Regenerative implant innovators Osteopore and plastic and reconstructive surgeon Dr Michael Wagels have teamed up to conduct two ground-breaking human clinical trials.
Two of Osteopore’s polycaprolactone/tricalcium phosphate (PCL-TCP) 3D-printed bone scaffold systems will be tested, along with the world-leading surgical techniques used to treat patients with cranial or lower limb bone defects.
Each trial will involve 10 patients and Dr Wagels and the team at the Australian Centre for Complex Integrated Surgical Solutions will follow them closely for up to five years.
The patients will be treated at the Princess Alexandra Hospital in Brisbane and supported by the Herston Biofabrication Institute – with future expansion to the Royal Brisbane and Women’s Hospital.
Clinically validating the bone scaffold systems
Osteopore (ASX:OSX) CTO Dr Lim Jing said the trials are an important milestone in the development of the company’s second-generation regenerative implants.
“This study aims to clinically validate our regenerative solution for cranioplasty and cements our standing in the field of in-situ tissue engineering,” he said.
“We look forward to keeping stakeholders abreast of our progress as we move through the recruitment period expected to be completed over the next 2-3 years, and as we follow our patients’ progress at regular intervals for up to 24 months.”
An exciting era in regenerative medicine
One study will evaluate Osteopore’s PCL-TCP scaffold system with corticoperiosteal tissue transfer for the reconstruction of acquired calvarial or upper cranial defects in adults.
The other study will evaluate the company’s PCL-TCP scaffold system with corticoperiosteal tissue transfer for the reconstruction of critical sized lower limb bone defects.
Dr Wagels, who has conducted three world-first operations using Osteopore’s patient specific implants, said the biomimetic scaffolds and technique used are the “beginnings of a new and exciting era in regenerative medicine”.
“We know from the operations we have performed that the technology can have a life-changing effect on patients’ lives,” he said.
“We now have an opportunity to treat more patients in the same way and to study their outcomes in great detail, which will build on existing knowledge.”
Patient data key to market adoption
Plus, the research is a key step in expanding the commercial use of the bone scaffold systems and will provide Osteopore with important patient data to further support market adoption and penetration.
“We are pleased to be working with Dr Wagels and his team to evaluate and further develop the applications of a new generation of implants,” Osteopore CEO Khoon Seng Goh said.
“This is an important step in commercialising our latest innovations, which will increase our competitive edge in the regenerative industry and better improve the quality of patients’ lives.”
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.
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