Tissue Regenix said today it expects to pick up CE Mark approval in the European Union for its OrthoPure XT and XM procine tendon and meniscus products approximately 6 months ahead of schedule.
Clinical trials are currently underway for both products, the company said, and positive clinical data from the trials has resulted in an accelerated date to CE Mark approval set for the end of 2016, 6 months ahead of previous estimates.
“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. Positive data from the OrthoPure XM EU clinical trial, and the confirmation of a 510(k) route to the US market, means that we can undertake the additional study to implement improvements and pursue one common version of the product, expected for launch within the EU during 2018, and allow us to initiate the work required for US regulatory approval,” CEO Antony Odell said in a press release.
Tissue Regenix said the results have ‘encouraged’ it into applying for a U.S. pilot clinical trial with the FDA, expecting to submit it in the 4th quarter this year. The company added that it may be able to pursue 510(k) clearance for its OrthoPure XM.
Last August, Tissue Regenix put Kevin Barton on-point to direct U.S. sales and marketing for its dCell tissue regeneration device. The company’s new marketing VP hails from a wound care company Kinetic Concepts , where he was a senior product manager. Barton also formerly worked at Novartis, Sulzer Carbomedics and Dell Computer Corp.