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Orthocell 'in exciting regulatory phase' as it looks to drive its technologies into the US market

Orthocell Ltd's (ASX:OCC) Paul Anderson says the company's in an exciting regulatory phase having validated its technologies in the clinic and defining pathways to market through the US FDA process. ''We have some significant milestones ahead of us - we have an application within the FDA at the moment for our bone application for CelGro and we've followed that up with an application into the Australian marketplace''. ''We're very soon to begin a preclinical animal study which will help us get our nerve product into the US market as well and we're also following that up with an Australian application''. Last week Orthocell had the positive pre-clinical and clinical results for the use of CelGro® in enhancing repair of critical bone defects published in the highly regarded Tissue Engineering journal.

Quick facts: Orthocell Ltd

Price: 0.36 AUD

ASX:OCC
Market: ASX
Market Cap: $66.52 m
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Orthocell preparing for launch in the US for its CelGro® bone regeneration...

Orthocell Ltd's (ASX:OCC) Paul Anderson speaks to Proactive's Andrew Scott following the news they've completed a submission to the US Food and Drug Administration (FDA) seeking 510(k) clearance for marketing its CelGro® product for dental guided bone and soft tissue regeneration...

on 26/5/20

2 min read