<PAGE>

                       SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 20549

                                   FORM 10-QSB


(MARK ONE)

XX     Quarterly Report Pursuant to Section 13 or 15(d) of the Securities
---    Exchange Act of 1934.

For the period ended March 31, 2004.

       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:                                                  0-16128

                              TUTOGEN MEDICAL, INC.
             (Exact name of registrant as specified in its charter)

FLORIDA                                                               59-3100165
(State or other Jurisdiction of                                 (I.R.S. Employer
Incorporation or Organization)                               Identification No.)


1130 MCBRIDE AVENUE, WEST PATERSON, NEW JERSEY                             07424
(Address of Principal Executive Offices)                              (Zip Code)


REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE:               (973) 785-0004


SECURITIES REGISTERED PURSUANT TO SECTION 12(B) OF THE ACT:                 NONE


SECURITIES REGISTERED PURSUANT TO SECTION 12(G) OF THE ACT:


   COMMON STOCK, PAR VALUE $.01
          (Title of Class)           (Name of Each Exchange on Which Registered)

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 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  .
                                       -    -

As of April 30, 2004 there were outstanding 15,778,960 shares of Tutogen
Medical, Inc. Common Stock, par value $0.01.

<PAGE>

                     TUTOGEN MEDICAL, INC. AND SUBSIDIARIES

                                      INDEX


PART I.            Financial Information.                               Page No.

         ITEM 1.   Financial Statements.

                   Consolidated Balance Sheets - March 31, 2004            1
                   (unaudited) and September 30, 2003.

                   Consolidated Statements of Operations for the           2
                   three and six months ended March 31, 2004 and
                   2003(unaudited).

                   Consolidated Statements of Cash Flows for
                   the six 3 months ended March 31, 2004 and
                   2003(unaudited).

                   Consolidated Statements of Stockholders'
                   Equity 4 for the year ended September 30,
                   2003 and the six months ended March 31,
                   2004 (unaudited).
                                                                           5
                   Notes to Consolidated Financial Statements
                   (unaudited).
         ITEM 2.                                                          11
                   Management's Discussion and Analysis of Financial
                   Condition and Results of Operations.

         ITEM 4.   Controls and Procedures                                16

PART II.           Other Information.

         ITEM 4.   Submission of Matters to a Vote of Security-           17
                   Holders

         ITEM 6.   Reports on Form 8-K                                    17

SIGNATURES                                                                18

<PAGE>

<TABLE>
<CAPTION>
                              PART I. FINANCIAL INFORMATION

ITEM 1.  FINANCIAL STATEMENTS.

                          TUTOGEN MEDICAL, INC. AND SUBSIDIARIES
                                CONSOLIDATED BALANCE SHEETS
                                      (IN THOUSANDS)

                                                                   (UNAUDITED)
                                                                    MARCH 31,      SEPTEMBER 30,
                                                                      2004             2003
                                                                  ------------     ------------
<S>                                                                <C>              <C>
ASSETS

CURRENT ASSETS
    Cash and cash equivalents                                      $    5,438       $    5,049
    Accounts receivable - net                                           4,415            5,526
    Inventories - net                                                  15,430           11,992
    Deferred income taxes                                                 741              709
    Other current assets                                                  875            1,098
                                                                  ------------     ------------
                                                                       26,899           24,374

PROPERTY, PLANT AND EQUIPMENT, NET                                      5,144            4,842

DEFERRED INCOME TAXES                                                   1,578            1,187
                                                                  ------------     ------------

TOTAL ASSETS                                                       $   33,621       $   30,403
                                                                  ============     ============

LIABILITIES AND SHAREHOLDERS' EQUITY

CURRENT LIABILITIES
    Accounts payable and other accrued expenses                    $    7,939       $    7,438
    Accrued commissions                                                   520              445
    Current portion of deferred distribution fees                         646              617
    Current portion of long-term debt                                      98               91
                                                                  ------------     ------------
                                                                        9,203            8,591

OTHER LIABILITIES
    Deferred distribution fees                                          2,867            3,038
    Long-term debt                                                        728              728

SHAREHOLDERS' EQUITY                                                   20,823           18,046
                                                                  ------------     ------------

TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY                         $   33,621       $   30,403
                                                                  ============     ============


See accompanying Notes to Consolidated Financial Statements.



                                           1
</TABLE>

<PAGE>

<TABLE>
<CAPTION>
                                         TUTOGEN MEDICAL, INC. AND SUBSIDIARIES
                                          CONSOLIDATED STATEMENTS OF OPERATIONS
                                          (IN THOUSANDS EXCEPT PER SHARE DATA)
                                                       (UNAUDITED)



                                                        THREE MONTHS ENDED MARCH 31,          SIX MONTHS ENDED MARCH 31,
                                                       -----------------------------        -----------------------------
                                                          2004             2003                 2004             2003
                                                          ----             ----                 ----             ----
<S>                                                     <C>              <C>                 <C>              <C>
REVENUE                                                 $    7,089       $    6,743          $    14,574      $    13,317

COST OF REVENUE                                              1,998            2,520                4,987            5,366
                                                       ------------     ------------        -------------    -------------

       Gross margin                                          5,091            4,223                9,587            7,951

OPERATING EXPENSES
    General and administrative                               1,221            1,130                2,379            2,059
    Distribution and marketing                               2,236            2,419                4,306            4,761
    Research and development                                   386              298                  725              546
    Depreciation and amortization                               56               46                  128               87
                                                       ------------     ------------        -------------    -------------
                                                             3,899            3,893                7,538            7,453

OPERATING INCOME                                             1,192              330                2,049              498

OTHER EXPENSE                                                  (63)             (33)                 (80)             (59)

INTEREST EXPENSE                                               (13)             (13)                 (27)             (25)
                                                       ------------     ------------        -------------    -------------
                                                               (76)             (46)                (107)             (84)

INCOME BEFORE INCOME TAX EXPENSE                             1,116              284                1,942              414

Income tax expense                                             463              149                  706              148
                                                       ------------     ------------        -------------    -------------

