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Anteris Technologies Global Corp. — Capital/Financing Update 2011
Mar 8, 2011
33869_rns_2011-03-08_3024daa8-94b1-4710-8a6d-7f84a60e418c.pdf
Capital/Financing Update
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Innovative BioMedical Devices
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bioMD Limited Telephone +61 8 9385 5038 ABN 35 088 221 078 Facsimile +61 8 9385 5028 Unit 9, 589 Stirling Hwy www.biomd.com.au Cottesloe, Western Australia 6010 PO Box 956, Cottesloe Western Australia 6850
ASX RELEASE
MARKET UPDATE PROGRESS ‐ TISSUE HEART VALVE STUDY
PERTH, Australia, 9 March 2011: bioMD Limited (ASX: BOD) who last month announced an off‐ market takeover of Allied Medical Limited, today announced it has signed a Material Transfer Agreement which will allow the continuation of the tissue heart valve feasibility study commenced last year. A number of “ready for sale” tissue heart valves have arrived in Australia and the current study will commence tomorrow.
The study is being jointly conducted by bioMD’s subsidiary Celxcel and a global tissue heart valve manufacturer. The feasibility study successfully completed its first major milestone late last year and will now continue to the second phase. This phase will include two simultaneous studies, an in vivo tissue comparison study and an in vitro fatigue testing calcification model.
The aim of the in vivo rat study:
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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.
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To determine the effect of the ADAPT technology on the performance (biocompatibility and calcification potential) of the commercial heart valve tissue after treatment with the ADAPT anticalcification process.
Expected outcome:
The explanted material will be subjected to histological examination to determine which cell types enter the implanted material. The calcium content of these materials will be determined, as well as the presence of host protein markers inside the explanted materials.
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). 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.
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To measure the calcification reduction potential of the ADAPT treated valves with the addition of Celxcel’s sterilisation process.
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The valves will be continually monitored over 15 million cycles and then removed and evaluated for calcification.
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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Achievement of all the expecte d outcomes w ill significa n tly increase the lifespa n of tissue h e art valves and reduce f a ilure rates c aused by calcification.
Heart Valve Fatigue Tester
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For more information, please contact:
Robert T owner ‐ Ex e cutive Dire c tor Tel: +61 8 9385 503 8 or 0414 59 4 868 Michael Bennett ‐ M anaging Dir e ctor Tel: + 6 1 8 9385 5038 or 0419 9 44 567
About bioMD Limited
bioMD (ASX: BOD) i s an Australi a n company commercialising regen e rative tissu e engineerin g technol o gies for us e in cardioth o racic, cardi o vascular and soft tissu e repair surg e ry. The AD A PT® technol o gy offers si g nificant im p rovements t o current tissue proces s ing technol o gies in ter m s of calcification levels and tissue durability. Its l e ad product , CardioCel, i s a biomate r ial patch used in cardiov a scular repair procedure s . bioMD is c urrently maximising sh a reholder va l ue via purs u it of corpora t e partners h ips, success f ul completi o n of clinical milestones and rapid c o mmercialis a tion strategi e s.
About the ADAPT® Tissue Engineering Process
ADAPT® Tissue Engi n eering Pro c ess (TEP) pr o duces a bi o prosthetic scaffold (ext r acellular m a trix) made fr o m animal t i ssue. Depe n ding on the site of impl a ntation, th e patient's o w n cells will migrate into the matrix and s timulate si t e specific c o ntrolled re m odelling. At the same ti m e, new blood vessels a re formed in the matri x and they d e liver appro p riate cells t h at lead to a functional tissue repair. T he implant e d extracellular matrix is gradually remodelled a n d replaced b y the body’s own new tis s ue structur e s.
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