Anteris Technologies Global Corp. — AGM Information 2010

Nov 9, 2010

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AGM Presentation November 2010

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OUTLOOK 2010/11 - Biomaterial Mesh Patches utilising CELXCEL’s ADAPT Tissu e Engineering Process

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• Phase II human clinical trial completed final report end 2010;

• CELXCEL has a boutique manufacturing plan for the “CARDIOCEL” ADAPT biomaterial mesh patch;

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• Quality Management System (QMS) /ISO 13485 systems in place;

• Global regulatory applications being implemented – TGA/CE and FDA ;

• Feasibility study plan continuing with a global heart valve company ;

• Commercialisation partnerships being explored for specialty products, e.g. percu aneous ssue ear va ves; t ti h t l

• R&D continuing for emerging growth opportunities utilizing the ADAPT biomaterial mesh – for the g rowth of stem cells , chrondoc y tes ( cartila g e ) and keratinoc y tes (skin);

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HUMAN CARDIOVASCULAR CLINICAL TRIAL SAFETY & EFFICACY RESULTS – “CARDIOCEL” PATCH

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• 30 patient study evaluating the performance of the ADAPT treated Cardiocel pericardial patch for heart deformities - completed September 2009

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• 12 month follow up completed October 2010

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• MRI results show no signs of calcification after 12 months

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HUMAN PELVIC FLOOR REPAIR PILOT STUDY

• This study was discontinued after 4 patients due to post operative infections

• Th ese inf ect i o n s w e r e not caused by t h e b i o m ate ri a l patc h , but possibly due to a number of other factors

• The study protocol will be re evaluated

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AUSTRALIAN HUMAN CARDIOVASCULAR CLINICAL TRIAL

• It is intended to commence a further cardiovascular trial in Australia, subject to protocol approvals and funding

• The intention is to use 50 Cardiocel biomaterial patches in the repair of ven ra sep a t l t l d e ec s n c f t i hild ren

• • The study will be conducted at a major Australian children's hospital by the Head of Cardiothoracic Surgery

• The study will be conducted at a major Australian children's hospital by

• The study will be a lead in to the general availability of the TGA approved Cardiocel biomaterial patch in Australia

• The same cardiothoracic unit intends to conduct a large animal study using the Cardiocel patch for paediatric heart valve reconstruction

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CELXCEL Quality Management System for Medical Devices

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• QMS / ISO 13485 has commenced

• Conformity Assessment for TGA (Aust)/CE (Europe) regulatory approval commenced

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• • Cardiocel ” regulatory application expected filing by Q01 , 2011

• FDA filing will follow CE, expected Q2,2011

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NAMSA

BIOCOMPATIBILITY TESTING

• 26 Week Rat Implants: Test for subchronic systemic toxicity & local irritation at implant site

Outcome:

• No evidence of systemic toxicity with ADAPT implants

• No significant difference between cellular response of ADAPT and contro l

• No evidence of treatment related response by ADAPT tissue

• Microscopically classified as a non-irritant

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CELXCEL ONGOING R&D PROJECTS

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• ADAPT II Pore Size Study

• Mesenchymal Stem Cell Study

ADAPT I

• Percutaneous Valve Project SA

• Chondroc te / Keratinoc te Stud y y y

• Differential Cross Linking

• Viral Inactivation Study

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• Ventral Hernia Repair

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ADAPT II
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CELXCEL ONGOING R&D PROJECTS - Histology Detail

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Large pore matrix

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Layer of
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Formation of procollagen

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Chondrocyte infiltration

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COMMERCIALISATION STRATEGY “Cardiocel” Biomaterial Patch

Completed cardiovascular human clinical trial

GMP sca e-up o manu ac ure l t f t “Cardiocel” patches

Secure commercial co-operation with global heart valve company

Conformity Assessment application for Cardiocel patch

• •Regulatory Approval TGA/CE

•FDA

Expected Revenue:

• “Cardiocel” p atch sales Aust/Asia/EU

• Royalties from global heart valve partner

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	KEY COMMERCIALISATION MILESTONES ACHIEVED AND IN PROGRESS - 2011	KEY COMMERCIALISATION MILESTONES ACHIEVED AND IN PROGRESS - 2011	KEY COMMERCIALISATION MILESTONES ACHIEVED AND IN PROGRESS - 2011	KEY COMMERCIALISATION MILESTONES ACHIEVED AND IN PROGRESS - 2011
	KEY COMMERCIALISATION MILESTONES ACHIEVED AND IN PROGRESS - 2011
	Completed 30 patient heart patch trial (safety & efficacy)	Q2,2009	�
	NAMSA bi tibilit t ti f l t li ti l t d ocompa y es ng or regu a ory s ng comp e e	Q2 2010 ,	�
	Regulatory conformity assessment application completed	Q4.2010	~~�~~
	Global Heart Valve ADAPT Sterilisation phase	Q4.2010	�
	A t li TGA d E CE l t li ti fil d us ra an , an uropean regu a ory app ca ons e	Q1 2011 ,
	Global Heart Valve Project Completed	Q2,2011
	Commercial product ”Cardiocel” ready for AUST & ASIAN markets	Q2,2011
	Cdil h diibi f E	32011
	aroce patc struton agreement or urope	Q .

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ADAPT TECHNOLOGY APPLICATIONS

The ADAPT Tissue Engineering Process can be used to produce the following biomaterial devices:

• E x s i ti ng ssue ear va ves – va ve ea ti h t l l l fl e s; t

• Pericardial closure biomaterial;

• • Ne w perc u taneo u s heart v al v es ;

• Cardiovascular (heart) mesh patches;

• Pelvic floor reconstruction biomaterial mesh;

• Hernia biomaterial mesh;

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• Orthopaedic rotator cuff and tendon repair implants;

• Plastic and reconstructive surgery - e.g. breast reconstruction;

• Wound dressings – e . g . for diabetic skin ulcers and burn wounds .

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Tissue Processing Initiatives Leveraging our tissue processing strengths

• L A t li b i ti b i ree everage on us ra an ov ne ssue e ng GBR1 (BSE f )

• Offer to value add tissue - by processing to international manufacturers requirements

• Initiatives commenced with 3 Euro ean start-u manufacturers for the p p

• supply of raw and partly processed tissue

• Explored possible JV with current exporter of raw bovine tissue

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At a glance…

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Grou p Cash
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position
Fully Paid
@ 31/9/10
Ordinary 24 March
Shares 2004
$1.0 million
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129 million
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Group Average
Top 50
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Shareholders M ar k e t
(Sep QTR)
Capitalisation
76% @ 31/10/10 $97K/month
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. m on
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For all the latest news and updates visit: www.biomd.com.au

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