Board of Directors, Board of Statutory Auditors, Independent Auditors, Committees 2. Sorin Group 4. Consolidated Financial Highlights 6

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1 ANNUAL REPORT 2008

2 CONTENTS Board of Directors, Board of Statutory Auditors, Independent Auditors, Committees 2 Sorin Group 4 Consolidated Financial Highlights 6 Report on Operations 7 Alternative Performance Indicators 10 Operating Performance 13 Sorin Group s Operating and Financial Results 22 Operating and Financial Results of 33 Research and Development 37 Human Resources and Industrial Relations 40 IntraGroup Transactions and Transactions with Related Parties 42 Main Risks and Uncertainties to Which and the Group Are Exposed 43 Corporate Governance 47 Significant Events Occurring After December 31, Business Outlook for Motion to Replenish the Loss Incurred in Sorin Group Consolidated Financial Statements at December 31, Consolidated Balance Sheet 78 Consolidated Income Statement 80 Statement of Changes in Consolidated Shareholders Equity 81 Consolidated Cash Flow Statement 82 Notes to the Consolidated Financial Statements 84 Annex: Disclosures Required pursuant to Article 149duodecies of the Consob s Issuers Regulations 169 Certification of the Consolidated Financial Statements at December 31, 2008 Pursuant to 154 bis of Legislative Decree No. 58/ Statutory Financial Statements at December 31, Balance Sheet 172 Income Statement 174 Statement of Changes in Shareholders Equity 175 Cash Flow Statement 176 Balance Sheet in Accordance with Consob Resolution No of July 27, Income Statement in Accordance with Consob Resolution No of July 27, Notes to the Financial Statements 180 Annex: Disclosures Required pursuant to Article 149duodecies of the Consob s Issuers Regulations 253 Certification of the Statutory Financial Statements at December 31, 2008 Pursuant to 154 bis of Legislative Decree No. 58/ Report of the Board of Statutory Auditors 255 Report of the Independent Auditors 259

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4 REPORT ON OPERATIONS CONSOLIDATED FINANCIAL STATEMENTS STATUTORY FINANCIAL STATEMENTS OF SORIN S.P.A. AT DECEMBER 31, 2008 SORIN S.p.A. Share Capital: 470,412, euros Registered Office: 17 Via Benigno Crespi, Milan Milan Company Register No RE

5 BOARD OF DIRECTORS CHAIRMAN Rosario Bifulco DEPUTY CHAIRMAN Giovanni Gorno Tempini CHIEF EXECUTIVE OFFICER AndréMichel Ballester DIRECTORS Giuliano Asperti Paolo Baessato Andrea Bovone Paolo Braghieri Gabriele Casati Michele Cappone Sandro De Poli (*) Enzo Nicoli Ettore Morezzi Giovanni Pavese Francesco Silva Claudio Agostino Zulli (*) Coopted by the Board of Directors on March 19, 2009 to replace Luca Di Giacomo, who resigned. BOARD OF STATUTORY AUDITORS CHAIRMAN Marco Spadacini STATUTORY AUDITORS Diego Rivetti Andrea Zaglio INDEPENDENT AUDITORS Reconta Ernst & Young S.p.A. 2

6 COMMITTEES EXECUTIVE COMMITTEE Provides support to the Chairman and the Board of Directors in connection with major decisions involving the Group. Its members are: Rosario Bifulco Giovanni Gorno Tempini AndréMichel Ballester Andrea Bovone Paolo Braghieri Chairman INTERNAL AUDIT COMMITTEE Provides consulting support and makes recommendations. Its members are: Claudio Agostino Zulli Giuliano Asperti Michele Cappone Chairman COMPENSATION COMMITTEE Provides consulting support with regard to the fees received by Directors, the compensation of top management and the Company s overall compensation policies. Its members are: Giovanni Pavese Paolo Baessato Enzo Nicoli Chairman 3

