Australian regenerative medicine company Orthocell (ASX:OCC) has announced positive results from its guided bone regeneration study.
The company said the study is a key component of the FDA submission to gain US marketing approval. It is seeking marketing approval for CelGro in guided bone regeneration (GBR) procedures, especially in conjunction with dental implants.
According to managing director Paul Anderson, “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.”
The study showed CelGro is effective in facilitating bone regeneration when used in conjunction with bone substitute and a dental implant.
"This Study provides critical regulatory data and is a key component of the US regulatory submission required for US market approval," said the company, adding it is planning a US 510(k) regulatory application by end of the first quarter of calendar year 2020.
"The Study outcomes reinforce previous dental implant clinical study results indicating that CelGro® results in rapid mature bone formation around dental implants," it said.
"All patients successfully generated enough new bone to stabilise their implants and complete their treatment in an average of approximately four months – this is almost half the time of the usual two-stage (eight month) dental implant treatment."
Study investigator Professor Ming Hao Zheng said, “The Study results provide further vaildation that CelGro is not just a barrier membrane. CelGro has distinct advantages in handling qualities and facilitating high quality guided bone and soft tissue regeneration. CelGro will support surgeons in reducing the treatment timeframe and cost for patients to achieve their dental implant goals.”
In the study, 18 animals received dental GBR treatment. A titanium dental implant was fixed into the empty socket after tooth extraction and packed with a granular bone matrix. The implant and bone matrix were covered with either CelGro, the predicate product or no membrane (control). Animals were followed for 4, 8 or 12 weeks and treatment sites were then examined to measure bone growth in the tooth socket, to identify any adverse responses to the treatment, and to monitor resorption of the collagen devices.