Slide Gallery Simple Slide Format AvA Aortic Valve Bypass Graft System

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CARDIOUSA Heart Technology CompanyCARDIOUS

A Heart Technology Company

AvA™ Aortic Valve Bypass Graft

System



Heart Valve Therapy Has RemainedUnchanged Over the Last 30 Years

Diseased Aortic Valve

• Difficulty Tolerating Cardiopulmonary Bypass• No Surgical Option

• High Mortality Risk

Unserved Patient Population is Driving the Development of Alternative Treatments



• Aortic Valve Bypass Graft (AVBG)

• Transcatheter Valve Patient Populations AVBG

Transcatheter Valve

Tricuspid X X

Bicuspid X

Coronary Artery Disease X

Alternative Therapies under Development





AVBG Clinical History

Human Experience• “On pump” • Non-standardized

components

Physiology works• Reduced pressure gradients• Normal coronary flow• 20+ year survival

1910 Carrel First Concept

1955 Sarnoff Animal Series

1962 Templeton First Human

1974-84 Brown Human Series

1975-00 Cooley Human Series

2003 Vassiliades Human Series

2005-07 Gammie Human Series



AvA Valve Bypass System

AvA = Apex Valve Aorta

Access Tool

Implant

Apical Graft Aortic Graft

Prosthetic Heart Valve (selected by surgeon)

051 01 52 02 5

0 5 1 0 1 5 2 0 2 5

0 5 1 0 1 5 2 5 3 0

Apical Graft Aortic Graft

Implant Tool



How It Works

Bioprosthetic valve

Clamp

Clamp

5th ICS

0 5 10 15 20 25

0510152025

0510152530

Clamp

05

1015

2025

05

10

15

20

25

05

10

15

25

30



AvA Aortic Valve Bypass System



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

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.”

Edwards LifeScienceest. $350 MM development program

Medtronicest. $1.2 B development program

Other Start-upsest. $250 MM

Est. Total Transcatheter Investment – $1.8 Billion

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

“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.”

Est. Total Transcatheter Investment – $1.8 Billion

Anonymous venture capitalist


Dislodge particles to brain

Prevent angioplasty catheter placement into coronary

Disrupt heartbeat signal

Dislodge particles to brain

Prevent angioplasty catheter placement into coronary

Disrupt heartbeat signal

Angioplasty Catheter

StentValve



AVR Distribution by Age, Cusp, and CAD

Data932 consecutive AVR patients1993–2004Roberts, Circulation. 2005; 111:920–925

Cusp Type and/or CAD

Prevalence in AVR pts. over age

70

AVBGTranscathete

rValve

Bicuspidw/o CAD 20%20% ++ ContraindicateContraindicate

dd**

Bicuspidw/CAD 20%20% ++ ContraindicateContraindicate

dd**

Tricuspidw/o CAD 21%21% ++ ++Tricuspidw/ CAD 39%39% ++ ContraindicateContraindicate

dd**

Alternative Therapies by Cusp Type and CAD

Edwards LifeScience PARTNER Trial protocolEuropean Association of Cardio-Thoracic Surgeons guidelinesEuropean Society of Cardiology guidelines

* Patients with Bicuspids or Untreated Significant CAD are contraindicated for transcather valve implantaion

Future CAD Intervention

Bicuspid

Will Transcatheter procedures be applicable to broad market segment?

Attribute No CAD CAD

Tricuspid 21% 39%

Bicuspid 20% 20%

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

AVR Patients Age 70+

Data932 consecutive AVR patients1993–2004Roberts, Circulation. 2005; 111:920–925



AvA™ Valve Bypass System

A reasonable next step in aortic valve therapy

A SAFER alternative for high risk aortic valve patients

Something NEW combined with something PROVEN

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Slide Gallery Simple Slide Format AvA Aortic Valve Bypass Graft System