”, “intends”, “expects”, and similar expressions, including the negative of such expressions. These statements are only predictions.

Forward-looking statements and information should be considered carefully. Undue reliance should not be placed on forward-looking statements and information as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements and information involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, which contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements and information will not occur and may cause actual results or events to differ materially from those anticipated in such forward-looking statements and information. The assumptions made by Neovasc include the ability of the Company to obtain and enforce timely patent protection for its technologies, the development of products; the timing of receipt of regulatory approvals; the sufficiency of budgeted capital expenditures in carrying out planned activities; and the availability and cost of labour and services (see ‘Risks and Uncertainties’).

More particularly and without limitation, this discussion and analysis contains forward-looking statements and information concerning the potential of Neovasc and the timing of market acceptance of the Company’s technology products.

There are also other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements and information. Such factors include, among others, the stage of development of Neovasc, additional capital requirements, the impact of the global economic downturn, the ability to develop, manufacture and commercialize its products in a cost-effective manner, the ability to integrate newly-acquired businesses and the ability to protect Neovasc’s intellectual property.

A more complete discussion of the risks and uncertainties facing Neovasc appears in Neovasc’s management information circular available at www.sedar.com. Neovasc disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements or information contained herein to reflect future results, events or developments, except as required by law.

All financial information is prepared in accordance with Canadian generally accepted accounting principles (“GAAP”) and is expressed in Canadian dollars.

Date: June 1, 2009

OVERVIEW

Description of the Business
Neovasc Inc. (formerly Medical Ventures Corp.) (“Neovasc” or the “Company”) develops, manufactures and commercializes medical devices, focusing on products that address clinical needs in the vascular and surgical marketplace.

Neovasc was established to develop and commercialize a portfolio of medical devices from which the Company generates revenue from the distribution, licensing or sale of each of these products.

Neovasc’s business operations started in March 2002, with the acquisition of Neovasc Medical Inc. (formerly PM Devices Inc. (“PMD”). PMD manufactures a line of collagen based surgical patch products made for use in cardiac reconstruction and vascular repair procedures as well as other surgeries. The products are made from chemically treated bovine and equine pericardial tissue.

In May 2003, Neovasc acquired Angiometrx Inc. (“ANG”). ANG has developed a technology called the “Metricath® System,” a catheter-based device that allows clinicians to measure artery and stent size and confirm stent deployment during interventional treatment of coronary and peripheral artery disease.

Neovasc Management’s Discussion & Analysis 2 of 11

On July 1, 2008, Neovasc acquired two pre-commercial vascular device companies based in Israel: Neovasc Medical Ltd. (“Neovasc Medical”) and B-Balloon Ltd. (“B-Balloon”) (the “Acquisitions”). Neovasc Medical is developing a novel catheter-based treatment for refractory angina, a debilitating condition resulting from inadequate blood flow to the heart muscle. Refractory angina affects millions of patients and at present there is no effective cure. B-Balloon is developing a suite of vascular catheter products to solve problems physicians frequently encounter when attempting to place vascular stents at locations where an artery branches from the aorta (the “ostium”) or where an artery splits into multiple branches (a “bifurcation”). Neovasc Medical and B-Balloon offer a potential pipeline of technologies that complement Neovasc’s existing products and sales call points.

Neovasc issued 4,610,091 and 5,273,800 common shares for each of Neovasc Medical and B-Balloon.

Concurrently with the Acquisitions, the Company undertook:

  a)

a private placement of units, each unit consisting of one common share priced at $4.00 per share and a warrant to purchase 0.62 of a common share at price of $5.00 per share for a period of 18 months from the date of closing. The Frost Group, a shareholder of Neovasc Medical and B- Balloon, acted as lead investor for the private placement financing and, together with other investors, invested an aggregate of $8,325,004.

     
  b)

a consolidation of its outstanding 111 million shares (136 million fully diluted), at 20 old shares for one new share.

Completing the Acquisitions significantly broadened the Company’s vascular device product and IP portfolio.

In conjunction with the completion of the Acquisitions, the Company changed its name to Neovasc Inc. to better reflect the focus of its ongoing operations as a specialty vascular device company.

Valuation of Goodwill and Technology
Subsequent to the completion of the Acquisitions, an independent valuation of the fair value of the acquired tangible assets and identifiable intangible assets was conducted. The purchase price was allocated among acquired tangible assets, identifiable intangible assets and goodwill in accordance with Canadian GAAP. As a result of the valuation and related purchase price allocation, $448,475, $10,907,300, and $2,668,079 was initially allocated to liabilities, proprietary technologies and goodwill for B-Balloon, and $716,688, $10,726,200, and $889,003 was initially allocated to tangible assets, proprietary technology and goodwill for Neovasc Medical.

Amortization of Technology
The Company’s policy is to amortize the acquired technologies over the shorter of the life of the major patents for the technologies and the expected period of technological obsolescence. All the significant patents have at least 10 years to expiration and therefore the technologies are being amortized over the term until estimated technological obsolescence: 4 years for the B-Balloon technology and 7 years for the Neovasc technology. The ostial and bifurcation technologies acquired from B-Balloon are competing against other products to improve the treatment of disease at ostial and bifurcation sites. Management is aware of several competitive companies developing products for these types of disease and there is an increased risk that our technologies will be made obsolete by a competitor. The technology acquired from Neovasc Medical is a unique technology that is targeting a treatment for an end stage disease when other currently available procedures and/or medications having limited incremental impact on the patient. We are unaware of any direct competitors to the Neovasc product at this time.

An amortization charge of $2,129,570 has been incurred in the year ended December 31, 2008. As at December 31, 2008, the net book value of the acquired technologies, before any impairment charges was $9,543,887 for technology acquired from B-Balloon and $9,960,043 for technology acquired from Neovasc Medical.

Impairment of Goodwill and Technology
Goodwill is tested for impairment annually or more frequently if circumstances suggest impairment may exist. Definite-lived intangibles such as the acquired technologies are tested for recoverability whenever facts or circumstances suggest the possibility of impairment. During the fourth quarter of 2008, the Company’s market capitalization remained below the value of the shareholders equity for a significant period of time, indicating potential impairment of the Company’s goodwill and other intangible assets.

As a result of these market indicators and the Company’s impairment testing, the Company recorded an impairment charge of $3,557,082 to write down goodwill to $nil.

During the fourth quarter of 2008, the company reviewed its estimates and judgments regarding forecasts on the success and lifecycle of the technologies and future cash flows generated by acquired the technologies.