7 SORIN GROUP Europe s Largest Medical Technology Group Specializing in the Treatment of Cardiovascular Diseases Sorin, a world leader in the production of cardiac surgery systems (Cardiopulmonary) with a significant and consolidated position in the market for implantable devices (Heart Valves), offers innovative therapies for cardiac rhythm dysfunctions (Cardiac Rhythm Management). A Unique Wealth of Innovative Technologies For over 40 years, the world s medical community has known and appreciated the brands of Sorin Group: Dideco, CarboMedics, Stöckert, Mitroflow, ELA Medical and Sorin Biomedica. A Global Presence Sorin is present in more than 80 countries throughout the world, serving over 5,000 public and private health institutions. Each year, over one million people are treated with products and therapies developed by Sorin Group. An Unwavering Commitment to Health Sorin Group is committed to using the wealth of knowhow it has acquired through decades of research to develop innovative products to treat cardiovascular diseases, which are among the most common and socially burdensome illnesses. About 450 research professionals work every day to improve the quality of life for millions of people. Sorin s Vision Sorin Group wants to be recognized by the medical community, patients, shareholders, the financial community, the biomedical industry, government agencies and its employees not only as a top player in heart valves and the cardiopulmonary fields, but also as a world leader in the overall cardiovascular market and as a true innovator in the area of cardiac rhythm management. Reply TM Pacemaker family Paradym TM CRT Cardiac Resynchronization Therapy Defibrillator Mitroflow TM Tissue Valve Slimline TM Mechanical Valve 4

8 SORIN GROUP S OPERATIONS BUSINESS UNITS MAIN PRODUCTS BRANDS Heart Valves Implantable products used in cardiac surgery Mechanical and tissue heart valves Annuloplasty rings Carbomedics Mitroflow Sorin Biomedica Cardiopulmonary Disposable devices and systems used in cardiac surgery Cardiopulmonary systems (oxygenators, custom packs) Heartlung machines Disposables and systems for autologous blood transfusion Sorin Group Dideco Stöckert Sorin Biomedica Cardiac Rhythm Management Implantable devices, monitoring systems and cardiac rhythm control accessories Pacemakers Implantable defibrillators Systems to treat heart failure (CRTD, CRTP) Programmers Electrodes Electrophysiology leads Holter monitors Sorin Group Ela Medical Sorin Biomedica S5 TM HeartLung Machine Primo 2 x TM Oxygenator Kids TM D100 and D101 Infant and neonatal Oxygenators 5

9 CONSOLIDATED FINANCIAL HIGHLIGHTS 12/31/08 12/31/07 Income Statement Data Net revenues (1) EBITDA EBITDA before special items EBIT EBIT before special items Profit (Loss) before taxes Net profit (loss) from continuing operations Net profit (loss) from divested operations Net profit (loss) before minority interest Group interest in net profit (loss) Balance Sheet Data at December 31 Net invested capital Net indebtedness (2) Shareholders equity before minority interest Group interest in shareholders equity Other Data Number of employees at end of the year Average number of employees for the year Data per Share (in euros) Profit (loss) per share: (3) basic and diluted, based on the Group s interest in net profit (loss) for the year basic and diluted, based on the Group s interest in net profit (loss) from continuing operations Dividend per share Group interest in shareholders equity per share (3) Stock market price (average for the year) Key Indicators EBITDA/Net revenues (%) EBITDA before special items/net revenues (%) EBIT/Net revenues (%) EBIT before special items/net revenues (%) EBIT/Average net invested capital (%) Net profit (loss) before minority interest/net revenues (%) Group interest in net profit (loss)/group interest in average shareholders equity (%) Net indebtedness/shareholder s equity before minority interest (37.6) (37.1) (37.1) (253.1) ,618 4,162 (0.079) (5.8) (9.2) (16.6) 31.5 (32.4) (51.2) (31.5) (82.7) (82.9) (293.3) ,341 4,450 (0.176) (0.109) (2.5) 4.8 (2.2) (12.5) (18.0) 0.70 (IN MILLIONS OF EUROS) (1) Includes sales and service revenues and cost recoveries. (2) A breakdown of net indebtedness is provided after the consolidated balance sheet. (3) The number of shares used as a basis for computation purposes is the adjusted weighted average number of shares (Note 34 to the Consolidated Financial Statements). As required by IFRS 5, the result attributable to the Vascular Therapy and Renal Care business operations, which were divested in 2008, is shown separately in the income statement as Profit (Loss) from divested operations. To ensure data comparability, the corresponding amounts for 2007 were restated accordingly. 6

