New 3D Printed Bone Implant Technology Seeks Regulatory Approval

QUT and medical devices manufacturer Osteopore have signed an Exclusive Option to Licence for a 3D printed modular bone implant technology. The partnership is part of a collaborative project to enable clinical trials to gain regulatory approval for the technology.

QUT Professor Dietmar W Hutmacher, director of the ARC Industrial Transformation Training Centre in Additive Biomanufacturing, said the technology was the next generation of personalised 3D printed scaffolds to guide the regrowth of long bone defects in people who had lost more than six centimetres of bone to injury or disease.

Image via QUT

“This technology is designed for the reconstruction of long bones in upper and lower limbs by orthopaedic and plastic surgeons with patient-specific scaffolds printed from an innovative biodegradable composite material,” Professor Hutmacher said.

“The first generation of this technology has already shown real-world results after being implanted in patients in four clinical case studies and, together QUT and Osteopore are producing a package of data to support the application to the TGA, FDA and European regulators for the next-gen technology.”

Professor Hutmacher said 2.2 million grafting procedures were estimated to be carried out worldwide each year.

“Approximately 10 per cent of the grafting is for long bones, which means 220,000 procedures.

“With the ability to regrow the patient’s own bone, the modular implant technology has a significant advantage over traditional bone grafting procedures, where bone needs to be harvested from other locations of the patient’s body which causes pain among other problems.”

Osteopore chief technology officer Lim Jing said the technology complemented Osteopore’s current bone regenerating products and had shown encouraging early-stage results for regrowth of long bone defects.

“This modular implant technology is unique as it allows stacking and locking between implants while empowering the surgeon to reconstruct bone defects based on needs at the point of surgery,” Dr Lim said.

“This latest technology has the potential to disrupt the supply chain model of customized implants, because customization may be achieved at the point of use.”

Osteopore International Pte Ltd is a Singaporean medical device manufacturer of 3D printed biomimetic scaffolds for empowering natural tissue regeneration. They have obtained US FDA, TGA and CE marking on their first-generation products and have marketed their products for more than 10 years. More than 25,000 patients globally have benefitted from their products.

Source: QUT