Neovasc has been through a significant cost rationalization process, including a 40% reduction in personnel, a reduction in the scale of the Israeli operations and the suspension of development on three of the four technologies acquired from B-Balloon: the Ostial Stent, the Ballerina and the BOSS. Together

Neovasc Management’s Discussion & Analysis 3 of 11

these technologies had an initial valuation on July 1, 2008 of $8.8 million. Neovasc is uncertain when it will be able to recommence development of these technologies and does not anticipate any revenues from these technologies in the next three years. Neovasc has fully written down these technologies.

Both the Reducer, from Neovasc Medical, initially valued at $10.7 million and the Ostial Balloon device, from B-Balloon, which has evolved into the Ostial D3, initially valued at $2.1 million are still under development. Their amortized valuation before any impairment testing at December 31, 2008 was $10.0 million and $1.8 million respectively. Their combined valuation of $11.8 million before impairment is 17 times greater than the capital market valuation of the intangible assets of the Company and there is strong evidence to suggest that the assets have been impaired.

When comparing the forecasts for the two technologies prepared in January 2009 to those prepared in June 2008 there are some marked differences: The start of revenue from each product has been deferred by as much as a year, as the development process has slowed because of cost restrictions, and the revenue projections have been revised down as Neovasc believes that adoption may be slower, demand may be lower and selling price may be impacted by the economic crisis.

As a result of the market indicators and the Company’s impairment testing, the Company recorded an impairment charge of $19,503,930 to write down the net book value of acquired technologies to $nil.

Termination of Distribution Agreement
On December 22, 2008, the distribution agreement between Neovasc and a third party distributor was terminated. On termination the Company was required to repurchase inventory held by the distributor less a 25% restocking fee. As a result, Neovasc repurchased $198,838 of Peripatch inventory and $200,383 of Aegis inventory. To recognize the liability for the repurchase of the inventory the Company offset $305,831 of accounts receivable and interest due from the distributor (the right of offset being specifically allowed under the terms of the agreement) and set up an additional liability of $301,788 for the balance remaining.

Under EIC-156 Accounting by a vendor for consideration given to a customer, Neovasc is required to recognize the inventory repurchase as a reduction in revenue and the income statement impact of the termination was to reverse revenue of $516,601, decrease cost of goods sold by $308,203 and recognize interest income of $45,024 (for the interest due on accounts receivable.)

On March 26, 2009, once the inventory had been received and passed quality control inspection Neovasc notified the distributor of the value of the inventory returned. As at the date of this filing the Company has not received any notice of litigation or arbitration from the distributor regarding this termination.

Inventory Write Down
During the fourth quarter of the 2008 Neovasc severed its direct sales force employees who sold the Company’s Metricath products and terminated its distributor of Aegis products. As a result, the Company has limited sales channels through which to sell the Metricath and Aegis product lines. While Management continues to look for new distributors to carry these products there is no certainty, when, or if, they will be able to find a suitable partner.

The Company values inventory at the lower of cost and net realizable value. With no certain sales in 2009 from these products the Company could not reasonably estimate the net realizable value for these product lines and attributed a $nil value to all Metricath and Aegis inventory. As a result the Company incurred an inventory write down of $626,925, including the Aegis product returned by Medsurg.

Repayable contribution write back
As noted above, the Metricath products do not currently have an established sales channel and Neovasc cannot predict whether or not it will be able to establish a suitable channel in the future and generate revenue from these products in 2009. As a result, the Company released the $320,445 liability for the repayable contribution agreement. The repayable contribution agreement is an Industrial Research Assistance Program forgivable loan which is repayable at a royalty rate of 2.1% of gross revenues from Metricath products and which is wholly forgiven on July 1, 2015 if not already paid out through royalties.

Product Portfolio

Peripatch Products
Neovasc manufactures the PeriPatch™ line of surgical tissue products. The Peripatch line consists of several flexible, biomaterial tissue products made from animal sources. They are chemically treated with proprietary technology to prevent their degradation and to maintain their biocompatibility. Peripatch products are used for vascular repair and reconstruction, as well as in other soft tissue repair. The products are biocompatible, allowing optimal incorporation with the body’s host tissue, and no special sutures are required to make a secure seal.

The product line includes: the PeriPatch™ Sheet, MatrixBP and PeriPatch™ EQ Sheet, rectangular patches made from bovine (cow) or equine (horse) tissue, that are applied as internal bandages to repair weak or damaged organs or vessels; and the PeriPatch™ Aegis, and PeriPatch™ Aegis EQ, new

Neovasc Management’s Discussion & Analysis 4 of 11

(products for staple line reinforcement used during endoscopic (minimally invasive) surgical procedures.) There are approximately two million surgical procedures performed annually around the world where tissue products may be applied.

Regulatory Status
The Peripatch Sheet and MatrixBP are cleared for sale in the U.S., Canada and Mexico. The Peripatch EQ Sheet is approved for sale in the European Union and in Canada. The Aegis is cleared for sale in the United States.

Distribution
As discussed above, on December 22, 2008 the existing distribution agreement for the Peripatch and Aegis products was terminated and Neovasc subsequently signed a new third party distribution contract to distribute certain Peripatch products in the United States and Europe and continues to supply a number of other Peripatch distributors in the rest of the world.

Going forward Neovasc intends to find strategic partners and distributors to market the Peripatch products to specific market segments. For example, the Company has signed a distribution agreement with a company which specifically focused on vascular surgical call points.

The Company provides training and promotional materials to its current distributors and is working to find new distributors in selected target markets. The Company’s goal is to steadily increase its distribution reach in new target markets, while increasing market share in current markets and in particular in the U.S.

Currently, the Company has distribution agreements for its Peripatch products covering the United States and Canada as well as selected countries in Europe and elsewhere.

Metricath System
The Metricath product line consists of a small, pole-mounted console unit and two distinct catheter models: the Metricath Libra® measure-only catheter, and the Metricath Gemini® measure-and-treat catheter.

Metricath catheters are used during angioplasty, a procedure used to open arteries where blood flow is restricted by plaque (the accumulation of fats and cholesterol). To perform angioplasty, doctors thread a balloon-tipped catheter through the vasculature and inflate the balloon at the site of the blockage, opening the narrowed vessel. Once the vessel is open, doctors often implant a stent (a small metal mesh tube) to prevent it from re-closing and to maintain proper blood flow.

