Regenerative medicine company Orthocell (ASX:OCC) has provided a US market entry update for the Striate+ premium dental membrane.
The company said following FDA 510(k) clearance to supply Striate+ for dental bone and tissue regeneration procedures in the US, it has been executing a strategy to engage a US distribution partner.
It said the strategy involves establishing a high-quality logistics solution, developing a key opinion leader (KOL) network and implementing a clinician advocacy program.
Orthocell said its clinician advocacy program has progressed significantly, with eighteen highly respected KOLs across Europe, the UK, US and Australia, who are actively representing as product ambassadors and using Striate+ in their dental surgeries.
It said product sales of Striate+ from the US KOLs alone have reached over 1,500 units and that it has approval to commence construction of a new cleanroom that will increase the manufacturing capacity to over 100,000 Striate+ units per year.
Managing director Paul Anderson said, “Orthocell has made significant progress towards US market entry, forming a strong clinical network validating Striate+ as a premium dental membrane. We are now well-positioned to secure a US distributor and I look forward to what is shaping up to be a very exciting year ahead for the company.”