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HYPERTENSION DIAGNOSTICS INC /MN - Quarter Report: 2010 March (Form 10-Q)

form10-q.htm

 
 

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

_____________________


FORM 10-Q
 
(Mark One)
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
   
 
For the quarterly period ended March 31, 2010
   
 
or
   
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
 
For the transition period from          to        


Commission File Number:  0-24635


HYPERTENSION DIAGNOSTICS, INC.
(Exact name of small business issuer as specified in its charter)


MINNESOTA
(State of incorporation)
 
41-1618036
(I.R.S. Employer Identification No.)


2915 WATERS ROAD, SUITE 108
EAGAN, MINNESOTA 55121-3528
(651) 687-9999
(Address of issuer’s principal executive offices and telephone number)


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.                                                    YES x  NO 
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
 
 
Large accelerated filer 
 
Accelerated filer 
 
Non-accelerated filer 
 
Smaller reporting company x
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
 
YES  NO x
 
The number of shares of Common Stock outstanding as of May 17, 2010 was 41,426,684
 

 

HYPERTENSION DIAGNOSTICS, INC.

INDEX TO FORM 10-Q

   
Page No
     
PART I.
FINANCIAL INFORMATION:
 
     
Item 1.
Financial Statements
 
     
 
Balance Sheets – March 31, 2010 (unaudited) and June 30, 2009
4
     
 
Statements of Operations (unaudited) – Three Months and Nine Months Ended March 31, 2010 and 2009
5
     
 
Statements of Cash Flows (unaudited) – Nine Months Ended March 31, 2010 and 2009
6
     
 
Notes to Financial Statements
7
     
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
10
     
Item 4T.
Controls and Procedures
18
     
PART II.
OTHER INFORMATION:
 
     
Item 6.
Exhibits
18
     
 
SIGNATURES
19
     
 
CERTIFICATIONS
20
     









 
 2

 

Forward-Looking Statements
 
    This report contains forward-looking statements that are based on the current beliefs of our management as well as assumptions made by and information currently available to management.  In addition, we may make forward-looking statements orally in the future by or on behalf of the Company.  When used, the words “believe,” “expect,” “can,” “estimate,” “anticipate” and similar expressions are intended to identify forward-looking statements.  We caution readers not to place undue reliance on any forward-looking statements and to recognize that the statements are not predictions of actual future results.  Actual results could differ materially from those anticipated in the forward-looking statements due to the risks and uncertainties set forth in our 2009 Annual Report on Form 10-K under the caption “Risk Factors,” as well as others not now anticipated.
 
    These risks and uncertainties include, without limitation: our ability to develop a business model to timely generate acceptable levels of revenues; negative effect on our stock price resulting from available securities for sale; our need for additional capital; our dependence on our CVProfilor® DO-2020; the availability of third-party reimbursements for the use of our products; increased market acceptance of our products; our marketing strategy potentially resulting in lower revenues; the illiquidity of our securities on the OTC Bulletin Board and the related restrictions on our securities relating to “penny stocks” potential violations by us of federal and state securities laws; the availability of integral components for our products; our ability to develop distribution channels; increased competition; changes in government regulation; health care reforms; exposure to potential product liability; our ability to protect our proprietary technology; regulatory restrictions pertaining to data privacy issues in utilizing our Central Data Management Facility; and the ability to manufacture our products on a commercial scale and in compliance with regulatory requirements.  We undertake no responsibility to update any forward-looking statement. These forward-looking statements are only made as of the date of this report.  In addition to the risks we have articulated above, changes in market conditions, changes in our business and other factors may result in different or increased risks to our business in the future that are not foreseeable at this time.


 
  3

 

PART I.  FINANCIAL INFORMATION
Item 1.  Financial Statements
Hypertension Diagnostics, Inc.
Balance Sheets
(Unaudited)
     
March 31,                                June 30,
   
 
2010
 
2009
Assets
 
 
 
 
 
Current Assets:
         
   Cash and cash equivalents
   
     $       942,976
 
 $       697,918
   Accounts receivable
   
              4,885
 
            42,500
   Inventory, net
   
          288,587
 
          278,873
   Prepaid and other current assets
   
              7,921
 
              3,237
               Total Current Assets
   
       1,244,369
 
       1,022,528
           
Property and Equipment:
         
   Leasehold improvements
   
            17,202
 
            17,202
   Furniture and equipment
   
          172,052
 
          172,052
   Computer & electronic equipment
   
          580,324
 
          580,324
   Equipment rental units
   
          162,351
 
          162,351
Total Property and Equipment
   
          931,929 
 
          931,929
   Less accumulated depreciation and amortization
   
         (930,274)
 
         (928,200)
               Property and Equipment, net
   
              1,655
 
              3,729
           
Other Assets
   
              6,530
 
              6,530
               Total Assets
   
 $    1,252,554
 
 $    1,032,787
           
Liabilities and Shareholders' Equity / (Deficit)
         
Current Liabilities:
       
 
   Accounts payable
   
 $            8,480
 
 $          16,343
   Accrued vacation, payroll and payroll taxes
   
           101,903
 
             47,579
   Deferred revenue
   
71,755
 
        48,246 
   Deposits from customers
   
       44,012
 
            970 
   Other accrued expenses
   
             20,628
 
               6,746
               Total Current Liabilities
   
           246,778
 
            119,884
           
Long Term Liabilities:
   Deferred compensation
   
       1,542,750
 
          220,500
   Deferred revenue, less current portion
   
          72,907
 
            32,362
               Total Long Term Liabilities
   
        1,615,657
 
           252,862
           
Shareholders' Equity / (Deficit):
         
   Series A Convertible Preferred Stock, $.01 par value:
         
      Authorized shares--5,000,000
         
      Issued and outstanding shares--722,488 and 744,536
         
        at March 31, 2010 and June 30, 2009, respectively;
   
 
 
 
        each share of preferred stock is convertible into 12 shares
        of common stock at the option of the holder (aggregate
         
        liquidation preference of $8,279,869 and $7,422,487 at
         
        March 31, 2010 and June 30, 2009, respectively)
   
             7,225
 
             7,445
   Common Stock, $.01 par value:
         
      Authorized shares--150,000,000
         
      Issued and outstanding shares--41,242,664 and 40,963,088
         
      at March 31, 2010 and June 30, 2009, respectively
 
 
          412,427
 
          409,631
   Additional paid-in capital
 
 
      27,752,647
 
      27,677,572
   Accumulated deficit
 
 
    (28,782,180)
 
    (27,434,607)
               Total Shareholders' Equity / (Deficit)
 
 
        (609,881)
 
         660,041
               Total Liabilities and Shareholders' Equity / (Deficit)
 
 
 $     1,252,554
 
 $     1,032,787
           
See accompanying notes.
         