Metricath provides the user with precise measurements of an artery by inflating the balloon at the catheter’s tip and monitoring its volume and pressure as it comes up against the artery walls. These measurements allow doctors to quickly diagnose artery blockages and treat them with balloons and stents that are optimally sized for the artery. As an added benefit, Metricath catheters can also take measurements inside an implanted stent to ensure that it is fully open. In the case of the Metricath Gemini, a second, high-pressure balloon on the catheter may be used to expand under-deployed stents.

Accurate measurement is believed to be an important factor in patients’ post-procedure outcomes, as it helps doctors confirm that stents are deployed properly within arteries. In 2006, the medical community identified a link between the use of drug-coated stents and an increased risk of blood clotting, or “thrombosis,” as compared to situations where bare-metal (uncoated) stents are used. While it has not been determined definitively why this is the case, there are clinical indications that factors include the under-sizing of stents and/or under-expansion of stents against the artery wall in conjunction with the stents’ drug coating or polymer. As a result, there has been increased clinical focus on proper stent selection and expansion to help minimize the risk of stent thrombosis. Anecdotal evidence from the field suggests that physician awareness of the need to accurately size and place stents is continuing to increase, for reasons of potential liability as well as clinical utility. Metricath has the potential to offer improved care by reducing the risk of thrombosis associated with drug-coated stents. By using Metricath to confirm artery and stent size, doctors can be more confident that stents fit correctly within the arteries in which they are placed.

The Metricath System was developed in response to the limitations of existing measurement technologies that are either insufficiently accurate or prohibitively expensive and time-consuming to gain widespread market acceptance. Obtaining accurate measurements is problematic using conventional imaging techniques such as angiography. Intravascular ultrasound (IVUS) catheters can provide precise vascular measurements; however, IVUS is comparatively expensive and time-consuming to use. IVUS takes approximately three times longer to set up and use than Metricath and has a disposable cost of between two and three times that of Metricath. In addition, where IVUS requires the purchase or lease of a complex image acquisition and analysis system, Metricath imposes minimal capital costs on users.

Current estimates are that approximately 2.5 million stent implantation procedures are performed globally each year. The Metricath System is intended to be a simple and cost-effective vascular measurement tool

Neovasc Management’s Discussion & Analysis 5 of 11

that can be adopted easily into standard treatment practices.

Regulatory Status
The Metricath Libra is cleared for sale in the United States, Canada, the European Union, Australia, Brazil and Israel. The Metricath Gemini is cleared for sale for peripheral artery use in the United States, for coronary arteries in Canada, and for all vascular applications in the European Union. In the fourth quartet of 2007 the Company filed a Pre-Market Approval (“PMA”) application for U.S Food and Drug Administration (“FDA”) approval of the Metricath Gemini for coronary procedures in the U.S. This application followed completion of the Gemini Angioplasty and Arterial Measurement Evaluation (“GAAME”) clinical trial which was undertaken to provide the clinical data required to support this application (see “Product Development and Clinical Trials”). In April 2008, the Company received an initial FDA response to this application completed its response to the FDA and submitted additional supporting data in the first quarter of 2009.

Distribution
During 2008, the Metricath line was sold via direct sales in the U.S. and Canada and via distributors in other countries. As part of a larger cost reduction exercise the direct sales force staff were terminated and as discussed above there is currently a limited sales channel for the Metricath product.

Additional Products and Third Party Sales
Neovasc provides consulting and original equipment manufacturing services to other medical device companies when these services fall within the scope of its expertise and capabilities. This includes provision of treated tissue for incorporation into products such as percutaneous heart valves and covered stents. Revenue earned from various contract agreements varies throughout the year depending on customer needs.

Regulatory Affairs and Clinical Trials
In the fourth quarter of 2007, the Company submitted a PMA application to the FDA to approve the Metricath Gemini for coronary applications in the U.S. The Company supported its application with data from the GAAME trial which was completed in the third quarter of 2007. In April 2008, Neovasc announced that it had received an interim response to its PMA application from the FDA. The response requested additional information related to clinical and non-clinical aspects of the application. Neovasc has submitted the requested information and is awaiting response from the FDA. The FDA has also completed an inspection of Neovasc’ manufacturing and sterilization facility as part of the PMA application process. The FDA inspection took place at the beginning of June, 2008 and the Company successfully passed the inspection with no deviations or warnings.

Product Development
Product development at the Company is presently focused on the commercialization of key technologies obtained through the Acquisitions, as well as extension of the tissue product lines to specialty applications.

The primary focus of Neovasc’s product development activities is on the Reducer product. Reducer is an hourglass shaped stent which is implanted in the coronary sinus to treat refractory angina – chronic heart pain resulting from inadequate blood flow to the heart muscle which typically does not respond well to conventional treatments. The Reducer acts to restrict outflow of de-oxygenated blood from the heart muscle which may provide relief of symptoms of refractory angina in certain patients. Reducer prototypes have demonstrated positive results in multiple animal trials and in human trials published in peer-reviewed journals and Neovasc intends to file for a CE mark approval of the device in May 2009. Receipt of approval for this CE mark application would enable the Company to begin marketing the product in the European Union.

Sales & Marketing
The Company’s sales and marketing activities for 2009 are being focused on serving tissue product customers and distributors, and contract manufacturing clients as well as maintaining the existing client base for Metricath products.

TRENDS, RISKS AND UNCERTAINTIES

The Company has incurred operating losses of $1,746,240 for the quarter ended March 31, 2009 (2008: $1,741,575) and has a deficit of $61,636,203 as at March 31, 2009 (2008: $27,371,973). The Company’s ability to continue as a going concern is dependent on the profitable commercialization of its products or obtaining additional debt or equity financing to fund ongoing operations until profitability is achieved. The current economic crisis which has significantly tighten the credit and equity markets may result in required funds not being available to the Company at the time required or on terms acceptable to the Company and may reduce demand for the Company’s products.

Neovasc has a limited operating history which makes it difficult to predict how its business will develop or its future operating results. The Company has a history of fiscal losses since its inception and will need to generate significantly greater revenues than it has to date to achieve and maintain profitability. There is no certainty of future profitability, and results of operations in future periods cannot be predicted based on results of operations in past periods. Generally, the securities of

Neovasc Management’s Discussion & Analysis 6 of 11

the Company should be considered a highly speculative investment.

