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HYPERTENSION DIAGNOSTICS INC /MN - Quarter Report: 2009 December (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 December 31, 2009
   
 
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 February 16, 2010 was 41,227,664.

 

 

HYPERTENSION DIAGNOSTICS, INC.

INDEX TO FORM 10-Q

   
Page No
     
PART I.
FINANCIAL INFORMATION:
 
     
Item 1.
Financial Statements
 
     
 
Balance Sheets – December 31, 2009 (unaudited) and June 30, 2009
4
     
 
Statements of Operations (unaudited) – Three Months and Six Months Ended December 31, 2009 and 2008
5
     
 
Statements of Cash Flows (unaudited) – Six Months Ended December 31, 2009 and 2008
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
17
     
PART II.
OTHER INFORMATION:
 
     
Item 6.
Exhibits
17
     
 
SIGNATURES
18
     
 
CERTIFICATIONS
19
     









 

 

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.

 

 

PART I.  FINANCIAL INFORMATION
Item 1.  Financial Statements
Hypertension Diagnostics, Inc.
Balance Sheets
(Unaudited)

     
      December 31,                       June 30,
   
 
2009
 
2009
Assets
 
 
 
 
 
Current Assets:
 
 
     
   Cash and cash equivalents
 
 
 $    1,071,822
 
 $       697,918
   Accounts receivable
 
 
              5,586
 
            42,500
   Inventory, net
 
 
          281,255
 
          278,873
   Prepaid and other current assets
 
 
              6,192
 
              3,237
               Total Current Assets
 
 
       1,364,855
 
       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
 
 
         (929,957)
 
         (928,200)
               Property and Equipment, net
 
 
              1,972
 
              3,729
           
Other Assets
 
 
              6,530
 
              6,530
               Total Assets
 
 
 $    1,373,357
 
 $    1,032,787
           
Liabilities and Shareholders' Equity / (Deficit)
         
Current Liabilities:
   
 
 
 
   Accounts payable
 
 
 $          40,623
 
 $          16,343
   Accrued vacation, payroll and payroll taxes
 
 
             74,537
 
             47,579
   Deferred revenue
          
             62,690
 
             48,246
   Deposits from customers
   
             47,331
 
                  970
   Other accrued expenses
 
 
             29,828
 
               6,746
               Total Current Liabilities
 
 
           255,009
 
           119,884
           
Long Term Liabilities:
   Deferred compensation
   
        1,344,000
 
          220,500
   Deferred revenue, less current portion
   
             81,753
 
            32,362
               Total Long Term Liabilities
   
        1,425,753
 
           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 December 31, 2009 and June 30, 2009, respectively;
   
 
 
 
        each share of preferred stock convertible into 12 shares
        of common stock at the option of the holder (aggregate
         
        liquidation preference $7,908,637 and $7,422,487 at
         
        December 31, 2009 and June 30, 2009, respectively)
   
             7,225
 
             7,445
   Common Stock, $.01 par value:
         
      Authorized shares--150,000,000
         
      Issued and outstanding shares--41,227,664 and 40,963,088
         
      at December 31, 2009 and June 30, 2009, respectively
 
 
          412,277
 
          409,631
   Additional paid-in capital
 
 
      27,720,896
 
      27,677,572
   Accumulated deficit
 
 
    (28,447,803)
 
    (27,434,607)
               Total Shareholders' Equity / (Deficit)
 
 
         (307,405)
 
           660,041
               Total Liabilities and Shareholders' Equity / (Deficit)
 
 
 $     1,373,357
 
 $     1,032,787
           
See accompanying notes.
         

