FDA significance, page-388

CelGro Study Results Open Up New US Market Access Strategy

- US 510(k) pilot animal study results indicate CelGro® facilitates superior nerve regeneration when compared to the market leading nerve repair device, restoring the sciatic nerve to its pre-injured state with no adverse reactions;
- Pilot study provides critical insights into CelGro®’s mode of action in nerve regeneration and underpins the consistent restoration of arm and hand function to paralysed upper limbs observed in patients treated in the CelGro® nerve clinical trial;
- Breakthrough results position CelGro® as the potential market leader in nerve regeneration and restoration of voluntary muscle control in patients with tetraplegia or paralysed upper limbs;
- In light of these results, strategic evaluation of medical device US regulatory pathways underway to identify opportunity for expedited approval of CelGro® and route to the highest reimbursement value;
- Further CelGro® nerve clinical trial data from all patients at 12 months post treatment on track for release in Q2 2021.
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