10 REPORT ON OPERATIONS 2008 AT A GLANCE Revenues totaled million euros, or 1.4% more than in 2007, at constant exchange rates EBIT were positive by 45.1 million euros, as against negative EBIT of 16.6 million euros in This improvement was achieved despite a negative translation effect, thanks to efficiency gains in the production processes and programs to contain general, administrative and selling expenses Net of special items, EBIT amounted to 40.0 million euros, up from 31.5 million euros in The net profit from continuing operations totaled 0.5 million euros, as against a net loss of 51.2 million euros in The net loss for the year amounted to 37.1 million euros, compared with a net loss of 82.7 million euros in The entire loss is attributable to operations that were divested during the year Net indebtedness decreased to million euros, down significantly compared with the million euros owed in 2007, thanks to an improved operating performance and a more efficient management of working capital Report on Operations at December 31, 2008

11 Dear Shareholders: The crisis that characterized 2008 was the most severe of the past decades for its duration and intensity. Thus far, the area of business in which we operate has not been affected by a contraction in demand, as has been the case for most manufacturing industries and many areas in the service sector. The Group s relative immunity to the effects of the economic cycle could wane over the long term as governments will undoubtedly curtail spending, particularly on health care, to offset the impact of the higher costs entailed by programs to support demand and employment, which are being implemented to mitigate the effects of the economic crisis. The increased difficulty in accessing the credit market did not have direct repercussions on Sorin, which, owing in part to its solidly structured indebtedness, always maintained adequate liquidity reserves and financial flexibility; some marginal indirect effects did occur due to the restrictions and difficulties experienced in accessing credit by some of our customers and private distributors. The trends that characterized the foreign exchange markets had a negative impact during the first three quarters of the year, with the U.S. dollar and Japanese yen losing considerable value versus the euro. Given the Group s significant commercial and industrial presence in the United States and Japan, this situation had a negative translation impact on the results included in the consolidated financial statements, even though Sorin had fully hedged its foreign exchange risk. This trend reversed itself in the fourth quarter, but the impact for the full year remained negative. In 2008, even though the macroeconomic framework was unfavorable, Sorin continued to pursue with determination its announced strategies, reducing the scope of business operations, improving efficiency and increasing profitability. The Vascular Therapy and Renal Care nonstrategic divisions were divested in November and December 2008, respectively. In both cases, the goals pursued with these transactions, in addition to maximizing value for our shareholders, also included ensuring that the divested operation would continue functioning as a going concern, so that any resulting social costs would be held to a minimum. By simplifying its portfolio of businesses the Group will be able to focus more effectively its human, financial and technological resources on its core operations. In addition, by streamlining its business operations the Group will increase its profitability and strengthen its balance sheet, thanks to a reduction in invested capital and indebtedness and a resulting improvement of its leverage ratio. In the early months of 2008, the Group completed its reorganization, adopting a model based on business units instead of the old matrixbased model. This reorganization made it possible to significantly shrink the size of staffs functions, with an attendant reduction in overhead, and made the entire organization more fluid and effective by establishing a more direct correlation between accountability and responsibility: the staff not engaged in manufacturing or research activities was downsized by more than 150 employees in Moreover, while general and administrative expenses decreased both in absolute terms and as a percentage of revenues, research and development expenditures increased, demonstrating Sorin s commitment to invest in strengthening its technology platform, which, in the final analysis, is the foundation upon which the Group s longterm growth will be built. Cost containment processes also targeted the manufacturing operations, as the Company defined and implemented several projects to improve the production and logistics organization of its factories. Specifically, the plant in Arvada, Colorado, was further downsized and the facility in Austin, Texas, was closed, while the Mirandola and Saluggia factories in Italy were expanded. In addition, the Cardiac Rhythm Management Business Unit began construction of a new plant in the outskirts of Paris, in France. Our Future In 2008, the Group achieved important results that enable it to look at the future with confidence. First of all, it redefined the scope of its business operations, refocusing on its strategic Cardiovascular and Cardiac Rhythm Management areas of competency. Moreover, it virtually completed a reorganization based on a structure by business units, which is not only more flexible, but also more effective. Report on Operations at December 31,

12 It also continued to invest in program to improve its manufacturing processes and strengthen its technology platform, which, in turn, translates into a richer and more innovative pipeline of new product and therapies. Lastly, the Group strengthened its distribution channels both by signing important commercial agreements with independent distributors and by expanding its direct and indirect sales organization. We do not believe that our industry will be significantly affected by the deep crisis that has engulfed the global financial and industrial economy. Taken together, the actions that we have implemented, which have already produced important results in 2008, enable us to view with confidence the Group s performance over the near term. This confidence is reflected in the guidance that we provided to the market, calling for an acrosstheboard improvement in the main indicators of profitability and financial strength and, most importantly, projecting the Group s return to a positive bottom line. Milan, March 19, 2009 Chairman Rosario Bifulco Chief Executive Officer AndréMichel Ballester 9 Report on Operations at December 31, 2008

