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Anteris Technologies Global Corp. — Capital/Financing Update 2011
Jun 2, 2011
33869_rns_2011-06-02_9ee7ebf3-b5ee-4665-9016-dbc7ca094ed6.pdf
Capital/Financing Update
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Innovative BioMedical Devices
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bioMD Limited ABN 35 088 221 078 Unit 9, 589 Stirling Hwy Cottesloe, Western Australia 6010 PO Box 956, Cottesloe Western Australia 6850
Telephone +61 8 9385 5038 Facsimile +61 8 9385 5028
ASX RELEASE
MARKET UPDATE PROGRESS ‐ TISSUE HEART VALVE STUDY
PERTH, Australia, 3 June 2011 bioMD Limited (ASX: BOD) today announced progress with its tissue heart valve feasibility study that commenced last year.
The study is being jointly conducted by bioMD’s subsidiary Celxcel Pty Ltd and a global tissue heart valve manufacturer. The feasibility study successfully completed its first major milestone late last year and is now continuing to the second phase. This phase consists of two simultaneous studies, an in vivo tissue calcification comparison study and an in vitro fatigue testing calcification model.
1. The aim of the in vivo rat study:
- To compare the performance (biocompatibility and calcification potential) of bovine pericardial tissue, treated with the ADAPT anticalcification process with the commercial tissue product (from our global tissue heart valve partner) in a rat model. Explanted tissue samples from 30 animals each with 4 implants will be tested and subjected to histological examination at 8, 16 and 24 week intervals.
Outcome to date:
This study commenced March 22nd and the 8 week tissue samples from 10 animals have been explanted. Macroscopic and histological examination showed no calcification in the ADAPT treated samples while 2 of the commercial heart valve tissue samples showed mild to moderate calcification.
2. The aim of the fatigue testing calcification model:
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To measure the calcification reduction potential of ADAPT treated tissue heart valves when mounted in a pulse duplicator (a dynamic and functional flow testing machine that mimics the opening and closing of a tissue heart valve).
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To measure the calcification reduction potential of the ADAPT treated valves with the addition of Celxcel’s sterilisation process.
Commencement date:
The fatigue testing commenced on May 16th after a short delay in validating the test protocol. The valves will be continually monitored over 50 million cycles and then removed and evaluated for calcification. During the testing procedure, valves will function at an accelerated speed of 300 beats per minute in a physiological solution which contains a high level of calcium phosphate.
Currently the testing is at 26 million cycles with all monitoring and systems operating correctly.
Expected outcome:
It is anticipated the untreated commercial tissue heart valves will calcify over time. The ADAPT treated commercial tissue heart valves should show a significant reduction in calcification while the addition of the sterilisation process should further reduce the calcification potential of the valves.
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For more information, please contact:
Robert Towner – Executive Director Tel: +61 8 9385 5038 or 0414 495 868 Michael Bennett – Managing Director Tel: +61 8 9385 5038 or 0419 944 567
About bioMD Limited
bioMD (ASX: BOD) is an Australian company commercialising regenerative tissue engineering technologies for use in cardiothoracic, cardiovascular and soft tissue repair surgery. The ADAPT ® technology offers significant improvements to current tissue processing technologies in terms of calcification levels and tissue durability. It’s lead product, CardioCel, is a biomaterial patch used in cardiovascular repair procedures. bioMD is currently maximising shareholder value via pursuit of corporate partnerships, successful completion of clinical milestones and rapid commercialisation strategies.
About the ADAPT® Tissue Engineering Process
ADAPT ® Tissue Engineering Process (TEP) produces a bioprosthetic scaffold (extracellular matrix) made from animal tissue. Depending on the site of implantation, the patient’s own cells will migrate into the matrix and stimulate site specific controlled remodelling. At the same time, new blood vessels are formed in the matrix and they deliver appropriate cells that lead to a functional tissue repair. The implanted extracellular matrix is gradually remodelled and replaced by the body’s own new tissue structures.
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