 

 

Hypertension Diagnostics, Inc.
Statements of Operations
                                                                                                         (Unaudited)



                                                                                                                                 Three Months Ended                      Six Months Ended
                                                                                                                                        December 31                                   December 31
 
2009
 
2008
 
2009
 
2008
Revenue:
           
   Equipment sales
 $405,590
 
 $96,837
 
 $659,825
 
 $178,837
   Equipment rental
 20,082
 
 24,119
 
 45,243
 
 49,816
   Warranty, parts & supplies income
 32,653
 
 16,251
 
 55,332
 
45,066
 
 458,325
 
 137,207
 
 760,400
 
 273,719
Cost of Sales:
             
   Cost of sales
 80,822
 
 48,618
 
131,444
 
 97,880
   Inventory reserve allowance
 (37,628)
 
 (12,979)
 
 (55,466)
 
(26,094)
             Net Cost of Sales
 43,194
 
 35,639
 
75,978
 
71,786
             Gross Profit
 415,131
 
 101,568
 
 684,422
 
201,933
               
Expenses:
             
   Selling, general and administrative expenses
650,666
 
 296,096
 
 1,701,507
 
281,340
             Total Expense
 650,666
 
 296,096
 
 1,701,507
 
281,340
Operating Income (Loss)
 (235,535)
 
 (194,528)
 
 (1,017,085)
 
 (79,407)
               
Other Income:
             
   Interest income
 2,406
 
 3,363
 
3,889
 
9,847
              Total Other Income
2,406
 
3,363
 
3,889
 
9,847
               
Net loss before income taxes
 (233,129)
 
 (191,165)
 
 (1,013,196)
 
 (69,560)
   Income Taxes
-
 
 -
 
-
 
 -
              Net loss before income taxes
 $(233,129)
 
 $(191,165)
 
 $(1,013,196)
 
 $(69,560)
               
               
Basic and Diluted Net Loss per Share
$          (.01)
 
$          .00
 
$         (.02)
 
$         .00
Weighted Average Shares Outstanding Basic & Diluted
 41,217,897
 
 40,795,820
 
 41,095,804
 
 40,579,411
               
See accompanying notes.
             

 




 
 5

 

Hypertension Diagnostics, Inc.
Statements of Cash Flows
(Unaudited)

 
                                                                                                        Six Months Ended
                                                     December 31
   
2009
 
2008
Operating Activities:
       
Net loss
 
$  (1,013,196)
 
$  (69,560)
Adjustments to reconcile net loss to net
       
   cash provided by / (used in) operating activities:
       
      Deferred stock based compensation expense
 
1,123,500
 
(162,750)
      Depreciation
 
1,757
 
5,145
      Stock options expense
 
45,750
 
45,750
      Change in operating assets and liabilities:
       
            Accounts receivable
 
36,914
 
25,282
            Inventory
 
(2,382)
 
8,151
            Prepaid and other current assets
 
(2,955)
 
6,379
            Accounts payable
 
24,280
 
(15,367)
            Accrued payroll and payroll taxes
 
26,958
 
(38,788)
            Deferred revenue
 
63,835
 
25,023
            Other accrued expenses
 
69,443
 
3,608
               Net cash provided by / (used in) operating activities
373,904
 
(167,127)
         
Net increase/(decrease) in cash and cash equivalents
373,904
 
(167,127)
               Cash and cash equivalents at beginning of period
697,918
 
1,081,868
Cash and cash equivalents at end of period
 
$   1,071,822
 
$   914,741
         
See accompanying notes.
       

 






 
6

 

Hypertension Diagnostics, Inc.
Notes to Financial Statements
December 31, 2009

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 six months ended December 31, 2009 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. FASB 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.

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 1,300,000 stock options during the three and six months ended December 31, 2009. During the three and six months ended December 31, 2008, there were no stock options granted. The Company recognized compensation expense of $22,875 and $45,750 for the three months and six months ended December 31, 2009, and December 31, 2008 respectively, related to options previously granted.  The Company estimates $60,500 of additional expense for the remainder of fiscal year 2010 based on the value of options outstanding on December 31, 2009 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
December 31, 2009

5.           Deferred Compensation
           
The Company has a Deferred Equity Compensation Agreement with its CEO, Mark N. Schwartz (the “Agreement”), whereby the Company will grant 175,000 phantom shares of its common stock to its CEO for every month of employment for the period January 1, 2006 through December 31, 2009.  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 $1,344,000 at December 31, 2009, which is the fair market value of 8,400,000 phantom shares granted as of December 31, 2009, pursuant to the Agreement.  Due to the aggregate number of phantom shares granted since January 1, 2006 which totals 8,400,000 as of December 31, 2009 and the changes in the closing price of the Company’s common stock during the quarter (an increase from $0.125 to $0.16 per share), the Company recorded a total expense of $359,625 and $1,123,500 in compensation cost for the three and six months ended December 31, 2009, compared to $66,938 in compensation expense and $162,750 in compensation benefit for the three and six months ended December 31, 2008, 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 six months ended December 31, 2009 results from an increase in the Company’s stock price and phantom shares granted from the prior period ended September 30, 2009 to the period ended December 31, 2009.  On the last trading day of the period ended September 30, 2009, the Company’s average closing stock price was $0.125 per share, and on the last trading day of the period ended December 31, 2009, the Company’s average closing stock price was $0.16 per share.
 
