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Added 5 months ago

Orthocell receives A$2.9m R&D tax incentive refund

  • Orthocell receives R&D Tax Incentive refund of A$2.9m
  • Funds will be invested into the acceleration of regulatory approvals and commercialisation of CelGro® and to advance the development and commercialisation of Ortho-ATI®
  • Orthocell is well positioned to deliver leading regenerative medicine products to the world’s largest health care markets including US,EU and AUS.
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#ASX Announcements
Added 6 months ago

US Nerve Repair Study Design Meets FDA Requirements

  • FDA confirms CelGro ® Nerve regeneration study design meets US 510(k) submission requirements
  • US 510(k) study expected to commence Q1 CY2020
  • Follows recent study results showing CelGro ® facilitates high quality nerve repair and restores function to previously paralysed muscles
  • Orthocell is well positioned to accelerate US, EU and AUS regulatory approvals and commercialisation of CelGro®
  • CelGro®’s addressable market in peripheral nerve repair is estimated to be worth more than US$1.1 billion per annum

Perth, Australia; 16 December 2019: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell”, or the “Company”) is pleased to announce that it has received confirmation from the FDA that the proposed CelGro® nerve regeneration animal study protocol meets requirements to support the near term 510(k) submission. The Company has now accelerated ethics applications to commence the study in Q1 CY2020


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#ASX Announcements
Added 4 months ago

Quarterly Report – December 2019

Key highlights for the quarter:

  • CelGro® interim clinical study results show 96% of nerve repairs restored voluntary movement to previously paralysed muscles - All quadriplegic patients increased movement and power of affected muscles following CelGro® nerve regeneration treatment
  • FDA confirms CelGro® Nerve regeneration study design meets US510(k) submission requirements - US 510(k) study expected to commence Q1 CY2020
  • Company advances CelGro® regulatory program - Australian submission under review by the TGA and market entry study for the FDA (US) submission progressed
  • United States patent has been accepted for a potential breakthrough CelGro® collagen rope device to enhance the surgical repair of Anterior Cruciate Ligament injuries
  • Orthocell successfully completes placement and share purchase plan raising $14.4m with demand for the placement well in excess of funds sought, and supported by existing shareholders, new institutions and other sophisticated investors.
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#ASX Announcements
Last edited 5 months ago

CelGro® accelerates dental implant treatments

•Patients regain normal oral function and enjoy a normal diet following CelGro® bone regeneration treatment.

•Patients experience a 40% reduction in dental implant treatment timeframe.

•Results further validate CelGro® as the superior medical device for bone and soft tissue repair.

•CelGro® continues to gain traction in Europe, with strategic partnering activities ongoing.

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