Orthocell (ASX $OCC) has today published its Quarterly Report for the period ended 31 December 2021.
Primary achievements include:
- Phase 2a clinical study results show that OrthoATI™ is significantly more effective than steroid injection for treatment of rotator cuff tendon tears.
- OrthoATI™US commercialisation plans accelerated with FDA engagement and commercial preparation to support a randomised controlled study.
- Significant progress towards engaging a US market distribution partner for Striate+ dental membrane, together with promising use and feedback from key opinion leaders.
- Discussions and tangible progress with the Australian TGA regarding our application for approval to supply Remplir™ in the Australian market for peripheral nerve repair.
- Focused discussions with US FDA regarding the US regulatory pathway for Remplir™, with data to support expedited review and reimbursement positioning.
We have a strong balance sheet, with a closing cash balance of A$13.6m at the end of the Quarter – sufficient funds to support key regulatory approvals and our commercialisation goals.