Health Canada has granted a Medical Device Licence (MDL) for the Striate+™ product of Orthocell Ltd (ASX:OCC, OTC:ORHHF) for use in guided bone regeneration in dental implant procedures.
This approval paves the way for Orthocell to sell the product in another key region, complementing existing approvals in the US, Europe/UK, Australia and New Zealand.
"Further validation"
“Canadian approval for Striate+™ is further validation of Orthocell’s expanding global footprint," Orthocell managing director Paul Anderson said.
"Approval in this market complements our FDA approval and strengthens the company's position to increase revenue, in collaboration with our valued partner BioHorizons.
“Additionally, it reaffirms the high quality of our product and world-class, scalable manufacturing process.”
The Canadian market for Striate+™ is estimated to be worth A$60 million, while the global market opportunity exceeds A$1 billion.
Striate+™ continues growth
Striate+™, a collagen membrane designed to support guided bone regeneration in dental implant procedures, has shown strong sales traction in its existing markets, supported by a 98.6% success rate from a dental implant post-market clinical study.
This product, which has received approval for use in the United States, Australia, New Zealand, Europe and the United Kingdom, is distributed globally by BioHorizons Implant Systems Inc, a major player in the global dental implant market.
The high-quality performance of Striate+™ since its launch has supported BioHorizons in pursuing entry into other significant markets where they already have established accounts and distribution networks.
Orthocell is collaborating with BioHorizons to expedite the development of the regulatory strategy for Striate+™, aiming to expand its accessibility to additional regions as soon as possible.
Record annual total revenue
This strategic partnership with BioHorizons has led to significant revenue growth for Orthocell. The company has seen an average quarterly revenue growth of 9%, compounded over the last seven quarters.
Recently, Orthocell announced a record annual total revenue of A$6.72 million for FY24. This revenue growth demonstrates the strong market uptake of Orthocell’s products.
Orthocell is well-funded for global market expansion, supported by a strong balance sheet and A$20.6 million in cash to drive its growth strategy.