Orthocell Ltd (ASX:OCC) is in a trading halt pending the release of an announcement relating to its Celgro® US FDA regulatory application.
This halt will remain in place until the beginning of regular ASX trade on Thursday, January 14, or when an announcement is released to the market, whichever occurs earliest.
Shares of the company, which has a market cap of approximately $87.1 million, last traded at 46 cents and have climbed from 33 cents at the market close on November 2.
Approval to supply CelGro®
On December 23 Orthocell received the green light to introduce its CelGro® collagen medical device into the Australian dental bone and tissue regeneration market.
CelGro® Dental is now included in the Australian Register of Therapeutic Goods (ARTG).
The approval positions Orthocell well for US Food and Drug Administration (FDA) approval, targeted for 2021.
At that time, Orthocell managing director Paul Anderson said: “Gaining Australian approval is a significant inflection point for our company.
“This validates the CelGro® platform technology with a respected regulator and positions us well to achieve further approvals for the manufacture and supply of CelGro® in nerve and tendon repair – key growth areas for our business, responding to significant unmet need.”