Orthocell Ltd (ASX:OCC) has completed a submission to the US Food and Drug Administration (FDA) seeking 510(k) clearance for marketing its CelGro® product for dental guided bone and soft tissue regeneration applications.
The submission follows positive results from Orthocell's US FDA guided bone regeneration study, a key component of the FDA submission to gain US market approval.
Managing director Paul Anderson, said: “This is a significant milestone for Orthocell as we drive our innovative regenerative medicine products into the US, the largest global healthcare market.
“We are in a strong position to gain US approval and are actively progressing our US market launch strategy.”
The US 510(k) submission complements the company’s regulatory submission in Australia for dental bone and soft tissue regeneration applications and will be followed by submissions to the US, EU and Australia for CelGro® for repair of crushed or severed nerves and augmentation of tendon repair.
Positive study results
Positive results were received from the company’s US FDA guided bone regeneration study showing CelGro® is effective in facilitating bone regeneration when used in conjunction with bone substitute and a dental implant.
The study provided critical regulatory data and is a key component of the US regulatory submission.
CelGro® accelerates dental implant procedures
Market demand
Dental implants are an effective and rapidly growing area of orthodontic treatment.
CelGro®’s dental bone regeneration addressable market is estimated to be worth more than US$1 billion per annum, with approximately 4.3 million procedures that require dental membranes completed each year.
Market demand is expected to be underpinned by an ageing population, significant growing demand for dental therapies and surgeons’ preference for quality and functional bio-absorbable membranes.
Looking forwards
Orthocell is well-positioned to execute on its partnering strategy underpinned by CelGro®’s distinct competitive advantages over existing dental membranes, particularly in the areas of cell biocompatibility, handling qualities and the promotion of high-quality guided bone and tissue regeneration.