13 ALTERNATIVE PERFORMANCE INDICATORS In order to allow a more meaningful assessment of the operating and financial performance of Sorin Group and of at December 31, 2008, the Report on Operations, the Consolidated Financial Statements and the Separate Financial Statements include certain income statement, balance sheet and financial position items, which are used as part of the decision making process, both when reviewing actual data and formulating budgets and plans, and in presentations to financial analysts and investors. These indicators should not be viewed as alternative for the conventional indicators provided in the IFRSs and, for all intents and purposes, constitute a replacement disclosure. EBIT and EBITDA are indicators of operating performance. They are computed as follows: Profit (Loss) before taxes and profit (loss) from divested operations + Financial expense Financial income /+ Currency translation gains/losses /+ Income from/expenses on investments in affiliated companies EBIT + Depreciation, amortization and writedowns + Additions to provisions for risks and charges /+ Gains/Losses from sale of investments in subsidiaries + Restructuring charges and provisions /+ Income (Expense) from material nonrecurring transactions EBITDA Percentage changes in net sales revenues, EBIT and EBITDA compared with the same items in prior periods provided for comparison purposes are computed on a comparable basis, which means using the same scope of consolidation and/or the same exchange rate versus the euro. This approach provides a more effective means of depicting the operating performance of the Group and its Business Units. Net invested capital and Net financial assets/net indebtedness are indicators of financial performance that are computed as follows: + Property, plant and equipment + Goodwill and Other intangible assets + Investments in subsidiaries (1) + Investments in affiliated companies + Investments in other companies (2) Capital invested in noncurrent assets + Inventories + Trade accounts receivable Trade accounts payable + Other assets (3) / Other liabilities (4) Working capital (1) Used only in the financial statements of (2) Included among Noncurrent financial assets. (3) This item includes: Deferredtax assets, Miscellaneous noncurrent assets, Other current receivables, Prepaid expenses and Tax credits. (4) This item includes: Miscellaneous noncurrent liabilities, Deferredtax liabilities, Other current liabilities, Government grants and Taxes payable. Report on Operations at December 31,

14 Provision for employee severance indemnities and other employeebenefit provisions Provisions for risks and charges (5) Net invested capital (Capital invested in noncurrent assets + Working capital Provision for employee severance indemnities and Other employeebenefit provisions Provisions for risks and charges) + Noncurrent financial assets (6) + Receivables under financial derivative contracts + Other current financial assets + Cash and cash equivalents Noncurrent financial liabilities Payables under financial derivative contracts Other current financial liabilities Net financial assets (Net indebtedness) Average Net invested capital and average Shareholders Equity are computed as the arithmetic average of the corresponding amounts at the end of the period and at December 31 of the previous year. Because the composition of the alternative performance indicators described above is not governed by generally accepted accounting principles, the computation criteria adopted by the Group could be different from those adopted by other company and, consequently, not comparable. The Group presents its income statement in accordance with a format with expenses broken down by type. In addition, it has developed and uses for internal reporting and business management purposes an income statement format in which costs are broken down by function (also known as cost of sales or by destination income statement). The Group s management believes that the disclosure of additional information in accordance with such functionbased presentation format provides an additional tool to assess more effectively its operating and financial performance. Moreover, the income statement reclassified in accordance with such a format, which was not reviewed by the Independent Auditors, is more consistent with the data presentation format used by the main operators in the global market for medical devices, which is also the Group s target market. The two income statement presentation formats (by type and by function/destination) show the same data for net revenues and EBIT. The economic indicators provided by the income statement presentation format by function/destination include the following: Gross profit, which is an indicator of performance at the industrial level and is computed by deducting the cost of sales from net revenues; Operating selling, general and administrative expenses, which represent the amount corresponding to the operating costs (personnel expense, cost of materials and services used, depreciation and amortization) incurred by the departments responsible for sales, marketing, administration and management and the other operating costs that are not included in cost of sales or research and development expenditures; Research and development operating expenses, which represent the amount corresponding to the operating costs (personnel expense, cost of materials and services used, depreciation and amortization) incurred by the departments responsible for research and development (net of costs capitalized as development costs). Sorin s management measures the performance of the Group and its business units without taking into account the impact of special items on EBIT, EBITDA and net indebtedness. Material income statement and balance sheet items are classified as special items when (i) they arise from events or transactions that are not recurring or from transactions or situations that do not occur frequently in the normal course of business, or (ii) they arise from events or transactions that that are not indicative of the Group s regular business activity. The IFRSs do not provide a definition for special items. Consequently, information about special items should be viewed as a supplemental disclosure provided for the purpose of measuring more effectively the actual result from regular operations. Material income statement and balance sheet items that arise from nonrecurring operations are shown separately in the comments provided by management and in the financial disclosures included in this Report. (5) This item includes provisions included among noncurrent and current liabilities. (6) Excluding Investments in other companies valued by the equity method. 11 Report on Operations at December 31, 2008

