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Anteris Technologies Global Corp. — AGM Information 2010
Nov 9, 2010
33869_rns_2010-11-09_ef8cfb65-c600-4963-9bd0-820451c8ecd3.pdf
AGM Information
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Innovative BioMedical Devices
Telephone (08) 9262 6777 Facsimile (08) 9322 3433
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bioMD Limited ABN 35 088 221 078
Level 11, 225 St Georges Terrace Perth, Western Australia 6000 PO Box 7209, Cloisters Square Western Australia 6850
ANNOUNCEMENT TO THE AUSTRALIAN STOCK EXCHANGE
10 November 2010
Company Announcements Office Australian Stock Exchange Limited 10th Floor, 20 Bond Street SYDNEY NSW 2000
Dear Sir/Madam,
CHAIRMAN’S ADDRESS
The Directors of bioMD Limited are pleased to announce the Chairman’s Address for the Annual General Meeting of the Company to be held today.
Yours faithfully
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Darren Bromley Company Secretary
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CHAIRMAN’S ADDRESS
Seventh Annual General Meeting of bioMD Ltd
2009/10 HIGHLIGHTS
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Raised $1,288 million in fully underwritten Options Rights Issue to shareholders
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Concluded Patient Implantations in Phase II Human Clinical Trial of “CardioCel”
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Commenced Australian Clinical Trial of “Gynecel” for pelvic floor repair
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Commenced NAMSA testing of ADAPT treated tissue to obtain biocompatibility certification
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Entered into heart valve feasibility study
2009/2010 overview:
The year has been a busy one for bioMD with two clinical trials underway, a feasibility study being entered into for the possible use of ADAPT Tissue Engineering Process (TEP) on an existing FDA-approved tissue heart valve, and further research activities into the use of mesenchymal stem cells with ADAPT treated patches.
The Principal Investigator’s final report will be released shortly to conclude our Phase II Clinical Trial in South Africa. A total of 30 pediatrics patients were implanted with CardioCel. Preliminary data from the 12 month clinical evaluations has been very encouraging. Results from the MRI assessments have demonstrated that no calcification of the CardioCel patch was detected in any of the patients, which is a significant result as calcification is the foremost limiting factor in the longevity of biomaterial patches implanted in pediatrics patients. Zero calcification in implanted tissue patches reduces the requirement for further surgery.
During the year a pilot study was commenced using ADAPT treated biomaterial patches (Gynecel) for pelvic floor reconstruction surgery, specifically for anterior vaginal wall prolapse reconstruction. The study was undertaken to assess a number of issues associated with the use of an ADAPT treated patches in pelvic floor surgery, including patch shape, anatomical attachment, placement technique, suturing technique and antibiotic regimes. A total of four patients were implanted, however, it was decided to discontinue the study due to the high rate of post operative infections being seen in the patients.
We recently announced to the market that the first milestone has been successfully achieved in a feasibility study with a leading global tissue heart valve company.
This milestone, which is considered to be one of the most important, used the ADAPT[®] terminal sterilisation technology to sterilise the valve within its final packaging. As a result of this positive achievement, the study will now continue through into next year with further elements of the technology being evaluated and tested.
We are encouraged by this positive result and hope that this level of success is continued through the other testing. If it does then we would expect to have a commercial outcome for the use of the ADAPT[®] process in tissue heart valve production.
Celxcel is in discussions with the manufacturer regarding the next steps of the study. This will include further testing of the potential for integration of the ADAPT[®] technology into one of the companies FDA approved tissue heart valves. It is expected that the study will become an integral part of their 2011 R&D programme and will lead to the quantification of the multiple business opportunities for the two companies.
The Company’s research and development during the year was primarily focused on pore size reconfiguration of the ADAPT matrix and the use of human mesenchymal stem cells with the matrix. The use of stem cells in tissue regeneration is a rapidly expanding field of science and we are pleased to be involved in this research in conjunction with a leading cell and tissue research laboratory.
The Company has continued to maintain its patent portfolios for the Prefilled Syringe and for the ADAPT process in a number of countries. These patents afford the Company protection of the intellectual property in relation to our inventions.
Financial Results
The operating loss after tax of the Group for the year ended 30 June 2010 amounted to $1.3 million for the consolidated entity, compared to the previous year’s loss of $1.1 million.
The Board of Directors is of the opinion that the Company is nearing the commercialisation stage of its products, which will be an exciting time.
Competition for biotechnology comes from sectors such as property, resources and infrastructure. The biotechnology sector offers investors high growth prospects but also has high risk factors. Even before the impact of the GFC was felt, funding for biotechnology stocks was not easy. As a result of the GFC, investors’ appetite for risk (including biotechnology investing) has reduced, although this is expected to return once there is a recovery in broader markets. It is therefore pleasing to be able to report to you on our continuing progress.
On behalf of the Board of Directors I would like to thank our shareholders for your continued support of this Company.
Finally, I would like to extend my appreciation to my fellow directors, executive management, staff and the advisory team who have worked tirelessly over the past twelve months I what has been a very significant year in the progression of bioMD.