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Cardiac Science Announces Third Quarter Results
Date:11/9/2009

BOTHELL, Wash., Nov. 9 /PRNewswire-FirstCall/ -- Cardiac Science Corporation (Nasdaq: CSCX), a global leader in automated external defibrillator (AED) and diagnostic cardiac monitoring devices, today announced revenue of $38.9 million for the third quarter ended September 30, 2009, in line with its previous guidance. The Company also recorded a charge of $18.5 million for an AED field product update and a non-cash charge of $44.0 million to increase its valuation allowance against deferred income tax assets. Including these charges, the Company reported a net loss for the quarter of $66.5 million, or $2.85 per share.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080306/AQTH510LOGO)

Sales in all areas of the business continued to stabilize during the period and execution of the Company's turnaround initiatives should help to reinstate revenue growth in the coming year.

Cardiac monitoring revenue was $13.0 million and defibrillation products revenue was $21.6 million for the third quarter of 2009. As anticipated, AED sales in Japan were approximately $10.0 million less than in the prior year quarter, due primarily to market weakness and a competing AED product introduction by the Company's current distribution partner. North American AED sales were down 9% compared to the prior year period. However, following the resumption of AED shipments in August after a temporary ship hold, the Company's manufacturing and quality teams performed well, filling the vast majority of open orders that had accumulated during the ship hold. Cardiac monitoring revenue decreased 15% compared to the prior year period, driven by slowed demand in the hospital and physician office markets.

The Company recorded a charge of $18.5 million for estimated costs relating to an initiative to improve the reliability of approximately 300,000 AEDs in the field. The Company has determined that, in very rare instances, AEDs may fail to deliver therapy due to a suspect component. The Company has improved its manufacturing process to enhance component reliability in forward production and has elected to undertake an initiative to further strengthen the reliability of field units. The initiative is expected to cost $18.5 million, but the Company is still in discussion with the FDA and other stakeholders to determine the final scope and details. Actual costs may be more or less than the amount of the estimated charge, based on a number of factors.

In addition, the Company's third quarter results reflect a charge to earnings of $44.0 million to increase its valuation allowance against deferred income tax assets. In light of recent losses, including the $18.5 million charge relating to the anticipated field initiative, the Company has made an assessment that the realization of the benefit of its deferred tax assets, primarily comprised of income tax loss and tax credit carry-forwards, is not "more likely than not" in accordance with applicable GAAP guidelines and has therefore increased its valuation allowance against those assets. This is a non-cash charge that has no impact on the Company's liquidity and the tax loss and credit carry-forwards remain available to offset future cash income taxes when the Company regains profitability.

"Gaining clarity on the financial impact of the component issue will allow all of our stakeholders to eliminate uncertainty and begin to focus on the progress we've made in our turnaround. Operationally, we continue to move at a brisk pace in improving our systems and capabilities with an eye toward building a stronger foundation for future growth," said Dave Marver, president and chief executive officer. "We have several new technologies slated for introduction in the next 12 months. The introduction of our new vital signs monitors in cooperation with Omron is one of many enhancements we'll be making to our product line that leverage our brands, distribution, and large installed customer base."

Third Quarter Financial Results

Third quarter revenue of $38.9 million represented a decrease of 28% compared to the $54.0 million in revenue reported in the third quarter of 2008. Third quarter gross margin was 0.2%, inclusive of the $18.5 million charge relating to the AED field initiative. Excluding this charge, pro forma gross margin would have been 47.8%, a slight decrease from reported third quarter 2008 gross margin, which was 48.4%. The decrease in gross margin on a pro forma basis was due primarily to lower service margins relating to lower revenue being spread over a somewhat fixed cost structure.

Operating expenses in the third quarter of 2009 were $22.8 million, a modest increase from the $22.1 million for the third quarter of 2008. Inclusive of the $18.5 million charge relating to the AED field product update and the $44.0 million charge related to deferred tax assets, the Company reported a net loss of $66.5 million, or $2.85 loss per share in the third quarter of 2009.

EBITDA was negative $21.1 million for the third quarter of 2009. Adjusted EBITDA, which excludes stock-based compensation expense and the costs relating to the AED field initiative, was negative $1.9 million for the third quarter of 2009.

