Orthocell receives regulatory approval to sell dental guided bone regeneration product Striate+ in Canada
Approval complements existing approvals for Striate+ in other key markets including the US
Orthocell’s distribution partner Bio Horizons Implant Systems well established in Canadian dental market
Special Report: Regenerative medicine company Orthocell is expanding its global footprint and will start selling its market leading dental guided bone regeneration product, Striate+ in its key market of Canada after receiving regulatory approval in the country.
Orthocell (ASX:OCC) has announced it has received a medical device licence from Health Canada, allowing the company to commence sales of Striate+ in the Canadian market, which it estimates to be worth $60m.
OCC says Canadian regulatory approval complements existing approvals in the US, Europe/UK, Australia and New Zealand for its trademarked Striate+ product, where the company has fast growing sales.++
OCC’s distribution partner for Striate+, Bio Horizons Implant Systems, which is one of the largest global dental implant companies, is well established in the Canadian market, which will facilitate a fast transition to first sales and revenue generation from the region.
Orthocell’s Striate+ device was invented, manufactured, and clinically validated in Australia – and is now being exported globally, at scale. A big win for the nation’s bio-manufacturing sector.
98.6% success rate supports sales
Striate+ is a collagen membrane used to support guided bone regeneration in dental implant procedures.
OCC says Striate+ is gaining strong traction in its existing markets, supported by a 98.6% success rate from the Striate+ dental implant post-market clinical study.
Given sales in existing markets, OCC says it is working with BioHorizons to accelerate approvals in several other key global markets where it has large key accounts and/or distribution networks.
The company estimates the global market opportunity for its Striate+ products to be in excess of $1 billion.
Bio Horizons partnership pays off
In June 2022, Orthocell secured a global exclusive license and manufacturing agreement for its dental bone and tissue regeneration product, Striate+, worth AUD $23.1 million (USD $16 million).
BioHorizons is part of Fortune 500 company Henry Schein and the acquisition of Orthocell’s Striate+ represented one of its first deals to secure a biological medical device.
OCC’s strategic partnership with Bio Horizons, which is now in its second year, has resulted in quarterly revenue growth of an average 9%, compounded for the last seven quarters.
The company recently announced record revenue for FY24 of $6.72m and says the revenue growth is evidence its products are achieving strong uptake in their respective markets.
OCC says it is well funded for global market expansion, with a strong balance sheet and $20.6m in cash to support its growth strategy.
Expanding global footprint
OCC managing director Paul Anderson says Canadian approval for Striate+ is further validation of its expanding global footprint.
“Approval in this market complements our FDA approval and strengthens the company’s position to increase revenue, in collaboration with our valued partner BioHorizons,” he says.
“Additionally, it reaffirms the high quality of our product and world-class, scalable manufacturing process.”
This article was developed in collaboration with Orthocell, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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