Focused right on cardiac surgery.

Transcription

1 NASDAQ Symbol: ATSI

2 SAFE HARBOR THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT ARE SUBJECT TO NUMEROUS RISKS AND UNCERTAINTIES. SEE OUR SECURITIES AND EXCHANGE COMMISSION FILINGS FOR A DESCRIPTION OF MANY OF THE RISKS AND UNCERTAINTIES. THIS PRESENTATION HAS BEEN PREPARED SOLELY BY US AND IS SOLELY OUR RESPONSIBILITY. THIS PRESENTATION DOES NOT PURPORT TO BE COMPREHENSIVE OR TO CONTAIN ALL THE INFORMATION THAT YOU MAY DESIRE IN EVALUATING AN INVESTMENT IN OUR SHARES. YOU SHOULD NOT CONSTRUE THE CONTENTS OF THIS PRESENTATION AS INVESTMENT, TAX OR LEGAL ADVICE. THIS PRESENTATION DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION TO BUY ANY OF OUR SHARES IN ANY STATE OR OTHER JURISDICTION OR TO ANY PERSON IF SUCH AN OFFER OR SOLICITATION IS UNLAWFUL OR UNAUTHORIZED.

3 Focused right on cardiac surgery.

4 9000 Cardiac Surgeons Operating in 3000 Open Heart Centers Performing 1.2 Million Cardiac Procedures Creating a $2.5 Billion Market

5 AGING TRENDS AND STRUCTURAL HEART DISEASE Population 60 Aging Global Population = Structural Heart = Disease Treatment of Atrial Fibrillation & Heart Valve Disease

6 HEART VALVE DISEASE 98% of Valve Disease Involves The Left Side Mitral Valve Options Aortic Valve Options Repair Replacement Replacement

7 ATRIAL FIBRILLATION AFIB Involves the Upper Chambers of the Heart

8 ATS INVESTMENTS IN CARDIAC SURGERY

9 EXPANDING MARKET OPPORTUNITY THROUGH TARGETED INVESTMENT

10 GROWTH TRENDS BY AREA OF INVESTMENT IN CARDIAC SURGERY Sources: Millennium Research Group, 2006 Health Research International Piper Jaffray Equity Research

11 Heart Valve Therapy

12 HEART VALVE THERAPY MARKET TRENDS Sources: Millennium Research Group, 2006 Health Research International Piper Jaffray Equity Research

13 ATS OPEN PIVOT MECHANICAL HEART VALVE Fundamentally unique design, first new standard of care in twenty years.

14 ATS Open Pivot Heart Valve Market Share

15 Revenue History ($ Millions)

16 ATS OPEN PIVOT MECHANICAL HEART VALVE MHV Revenue Potential ($ Millions) Fundamentally unique pivot design, first new standard of care in twenty years.

17 ATS SIMULUS ANNULOPLASTY RING/BAND Heart Valve Repair Revenue Potential ($ Millions) Designed with surgeon input to be the sew- easy ending to complex valve repairs.

18 ATS 3f TISSUE VALVES Revolutionary approach to valve design and implantation that mimics native valve function in vivo and enables less invasive surgery form follows function.

19 TISSUE VALVE MARKET OPPORTUNITY DURABILITY IMPLANTATION the average life span of a bioprosthetic valve is years. Time consuming Technique dependant Barrier to less invasive approaches Thoracic Surgery News. Vol. 2, NO.1 January/February The official newspaper of the American Association For Thoracic Surgery 20 + sutures and >30 Min to deploy

20 3f AORTIC BIOPROSTHESIS HEART VALVE Native Valve Function Superior Flow Dynamics Superior Stress Distribution

21 BY DESIGN ATS 3f BIOPROSTHESES REPLICATE NATIVE VALVE GEOMETRY AND SINUS FUNCTION Sino-tubular junction 3f Aortic Bioprosthesis Aortic Annulus