15 FOREWORD There was no material change in accounting principles compared with those applied to prepare the financial statements at December 31, Additional information is provided in Note 1 to the Consolidated Financial Statements. The annual financial statements were prepared on a going concern basis. Specifically, the Group concluded that, despite the current challenging economic and financial environment, there are no material uncertainties (as defined in Paragraph 25 of IAS 1) as to the Company's ability to continue as a going concern, owing in part to the actions already taken to address perceived risks and adapt the Group s operating and financial structure to the new economic environment. Two major transactions involving divestitures of business operations were executed in 2008: On November 30, 2008, the Group sold its Vascular Therapy Business unit, which included Sorin s global vascular coronary business operations and the related portfolio of intellectual property assets, to CID Investimenti S.r.l., an investment consortium headed by IP Investimenti e Partecipazioni S.p.A., an independent private equity company. On December 30, 2008, the Group completed the sale of its Renal Care Business Unit, which included all of the business activities that operate globally in the kidney hemodialysis area with the Bellco and Laboratoire Soludia brands. The buyer was a consortium headed by Argos Soditic, an independent European private equity fund, and MPS Venture SGR, which represented the Emilia Venture closedend fund. As required by IFRS 5, the result attributable to the Vascular Therapy and Renal Care business operations, which were divested in 2008, is shown separately in the income statement as Profit (Loss) from divested operations. To ensure data comparability, the corresponding amounts for 2007 were restated accordingly. Report on Operations at December 31,

16 OPERATING PERFORMANCE In 2008, following the profound transformations decided in the second half of 2007, the Group focused on implementing the strategic plan it unveiled in January 2008, within the framework of its new organization based on Business Units. During the year, the economic environment was characterized by alternating trends for the exchange rates of major currencies versus the euro and by the dramatic crisis that developed during the latter part of the year, with only a marginal effect on the Group s operations. The main internal developments concerning the Group that occurred in 2008 included the following: In January 2008, the presentation of the strategic plan to the financial community. The implementation of restructuring programs, consistent with the adoption of an organizational model based on Business Units at the end of 2007, and further progress on the industrial restructuring processes launched in previous years. The completion of the SAP project, which resulted in the adoption of a common IT platform by all Group companies in Europe. In April 2008, the approval to market the S5 heartlung machine in Japan. In May 2008, the approval to market the OVATIO CRTD cardiac resynchronization device in the United States. In May 2008, the agreement with Greatbatch Inc. (USA) enabling Sorin to use Greatbatch s exclusive technology in its future cardiac rhythm management systems. The exercise by InterVascular C.V. (Datascope Corp.) of the option to buy the intangible assets of Sorin Biomedica Cardio S.r.l. applicable to the Group s endovascular stent product line. As a result of this transaction, Sorin Group recognized a net gain of 8.9 million euros (favorable financial impact of 6.5 million euros). In August 2008, the approval to market REPLY TM, the family of latestgeneration single and dualchamber pacemakers, in the United States. In November 2008, the signing of an agreement with Sphere Medical (UK) enabling the Group to use in its cardiopulmonary products the microsensor technology developed by Sphere Medical. On November 30, 2008, the sale of Sorin s global vascular coronary business operations to CID Investimenti S.r.l. In December 2008, the settlement of a lawsuit filed against ATS Medical (USA), with payment of US$7.5 million to Sorin Group. Election of a new Board of Directors of by the Shareholders Meeting of December 30, On December 30, 2008, the sale of the Renal Care Business Unit to a consortium headed by Argos Soditic and MPS Venture SGR. In 2008, Sorin Group booked revenues totaling million euros, compared with million euros the previous year. When the data are restated at constant exchange rates, revenues show an increase of 0.2%. 13 Report on Operations at December 31, 2008

