Yes, you can see that, outside of Remplir launch in the U.S., I am most excited about the prospect of near term TGA approval for SmrtGraft to unlock a market segment for rotator cuff tendon surgery worth over US$1.2 billion (over 800,000 surgical tendon repairs performed annually in AUS, USA & EU)
We should be closer to the tail end of that maximum 255 working day TGA review process. In terms of the likely outcome, what gives me real confidence is our compelling clinical data used as a basis of that application which shows 100% success rate for the tendon repair and 0% need or no need for subsequent revision surgeries (with significant improvement in pain, function and QOL) and SmrtGraft is presently used under the TGA’s Special Access Scheme.
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- Ann: Regulatory approval to commence Striate sales in Singapore
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Ann: Regulatory approval to commence Striate sales in Singapore, page-16
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