 
  4

 

Hypertension Diagnostics, Inc.
Statements of Operations
(Unaudited)


 
                                                       
   Three Months Ended    Nine Months Ended
   March 31,    March 31,
   2010    2009    2010    2009
Revenue:
           
   Equipment sales
 $ 71,000
 
 $28,000
 
 $730,825
 
 $206,837
   Equipment rental
 15,092
 
17,627
 
 60,335
 
 67,443
   Warranty, parts & supplies income
 40,169
 
 19,138
 
 95,501
 
64,204
 
 126,261
 
  64,765
 
 886,661
 
 338,484
Cost of Sales:
             
   Cost of sales
 31,445
 
30,840
 
162,889
 
128,720
   Inventory reserve allowance
 (7,859)
 
 (3,471)
 
 (63,325)
 
(29,565)
             Net Cost of Sales
 23,586
 
27,369
 
99,564
 
99,155
             Gross Profit
102,675
 
37,396
 
 787,097
 
239,329
               
Expenses:
             
   Selling, general and administrative expenses
440,388
 
  58,331
 
 2,141,895
 
339,671
             Total Expense
 440,388
 
  58,331
 
 2,141,895
 
339,671
Operating Income (Loss)
 (337,713)
 
 (20,935)
 
 (1,354,798)
 
 (100,342)
               
Other Income:
             
   Interest income
 3,336
 
 1,946
 
7,225
 
11,793
              Total Other Income
3,336
 
1,946
 
7,225
 
11,793
               
Net loss before income taxes
 (334,377)
 
 (18,989)
 
 (1,347,573)
 
 (88,549)
   Income Taxes
-
 
 -
 
-
 
 -
              Net loss before income taxes
 $(334,377)
 
 $(18,989)
 
 $(1,347,573)
 
 $(88,549)
               
               
Basic and Diluted Net Loss per Share
$          (.01)
 
$          .00
 
$         (.03)
 
$         .00
Weighted Average Shares Outstanding Basic & Diluted
 41,238,664
 
 40,795,820
 
 41,142,729
 
 40,650,494
               
See accompanying notes.
             

                                          5  
 

 

Hypertension Diagnostics, Inc.
Statements of Cash Flows
(Unaudited)
 
                                                         
                                                    
                                     Nine Months Ended
    March 31,
   
2010
 
2009
Operating Activities:
       
Net loss
 
$  (1,347,573)
 
$  (88,549)
Adjustments to reconcile net loss to net
       
   cash provided by / (used in) operating activities:
       
      Deferred stock based compensation expense
 
1,322,250
 
(309,750)
      Depreciation
 
2,074
 
7,146
      Stock options expense
 
76,001
 
68,625
      Change in operating assets and liabilities:
       
            Accounts receivable
 
37,615
 
26,000
            Inventory
 
(9,714)
 
7,994
            Prepaid and other current assets
 
(4,684)
 
2,202
            Accounts payable
 
(7,863)
 
(12,166)
            Accrued payroll and payroll taxes
 
54,324
 
(33,010)
            Deferred revenue
 
64,054
 
21,430
            Other accrued expenses
 
56,924
 
31,995
               Net cash provided by / (used in) operating activities
243,408
 
(278,083)
         
 Financing Activities:        
   Proceeds from stock option exercise     1,650    
       
Net increase/(decrease) in cash and cash equivalents
245,058
 
(278,083)
               Cash and cash equivalents at beginning of period
697,918
 
1,081,868
Cash and cash equivalents at end of period
 
$     942,976
 
$   803,785
         
See accompanying notes.
       
 
 

 
  6

 

Hypertension Diagnostics, Inc.
Notes to Financial Statements
March 31, 2010

1. Basis of Presentation
 
    The accompanying unaudited financial statements of Hypertension Diagnostics, Inc. (the “Company” or “HDI”) have been prepared in accordance with the instructions to Form 10-Q and do not include all the information and notes required by generally accepted accounting principles for complete financial statements.  In the opinion of management, these unaudited financial statements reflect all adjustments, consisting only of normal and recurring adjustments necessary for a fair presentation of the financial statements.  The results of operations for the three months and nine months ended March 31, 2010 are not necessarily indicative of the results that may be expected for the full year ending June 30, 2010.  The June 30, 2009 balance sheet was derived from audited financial statements.  For further information, refer to the financial statements and notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2009.  The policies described in that report are used for preparing quarterly reports.

2. Recent Accounting Pronouncements
 
    In June 2009, the FASB issued  Accounting for Transfers of Financial Assets  effective for fiscal years beginning after November 15, 2009.  This pronouncement eliminates the quantitative approach previously required for determining the primary beneficiary of a variable interest entity and requires ongoing qualitative reassessments of whether an enterprise is the primary beneficiary of a variable interest entity. The Company does not expect the adoption of this standard to have any current impact on the consolidated financial statements.
 
    In October 2009, the FASB issued FASB ASU No. 2009-13, “Multiple-Deliverable Revenue Arrangements,” which is now codified under FASB ASC Topic 605, “Revenue Recognition.” This ASU establishes a selling price hierarchy for determining the selling price of a deliverable; eliminates the residual method of allocation and requires arrangement consideration be allocated at the inception of the arrangement to all deliverables using the relative selling price method; and requires a vendor to determine its best estimate of selling price in a manner consistent with that used to determine the selling price of the deliverable on a standalone basis. The ASU also significantly expands the required disclosures related to a vendor’s multiple-deliverable revenue arrangements. FASB ASU No. 2009-13 is effective on a prospective basis for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010, with early adoption permitted. We are evaluating the effect from the adoption of this ASU on our consolidated financial position, results of operations and cash flows.

3. Litigation
 
    The Company is involved in various legal actions in the ordinary course of its business.  Although the outcome of any such legal actions cannot be predicted, management believes that there are no pending legal proceedings against or involving the Company for which the outcome is likely to have a material adverse effect upon the Company’s financial position or results of operations.