17 A breakdown of revenues by Business Unit and a comparison with the corresponding data for 2008 is as follows: NET REVENUES BY BUSINESS UNIT 2008 MILLIONS OF EUROS 2007 MILLIONS OF EUROS CHANGE % CHANGE AT CONSTANT EXCH. RATES % Cardiopulmonary Heart Valves Cartiac Rhythm Management , other revenues and adjustments Endovascolare Total When the reduced contribution of thirdparty sales is taken into account (i.e., neutralizing the impact on revenues of outsourcing activities and some contract manufacturing), revenues stated at constant exchange rates show an increase of 1.4%. The revenues generated by the Vascular Therapy and Renal Care business operations divested in 2008, which are reflected under Profit (Loss) from divested operations, totaled million euros in 2008, compared with million euros in Group EBIT were positive by 45.1 million euros, as against negative EBIT of 16.6 million euros in Group EBIT reflect the impact of special items, which provided a net positive contribution of 5.1 million euros (net negative contribution of 48.2 million euros in 2007). Net of special items, EBIT amounted to 40.0 million euros, up from 31.5 million euros the previous year. Group EBIT were also adversely affected by a deterioration in the exchange rates of some currencies versus the euro. This was particularly true for the U.S. dollar, with an attendant reduction of the sales margins generated in the United States. The Group s interest in the consolidated result was a net loss of 37.1 million euros, compared with a net loss of 82.7 million euros in The net profit from continuing operations totaled 0.5 million euros, a significant turnaround from the net loss of 51.2 million euros reported the previous year. The divested operations reported a net loss of 37.6 million euros, compared with a net loss of 31.5 million euros in At December 31, 2008, net indebtedness totaled million euros, or 40.2 million euros less than the million euros owed at the end of Restated to eliminate the positive financial effect of special items and the impact of an increased use of nonrecourse factoring transactions (20.2 million euros in total), net indebtedness shows a decrease of 20 million euros. The 2008 financial statements of, which were prepared in accordance with International Financial Reporting Standards (IFRSs), show a loss of 56.7 million euros, compared with a loss of 43.9 million euros the previous year. Writedowns of some equity investments in subsidiaries, which were recognized based on the results of impairment tests, a decrease in dividends distributed by subsidiaries and the foreign exchange losses incurred during the year account for most of the loss reported in Report on Operations at December 31,

18 CARDIOPULMONARY The Cardiopulmonary Business Unit designs, manufactures and markets biomedical devices that are used mainly to treat cardiac patients who require surgery and blood treatment. In 2008, revenues totaled million euros, or 6.1% less than the million euros reported the previous year. If the data are restated using constant exchange rates and taking into account the reduced contribution of thirdparty sales, 2008 revenues are in line with the amount reported in 2007, as a slight decrease during the first six months of 2008 was followed by an upturn during the second half of the year. Overall, the Cardiopulmonary Business Unit consolidated its global leadership position in 2008 (with a market share at 40% and peaks of more than 60% in specific segments and geographic regions) in a stable but profitable market segment, demonstrating the excellence of its products and strengthening its position as a quality and service leader. Insofar as the different product segments are concerned, Oxygenators generated revenues of million euros, about the same as in the previous year, when the data are restated using constant exchange rates and taking into account the reduced contribution of thirdparty sales. In 2008, the Business Unit launched the KIDS TM product family, which includes the KIDS D 101 infant oxygenator (for patients weighing up to 25 kg) and the D 131 infant filter. These products and the KIDS D 100 oxygenator (neonatal oxygenator for patients weighing up to 5 kg) rounded out the Group s neonatal and pediatric line. Sorin Group is the only manufacturer in its industry that offers a line of oxygenators specifically designed for the neonatal and infant patient segment. The Autologous Transfusion product segment generated revenues of 57.7 million euros, for a yearoveryear gain of 4.9%, when the data are restated using constant exchange rates and taking into account the reduced contribution of thirdparty sales. The results achieved in 2008 confirmed the excellent performance of 2007, with revenues increasing in all of the major markets, with the best gains reported in the United States, Europe, Japan and the emerging countries, thanks to the growing popularity that this technology has been gaining globally. The HeartLung Machine (HLM) product segment, which enjoyed record sales in 2007, reported revenues 57.4 million euros that, when restated a constant exchange rates, were understandably lower (2.6%) than the previous year. The success of the HLM S5 TM is continuing, following its launch in Japan in the second quarter of Sorin Group continues to be the unchallenged worldwide leader in the HLM segment, thanks to a growing line of devices and accessories for its S5 machine, such as the electrical Venous Occluder (EVO), which was introduced in Europe in the first quarter of 2008 and the United States during the second half of the year. Kids TM D100 and D101 Infant and neonatal Oxygenators D131 TM Infant Arterial Filter Electa TM Autotransfusion Machine S5 TM HeartLung Machine At the industrial level, the Business Unit made further progress in the restructuring of its manufacturing organization in Specifically, the transfer to the Mirandola plant of production activities carried out at a facility in Denver was completed in the first half of 2008 with the relocation of the Autologous Transfusion line and molding department. The Business Unit continued to invest significant amounts in research and innovation with the goal of providing the best clinical outcome for patients. Specifically, the Business Unit is focusing on the development of various aspects of the Advanced Patient Oriented Perfusion System (APOPS), which has been designed to provide greater patient safety and quality of life. In addition, work is continuing on a research and development project for the definition of a New Generation of Autologous Transfusion System (NGATS) scheduled for market launch at the end of In addition, the Group entered into an agreement with Sphere Medical Limited (UK) to use in its cardiopulmonary products the microsensor technology developed by Sphere Medical. Pursuant to this 15 Report on Operations at December 31, 2008

