Clinical data for OrthoPure XT, a porcine tendon, was so compelling the company expects to receive its CE Mark for the product by the end of the year – a full six months ahead of schedule.
The accelerated European approval was revealed in tandem with an update from the US, which also provided a significant boost.
“Positive discussions” with America’s Food & Drug Administration have encouraged Tissue Regenix to apply for a pilot clinical trial with results expected to be submitted by the fourth quarter.
This would provide the company with a “key milestone” towards formal product approval Stateside.
It may be able to make an abridged 510 (k) FDA submission for sister product, OrthoPure XM, a porcine meniscus, which would “considerably less expensive and time consuming option than previously thought”.
"The possibility of earlier EU approval for OrthoPure XT, and the potential for a US pilot study, would allow us to access these key markets via a more rapid regulatory route, where sales momentum can be quickly established, particularly with our 'off the shelf' alternative to the existing approaches,” said chief executive Antony Odell.