NET INCOME                                              $      653       $      135          $     1,236      $       266
                                                       ============     ============        =============    =============

Comprehensive Income:
  Foreign currency translation adjustments                   1,189              189                1,389              386
                                                       ------------     ------------        -------------    -------------

COMPREHENSIVE INCOME                                    $    1,842       $      324          $     2,625      $       652
                                                       ============     ============        =============    =============

AVERAGE SHARES OUTSTANDING FOR BASIC
  EARNINGS PER SHARE                                    15,738,218       15,527,577           15,702,512       15,340,813
                                                       ============     ============        =============    =============

BASIC EARNINGS PER SHARE                                $     0.04       $     0.01          $      0.08      $      0.02
                                                       ============     ============        =============    =============

AVERAGE SHARES OUTSTANDING FOR DILUTED
  EARNINGS PER SHARE                                    16,566,237       16,070,210           16,602,321       15,881,977
                                                       ============     ============        =============    =============

DILUTED EARNINGS PER SHARE                              $     0.03       $     0.01          $      0.07      $      0.02
                                                       ============     ============        =============    =============


See accompanying Notes to Consolidated Financial Statements


                                                         2
</TABLE>
<PAGE>

<TABLE>
<CAPTION>
                        TUTOGEN MEDICAL, INC. AND SUBSIDIARIES
                         CONSOLIDATED STATEMENTS OF CASH FLOWS
                                    (IN THOUSANDS)
                                      (UNAUDITED)


                                                              SIX MONTHS ENDED MARCH 31,
                                                            -----------------------------
                                                               2004             2003
                                                               ----             ----
<S>                                                          <C>              <C>
CASH FLOWS FROM OPERATING ACTIVITIES
Net income                                                   $    1,236       $      266
Adjustments to reconcile net income to net cash
  provided by operating activities:
  Depreciation and amortization                                     473              283
  Deferred distribution fees revenue                               (321)            (278)
  Deferred income taxes                                             706              148
  Changes in assets and liabilities:
     Accounts receivable                                          1,187           (1,416)
     Inventories                                                 (3,165)            (407)
     Other current assets                                           274             (323)
     Accounts payable and other accrued expenses                     49            1,653
     Accrued commissions                                             76              151
                                                            ------------     ------------
        Net cash provided by operating activities                   515               77

CASH FLOWS USED IN INVESTING ACTIVITIES
   Purchase of property and equipment                              (542)            (229)
   Increase in patents and trade marks                                -              (21)
                                                            ------------     ------------
        Net cash used in investing activities                      (542)            (250)

CASH FLOWS FROM FINANCING ACTIVITIES
    Issuance of common stock                                        153              829
    Repayment of long-term debt                                     (39)             (31)
                                                            ------------     ------------
         Net cash provided by financing activities                  114              798


EFFECT OF EXCHANGE RATE CHANGES ON CASH                             302              195
                                                            ------------     ------------

NET INCREASE IN CASH AND CASH EQUIVALENTS                           389              820

CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD                  5,049            3,083
                                                            ------------     ------------

CASH AND CASH EQUIVALENTS AT END OF PERIOD                   $    5,438       $    3,903
                                                            ============     ============


SUPPLEMENTAL CASH FLOW DISCLOSURES
      Interest paid                                          $       27       $       25
                                                            ============     ============



See accompanying Notes to Consolidated Financial Statements



                                             3
</TABLE>
<PAGE>
<TABLE>
<CAPTION>

TUTOGEN MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
YEAR ENDED SEPTEMBER 30, 2003 AND SIX MONTHS ENDED MARCH 31, 2004
(IN THOUSANDS, EXCEPT FOR SHARE DATA)
------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------


                                                                          ACCUMULATED                                COMMON
                                                COMMON      ADDITIONAL       OTHER                                   SHARES
                                                STOCK        PAID-IN     COMPREHENSIVE  ACCUMULATED                ISSUED AND
                                              ($.01 PAR)     CAPITAL       INCOME (1)     DEFICIT       TOTAL      OUTSTANDING
<S>                                           <C>           <C>            <C>          <C>           <C>           <C>
BALANCE, OCTOBER 1, 2002                      $     152     $  35,135      $     (925)  $  (20,434)   $  13,928     15,158,110

  Stock issued on exercise of options                 5           845               -            -          850        509,000
  Net income                                          -             -               -        2,262        2,262              -
  Foreign currency translation adjustment             -             -           1,006            -        1,006              -
                                              ---------     ---------      ----------   ----------    ---------    -----------

BALANCE, SEPTEMBER 30, 2003                         157        35,980              81      (18,172)      18,046     15,667,110

  Stock issued on exercise of options                 1           152               -            -          153         91,850
  Net income                                          -             -               -        1,235        1,235              -
  Foreign currency translation adjustment             -             -           1,389            -        1,389              -
                                              ---------     ---------      ----------   ----------    ---------    -----------

BALANCE, MARCH 31, 2004                       $     158     $  36,132      $    1,470   $  (16,937)   $  20,823     15,758,960
                                              =========     =========      ==========   ==========    =========    ===========


(1) Represents foreign currency translation adjustments.
See accompanying Notes to Consolidated Financial Statements.
                                                                  4
</TABLE>

<PAGE>

                     TUTOGEN MEDICAL, INC. AND SUBSIDIARIES
             NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
                                 March 31, 2004
                        (in thousands, except share data)


(1)  OPERATIONS AND ORGANIZATION

     Tutogen Medical, Inc. with its consolidated subsidiaries (the "Company")
     processes, manufactures and distributes worldwide, specialty surgical
     products and performs tissue processing services for neuro, orthopedic,
     reconstructive and general surgical applications. The Company's core
     business is processing human donor tissue, utilizing its patented
     Tutoplast(R) process, for distribution to hospitals and surgeons. The
     Company processes at its two manufacturing facilities in Germany and the
     United States and distributes its products and services to over 30
     countries worldwide.