Neovasc is subject to risks and uncertainties associated with operating in the life sciences industry and as a company engaged in a significant level of development, regulatory, production and commercialization activity. Other than the standard operating risks associated with such a venture, the Company’s management is not aware of any trend, commitment, event or uncertainty in the life science industry that is presently known or is reasonably expected to have a material effect on the Company’s business, financial condition or results of operations. Neovasc cannot anticipate or prevent all of the potential risks to its success, nor predict the impact of any such risk. To the extent possible, management implements strategies aimed at reducing or mitigating risks and uncertainties associated with the business.

Operating risks include but are not limited to: market acceptance of the Company’s technology and products; the Company’s ability to obtain and enforce timely patent protection of its technology and products; the Company’s ability to develop, manufacture and commercialize its products cost-effectively and according to regulatory standards of numerous governments; the competitive environment and impact of technological change and/or product obsolescence; the continued availability of capital to finance the Company’s activities; the Company’s ability to conduct and complete successful clinical trials; the Company’s ability to garner regulatory approvals for its products in a timely fashion; the Company’s ability to attract and retain key personnel, effectively manage growth, and smoothly integrate newly acquired businesses or technologies; limitations on third-party reimbursement; instances of product or third-party liability; dependence on a single supplier for some products; animal disease or other factors affecting the quality and availability of raw materials; conflicts of interest among the Company’s directors, officers, promoters and members of management; fluctuations in the values of relative foreign currencies; volatility of the Company’s share price; fluctuations in quarterly financial results; unanticipated expenses; changes in business strategy; impact of any negative publicity; general political and economic conditions; and Acts of God and other unforeseeable events, natural or human-caused.

A portion of Metricath catheter sales efforts are targeting use in renal artery stenting procedures. In addition, certain ostial catheter products under development also target use in renal artery stenting procedures. In 2007, the Centers of Medicare and Medicaid Services (CMS), the largest U.S. health care payer, generated a national coverage analysis and initiated reconsideration of its coverage policy for percutaneous transluminal angioplasty of the renal arteries. On February 14, 2008, CMS issued its final decision memo to make no changes, continuing to leave coverage and reimbursement decisions to the discretion of regional Medicare contractors. Individual contractor decisions may adversely affect this market by reducing the number of renal stent implantations undertaken in the U.S.

FOREIGN OPERATIONS

The majority of the Company’s revenues are derived from product sales in the United States, primarily denominated in United States currency. The Company expects that international sales will continue to account for a significant portion of its revenues that are denominated in foreign currencies. Consequently, a decrease in the value of a relevant foreign currency in relation to the Canadian dollar, occurring after establishment of prices and before receipt of payment by Neovasc, has an adverse effect on the Company’s results of operations. The fluctuation of foreign exchange may impose an adverse effect on the Company’s results of operations and cash flows in the future. Additionally, Neovasc may be materially and adversely affected by increases in duty rates, exchange or price controls, repatriation restrictions, or other restrictions on foreign currencies. The Company’s international operations are subject to certain other risks common to international operations, including, without limitation: government regulations; import restrictions and, in certain jurisdictions, reduced protection for the Company’s intellectual property rights.

Foreign currency translation gains and losses arising from normal business operations are credited to or charged to operations in the period incurred. To date, Neovasc has not entered into any foreign exchange forward contracts.

SELECTED ANNUAL FINANCIAL INFORMATION

The following discussion should be read in conjunction with the unaudited interim consolidated financial statements for the three months ended March 31, 2009 and 2008.

DISCUSSION OF OPERATIONS AND FINANCIAL CONDITION

This section analyzes the significant changes in the unaudited interim consolidated financial statements of operations and deficit and cash flows for the three months ended March 31, 2009, compared to those for the same period ended March 31, 2008 and compares the financial condition at March 31, 2009 to that at December 31, 2008.

The statements of operations include the results of Neovasc, Neovasc Medical and B-Balloon for the three months ended March 31, 2009. Comparatively, the results of operations for the three months ended March

Neovasc Management’s Discussion & Analysis 7 of 11

31, 2008 only reflected the results of operation of Neovasc.

Results of Operations
Results for the three months ended March 31, 2009 and 2008 follow:

Net Losses
The consolidated net loss for the three months ended March 31, 2009 was $1,746,240 or $0.10 basic loss per share as compared with a net loss of $1,741,575 or $0.31 basic loss per share for the comparative period in 2008.

Revenues
Revenues decreased 18% year over year from $433,485 for the quarter ended March 31, 2008 to $355,484 for the quarter ended March 31, 2009.

Sales of catheter products for the quarter ended March 31, 2009 were $16,207, an 80% decrease over sales of $80,236 in the comparable period in 2008. The termination of direct sales force for Methricath products at the end of 2008 contributed to this decrease in sales.

Sales of tissue and surgical products and services for the three months ended March 31, 2009 were $339,277, as compared to sales of $353,249 for the same period of 2008, representing a 4% decrease. These revenues were derived from the sales of Peripatch products, consulting services and contract manufacturing revenues for tissues and surgical products. The company is working to develop more consulting services and contract manufacturing clients.

Cost of Sales
The cost of sales for the three months ended March 31, 2009 were $149,760 as compared to $208,260 in 2008, and the overall gross margin for 2009 was 58% as compared to 52% in 2008. The improvement in gross margin can be explained by a shift to certain contract and patch products with higher margins than the Metricath or standard Peripatch products.

Expenses
Total expenses for the three months ended March 31, 2009 and 2008 were $1,930,494 and $1,909,534 respectively.

Sales and marketing expenses declined 60% to $302,885 for the three months ended March 31, 2009 as compared to $749,504 for the same period in 2008. Without additional products to sell and without significant growth in the Metricath sales the Company terminated the direct sales force in the fourth quarter of 2008 and will continue to minimize sales and marketing costs until new products from the acquisitions and other sources are ready for market.

General and administrative expenses for the three months ended March 31, 2009 were $750,829 as compared to $538,285 in 2007, an increase of 39%. In the first quarter of 2009, the increase in general and administrative costs of $212,544 over the comparative period can largely be explained by a stock compensation charge relating to the immediate vesting of the options granted to the Board of Directors in February 2009 of $86,052 and approximately increased expenses related to the Israel operation.

Product development and clinical trial expenses of $876,780 for the three months ended March 31, 2009 as compared to $621,745 for the same period of 2008, an increase of 41%. The final Gemini PMA submission in March 2009 and the additional expense of the Isreal operation contributed to the increase.

