Strategy
The Board has decided to focus the business entirely around Aorfix™ and significantly reduce costs. The restructuring of the business is now largely complete with the Group headcount now significantly reduced to 56 (June 09), compared with 105 in October 2008. Other strategic objectives for 2009 are as follows:
| 1. | Unique label claim in Europe Having received the regulatory approval to widen the existing label claim for Aorfix™ to include its use in patients with high-angle-neck aneurysms of up to 90 degrees; The Company is ensuring as many users of AAA devices in our target markets are aware of Aorfix™, it's offering and clinical results;
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| 2. | European sales To implement measures to maximise the opportunities for increasing sales in Europe in conjunction with the enhanced label claim;
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| 3. | US trial for Aorfix™ To complete recruitment of the Aorfix™ US trial and progress the PMA modular filings in line with the objective of receiving FDA approval at the earliest opportunity and in any event no later than Q1 2011; and
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| 4. | Commercialisation in the US To continue discussions with industry leaders to explore mutually beneficial opportunities for the commercialisation of Aorfix™ in the US. |
Completion of these objectives is providing significant news flow during 2009 which is proving to be a transformational year for the Company.
Although it was disappointing to have to put the US trial for the Company’s endovascular stapling product EndoRefix™ on hold due to a lack of funds, this product continues to be a valuable asset. Following the recent termination of the distribution and licensing agreements with Medtronic, Inc., the Company is free to seek alternative partners for this product to fund completion of the US trial and gain 510k approval for the product in the USA.
The thoracic version of Aorfix™ is also a valuable asset which the Company intends to resume development of as soon as funds become available either through commercial arrangements for the AAA version of Aorfix™ in the US or from a development partner.
Updated December 2009
