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 Atrial Fibrillation & Valve Disease Treatment

6 ATS INVESTMENTS IN CARDIAC SURGERY

7 ATS Medical has acquired the surgical ablation assets of CryoCath Technologies. Achieve profitability in 2008 Gain full access to large, rapidly growing atrial fibrillation market Enhance cash flow immediately Leverage infrastructure

8 SURGICAL BUSINESS AND TRANSACTION OVERVIEW SURGICAL BUSINESS OVERVIEW TRANSACTION OVERVIEW End user sales of $11.0 million in 2006 SurgiFrost and FrostByte Cryoablation System for open procedures SurgiFrost XL Probe for stand-alone MIS procedures In process product development Initial payment $22 million $2 million on MFG Transfer $2 million in 2 years Up to $4 million earn-out on SurgiFrost XL Funded by $16.5 million in equity and $8.6 million in debt Exclusive license to all cardiac surgery related technology Manufacturing know how and all related assets

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

10 TREATMENT OPTIONS & GROWTH RATES FOR ATRIAL FIBRILLATION Atrial Fibrillation Treatment Modalities Treatment Modality Growth Forecasts Health Research International, 2007.

11 MARKET FORECAST FOR SURGICAL TREATMENT OF ATRIAL FIBRILLATION Sources: Millennium Research Group, 2006, Health Research International, Piper Jaffray Equity Research

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

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

14 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

15 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

16 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.

17 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:

18 Looking ahead A totally endoscopic and offpump strategy of creating complete maze lesions is required to attract Lone A Fib patients in the real world. Saqib Masroor, MD, MHS Division of Cardiothoracic Surgery Lenox Hill Hospital New York, New York Nov 11, 2004

19 SURGIFROST XL CRYOABLATION PROBE FOR BEATING HEART MIS PROCEDURES 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 2 nd half 2007

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

21 FINANCIAL IMPACT OF THE TRANSACTION (ALL NUMBERS IN MILLIONS) Accretive Day One, significant SG&A leverage Margin expansion & clear path to profitability Diversified company with three major product platforms Significant high growth/high potential products

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

23 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.

24 SURGICAL TOOLS AND ACCESSORIES Surgical Tools and Accessories Revenue Potential ($ Millions)

25 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.

26 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

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

28 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

29 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

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

31 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

32 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

33 2007 ATS 3f MILESTONES ATS 3f Aortic Bioprosthesis OUS Limited Market Launch ATS 3f Enable Begin Pivotal Studies ATS 3f Aortic Bioprosthesis New Holder and Rinse Procedure Approval ATS 3f Aortic Bioprosthesis US Market Approval Begin Clinical Entrata Feasibility Study = Completed

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

35 Open Pivot Heart Valve Prosthesis Electronic sensing, monitoring and/or pacing circuitry in heart valves Anti-coagulation and Demineralization system for conductive medical devices (ForceField anti-platelet technology) PARSUS ultrasonic technology for blood filtration Tubular Heart Valve Technology Easily compressed and expanded, ideal for creating less invasive valves Minimally Invasive Heart Valve Designs Trans-apical Valve Technologies Valve Delivery Distal Embolic Protection Imaging (using IVUS, etc) 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 towards new and more complicated designs, especially in the field of minimally invasive & percutaneous valves Venpro Venous Valve IP (Licensed & Owned) Tricuspid Valve Regurgitation Methods and devices for preventing tricuspid valve regurgitation 19 Patents and Patent Applications Related to Cardiac Surgical Ablation Added to Existing Portfolio of 130+ Issued and Pending Patents

36 Revenue History ($ Millions)

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

38 FINANCIAL RESULTS AND PROJECTIONS *2006 EBITDA and Net Loss as adjusted to exclude $14.4 million IPR&D charge related to the acquisition of 3f Therapeutics. **2007 Excludes the impact of any IPR&D charges that may be recorded upon closing of the transaction

39 EXECUTIVE TEAM Mike Dale, President & CEO Endocardial Solutions, Cyberonics, St. Jude Medical, Edwards Laboratories Mike Kramer, Acting CFO CABG Medical, ECOLAB, Ernst & Young Jeremy Curtis, VP of Marketing GE Healthcare, CHIQUITA Brands International Richard Curtis, VP of Corporate Development & GM of Cryoablation Cardinal Health, Hill-Rom St. Jude Medical, Pharmacia Deltec Terrie Ajamil, VP of International St. Jude Medical, 3M Allen Putnam, VP, Regulatory, Clinical and Quality Urologix, Uroplasty, St. Jude Medical, BioVascular & Baxter Travenol David Elizondo, VP, Research & Development General Manager of Tissue Operations Boston Scientific, Cryolife, St. Jude Medical

40 Thank You!