Orthocell Secures FDA Clearance for Remplir™, Eyes US Market Expansion

Orthocell Ltd ( (AU:OCC) ) has issued an announcement.

Orthocell Limited has achieved a significant milestone with the US FDA 510(k) clearance for its nerve repair product, Remplir™, positioning the company to enter the lucrative US$1.6 billion nerve repair market. This clearance is expected to drive a substantial increase in revenue as the company has prepared logistics and sales pathways for its US launch. Additionally, Orthocell reported strong quarterly revenue growth, maintaining a robust cash position, and is expanding its market reach with regulatory applications in Canada and Thailand. The company’s inclusion in the S&P/ASX All Ordinaries Index further underscores its growing market presence.

More about Orthocell Ltd

Orthocell Limited is a regenerative medicine company specializing in innovative products for nerve repair and dental guided bone regeneration. The company focuses on the global market, particularly the US, with its flagship products Remplir™ and Striate+™.

YTD Price Performance: 4.80%

Average Trading Volume: 1,559,039

Technical Sentiment Signal: Strong Sell

Current Market Cap: A$343.6M

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