Osteopore looks to expand its range of 3D-printed bioresorbable implants
Osteopore has received TGA approval for its craniofacial healing products Osteomesh, Osteoplug and Osteoplug-C.
Medical technology company Osteopore (ASX: OSX) has taken a step towards expanding its range of 3D-printed bioresorbable products by signing a research collaboration agreement with the National University of Singapore (NUS) Yong Loo Lin School of Medicine’s Department of Surgery and the National University Hospital (NUH).
The initiative is being funded by the National Additive Manufacturing Innovation Cluster (NAMIC), Singapore’s national additive manufacturing accelerator.
As part of the deal, Osteopore has agreed to contribute “significant support” in the form of guiding the study and data collection methods to ensure alignment to regulatory needs.
According to the deal terms, upon completion of the project, Osteopore will retain a first right to negotiate for a licence to commercialise any project intellectual property (IP) developed through the collaboration.
The two entities plan to collaborate on a preliminary in-vivo study to determine if the combination of Osteopore’s 3D printed bioresorbable products with bone marrow aspirates (BMA), or similar extracts, could be used to regrow bone following mandibular reconstruction surgery.
Aims of the study
Osteopore is aiming for its implants to exhibit distinct and unique advantages and can be custom manufactured to fit each patient.
The main objective is to evaluate the effectiveness of Osteopore’s technology for reconstruction of mandibular defects, to provide pre-clinical data for the evaluation of future studies, as well as to support first-in-man studies.
If the study is successful, researchers will assess options to take the project into targeted first-in-man studies, followed by clinical trials – an essential step required for final regulatory approval.
According to Osteopore, the project has been designed to investigate the potential for its 3D-printed implants to be used in mandibular reconstruction, the largest bone in the human facial skeleton, and to gather adequate data for future regulatory submission.
Mandibular reconstruction
The need for mandibular reconstruction stems from bone loss due to trauma or disease.
Currently, the primary solutions for such injuries are fibula grafts and iliac crests; however, both methods can lead to post-surgical complications and donor site morbidities. In Singapore, an estimated two to three mandibular reconstructions are conducted at the NUH each week.
Osteopore is developing a range of proprietary oral-maxillofacial (OMF) reconstruction options with its Osteoplug and Osteomesh products already approved by Singaporean regulators for clinical usage in dental reconstruction such as socket preservation and alveolar ridge reconstruction.
The medical technology company said it is progressing into further clinical trials to secure broader regulatory clearances as well as developing “second generation material”, incorporating additives into the polycaprolactone matrix, to further improve bone regeneration.
“This collaboration structure offers the company a cost-effective and highly leveraged opportunity to continue to develop the Osteopore technology into new therapeutic applications,” the company said.