(2)  SIGNIFICANT ACCOUNTING POLICIES

     The accompanying unaudited consolidated balance sheet of the of the Company
     as of March 31, 2004 and the unaudited results of operations for the three
     and six months ended March 31, 2004 and 2003 and the unaudited cash flows
     for the six months ended March 31, 2004 have been prepared in conformity
     with accounting principles generally accepted in the United States of
     America for interim financial reporting. Accordingly, they do not include
     all of the information and notes required by accounting principles
     generally accepted in the United States of America for complete financial
     statements. In the opinion of management, all adjustments necessary in
     order to make the financial statements not misleading have been made.
     Operating results for the three and six months ended March 31, 2004 are not
     necessarily indicative of the results, which may be expected for the fiscal
     year ending September 30, 2004. The interim financial statements should be
     read in conjunction with the audited consolidated financial statements of
     the Company for the year ended September 30, 2003.

     NEW ACCOUNTING PRONOUNCEMENTS - The FASB issued SFAS No. 146, ACCOUNTING
     FOR COSTS ASSOCIATED WITH EXIT OR DISPOSAL ACTIVITIES. SFAS NO. 146
     NULLIFIES EMERGING ISSUES TASK FORCE ("EITF") NO. 94-3, LIABILITY
     RECOGNITION FOR CERTAIN EMPLOYEE TERMINATION BENEFITS AND OTHER COSTS TO
     EXIT AN ACTIVITY (INCLUDING CERTAIN COSTS INCURRED IN AS RESTRUCTURING).
     The principal difference between SFAS No. 146 and EITF No. 94-3 relates to
     its requirements for recognition of a liability for a cost associated with
     an exit or disposal activity. SFAS No. 146 requires that a liability for a
     cost associated with an exit or disposal activity be recognized when the
     liability is incurred. Under EITF No. 94-3, a liability for an exit cost
     was recognized at the date of an entity's commitment to an exit plan. SFAS
     No. 146 was effective for exit and disposal activities that are initiated
     after December 31, 2002. The provisions of SFAS No. 146 did not have a
     material impact on its financial position or results of operations.

     The FASB issued SFAS No. 148, ACCOUNTING FOR STOCK-BASED
     COMPENSATION-TRANSITION AND DISCLOSURE, which amends SFAS No. 123,
     ACCOUNTING FOR STOCK-BASED COMPENSATION. SFAS 148 provides alternative
     methods of transition for a voluntary change to the fair value based method
     of accounting for stock-based employee compensation. (Under the fair value
     based method, compensation cost for stock options is measured when options
     are issued). In addition, SFAS No. 148 amends the disclosure requirements
     of SFAS No. 123 to require more prominent and more frequent disclosures in
     financial statements of the effects of stock-based compensation. The
     Company adopted SFAS No. 148 beginning in the second fiscal quarter of
     fiscal 2003 and such disclosures are included as herein.

                                       5
<PAGE>

     The following table reconciles net income and basic and diluted earnings
     pre share (EPS), as reported, to pro-forma net income and basic and diluted
     EPS, as if the Company had expensed the fair value of stock options as
     permitted by SFAS No. 123, as amended by SFAS No. 148, since it permits
     alternative methods of adoption.

<TABLE>
<CAPTION>
                                                             Three Months Ended     Six Months Ended
                                                                   March 31,            March 31,
                                                               2004        2003     2004        2003
                                                               ----        ----     ----        ----
<S>                                                           <C>         <C>       <C>        <C>
     Net Income, as reported:                                  $653        $135    $1,236       $266

     Pro-forma expense as if stock options were
          charged against net income                              5          42        21         57
                                                              -----       -----    ------      -----

     Pro-forma net income using the fair value method          $648         $93    $1,215       $209
                                                               ====       =====    ======      =====

     Basic EPS:
     As reported                                              $0.04       $0.01     $0.08      $0.02
     Pro forma using the fair value method                    $0.04       $0.01     $0.07      $0.01

     Diluted EPS:
     As reported                                              $0.04       $0.01     $0.08      $0.02
     Pro forma using the fair value method                    $0.04       $0.01     $0.07      $0.01
</TABLE>

     In April 2003, the FASB issued SFAS No. 149, AMENDMENT OF STATEMENT 133 ON
     DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES. SFAS No. 149 amends SFAS No.
     133 for certain decisions made by the Board as part of the Derivatives
     Implementation Group ("DIG") process and is effective for contracts entered
     into or modified after June 30, 2003. In addition, SFAS No. 149 should be
     applied prospectively. The provisions of SFAS No. 149 that relate to SFAS
     No. 133 Implementation Issues that have been effective for fiscal quarters
     that began prior to June 15, 2003, should continue to be applied in
     accordance with their respective effective dates. The adoption of SFAS No.
     149 did not have an impact on the results of operations or financial
     position.

     In June 2003, the FASB issued SFAS No. 150, ACCOUNTING FOR CERTAIN
     FINANCIAL INSTRUMENTS WITH CHARACTERISTICS OF BOTH LIABILITIES AND EQUITY
     to improve the accuracy of securities issuers' accounting for such
     financial instruments. For earlier transactions, the provisions of SFAS No.
     150 take effect at the start of the first interim period beginning after
     December 15, 2003. The adoption of SFAS No. 150 did not have a material
     impact on the results of operations or financial position.

     In January 2003, the FASB issued FIN No. 46, as restated by FIN No. 46R,
     CONSOLIDATION OF VARIABLE INTEREST ENTITIES, AND AN INTERPRETATION OF ARB
     51. FIN No. 46 defines when a business enterprise must consolidate a
     variable interest entity. This interpretation applies immediately to
     variable interest entities created after January 31, 2003. It applies in
     the first fiscal year or interim period beginning after December 15, 2003,
     to entities in which an enterprise holds a variable interest that it
     acquired before February 1, 2003. The Company does not have variable
     interest entities as of March 31, 2004.


