Company Presentation. December 2011

Transcription

1 AngioScore Company Presentation December 2011

2 AngioSculpt Scoring Balloon Catheter Technology Platform Coronary & Drug Coated Valvuloplasty/TAVI Peripheral AngioSculpt AngioSculpt AngioSculpts FIM Clinical FIM Clinical Selling Today Trial Trial Venous System AngioSculpt Potential New Opportunity

3 AngioScore - Business Characteristics AngioSculpt Technology A Technology Platform not just a Product Big Market Opportunity - Over $2+ Billion Annually High margin disposable products - No capital equipment required Well established reimbursement - Covered under existing DRG s Clinical data - 32 Published Abstracts and Manuscripts Regulatory Approvals - Granted for the U.S., Europe, and Japan Patent protected technology - 25 Filed, Pending and Issued Patents Product Traction - Over 175,000 AngioSculpts sold Worldwide Sales - Over $125 Million in sales since inception Worldwide Customers Hospitals in the U.S., Europe and Japan Senior Management Team - Very Experienced in Medical Devices

4 AngioSculpt Scoring Balloon Catheter Laser Cut Nitinol Scoring Element 360 Degree Coverage Scoring Element Flat Edges Safe Deployment Semi-compliant Balloon High Pressure Capability Strong IP protection ti Issued Patents t

5 The Physics of Scoring Edges lock in ~15-25x force 1x force

6 AngioSculpt Mechanism of Action Acute histopathology specimen of a patient post-poba demonstrating extensive dissection and laceration (yellow arrows) Post-AngioSculpt scoring of porcine ISR (yellow arrows) Human IVUS demonstrating scoring post-angiosculpt (yellow arrows)

7 Regulatory Approvals U.S. - Europe - Japan - PMA for Coronary indications 510(k) s for Peripheral indications CE Mark for Coronary & Peripheral indications Shonins (PMA equivalents) for Coronary & Peripheral indications

8 Distribution United States Direct Sales Force Coronary & Peripheral Products Europe Distributors Coronary & Peripheral Products Biotronik (Central Europe) NGC Italy, Cardiva-Spain, Paramed- UK, Tzamal Israel, Meril Life- India Japan Distributor - Coronary & Peripheral Products Volcano

9 Worldwide Sales Activity U.S. Market Over 900 Hospitals have purchased AngioSculpt Catheters Very high re-order rates - 90%+ of the on-going business Average Selling Price (ASP) 3 X POBA, 20% higher that the Cutting Balloon 150, Catheters t sold since the initial iti launch in 2006 Key Customers Include: Columbia-NYC, Cleveland Clinic, Johns Hopkins, Beth Israel-Boston, Mass General, Washington Hospital Center, Duke, Emory, Texas Heart, UCLA, Scripps Clinic, Cedars-Sinai-LA, Mayo Clinic OUS Markets Over 20, catheters sold in Europe, Middle East, and Asia (outside Japan) 500+ hospitals in Japan, over 5000 catheters sold to date

10 AngioScore Worldwide Sales (Projected)

11 New Product Pipeline Longer (100mm) Peripheral AngioSculpt Next Generation Coronary AngioSculpt Drug Coated AngioSculpt Valvuloplasty & TAVI Pre-Dil AngioSculpt

12 Longer (100mm) Peripheral AngioSculpt Longer/Larger Peripheral Devices 3.5 x 20 mm 6.0 x 100 mm

13 Next Generation Coronary AngioSculpt New Tapered Tip Hydrophilic Coating Added d Lower Crossing Profile CAUTION -- Investigational device. Limited by Federal (or United States) law to investigational use. Not Available for Sale in the United States

14 Drug Coated AngioSculpt CAUTION -- Investigational device. Limited by Federal (or United States) law to investigational use. Not Available for Sale in the United States

15 AngioSculpt - Without Drug Coating (Standard ISR Porcine Model) Baseline 30-day f/u CAUTION -- Investigational device. Limited by Federal (or United States) law to investigational use. Not Available for Sale in the United States

16 AngioSculpt - With Drug Coating (Standard d ISR Porcine Model) Baseline 30-day f/u CAUTION I ti ti l d i Li it d b F d l ( U it d St t ) l t CAUTION -- Investigational device. Limited by Federal (or United States) law to investigational use. Not Available for Sale in the United States

17 Valvuloplasty & TAVI Pre-Dil AngioSculpt 17 20, 23, 25 mm diameter x 4.0 cm length High RBP ~8 atm Rapid Deflation - Excellent Re-Wrap Profile less than 6 seconds CAUTION -- Investigational device. Limited by Federal (or United States) law to investigational use. Not Available for Sale in the United Statest

18 Summary 10 Key Takeaways AngioSculpt Technology A Platform not just a product Big Market Opportunity $2+ Billion worldwide High Margin Disposables No capital equipment required Well Established Reimbursement Covered under DRG s Clinical Data - 32 published abstracts and manuscripts Regulatory Approvals Granted for U.S., Europe, and Japan Patented Technology - 25 filed, pending or issued patents Product Pipeline - Exciting new AngioSculpts in development Sales Over $125 million worldwide since inception Profitability On-track to achieve Positive EBITDA in Q4 2011