- Regenerative medicine company Orthocell (OCC) has received positive results from its bone regeneration study using CelGro
- These positive results form a key component of the Food and Drug Administration submission to gain entry in the U.S. market
- CelGro is a medical device that increases tissue repair and regeneration and assists in the re-joining of severed or damaged nerves
- Applying for U.S. regulatory approval is slated for quarter one of the 2020 calendar year
- Orthocell has jumped 13.1 per cent on the market and shares are currently trading for 34.5 cents each
Regenerative medicine company Orthocell (OCC) has received positive results from its bone regeneration study using CelGro.
These positive results form a key component of the Food and Drug Administration (FDA) submission to gain U.S. marketing approval.
Orthocell’s U.S. regulatory application is planned for Q1 CY2020.
CelGro’s addressable market is estimated to be worth more than US$1 billion (AUD$1.5 billion) per year.
The study was conducted in collaboration with U.S. research scientist Professor Lynne Opperman from the Texan A&M University, and Professor Ming Hao Zheng of the University of Western Australia.
CelGro is a unique medical device that increases tissue repair and regeneration and assists in the re-joining of severed or damaged peripheral nerves.
It has a bilayer structure which features smooth and rough sides, which creates a bioactive chamber to guide new tissue formation and protect the repair site.
The smooth layer consists of a parallel arrangement of densely packed collagen bundles with abundant pores that allow fluids and nutrients to pass through.
It also prevents the invasion of external tissue to the site of repair.
The rough layer consists of loosely arranged collagen bundles to provide a scaffold to support new cell growth.
The primary objective of this recently completed study was to generate critical data supporting the effectiveness of CelGro in facilitating bone regeneration to support U.S. FDA submission and gain U.S. market approval.
“We are thrilled with the recent study results, further demonstrating that CelGro facilitates high-quality bone formation,” Managing Director Paul Anderson said.
“The results reinforce the superior clinical outcomes previously reported and provides critical data for the U.S. 510(k) FDA submission to gain market approval in the U.S.,” he added.
In this study, 18 animals with bone damage received CelGro treatment over either a four, eight or 12 week period.
Results show CelGro to be effective in facilitating bone regeneration when used jointly with bone substitute and a dental implant.
CelGro is biocompatible, meaning no adverse tissue reactions were identified and it was completely reabsorbed by 12 weeks of treatment.
“The study results provide further validation that CelGro is not just a barrier membrane. It also has distinct advantages in handling qualities and facilitating high quality guided bone and soft tissue. regeneration,” Professor Ming Hao commented.
The outcomes of this study reinforces the results form Orthocell’s study in humans, indicating that CelGro results in the quick formation of high quality, mature bone around dental implants.
All patients in the study successfully generated enough new bone to stabilise their implants and complete their treatment in an average of four months – almost half the time of the usual eight-month dental implant treatment.
Orthocell has jumped 13.1 per cent on the market and shares are trading for 34.5 cents each at 12:31 pm AEDT.