                                        6
<PAGE>

(3)  INVENTORIES

     Major classes of inventory at March 31, 2004 and September 30, 2003 were as
     follows:

                                                  March 31,    September 30,
                                                    2004            2003
                                                    ----            ----

         Raw materials                           $   2,842       $   2,439
         Work in process                             3,819           3,316
         Finished goods                             12,112           9,335
                                                 ---------       ---------
                                                    18,773          15,090
         Less reserves for obsolescence              3,343           3,098
                                                 ---------       ---------

                                                 $  15,430       $  11,992
                                                 =========       =========

(4)  INCOME TAXES

     The Company has incurred cumulative net operating losses through March 31,
     2004 of approximately $16 million, generated from its U.S. and German
     operations of $8 million and $8 million, respectively. These net operating
     losses are the primary component of the Company's net deferred tax asset of
     $2.0 million as of March 31, 2004, generated from its U.S. and German
     operations. A full valuation allowance had been provided on all but $135
     thousand of the U.S. deferred tax asset and no valuation allowance has been
     provided on its German operations in the Company's consolidated financial
     statements. The Company establishes valuation allowances in accordance with
     the provisions of FASB Statement No. 109, Accounting for Income Taxes. The
     Company continually reviews the adequacy and necessity of the valuation
     allowance and recognizes these benefits only as reassessment, based on
     recent developments including income from new contracts, indicates that it
     is more likely than not that the benefits will be realized. As of March 31,
     2004 the Company continues to record the existing valuation allowance on
     its U.S. operations and has not provided a valuation allowance on its
     German operations based upon future taxable income projections.

(5)  SEGMENT DATA

     The Company operates principally in one industry providing specialty
     surgical products and tissue processing services. These operations include
     two geographically determined segments: the United States and Europe
     ("International"). The accounting policies of these segments are the same
     as those described in the summary of significant accounting policies. The
     Company evaluates performance based on net profit or loss from operations,
     not including non-recurring and foreign exchange gains or losses. The
     Company accounts for intersegment sales and transfers at contractually
     agreed-upon prices.

     The Company's reportable segments are strategic business units that offer
     products and services to different geographic markets. They are managed
     separately because of the differences in these markets as well as their
     physical location.

                                        7
<PAGE>

     A summary of the operations and assets by segment as of and for the three
     months ended March 31, 2004 and 2003, respectively are as follows:

<TABLE>
<CAPTION>

     2004                                 INTERNATIONAL     UNITED STATES      CONSOLIDATED

<S>                                         <C>               <C>               <C>
     Gross revenue                          $    6,236        $    4,016        $   10,252
     Less - intercompany                        (3,163)                -            (3,163)
                                            ----------        ----------        ----------

     Total revenue - third party            $    3,073        $    4,016        $    7,089
                                            ==========        ==========        ==========

     Depreciation and amortization          $      113        $       60        $      173
                                            ==========        ==========        ==========

     Interest expense                       $       12        $        1        $       13
                                            ==========        ==========        ==========

     Net income                             $      780        $     (127)       $      653
                                            ==========        ==========        ==========

     Capital expenditures                   $      178        $       60        $      238
                                            ==========        ==========        ==========

     Total assets                           $   12,732        $   33,418        $   46,150
     Less intercompany advances                      -           (12,529)          (12,529)
                                            ----------        ----------        ----------

                                            $   12,732        $   20,889        $   33,621
                                            ==========        ==========        ==========


     2003                                 INTERNATIONAL     UNITED STATES      CONSOLIDATED

     Gross revenue                          $    3,573        $    4,283        $    7,856
     Less - intercompany                        (1,113)                -            (1,113)
                                            ----------        ----------        ----------

     Total revenue - third party            $    2,460        $    4,283        $    6,743
                                            ==========        ==========        ==========

     Depreciation and amortization          $       83        $       60        $      143
                                            ==========        ==========        ==========

     Interest expense                       $       11        $        2        $       13
                                            ==========        ==========        ==========

     Net income (loss)                      $      204        $      (69)       $      135
                                            ==========        ==========        ==========

     Capital expenditures                   $       85        $       56        $      141
                                            ==========        ==========        ==========

     Total assets                           $   12,323        $   31,192        $   43,515
     Less intercompany advances                      -           (16,041)          (16,041)
                                            ----------        ----------        ----------

                                            $   12,323        $   15,151        $   27,474
                                            ==========        ==========        ==========
</TABLE>


                                        8
<PAGE>

     A summary of the operations and assets by segment as of and for the six
     months ended March 31, 2004 and 2003, respectively are as follows:

<TABLE>
<CAPTION>

     2004                                 INTERNATIONAL     UNITED STATES      CONSOLIDATED

<S>                                         <C>               <C>               <C>

     Gross revenue                          $   11,932        $    9,079        $   21,011
     Less - intercompany                        (6,437)                -            (6,437)
                                            ----------        ----------        ----------

     Total revenue - third party            $    5,495        $    9,079        $   14,574
                                            ==========        ==========        ==========

     Depreciation and amortization          $      247        $      226        $      473
                                            ==========        ==========        ==========

     Interest expense                       $       24        $        3        $       27
                                            ==========        ==========        ==========

     Net income                             $    1,226        $       10        $    1,236
                                            ==========        ==========        ==========

     Capital expenditures                   $      341        $      201        $      542
                                            ==========        ==========        ==========

     Total assets                           $   12,732        $   33,418        $   46,150
     Less intercompany advances                      -           (12,529)          (12,529)
                                            ----------        ----------        ----------

                                            $   12,732        $   20,889        $   33,621
                                            ==========        ==========        ==========
</TABLE>



                                        9
<PAGE>

<TABLE>
<CAPTION>

     2003                                 INTERNATIONAL     UNITED STATES      CONSOLIDATED

<S>                                         <C>               <C>               <C>

     Gross revenue                          $    6,280        $    8,808        $   15,088
     Less - intercompany                        (1,771)                -            (1,771)
                                            ----------        ----------        ----------

     Total revenue - third party            $    4,509        $    8,808        $   13,317
                                            ==========        ==========        ==========

     Depreciation and amortization          $      160        $      123        $      283
                                            ==========        ==========        ==========

     Interest expense                       $       23        $        2        $       25
                                            ==========        ==========        ==========

     Net income                             $        9        $      257        $      266
                                            ==========        ==========        ==========

     Capital expenditures                   $      144        $      106        $      250
                                            ==========        ==========        ==========

     Total assets                           $   12,323        $   31,192        $   43,515
     Less intercompany advances                      -           (16,041)          (16,041)
                                            ----------        ----------        ----------

                                            $   12,323        $   15,151        $   27,474
                                            ==========        ==========        ==========
</TABLE>



                                       10
<PAGE>


       ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
                           AND RESULTS OF OPERATIONS
                                 (IN THOUSANDS)

RESULTS OF OPERATIONS

REVENUE AND COST OF REVENUE

In April 2003, the Company signed a renegotiated U.S. Distribution Agreement
with Centerpulse Spine-Tech, now known as Zimmer Spine ("Spine"), whereby Spine
has become a "stocking distributor". The effect of this new arrangement means
that Spine is now invoicing the end customer directly. The new agreement also
eliminates marketing fees paid to Spine included in Distribution and Marketing.