The Company had $31.6 million in cash and cash equivalents as of September 30, 2009, down from $37.9 million at the end of the second quarter. The most significant reason for the decrease was a delay in cash collections during the quarter relating to the delay in shipping AEDs until the second half of the period as a result of the earlier ship hold. As those collections normalize, the cash position is expected to be positively impacted during the fourth quarter.

Outlook

The Company expects revenue for the fourth quarter of 2009 to be in a range between $39.0 million and $41.0 million. During the fourth quarter, the Company will continue to incur higher regulatory and quality assurance expenses as it upgrades its internal capabilities in this area and draws upon outside consultants to assist with the establishment of improved systems. In addition, the Company expects to incur higher research and development and marketing expenses associated with product development initiatives - both internal and with strategic partners.

The Company expects to report a net loss for the quarter in a range between $4.0 and $5.0 million, or between $0.17 and $0.21 per share. The expected loss includes non-cash expenses of approximately $2.2 million related primarily to depreciation, amortization, and stock-based compensation. The Company will not record any tax benefit for operating losses, so these estimates are not tax effected.

Non-GAAP and Pro Forma Financial Information

This news release contains a discussion of EBITDA, Adjusted EBITDA, and Pro Forma Gross Margin, which are non-GAAP financial measures provided as a complement to results provided in accordance with U.S. generally accepted accounting principles ("GAAP"). The term "EBITDA" refers to a financial measure defined as earnings before net interest, income taxes, depreciation, and amortization. "Adjusted EBITDA" refers to EBITDA before stock-based compensation and costs associated with the AED field product update. "Pro Forma Gross Margin" refers to Gross Profit before costs associated with the AED field product update as a percentage of Total Revenues. These measures are a substitute for measures determined in accordance with GAAP, and may not be comparable to the same measures as reported by other companies. EBITDA and Adjusted EBITDA are an integral part of the internal management reporting and planning process and are the primary measures used by management to evaluate the operating performance of the Company. The components of these measures include the key revenue and expense items for which operating managers are responsible and upon which their performance is evaluated. The Company also uses Adjusted EBITDA for planning purposes and in presentations to its board of directors. Pro Forma Gross Margin is being presented because of the impact of the extraordinary charge related to the AED field product update on the Company's Gross Margin for the third quarter of 2009. Presentation of our Gross Margin excluding this charge allows for a comparison of the Company's performance on a basis that management believes is more consistent from period to period. Reconciliations of EBITDA and Adjusted EBITDA to net income, and Pro Forma Gross Margin to Gross Margin, the most comparable GAAP measures, are contained in this press release.

Conference Call Information

Cardiac Science will conduct a conference call at 4:30 p.m. Eastern Standard Time today to discuss the Company's financial results for the third quarter. The call will be hosted by Dave Marver, president and chief executive officer, and Mike Matysik, senior vice president and chief financial officer.

To access the conference call, please dial 877.941.2332 and reference conference ID 4179087. Callers outside the U.S. can dial 480.629.9724. The call will also be webcast live at www.cardiacscience.com. An audio replay of the call will be available for 7 days following the call at 800.406.7325 for U.S. callers or 303.590.3030 for those calling from outside the U.S. The password required to access the replay is 4179087#. An archived webcast will also be available at www.cardiacscience.com for 90 days.

About Cardiac Science

Cardiac Science develops, manufactures, and markets a family of advanced diagnostic and therapeutic cardiology devices and systems, including automated external defibrillators (AED), electrocardiograph devices (ECG/EKG), cardiac stress test treadmills and systems, Holter monitoring systems, hospital defibrillators, cardiac rehabilitation telemetry systems, and cardiology data management systems (informatics) that connect with hospital information (HIS), electronic medical record (EMR), and other information systems. The Company sells a variety of related products and consumables and provides a portfolio of training, maintenance, and support services. Cardiac Science, the successor to the cardiac businesses that established the trusted Burdick(®), HeartCentrix(®), Powerheart(®), and Quinton(®) brands, is headquartered in Bothell, Washington. The Company distributes its products in nearly 100 countries worldwide, with operations in North America, Europe, and Asia. For information, call 425.402.2000 or visit http://www.cardiacscience.com.