22 ATS 3f AORTIC BIOPROSTHESIS PRESERVES NATIVE VALVE GEOMETRY Conventional AVR ATS 3f AVR Sinuses provide better distribution of pressure across the leaflets when closed and more efficient coronary filling. No Sinus Aortic Sinus Preserved Source: Xu Yu Jin, Department of Cardiac Surgery, John Radcliffe Hospital, Oxford, UK 2006

23 NATIVE GEOMETRY ENHANCES HEMODYNAMIC FUNCTION Native Geometry Preservation = Superior Function Source: James Cox, MD et al. J Thoracic Surg 2005; 130:520-7

24 NATIVE GEOMETRY ENHANCES VALVE DURABILITY Valve Survival in Accelerated Wear Tester at 200 million cycles little or no evidence of structural failure. Source: James Cox, MD et al. J Thoracic Surg 2005; 130:520-7

25 ATS 3f ENABLE AORTIC BIOPROSTHESIS Implanted without sutures ~1-3 Min Nitinol frame expands to preset diameter to secure valve in position Significant reduction in CPB and aortic x-clamp time Enables stopped heart MIS techniques Pivotal trials began in 1 st half 2007

26 ATS 3f ENTRATA AORTIC VALVE SYSTEM Closed chest implantation without sutures Balloon deployed on annealed 316L stainless steel stent Stopped or Beating heart surgery using trans-apical or other thoracic approach Feasibility work through 2007

27 ATS 3f AORTIC BIOPROSTHESIS Tissue Valve Revenue Potential ($ Millions)

28 Surgical Treatment of Atrial Fibrillation - Concomitant Market - Sole Therapy (Stand-alone) Market

29 ATRIAL FIBRILLATION TRENDS Estimated Number of Patients with Atrial Fibrillation by Year (US) Health Research International, 2007.

30 SURGICAL ATRIAL FIBRILLATION MARKET TRENDS Sources: Millennium Research Group, 2006 Health Research International Piper Jaffray Equity Research

31 SURGICAL SOLUTION FOR TREATMENT OF ATRIAL FIBRILLATION THE COX MAZE LESION SET Left Side CM III Lesions Right Side CM III Lesions Critical Line to Mitral Annulus (P3) Flutter Line IVC to CS to TV

32 CRYOABLATION IS SAFE AND EASY TO USE Achieve Transmural Lesions in One Short Application Link to Mitral Valve Annulus (AV groove) Gallegos R, et al. PCP-108. University of Minnesota. Presented at the Surgical Treatment of AF Meeting

33 SURGIFROST CRYOABLATION SYSTEM The only system that can complete the Gold Standard Cox Maze III procedure: Safely Effectively Easily - with one system

34 METHODS OF TISSUE ABLATION Cold-based Ablation Preserves Cellular Structure Disrupted Endothelial Boundary Endothelial Boundary Maintained Thrombus Present Minimal Thrombus Hemorrhage Still Present Fibrosis Complete Fibrosis Started RF, Ultra Sound, Micro-wave Cryoablation Well Demarcated

35 CRYOABLATION IS EFFECTIVE As Effective as Traditional Cut and Sew Maze Cut and Sew Maze Cryo Maze # of Patients Follow-up 5.3 years 1.6 years % of Patients Free of Atrial Fibrillation at 3 years 90.4% 97.7% The cryo-maze procedure including cryoablation for PV isolation was as reliable as the conventional maze procedures Nakajima, 2002 Nakajima H, et al. The Effect of Cryo-Maze Procedure on Early and Intermediate Term Outcome in Mitral Valve: Case Matched Study. Circulation. 2002; 106 [suppl I]: I46-I50.