Amortization and Other expenses
Amortization and other expenses for the three months ended March 31, 2009 were $21,470 as compared to other expense of $57,266 for the same period in 2008. The variance mostly being explained by a change in the foreign exchange from a $9,242 loss in 2008 to a $8,518 gain in 2009.

Neovasc Management’s Discussion & Analysis 8 of 11

Quarterly Information

The following is a summary of selected unaudited financial information for the eight fiscal quarters to March 31, 2009:

    Quarter Ended - Unaudited  
    March 31,     December 31,     September 30,     June 30,  
    2009     2008     2008     2008  
Sales                        
Catheter products $  16,207   $  75,920   $  53,687   $  45,904  
Tissue and surgical products and services   339,277     15,889     534,197     387,157  
    355,484     91,809     587,884     433,061  
                         
Cost of sales   149,760     (3,374 )   283,070     220,344  
                         
Expenses                        
Selling   302,885     894,470     816,421     785,491  
General and administration   750,829     844,819     1,297,333     779,363  
Product development and clinical trials   876,780     977,874     1,087,292     414,958  
Impairment of intangible assets   -     23,061,012     -     -  
Inventory Write Down   -     532,521     -     94,404  
Repayable contribution write back   -     (320,445 )   -     -  
    1,930,494     25,990,251     3,201,046     2,074,216  
EBITDA   (1,724,770 )   (25,895,068 )   (2,896,232 )   (1,861,499 )
Amortization/Other expenses   21,470     703,225     1,107,791     54,174  
Net loss   (1,746,240 )   (26,598,294 )   (4,004,023 )   (1,915,673 )
Basic loss per share   (0.10 )   (1.50 )   (0.23 )   (0.34 )

    Quarter Ended - Unaudited  
    March 31,     December 31,     September 30,     June 30,  
    2008     2007     2007     2007  
Sales                        
Catheter products $  80,236   $  81,004   $  55,306   $  51,432  
Tissue/surgical products   353,249     545,970     163,534     294,379  
    433,485     626,974     218,840     345,811  
                         
Cost of sales   208,260     372,956     105,897     201,189  
                         
Expenses                        
Selling   749,504     785,773     801,805     785,131  
General and administration   538,285     483,681     504,988     783,663  
Product development and clinical trials   621,745     683,379     618,971     790,643  
Inventory Write Down   -     434,961     -     124,170  
    1,909,534     2,387,794     1,925,764     2,483,607  
EBITDA   (1,684,309 )   (2,133,776 )   (1,812,821 )   (2,338,985 )
Amortization/Other expenses   57,266     166,453     (10,645 )   (30,488 )
Net loss   (1,741,575 )   (2,300,229 )   (1,802,176 )   (2,308,497 )
Basic loss per share   (0.31 )   (0.47 )   (0.32 )   (0.46 )

Neovasc Management’s Discussion & Analysis 9 of 11


LIQUIDITY AND CAPITAL RESOURCES

The Company finances its operations and capital expenditures with cash generated from operations, lines of credit, long-term debt and equity financings. At March 31, 2009, the Company had cash and cash equivalents of $972,510 as compared to cash of $2,498,439 as of December 31, 2008. At March 31, 2009 the Company had working capital of $483,896 as compared to working capital of $2,123,519 at December 31, 2008. In addition, at March 31, 2009 the Company had restricted cash related to a security on long-term debt of $50,000 (December 31, 2008 - $50,000) included in long-term assets. The decrease in working capital was predominantly due to the decline in cash during the quarter.

Cash used in operations was $1,514,482 for the three months ended March 31, 2009, as compared to $1,799,811 for the same period of 2008, a decrease of $285,329. The decrease in cash usage was facilitated by the accumulation of accounts payable at March 31, 2009 for expenses related to the filing of the Metriacth Gemini PMA submission.

Net cash used in investing activities was $7,971 for the three months ended March 31, 2009 compared to cash used of $7,182 in 2008. The company made minimum purchase of equipments in the first three months of 2008 and 2009.

Net cash used in financing activities was $3,476 for the three months ended March 31, 2009 compared to cash used of $6,498 in 2008.

Since its inception the Company has had negative cash flows from operations as it continues its product development activities The Company anticipates that it will require additional funding in 2009 to support its ongoing operations and product development. However, the current financial market conditions have increased the risk that such funding will not be possible. There is no assurance that such additional funds will be available for the Company. If adequate funds are not available, the Company may be required to scale back or abandon some activities and may in a worst case impact the Company’s ability to continue as a going concern. The Company’s financial statements do not include any adjustments that might result from this uncertainty.

CONTINGENCIES

On November 14, 2008, the Company received a claim from an ex-employee claiming wrongful dismissal. The employee was made redundant as part of the rationalization process undertaken subsequent to the period end. The maximum amount of the claim is $25,000.

SUBSEQUENT EVENTS

On April 23, 2009, the Company completed a non-brokered private placement of 9,523,810 units at the price of $0.21 per unit for aggregate gross proceeds of $2.0 million. Each unit consists of one common share of Neovasc stock and one-half of one common share purchase warrant of Neovasc stock. Each whole warrant will entitle the holder thereof to purchase one common share of Neovasc stock at the exercise price of $0.30 per share for a period of one year after the closing date of the offering.

OUTSTANDING SHARE DATA

As at March 31, 2009, the Company had 17,860,555 common voting shares issued and outstanding. Further, the following securities are convertible into exercisable or exchangeable for common shares of the Company: 2,410,406 stock options with a weighted average price of $0.47, and 2,065,769 share purchase warrants with exercise prices ranging from $1.38 to $5.00. The fully diluted share capital of the Company at March 31, 2009 is 22,336,730.

OFF BALANCE SHEET ARRANGEMENTS

The Company has no off balance sheet arrangements.

RELATED PARTY TRANSACTIONS

Related party transactions are disclosed in Note 12 of the unaudited interim consolidated financial statements. Neovasc has a contract with a corporation owned by its Chairman for his services that are invoiced monthly. All other related party transactions are invoiced to Neovasc on a month-to-month basis for services rendered. There are no potential material termination clauses in any of the related party agreements.

PROPOSED TRANSACTIONS

The Company is not party to any transaction requiring additional disclosure.