Forward-Looking Statements

This press release contains forward-looking statements. The word "believe," "expect," "intend," "anticipate," variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Forward-looking statements in this press release include, but are not limited to, those relating to Cardiac Science Corporation's future financial results and condition, actual costs of the AED field product update, potential negative impact on future sales of AED products resulting from the announced AED field product update, constraints on our ability to pursue strategic initiatives as a result of the costs associated with implementing the AED field product update, including future product releases, and income taxes on future pre-tax results. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results and performance may vary significantly from those expressed or implied in such statements. Factors that could cause or contribute to such varying results and other risks include those with respect to the quality of our processes, products and services and the implementation of voluntary actions or those taken at the request of regulatory authorities relating to our business, as well as those more fully described in the Annual Report on Form 10-K filed by Cardiac Science Corporation for the year ended December 31, 2008, as updated by subsequent quarterly reports on Form 10-Q. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.

For more information,

    Company Contact:              Investor Contact:   Media Contact:
    ----------------              -----------------   --------------
    Mike Matysik                  Matt Clawson        Christopher Gale
    Cardiac Science Corporation   Allen & Caron       EVC Group Inc.
    Senior Vice President and CFO 949.474.4300        646.201.5431
    425.402.2009                  matt@allencaron.com 203.570.4681
                                                      cgale@evcgroup.com

CSCX-F

                         - Tables to Follow -

    Cardiac Science Corporation and Subsidiaries
    Condensed Consolidated Statements of Operations (unaudited)
    (in thousands, except share and per share amounts)

                                              Three Months Ended
                                                 September 30,
                                           -----------------------
                                           2009               2008
                                           ----               ----
                                        $         %         $        %
                                       ---       ---       ---     ---

    Revenues:
      Cardiac monitoring products    $13,000    33.4%    $15,316   28.4%
      Defibrillation products         21,646    55.7%     34,071   63.1%
                                      ------    ----      ------   ----
          Total product
           revenues                   34,646    89.1%     49,387   91.4%
      Service                          4,238    10.9%      4,619    8.6%
                                       -----    ----       -----    ---
          Total revenues              38,884   100.0%     54,006  100.0%
                                      ------   -----      ------  -----

    Cost of Revenues:
      Products                        17,194    49.6%     24,799   50.2%
      AED field initiative            18,500    47.6%          -    0.0%
      Service                          3,095    73.0%      3,088   66.9%
                                       -----    ----       -----   ----
          Total cost of
           revenues                   38,789    99.8%     27,887   51.6%
                                      ------    ----      ------   ----

    Gross Profit:
      Products                        (1,048)   -3.0%     24,588   49.8%
      Service                          1,143    27.0%      1,531   33.1%
                                       -----    ----       -----   ----
          Gross profit                    95     0.2%     26,119   48.4%
                                         ---     ---      ------   ----

    Operating Expenses:
       Research and development        4,270    11.0%      4,103    7.6%
       Sales and marketing            11,923    30.7%     12,934   23.9%
       General and administrative      6,571    16.9%      5,096    9.4%
                                       -----    ----       -----    ---
          Total operating
           expenses                   22,764    58.5%     22,133   41.0%
                                      ------    ----      ------   ----

          Operating income
           (loss)                    (22,669)  -58.3%      3,986    7.4%
                                     -------   -----       -----    ---

    Other Income:
      Interest income                     23     0.1%        156    0.3%
      Other income, net                  158     0.4%         20    0.0%
                                         ---     ---          --    ---

        Total other
         income                          181     0.5%        176    0.3%
                                         ---     ---         ---    ---


    Income (loss) before income
     tax expense:                    (22,488)  -57.8%      4,162    7.7%
      Income tax expense             (43,923) -113.0%     (1,598)  -3.0%
                                     -------  ------      ------   ----

    Net income (loss)                (66,411) -170.8%      2,564    4.7%
      Less:  Net income
       attributable to
       noncontrolling interests         (135)   -0.3%        (86)  -0.2%
                                        ----    ----         ---   ----


    Net income (loss)
     attributable to Cardiac
     Science Corporation            $(66,546) -171.1%     $2,478    4.6%
                                    ========  ======      ======    ===

    Net income (loss) per share
     attributable to Cardiac
     Science Corporation:
      Basic                           $(2.85)              $0.11
      Diluted                         $(2.85)              $0.11
    Weighted average shares
     outstanding:
      Basic                       23,368,778          22,892,161
      Diluted                     23,368,778          23,413,042



