Australian-Singaporean medical technology company Osteopore (ASX: OSX) has received European CE Mark certification for seven new designs in its range of 3D-printed biomimetic, bioresorbable craniofacial scaffold products for regenerative bone healing.
The company now has a total of 10 shape and size variants relating to Osteomesh, Osteoplug and Osteoplug-C surgical products and has extended their shelf life by 12 months to three years, allowing distributors to carry more stock to support high and low-volume hospitals.
The new designs allow Osteopore to cater to an estimated 100,000 craniotomy cases per year to bridge fresh cuts created with associated surgical instruments, as well as to accommodate standard therapeutic devices.
CE marking is a medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives.
The directives outline the safety and performance requirements for medical devices marketed in the European Union.
Osteopore’s extended certification allows its market reach in Europe to grow from around 110,000 on-indication procedures to an estimated 210,000 cranial surgeries annually.
The estimated serviceable available market value of the extended certification exceeds $115 million, with Germany and the UK accounting for over 40%.
Osteopore chief executive officer Goh Khoon Seng said approval of the expanded product range was a positive development for the field of regenerative medicine.
“Our products work with the body’s natural regenerative capabilities rather than having to rely on artificial replacement parts,” he said.
“This expanded approval means more patients will have access to the benefits of Osteopore technology when undergoing cranial surgery.”
Natural bone healing
Osteopore’s regenerative products facilitate and support the body’s natural bone healing process.
“When compared to traditional bone graft and permanent implant procedures, we believe our products are superior and offer improved patient outcomes,” Mr Goh said.
“Our implants naturally dissolve over time to leave only healthy bone tissue and have been used in around 50,000 procedures with extremely low post-surgery complication rates.”
Osteopore’s products are fabricated in-house using proprietary 3D-printing technology which allows for customisation of shape and geometry necessary for accurate therapeutic effect.
In April 2020, Osteopore received Australian Therapeutics Goods Administration approval for Osteomesh, Osteoplug, and Osteoplug-C relating to their application as bone void fillers for regeneration of natural bone.
The approval allows the company to make its products more broadly commercially-available to doctors and hospitals across the country.