4. Stock Options
 
    The Company regularly grants stock options to individuals under various plans as described in Note 6 of the Company’s Annual Report on Form 10-K for the year ended June 30, 2009.  The Company recognizes share-based payments, as compensation costs for transactions, including grants of employee stock options, to be recognized in the financial statements.  Stock based compensation expense is measured based on the fair value of the equity or liability instrument issued.  Share-based compensation arrangements include: stock options, restricted share plans, performance-based awards, share appreciation rights, and employee share purchase plans.  The Company measures the cost of employee and directors services received in exchange for stock options based on the grant-date fair value of the award, and the cost over the period in which the employee and director is required to provide services for the award.  The Company uses the Black-Scholes option-pricing model that meets the fair value objective.
 
    The Company granted 0 and 1,300,000 stock options during the three and nine months ended March 31, 2010, respectively.  During the three and nine months ended March 31, 2009, there were no stock options granted. The Company recognized compensation expense of $30,251 for the three months ended March 31, 2010 and compensation expense of $76,001 for the nine months ended March 31, 2010.  The Company recognized compensation expense of $22,875 and $68,625 for the three months and the nine months ended March 31, 2009, respectively.  The Company estimates $30,250 of additional expense for the remainder of fiscal year 2010 based on the value of options outstanding on March 31, 2010 that will vest during the remainder of fiscal year 2010.  These estimates do not include any expense for options that may be granted and vest in the future.

 
 7

 

Hypertension Diagnostics, Inc.
Notes to Financial Statements
March 31, 2010

5. Deferred Compensation
 
    The Company has a Deferred Equity Compensation Agreement with its CEO, Mark N. Schwartz (the “Agreement”), whereby the Company currently grants 225,000 phantom shares of its common stock to its CEO for every month of employment through December 31, 2010.  The Agreement was first entered into in January 2006 for a period of one year and the Board of Directors of the Company has extended the Agreement each year.  A cash payment will be made to the CEO equal to the price per share of the Company’s common stock times the number of phantom shares accrued at the earliest of certain Event Dates (as defined in the Agreement).  Accordingly, the Company has accrued a deferred compensation liability of $1,542,750 at March 31, 2010, which is the fair market value of 9,075,000 phantom shares granted as of March 31, 2010, pursuant to the Agreement.  Due to the aggregate number of phantom shares granted since January 1, 2006 which totals 9,075,000 as of March 31, 2010 and the changes in the closing price of the Company’s common stock during the quarter (an increase from $0.16 to $0.17 per share), the Company recorded a total expense of  $198,750 and $1,322,250 in compensation cost for the three and nine months ended March 31, 2010, compared to $147,000 and $309,750 in compensation benefit for the three and nine months ended March 31, 2009, respectively.  An increase in the Company’s common stock price would cause an increase in the deferred compensation, while a decrease in the Company’s stock price would cause a decrease in the deferred compensation liability.  Therefore, the expense that the Company recorded for the three and nine months ended March 31, 2010 results from an increase in the Company’s stock price and phantom shares granted from the prior period ended December 31, 2009 to the period ended March 31, 2010.  On the last trading day of the period ended December 31, 2009, the Company’s average closing stock price was $0.16 per share, and on the last trading day of the period ended March 31, 2010, the Company’s average closing stock price was $0.17 per share.
 
    Per the terms of the employment agreement, payment of the deferred compensation liability will occur upon one of the following Event Dates: i) execution of a definitive agreement resulting in a change of control of the Company’s common stock; ii) termination of employment; iii) death of the CEO; or iv) no later than January 1, 2012.  Upon one of these events, a cash payment over 24 months will be made to the CEO equal to the trading price per share of the Company’s common stock times the number of phantom stock shares accrued to the Event Date.

6. Shareholders Equity
 
    For the three months ended March 31, 2010 and March 31, 2009, no shares of the Company’s Series A Convertible Preferred Stock were converted.  For the nine months ended March 31, 2010, 22,048 shares of the Company’s Series A Convertible Preferred Stock were converted into 264,576 shares of Common Stock compared to the nine months ended March 31, 2009 when 85,084 shares of Series A Convertible Preferred Stock converted into 1,021,008 shares of Common Stock.
 
    In January 2010, the Company received proceeds of $1,650 from the exercise of 15,000 stock options at an $0.11 excercise price.
 
7. Net Income / (Loss) Per Share
 
    Basic net income (loss) per share is computed using the weighted average number of common shares outstanding during each period.  Diluted net income (loss) per share would normally include the dilutive effect of common shares potentially issuable upon the exercise of stock options, warrants, or the conversion of preferred stock.  However, since the Company reported a loss for the three and nine months ended March 31, 2010 or the exercise price for options outstanding at the end of the period is higher than the average stock price for the period; all potential common shares have been excluded from the calculation of diluted net loss per share, as the effect would have been anti-dilutive.
 
    The following table provides a reconciliation of the numerators and denominators used in calculating basic and diluted earnings per share at March 31, 2010 and 2009:

 

 

Hypertension Diagnostics, Inc.
Notes to Financial Statements
March 31, 2010

7. Net Income / (Loss) Per Share (continued)


     
            March 31
   
              March 31
 
     
               2010
   
                  2009
 
 
Basic earnings (loss) per share calculation:
           
 
Net income (loss) to common shareholders
$
     (1,347,573)
 
$
        (88,549)
 
 
Weighted average of common shares outstanding
 
         41,142,729
   
       40,650,494
 
 
Basic net earnings (loss) per share
$
        (0.03)
 
$
               0.00
 
               
 
Diluted earnings (loss) per share calculation:
           
 
Net income (loss) to common shareholders
$
     (1,347,573)
 
$
         (88,549)
 
 
Weighted average of common shares outstanding
 
 41,142,729
   
        40,650,494
 
 
Series A Convertible Preferred Stock (1)
 
     -
   
      -
 
 
           Stock Options (2)
 
     -
   
      -
 
 
           Warrants (3)
 
     -
   
      -
 
 
Diluted weighted average common shares outstanding
 
 41,142,729
   
          40,650,494
 
 
Diluted net income (loss) per share
$
       (0.03)
 
$
                 0.00
 

(1)
At March 31, 2010, there were 722,488 shares of  Series A Convertible Preferred Stock outstanding and 758,475 at March 31, 2009. Using the preferred stock conversion ratio of 12:1, the common stock equivalents attributable to these preferred shares are 8,669,856 at March 31, 2010 and 9,101,700 at March 31, 2009.  These common stock equivalents are anti-dilutive at March 31, 2010 and 2009 and therefore, have been excluded from diluted earnings per share.
 
(2)
At March 31, 2010, there were common stock equivalents attributable to outstanding stock options of 7,259,914 common shares and 6,050,342 common shares at March 31, 2009. The stock options are anti-dilutive at March 31, 2010 and 2009 and therefore, have been excluded from diluted earnings per share.
 