    Cardiac Science Corporation and Subsidiaries
    Condensed Consolidated Statements of Operations (unaudited)
    (in thousands, except share and per share amounts)

                                              Nine Months Ended
                                                 September 30,
                                           -----------------------
                                           2009               2008
                                           ----               ----
                                        $        %         $        %
                                       ---      ---       ---      ---

    Revenues:
      Cardiac monitoring products    $40,151   35.0%    $48,613   31.3%
      Defibrillation products         61,413   53.6%     92,371   59.6%
                                      ------   ----      ------   ----
          Total product
           revenues                  101,564   88.6%    140,984   90.9%
      Service                         13,098   11.4%     14,113    9.1%
                                      ------   ----      ------    ---
          Total revenues             114,662  100.0%    155,097  100.0%
                                     -------  -----     -------  -----

    Cost of Revenues:
      Products                        49,261   48.5%     69,260   49.1%
      AED field initiative            18,500   16.1%          -    0.0%
      Service                          9,376   71.6%      9,557   67.7%
                                       -----   ----       -----   ----
          Total cost of
           revenues                   77,137   67.3%     78,817   50.8%
                                      ------   ----      ------   ----

    Gross Profit:
      Products                        33,803   33.3%     71,724   50.9%
      Service                          3,722   28.4%      4,556   32.3%
                                       -----   ----       -----   ----
          Gross profit                37,525   32.7%     76,280   49.2%
                                      ------   ----      ------   ----

    Operating Expenses:
       Research and development       11,358    9.9%     11,762    7.6%
       Sales and marketing            34,392   30.0%     38,170   24.6%
       General and administrative     18,536   16.2%     15,568   10.0%
                                      ------   -----     ------   -----
          Total operating
           expenses                   64,286   56.1%     65,500   42.2%
                                      ------   ----      ------   ----

          Operating income
           (loss)                    (26,761) -23.3%     10,780    7.0%
                                     -------  -----      ------    ---

    Other Income:
      Interest income                     55    0.0%        434    0.3%
      Other income, net                  555    0.5%        106    0.1%
                                         ---    ---         ---    ---

        Total other
         income                          610    0.5%        540    0.3%
                                         ---    ---         ---    ---


    Income (loss) before income
     tax expense:                    (26,151) -22.8%     11,320    7.3%
      Income tax expense             (42,563) -37.1%     (4,245)  -2.7%
                                     -------  -----      ------   ----

    Net income (loss)                (68,714) -59.9%      7,075    4.6%
      Less:  Net income
       attributable to
       noncontrolling interests         (476)  -0.4%       (257)  -0.2%
                                        ----   ----        ----   ----


    Net income (loss)
     attributable to Cardiac
     Science Corporation            $(69,190) -60.3%     $6,818    4.4%
                                    ========  =====      ======    ===

    Net income (loss) per share
     attributable to Cardiac
     Science Corporation:
      Basic                           $(2.98)             $0.30
      Diluted                         $(2.98)             $0.29
    Weighted average shares
     outstanding:
      Basic                       23,209,181         22,840,524
      Diluted                     23,209,181         23,402,011



    Cardiac Science Corporation and Subsidiaries
    Condensed Consolidated Balance Sheets (unaudited)
    (in thousands)
                                                 September          December
                                                    30,                31,
                                                   2009               2008
                                                 ---------          --------

    ASSETS
      Current Assets:
        Cash and cash equivalents                  $31,628           $34,655
        Accounts receivable, net                    28,387            31,665
        Inventories                                 26,011            24,692
        Deferred income taxes                            -             8,366
        Prepaid expenses and other
         current assets                              2,763             3,144
                                                     -----             -----
          Total current assets                      88,789           102,522

      Other assets                                     358               428
      Machinery and equipment, net of
       accumulated depreciation                      7,951             6,994
      Deferred income taxes                              -            28,452
      Intangible assets, net of
       accumulated amortization                     28,672            31,278
      Investments in unconsolidated
       entities                                        664               534
                                                       ---               ---

          Total assets                            $126,434          $170,208
                                                  ========          ========

