Transcript Slide 1

CARDIOUS
A Heart Technology Company
AvA™ Aortic Valve Bypass Graft
System
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Heart Valve Therapy Has Remained
Unchanged Over the Last 30 Years
Diseased Aortic Valve
CARDIOUS
A Heart Technology Company
Unserved Patient Population is Driving the
Development of Alternative Treatments
• Difficulty Tolerating Cardiopulmonary Bypass
• No Surgical Option
• High Mortality Risk
CARDIOUS
A Heart Technology Company
Alternative Therapies under Development
• Aortic Valve Bypass Graft (AVBG)
Patient
Populations
• Transcatheter Valve
CARDIOUS
A Heart Technology Company
AVBG
Transcatheter
Valve
Tricuspid
X
X
Bicuspid
X
Coronary
Artery
Disease
X
AVBG Clinical History
Human Experience
• “On pump”
• Non-standardized
components
Physiology works
• Reduced pressure gradients
• Normal coronary flow
• 20+ year survival
CARDIOUS
A Heart Technology Company
1910
Carrel
First Concept
1955
Sarnoff
Animal Series
1962
Templeton
First Human
1974-84 Brown
Human Series
1975-00 Cooley
Human Series
2003
Human Series
Vassiliades
2005-07 Gammie
Human Series
AvA Valve Bypass System
Prosthetic Heart Valve
(selected by surgeon)
Apical Graft
Aortic Graft
Implant
Apical Graft
Aortic Graft
AvA = Apex Valve Aorta
0
25 20 15 10 5
0
0
5
10 15
5
10 15 20 25
25 30
Access Tool
Implant Tool
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A Heart Technology Company
How It Works
Clamp
25
25 20 15 10
5
0
20
30 25
15 10
5
0
0
5
15
10 15 20 25
10
5
0
Clamp
Clamp
30
25
15
10
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10
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20
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5th ICS
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A Heart Technology Company
Bioprosthetic valve
AvA Aortic Valve Bypass System
CARDIOUS
A Heart Technology Company
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
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A Heart Technology Company
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 LifeScience
est. $350 MM development program
Medtronic
est. $1.2 B development program
Other Start-ups
est. $250 MM
Est. Total Transcatheter Investment – $1.8 Billion
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
Does not fit Into bicuspid
shaped valves
40 % of pts. over age 70
have a bicuspid valve
Dislodges particles to brain
5 - 10 % Stroke Rate
Prevents future coronary
interventions
65 % of pts. over age 70 with a
stenotic tricuspid valve have CAD
Disrupts Heartbeat
20-30 % Pacemaker implantation
Est. Total Transcatheter Investment – $1.8 Billion
Transcatheter Competition
Angioplasty Catheter
Dislodge
particles
to brain
Prevent angioplasty
catheter placement
into coronary
Stent
Valve
Disrupt
heartbeat
signal
Market Share by Age, Cusp, and CAD
AVR Distribution by Age, Cusp, and CAD
45%
40%
35%
Percent of Market
30%
25%
Bicuspid w/ CAD
20%
Bicuspid w/o CAD
Tricuspid w/ CAD
15%
Tricuspid w/o CAD
Data
932 consecutive AVR
10%
patients
1993–2004
Roberts, Circulation. 2005;
111:920–925
5%
0%
21-30
31-40
41-50
51-60
61-70
Patient Age
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A Heart Technology Company
71-80
81-90
90-100
Alternative Therapies by Cusp Type and CAD
Prevalence in
AVR pts. over
age 70
AVBG
Transcatheter
Valve
Bicuspid
w/o CAD
20%
+
Contraindicated*
Bicuspid
w/CAD
20%
+
Contraindicated*
Tricuspid
w/o CAD
21%
+
+
Tricuspid
w/ CAD
39%
+
Contraindicated*
Cusp Type
and/or CAD
Bicuspid
Future CAD Intervention
* Patients with Bicuspids or Untreated Significant CAD are contraindicated
for transcather valve implantaion
Edwards LifeScience PARTNER Trial protocol
European Association of Cardio-Thoracic Surgeons guidelines
European Society of Cardiology guidelines
Will Transcatheter procedures be applicable
to broad market segment?
AVR Patients Age 70+
Attribute
No CAD
CAD
Tricuspid
21%
39%
Bicuspid
20%
20%
Data
932 consecutive AVR patients
1993–2004
Roberts, Circulation. 2005; 111:920–925
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
™
AvA Valve Bypass System
Something NEW combined with something PROVEN
A reasonable next step in aortic valve therapy
A SAFER alternative for high risk aortic valve patients
CARDIOUS
A Heart Technology Company