Revenues for the three months ended March 31, 2004, increased 5% to $7,089 from
$6,743 for the comparable period. The International operation generated an
increase in revenue of $613 ($273 of the increase was due to currency
translation) from $2,460 to $3,073. This was partially offset by a decrease in
revenue from the U.S. operation of $267 from $4,283 to $4,016 for this quarter.
The U.S. revenue increased as a result of an increase in the demand for the
Company's Tutoplast(R) bone products for dental applications sold by Zimmer
Dental ("Dental"), the Company's marketing partner. This product line
contributed $700 of an increase in revenue. However, as pointed out above, the
Company's revenues for the prior year quarter would have been $800 lower under
the new agreement with Spine, therefore, resulting in an increase of U.S.
revenue for this quarter of 19%. The increase in international revenue was due
to an overall increase in the European and international distributor business.

Revenues for the six months ended March 31, 2004 increased 9% to $14,574 from
$13,317 for the comparable period. Adjusting for new agreement with Spine, the
sales for the comparable period in 2003 would have been $11,617. Therefore,
revenues for the six months ended March 31, 2004 actually increased 25% over the
comparable period in 2003. Revenues from the U.S. operation increased 28% to
$9,079 from $7,108 (as adjusted for the change in the new distribution
arrangement with Spine) for the same period last year and revenues from the
international operations increased 21% from $4,509 in 2003 to $5,495 in 2004.
Incremental Spine and Dental revenues contributed the entire increase in
revenue.

Cost of revenue, for the three and six months ended March 31, 2004 were 28% and
34%, respectively, as compared to 37% and 40%, respectively for the comparable
periods last year. The lower cost of revenue margin was primarily due to the
significant reduction in scrap as the result of improved manufacturing
efficiencies from the International operation, partially offset by start-up
expenses related to the introduction of bone production in the U.S. operation.
Historically, the U.S. operation solely manufactured membranes or soft tissue.

GENERAL AND ADMINISTRATIVE

General and administrative expenses increased 8% and 16% for the three and six
months ended March 31, 2004, from the comparable periods last year. Second
quarter expenses increased $91, primarily due to the foreign exchange impact of
$81. Year-to-date expenses increased $320, due to foreign exchange variance
($161), expenditures related to the hiring of an investor relations/banker firms
($57), higher legal expenses related to merger opportunities ($40) and other
($60). As a percentage of revenues, for year-to-date, General and Administrative
expenses were flat in 2004 and 2003 at 16%.

                                       11

<PAGE>

DISTRIBUTION AND MARKETING

Distribution and marketing expenses decreased 8% from $2,419 to $2,236, and
decreased 10% to $4,306 from $4,761 for the three and six months ended March 31,
2004, from the comparable periods last year. The decrease was primarily due to
lower marketing fees as a result of the new agreement with Spine, whereby the
Spine marketing fees have been eliminated. Such fees decreased $1,053 for the
quarter and $2,166 for the six months ended March 31, 2004 as compared to the
comparable periods in 2003. The partial offset to the decrease in the Spine
marketing fees was due to higher marketing fees paid to Dental of $323 and $609
for the quarter and year-to-date, respectively as a result of increased Dental
sales. The balance of the increase was due to increased sales efforts
internationally and foreign exchange variances. For the three and six months
ended March 31, 2004, as a percentage of revenues, Distribution and Marketing
expenses decreased from 36% in 2003 to 32% in 2004 and from 36% to 30%,
respectively.

RESEARCH AND DEVELOPMENT

Research and development expenses increased 30% and 33%, respectively, for the
three and six months ended March 31, 2004, from the comparable periods last
year. The increase was due to increased development efforts in the spine, dental
and ligament product areas. As a percentage of revenues, Research and
Development expenses increased from 4% in 2003 to 5% in 2004.

DEPRECIATION AND AMORTIZATION

Depreciation and amortization was essentially flat for the three months ended
March 31, 2004 as compared to the same period last year, but for the six months
ended the same period depreciation increased from $87 to $128, primarily due to
the foreign exchange impact and additions to fixed assets.

OTHER EXPENSE

Other expenses were essentially flat from period to period.

INTEREST EXPENSE

Interest expense was essentially flat from period to period.

NET INCOME

As a result of the above, net income for the three and six months ended March
31, 2004 totaled $653 or $0.04 basic and $0.03 diluted earnings per share and
$1,236 or $0.08 basic and $0.07 diluted earnings per share, respectively, as
compared to a net income of $135 or $0.01 basic and diluted earnings per and net
income of $266 or $0.02 basic and diluted earnings per share for the same
periods in 2003.

CRITICAL ACCOUNTING POLICIES

The Company's significant accounting policies are more fully described in Note 2
to the consolidated financial statements in the annual report. However, certain
of the accounting policies are particularly important to the portrayal of the
financial position and results of operations and require the application of


                                       12
<PAGE>

significant judgment by management; as a result, they are subject to an inherent
degree of uncertainty. In applying those policies, management uses its judgment
to determine the appropriate assumptions to be used in the determination of
certain estimates. Those estimates are based on historical experience, terms of
existing contracts, observance of trends in the industry, information provided
by customers and information available from other outside sources, as
appropriate. The Company's significant accounting policies include:

INVENTORIES. Inventories are valued at the lower of cost (weighted average
basis) or market. Work in process and finished goods include costs attributable
to direct labor and overhead. Reserves for slow moving and obsolete inventories
are provided based on historical experience and current product demand. The
adequacy of these reserves are evaluated quarterly.

