Orthocell Ltd (ASX:OCC) has achieved a significant US key opinion leader (KOL) sales growth milestone of 1,500 Striate+™, its premium dental membrane.
It has also received approvals to upgrade its existing facility and scale-up Striate+™ manufacturing capacity to more than 100,000 units per year.
The commissioning of the upgraded facility is expected in the fourth quarter of 2022.
In addition, distributor discussions are progressing, with the company in advanced talks to engage its first US distributor and establish Striate+™ as the premium dental membrane.
Exciting year ahead
Orthocell 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.”
Clinician advocacy program
Following on from the FDA 510(k) clearance to supply Striate+™ for dental bone and tissue regeneration procedures in the US, the company has been executing a strategy to engage a US distribution partner.
The strategy involves establishing a high-quality logistics solution, developing a KOL network and implementing a KOL-led education and product awareness program (clinician advocacy program).
Orthocell’s clinician advocacy program has progressed significantly, with 18 highly respected KOLs across the EU, UK, US and Australia, who are actively representing the company as product ambassadors and using Striate+™ in their dental surgeries.
Product sales of Striate+™ from the US KOLs alone have reached more than 1,500 units.
These industry-leading clinicians continue to assist the company in growing product awareness, expanding the network of key accounts and supporting ongoing discussions with potential distribution partners.
Upgraded facilities fully funded
Orthocell has been actively preparing to scale up its manufacturing capacity of Striate+™ and has received approval to commence construction of a new cleanroom.
The cleanroom, equipment and operator costs are fully funded and construction is scheduled to commence in the first quarter of 2022.
Commissioning of the manufacturing facility is expected in the fourth quarter.