Good day!
How is it? Could it be possible that the Remeos trauma screw receives FDA market clearance for portfolio expansion still during 2026? The CE mark includes four product lines and over 200 products. Sales have been ongoing in Europe for over a year now, and clinical evidence is being gathered from there for the FDA expansion. If we consider that clinical results from 20 patients per product line are sufficient for this, it shouldn’t be a very long task. Will it make it in 2026 or will it spill into H1 2027?
The same consideration applies to the Drillpin. Separate studies are currently underway at two centers in Austria. Both are collecting that 20 (20–22?) patients. Bioretec’s message in connection with both Q1 and Q2 was similar…“first/first few patients recruited and in follow-up”. Thus, only those 20 patients are needed here, so it shouldn’t be an impossibly long task.
Trauma screw FDA expansion in 2026 and Drillpin in H1 2027?