The Orthocell Ltd (ASX: OCC) share price is one of the best performers on the market today. This comes after the company announced that it has received its first FDA approval for its flagship product.
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The Orthocell Ltd (ASX: OCC) share price is one of the best performers on the market today. This comes after the company announced that it has received regulatory approval for its flagship product, CelGro.
At the time of writing, the regenerative medicine company’s shares are up 23.91% to 57 cents.
What’s pushing the Orthocell share price higher?
The Orthocell share price is soaring higher today, with investors fighting to get a hold of its shares after this most recent announcement.
Orthocell advised it has achieved 510(k) clearance from the United States Food and Drug Administration (FDA) to market and supply its CelGro device.
CelGro is a collagen scaffold that supports tissue reconstruction and repair, with a wide range of uses in orthopaedics, general, gynaecology and ENT surgeries.
In the United States however, CelGro will be used for dental bone and tissue regenerations procedures. This includes dental bone repairs, growth around dental implants in extraction sockets, and tissue regeneration in intrabony defects.
The approved clearance will see Orthocell supply Striate+ for the United States dental market. Striate+, formerly branded as CelGro Dental, is manufactured in Australia, using the company’s SMRT technology.
Following the milestone achievement, Orthocell will now seek negotiations with United States dental companies for marketing and distribution rights. Orthocell highlighted that after this recent success, it is confident of securing a distribution partner to bring the product to market.
Orthocell stated that CelGro can be further developed to service the peripheral nerve repair market. It is estimated that this sector alone is worth more than US$7.5 billion per annum, with 3 million potential CelGro procedures each year.
Orthocell managing director Mr Paul Anderson welcomed the positive outcome, saying:
US approval has come sooner than expected and is a significant inflection point for our Company. I am excited by this strategic milestone and the positive step it represents on our pathway to partnering Striate+ in dental GBR indications. I look forward to working with our leading dental surgeons to introduce the new global brand, Striate+, previously branded as CelGro Dental, and to make a meaningful impact in the US market.
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Motley Fool contributor Aaron Teboneras has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.