{"id":4740,"date":"2024-12-02T11:33:04","date_gmt":"2024-12-02T01:33:04","guid":{"rendered":"\/eu-uk\/?p=4740"},"modified":"2025-01-21T08:54:29","modified_gmt":"2025-01-20T22:54:29","slug":"the-australian-business-review-orthocell-leaps-closer-to-fda-approval-after-pivotal-nerve-repair-product-study-success","status":"publish","type":"post","link":"\/eu-uk\/blog\/2024\/12\/02\/the-australian-business-review-orthocell-leaps-closer-to-fda-approval-after-pivotal-nerve-repair-product-study-success\/","title":{"rendered":"The Australian Business Review | Orthocell leaps closer to FDA approval after pivotal nerve-repair product study success"},"content":{"rendered":"<p>Orthocell has been featured in The Australian Business Review, following today\u2019s announcement that the US FDA 510(k) regulatory study of peripheral nerve-repair product Remplir meets all endpoints.<\/p>\n<p>The successful completion of the study is a key component of the Company\u2019s 510(k) application, which remains on schedule for submission in December CY24.<\/p>\n<p>Here\u2019s an excerpt:<\/p>\n<p>\u201c\ud835\ude0a\ud835\ude0c\ud835\ude16 \ud835\ude22\ud835\ude2f\ud835\ude25 \ud835\ude2e\ud835\ude22\ud835\ude2f\ud835\ude22\ud835\ude28\ud835\ude2a\ud835\ude2f\ud835\ude28 \ud835\ude25\ud835\ude2a\ud835\ude33\ud835\ude26\ud835\ude24\ud835\ude35\ud835\ude30\ud835\ude33 \ud835\ude17\ud835\ude22\ud835\ude36\ud835\ude2d \ud835\ude08\ud835\ude2f\ud835\ude25\ud835\ude26\ud835\ude33\ud835\ude34\ud835\ude30\ud835\ude2f \ud835\ude34\ud835\ude22\ud835\ude2a\ud835\ude25 \ud835\ude24\ud835\ude30\ud835\ude2f\ud835\ude34\ud835\ude2a\ud835\ude25\ud835\ude26\ud835\ude33\ud835\ude2a\ud835\ude2f\ud835\ude28 \ud835\ude35\ud835\ude29\ud835\ude26 \ud835\ude34\ud835\ude35\ud835\ude36\ud835\ude25\ud835\ude3a \ud835\ude33\ud835\ude26\ud835\ude34\ud835\ude36\ud835\ude2d\ud835\ude35\ud835\ude34, \ud835\ude31\ud835\ude36\ud835\ude23\ud835\ude2d\ud835\ude2a\ud835\ude34\ud835\ude29\ud835\ude26\ud835\ude25 \ud835\ude24\ud835\ude2d\ud835\ude2a\ud835\ude2f\ud835\ude2a\ud835\ude24\ud835\ude22\ud835\ude2d \ud835\ude25\ud835\ude22\ud835\ude35\ud835\ude22 \ud835\ude22\ud835\ude2f\ud835\ude25 \ud835\ude35\ud835\ude29\ud835\ude26 \ud835\ude33\ud835\ude22\ud835\ude31\ud835\ude2a\ud835\ude25 \ud835\ude31\ud835\ude33\ud835\ude30\ud835\ude25\ud835\ude36\ud835\ude24\ud835\ude35 \ud835\ude22\ud835\ude25\ud835\ude30\ud835\ude31\ud835\ude35\ud835\ude2a\ud835\ude30\ud835\ude2f \ud835\ude2a\ud835\ude2f \ud835\ude26\ud835\ude39\ud835\ude2a\ud835\ude34\ud835\ude35\ud835\ude2a\ud835\ude2f\ud835\ude28 \ud835\ude2e\ud835\ude22\ud835\ude33\ud835\ude2c\ud835\ude26\ud835\ude35\ud835\ude34, \ud835\ude19\ud835\ude26\ud835\ude2e\ud835\ude31\ud835\ude2d\ud835\ude2a\ud835\ude33 \ud835\ude24\ud835\ude30\ud835\ude36\ud835\ude2d\ud835\ude25 \ud835\ude33\ud835\ude22\ud835\ude31\ud835\ude2a\ud835\ude25\ud835\ude2d\ud835\ude3a \ud835\ude23\ud835\ude26\ud835\ude24\ud835\ude30\ud835\ude2e\ud835\ude26 \ud835\ude22\ud835\ude2f \ud835\ude2a\ud835\ude2e\ud835\ude31\ud835\ude30\ud835\ude33\ud835\ude35\ud835\ude22\ud835\ude2f\ud835\ude35 \ud835\ude26\ud835\ude2d\ud835\ude26\ud835\ude2e\ud835\ude26\ud835\ude2f\ud835\ude35 \ud835\ude2a\ud835\ude2f \ud835\ude2f\ud835\ude26\ud835\ude33\ud835\ude37\ud835\ude26-\ud835\ude33\ud835\ude26\ud835\ude31\ud835\ude22\ud835\ude2a\ud835\ude33 \ud835\ude34\ud835\ude36\ud835\ude33\ud835\ude28\ud835\ude26\ud835\ude33\ud835\ude3a \ud835\ude35\ud835\ude30 \ud835\ude33\ud835\ude26\ud835\ude35\ud835\ude36\ud835\ude33\ud835\ude2f \ud835\ude27\ud835\ude36\ud835\ude2f\ud835\ude24\ud835\ude35\ud835\ude2a\ud835\ude30\ud835\ude2f \ud835\ude35\ud835\ude30 \ud835\ude31\ud835\ude22\ud835\ude33\ud835\ude22\ud835\ude2d\ud835\ude3a\ud835\ude34\ud835\ude26\ud835\ude25 \ud835\ude36\ud835\ude31\ud835\ude31\ud835\ude26\ud835\ude33 \ud835\ude2d\ud835\ude2a\ud835\ude2e\ud835\ude23\ud835\ude34.