Database lock was dated 15th Nov....analysis done.
2 big points:injuries
- There are currently no proven long-term, non-surgical solutions to repair chronic shoulder tendon
• Ortho-ATI® is well positioned to become the first FDA approved injectable cell therapy in orthopaedics
for the treatment of chronic tendon injuries
Remembering its only the result from Rotator cuff trial, still recruiting for Tennis elbow 92% completed last 4c, pending full recruitment CY2021.
"The Company remains on track to complete data analysis for the RC Study with data expected to be
available in Q4, 2021. The Company will provide further updates in relation to the market opportunity
for Ortho-ATI®, the regulatory strategy to be pursued to enable rapid approval by FDA and also the
study design to facilitate the first global approval of a cell therapy for tendon injuries. Plans for the
development of a US commercial and development team are well advanced and are pending
successful outcomes from this important study".....going it alone in US??
Huge prospects for Nerve repair unmet need.....
The Company continues to work closely with the Experien Group, headquartered in Silicon Valley as
the Company’s US regulatory advisers to evaluate opportunities for expedited approval of Remplir
for nerve regeneration. The team is now finalising the US FDA submission to confirm the most
appropriate US regulatory pathway, potential for inclusion in expedited programs and what this will
mean for reimbursement value for the product.
End the year with a BANG...yep sure. gltah cept Lopez
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Database lock was dated 15th Nov....analysis done.2 big points:...
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