Tissue regeneration technology developer Orthocell has received Food and Drug Administration approval to market its first product in the US, its CelGro Dental collagen device which aids dental bone and tissue regeneration.
The Perth company announced the approval and a new brand name for the products, Striate+.
Managing director Paul Anderson said CelGro would now compete in a US$500 million a year market for dental bone repair, guided tissue regeneration and repair of periodontal defects.
CelGro is surgically implanted and remains in situ long enough to for bone regeneration to occur before being completely resorbed into the body.
The company is now negotiating with potential distributors and will retain manufacturing at its Perth factory, utilising manufacturing techniques developed in conjunction with Professor Minghao Zheng and the University of Western Australia.
The company said: “Orthocell is well positioned to secure a distribution partner and establish Striate+ as the best in class dental resorbable collagen membrane.”
Picture: CelGro Dental
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