19 agreement, Sorin and Sphere Medical will work jointly on a product development program in the cardiopulmonary bypass area. The microsensor technology will be integrated into a family of online blood monitoring devices and will help improve the clinical outcome for patients who undergo cardiac surgery. HEART VALVES The Heart Valve Business Unit designs, manufactures and markets mechanical and tissue valves and devices to repair heart valves (annuloplasty rings). The unfavorable trends in the foreign exchange markets penalized to an especially significant extent the Business Unit s performance, which enjoyed its largest revenue increases in the United States. In 2008, it reported revenues of million euros, compared with 99.3 million euros in 2007, for a yearoveryear gain of 5.6%, but a larger increase of 8.8% at constant exchange rates. The market trend that characterized previous years continued in 2008, with rising sales both for Tissue Valves (bovine pericardium valves in particular), which generated revenues of 38.6 million euros, for an abovemarket increase of 40.1% at constant exchange rates, and for Annuloplasty Rings, which produced revenues of 4.7 million euros (+6.1% at constant exchange rates). These improvements, more than offset a limited decline in demand for mechanical valves (4.6% at constant exchange rates) that was consistent with market trends. The growth enjoyed by the Business Unit in 2008 was driven mainly by sales of the Mitroflow TM bovine pericardium valve in the United States, the most important market in terms of size and profitability. The U.S. Food and Drug Administration (FDA) authorized the Business Unit to market the Mitroflow TM valve in the United States at the end of The FDA approval enabled the Business Unit to round out the portfolio of products it offers in the U.S. market, where tissue valve penetration is greater than 70%. In another significant development, clinical data about the durability of the Mitroflow TM valve (21 years) were published in the September issue of the Journal of Thoracic and Cardiovascular Surgery. Even though demand for mechanical valves contracted slightly during the year, the Business Unit reported higher unit sales in 2008, thereby increasing its market share. In addition, it reported further growth in the annuloplasty ring segment, thanks to the launch of the new MEMO 3D TM semirigid annuloplasty ring in the United States, following receipt of FDA approval to market this product in September The Business Unit is focusing its efforts on select research projects, the most important Mitroflow TM Tissue Valve Tophat TM Slimline Mechanical Valve Memo 3D TM Annuloplasty Ring Perceval TM Minimally Invasive Heart Valve of which involves the development of prostheses made of bovine pericardium that can be implanted with less and less invasive procedures. The First In Man (FIM) clinical trial of the first device in this new family of products (Perceval), a sutureless implantable tissue valve (Perceval Sutureless), was completed in Further research activities carried out on the heels of the excellent results of this trial focused on the design and organization of clinical trials and the validation of the production processes for this new noninvasive device. Specifically, the Business Unit secured in 2008 all of the permits needed to start a clinical trial that will lead to the award of the CE mark, which is required before a product can be marketed in Europe. Within the same project, the collaboration with the Mayo Clinic, in the United States, continued in accordance with the guidelines of a threeyear contract signed in The purpose of this collaborative effort is to develop a minimally invasive aortic valve replacement procedure that uses a heart valve elastically compressed inside a stent that can be implanted without sutures. This innovative approach could make it possible to broaden the population of patients eligible for the replacement of a damaged native valve. Leveraging its wealth of knowhow, Sorin Group will work with the Mayo Clinic to develop not only the therapy described above, but also the equipment and techniques needed for the implantation and optimum positioning of the valve prosthesis. Once the implantation procedure is completed, the Mayo Clinic will participate in the U.S. clinical trials. Report on Operations at December 31,

