NAL 0.00% 0.6¢ norwood abbey limited

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  1. 620 Posts.

    HOMEX - Melbourne

    Norwood Abbey Ltd (ASX: NAL) today announced that the US Food and
    Drug Administration (FDA) has granted 510(k) marketing approval for
    the Company's Laser-Assisted Drug Delivery (LAD) device for "ablation
    of the outer layer of the skin prior to the application of OTC
    topical 4% lidocaine cream, for local dermal anaesthesia". This
    device, which is comprised of a laser device together with single-use
    disposable tips, is designed to painlessly and temporarily alter the
    stratum corneum, or outer layer of skin, allowing for more
    efficacious delivery of topically applied drugs.

    The Company believes that this proprietary technology represents a
    breakthrough in transdermal drug delivery, and is very pleased to now
    be in the position to have achieved this important milestone related
    to release of the product in the US market.

    "The approval represents a major milestone to achieving the Company's
    goal of generating profits from the LAD project and becoming cash
    flow positive", commented Peter Hansen, Executive Chairman of Norwood
    Abbey. "Our research indicates that in addition to local
    anaesthetics, there are a large number of additional drugs that
    potentially can be delivered more effectively when used with the

    Norwood's North American marketing partner for the LAD, Ferndale
    Laboratories Inc, will package Norwood disposable LAD tips with its
    over-the-counter topical anaesthetic, Ela-Max(R).

    The primary market for the product is expected to be patients
    undergoing various procedures requiring needle-sticks, including
    injections, intra-venous insertions and blood donations. Prime
    initial target customers include clinicians and health care
    professionals in the fields of:

    * Dermatology/Plastic Surgery (Approximately 15,000 in USA)
    * Oncology (Approximately 2000 in USA)
    * Paediatrics (Approximately 11,000 in USA)
    * Blood Donations

    While the strategy with respect to the laser project has always been
    to primarily concentrate on the receipt of an annuity or continuing
    revenue stream from the sale of single use disposable tips, the
    Company also expects to generate profits from the sale of the device.

    Under the commercial arrangements that have been negotiated with
    Ferndale Laboratories Inc in Detroit, Norwood Abbey, through a
    network of direct sales representatives, medical wholesalers and
    distributors, will sell disposable tips and drug in a single package
    throughout North America. Market research has indicated that devices
    are likely to be used, on average, 1,000 times per annum. Norwood
    expects to net approx AUD$2.00 per disposable/procedure and
    approximately AUD$2,000 per device per annum.

    The Company currently expects to have sold or placed 10,000 devices
    by the end of calendar 2005. This would generate - on an ongoing
    basis - approximately AUD$20 million per annum in gross profit or
    approximately 15 cents (pre-tax) for each Norwood share on issue.

    In order to maximize market penetration, the Company has negotiated
    an arrangement with Ferndale whereby in a situation where a potential
    customer is not able to 'fund' the capital cost of the device,
    Norwood - together with Ferndale - will be able to place a device
    with a customer in return for the ongoing purchase of a minimum
    number of 'procedures' ie drugs and disposable tips.

    Norwood has appointed a Vice-President for the laser project in North
    America, Mark McLoughlin, a distinguished healthcare industry
    specialist. Mr McLoughlin will take the project to the next step of
    manufacturing, market development, sales, marketing and distribution.
    The Company will also seek to pursue further commercial applications,
    such as the possible delivery of vaccines, anti-inflammatories and
    other drugs.

    To keep costs low, both the manufacture of the LAD and disposable
    tips is being outsourced to international groups with experience in
    manufacturing medical devices. This will of course, also reduce
    Norwood's need for working capital and reduce the cost of the LAD and
    the disposable tips.

    Besides the significant initial market for its use in North America,
    Norwood has also commenced discussions with respect to targeting the
    European and Australasian markets. Limited sales have already been
    made in Australasia for specific applications and the project is
    expected to progressively generate substantial revenue from Asia.

    As a result of positive feedback from the USA market, work is now
    under way on a second-generation laser device for local anaesthetics
    that would cover a wider area of the skin.

    Norwood Abbey Ltd is a drug delivery and immunology company with
    three proprietary delivery platforms in various stages of
    commercialisation and development. Its delivery technologies include
    laser-assisted delivery, micro-needle arrays and pressure wave
    technology for the transfer of both drugs and genetic material.

    In addition, the Company holds patent applications for the use of
    GnRH analogue drugs in the re-growth of the Thymus gland and
    production of new T-cells. GnRH drugs are already approved for the
    treatment of prostate and breast cancer and have been available on
    the market for many years.

    For further information about Norwood, visit the Company's web site


    Peter Hansen Lippert/Heilshorn & Associates Inc
    EXECUTIVE CHAIRMAN Kim Sutton Golodetz ([email protected])
    +613 9782 7333 212 838 377
    Bernie Romanin Bruce Voss ([email protected])
    DIRECTOR OF MARKETING 310 691 7100
    +613 9782 7333
    [email protected]
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