Allegra Orthopaedics Limited (ASX: AMT) has reached a major milestone in the development of its unique biodegradable cervical fusion device. with the commencement of the preclinical large animal study.
Jenny Swain, Allegra’s Chief Executive Officer, said the FDA approved study is taking place in Lyon France and being undertaken by a Board certified Australian orthopaedic spinal surgeon.
The study will follow the Good laboratory practice (GLP) principles intended to assure the quality and integrity of non-clinical laboratory studies.
The purpose of this nonclinical GLP study is to evaluate the safety, efficacy and performance of the device in the sheep model, closely translatable to the human spine. The study will also demonstrate the load bearing capability of the Sr-HT-Gahnite spinal fusion cage.
The animals will be evaluated at three, six and 12 month time points, representing early, mid and long-term implantation.
Ms Swain said the fusion is expected to occur by six months and full degradation is not expected prior to years four to five. All animal breeding and experiments will conform to Australian code, European Directive 2010/63/EU and the French regulation on the protection of animals used for scientific purposes.
The success of this study at the six month time point will lead to a small confirmatory human clinical trial in Australia, the final step before commercialisation.
“We are extremely excited to start the large animal study in line with FDA requirements,” Ms Swain said.
Allegra have successfully reached a significant stage in the commercialization of our bio-ceramic material. The project is gaining momentum, leading us into the next chapter of human clinical trials being undertaken in Australia.”
Allegra is commercialising a synthetic bone graft medical device, the Sr-HT-Gahnite bone substitute. We have exclusively licensed the Sr-HT-Gahnite Intellectual Property from The University of Sydney.
The medical device is a 3D printed bioceramic scaffold with outstanding potential for supporting bone regeneration in load bearing applications.
Current synthetic bone substitutes, of over 150 products, either regenerate bone or weight-bear. Sr-HT-Gahnite is capable of doing both!