Per the terms of the employment agreement, payment of the deferred compensation liability will occur upon one of the following events: 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 and six months ended December 31, 2009, 5,760 and 22,048 shares of the Company’s Series A Convertible Preferred Stock were converted into 69,120 and 264,576 shares of Common Stock compared to 0 and 85,084 shares of Series A Convertible Preferred Stock converted into 0 and 1,021,008 shares of Common Stock for the three and six months ended December 31, 2008, respectively.

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 six months ended December 31, 2009 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 December 31, 2009 and 2008:



 

 


Hypertension Diagnostics, Inc.
Notes to Financial Statements
December 31, 2009

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


     
    December 31
   
    December 31
 
     
          2009
   
          2008
 
 
Basic earnings (loss) per share calculation:
           
 
Net income (loss) to common shareholders
$
   (1,013,196)
 
$
  (69,560)
 
 
Weighted average of common shares outstanding
 
41,095,804
   
  40,579,411
 
 
Basic net earnings (loss) per share
$
        (0.02)
 
$
            0.00
 
               
 
Diluted earnings (loss) per share calculation:
           
 
Net income (loss) to common shareholders
$
   (1,013,196)
 
$
  (69,560)
 
 
Weighted average of common shares outstanding
 
41,095,804
   
  40,579,411
 
 
Series A Convertible Preferred Stock (1)
 
-
   
-
 
 
           Stock Options (2)
 
-
   
-
 
 
           Warrants (3)
 
-
   
-
 
 
Diluted weighted average common shares outstanding
 
 41,095,804
   
 40,579,411
 
 
Diluted net income (loss) per share
$
         (0.02)
 
$
            0.00
 

(1)
At December 31, 2009, there were 722,488 shares of  Series A Convertible Preferred Stock outstanding and 744,536 at December 31, 2008. Using the preferred stock conversion ratio of 12:1, the common  stock equivalents attributable to these preferred shares are 8,669,856 at December 31, 2009 and 8,934,432 at December 31, 2008.  These common stock equivalents are anti-dilutive at December 31, 2009 and 2008 and therefore have been excluded from diluted earnings per share.
 
(2)
At December 31, 2009, there were common stock equivalents attributable to outstanding stock options of 7,310,342 common shares and 6,080,342 common shares at December 31, 2008. The stock options are anti-dilutive at December 31, 2009 and 2008 and therefore have been excluded from diluted earnings per share.
 
(3)
At December 31, 2009 and 2008, 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 December 31, 2009 and 2008 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 six months ended December 31, 2008 financial statements have been reclassified to conform to the three and six months ended December 31, 2009 presentation.  The reclassifications had no effect on the three and six months ended December 31, 2008 cash flows, financial position or net income (loss), as originally reported.

10.  
Subsequent Events:

There are no subsequent events through February 16, 2010, the date the financial statements were available to be issued.

 

 

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.
 
For the three months ended December 31, 2009, the Company’s revenues have increased significantly due to 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.  The vast majority of the revenue from this contract was recognized in the six months ended December 31, 2009.  This contract will not produce significant revenue in subsequent quarters.
 
Additionally, sales for the three months ended December 31, 2009 also improved due to increased sales by our independent distributors because of compensation incentives provided to them for sales generated during that period.  As a result, the Company feels that for the three months ending March 31, 2010, revenues may be lower.
 
Recent Accounting Pronouncements

In June 2009, the FASB issued  Accounting for Transfers of Financial Assets effective for fiscal years beginning after November 15, 2009. FASB 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.
 
