Singapore’s Health Science Authority has granted regulatory approval for John Van Der Wielen-chaired Orthocell for use of its dental membrane project, Striate+.
Singapore’s Health Science Authority has granted regulatory approval for John Van Der Wielen-chaired Orthocell for use of its dental membrane project, Striate+.
This approval follows on from the product’s pre-existing clearances in Australia, Canada, Europe, New Zealand, the US and UK.
A resorbable, sterile, collagen-based membrane, Striate+ offers protection from bone defects from the potential in-growth of gingival tissue.
The company is also hopeful of attaining regulatory endorsement in Brazil by September at the latest.
“We are delighted to receive Singaporean regulatory approval for Striate+ in this important regional gateway market,” Orthocell managing director and chief executive Paul Anderson said.
“This approval provides additional validation of Orthocell’s high-quality products, manufacturing processes, and quality systems.
“Moreover, it enhances our ability to drive revenue growth as our distribution partner expands into global markets.”
Tuesday’s market update follows on from news last month that the Murdoch-based medtech firm had lodged an application to sell its nerve repair product, Remplir, in Canada – following the launch of sales in Australia, New Zealand and Singapore.
Remplir is a collagen-based wrap, which can be used by surgeons who are completing nerve repair surgery.
Last month, Orthocell said it was hopeful of being able to enter Remplir into the US market after submitting an application to the Food and Drug Administration, with approval expected to be granted in due course.
Orthocell closed trade up 5 per cent to $1.44.
