Orthocell (ASX: OCC) has received regulatory approval from Singapore’s Health Sciences Authority to commence regional sales of its dental membrane product Striate+ for use in guided bone and tissue regeneration applications.
The company said its Striate+ global marketing and distribution partner BioHorizons was already established in the Singapore market and would facilitate a fast transition to first sales and revenue generation.
Orthocell considers Singapore a key regulatory hub and a stepping stone to approvals in other Asian markets.
Orthocell chief executive officer Paul Anderson said the company was pleased to have received approval to sell Striate+ in an important regional market.
“This approval provides additional validation of our high-quality products, manufacturing processes and quality systems,” he said.
“Moreover, it enhances our ability to drive revenue growth as our distribution partner expands into global markets.”
The approval complements existing clearances in the US, Europe, the UK, Australia, New Zealand and Canada.
Mr Anderson said that “overwhelmingly positive feedback” from dental surgeons was fuelling strong sales growth for for Striate+ in these markets and that the company was well-funded to progress a global regulatory strategy aimed at broadening its commercial footprint.
“The product’s unique features — such as its ease of use, ability to conform to treatment surfaces and promotion of more efficient bone growth — have driven high adoption and contributed significantly to its success to date,” he said.
Orthocell remains on track to receive approval for Striate+ in the Brazilian market within the next six months.
Striate+ is a sterile, resorbable collagen membrane for use in dental bone and tissue regeneration applications including dental implant procedures.
The product aims to protect bone defects from the ingrowth of gingival tissue, provide a favourable environment for osteogenesis and assure reliable formation of high-quality bone.
Orthocell estimates the combined global opportunity for Striate+ to be approximately $1 billion, with the company targeting a 20% market share.
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