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Investor Presentation
February 2009
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Company Status - CurrentPhase II Human Clinical Trial of CardioCel (20 patients implanted)Preparing documentation for approval for Australian Human Clinical Trial (Sydney) in pelvic floor repairCommercialisation discussions / global partnering – hernia & pelvic floor reconstruction
Services Agreement with Cell & Tissue Therapies WA, Royal Perth Hospital, for the provision of laboratory services for CardioCel production
Inclusion of CardioCel on Australian Register of Therapeutic Goods (ARTG No. 150536 for Export only)
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What is tissue engineering?
“An interdisciplinary field that applies theprinciples of engineering and life sciences
toward the development of biological substitutes that restore, maintain, or improvetissue function or a whole organ.”
Source: Langer and VacantiFor
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Growth in Biologics
“Because commercial soft tissue meshes are indicated for use in a wide variety of minimally invasive
and open surgical procedures, rising procedure volumes will increase the
size of the potential pool for commercial soft tissue devices.
Accordingly, unit sales will accelerate, thus driving revenue increases in the overall tissue
market.”
Source: Millennium Research Group
Change in demographics
(ageing population)
Technological advancements
Reduced hospitalisation
costsIncreasing
obesity levels
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ADAPT®TISSUE ENGINEERING
PROCESS (TEP)
Removes all cells, RNA and DNALeaves behind a biological collagen scaffold which encourages the patient’s own cells and blood vessels to grow without triggering the immune systemPatient’s cells populate, they lay down their own collagenNew collagen matures over time to form a functional tissue repair
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What is our market?
Cardiovascular patches
Abdominal patches
Heart valves
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Cardiovascular patches are commonly used to seal openings in blood vessels and the heart.
The term "cardiovascular patch" is intended to encompass any such material, regardless of shape, which is applied over a cut, tear, or other opening in a blood vessel or similar organ.
The patches reconstruct the opening,preventing leakage which results in a stronger and healthier blood vessel.
Cardiovascular PatchesF
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Collaboration into ADAPT TEP treated human pericardium comparison
Phase II Human Clinical Trial underway in South Africa
20 patients implanted with CardioCel bovine pericardial patches treated with ADAPT TEP
Cardiovascular PatchesF
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Abdominal patches for hernia repair, vaginal slings and pelvic floor reconstruction
Enables normal healing, including remodelling to the host tissue
US market = US$865M in 2007
Expanding market due to lifestyle changes
Forecast US Market = US$1.5 billion in 2011
Abdominal PatchesF
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2 types of artificial heart valve:
Tissue valves usually made from animal tissues, either animal heart valve tissue or animal pericardial tissue
Tissue must be treated to prevent rejection and calcification
Current US market is US$900 million
mechanical tissue
Heart ValvesF
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The Future…Percutaneous Heart Valve Replacement
Percutaneous valve replacement - the implantation of valves using a catheter without open heart surgeryAlternative to open heart surgery – minimally invasive surgeryTransfemoral / transapicalplacementStill being evaluated in worldwide clinical trials -1500 patients implanted to date
Heart ValvesF
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Research collaboration in South Africa to develop a kangaroo tissue percutaneous heart valve
(.avi)
Research collaboration in Australia to develop a replacement mitral valve using ADAPT TEP tissue valve leaflets
Heart ValvesF
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Initial in-vitro research at the CTTWA indicates that ADAPT treated patches when seeded with
mesenchymal stem cells will perform as a delivery scaffold for these stem cells to treat heart attack victims and help regenerate their heart muscle.
The CIRM has confirmed that this delivery will be the preferred method of delivery.
Stem Cells
Something new…F
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The Year Ahead…
Completion of Cardiovascular Phase II Human Clinical Trial
Commencement of an Australian Human Clinical Trial in the Pelvic Floor / Hernia
FDA 510K Application completed
Global partnering for ADAPT TEPFor
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At a glance…
24 March 2004
Fully Paid Ordinary Shares
85.9 million
Top 50 Shareholders
75.9%
Group Cash position
@ 31/01/09
$608K
Group Average Cash Burn (Dec QTR)
$115K/month
Market Capitalisation @ 31/01/09
$3.6 million
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Investor PresentationCompany Status - CurrentWhat is tissue engineering?Growth in BiologicsADAPT®�TISSUE ENGINEERING �PROCESS (TEP)What is our market?Slide Number 7Slide Number 8Slide Number 9Slide Number 10The Future…�Percutaneous Heart Valve ReplacementSlide Number 12Slide Number 13The Year Ahead…At a glance…