CONTROLS AND PROCEDURES

The Chief Executive Officer (CEO) and Chief Financial Officer (CFO), in cooperation with the other members of senior management and Directors, are responsible for the Company’s disclosure policy. The effectiveness of the Company’s internal disclosure controls have been evaluated by the CEO and the CFO, and they have concluded that the Company’s control procedure provides reasonable assurance that (i) information required to be disclosed by the Company in its annual and interim reports or other reports filed or submitted by it under applicable securities legislation is recorded, processed, summarized and reported within the

Neovasc Management’s Discussion & Analysis 10 of 11

prescribed time periods, and (ii) material information regarding the Company is accumulated and communicated to the Company’s management, including its CEO and CFO, in a timely manner.

The CEO and CFO are responsible for the design of internal controls over financial reporting in order to provide reasonable assurance that the Company’s financial reporting is reliable and that financial statements prepared for external purposes are prepared in accordance with Canadian GAAP and for the safeguarding of Company assets. The CEO and CFO are aware that internal controls relating to the accounting function could be strengthened by adhering to a strict policy of segregating the duties of accounting staff to reduce the risk of unauthorized journal entries being made or a misappropriation of cash. At the Company’s current size, adoption of such a policy is impractical. To reduce these risks, the CFO reviews bank reconciliation statements and performs periodic reviews of nonstandard entries after they have been recorded; all cheque payments require two signing authorities. The CEO periodically reviews recorded financial information. The CEO and CFO believe that these reviews are an adequate compensating control; accordingly, there are no plans to remediate this internal control weakness.

No material changes were made to the Company’s system of internal controls relating to financial reporting during the three months ended March 31, 2009.

INTERNATIONAL FINANCIAL REPORTING STANDARDS ("IFRS")

In February 2008, the Canadian Accounting Standards Board confirmed that the use of International Financial Reporting Standards (“IFRS”) would be required for Canadian publicly accountable enterprises for fiscal years beginning on or after January 1, 2011. In preparation for the conversion to IFRS, the Company has developed an IFRS changeover plan. We are currently in the process of reviewing the differences between current Canadian GAAP and IFRS and assessing the impacts on the other key elements of our conversion plan in this phase. These key elements include: accounting policy changes, information technology changes, education and training requirements, internal control over financial reporting, and impacts on business activities. While the Company has begun assessing the adoption of IFRS for 2011, the financial reporting impact of the transition to IFRS cannot be reasonably estimated at this time.

Neovasc Management’s Discussion & Analysis 11 of 11

EX-99.3 4 exhibit99-3.htm FORM 52-109FV1 - CEO CERTIFICATION Filed by sedaredgar.com - Neovasc Inc. - Exhibit 99.3

Form 52-109FV1
Certification of interim filings - venture issuer basic certificate

I, Alexei Marko, Chief Executive Officer of Neovasc Inc certify the following:

1.

Review: I have reviewed the interim unaudited financial statements and interim MD&A, including, for greater certainty, all documents and information that are incorporated by reference in the filings (together, the “interim filings”) of Neovasc Inc (the “issuer”) for the period ended March 31, 2009.

   
2.

No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, for the period covered by the annual filings.

   
3.

Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial statements together with the other financial information included in the interim filings fairly present in all material respects the financial condition, results of operations and cash flows of the issuer, as of the date of and for the periods presented in the annual filings.

Date: June 1, 2009

(signed) Alexei Marko
_______________________
Alexei Marko
Chief Executive Officer

 NOTE TO READER

 

In contrast to the certificate required for non-venture issuers under National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings (NI 52-109), this Venture Issuer Basic Certificate does not include representations relating to the establishment and maintenance of disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as defined in NI 52-109. In particular, the certifying officers filing this certificate are not making any representations relating to the establishment and maintenance of

 

i)

controls and other procedures designed to provide reasonable assurance that information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and

 

ii)

a process to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP.

 

The issuer’s certifying officers are responsible for ensuring that processes are in place to provide them with sufficient knowledge to support the representations they are making in this certificate. Investors should be aware that inherent limitations on the ability of certifying officers of a venture issuer to design and implement on a cost effective basis DC&P and ICFR as defined in NI 52- 109 may result in additional risks to the quality, reliability, transparency and timeliness of interim and annual filings and other reports provided under securities legislation.



EX-99.4 5 exhibit99-4.htm FORM 52-109FV1 - CFO CERTIFICATION Filed by sedaredgar.com - Neovasc Inc. - Exhibit 99.4

Form 52-109FV1
Certification of interim filings - venture issuer basic certificate

I, Chris Clark, Chief Financial Officer of Neovasc Inc certify the following:

1.

Review: I have reviewed the interim unaudited financial statements and interim MD&A, including, for greater certainty, all documents and information that are incorporated by reference in the filings (together, the “interim filings”) of Neovasc Inc (the “issuer”) for the period ended March 31, 2009.

   
2.

No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, for the period covered by the annual filings.

   
3.

Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial statements together with the other financial information included in the interim filings fairly present in all material respects the financial condition, results of operations and cash flows of the issuer, as of the date of and for the periods presented in the annual filings.

Date: June 1, 2009


(signed) Chris Clark
_______________________
Chris Clark
Chief Financial Officer

 NOTE TO READER

 

In contrast to the certificate required for non-venture issuers under National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings (NI 52-109), this Venture Issuer Basic Certificate does not include representations relating to the establishment and maintenance of disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as defined in NI 52-109. In particular, the certifying officers filing this certificate are not making any representations relating to the establishment and maintenance of

 

i)

controls and other procedures designed to provide reasonable assurance that information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and

 

ii)

a process to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP.

 

The issuer’s certifying officers are responsible for ensuring that processes are in place to provide them with sufficient knowledge to support the representations they are making in this certificate. Investors should be aware that inherent limitations on the ability of certifying officers of a venture issuer to design and implement on a cost effective basis DC&P and ICFR as defined in NI 52- 109 may result in additional risks to the quality, reliability, transparency and timeliness of interim and annual filings and other reports provided under securities legislation.



EX-99.5 6 exhibit99-5.htm NEWS RELEASE JUNE 1, 2009 Filed by sedaredgar.com - Neovasc Inc. - Exhibit 99.5
 
13700 Mayfield Place, Suite 2135
Richmond BC V6V 2E4 Canada
P:604.270.4344 F:604.270.4384
www.neovasc.com

NEWS RELEASE
TSX Venture Exchange: NVC

Neovasc Inc. Reports First Quarter 2009 Financial Results

--Company Focuses on Rebuilding Revenue Base While Stabilizing Costs--

June 1, 2009 - Vancouver, BC, Canada - Neovasc Inc. (TSXV: NVC), today announced financial results for the three months ended March 31, 2009.