 
10

 
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.
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 December 31, 2009 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 December 31, 2009 and June 30, 2009, there was an inventory allowance of $357,013 and $412,480, respectively.

             Research and Development.  For the three months and six months ended December 31, 2009, we incurred $1,470 and $1,470 in research and development costs. The Company did not incur any research and development costs for the three and six months ended December 31, 2008, 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 $144,443 and $80,608 at December 31, 2009 and June 30, 2009, respectively. 

Results of Operations

As of December 31, 2009, we had an accumulated deficit of $28,447,803.  Until we are able to generate significant revenue from our activities, we expect to continue to incur operating losses.  As of December 31, 2009, we had cash and cash equivalents of $1,071,822.  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 December 31, 2009.

Three Months Ended December 31, 2009 Compared to Three Months Ended December 31, 2008

The following is a summary of our Revenue and Cost of Sales for the three months ended December 31, 2009 and 2008, respectively:

                                                                   Three Months Ended December 31, 2009
       
Equipment
 
Equipment
 
Warranty,
   
Total
 
Sales
 
Rental
 
Parts & Supplies
                 
Revenue
 
 $458,325
 
 $405,590
 
 $20,082
 
 $32,653
Cost of Sales
 
 43,194
 
38,224
 
1,893
 
 3,077
Gross Profit
 
 $415,131
 
 $367,366
 
 $18,189
 
 $29,576
                 

 
 Three Months Ended December 31, 2008
       
Equipment
 
Equipment
 
Warranty,
   
Total
 
Sales
 
Rental
 
Parts & Supplies
                 
Revenue
 
 $137,207
 
 $96,837
 
 $24,119
 
 $16,251
Cost of Sales
 
 35,639
 
 25,153
 
6,265
 
 4,221
Gross Profit
 
 $101,568
 
 $71,684
 
 $17,854
 
 $12,030
                 
 

 
 
11

 
Revenue.  Total Revenue for the three months ended December 31, 2009 was $458,325, compared to $137,207 for the three months ended December 31, 2008, a 234.0% increase.
 
               Equipment Sales Revenue for the three months ended December 31, 2009 was $405,590, compared to $96,837 for the three months ended December 31, 2008, a 318.8% increase.  Part of this increase is a result of the revenue recognized 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, a contract which accounted for $106,340 in equipment sales revenue for the three month period ended December 31, 2009. Without the revenue from NIH funded study, equipment sales revenue for the three months ended December 31, 2009 would have been $299,250, a 209.0% increase from the $96,837 of equipment sales revenue for the three months ended December 31, 2008.
 
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 December 31, 2009, we recognized revenue for the CVProfilor® DO-2020 System “per-patient-tested” rental program of $20,082, compared to $24,119 for the three months ended December 31, 2008, a 16.7% 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 December 31, 2009, warranty, parts & supplies revenue was $32,653, compared to $16,251 for the three months ended December 31, 2008, a 100.9% increase.  During the first quarter ended December 31, 2009, the Company sold three replacement sensors but did not have any replacement sensor sales for the December 31, 2008 quarter.  Part sales will fluctuate based on our customers need for parts.

                Expenses.  Total selling, general and administrative expenses for the three months ended December 31, 2009 were $650,666, compared to $296,096 for the three months ended December 31, 2008. The following is a summary of the major categories included in selling, general and administrative expenses:

   
Three Months Ended
 
   
December 31
 
 
2009
 
2008
Wages, expenses, benefits before deferred compensation……………
 $121,549
 
 $122,149
Deferred compensation…...…………………………………………..
 359,625
 
 66,938
Outside consultants…………………………………………………...
 5,312
 
 3,088
Patents and related expenses..…………………………………….….
 2,875
 
   -
Research & Development………………………………………….….
 1,470
 
   -
Rent (building/equipment) and utilities……………………..………..
13,360
 
 14,036
Insurance-general and directors/officers liability……..……..………..
 4,783
 
 8,471
Selling, marketing and promotion, including applicable wages and sales commissions.
 92,750
 
                           -
Legal and audit/accounting fees……………………………..………..
 5,538
 
 28,884
Depreciation and amortization…………………………………….….
 317
 
 2,220
Stock option expense………………………………………………...
 22,875
 
 22,875
Other-general and administrative…………………………………….
 20,212
 
 27,435
            Total selling, general and administrative expenses………….
 $650,666
 
$296,096

Wages, related expenses and benefits before deferred compensation decreased from $122,149 to $121,549 for the three months ended December 31, 2008 and 2009, respectively, a 0.5% decrease.

