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Anteris Technologies Global Corp. — AGM Information 2009
Nov 10, 2009
33869_rns_2009-11-10_8f2f2a99-48c6-41e6-8876-3be4705ff91d.pdf
AGM Information
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Innovative BioMedical Devices ABN 35 088 221 078
bioMD Limited Level 11, 225 St Georges Terrace Perth, Western Australia 6000 PO Box 7209, Cloisters Square Western Australia 6850
Telephone (08) 9262 6777 Facsimile (08) 9322 3433 ABN 35 088 221 078 www.biomd.com.au
ANNOUNCEMENT TO THE AUSTRALIAN STOCK EXCHANGE
1 of 12 pages
11 November 2009
Company Announcements Office Australian Stock Exchange Limited 10th Floor, 20 Bond Street SYDNEY NSW 2000
ANNUAL GENERAL MEETING PRESENTATION
The Directors of bioMD Limited are pleased to announce the Presentation for the 6[th] Annual General Meeting of the Company to be held today.
Yours faithfully
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Caroline Bentley Company Secretary
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Annual General Meeting
11 November 2009
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OUTLOOK 2009/2010 - Biomaterial Mesh Patches utilising the ADAPT Tissue Engineering Process
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A heart deformity human clinical trial completed
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interim report due Dec 2009
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final report mid 2010;
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A pelvic floor reconstruction human clinical trial in progress;
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Australian manufacturing plan for ADAPT biomaterial mesh patch;
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Global regulatory applications being implemented - TGA/FDA/CE;
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Commercialisation partnerships being explored for specialty products, e.g. tissue heart valves;
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Currently these include a feasibility study plan being negotiated with a global heart valve company;
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CARDIOVASCULAR HUMAN CLINICAL TRIAL SAFETY & EFFICACY RESULTS 30 patient study evaluating the performance of the ADAPT treated CardioCel pericardial patch for heart deformities - completed October 2009
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No patch-related clinical adverse effects;
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No additional calcification at 6 month follow-up;
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Safety, efficacy and clinical performance proven in a demanding surgical environment;
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Provided platform of security to pursue other human clinical studies;
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HUMAN PELVIC FLOOR REPAIR PILOT STUDY 20 women requiring Anterior Vaginal Prolapse repair to be enrolled – clinical trial already commenced with first patients due for follow-up by end 2009
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“
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• GYNECEL” - a biomaterial mesh ideal for all abdominal
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soft tissue repairs;
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Remodels into host tissue and avoids erosions often experienced with synthetic meshes;
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Global market in 2007 >USD1 billion (projected >USD1.5 billion in 2011**);
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Expanding market (>15% p.a.) due to “quality of life” demands.
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** Millennium Research “Global markets for Soft Tissue Repair, 2008”
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THE GLOBAL MARKET – BIOMATERIAL MESH 2010
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Significant acquisition activity amongst global players – sector strengthening in biomaterial tissue technologies versus synthetics - e.g. Covidien/TSL, Kinetic/LifeCell, Synovis/Pegasus, RTI Biologics;
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Surgical fields including cardiovascular, abdominal and orthopedic with combined global revenue projected 2011 of >USD2 billion;
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Surgical fields of emphasis by US companies is presently concentrated on hernia repair and breast reconstruction;
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Surgical community concerned at poor performance of current competitor products and seeking better patient outcomes;
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COMPETITION / MARKET DRIVERS
Synovis Life Technologies Inc. – Veritas Ventral Hernia Repair Patch CEO, third quarter of fiscal 2009 –
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“We again posted double-digit revenue gains and realized the 12[th] record revenue quarter in the last 13 quarters. Revenue from patch products based on Synovis’ unique Veritas remodelable biomaterial rose to $2.3 million in the third quarter ……….Synovis launched Veritas into the ventral hernia repair market in 2007 ……Veritas has demonstrated performance advantages and we continue to see exceptional revenue
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ADAPT TECHNOLOGY APPLICATIONS The ADAPT Tissue Engineering Process can be used to produce the following biomaterial devices:
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Existing tissue heart valves – valve leaflets;
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New percutaneous heart valves;
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Cardiovascular heart biomaterial mesh patches;
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Pelvic floor reconstruction biomaterial mesh;
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Hernia biomaterial mesh;
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Orthopaedic rotator cuff and tendon repair implants;
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- Suture/staple line reinforcement;
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ADAPT Biomaterial Products
Mesh Product Pre-clinical Phase I/II Regulatory Marketed Candidate CardioCel Gynecel Hernia Mesh Breast Reconstruction Orthopaedics
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| KEY COMMERCIALISATION MILESTONES ACHIEVED AND IN PROGRESS |
KEY COMMERCIALISATION MILESTONES ACHIEVED AND IN PROGRESS |
KEY COMMERCIALISATION MILESTONES ACHIEVED AND IN PROGRESS |
|---|---|---|
| Completed 30 patient heart patch trial (safety & efficacy) | Q209 | ~~�~~ � |
| Started 20 patient pelvic floor reconstruction (PFR) clinical trial | Q309 | � |
| Interim report 20 patient PFR study | Q210 | ~~�~~ |
| NAMSA biocompatibility testing for regulatory listing completed | Q210 | |
| Expanded pelvic floor study under Special Access Scheme | Q210 | |
| Ventral hernia study ethics approval | Q210 | |
| Regulatory conformity assessment application completed | Q310 |
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At a glance…
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Group Cash
position
Fully Paid
@ 31/10/09
Ordinary 24 March
Shares 2004
$0.8 million
128.8 million
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Group Average
Top 50
Cash Burn
Shareholders Market
(Sep QTR)
Capitalisation
76.4%
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For all the latest news and updates visit: www.biomd.com.au