“The first quarter continued to show financial effects from our strategic decision late last year to refocus Neovasc on our most promising growth areas,” said Alexei Marko, chief executive officer of Neovasc. “During this transition period we have been laying the groundwork to increase sales from our tissue product line and have continued to advance the development and approval process for our Reducer device for the treatment of refractory angina. Despite the fact that we started the year without a US distributor for our biological tissue products, sales for the quarter were only down slightly compared to last year. We have seen a significant ramp in sales since our agreement with LeMaitre Vascular came into effect and as we continue to grow our business supplying tissue to industry partners developing and manufacturing vascular devices. On the cost side, we have made good progress in reducing our cost structure and continue to focus on wringing unnecessary expense out of the business.”

Mr. Marko continued, “Since the close of the quarter, we have had several encouraging developments:  We successfully completed a non-brokered private placement of approximately $2.0 million to strengthen our cash position and earlier this month we reported very encouraging preliminary data from the three-year follow-up study of refractory angina patients implanted with our Neovasc Reducer™.  Refractory angina is a painful and debilitating condition that affects millions of patients and currently lacks effective treatments.  The preliminary three-year data indicates that the Reducer was very well tolerated and showed positive signs of efficacy in the majority of patients.  We look forward to releasing the full study data in a peer-reviewed forum and to seeking regulatory approval for Reducer in Europe later this year.  We remain optimistic that 2009 will be a turning point for Neovasc, generating good revenue growth and achiev ing significant progress in advancing our Reducer device that has the potential to transform the treatment of refractory angina.”

Financial Results
Results for the three months ended March 31, 2009 follow. All amounts are in Canadian dollars.

Net Losses
The consolidated net loss for the three months ended March 31, 2009 was $1,746,240 or $0.10 basic loss per share as compared with a net loss of $1,741,575 or $0.31 basic loss per share for the comparative period in 2008.

Revenues
Revenues decreased 18% year over year from $433,485 for the quarter ended March 31, 2008 to $355,484 for the quarter ended March 31, 2009. Sales of catheter products for the quarter ended March 31, 2009 were $16,207, an 80% decrease over sales of $80,236 in the comparable period in 2008. The termination of a direct sales force for Metricath products at the end of 2008 contributed to this decrease in sales. Sales of tissue and surgical products and services for the three months ended March 31, 2009 were $339,277, as compared to sales of $353,249 for the same period of 2008, representing a 4% decrease. These revenues were derived from the sales of Peripatch products, consulting services and contract manufacturing revenues for tissues and surgical products. The company revamped its internal sales and marketing activities during the quarter to attract more consulting services and contract manufacturing clients for its tissues business and has begun to experience an increase in interest from potential new customers.



13700 Mayfield Place, Suite 2135
Richmond BC V6V 2E4 Canada
P:604.270.4344 F:604.270.4384
www.neovasc.com

Cost of Sales
The cost of sales for the three months ended March 31, 2009 were $149,760 as compared to $208,260 in 2008, and the overall gross margin for 2009 was 58% as compared to 52% in 2008. The improvement in gross margin reflects a shift to certain contract and patch products with higher margins than the company’s Metricath or standard Peripatch products.

Expenses
Total expenses for the three months ended March 31, 2009 and 2008 were $1,930,494 and $1,909,534 respectively. Sales and marketing expenses declined 60% to $302,885 for the three months ended March 31, 2009 as compared to $749,504 for the same period in 2008. The company made a strategic decision to terminate its endovascular direct sales force in the fourth quarter of 2008 and will continue to minimize sales and marketing costs until new products from its acquisitions and other sources are ready for market. General and administrative expenses for the three months ended March 31, 2009 were $750,829 as compared to $538,285 in 2008, an increase of 39%. In the first quarter of 2009, the increase in general and administrative costs of $212,544 is largely attributable to a stock compensation charge of $86,052 relating to the immediate vesting of options granted to the Board of Directors in February 2009 and approximately $65,485 in increased expenses related to the costs of the company’s operations in Israel. Product development and clinical trial expenses were $876,780 for the three months ended March 31, 2009 as compared to $621,745 for the same period of 2008, an increase of 41%. The final PMA submission to the U.S. Food and Drug Administration in March 2009 for the Gemini Metricath product and the additional expense of the Israel R&D operation contributed to the increase.

Liquidity and Capital Resources
The company finances its operations and capital expenditures with cash generated from operations, lines of credit, long-term debt and equity financings. At March 31, 2009, the company had cash and cash equivalents of $972,510 as compared to cash of $2,498,439 as of December 31, 2008. At March 31, 2009 the company had working capital of $483,896 as compared to working capital of $2,123,519 at December 31, 2008. In addition, at March 31, 2009 the company had restricted cash related to a security on long-term debt of $50,000 (December 31, 2008 - $50,000) included in long-term assets. The decrease in working capital was predominantly due to the decline in cash during the quarter. Cash used in operations was $1,514,482 for the three months ended March 31, 2009, as compared to $1,799,811 for the same period of 2008, a decrease of $285,329. The decrease in cash usage was facilitated by the accumulation of accounts payable at March 31, 2009 for expenses related to the filing of the Metricath Gemini PMA submission. Net cash used in investing activities was $7,971 for the three months ended March 31, 2009 compared to cash used of $7,182 in the same period in 2008. The company made minimum purchase of equipments in the first three months of 2008 and 2009. Net cash used in financing activities was $3,476 for the three months ended March 31, 2009 compared to cash used of $6,498 in 2008. After the close of the quarter on April 24, 2009 the company reported completion of a non-brokered private placement of approximately 9.52 million units at the price of $0.21 per unit for aggregate gross proceeds to Neovasc of $2.0 million.