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), was an expense of $359,625 for the three months ended December 31, 2009, compared with an  expense of  $66,938 for the three months ended December 31, 2008.  The increased expense for the three month period ended December 31, 2009 compared to 2008 is the result of the increase in  the Company’s stock price.  The expense includes the additional phantom shares granted during the three month period ended December 31, 2009 and 2008.

 
12

 
Outside consultant’s expense increased from $3,088 to $5,312 for the three months ended December 31, 2008 and 2009, respectively, a 72.0% 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 December 31, 2009, compared to 2008.

Rent (building/equipment) and utilities decreased from $14,036 to $13,360 for the three months ended December 31, 2008 and 2009, respectively, a 4.8% decrease.

Insurance expense decreased from $8,471 to $4,783 for the three months ended December 31, 2008 and 2009, respectively, a 43.5% decrease.  This decrease is due to a decrease in the cost of the Company’s directors’ and officers’ liability insurance as well as a decrease in property insurance premiums.

Selling, marketing and promotion expense increased from $0 to $92,750 for the three months ended December 31, 2008 and 2009, respectively.  This category includes commissions paid to our third-party distributors.  This increase is due to a change to indirect distribution for the three month period ended December 31, 2009.

Legal and audit/accounting fees decreased from $28,884 to $5,538 for the three months ended December 31, 2008 and 2009, respectively, a 80.8% decrease.  This decrease was largely the result of lower audit and related fees.

Stock option expense was $22,875 for the three months ended December 31, 2008 and 2009, respectively. This expense is based on the grant date fair value related to stock options that vested during the three months ended December 31, 2008 and 2009, respectively.  This expense is a result of the stock options granted to the non-management board of directors effective January 1, 2007, which vest quarterly through December 31, 2009.

Other – general and administrative expenses decreased from $27,435 to $20,212 for the three months ended December 31, 2008 and 2009, respectively, a 26.3% decrease.
 
Interest income was $2,406 and $3,363 for the three months ended December 31, 2009 and 2008, respectively a 28.5% decrease. This decrease was a result of the reduced bank deposit rates during the 2009 period.

Our net loss was $233,129 for the three months ended December 31, 2009, compared to net loss of $191,165 for the three months ended December 31, 2008.  For the three months ended December 31, 2009, basic and diluted net loss per share was $(.01), based on weighted average shares outstanding of 41,217,897.  For the three months ended December 31, 2008, basic and diluted net loss per share was $.00, based on weighted average shares outstanding of 40,795,820.

Six Months Ended December 31, 2009 Compared to Six Months Ended December 31, 2008

The following is a summary of our Revenue and Cost of Sales for the six months ended December 31, 2009 and 2008 respectively:
 
                               Six Months Ended December 31, 2009
       
Equipment
 
Equipment
 
Warranty,
   
Total
 
Sales
 
Rental
 
Parts & Supplies
                 
Revenue
 
 $760,400
 
 $659,825
 
 $45,243
 
 $55,332
Cost of Sales
 
 75,978
 
 65,815
 
4,624
 
 5,539
Gross Profit
 
 $684,422
 
 $594,010
 
 $40,619
 
 $49,793
                 
 
                                                                                   Six Months Ended December 31, 2008
       
Equipment
 
Equipment
 
Warranty,
   
Total
 
Sales
 
Rental
 
Parts & Supplies
                 
Revenue
 
 $273,719
 
 $178,837
 
 $49,816
 
 $45,066
Cost of Sales
 
 71,786
 
 46,866
 
13,069
 
 11,851
Gross Profit
 
 $201,933
 
 $131,971
 
 $36,747
 
 $33,215
                 
                       
 
 
13

 
Revenue. Total Revenue for the six months ended December 31, 2009 was $760,400, compared to $273,719 for the six months ended December 31, 2008, a 177.8% increase.
 
