Emerging biotech company Orthocell (ASX: OCC) has received positive news regarding its CelGro medical device that improves dental bone regeneration.
The clinical study was performed in collaboration with leading West Australian maxillofacial surgeon Dr Brent Allan, Professor Ming Hao Zheng from the University of Western Australia and St John of God Subiaco Hospital.
According to Dr Allan, CelGro is a new scaffold which has been shown to effectively induce bone formation in alveolar bone defects, enabling “outstanding guided bone regeneration”, restoring both the quality and quantity of bone. Dr Allan also said that CelGro is able to restore normal anatomy with “predictability”.
Importantly for Orthocell, and the future marketability of CelGro, was that the clinical study showed superior performance to the current market leading product, BioGide.
According to industry research, BioGide collagen membranes generate approximately €50 million per year in dental bone graft sales, in Europe alone.
Top line data indicated the quality of newly formed bone following use of CelGro, was around 26% higher than comparable tests for BioGide.
The study also showed no adverse events related to CelGro with “no evidence of systemic adverse reaction or side-effects” observed in any participant or implant site.
“CelGro is ideally positioned to gain market traction in this rapidly growing and significant market of oral medicine, which has seen very little innovation over the last 10 years,” said Paul Anderson, managing director of Orthocell.
The growth in demand for dental procedures that require collagen medical devices (and eventually lead to further procedures such as crowns) is being fuelled by an aging population in developed countries with higher disposable incomes (regions such as the EU), combined with growing demand for bio-absorbable membranes by surgeons given their advantages over synthetic alternatives.
Orthocell recently signed a deal with Bimar, an Italian-based distributor for its CelGro product for the next five years; a move expected to drive product adoption across the EU.
According to the company, Orthocell is executing a commercialisation strategy that will drive initial sales of CelGro, with the recent appointments to the Medical and Scientific Advisory Board as well as engaging its first EU distributor, expected to boost sales significantly.
Orthocell said it was “currently finalising further commercial partner agreements for product distribution in other key regions”.
So far, Orthocell has obtained a CE Mark authorisation to market CelGro which allows CelGro to be sold within EU countries and affiliated jurisdictions.
Obtaining the CE Mark is likely to mean further regulatory approvals are more straightforward to obtain given the strong foundation established by the approval and its latest clinical study.
The broader market Orthocell is vying for is estimated to be in the region of US$600 million per year, with around 1.5 million procedures utilising scaffolds such as CelGro being done annually around the world.