13700 Mayfield Place, Suite 2135
Richmond BC V6V 2E4 Canada
P:604.270.4344 F:604.270.4384
www.neovasc.com

Neovasc Inc. (formerly Medical Ventures Corp.)
Consolidated Balance Sheets

    March 31,     December 31,  
    2009     2008  
             
ASSETS            
             
CURRENT            
     Cash and cash equivalents $  972,510   $  2,498,439  
     Accounts receivable   335,694     470,200  
     Inventory   490,176     341,564  
     Prepaid expenses and other assets   58,635     52,356  
    1,857,015     3,362,559  
RESTRICTED CASH AND CASH EQUIVALENTS   50,000     50,000  
RETIREMENT ASSETS   8,320     -  
PROPERTY AND EQUIPMENT   1,375,259     1,399,644  
  $  3,209,594   $  4,820,523  
             
LIABILITIES            
             
CURRENT            
     Accounts payable and accrued liabilities $  1,352,140   $  1,218,405  
     Current portion of long-term debt   20,979     20,635  
    1,373,119     1,239,040  
LONG-TERM DEBT   413,237     418,612  
RETIREMENT LIABILITIES   8,964     -  
    1,795,320     1,666,616  
             
SHAREHOLDERS’ EQUITY            
             
Share capital   58,608,624     58,607,066  
Contributed surplus   4,522,856     4,436,804  
Deficit   (61,636,203 )   (59,889,963 )
    1,495,203     3,153,907  
  $  3,290,594   $  4,820,523  



13700 Mayfield Place, Suite 2135
Richmond BC V6V 2E4 Canada
P:604.270.4344 F:604.270.4384
www.neovasc.com

Neovasc Inc. (formerly Medical Ventures Corp.)
Consolidated Statements of Operations, Comprehensive Loss and Deficit
For the three months ended March 31

    2009     2008  
             
             
SALES            
       Product sales $  298,630   $  404,863  
       Consulting services   56,854     28,622  
    355,484     433,485  
COST OF SALES,            
     including underutilized capacity of $12,345 (2008: $12,579)   149,760     208,260  
GROSS PROFIT   205,724     225,225  
             
EXPENSES            
       Selling   302,885     749,504  
       General and administration   750,829     538,285  
       Product development and clinical trials   876,780     621,745  
       Amortization   32,356     45,766  
    1,962,850     1,955,300  
LOSS BEFORE OTHER            
       INCOME (EXPENSES)   (1,757,126 )   (1,730,075 )
OTHER INCOME (EXPENSES)            
       Interest income   9,621     9,095  
       Interest on long-term debt   (7,253 )   (7,514 )
     Accreted interest on repayable contribution agreement   -     (3,839 )
       Gain (Loss) on foreign exchange   8,518     (9,242 )
    10,886     11,500  
NET LOSS AND COMPREHENSIVE            
       LOSS FOR THE PERIOD   (1,746,240 )   (1,741,575 )
DEFICIT, BEGINNING OF PERIOD   (59,889,963 )   (25,630,398 )
DEFICIT, END OF PERIOD $  (61,636,203 ) $  (27,371,973 )
             
BASIC AND DILUTED LOSS PER SHARE $  (0.10 ) $  (0.31 )
             
WEIGHTED AVERAGE NUMBER OF            
       COMMON SHARES OUTSTANDING   17,756,951     5,560,477  
WEIGHTED AVERAGE NUMBER OF            
       FULLY DILUTED SHARES OUTSTANDING   22,142,567     5,560,477  



13700 Mayfield Place, Suite 2135
Richmond BC V6V 2E4 Canada
P:604.270.4344 F:604.270.4384
www.neovasc.com

Neovasc Inc. (formerly Medical Ventures Corp.)
Consolidated Statements of Cash Flows
For the three months ended March 31

    2009     2008  
OPERATING ACTIVITIES            
     Net loss for the period $  (1,746,240 ) $  (7,830,954 )
     Items not affecting cash            
               Amortization   32,356     45,766  
               Interest on repayable contribution agreement   -     3,839  
               Stock-based compensation   86,052     13,283  
    (1,627,832 )   (1,678,687 )
     Change in non-cash operating assets and liabilities            
               Accounts receivable   134,506     190,081  
               Inventory   (148,612 )   (169,160 )
               Prepaid expenses and other assets   (6,279 )   (129,145 )
               Accounts payable and accrued liabilities   133,735     (12,900 )
    (1,514,482 )   (1,799,811 )
INVESTING ACTIVITY            
     Purchase of property and equipment   (7,971 )   (7,182 )
    (7,971 )   (7,182 )
FINANCING ACTIVITIES            
     Repayment of long-term debt   (5,031 )   (4,770 )
     Repayment of repayable contribution agreement   -     (1,728 )
     Proceeds from exercise of stock options   1,555     -  
    3,476     (6,498 )
(DECREASE)/INCREASE IN CASH   (1,525,929 )   (1,813,491 )
CASH AND CASH EQUIVALENTS,            
     BEGINNING OF PERIOD   2,498,439     3,242,404  
     END OF PERIOD $  972,510   $  1,428,913  
REPRESENTED BY:            
     Cash   (33,120 )   (72,753 )
     Cashable guaranteed investment certificates   1,005,630     1,501,666  
  $  972,630   $  3,242,404  
SUPPLEMENTAL CASH FLOW INFORMATION            
     Interest paid   7,253     7,514  



13700 Mayfield Place, Suite 2135
Richmond BC V6V 2E4 Canada
P:604.270.4344 F:604.270.4384
www.neovasc.com

About Neovasc Inc.
Neovasc Inc. is a new specialty vascular device company that develops, manufactures and markets medical devices for the rapidly growing vascular and surgical marketplace. The company's current products include the Neovasc Reducer™, a novel product in development to treat refractory angina, as well as a line of advanced biological tissue technologies that are used to enhance surgical outcomes and as key components in a variety of third party medical products. For more information, visit: www.neovasc.com.

Statements contained herein that are not based on historical or current fact, including without limitation statements containing the words “anticipates,” “believes,” “may,” “continues,” “estimates,” “expects,” and “will” and words of similar import, constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, the following: general economic and business conditions, both nationally and in the regions in which the Company operates; history of losses and lack of and uncertainty of revenues, ability to obtain required financing, receipt of regulatory approval of product candidates, ability to properly integrate newly acquired businesses, technology changes; competition; changes in business strategy or development plans; the ability to attract and retain qualified personnel; existing governmental regulations and changes in, or the failure to comply with, governmental regulations; liability and other claims asserted against the Company; and other factors referenced in the Company’s filings with Canadian securities regulators. Although the Company believes that expectations conveyed by the forward-looking statements are reasonable based on the information available to it on the date such statements were made, no assurances can be given as to the future results, approvals or achievements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company does not assume the obligation to update any forward-looking statements except as otherwise required by applicable law.

###

Corporate contact: U.S. media & investor contact:
Neovasc Inc. GendeLLindheim BioCom Partners
Chris Clark Barbara Lindheim
604 248-4138 212 918-4650


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-----END PRIVACY-ENHANCED MESSAGE-----