(3)
At March 31, 2010 and 2009, there were common stock equivalents of 18,895,254 common shares attributable to warrants. The warrants expire on September 30, 2010, and have an exercise price of $.22 to $.30 per share. The warrants are anti- dilutive at March 31, 2010 and 2009 and therefore, have been excluded from diluted earnings per share.


8. Exercise Dates of Warrants
 
    In June 2009, the Company agreed to extend to September 30, 2010, the exercise date of all of its outstanding warrants to purchase shares of its Common Stock, $0.01 par value per share, and Series A Convertible Preferred Stock, $0.01 par value per share, which were granted in connection with the Company’s private offerings which closed on August 28, 2003 and February 9, 2004.  The exercise prices of $0.22 and $0.30 of the various warrants were not changed with the extension of the time to exercise.  

9. Reclassifications
 
    Certain amounts in the three and nine months ended March 31, 2009 financial statements have been reclassified to conform to the three and nine months ended March 31, 2010 presentation.  The reclassifications had no effect on the three and nine months ended March 31, 2009 cash flows, financial position or net income (loss), as originally reported.


 
  9

 

Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations

Overview
 
    We are engaged in the design, development, manufacture and marketing of proprietary medical devices that we believe non-invasively detect subtle changes in the elasticity of both large and small arteries.  We are currently marketing two products: the HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System and the CVProfilor® DO-2020 CardioVascular Profiling System.
 
    The CR-2000 Research System is being marketed worldwide “for research purposes only” to clinical research investigators for the purpose of collecting data in cardiovascular studies. Because the CR-2000 Research System bears the CE Mark and meets the European Union Medical Device Directive, physicians may use the CR-2000 Research System with patients in a clinical setting in the European Union.
 
    In the U.S., the CVProfilor® DO-2020 System is being marketed to primary care physicians and other health care professionals on a purchase or lease basis.  Some Systems previously marketed under a per-patient-tested rental basis remain in use although we no longer offer that option in our current marketing. Utilizing our Central Data Management Facility, we are able to track rental unit utilization of the CVProfilor® DO-2020 System in each physician’s office and medical clinic and to invoice our physician customers on the number of CardioVascular Profile Reports (CVProfile™ Reports) which they generate each month.
 
 
Recent Accounting Pronouncements

In June 2009, the FASB issued  Accounting for Transfers of Financial Assets effective for fiscal years beginning after November 15, 2009.  This pronouncement eliminates the quantitative approach previously required for determining the primary beneficiary of a variable interest entity and requires ongoing qualitative reassessments of whether an enterprise is the primary beneficiary of a variable interest entity. The Company does not expect the adoption of this standard to have any current impact on the consolidated financial statements.

In October 2009, the FASB issued FASB ASU No. 2009-13, “Multiple-Deliverable Revenue Arrangements,” which is now codified under FASB ASC Topic 605, “Revenue Recognition.” This ASU establishes a selling price hierarchy for determining the selling price of a deliverable; eliminates the residual method of allocation and requires arrangement consideration be allocated at the inception of the arrangement to all deliverables using the relative selling price method; and requires a vendor determine its best estimate of selling price in a manner consistent with that used to determine the selling price of the deliverable on a standalone basis. The ASU also significantly expands the required disclosures related to a vendor’s multiple-deliverable revenue arrangements. FASB ASU No. 2009-13 is effective on a prospective basis for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010, with early adoption permitted. We are evaluating the effect from the adoption of this ASU on our consolidated financial position, results of operations and cash flows.

Critical Accounting Policies

The financial statements are prepared in accordance with accounting principles generally accepted in the U.S., which requires us to make estimates and assumptions in certain circumstances that affect amounts reported in the accompanying financial statements and related footnotes.  In preparing these financial statements, management has made its best estimates and judgments of certain amounts included in the financial statements, giving due consideration to materiality.  We do not believe there is a great likelihood that materially different amounts would be reported related to the accounting policies described below.  However, application of these accounting policies involves the exercise of judgment and use of assumptions as to future uncertainties and, as a result, actual results could differ from these estimates.

Revenue Recognition.  We recognize revenue in accordance with U.S. Securities and Exchange Commission’s Staff Accounting Bulletin (SAB) No. 104, “Revenue Recognition.”  Pursuant to SAB No. 104, the Company recognizes revenue from the sale of equipment at the time of shipment to a customer or distributor.  Shipment occurs only after receipt of a valid purchase order and signed sale agreement.  Payments from customers and distributors are either made in advance of shipment or within a short time frame after shipment.  In the case of sales to distributors, such payment is not contingent upon resale of the product to end users.  Shipping and handling costs are included as cost of equipment sales.  At the time of shipment, all of the criteria for recognition set forth in SAB No. 104 have been met:  persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the selling price is fixed or determinable and collectability is reasonably assured.
 
Equipment rental revenue, whether from the minimum monthly fee or from the per-patient-tested fee, is recognized when all of the criteria for recognition set forth in SAB No. 104 have been met:  persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the selling price is fixed or determinable and collectability is reasonably assured.

 
10 

 

In the case of either a sale or rental of our product, there are no post-shipment obligations which affect the timing of revenue recognition.  Once purchased, neither customers nor distributors have a right to return or exchange our product.  Warranty, parts & supplies revenue is recognized upon shipment, as all parts sent to customers are prepaid before the part is shipped. Warranty repairs are handled on a repair or replacement basis, at our discretion.  Further, there is no installation of our product; it is ready to use when plugged into an electrical outlet and no specialized knowledge is required to ready it for use.  For these reasons, we have concluded that our revenue recognition policy is appropriate and in accordance with SAB No.104.

Allowance for Doubtful Accounts.  Accounts receivable are reviewed to determine the need for an allowance for amounts that may become uncollectible in the future.  The necessity of an allowance is based on management’s review of accounts receivable balances and historical write-offs.  As of March 31, 2010 and June 30, 2009, there was no allowance for doubtful accounts.

Inventories and Related Allowance for Excess and Obsolete Inventory.  Inventories are valued at the lower of cost or market and reviewed to determine the need for an allowance for excess and obsolete inventories.  The need for an allowance is based on management’s review of inventories on hand compared to estimated future usage and sales.  As of March 31, 2010 and June 30, 2009, there was an inventory allowance of $349,155 and $412,480, respectively.

                Research and Development.  For the three months and nine months ended March 31, 2010, we incurred $0 and $1,470 in research and development costs. The Company did not incur any research and development costs for the three and nine months ended March 31, 2009, respectively.