 Equipment Sales Revenue for the six months ended December 31, 2009 was $659,825, compared to $178,837 for the six months ended December 31, 2008, a 269.0% increase.  A large part of this increase is a result of the revenue recognized 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, a contract which accounted for $205,085 in equipment sales revenue for the six month period ended December 31, 2009. Without the revenue from NIH funded study, equipment sales revenue for the six months ended December 31, 2009 would have been $454,740, a 154.3% increase from the $178,837 of equipment sales revenue for the six months ended December 31, 2008.

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 six months ended December 31, 2009, we recognized Revenue for the CVProfilor® DO-2020 “per-patient-tested” rental program of $45,243, compared to $49,816 for the six months ended December 31, 2008, a 9.2% 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.

             For the six months ended December 31, 2009, Service/Contract Income was $55,332 compared to $45,066 for the six months ended December 31, 2008, a 22.8% increase.  This increase is due mainly to our increase in warranty service agreements.

Expenses.   Total selling, general and administrative expenses for the six months ended December 31, 2009 were $1,701,507, compared to $281,340 for the six months ended December 31, 2008.  The following is a summary of the major categories included in selling, general and administrative expenses:
 
                                                              
   
  Six Months Ended
   
      December 31
 
           2009
                                              2008
Wages, expenses, benefits before deferred compensation……………
 $261,468
 
 $229,819
Deferred compensation…...…………………………………………..
 1,123,500
 
 (162,750)
Outside consultants…………………………………………………...
 13,367
 
16,720
Patents and related expenses..…………………………………….….
 2,875
 
   -
Research & Development………………………………………….….
 1,470
 
   -
Rent (building/equipment) and utilities………………………………
 26,586
 
 28,139
Insurance-general and directors/officers liability…………………….
 9,613
 
 17,023
Selling, marketing and promotion, including applicable wages and sales commissions.
 142,740
 
                                -
Legal and audit/accounting fees……………………………..………..
 31,451
 
 56,874
Depreciation and amortization…………………………………….….
 1,757
 
4,481
Stock option expense………………………………………………...
 45,750
 
 45,750
Other-general and administrative…………………………………….
 40,930
 
 45,284
            Total selling, general and administrative expenses………….
 $1,701,507
 
 $281,340



Wages, related expenses and benefits before Stock Based CEO Compensation increased from $229,819 to $261,468 for the six months ended December 31, 2008 and 2009, respectively, a 13.8% increase.  The primary reason for the increase was the FICA and income tax expense related to the deferred compensation, increased from a benefit of $5,867 to an expense of $40,499 for the six months ended December 31, 2008 and 2009, respectively.

 
14

 
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), was an expense of $1,123,500 for the six months ended December 31, 2009, compared with a benefit of $162,750 for the six months ended December 31, 2008.  The expense for the six month period ended December 31, 2009 is a result of the increase in the Company’s stock price including the additional phantom shares granted during the six month period ended December 31, 2009.  The benefit for the six month period ended December 31, 2008 is a result from the decrease in the Company’s stock price.

Outside consultants’ expense decreased from $16,720 for the six months ended December 31, 2008 to $13,367 for the six months ended December 31, 2009, a 20.1% decrease.  This decrease is largely due to a decrease in the expenses for our quality systems, regulatory affairs, and engineering consultants in the six months ended December 31, 2009.

Insurance expense decreased from $17,023 to $9,613 for the six months ended December 31, 2008 and 2009, respectively, a 43.5% decrease.  This decrease is due to a decrease in the cost of the Company’s directors’ and officers’ liability insurance as well as a decrease in property insurance premiums.

Selling, marketing and promotion expense increased from $0 to $142,740 for the six months ended December 31, 2008 and 2009, respectively.  This category includes commissions paid to our third-party distributors.  This increase is due to a change to indirect distribution for the six month period ended December 31, 2009.

Legal and audit/accounting fees decreased from $56,874 for the six months ended December 31, 2008 to $31,451 for the six months ended December 31, 2009, a 44.7% decrease.  Accounting & audit fees have decreased from $50,063 for the six months ended December 31, 2008 to $28,709 for the six months ended December 31, 2009, a 42.7% decrease.