36 CRYOABLATION IS EFFECTIVE Cryoablation vs. Bi-polar Radiofrequency (RF) Cryoablation Mack 2005 Bi-Polar RF Gillinov 2005 # of Patients Follow-up 12 mos. 18 mos. Lesion Set 63 Left atrial ablation, 18 with additional right atrial isthmus ablation Cox Maze IV or PVI (33% received flutter line ablation with cryo probe) % of Patients Free of Atrial Fibrillation 88.5% 66% Mack C, et al. Surgical Treatment of Atrial Fibrillation Using Argon- Based Cryoablation During Concomitant Cardiac Procedures. Circulation. 2005; 112[suppl I: I-1-I-5]. Gillinov M, et al. Surgical Ablation of Atrial Fibrillation with Bipolar Radiofrequency as the Primary Modality. J Thorac Cardiovasc Surg. 2005; 129:

37 MARKET SHARE Surgical AFIB Treatment (2006 US Market Share) Source: HRI, 2007

38 STAND-ALONE SURGICAL TREATMENT OF AF (STAF) Requirement for Success The Ideal AF Procedure Off-Pump Minimally invasive, but ALL lesions Epicardial vs endocardial Success rates >90% Low morbidity/mortality

39 SURGIFROST XL CRYOABLATION PROBE FOR BEATING HEART MIS PROCEDURES 240º insulation of the ablating segment Stronger cooling to -130ºC Designed to meet the specific needs of the emerging stand-alone, MIS ablation market FDA and CE Mark approved Excellent early clinical results Commercial release planned for Q4 2007

40 SURGIFROST CRYOABLATION SYSTEM Surgical Ablation Revenue Potential ($ Millions)

41 Summary Highlights

42 REVENUE HISTORY ($ Millions)

43 EXPANDING MARKET OPPORTUNITIES ATS Revenue Opportunity

44 GROWTH TRENDS BY AREA OF INVESTMENT IN CARDIAC SURGERY Sources: Millennium Research Group, 2006 Health Research International Piper Jaffray Equity Research

45 Open Pivot Heart Valve Prosthesis Electronic sensing, monitoring and/or pacing circuitry in heart valves Anti-coagulation and Electronic sensing, monitoring and/or pacing circuitry in heart valves Manufacturing technique Laser Method patent regarding the use of a laser to cut tissue Cut edges are melted to discourage delamination or fraying Beneficial as tissue valves move A Strong Portfolio of 140+ Issued and Demineralization system for conductive medical devices (ForceField anti-platelet technology) Pending Patents Covering Heart Valve PARSUS ultrasonic technology for blood Therapy filtration and Cardiac Surgical towards new and Ablation more Tubular Heart Valve Technology complicated designs, especially Easily compressed and expanded, in the field of minimally invasive ideal for creating less invasive & percutaneous valves valves Venpro Venous Valve IP (Licensed Minimally Invasive Heart Valve & Owned) Designs Tricuspid Valve Regurgitation Trans-apical Valve Technologies Methods and devices for Valve Delivery preventing tricuspid valve Distal Embolic Protection regurgitation Imaging (using IVUS, etc)

46 EXECUTIVE TEAM Mike Dale, President & CEO Endocardial Solutions, Cyberonics, St. Jude Medical, Edwards Laboratories Mike Kramer, CFO CABG Medical, ECOLAB, Ernst & Young Jeremy Curtis, VP of Marketing GE Healthcare, CHIQUITA Brands International Astrid Berthe, VP, Regulatory and Quality Assurance 3f Therapeutics, Medtronic, Baxter David Elizondo, VP, R & D and Clinical Affairs General Manager of Tissue Operations Boston Scientific, Cryolife, St. Jude Medical

47 FINANCIALS Income Statement Revenue of $35.4 million up 19% Gross Margin up 4.5 points to 56.4% Non-MHV Revenue is 26.1% up from 16.9% Operating Loss excluding IPR&D and Impairment of $11.8 million Balance Sheet Cash & Investments $16.9 million Accts Rec DSO down 30 days year-over-year Working Capital $35.1 million

48 PROGRESS TOWARD PROFITABILITY ($ Millions) Diversified revenue Stream Continuous margin improvement Leveraged distribution infrastructure

49 Thank You!