Deferred Revenue.   The Company has warranty maintenance contracts with its customers ranging from one to three years to provide replacement parts to its customers.  The Company requires full payment in advance and these cash deposits are recorded as deferred revenue.  The Company recognizes the deferred revenue on a quarterly basis and has recorded total deferred revenue of $144,662 and $80,608 at March 31, 2010 and June 30, 2009, respectively. 

Results of Operations

As of March 31, 2010, we had an accumulated deficit of $28,782,180.  Until we are able to generate significant revenue from our activities, we expect to continue to incur operating losses.  As of March 31, 2010, we had cash and cash equivalents of $942,976.  We anticipate that these funds, in conjunction with revenue anticipated to be earned from sales of our CVProfilor® DO-2020 Systems, anticipated sales of our CR-2000 Research Systems, and anticipated operating costs, will allow us to pursue our business development strategy for at least the next twelve months following March 31, 2010.

Three Months Ended March 31, 2010 Compared to Three Months Ended March 31, 2009

The following is a summary of our Revenue and Cost of Sales for the three months ended March 31, 2010 and 2009, respectively:
 

 
    Three Months Ended March 31, 2010
         Equipment    Equipment    Warranty,
   
Total
 
Sales
 
Rental
 
Parts & Supplies
                 
Revenue
 
 $126,261
 
 $ 71,000
 
 $ 15,092
 
 $ 40,169
Cost of Sales
 
23,586
 
13,263
 
2,820
 
7,503
Gross Profit
 
 $102,675
 
 $ 57,737
 
 $ 12,272
 
 $ 32,666
                 
 
 
                           
    Three Months Ended March 31, 2009
       
Equipment
 
Equipment
 
Warranty,
   
Total
 
Sales
 
Rental
 
Parts & Supplies
                 
Revenue
 
 $ 64,765
 
 $ 28,000
 
 $ 17,627
 
 $ 19,138
Cost of Sales
 
 27,369
 
11,833
 
 7,449
 
 8,087
Gross Profit
 
 $ 37,396
 
 $ 16,167
 
 $ 10,178
 
 $ 11,051
                 

    Revenue.   Total Revenue for the three months ended March 31, 2010 was $126,261, compared to $64,765 for the three months ended March 31, 2009, a 95.0% increase.

Equipment Sales Revenue for the three months ended March 31, 2010 was $71,000, compared to $28,000 for the three months ended March 31, 2009, a 153.6% increase.  The $43,000 increase is due to selling more units at a higher price for the three months ending March 31, 2010, compared to the three months ending March 31, 2009.  Equipment Sales Revenue for the three months ended December 31, 2009 was $405,690.  Approximately $106,340 of that revenue was from the sale of CR-2000 Research Systems to the University of Minnesota – CCBR/BIOSTAT as part of an NIH funded study on cardiovascular disease risk during HIV infection.

 
  11

 
    Without the revenue from the NIH funded study, equipment sales revenue for the three months ended December 31, 2009 would have been $299,250. In the three months ended March 31, 2010, the Company recognized no revenue from the sale of CR-2000 Research Systems for the NIH funded study.  The decrease in revenue from $299,250 for the three months ended December 31, 2009 to $71,000 for the three months ended March 31, 2010 was a result of fewer units sold during that period.
 
    Market acceptance of the CVProfilor® DO-2020 System by physicians has taken more time and resources than originally anticipated due to the challenges associated with marketing new diagnostic equipment in the primary care physician market.  We have focused our resources on specific regional markets that we believe are more likely to generate higher levels of acceptance of the CVProfilor® DO-2020 System by physicians.  Our current marketing strategy focuses on marketing the CVProfilor® DO-2020 System to primary care physicians (internists and family practioners) who treat patients with hypertension and diabetes.  We believe these physicians have the greatest interest in, and use for, our product.  Therefore, the most critical factor in our ability to increase revenue rests in our ability to expand our distribution network to increase sales of our CVProfilor® DO-2020 System.
 
    The existence, timing and extent of reimbursement of physicians for the use of our CVProfilor® DO-2020 System affects the market acceptance of our product.  Reimbursement will vary by the patient’s medical necessity, by physician, by provider, by geography and by provider coverage plans, making the process of obtaining reimbursement for the CVProfilor® DO-2020 System by physician customers an important component of our product’s success.  To the extent that reimbursement is unavailable or inadequate, physicians will be less likely to use the CVProfilor® DO-2020 System.
 
    For the CVProfilor® DO-2020 Systems currently being rented on a per-patient-tested basis, utilization in one month is invoiced in the following month and payment is generally received within 30 to 60 days of invoicing.  Thus, physician payments for use of the CVProfilor® DO-2020 System follow actual utilization by some 60-90 days.
 
    For the three months ended March 31, 2010, we recognized revenue for the CVProfilor® DO-2020 System “per-patient-tested” rental program of $15,092, compared to $17,627 for the three months ended March 31, 2009, a 14.4% decrease.  The Company no longer offers a rental program as part of its current marketing strategy and therefore, expects equipment rental revenue to continue to decrease.
 
    For the three months ended March 31, 2010, warranty, parts & supplies revenue was $40,169 compared to $19,138 for the three months ended March 31, 2009, a 109.9% increase.  During the three months ended March 31, 2010, the Company sold two replacement sensors for a total of $7,990 and twelve software upgrades for $3,588, but did not have any replacement sensor sales or software upgrades for the three months ended March 31, 2009.  Warranty revenue was $20,780 for three months ended March 31, 2010 and $17,093 for the three months ended March 31, 2009, a 21.6% increase.
 
    Expenses.   Total selling, general and administrative expenses for the three months ended March 31, 2010 were $440,388, compared to $ 58,331 for the three months ended March 31, 2009. The following is a summary of the major categories included in selling, general and administrative expenses:

   
Three Months Ended
 
   
March 31
 
 
        2010
 
   2009
Wages, expenses, benefits before deferred compensation……………
 $139,665
 
      $ 123,489
Deferred compensation…...…………………………………………..
  198,750
 
        (147,000)
Outside consultants…………………………………………………...
 13,158
 
                    2,739
Rent (building/equipment) and utilities……………………..………..
14,186
 
           15,637
Insurance-general and directors/officers liability……..……..………..
 5,614
 
             4,841
Selling, marketing and promotion, including applicable wages and sales commissions.
10,000
 
                         -
Legal and audit/accounting fees……………………………..………..
 6,742
 
           13,102
Depreciation and amortization…………………………………….….
 317
 
             2,002
Stock option expense………………………………………………...
30,251
 
           22,875
Other-general and administrative…………………………………….
21,705
 
           20,646
            Total selling, general and administrative expenses………….
 $440,388
 
$   58,331         

    Wages, related expenses and benefits before deferred compensation for the three months ended March 31, 2010 were $139,665 compared to $123,489 for the three months ended March 31, 2009, at 13.1% increase. This increase is largely due to an increase in wages for the three months ended March 31, 2010 compared to March 31, 2009.