REVENUE RECOGNITION AND ACCOUNTS RECEIVABLE. Revenue on product sales is
recognized when persuasive evidence of an arrangement exists, the price is fixed
and final, delivery has occurred and there is a reasonable assurance of
collection of the sales proceeds. Oral or written purchase authorizations are
generally obtained from customers for a specified amount of product at a
specified price and consider delivery to have occurred at the time of shipment.
Customers are provided with a limited right of return. Revenue is recognized at
shipment. Reasonable and reliable estimates of product returns are made in
accordance with SFAS No. 48 and of allowances for doubtful accounts based on
significant historical experience. Revenue from service sales is recognized when
the service procedures have been completed or applicable milestones have been
achieved. Revenue from distribution fees include nonrefundable payments received
as a result of exclusive distribution agreements between the Company and
independent distributors. Distribution fees under these arrangements are
recognized as revenue as products are delivered.

FOREIGN CURRENCY TRANSLATION. The financial position and results of operations
of the Company's foreign subsidiary is measured using local currency (Euro) as
the functional currency. Assets and liabilities of the foreign subsidiary are
translated at the rate of exchange in effect at the end of the period. Revenues
and expenses are translated at the average exchange rated for the period.
Foreign currency translation gains and losses not impacting cash flows are
credited to or charged against other comprehensive income (loss). Foreign
currency translation gains and losses arising from cash transactions are
credited to or charged against current earnings.

LIQUIDITY AND CAPITAL RESOURCES

At March 31, 2004, the Company has working capital of $17.7 million as compared
to September 30, 2003 of $15.8 million. The Company maintains current working
capital credit lines totaling (euro)1.5 million Euros (approximately $1.9
million) with several German banks and a $1.0 million credit line with a U.S.
bank. At March 31, 2004, the Company had no borrowings against these lines.

The Company has experienced a positive cash flow of $389 for the six months
ended March 31, 2004 as compared to a positive cash flow of $820 for the same
period in 2003. In 2003, the cash flow was influenced by increased issuance of
common shares from the exercise of stock options and lower purchases of property
and equipment. The primary reason for the positive cash flow in 2004 was due to
the increase in net income for the period.

The Company's ability to generate positive operational cash flow is dependent
upon increasing processing revenues through increased recoveries by tissue banks
in the U.S. and Europe, and the


                                       13
<PAGE>

development of additional markets and surgical applications worldwide. While the
Company believes that it continues to make progress in both these areas, there
can be no assurances that changing governmental regulations will not have a
material adverse effect on the results of operations and cash flow.

Future minimum rental payments required under Company's leases that have initial
or remaining non-cancelable lease terms in excess of one year as of March 31,
2004 are as follows:






Long-term debt consists of senior debt, 5.75% interest until March 30, 2008 when
terms are renegotiable, due 2008. Future minimum payments as of March 31, 2004
are as follows:







NEW ACCOUNTING PRONOUNCEMENTS

In June 2002, the FASB issued SFAS No. 146, ACCOUNTING FOR COSTS ASSOCIATED WITH
EXIT OR DISPOSAL ACTIVITIES. SFAS No. 146 nullifies Emerging Issues Task Force
("EITF") No. 94-3, LIABILITY RECOGNITION FOR CERTAIN EMPLOYEE TERMINATION
BENEFITS AND OTHER COSTS TO EXIT AN ACTIVITY (INCLUDING CERTAIN COSTS INCURRED
IN AS RESTRUCTURING). The principal difference between SFAS No. 146 and EITF No.
94-3 relates to its requirements for recognition of a liability for a cost
associated with an exit or disposal activity. SFAS No. 146 requires that a
liability for a cost associated with an exit or disposal activity be recognized
when the liability is incurred. Under EITF No. 94-3, a liability for an exit
cost was recognized at the date of an entity's commitment to an exit plan. SFAS
No. 146 was effective for exit and disposal activities that are initiated after
December 31, 2002. The provisions of SFAS No. 146 did not have a material impact
on its financial position or results of operations.

On December 31, 2002, the FASB issued SFAS No. 148, ACCOUNTING FOR STOCK-BASED
COMPENSATION-TRANSITION AND DISCLOSURE, which amends SFAS No. 123, ACCOUNTING
FOR STOCK-BASED COMPENSATION. SFAS 148 provides alternative methods of
transition for a voluntary change to the fair value based


                                       14
<PAGE>

method of accounting for stock-based employee compensation. (Under the fair
value based method, compensation cost for stock options is measured when options
are issued). In addition, SFAS No. 148amends the disclosure requirements of SFAS
No. 123 to require more prominent and more frequent disclosures in financial
statements of the effects of stock-based compensation. The Company adopted SFAS
No. 148 beginning in the second fiscal quarter of fiscal 2003 and such
disclosures are included as herein.

The following table reconciles net income and basic and diluted earnings pre
share (EPS), as reported, to pro-forma net income and basic and diluted EPS, as
if the Company had expensed the fair value of stock options as permitted by SFAS
No. 123, as amended by SFAS No. 148, since it permits alternative methods of
adoption.