    LIABILITIES AND EQUITY
      Current Liabilities:
        Accounts payable                            11,885            12,711
        Accrued liabilities                         12,568            13,535
        Warranty liability                           3,861             3,796
        AED field initiative liability              18,500                 -
        Deferred revenue                             7,787             7,918
                                                     -----             -----
          Total current liabilities                $54,601           $37,960

      Deferred income taxes                          5,376                 -

          Total liabilities                        $59,977           $37,960
                                                   -------           -------

      Equity:
        Cardiac Science Corporation
         shareholders' equity                       65,422           131,703
        Noncontrolling interests                     1,035               545
                                                     -----               ---
          Total equity                              66,457           132,248
                                                    ------           -------

          Total liabilities and equity            $126,434          $170,208
                                                  ========          ========



    Cardiac Science Corporation and Subsidiaries
    Condensed Consolidated Statements of Cash Flows (unaudited)
    (in thousands)
                                                    Three Months Ended
                                                       September 30,
                                                       -------------
                                                       2009     2008
                                                       ----     ----

    Operating Activities:
      Net income (loss)                             $(66,411)  $2,564

      Adjustments to reconcile net income (loss)
       to net cash provided by (used in)
       operating activities:
         Stock-based compensation                        674      469
         Depreciation and amortization                 1,595    1,544
         Deferred income taxes                        43,996    1,493

        Changes in operating assets and
         liabilities, net of businesses acquired:
          Accounts receivable, net                    (5,552)    (526)
          Inventories                                      9     (929)
          Prepaid expenses and other assets              509     (151)
          Accounts payable                             1,672     (591)
          Accrued liabilities                           (672)   1,113
          Warranty liability                              56      825
          AED field initiative liability              18,500        -
          Deferred revenue                               539      555
                                                         ---      ---
            Net cash provided by (used in)
             operating activities                     (5,085)   6,366
                                                      ------    -----


    Investing Activities:
      Purchases of short-term investments                  -     (845)
      Purchases of machinery and equipment            (1,034)    (983)
      Proceeds from repayment of note                     27       38
      Purchases of intangibles                          (370)       -
      Cash paid for acquisitions                           -     (156)
                                                         ---     ----
            Net cash used in investing activities     (1,377)  (1,946)
                                                      ------   ------


    Financing Activities:
      Proceeds from exercise of stock options and
       issuance of shares under employee stock
       purchase plan                                     161      541
      Minimum tax withholding on restricted
       stock awards                                      (13)     (87)
                                                         ---      ---
            Net cash provided by financing activities    148      454
                                                         ---      ---

      Effect of exchange rate changes on
       cash and cash equivalents                          74        -

    Net change in cash and cash equivalents           (6,240)   4,874
    Cash and cash equivalents, beginning of period    37,868   27,721
                                                      ------   ------
    Cash and cash equivalents, end of period         $31,628  $32,595
                                                     =======  =======



    Cardiac Science Corporation and Subsidiaries
    Condensed Consolidated Statements of Cash Flows (unaudited)
    (in thousands)
                                                    Nine Months Ended
                                                      September 30,
                                                      -------------
                                                      2009     2008
                                                      ----     ----

    Operating Activities:
      Net income (loss)                             $(68,714)  $7,075

      Adjustments to reconcile net income (loss)
       to net cash provided by (used in)
       operating activities:
         Stock-based compensation                      1,887    1,515
         Depreciation and amortization                 4,662    4,777
         Deferred income taxes                        42,231    3,955

        Changes in operating assets and
         liabilities, net of businesses acquired:
          Accounts receivable, net                     3,165   (1,169)
          Inventories                                 (1,321)  (1,678)
          Prepaid expenses and other assets              545     (445)
          Accounts payable                              (785)    (827)
          Accrued liabilities                           (963)     729
          Warranty liability                              65    1,163
          AED field initiative liability              18,500        -
          Deferred revenue                              (131)      65
                                                        ----       --
            Net cash provided by (used in)
             operating activities                       (859)  15,160
                                                        ----   ------


    Investing Activities:
      Purchases of short-term investments                  -     (845)
      Maturities of short-term investments                 -      350
      Purchases of machinery and equipment            (2,688)  (2,425)
      Proceeds from repayment of note                    110       38
      Purchases of intangibles                          (370)       -
      Cash paid for acquisitions                         (54)    (580)
                                                         ---     ----
            Net cash used in investing activities     (3,002)  (3,462)
                                                      ------   ------


