AVR 2.27% $9.00 anteris technologies ltd

AHZ-- 100 baggers, page-75

  1. 611 Posts.
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    I don't believe so. The Paterson's report from March this year says "Neo is presently only available in the US market, with the EU and Asian markets likely to follow late in 2017."

    (http://www.admedus.com/wp-content/uploads/2017/04/AHZ170307.pdf)

    That report is still a good read. Their complete report on Neo is as follows;

    CARDIOCEL NEO
    One common problem that occurs with bovine pericardium patches is significant variations in thickness within the patch. Surgeons will sometimes be unable to use a patch if a section of the patch is thicker than the surrounding tissue it is being sutured into. This problem tends to occur most often in neonate cardiothoracic surgery, where native tissue is thinner.


    CardioCel Neo (‘Neo’) is a uniform, thinner version CardioCel, made from the same bovine pericardium, and undergoing a similar (although not identical) manufacturing process. The average thickness of a CardioCel patch is 0.6mm, whereas the average thickness of Neo is 0.3mm. Neo’s competitive advantage is that the ADAPT manufacturing process guarantees that the 0.3mm thickness of the patch is reliably uniform (that small variations in thickness are always within acceptable limits).

    While Neo is approved for all the uses that CardioCel is approved for, in reality, its use is likely to be limited to the following procedures in patients under the age of 2:
    (i) Ventricular septal defect (VSD) repair
    (ii) Atrial septal defect (ASD) repair
    (iii) Atrio-ventricular septal defect (AVSD) repair
    (iv) Tetralogy of Fallot (TOF) repair
    (v) Leaflet repair


    Unlike CardioCel, Neo’s thinness means that is unlikely to be used in the following procedures:
    (i) Reconstruction of the right ventricular outflow tract (RVOT)
    (ii) Aortic root enlargement
    (iii) Valve repair
    (iv) Annulus repair


    Neo is presently only available in the US market, with the EU and Asian markets likely to follow late in 2017. From the perspective of both regulators and potential buyers, CardioCel’s clinical data pack is also applicable to Neo. Based on the above-mentioned uses, when Neo is available in all the markets that CardioCel is available in, we expect Neo to cannibalize around 25% of CardioCel sales (around 75% of present CardioCel sales are for indications in patient groups where Neo would not be advantageous).

    While Neo will eventually cannibalize some CardioCel sales, we nevertheless think Neo will be a profitable addition to the ADAPT product line for two key reasons. First, our research indicates that it has only one direct competitor30 (as of March 2017), viz., the CorMatrix ‘Tyke’ patch. The CorMatrix Tyke received US FDA 510(k) clearance in February 2016, and sales numbers as well as the results from post-marketing observational studies are not yet publicly available. With Tyke having a minimal head start over Neo, and with the superiority (described above) of ADAPT patches over CorMatrix patches (which are not cross linked and have a tendency to rupture as per the adverse event reports cited in the previous section), we see this emerging neonatal ‘thin’ pericardial patch market as being wide open for Neo. Second, Neo’s premium pricing (average price globally is expected to be A$1,600 per unit versus A$1,200 for CardioCel) should entail a higher gross profit margin relative to CardioCel.
 
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