Bio Nova has recently experienced very rapid growth expanding into
several new markets. New implants have been made in Belgium,
Canada, Finland, Greece,
Netherlands, Norway, Slovakia,
and the United Kingdom.
Initial shipments have also been sent to Denmark,
India and Latvia where we are still waiting
for first implants. Agreements have also been put in place with distribution
partners in Egypt, Guatemala, Mexico
and Sweden, and far-reaching
discussions are being held with possible partners in Ireland,
Portugal, Slovenia, South
Africa and Thailand.
Two clinical phase IV studies covering Omniflow’s performance in
comparison to other prosthesis materials have recently been initiated by
independent investigator groups in Switzerland
and the United Kingdom.
One prospective randomised monocentre study comparing Omniflow with PTFE
prostheses for arteriovenous access is already underway at the Royal London
Hospital in the United Kingdom, lead by Mr Zafar
Chawdhery.
Another prospective randomised multicentre study comparing Omniflow with
PTFE for below- knee bypass is being initiated at the Inselspital in Bern, Switzerland
lead by Drs Jürg Schmidli and Hannu
Savolainen. The protocol is currently being reviewed by the
ethics committee and recruitment is expected to start late 2007 or early 2008.