20 In 2008, the Heart Valve Business Unit was an active participant at several internationally significant conventions, including the STS, held in January in Ft. Lauderdale, Florida, and the AATS, held in May in San Diego, California, in the United States; and the EACTS held in September in Lisbon, in Portugal. On each occasion, the Heart Valve Business Unit organized several events designed primarily to support the U.S. launch of the Mitroflow TM tissue valve and the MEMO 3D TM semirigid annuloplasty ring. The clinical data of a pilot trial of the Perceval sutureless cardiac valve were successfully presented both at the AATS and the EACTS. Lastly, in June, the Heart Valve Business Unit organized an extremely successful internal event At the Heart of Mitral Valve that was attended by about 100 heart surgeons from the main centers in Europe and beyond. In 2008, the Business Unit benefited from the efficiency gains generated by the streamlining of its manufacturing organization, which was completed in Specifically, production of mechanical valves was moved from the Austin plant (permanently closed in 2008) to the factory in Saluggia (Sorin Biomedica Cardio). As a result of this relocation, the number of production facilities decreased from three to two, with production of mechanical valves and Sorin branded tissue valves and related research activities concentrated at the Saluggia plant, while the Vancouver factory focused on the production of the production of tissue valves sold under the Mitroflow TM brand, with obvious benefits in terms of economies of scale, simplification of processes and logistics and distribution activities. Due to the efficiency improvements that resulted from the streamlining of its manufacturing organization, Sorin Biomedica Cardio applied for enrollment of some employees of its plant in Saluggia in the Special Layoff Benefits Fund. In September 2008, the Ministry of Welfare approved the application, enrolling in the Fund 120 employees of the Saluggia factory as of September The lawsuit filed by the Carbomedics Inc. subsidiary against ATS Medical Inc., a company based in Minneapolis, Minnesota, due to ATS s failure to perform its obligations under a multiyear supply contract covering purchases of mechanical valves, was settled in 2008, with ATS agreeing to pay US$7.5 million in damages to Sorin Group. CARDIAC RHYTHM MANAGEMENT The Cardiac Rhythm Management Business Unit designs, manufactures and markets a number of implantable devices, monitoring systems and accessories, all of which are used for cardiac stimulation, i.e., to control and manage cardiac rhythm and treat patients with related diseases. Revenues totaled million euros in 2008, little changed from the million Ovatio euros booked the previous year, both on an unadjusted basis (0.5%) and at constant TM CRT Cardiac Resynchronization exchange rates (+04%). Therapy Defibrillator The High Voltage segment (defibrillators and CRTD cardiac rhythm resynchronization devices) reported revenues of 67.0 million euros, for a yearoveryear gain of 5.7% at constant exchange rates, while the revenues generated by the Low Voltage segment (pacemakers) decreased to million euros, or 1.0 % less than in 2007, also at constant exchange rates. The two main factors that constrained revenue growth in 2008 were, first of all, the Reply decision to forfeit sales in some emerging markets when they became unprofitable due TM Pacemaker the decline of the U.S. dollar, and, second of all, the reorganization of the sales network in some regions of the United States. In 2008, the Business Unit launched a series of highly innovative products in its main markets. In the United States, in May 2008, the Food and Drug Administration (FDA) granted an authorization to market the OVATIO CRT family of products and the SITUS TM left ventricle pacing lead (a pacing lead is an insulated wire that is inserted into a vein in connection with the implantation of defibrillation system, of which it is an essential component because it connects the device with the heart and transmits electric impulses at the high voltage necessary to deliver to the heart the shock generated by the device, consistent with the individual needs of each patient). This device enables cardiologists in the United States to treat patients suffering from heart failure with a complete Sorin system. Specifically, the OVATIO TM CRT 6750, the smallest CRT (Cardiac Resynchronization Therapy) defibrillator available in the world market (volume of 30 cc, 11 mm), offers the 17 Report on Operations at December 31, 2008

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