AVS 0.00% 2.0¢ avastra sleep centres limited

latest asx

  1. 3,176 Posts.
    Avastra Ltd ABN 47 094 446 803,
    Suite 2, 5 Rosebery Place, BALMAIN 2041 AUSTRALIA
    phone: (61) 2 8755 1500, fax: (61) 2 8755 1550 www.avastra.com
    12 January 2005
    Avastra Ltd (AVS): Avastra signs BIF Contract for $250,000. First payment due with BioWeld ®
    ETS device showing promise in vitro as Research hits first milestone/ ETS Progress Report p2
    Avastra is pleased to announce the signing of an Agreement with the Commonwealth Government’s
    Industry Research and Development Board yesterday for a $250,000 grant under the AusIndustry
    Biotechnology Investment Fund scheme.
    The Company was awarded the grant last November towards the development of its proposed
    BioWeld ® ETS device for sutureless end-to-side (ETS) anastomosis of blood vessels. The first payment
    of $91,949 (including GST) is due shortly with additional payments due at agreed milestones over the
    project life.
    Following successful application by the Company, the NSW Department of State and Regional
    Development is expected to match the BIF Grant with an additional $50,000 under its Proof of Concept
    grant awards.
    Avastra aims to produce a biocompatible ETS anastomotic device capable of rapidly joining blood
    vessels without using sutures (and eliminating their inherent drawbacks) in complicated, high-risk
    cardio-vascular surgery such as cardio-arterial by-pass grafts where blood vessels [grafts] are
    conventionally joined end-to-side. The ETS device will be made from Avastra’s patented BioWeld ®
    (protein-based), laser activated technology.
    It is envisaged this BioWeld ® ETS device, like the BioWeld ® Tube for end-to-end joins, can be quickly
    and easily applied with 100% patency (free blood flow), no leakage and no internal scarring or
    hyperplasia. Unlike sutures (or surgical staples) which are permanent, the BioWeld ® ETS device will
    also be absorbed by the body in time. Clinical trials of the BioWeld ® ETS are planned for 2007.
    Avastra’s BioWeld ® Tube is now in an Australian clinical trial to demonstrate its efficacy and safety in
    joining blood vessels end to end in surgical procedures. The first patient underwent an arterial
    anastomosis using BioWeld ® Tube on 17 December 2004 in a free flap operation performed by Dr Peter
    Maitz AM, a burns specialist, plastic and reconstructive surgeon at Concord RG Hospital, Concord,
    NSW. It was a world first in successfully joining a human blood vessel without a mechanical device.
    Results of the 12 patient clinical trial (including six month post operative follow-up per patient) will be
    known later this year. The clinical trial data will be used as part of the Company’s submission for
    regulatory approval to begin marketing the BioWeld ® Tubes in Australia.
    More than 9 million surgical procedures (mainly coronary arterial by-pass grafts) are performed annually
    worldwide where blood vessels are needed to be joined. As a guide, the suture type used in these
    procedures cost about $A40 to $A50 each with about three sutures used per procedure.
    Yours faithfully,
    Greg Fagan

    Avastra Ltd ABN 47 094 446 803,
    Suite 2, 5 Rosebery Place, BALMAIN 2041 AUSTRALIA
    phone: (61) 2 8755 1500, fax: (61) 2 8755 1550 www.avastra.com
    BioWeld ® ETS Progress Report
    Preliminary in vitro (bench) work testing a prototype BioWeld ® ETS device on harvested sheep carotid
    arteries has started with encouraging early results. The project is expected to take approximately 15
    months culminating in testing the ETS device in a large-animal study.
    The project requires extensive prototype testing, in vitro, to assess the best concept design and ease of
    application, followed by in-depth in-vivo studies in a suitable animal model to demonstrate a proof-of-principle.
    Prototype manufacture began in early October 2004, with a number of designs gaining favour with our
    research team. This met our timeline target for the design and manufacture of prototypes.
    There is a high degree of technical difficulty in this project, given the challenges of joining one blood
    vessel to the side of another, without interfering with the internal fluid dynamics [bloodflow] of the
    recipient vessel. The relatively high pressures involved create fluid waveforms integral to the
    development of complications like thrombus formation and intimal hyperplasia. These factors may result
    in failure of the anastomosis. Current collaborative work with the University of New South Wales,
    Graduate School of Biomedical Engineering, is allowing us to test the fluid dynamics of BioWeld ®
    designs, providing us with an understanding of the implications of our novel model during tissue
    In-vitro testing of BioWeld ® ETS prototypes began in November 2004, with preliminary haemodynamic
    results, based on current designs, expected by the end of this month.
    Early tests in ovine (sheep) arterial vessels looked good, reinforcing the basic bonding concepts learnt
    during the End-to-End (ETE) anastomotic trials. An expansion of this initial in-vitro work is planned for
    the first third of 2005 to create data supportive of in-vivo (animal) work planned for the middle of the
    year. In-vivo testing in a large animal model representative of current cardio-arterial procedures will
    build on the knowledge and innovation currently powering the organisation.
    An ovine carotid artery model was designed to test our novel ETS anastomotic junction. The proposed
    protocol tests current and established ETE techniques in this new model, before progressing to the
    more difficult ETS procedure. Submission of this protocol to an Ethics Committee is due at the end of
    January, with approval likely by March or April.
    A pilot study involving short term follow-ups will then pave the way for larger, more intensive ovine
    studies towards July 2005. Our ability to adhere to the forecast timeline for ETS vascular research is
    indicative of the attainable milestones set early in the conceptual stages of development.
    BioWeld ® Tubes and ETS devices are made from human serum albumin (HSA), an abundant, universal
    protein found in the blood. It is biocompatible, expanding and contracting with the blood pulse. The
    BioWeld ® Tube is impregnated with a special dye called indocyanine green (ICG) which causes the
    BioWeld ® to become sticky and bond to adjacent tissue when activated by laser energy of a specific
    wavelength. As the laser only affects the green dye, it passes through human tissue without damage.
    The BioWeld ® Tube’s raw ingredients, the HSA and ICG, are approved for surgical use with albumin
    used daily in hospitals and ICG in ophthalmic surgery and as a marker in cardio-vascular procedures.
    A video demonstration of the BioWeld ® Tube technology being performed on an animal model may be
    seen on Avastra’s website at www.avastra.com A PDF version of this notice may be downloaded
    Avastra’s website at www.avastra.com
arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.