Quarterly Report – Period To December 2021

31 January 2022
Posted in Company News
31 January 2022 Orthocell

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.

Click here to read today’s ASX release.