Osteopore gets CE mark extension, significantly increases market access in Europe
Health & Biotech
Health & Biotech
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Today’s CE mark extension means that Osteopore will be able to almost double its serviceable available market.
Bone healing company Osteopore (ASX:OSX) has made further progress in its European expansion plans, announcing that it has received CE marking for an expanded set of products and product shelf life.
In a significant new development, the company advised that it has received notification of European Medical Devices Directive (MDD) certification for a significantly broader range of products.
This means the CE mark certification has been extended to now include all Osteomesh, Osteoplug and Osteoplug-C sizes, as well as seven new shape variants.
Osteomesh is the company’s renowned bioresorbable implant used in craniofacial surgery to repair various types of fractures, while the Osteoplug is used for covering post-trephination burr holes in neurosurgery.
The CE mark extension means that the shape variants in Osteopore products have now increased from three to ten.
These additional designs will allow the company access to an estimated 100,000 on-indication craniotomy procedures per annum.
This will include surgery that bridges fresh craniotomy cuts created with associated surgical instruments, as well as to accommodate standard therapeutic devices.
The expansion in MDD certification means that Osteopore’s serviceable available market will increase.
By all estimates, its products in Europe will grow from around 110,000 on-indication procedures to an estimated total of 210,000 cranial surgeries annually.
Based on the market research by CETAS Healthcare on annual cranial procedures, Osteopore has estimated that the market value of the incremental access afforded by the CE extension will exceed $115 million.
According to the research, Germany and the UK account for over 40 per cent of the European market, which is expected to grow to 255,000 procedures per annum by 2025.
Today’s extension also means that the shelf-life of Osteopore products has been extended from two years to three years.
This bodes well for its distributors, as the longer shelf-life means that distributors can now carry more stock to support both high and low volume hospitals.
Osteopore CEO Goh Khoon Seng remarked that the MDD approval is a significant advance not only for the company, but for the field of regenerative medicine, generally
“Our products work with the body’s natural regenerative capabilities rather than having to rely on artificial replacement parts.”
“This expanded approval means more patients have access to the benefits of Osteopore’s technology when undergoing cranial surgery,” Goh added.
Osteopore has recently made steady progress in its efforts to get its products into the European markets.
This development builds on the distribution agreements with MTG Medizintechnik Göhl and Nords Medical AB announced in the second half of 2020, and last month’s announcement that the company was granted a European patent for its “smart” 3D biomimetic scaffolds, which aims to improve the performance of regenerative implants.
The patent obtained is expected to increase its product sales in the global cranial and maxillofacial procedures market.
That market is estimated at around 1.1 million surgeries and is growing annually at more than two per cent, with Europe accounting for roughly a third of that.
Osteopore’s technology combines biomimetic tissue science with proprietary 3D printing and materials technology to produce medical implants that meet the needs of both tissue and bone reconstruction as well as restoration.
This article was developed in collaboration with Osteopore, 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.