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LONDON (Alliance News) - Tissue Regenix Group PLC on Monday said it is set to get approval for its OrthoPure product in Europe earlier than anticipated and is planning to submit a US clinical trial for the product.
Tissue Regenix, which makes regenerative medical devices, said it is currently undertaking clinical trials in the European Union for both its OrthoPure XT and XM products and now expects to get a CE market for OrthoPure by the end of 2016, six months ahead of schedule.
In addition, the company has applied for a US pilot clinical trial, with submission expected in the fourth quarter of 2016.
Tissue Regenix added it has established 510(k) market clearance may be possible for OrthoPure XM, which would be less expensive and time-consuming than the company had previously anticipated getting US approval would be.
"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 Tissue Regenix Chief Executive Antony Odell.
Tissue shares were up 8.6% to 19.00 pence Monday.
By Sam Unsted; samunsted@alliancenews.com; @SamUAtAlliance
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