 
12 

 

Deferred compensation, which is a non-cash charge that relates to phantom stock issuances issued to our chief executive officer as part of his compensation for services provided to us. (see Note 5 in the Company’s financial statements).  For the three months ended March 31, 2010, deferred compensation charge was $198,750, compared to a deferred compensation benefit of $147,000 (negative charge) for the three months ended March 31, 2009.  An increase in the Company’s stock price creates a deferred compensation charge; whereas, a decrease in the Company’s stock price creates a deferred compensation benefit. The increased charge for the three month period ended March 31, 2010 compared to the benefit for the three months ended March 31, 2009 is the result of the increase in the Company’s stock price.  The charge also reflects the additional phantom shares granted during the three month period ended March 31, 2010 and 2009.
 
Outside consultant’s expense increased from $2,739 to $13,158 for the three months ended March 31, 2009 and 2010, respectively, a 380.4% increase. This increase is largely due to an increase in the expenses associated with our quality systems, regulatory affairs, and engineering consultants in the three months ended March 31, 2010, compared to 2009.
 
Rent (building/equipment) and utilities decreased from $15,637 to $14,186 for the three months ended March 31, 2009 and 2010, respectively, a 9.3% decrease.
 
Insurance expense increased from $4,841 to $5,614 for the three months ended March 31, 2009 and 2010, respectively, a 16.0% increase.  This increase is due to an increase in the cost of the Company’s liability insurance as well as an increase in property insurance premiums.
 
In the three month period ended March 31, 2010, we had in place a new indirect distribution plan in which distributors purchased our equipment directly as well as having distributors who had their customers purchase equipment from our company and were then paid a commission.  Selling, marketing and promotion expense was $10,000 for the three months ended March 31, 2010, compared to no ($0) expense for the three months ended March 31, 2009.  At that time, we had a direct distribution arrangement that was limited to selling only to distributors who purchased our equipment directly from the Company.
 
Legal and audit/accounting fees decreased from $13,102 to $6,742 for the three months ended March 31, 2009 and 2010 respectively, a 48.5% decrease.  This decrease was largely the result of lower audit and related fees.
 
Stock option expense increased from $22,875 to $30,251 for the three months ended March 31, 2009 and 2010, a 32.2% increase. This expense is based on the grant date fair value related to stock options that vested during the three months ended March 31, 2009 and 2010, respectively.  This expense is a result of the stock options granted to the non-management board of directors effective January 1, 2010, which vest quarterly through December 31, 2010.
 
Other – general and administrative expenses increased from $20,646 to $21,705 for the three months ended March 31, 2009 and 2010, respectively, a 5.1% increase.
 
Interest income was $3,336 and $1,946 for the three months ended March 31, 2010 and 2009, respectively a 71.4% increase. This increase was a result of the Company’s larger cash balance as well as the Company’s cash management strategy which caused the Company to purchase higher yielding bank CDs in amounts not larger than the FDIC insurance protection.
 
Our net loss was $334,377 for the three months ended March 31, 2010, compared to a net loss of $18,989 for the three months ended March 31, 2009.  For the three months ended March 31, 2010, basic and diluted net loss per share was $(.01), based on weighted average shares outstanding of 41,238,664.  For the three months ended March 31, 2009, basic and diluted net loss per share was $.00, based on weighted average shares outstanding of 40,795,820.

 
  13

 


Nine Months Ended March 31, 2010 Compared to Nine Months Ended March 31, 2009

The following is a summary of our Revenue and Cost of Sales for the nine months ended March 31, 2010 and 2009 respectively:
 

                                     Nine Months Ended March 31, 2010
       
Equipment
 
Equipment
 
Warranty,
   
Total
 
Sales
 
Rental
 
Parts & Supplies
                 
Revenue
 
 $886,661
 
 $730,825
 
 $60,335
 
 $95,501
Cost of Sales
 
 99,564
 
 79,078
 
7,444
 
13,042
Gross Profit
 
 $787,097
 
 $651,747
 
 $52,891
 
 $82,459
 
 
                                     Nine Months Ended March 31, 2009
       
Equipment
 
Equipment
 
Warranty,
   
Total
 
Sales
 
Rental
 
Parts & Supplies
                 
Revenue
 
 $338,484
 
 $206,837
 
 $67,443
 
 $64,204
Cost of Sales
 
 99,155
 
 58,699
 
20,518
 
 19,938
Gross Profit
 
 $239,329
 
 $148,138
 
 $46,925
 
 $44,266
                 
                       

    Revenue.   Total Revenue for the nine months ended March 31, 2010 was $886,661, compared to $338,484 for the nine months ended March 31, 2009, a 162.0% increase.

     Equipment Sales Revenue for the nine months ended March 31, 2010 was $730,825 compared to $206,837 for the nine months ended March 31, 2009, a 253.3% increase.  During the nine months ended March 31, 2010, the Company recognized $205,085 from the sale of CR-2000 Research Systems to the University of Minnesota – CCBR/BIOSTAT as part of an NIH funded study on cardiovascular disease risk during HIV infection. During the nine months ended March 31, 2009, there were no sales associated with the NIH funded study.  Without the NIH study, Equipment Sales Revenue for the nine months ended March 31, 2010 was $525,740.  The difference between the year-to-date March 31, 2010 Equipment Sales Revenue of $525,740 and the year to date March 31, 2009 Equipment Sales Revenue of $206,837 was due to selling more units at higher prices for the nine months ended March 31, 2010, compared to the nine months ended March 31, 2009.

    Market acceptance of the CVProfilor® DO-2020 System by physicians has taken more time and resources than originally anticipated due to the challenges associated with marketing new diagnostic equipment in the primary care physician market.  We have focused our resources on specific regional markets that we believe are more likely to generate higher levels of acceptance of the CVProfilor® DO-2020 System by physicians.  Our current marketing strategy focuses on marketing the CVProfilor® DO-2020 System to primary care physicians (internists and family practioners) who treat patients with hypertension and diabetes.  We believe these physicians have the greatest interest in, and use for, our product.  Therefore, the most critical factor in our ability to increase revenue rests in our ability to expand our distribution network to increase sales of our CVProfilor® DO-2020 System.