<TABLE>
<CAPTION>
                                                   Three Months Ended     Six Months Ended
                                                       March 31,             March 31,

                                                     2004    2003           2004     2003
                                                     ----    ----           ----     ----
<S>                                                  <C>     <C>          <C>        <C>
Net Income, as reported:                             $653    $135         $1,236     $266

Pro-forma expense as if stock options were
charged against net income                              5      42             21       57
                                                     ----      --             --     ----

Pro-forma net income using the fair value method     $648     $93         $1,215     $209
                                                     ====     ===         ======     ====

Basic EPS:
As reported                                         $0.04   $0.01          $0.08    $0.02
Pro forma using the fair value method               $0.04   $0.01          $0.07    $0.01

Diluted EPS:
As reported                                         $0.04   $0.01          $0.08    $0.02
Pro forma using the fair value method               $0.04   $0.01          $0.07    $0.01
</TABLE>


In April 2003, the FASB issued SFAS No. 149, AMENDMENT OF STATEMENT 133 ON
DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES. SFAS No. 149 amends SFAS No. 133
for certain decisions made by the Board as part of the Derivatives
Implementation Group ("DIG") process and is effective for contracts entered into
or modified after June 30, 2003. In addition, SFAS No. 149 should be applied
prospectively. The provisions of SFAS No. 149 that relate to SFAS No. 133
Implementation Issues that have been effective for fiscal quarters that began
prior to June 15, 2003, should continue to be applied in accordance with their
respective effective dates. The adoption of SFAS No. 149 did not have an impact
on the results of operations or financial position.

In June 2003, the FASB issued SFAS No. 150, ACCOUNTING FOR CERTAIN FINANCIAL
INSTRUMENTS WITH CHARACTERISTICS OF BOTH LIABILITIES AND EQUITY to improve the
accuracy of securities issuers' accounting for such financial instruments. For
earlier transactions, the provisions of SFAS No. 150 take effect at the start of
the first interim period beginning after December 15, 2003. The adoption of SFAS
No. 150 did not have a material impact on the results of operations or financial
position.


                                       15
<PAGE>

In January 2003, the FASB issued FIN No. 46, as restated by FIN No. 46R,
CONSOLIDATION OF VARIABLE INTEREST ENTITIES, AND AN INTERPRETATION OF ARB 51.
FIN No. 46 defines when a business enterprise must consolidate a variable
interest entity. This interpretation applies immediately to variable interest
entities created after January 31, 2003. It applies in the first fiscal year or
interim period beginning after December 15, 2003, to entities in which an
enterprise holds a variable interest that it acquired before February 1, 2003.
The Company does not have variable interest entities as of March 31, 2003.

Item 4.  CONTROLS AND PROCEDURES

Within 90 days prior to the date of this report, the Company carried out an
evaluation, under the supervision and with the participation of the Company's
management, including the Company's Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of the Company's
disclosure controls and procedures pursuant to Exchange Act Rule 13 a-14. Based
upon that evaluation, the Company's Chief Executive Officer and Chief Financial
Officer concluded that the Company's disclosure controls and procedures are
effective in timely alerting them to material information relating to the
Company (including its consolidated subsidiaries) that is required to be
included in the Company's periodic filings with the Securities and Exchange
Commission. There have been no significant changes in the Company's internal
controls or, to the Company's knowledge, in other factors that could
significantly affect those internal controls subsequent to the date the Company
carried out its evaluation.


                                       16
<PAGE>

PART II.    OTHER INFORMATION

               ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY-HOLDERS

               An annual Meeting of Stockholders was held on April 20, 2004. All
               management's nominees for director, as listed in the Proxy
               Statement for the Annual Meeting, were elected. Listed below are
               the matters voted on by stockholders and the number of votes cast
               at the Annual Meeting:

          (A)  ELECTION OF EIGHT MEMBERS OF THE BOARD OF DIRECTORS.

<TABLE>
<CAPTION>
                                                                          Broker
                                                  Voted      Votes        Non-Votes
          Name                      Voted For     Against    Withheld     and Abstentions
          ----                      ---------     -------    --------     ---------------
<S>                                 <C>              <C>     <C>                 <C>
          G. Russell Cleveland      13,188,918       0       330,179             0
          Roy D. Crowninshield      13,190,903       0       328,194             0
          Robert C. Farone          13,219,875       0       299,222             0
          J. Harold Helderman       13,223,875       0       295,222             0
          Manfred K. Kruger         13,190,603       0       328,494             0
          Richard J. May            13,222,875       0       296,222             0
          Thomas W. Pauken          13,189,803       0       329,294             0
          Carlton E. Turner         13,221,875       0       297,222             0
</TABLE>

          (B)  RATIFICATION OF THE APPOINTMENT OF DELOITTE AND TOUCHE L.L.P. AS
               INDEPENDENT AUDITORS OF THE COMPANY FOR THE FISCAL YEAR ENDING
               SEPTEMBER 30, 2004.


               Voted For:                       13,460,426
               Voted Against:                       54,591
               Votes Abstained:                      4,080
               Broker Non-Votes                          0



          ITEM 6. REPORTS ON FORM 8-K

          The Company filed no Reports on Form 8-K during the quarter ended
          March 31, 2004.


                                       17
<PAGE>


CERTIFICATION

Each of the undersigned hereby certifies in his capacity as an officer of
Tutogen Medical, Inc. (the "Company") that the Quarterly Report of the Company
on Form 10-QSB for the periods ended March 31, 2004 fully complies with the
requirements of Section 13(a) of the Securities Exchange Act of 1934 and that
the information contained in such report fairly presents, in all material
respects, the financial condition of the Company at the end of such periods and
the results of operations of the Company for such periods.

SIGNATURES

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

                                           TUTOGEN MEDICAL, INC.




Date:  May 13, 2004                          /s/ Manfred Kruger
                                             ------------------
                                     President and Chief Executive Officer




Date:  May 13, 2004                          /s/ George Lombardi
                                             -------------------
                                           Chief Financial Officer
                                   (Principal Financial and Accounting Officer)


                                       18
<PAGE>

            CERTIFICATION OF THE CHIEF FINANCIAL OFFICER PURSUANT TO
                 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
                  SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002


In connection with the Quarterly Report on Form 10QSB of Tutogen Medical, Inc.
(the "Company") for the three months ended March 31, 2004 as filed with the
Securities and Exchange commission on the date hereof (the "Report"), I George
Lombardi, as the Chief Financial Officer of the Company, hereby certify,
pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of the
Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

     (1)  The Report fully complies with the requirements of Section 13 (a) or
          15 (d) of the Securities Exchange Act of 1934; and

     (2)  The information contained in the Report fairly presents, in all
          material respects, the financial condition and results of operations
          of the Company.