    Financing Activities:
      Proceeds from exercise of stock options and
       issuance of shares under employee stock
       purchase plan                                     897      887
      Minimum tax withholding on restricted
       stock awards                                     (110)    (149)
                                                        ----     ----
            Net cash provided by financing activities    787      738
                                                         ---      ---

      Effect of exchange rate changes on cash
       and cash equivalents                               47        -

    Net change in cash and cash equivalents           (3,027)  12,436
    Cash and cash equivalents, beginning of period    34,655   20,159
                                                      ------   ------
    Cash and cash equivalents, end of period         $31,628  $32,595
                                                     =======  =======



    Cardiac Science Corporation and Subsidiaries
    Reconciliation of GAAP Results to Non-GAAP Results (unaudited)
    (in thousands)


                                                 Reconciliation of Net Income
                                                            (Loss)
                                                   Attributable to Cardiac
                                                   Science Corporation
                                                      to Adjusted EBITDA


                                             Three Months       Three Months
                                                 Ended              Ended
                                             September 30,      September 30,
                                                 2009               2008
                                           -----------------------------------
                                                       % of             % of
                                                      revenue          revenue
                                           -----------------------------------
     Net income (loss) attributable to
      Cardiac Science Corporation          $(66,546)  -171.1%  $2,478     4.6%
     Depreciation and amortization            1,595      4.1%   1,544     2.9%
     Interest income                            (23)    -0.1%    (156)   -0.3%
     Income tax expense                      43,923    113.0%   1,598     3.0%
                                             ------    -----    -----     ---
     EBITDA                                 (21,051)   -54.1%   5,464    10.1%

     Stock-based compensation                   674      1.7%     469     0.9%
     AED field initiative                    18,500      n/m        -     n/m

     Adjusted EBITDA                        $(1,877)    -4.8%  $5,933    11.0%
                                            =======     ====   ======    ====



                                           Reconciliation of Net Income (Loss)
                                                 Attributable to Cardiac
                                                  Science Corporation to
                                                     Adjusted EBITDA


                                             Nine Months         Nine Months
                                                Ended               Ended
                                            September 30,       September 30,
                                                2009                2008
                                        -------------------------------------
                                                        % of            % of
                                                      revenue         revenue
                                        -------------------------------------
     Net income (loss) attributable to
      Cardiac Science Corporation       $(69,190)     -60.3%   $6,818    4.4%
     Depreciation and amortization         4,662        4.1%    4,777    3.1%
     Interest income                         (55)       0.0%     (434)  -0.3%
     Income tax expense                   42,563       37.1%    4,245    2.7%
                                          ------       ----     -----    ---
     EBITDA                              (22,020)     -19.2%   15,406    9.9%

     Stock-based compensation              1,887        1.6%    1,515    1.0%
     AED field initiative                 18,500        n/m         -    n/m

     Adjusted EBITDA                     $(1,633)      -1.4%  $16,921   10.9%
                                         =======       ====   =======   ====



                                 Reconciliation of Gross Margin to Pro
                                          Forma Gross Margin


                               Three Months Ended    Three Months Ended
                               September 30, 2009    September 30, 2008
                               ------------------    ------------------
                                     % of revenue          % of revenue
                                 --- ------------  ------- ------------
     Gross profit                $95          0.2% $26,119         48.4%
     AED field initiative     18,500         47.6%       -          0.0%
                              ------         ----      ---          ---
     Pro forma gross profit  $18,595         47.8% $26,119         48.4%
                             =======         ====  =======         ====



SOURCE Cardiac Science Corporation


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SOURCE Cardiac Science Corporation
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(Date:2/9/2016)... Mast Therapeutics, Inc. (NYSE MKT: MSTX), a biopharmaceutical ... heart failure, today announced that it intends to offer shares ... an underwritten public offering.  The offering is subject to market ... to whether or when the offering may be completed, or ...   --> --> Roth ...
(Date:2/9/2016)... 9, 2016 Hearing protection devices refer to ... transmitted to the inner ear. Hearing protection devices include ... devices are recommended for users exposed to noise levels ... to HPD that are inserted in the ear canal ... to provide more natural sound perception with the help ...
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