    The existence, timing and extent of reimbursement of physicians for the use of our CVProfilor® DO-2020 System affects the market acceptance of our product.  Reimbursement will vary by the patient’s medical necessity, by physician, by provider, by geography and by provider coverage plans, making the process of obtaining reimbursement for the CVProfilor® DO-2020 System by physician customers an important component of our product’s success.  To the extent that reimbursement is unavailable or inadequate, physicians will be less likely to use the CVProfilor® DO-2020 System.

    In addition, for the CVProfilor® DO-2020 Systems currently being rented on a per-patient-tested basis, we have a delay in the cost recovery of our working assets.  Although our per-patient-tested marketing approach reduces the risk and thereby increases the potential rate of acceptance for physician customers willing to use the CVProfilor® DO-2020 System as compared to a capital acquisition approach, it also delays our cash flow recovery of product costs.  Physician payments for use of the CVProfilor® DO-2020 System follow actual utilization by some 60-90 days; utilization in one month is invoiced in the following month and payment is generally received within 30 to 60 days of invoicing.
 
     For the nine months ended March 31, 2010, we recognized Revenue for the CVProfilor® DO-2020 “per-patient-tested” rental program of $60,335, compared to $67,443 for the nine months ended March 31, 2009, a 10.5% decrease.    The decrease is due to the customers who have decided to purchase the CVProfilor product rather than rent it and the elimination of the per-patient-tested rental program from our current marketing strategy.

 
  14

 
    For the nine months ended March 31, 2010, Warranty, Parts & Supplies Revenue was $95,501 compared to $64,204 for the nine months ended March 31, 2009, a 48.7% increase.  This increase is due mainly to an increase in sales of warranty service agreements.
 
    Expenses.   Total selling, general and administrative expenses for the nine months ended March 31, 2010 were $2,141,895, compared to $339,671 for the nine months ended March 31, 2009.  The following is a summary of the major categories included in selling, general and administrative expenses:
 
    
Nine Months Ended
   
            March 31
 
  2010
                                            2009
Wages, expenses, benefits before deferred compensation……………
 $ 401,133
 
 $353,308
Deferred compensation…...…………………………………………..
 1,322,250
 
 (309,750)
Outside consultants…………………………………………………...
 26,525
 
19,459
Patents and related expenses..…………………………………….….
 2,875
 
   -      
Research & Development………………………………………….….
 1,470
 
   -      
Rent (building/equipment) and utilities………………………………
 40,772
 
 43,776
Insurance-general and directors/officers liability…………………….
 15,227
 
 21,864
Selling, marketing and promotion, including applicable wages and sales commissions.
 152,740
 
                                   -
Legal and audit/accounting fees……………………………..………..
 38,193
 
 69,976
Depreciation and amortization…………………………………….….
 2,074
 
6,483
Stock option expense………………………………………………...
 76,001
 
 68,625
Other-general and administrative…………………………………….
 62,635
 
 65,930
            Total selling, general and administrative expenses………….
 $2,141,895
 
 $339,671
 
    Wages, related expenses and benefits before deferred compensation  for the nine months ended March 31, 2010 were  $401,133, compared to $353,308 for the nine months ended March 31, 2009, a 13.5% increase.  This increase is largely due to an increase in wages for the three months ended March 31, 2010 compared to March 31, 2009.
 
    Deferred compensation, which is a non-cash charge that relates to phantom stock issuances issued to our chief executive officer as part of his compensation for services provided to us. (see Note 5 in the Company’s financial statements) For the nine months ended March 31, 2010, deferred compensation charge was $1,322,250 compared to a deferred compensation benefit of $309,750 (negative charge) for the nine months ended March 31, 2009.  An increase in the Company’s stock price creates a deferred compensation charge, whereas, a decrease in the Company’s stock price creates a deferred compensation benefit. The increased charge for the nine month period ended March 31, 2010 compared to the benefit for the nine months ended March 31, 2009 is the result of the increase in the Company’s stock price.  The change also reflects the additional phantom shares granted during the nine month period ended March 31, 2010 and 2009.
 
    Outside consultants’ expense increased from $19,459 for the nine months ended March 31, 2009 to $26,525 for the nine months ended March 31, 2010, a 36.3% increase.  This increase is largely due to an increase in the expenses for our quality systems, regulatory affairs, and engineering consultants in the nine months ended March 31, 2010.
 
    Insurance expense decreased from $21,864 for the nine months ended March 31, 2009 to $15,227 for the nine months ended March 31, 2010, respectively, a 30.4% decrease.  This decrease is due to a decrease in the cost of the Company’s directors’ and officers’ liability insurance premiums.
 
    In the nine month period ended March 31, 2010, we had in place a new indirect distribution plan in which distributors purchased our equipment directly as well as having distributors who had their customers purchase equipment from our company and were then paid a commission.  Selling, marketing, and promotion expense was $152,740 for the nine months ended March 31, 2010, compared to no ($0) expense for the nine months ended March 31, 2009.  At that time, we had a direct distribution arrangement that was limited to selling only to distributors who purchased our equipment directly from the Company.
 
    Legal and audit/accounting fees decreased from $69,976 for the nine months ended March 31, 2009 to $38,193 for the nine months ended March 31, 2010, a 45.4% decrease.  Accounting & audit fees have decreased from $59,488 for the nine months ended March 31, 2009 to $33,459 for the nine months ended March 31, 2010, a 43.8% decrease.
 
    Stock option expense increased from $68,625 for the nine months ended March 31, 2009 to $76,001 for the nine months ended March 31, 2010, a 10.7% increase.  This expense is based on the grant date fair value related to stock options that vested during the nine months ended March 31, 2009 and 2010.  This expense is a result of the stock options granted to the non-management board of directors effective January 1, 2010, which vested quarterly through June 30, 2010.

 
  15

 
  
    Other – general and administrative expenses decreased from $65,930 for the nine months ended March 31, 2009 to $62,635 for the nine months ended March 31, 2010, a 5.0% decrease. This decrease is due to the decline in repairs and maintenance expenses, and telephone expenses for the nine month period ended March 31, 2010 compared to the nine month period ended March 31, 2009.
 