Stock option expense was $45,750 for the six months ended December 31, 2008 and 2009, respectively.  This expense is based on the grant date fair value related to stock options that vested during the six months ended December 31, 2008 and 2009.  This expense is a result of the stock options granted to the non-management board of directors effective January 1, 2007, which vested quarterly through December 31, 2009.

                Other – general and administrative expenses decreased from $45,284 for the six months ended December 31, 2008 to $40,930 for the six months ended December 31, 2009, a 9.6% decrease. This decrease is due to the decline in repairs and maintenance expenses, and telephone expenses for the six month period ended December 31, 2009 compared to the six month period ended December 31, 2008.

Interest income was $3,889 and $9,847 for the six months ended December 31, 2009 and 2008, respectively a 60.5% decrease. This decrease was a result of the reduced bank deposit rates during the 2009 period.

Our net loss was $1,013,196 and $69,560 for the six months ended December 31, 2009 and 2008, respectively.  For the six months ended December 31, 2009, basic and diluted net loss per share was $(.02), based on weighted average shares outstanding of 41,095,804.  For the six months ended December 31, 2008, basic and diluted net loss per share was $.00, based on weighted average shares outstanding of 40,579,411.

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 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 December 31, 2009, the Inventory Allowance balance is $357,013.  The following table shows the effect of this adjustment for the periods indicated:

 
   Three Months Ended December 31
 
    Six Months Ended December 31
 
  2009
 
          2008
 
       2009
 
        2008
Cost of Sales……………………….
$80,822
 
$48,618
 
$131,444
 
$97,880
Inventory Allowance Adjustment….
(37,628)
 
(12,979)
 
(55,466)
 
(26,094)
Cost of Sales, as reported…………
$43,194
 
$35,639
 
$75,978
 
$71,786


 
15

 
Liquidity and Capital Resources

Cash and cash equivalents had a net increase of $373,904 and a net decrease of $167,127 for the six months ended December 31, 2009 and December 31, 2008, respectively.  The significant elements of these changes were:
 
Net cash provided by / (used in) operating activities:
                  Six Months Ended December 31
 
  2009           
        2008                      
 
—  Net loss, as adjusted for non-cash items (expenses associated with deferred stock based compensation, depreciation, and stock option expense)
$    157,811
       $          (181,415)
 
 
 
—  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)  36,914
 
                 (A)   25,282
 
 
 
—  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)   26,958
 
                  (B)  (38,788)
 
 
      
 
—  Increase / (Decrease) in inventory:
–  (C)We sell mostly reconditioned units, and only replenish inventory for items that are needed to build new units.
 
(C)     2,382
 
 (C)   (8,151)
 
 
—  Increase / (Decrease) in deferred revenue:
–  (D)Cash received from warranty maintenance contracts, is amortized over the length of the contract.
 
 
(D)   63,835
 
 (D)    25,023
 
 
      
                We have incurred an operating loss for the six months ended December 31, 2009, however we were able to  generate positive cash flow from operations.  As of December 31, 2009, we had an accumulated deficit of $28,447,803.

As of December 31, 2009, we had cash and cash equivalents of $1,071,822 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 December 31, 2009.

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.


 
16

 
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, Mark N. Schwartz, and our Manager of Finance and Accounting, Mark O’Neill, 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 Manager of Finance and Accounting 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) Management’s Annual Report on Internal Controls Over Financial Reporting
 
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Securities Exchange Act of 1934, as amended). Our internal control system is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles.

Under the supervision and with the participation of management, including our Chief Executive Officer and Manager of Finance and Accounting, our management assessed the design and operating effectiveness of internal control over financial reporting as of December 31, 2009 based on criteria established in “Internal Control-Integrated Framework” issued by the Committee of the Sponsoring Organizations of the Treadway Commission (“COSO”).

Based on this assessment, management concluded that our internal controls over financial reporting were effective as of December 31, 2009.

This quarterly report does not include an attestation report from our registered public accounting firm regarding internal control over financial reporting.  Management’s report was not subject to attestation by our independent registered public accounting firm pursuant to rules of the Securities and Exchange Commission.

(c) 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 December 31, 2009, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 6.                 Exhibit

(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:  February 16, 2010

 
 
 
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