Orthocell clinches major regulatory win with approval for Striate+ in the regionally important Singapore market

Orthocell Ltd has the green light to kick off sales of its flagship dental guided bone regeneration product Striate™ in the gateway market of Singapore following regulatory approval from Singapore’s Health Sciences Authority (HSA).

Orthocell CEO and MD Paul Anderson said: “We are delighted to receive Singaporean regulatory approval for Striate+ in this important regional gateway market.

“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.”

Regulatory hub in Asia

The company can add this latest regulatory approval to existing approvals for Striate+ in the US, Europe/UK, Australia, New Zealand and Canada.

Singapore has particular relevance as a key regulatory hub that is recognised as a leading destination for advanced medical treatments in the Asia-Pacific region and a gateway to other major ASEAN markets.

The small Asian city-state is known for its high standards, efficiency and state of the art medical facilities, and is regarded as an important destination for medical treatments and tourism in the region.

Orthocell expects to transition to first sales and revenue generation in the market with ease – its global marketing and distribution partner for Striate+, BioHorizons, is already firmly established in the Singaporean market.

Striate+ is going from strength to strength, with healthy sales growth in the markets it has entered – collectively, a major global market opportunity valued at over A$1 billion, of which Orthocell seeks a 20% share.

Backed by the clinical community

The company says its momentum has been driven by positive feedback from dental surgeons, backed by an impressive 98.6% success rate from the Striate+ dental implant post-market clinical study.

And Orthocell has new markets on its horizons, including Brazil, where approval is expected in the next three to six months, thanks to its partnership with BioHorizons, which is helping to fast-track expansion.

The company currently boasts a strong balance sheet with around $33 million cash in the bank and is well-funded to continue to broaden its commercial footprint and grow revenues in existing and new markets.

About Striate+

Striate+ is a sterile, resorbable collagen membrane for use in dental bone and tissue regeneration applications including dental implant procedures. The product is designed to protect the bone defect from ingrowth of gingival tissue, to provide a favourable environment for osteogenesis and to assure reliable formation of high-quality bone.

The product's 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.