- Orthocell (OCC) has received Food and Drug Administration (FDA) 501K approval to supply and market its medical collagen product CelGro in the U.S.
- The approval means the CelGro — or as per its recent rebrand, Striate+ — is cleared for use on dental bone and tissue regeneration procedures in an auspicious U.S. dental market
- OCC’s Managing Director says the approval has come sooner than expected with the FDA lodgment taking place in May 2020
- The company has hinted it could pave the way for OCC’s entry into the peripheral nerve repair market
- OCC shares have soared well into the green by 26.1 per cent on the back of the announcement, trading at 58 cents each
Orthocell (OCC) has received Food and Drug Administration (FDA) 501K approval to supply and market its medical collagen product CelGro in the U.S.
The approval means the CelGro — or as per its recent rebrand, Striate+ — is cleared for use on dental bone and tissue regeneration procedures in the U.S. market.
A company statement indicates the dental market in the States is valued at US$500 million per annum or roughly A$645 million.
More specifically, Striate+ has been cleared for use in dental bone defect repair, augmentation around dental implants in immediate and delayed extraction sockets and tissue regeneration procedures.
Orthocell submitted an FDA application for the product in May 2020.
Striate+ is manufactured in is manufactured at Orthocell’s facilities in West Australia using the Company’s proprietary SMRTTM manufacturing technology.
The company says the FDA approval validates the SMRT manufacturing technology and could potentially pave the way for OCC’s entry into the peripheral nerve repair market.
Orthocell Managing Director, Paul Anderson, says the approval came sooner than expected.
“I am excited by this strategic milestone and the positive step it represents on our pathway to partnering Striate+ in dental GBR indications,” he commented.
Orthocell has also recently received approval to sale and market the product in Australia.
OCC shares have soared well into the green by 26.1 per cent on the back of the announcement, trading at 58 cents each at 10:45 am AEDT.