The Orthocell Ltd (ASX: OCC) share price is edging higher today. This comes after the company announced it has completed an important step to obtaining its commercial licence in Australia for its CelGro medical device.
During market open, the Orthocell share price reached as high as 43.5 cents. However, at the time of writing, the company’s shares have slightly retreated to 42.5 cents, up 1.2%.
Quick take on Orthocell
Orthocell focuses on the development and commercialisation of novel collagen medical devices and cellular therapies.
Its lead product, CelGro, facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications. This includes treating defects in areas of the body such as tendons, bones, nerves and cartilage.
Orthocell recently received European regulatory approval for CelGro, allowing the collagen medical device to be sold within the European Union. In addition, the company is striving for approval in the United States and Australian markets.
What’s moving the Orthocell share price today?
The Orthocell share price is in positive territory today as investors appear pleased with the company’s latest update.
According to its release, Orthocell has successfully completed the Therapeutic Goods Administration (TGA) conformity assessment process for CelGro .
The regulatory application looked at the safety and performance of CelGro in dental bone and tissue regeneration procedures. Furthermore, the conformity assessment reviewed the company’s management system and manufacturing process.
What’s next for Orthocell?
Following the positive outcome announced today, Orthocell has begun its application for market authorisation from the TGA to commercialise CelGro. The company anticipates the application will be completed within the first quarter of the new calendar year.
Orthocell has also progressed its application to the Prostheses List Advisory Committee for an inclusion on the prostheses list. This will enable the company to be reimbursed for its products by private health insurance agencies when patients have hospital cover. This application is expected to be finalised towards the last quarter of 2021.
Lastly, based on the successful completion of the conformity assessment, Orthocell believes it’s well placed to obtain US approval for CelGro next year.
What did management say?
Mr Paul Anderson, Orthocell managing director, commented on the achievement, saying:
This is an important milestone for the Company as we continue to commercialise our collagen medical device platform and I am excited to complete this important step towards gaining Australian and US FDA regulatory approval.
About the Orthocell share price
The Orthocell share price is hovering around 15% below the 50 cents level at which it commenced 2020. Orthocell shares have, however, strongly recovered from their 52-week low of 18 cents seen in March, up 136%.