Early clinical data put forward to support the CE mark application for OrthoPure XT has shown the “clinical relevance” of the product, with patients displaying “a statistically significant improvement” in recovery compared to the current gold standard.
“We are extremely encouraged by the initial results returned from the study,” said TRX Orthopaedics’ commercial director Peter Hamer.
“Having entered our first distributor agreements, which highlight the demand and market opportunity for OrthoPure XT, we remain on track for launch of OrthoPure XT by the end of the first half of 2017.”
The CE mark approval also remains on schedule for the first half of 2017, the regenerative medical devices company added.
Shares were up 2% to 16.5p in early deals on Monday.