Regenerative medicine company Orthocell (ASX: OCC) has completed a US FDA regulatory study demonstrating successful bone growth using its proprietary CelGro technology and intends to leverage the results to improve its chances of a successful US market entry.
The company said the results left it “well-positioned to gain US approval leading to further commercialisation of CelGro” with a US regulatory application to be lodged later this month.
According to the study, CelGro resulted in almost 60% more bone growth following dental implant treatment compared to bone growth without a collagen membrane; was biocompatible with no evidence of adverse tissue reactions; and was completely resorbed within 12 weeks.
The results add weight to CelGro’s marketability as a potential medical device platform for soft tissue regeneration and repair applications.
CelGro’s addressable market in dental restoration is estimated to be worth more than US$1 billion per annum within an industry that’s seeking innovative technology to deliver more efficient solutions, in terms of cost and quality.
Earlier today, Orthocell announced positive results from its guided bone regeneration study which is a key component of its submission to the FDA to gain US marketing approval.
The study was conducted in collaboration with US research scientist Professor Lynne Opperman, an expert in craniofacial bone repair of Texas A&M University, and Professor Ming Hao Zheng of the University of Western Australia.
Speaking about the study, Professor Zheng said the results validate CelGro and its advantage in handling qualities and facilitating high quality guided bone and soft tissue regeneration.
“CelGro will support surgeons in reducing the treatment time-frame and cost for patients to achieve their dental implant goals,” he said.
Study to market
In its conclusions, the study showed CelGro to be effective in facilitating bone regeneration when used in conjunction with bone substitute and a dental implant.
Furthermore, the completed study is expected to provide critical regulatory data and to serve as a key component of the submission required for US market approval, Orthocell said.
The study reinforced previous dental implant clinical study results indicating that CelGro does improve rapid mature bone formation around dental implants.
In a bid to put CelGro’s capabilities into perspective, Orthocell said that all patients successfully generated enough new bone to stabilise their implants and complete their treatment in an average of approximately four months – almost half the time of the usual eight-month dental implant treatment.
“We are thrilled with the recent study results, further demonstrating that CelGro facilitates high-quality bone formation. The results reinforce the superior clinical outcomes previously reported and provides critical data for the US 510(k) FDA submission to gain market approval in the US,” said Paul Anderson, managing director of Orthocell.
Given strong lab results from the lab, Orthocell said it is now rapidly finalising its submission documents and is planning a US 510(k) regulatory application by the end of this month.