<\/p>\n<p>\ud835\ude19\ud835\ude26\ud835\ude2e\ud835\ude31\ud835\ude2d\ud835\ude2a\ud835\ude33 \ud835\ude29\ud835\ude22\ud835\ude34 \ud835\ude22\ud835\ude2d\ud835\ude34\ud835\ude30 \ud835\ude23\ud835\ude26\ud835\ude26\ud835\ude2f \ud835\ude27\ud835\ude2d\ud835\ude22\ud835\ude28\ud835\ude28\ud835\ude26\ud835\ude25 \ud835\ude22\ud835\ude34 \ud835\ude29\ud835\ude22\ud835\ude37\ud835\ude2a\ud835\ude2f\ud835\ude28 \ud835\ude31\ud835\ude30\ud835\ude35\ud835\ude26\ud835\ude2f\ud835\ude35\ud835\ude2a\ud835\ude22\ud835\ude2d \ud835\ude27\ud835\ude30\ud835\ude33 \ud835\ude35\ud835\ude33\ud835\ude26\ud835\ude22\ud835\ude35\ud835\ude2a\ud835\ude2f\ud835\ude28 \ud835\ude24\ud835\ude30\ud835\ude2e\ud835\ude31\ud835\ude2d\ud835\ude26\ud835\ude39 \ud835\ude34\ud835\ude31\ud835\ude2a\ud835\ude2f\ud835\ude22\ud835\ude2d \ud835\ude24\ud835\ude30\ud835\ude33\ud835\ude25 \ud835\ude30\ud835\ude33 \ud835\ude35\ud835\ude33\ud835\ude22\ud835\ude36\ud835\ude2e\ud835\ude22\ud835\ude35\ud835\ude2a\ud835\ude24 \ud835\ude2f\ud835\ude26\ud835\ude33\ud835\ude37\ud835\ude26 \ud835\ude2a\ud835\ude2f\ud835\ude2b\ud835\ude36\ud835\ude33\ud835\ude2a\ud835\ude26\ud835\ude34.<\/p>\n<p>\u201c\ud835\ude1e\ud835\ude26 \ud835\ude23\ud835\ude26\ud835\ude2d\ud835\ude2a\ud835\ude26\ud835\ude37\ud835\ude26 \ud835\ude19\ud835\ude26\ud835\ude2e\ud835\ude31\ud835\ude2d\ud835\ude2a\ud835\ude33 \ud835\ude38\ud835\ude2a\ud835\ude2d\ud835\ude2d \ud835\ude33\ud835\ude26\ud835\ude25\ud835\ude26\ud835\ude27\ud835\ude2a\ud835\ude2f\ud835\ude26 \ud835\ude35\ud835\ude29\ud835\ude26 \ud835\ude2f\ud835\ude26\ud835\ude33\ud835\ude37\ud835\ude26-\ud835\ude33\ud835\ude26\ud835\ude31\ud835\ude22\ud835\ude2a\ud835\ude33 \ud835\ude2e\ud835\ude22\ud835\ude33\ud835\ude2c\ud835\ude26\ud835\ude35 \ud835\ude22\ud835\ude2f\ud835\ude25 \ud835\ude23\ud835\ude26\ud835\ude24\ud835\ude30\ud835\ude2e\ud835\ude26 \ud835\ude22\ud835\ude2f \ud835\ude2a\ud835\ude2e\ud835\ude31\ud835\ude30\ud835\ude33\ud835\ude35\ud835\ude22\ud835\ude2f\ud835\ude35 \ud835\ude26\ud835\ude2d\ud835\ude26\ud835\ude2e\ud835\ude26\ud835\ude2f\ud835\ude35 \ud835\ude2a\ud835\ude2f \ud835\ude35\ud835\ude29\ud835\ude26 \ud835\ude34\ud835\ude36\ud835\ude24\ud835\ude24\ud835\ude26\ud835\ude34\ud835\ude34 \ud835\ude30\ud835\ude27 \ud835\ude2f\ud835\ude26\ud835\ude33\ud835\ude37\ud835\ude26-\ud835\ude33\ud835\ude26\ud835\ude31\ud835\ude22\ud835\ude2a\ud835\ude33 \ud835\ude34\ud835\ude36\ud835\ude33\ud835\ude28\ud835\ude26\ud835\ude33\ud835\ude3a,\u201d \ud835\ude29\ud835\ude26 \ud835\ude34\ud835\ude22\ud835\ude2a\ud835\ude25.\u201d<\/p>\n<p><a href=\"https:\/\/www.theaustralian.com.au\/business\/stockhead\/content\/orthocell-leaps-closer-to-fda-approval-after-pivotal-nerverepair-product-study-success\/news-story\/d27a65280dc4720388d05411f849a1b1\">Click to read the article.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Orthocell has been featured in The Australian Business Review, following today\u2019s announcement that the US FDA 510(k) regulatory study of peripheral nerve-repair product Remplir meets all endpoints.<\/p>\n","protected":false},"author":2,"featured_media":4762,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-4740","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-media"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 4.9.8 - aioseo.com -->\n\t<meta name=\"description\" content=\"Orthocell has been featured in The Australian Business Review, following today\u2019s announcement that the US FDA 510(k) regulatory study of peripheral nerve-repair product Remplir meets all endpoints.\" \/>\n\t<meta name=\"robots\" content=\"max-image-preview:large\" \/>\n\t<meta name=\"author\" content=\"Orthocell\"\/>\n\t<link rel=\"canonical\" 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