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AvA™ Aortic Valve Bypass Graft System. Slide Gallery Simple Slide Format. Heart Valve Therapy Has Remained Unchanged Over the Last 30 Years. Diseased Aortic Valve. Unserved Patient Population is Driving the Development of Alternative Treatments.

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  1. AvA™ Aortic Valve Bypass Graft System Slide Gallery Simple Slide Format

  2. Heart Valve Therapy Has RemainedUnchanged Over the Last 30 Years Diseased Aortic Valve

  3. Unserved Patient Population is Driving the Development of Alternative Treatments • Difficulty Tolerating Cardiopulmonary Bypass • No Surgical Option • High MortalityRisk

  4. Alternative Therapies under Development • Aortic Valve Bypass Graft (AVBG) • Transcatheter Valve

  5. AVBG Clinical History • Human Experience • “On pump” • Non-standardized components • Physiology works • Reduced pressure gradients • Normal coronary flow • 20+ year survival

  6. AvA = Apex Valve Aorta AvA Valve Bypass System Implant Access Tool

  7. 5th ICS How It Works

  8. AvA Aortic Valve Bypass System

  9. AVBG Competitive Advantages • Eliminates Heart-Lung Bypass • Minimize Incision • Reduce Complications • Reduce Costs • Reduce Hospital Stay • Uses Established Heart Valve • Long Implant History • Surgeon Acceptance • Broad Clinical Application • Bicuspid or Tricuspid • Coronary Artery Disease

  10. Transcatheter Competition “While the current operative mortality is too high, it is improving and with hundreds of millions of dollars being invested, it’s hard to bet against them.” Anonymous venture capitalist Edwards LifeScienceest. $350 MM development program Medtronicest. $1.2 B development program Other Start-upsest. $250 MM Est. Total Transcatheter Investment – $1.8 Billion

  11. Transcatheter Competition “While the current operative mortality is too high, it is improving and withhundreds of millions of dollars being invested, it’s hard to bet against them.” Anonymous venture capitalist Does not fit Into bicuspid shaped valves Dislodges particles to brain Prevents future coronary interventions Disrupts Heartbeat 40 % of pts. over age 70 have a bicuspid valve 5 - 10 % Stroke Rate 65 % of pts. over age 70 with a stenotic tricuspid valve have CAD 20-30 % Pacemaker implantation Est. Total Transcatheter Investment – $1.8 Billion

  12. Transcatheter Competition

  13. AVR Distribution by Age, Cusp, and CAD Data932 consecutive AVR patients1993–2004 Roberts, Circulation. 2005; 111:920–925

  14. Alternative Therapies by Cusp Type and CAD Bicuspid Future CAD Intervention * Patients with Bicuspids or Untreated Significant CAD are contraindicated for transcather valve implantaion Edwards LifeScience PARTNER Trial protocolEuropean Association of Cardio-Thoracic Surgeons guidelinesEuropean Society of Cardiology guidelines

  15. Will Transcatheter procedures be applicable to broad market segment? AVR Patients Age 70+ Key PARTNER Trial Exclusion Criteria: Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified Untreated clinically significant coronary artery disease requiring revascularization Data932 consecutive AVR patients1993–2004 Roberts, Circulation. 2005; 111:920–925

  16. AvA™ Valve Bypass System Something NEW combined with something PROVEN A reasonable next stepin aortic valve therapy A SAFER alternative for high risk aortic valve patients

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