Date: May 13, 2004

                                TUTOGEN MEDICAL, INC.


                                /s/ George Lombardi
                                -------------------
                                George Lombardi
                                Chief Financial Officer, Treasurer and Secretary

<PAGE>

            CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER PURSUANT TO
                 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
                  SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002


In connection with the Quarterly Report on Form 10QSB of Tutogen Medical, Inc.
(the "Company") for the three months ended March 31, 2004 as filed with the
Securities and Exchange commission on the date hereof (the "Report"), I Manfred
Krueger, as the Chief Executive Officer, President and Chief Operating Officer
of the Company, hereby certify, pursuant to 18 U.S.C. ss. 1350, as adopted
pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that to the best of my
knowledge:

     (1)  The Report fully complies with the requirements of Section 13 (a) or
          15 (d) of the Securities Exchange Act of 1934; and

     (2)  The information contained in the Report fairly presents, in all
          material respects, the financial condition and results of operations
          of the Company.

Date: May 13, 2004

                                       TUTOGEN MEDICAL, INC.


                                       /s/ Manfred Krueger
                                       -------------------
                                       Manfred Krueger
                                       Chief Executive Officer, President and
                                       Chief Operating Officer

<PAGE>

CERTIFICATION

I George Lombardi certify that:

1.   I have reviewed this Quarterly Report on Form 10-QSB of Tutogen Medical,
     Inc.

2.   Based on my knowledge, this Quarterly Report does not contain any untrue
     statement of a material fact or omit to state a material fact necessary to
     make the statements made, in light of the circumstances under which such
     statements were made, not misleading with respect to the period covered by
     this Quarterly Report;

3.   Based on my knowledge, the financial statements and other financial
     information included in the Quarterly Report fairly present in all material
     respects, the financial condition, results of operations and cash flows of
     the registrant as of, and for, the periods presented in this Quarterly
     Report;

4.   The registrant's other certifying officer and I am responsible for
     establishing and maintaining disclosure controls and procedures (as defined
     in Exchange Act Rules 13a-14 and 15d-14) for the registrant and have:

          a) Designed such disclosure controls and procedures to ensure that
          material information relating to the registrant, including its
          consolidated subsidiaries, is made known to us by others within those
          entities, particularly during the period in which this Quarterly
          Report is being prepared;

          b) Evaluated the effectiveness of the registrant's disclosure controls
          and procedures as of a date within 90 days prior to the filing date of
          this Quarterly Report (the "Evaluation Date"); and

          c) Presented in this Quarterly Report our conclusions about the
          effectiveness of the disclosure controls and procedures based on our
          evaluation as of the Evaluation Date.

5.   The registrant's other certifying officer and I have disclosed, based on
     our most recent evaluation, to the registrant's auditors and the Audit
     Committee of registrant's Board of Directors (or persons performing the
     equivalent functions):

          a) All significant deficiencies in the design or operation of internal
          controls which could adversely affect the registrant's ability to
          record, process, summarize and report financial data and have
          identified for the registrant's auditors any material weaknesses in
          internal controls; and

          b) Any fraud, whether or not material, that involves Management or
          other employees who have a significant role in the registrant's
          internal controls.

<PAGE>

CERTIFICATION


6.   The registrant's other certifying officers and I have indicated in this
     Quarterly Report whether there were significant changes in internal
     controls or in other factors that could significantly affect internal
     controls subsequent to the date of our most recent evaluation, including
     any corrective actions with regard to significant deficiencies and material
     weaknesses.


Date:      May 13, 2004

BY:
Name:      /s/ George Lombardi

Title:     Chief Financial Officer,
           Treasurer and Secretary


                                     Page 2

<PAGE>

CERTIFICATION


I Manfred Krueger certify that:

1.   I have reviewed this Quarterly Report on Form 10-QSB of Tutogen Medical,
     Inc.

2.   Based on my knowledge, this Quarterly Report does not contain any untrue
     statement of a material fact or omit to state a material fact necessary to
     make the statements made, in light of the circumstances under which such
     statements were made, not misleading with respect to the period covered by
     this Quarterly Report;

3.   Based on my knowledge, the financial statements and other financial
     information included in the Quarterly Report fairly present in all material
     respects, the financial condition, results of operations and cash flows of
     the registrant as of, and for, the periods presented in this Quarterly
     Report;

4.   The registrant's other certifying officer and I am responsible for
     establishing and maintaining disclosure controls and procedures (as defined
     in Exchange Act Rules 13a-15 (e) and 15d-15(e)) for the registrant and
     have:

          a) Designed such disclosure controls and procedures to ensure that
          material information relating to the registrant, including its
          consolidated subsidiaries, is made known to us by others within those
          entities, particularly during the period in which this Quarterly
          Report is being prepared;

          b) Evaluated the effectiveness of the registrant's disclosure controls
          and procedures as of a date within 90 days prior to the filing date of
          this Quarterly Report (the "Evaluation Date"); and

          c) Presented in this Quarterly Report our conclusions about the
          effectiveness of the disclosure controls and procedures based on our
          evaluation as of the Evaluation Date.

5.   The registrant's other certifying officer and I have disclosed, based on
     our most recent evaluation, to the registrant's auditors and the Audit
     Committee of registrant's Board of Directors (or persons performing the
     equivalent functions):

          a) All significant deficiencies in the design or operation of internal
          controls which could adversely affect the registrant's ability to
          record, process, summarize and report financial data and have
          identified for the registrant's auditors any material weaknesses in
          internal controls; and

          b) Any fraud, whether or not material, that involves Management or
          other employees who have a significant role in the registrant's
          internal controls.

<PAGE>

CERTIFICATION


6.   The registrant's other certifying officers and I have indicated in this
     Quarterly Report whether there were significant changes in internal
     controls or in other factors that could significantly affect internal
     controls subsequent to the date of our most recent evaluation, including
     any corrective actions with regard to significant deficiencies and material
     weaknesses.


Date:       May 13, 2004

BY:
Name:       /s/ Manfred Krueger

Title:      CEO, President and Chief Operating Officer



                                     Page 2