Quarterly revenues $313K well up (+52%) on 1Q21 ($206K) but still too low to be making a decent dent in cash outflows and too low given their staff/general biz' expenditures on the area - some sales/marketing staff need kicking up the proverbial.
Remplir 24 month trial data this quarter will be a biggy, but most informed investors will have been expecting this. Simlarly Phase 2a data on J&J ATI data. Also the Tennis elbow ATI vs surgery completion in 2Q 22, as I have been saying. No surprises there.
Seems they progressed the FDA approval process for Remplir to an actual route, but are still not going to tell us which:
"During the quarter, the team progressed a US FDA submission to confirm the most appropriate US regulatory pathway, potential for inclusion in expedited programs and what this will mean for reimbursement value for the product".
Disappointing and too slow on progression given they forewent the 510K route for which they'd be done and dusted by now, but hardly a surprise.
Striate, "advanced" partnership discussions - these have been going on for a long time of course. Too slow again.
ATI with FDA does however look very promising for me (my personal interest of course being a grateful ATI recipient) with more data coming this quarter:
"In light of the initial study results, the Company is accelerating its US commercialisation plans with technology scale up, FDA engagement and commercial preparation activities being advanced to support a Phase 2b randomised controlled study for FDA submission."
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