Regenerative medicine company Orthocell Ltd (ASX:OCC, OTC:ORHHF) has had Striate+™, its market-leading dental regeneration membrane, re-certified in the EU, allowing for its continued sale for dental bone and tissue regeneration procedures in all 30 European Economic Area member countries and the UK.
Striate+ was originally approved in 2017 for dental bone and tissue regeneration procedures under the Medical Device Directives. However, to be legally sold in the EU from May 2021, all approved medical devices in Europe were required to be re-certified under the new and more stringent European Medical Device Regulations (MDR).
Orthocell managing director Paul Anderson said: “Re-certification to the MDR is a significant milestone for the company as it confirms Striate+, manufactured by the company in Western Australia, complies with the more stringent safety and efficacy standards now in place in the EU.
"Additionally, it enables BioHorizons, our marketing and distribution partner, to continue to execute their plans to enter the EU market without restriction. We look forward to working with BioHorizons to launch Striate+ in the EU and expand into multiple EU countries.”
The MDR places much stricter requirements on the quantity and quality of clinical data and more stringent post-market monitoring, setting significantly higher benchmarks for medical devices looking to gain marketing approval in the EU than under MDD.
The new MDR regulations expanded on the requirements of the MDD to enforce safety and performance improvements of medical devices.
This change was intended to ensure a higher level of protection for patients and medical devices users, with increased scrutiny on device safety throughout the full product lifecycle (design, testing, manufacturing, commercialisation, and long-term use).
BioHorizons: expanding into new markets
It has now been one year since Orthocell signed a global exclusive licence, manufacturing and distribution agreement for Striate+ with BioHorizons.
BioHorizons is a leading global provider of dental implants and tissue regeneration products for dentists and dental specialists. Its products, including dental implants, guided surgery, digital restorations and tissue regeneration solutions to replace missing teeth, are available in 90 markets around the world
BioHorizons launched Striate+ into the US market last November and sales unit volumes for the 2023 financial year beat expectations, while the outlook for FY24 looks even stronger.
Since signing the BioHorizons distribution agreement, Orthocell has supplied more Striate+ units than initially budgeted and is on track to launch Striate+ in the EU in the current quarter.
Orthocell also is leveraging existing regulatory approvals and working with BioHorizons to enter other international markets, including Canada, Brazil and Japan.
The partnership with BioHorizons, its established relationships with surgeons and successful track record in driving the market entry of high-quality products, now positions Orthocell to gain rapid product uptake and commercial traction in the US, Australia and Europe, and expand into other global healthcare markets.