    Interest income was $7,225 and $11,793 for the nine months ended March 31, 2010 and 2009 respectively, a 38.7% decrease.  This decrease was the result of reduced bank deposit rates during 2009 and timing differences on the recognition of interest income once the company purchased higher yielding bank CD’s in amounts not larger than FDIC insurance protection.
 
    Our net loss was $1,347,573 and $88,549 for the nine months ended March 31, 2010 and 2009, respectively.  For the nine months ended March 31, 2010, basic and diluted net loss per share was $(.03), based on weighted average shares outstanding of 41,142,729.  For the nine months ended March 31, 2009, basic and diluted net loss per share was $.00, based on weighted average shares outstanding of 40,650,494.
 
    At June 30, 2003, inventory which principally consists of raw materials had been written down to estimated net realizable value to account for quantities in excess of those expected to be sold currently.  The results of operations for the fiscal year ended June 30, 2003 included a corresponding charge to Cost of Sales of $850,000 related to this write-down.  As inventory, which was previously written down, is sold relating to Equipment Sales Revenue, a portion of this Inventory Allowance is recorded as an offset to Cost of Sales pertaining to these sales.  As of March 31, 2010, the Inventory Allowance balance is $349,155.  The following table shows the effect of this adjustment for the periods indicated:

 
                  Three Months Ended March 31
 
                         Nine Months Ended March 31
 
  2010
 
          2009
 
       2010
 
        2009
Cost of Sales……………………….
$31,445
 
$30,840
 
$162,889
 
$128,720
Inventory Allowance Adjustment….
(7,859)
 
(3,471)
 
(63,325)
 
(29,565)
Cost of Sales, as reported…………
$23,586
 
$27,369
 
$99,564
 
$99,155


Liquidity and Capital Resources

    Cash and cash equivalents had a net increase of $245,058 and a net decrease of $278,083 for the nine months ended March 31, 2010 and March 31, 2009, respectively.  The significant elements of these changes were:


Net cash provided by / (used in) operating activities:
      Nine Months Ended March 31
 
2010           
 2009                   
 
       
—  Net loss, as adjusted for non-cash items
       (expenses associated with deferred stock based compensation, depreciation,
          and stock option expense)
    $    52,752 
   $      (322,528)        
 
—  (Increase) / Decrease in accounts receivable:
–  (A) The increase in the collection of outstanding customer balances from unit sales,
       and less sales at quarter end.
(A)    37,615 
(A)     26,000
 
—  Increase / (Decrease) in accrued payroll and payroll taxes:
–  (B) Expense amounts that relate to the amount of accrued vacation, accrued payroll,
       and accrued payroll taxes.
(B)    54,324
(B)    (33,010)
 
 
—  (Increase) / Decrease in inventory:
–  (C) We sell mostly reconditioned units, and only replenish inventory for items that
       are needed to build new units.
(C)      (9,714)
 (C)     7,994
 
 
—  Increase / (Decrease) in deferred revenue:
–  (D) Cash received from warranty maintenance contracts, is amortized over the
       length of the contract.
 (D)    64,055
 (D)     21,430
 
 
 
 
    We have incurred an operating loss for the nine months ended March 31, 2010, however we were able to generate positive cash flow from operations.  As of March 31, 2010, we had an accumulated deficit of $28,782,180.
 
    As of March 31, 2010, we had cash and cash equivalents of $942,976 and anticipate that these funds, in conjunction with anticipated sales of our CVProfilor® DO-2020 Systems, anticipated sales of our CR-2000 Research Systems, and anticipated operating cost reductions, will allow us to pursue our business development strategy for at least the next twelve months following March 31, 2010.

 
16 

 

    Our current marketing strategy focuses on selling the CVProfilor® DO-2020 System to physicians who treat patients with hypertension and diabetes through a network of independent distributors.  We believe that these independent distributors know physicians who have the greatest interest in, and use for, our product.  The most critical factor in our ability to increase revenue rests in our ability to expand our network of independent distributors selling the CVProfilor® DO-2020 System.
 
    The existence, timing and extent of reimbursement of physicians for the use of our CVProfilor® DO-2020 affects demand for our product.  Reimbursement will always vary considerably by the patient’s medical necessity, by physician, by provider, by geography and by provider coverage plans, making the process of obtaining reimbursement for the CVProfilor® DO-2020 by physician customers an important component of our product’s success.  To the extent that reimbursement is unavailable or inadequate, physicians will be less likely to purchase the CVProfilor® DO-2020.
 
    No assurance can be given that additional working capital, when required, will be obtained in a timely manner or on terms and conditions acceptable to us or our shareholders. Our financing needs are based upon management estimates as to future revenue and expense.  Our business plan and our financing needs are also subject to change based upon, among other factors, market conditions, and our ability to materially increase the sales of our CVProfilor® DO-2020 System.  Any efforts to raise additional funds may be hampered by the fact that our securities are quoted on the OTC Bulletin Board, are illiquid and are subject to the rules relating to penny stocks.
 
 
Off-Balance Sheet Arrangements

    We have no off-balance sheet arrangements.

 
17 

 


Item 4T. Controls and Procedures.

(a) Disclosure Controls and Procedures
 
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, Mark N. Schwartz, we have evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined under Rule 13a-15(e) and 15d-15(e) promulgated under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this report. Based upon that review, our Chief Executive Officer and Principal Financial Officer have concluded that, as of the evaluation date, our disclosure controls and procedures were operating effectively for gathering, analyzing and disclosing the information that we are required to disclose in the reports we file under the Securities Exchange Act of 1934, within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Manager of Finance and Accounting, in a manner that allows for timely decisions regarding required disclosures.
 
(b) Changes in Internal Control Over Financial Reporting
 
There have been no significant changes in our internal control over financial reporting that occurred during the three months ended March 31, 2010, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 6.  Exhibits

(a)      The following Exhibits are furnished pursuant to Item 601 of Regulation S-B:

31.1  
Certification of Chief Executive Officer pursuant to 13a-14 and 15d-14 of the Exchange Act

31.2  
Certification of Chief Financial Officer pursuant to 13a-14 and 15d-14 of the Exchange Act

32  
Certificate pursuant to 18 U.S.C. § 1350

 
 
 
 
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SIGNATURES


In accordance with the requirements of the Exchange Act, the Registrant has caused this Form 10-Q to be signed on its behalf by the undersigned, thereunto duly authorized.


 
HYPERTENSION DIAGNOSTICS, INC.


                                                                                               
By /s/ Mark N. Schwartz
 
 
Mark N. Schwartz
 
Chief Executive Officer


Date:  May 17, 2010

 
 



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