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SUREFIRE RESOURCES NL Capital/Financing Update 2005

Mar 13, 2005

65857_rns_2005-03-13_acf68686-8f93-48af-bf3d-a2cad125c15d.pdf

Capital/Financing Update

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GENESIS BIOMEDICALE

5th Floor, 52 Phillip St, SYDNEY 2000 Telephone 61-2-9252 7380 Facsimile 61-2-9252 8466

COMPANY ANNOUNCEMENTS OFFICE TO: COMPANY: AUSTRALIAN STOCK EXCHANGE LIMITED FROM: SHANE HARTWIG - COMPANY SECRETARY 14th MARCH 2005 DATE: No. PAGES: 3 (INCLUDING THIS COVER PAGE)

STOCK EXCHANGE ANNOUNCEMENT

COMPANY UPDATE

Further to recent announcements the Board of GBL writes to provide the market with an update as to its current activities and to outline some of the recent initiatives the Company has undertaken moving forward.

Current Activities

As a recap, historically GBL was established for the purpose of developing various medical device and diagnostic technologies with the ultimate aim of "taking the products to market" through the customary commercialisation channels of:

  • $\mathbf{1}$ . Trade sale:
  • $2.$ Product manufacture and sale: and/or
  • $\overline{3}$ . Partnering/licensing arrangements.

GBL continues to have as its core mandate the objective of product development and ultimate commercialisation of either internally developed intellectual property or alternatively, externally developed IP that is seeking GBL specific know/how, funding, path to market or a combination of all three.

More recently the Board has undertaken a review of all aspects of its current activities including status of its products and associated intellectual property and the process for the review and assessment of new opportunities.

As a result of this review and as outlined below, the Board has looked to re-configure some of the existing processes and management to better suit GBL's objectives, continue the assessment of the commercialisation path for existing products and to continue to assess already identified opportunities and others as they are presented.

Review of Existing Processes and Management

Dr Robert Gilmour (current Non-Executive Director) has assumed a greater $\mathbf{1}$ . executive role within the Company including the direction of the process for the further assessment and development of the CellGen™ asset (see below) as well as being the primary conduit for the initial identification and review of other biomedical technologies.

As the existing assets are further developed and the Company becomes involved in the commercialisation of other bio-medical opportunities, there will be a need to appoint a full time Chief Executive Officer. The Board is in the process of determining the appropriate skills and experience required to fulfill such a role and will look to identify suitable candidates as and when appropriate;

  • It has been agreed the need to establish a "scientific advisory committee" to $2.$ be used as an independent party to assess and review those externally identified opportunities. The primary purpose of the committee will be to provide the Board with an independent description and assessment of the underlying science/intellectual property, existing markets, potential commercialisation paths and risks surrounding these presented opportunities. The Board is in the process of extending invitations to certain individuals who it thinks will be invaluable in providing independent assessments of these opportunities;
  • $\mathcal{R}$ . Further define the Company's expertise and access to networks to add value to "completed science" which when commercialised meets a defined market need. This will include ongoing development of the Company's "product distribution network" throughout the US and Europe to assist in the initial assessment of the markets for the technologies being considered/reviewed and ultimately, to potentially act as the sale/licensing partner in these markets;
  • $\overline{4}$ . Appointment of additional Non Executive Directors;

Further Development of Existing Products

CellGenTM

Background

GBL's proprietary asset CellGenTM is a clinically advantageous non-invasive therapy that promotes injury recovery and tissue regeneration through the reproduction of bioelectrical signals.

Modalities similar to that of CellGen are used extensively in the Northern Hemisphere markets as a treatment for non-uniting fractures, stress fractures and more recently in the treatment of osteoarthritis and other common musculoskeletal disorders.

The ultimate aim of the development of these devices was to fully commercialise these products through either, the manufacture and sale of the products directly or through a distribution model, or alternatively license the technology surrounding the products to existing medical device manufacturers.

GBL has undertaken various trials of the technology including a double blind clinical trial to assess the effectiveness of CellGenTM in treating patients with osteoarthritis of the knee and more recently a trial within the Pemex orthopaedic clinic in Mexico City) has trialled several prescriptions on 46 patients using Genesis's CellGen® treatments. The results have indicated that the clinical response to Cellgen in certain conditions is very positive.

The market for products such as Cellgen has changed in recent years. The bone growth market has grown considerably particularly in parallel with the growth of spinal surgery. The acceptance of this category of product has increased amongst healthcare professionals, and more particularly there is now an established market for these products in the conservative management of osteoarthritis of the knee.

Significantly the regulatory environment in the major markets is more favourable.

CellGen™ Going Forward

In order to continue the commercialisation of the CellGenTM intellectual property developed to date, the Board has resolved to undertake an assessment of the costs, timing, likelihood of success and steps involved in furthering the development of the $CellGen^{TM}$ product to a point where the Board could be in a position to confidently register a Pre-Market Notification ("PMN") or 510(k) to the US Food and Drug Administration ("FDA").

If the results of the above assessment are deemed to be positive the Board will look to implement a CellGenTM development plan including funding, appointment of distribution/marketing and manufacturing partners, intellectual property review, regulatory approvals, health insurance registration and ultimate PMN registration.

If successful in registering a PMN and implementing all arrangements as set out above. GBL would be moving closer to achieving its ultimate objective of deriving a sustainable revenue stream from the sale/licensing of its proprietary CellGenTM technology.

Other Opportunities

GBL is currently reviewing material on two opportunities involved in the medical diagnostic area and is in the early stages of conducting some preliminary due diligence in relation to these.

The Board will provide an update to the market on the various initiatives discussed above including the review and assessment of GBL's CellGenTM asset, the appointment of individuals to the scientific advisory committee and the results of the assessment and review of the opportunities currently presented to the Board.

Please feel free to contact the Company should you have any questions in regard to this announcement.