Orthocell has been featured in The Australian Business Review, following today’s announcement that the US FDA 510(k) regulatory study of peripheral nerve-repair product Remplir meets all endpoints.
The successful completion of the study is a key component of the Company’s 510(k) application, which remains on schedule for submission in December CY24.
Here’s an excerpt:
“𝘊𝘌𝘖 𝘢𝘯𝘥 𝘮𝘢𝘯𝘢𝘨𝘪𝘯𝘨 𝘥𝘪𝘳𝘦𝘤𝘵𝘰𝘳 𝘗𝘢𝘶𝘭 𝘈𝘯𝘥𝘦𝘳𝘴𝘰𝘯 𝘴𝘢𝘪𝘥 𝘤𝘰𝘯𝘴𝘪𝘥𝘦𝘳𝘪𝘯𝘨 𝘵𝘩𝘦 𝘴𝘵𝘶𝘥𝘺 𝘳𝘦𝘴𝘶𝘭𝘵𝘴, 𝘱𝘶𝘣𝘭𝘪𝘴𝘩𝘦𝘥 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘥𝘢𝘵𝘢 𝘢𝘯𝘥 𝘵𝘩𝘦 𝘳𝘢𝘱𝘪𝘥 𝘱𝘳𝘰𝘥𝘶𝘤𝘵 𝘢𝘥𝘰𝘱𝘵𝘪𝘰𝘯 𝘪𝘯 𝘦𝘹𝘪𝘴𝘵𝘪𝘯𝘨 𝘮𝘢𝘳𝘬𝘦𝘵𝘴, 𝘙𝘦𝘮𝘱𝘭𝘪𝘳 𝘤𝘰𝘶𝘭𝘥 𝘳𝘢𝘱𝘪𝘥𝘭𝘺 𝘣𝘦𝘤𝘰𝘮𝘦 𝘢𝘯 𝘪𝘮𝘱𝘰𝘳𝘵𝘢𝘯𝘵 𝘦𝘭𝘦𝘮𝘦𝘯𝘵 𝘪𝘯 𝘯𝘦𝘳𝘷𝘦-𝘳𝘦𝘱𝘢𝘪𝘳 𝘴𝘶𝘳𝘨𝘦𝘳𝘺 𝘵𝘰 𝘳𝘦𝘵𝘶𝘳𝘯 𝘧𝘶𝘯𝘤𝘵𝘪𝘰𝘯 𝘵𝘰 𝘱𝘢𝘳𝘢𝘭𝘺𝘴𝘦𝘥 𝘶𝘱𝘱𝘦𝘳 𝘭𝘪𝘮𝘣𝘴.
𝘙𝘦𝘮𝘱𝘭𝘪𝘳 𝘩𝘢𝘴 𝘢𝘭𝘴𝘰 𝘣𝘦𝘦𝘯 𝘧𝘭𝘢𝘨𝘨𝘦𝘥 𝘢𝘴 𝘩𝘢𝘷𝘪𝘯𝘨 𝘱𝘰𝘵𝘦𝘯𝘵𝘪𝘢𝘭 𝘧𝘰𝘳 𝘵𝘳𝘦𝘢𝘵𝘪𝘯𝘨 𝘤𝘰𝘮𝘱𝘭𝘦𝘹 𝘴𝘱𝘪𝘯𝘢𝘭 𝘤𝘰𝘳𝘥 𝘰𝘳 𝘵𝘳𝘢𝘶𝘮𝘢𝘵𝘪𝘤 𝘯𝘦𝘳𝘷𝘦 𝘪𝘯𝘫𝘶𝘳𝘪𝘦𝘴.
“𝘞𝘦 𝘣𝘦𝘭𝘪𝘦𝘷𝘦 𝘙𝘦𝘮𝘱𝘭𝘪𝘳 𝘸𝘪𝘭𝘭 𝘳𝘦𝘥𝘦𝘧𝘪𝘯𝘦 𝘵𝘩𝘦 𝘯𝘦𝘳𝘷𝘦-𝘳𝘦𝘱𝘢𝘪𝘳 𝘮𝘢𝘳𝘬𝘦𝘵 𝘢𝘯𝘥 𝘣𝘦𝘤𝘰𝘮𝘦 𝘢𝘯 𝘪𝘮𝘱𝘰𝘳𝘵𝘢𝘯𝘵 𝘦𝘭𝘦𝘮𝘦𝘯𝘵 𝘪𝘯 𝘵𝘩𝘦 𝘴𝘶𝘤𝘤𝘦𝘴𝘴 𝘰𝘧 𝘯𝘦𝘳𝘷𝘦-𝘳𝘦𝘱𝘢𝘪𝘳 𝘴𝘶𝘳𝘨𝘦𝘳𝘺,” 𝘩𝘦 𝘴𝘢𝘪𝘥.”