phase2 trials this week?, page-4

If only these were the only problems this company faces. Note that 160 patients have now had the Berlin Heart product!!!:

Ventracor faces a number of risks as it furthers its
commercialisation strategy:
• All of the current heart device manufacturers,
including Ventracor, are working on modified and
next-generation devices that aim to be smaller,
more durable, and more powerful.
• Uncertainty over the technology and therefore its
approval.
• The cost of the device (including surgery costs) is
expected to be US$100,000. This may affect the
uptake rate despite re-imbursement in the US.
• The LVAS implantation itself does not seem to be a
difficult procedure but additional infrastructure for
post-surgery patient management will be required.
• Surgeons and physicians may not accept the
VentrAssist device. Such acceptance will depend
on clinical trial results and use by key opinion
leaders.
• Terumo’s DuraHeart is expected to be the first thirdgeneration
device to market, giving them first mover
advantage in the market.
• In 2003, Thoratec estimated that they had in excess
of 90 per cent share of the US VAD market and
more than 50 per cent share for the international
VAD market.
• Ventracor may have a difficult task of marketing to
the European countries as there are cultural and
language barriers in addition to trying to convert
cardiac surgeons from the already established
Berlin Heart. It should be noted however that Berlin
Heart’s device is not widely known outside
Germany.
• LVAS technology could potentially be over taken by
cell therapy or better drugs. Companies like
MediGene, CorTherapeutics and Collateral are
researching drugs that will target the causes of CHF
rather than just treat the symptoms. We expect
these treatments to be 10 years away from being on
the market.