The Orthocell Ltd (ASX: OCC) share price is surging higher today. This comes after the biotechnology company received Australian market approval for its CelGro product. CelGro is a collagen scaffold that supports tissue reconstruction and repair, with a wide range of uses in orthopaedics, general, gynaecology and ENT surgeries.
At the time of writing, the Orthocell share price is up 6% to 43.5 cents.
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What's moving the Orthocell share price?
Investors appear to be pleased with the latest news from the company, pushing the Orthocell share price higher.
With the latest approval, Orthocell can now begin to supply and market CelGro in dental bone and tissue regeneration procedures. According to the company, the CelGro device provides distinct advantages in assisting surgeons in delivering better results. Orthocell is also seeking to gain authorisation for CelGro in nerve and tendon repair.
The market approval follows a recent announcement by Orthocell that it successfully completed its Therapeutic Goods Administration (TGA) conformity assessment process. The regulatory application looked at the safety and performance of CelGro in dental bone and tissue regeneration procedures and reviewed the company's management system and manufacturing process.
What's next for Orthocell?
Further to the release, Orthocell said it's now focusing on completing 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 submitted sometime before the middle of next year.
With European and Australian markets now approved, the company's next steps are to gain market entry into the United States. Orthocell hopes that use of CelGro in Australia and Europe will assist the United Stated Food and Drug Administration (FDA) to grant market access. The company is aiming to complete this target in the next calendar year.
Mr Paul Anderson, Orthocell's managing director, commented on the milestone achievement:
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.
Orthocell share price summary
The Orthocell share price is 7% lower from this time last year. The company's shares reached a low point in March, hitting just 18 cents. While the Orthocell share price has increased by 141% since, it's still a fair way off its all-time high of 64.5 cents in October 2019.
