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CytexOrtho receives FDA greenlight for clinical trials
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0px;width:100%"><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 0px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>Approvals</p></div></div><div id="outer" data-widget="horizontal-rule-widget" style="background-color:transparent;padding:0px 24px 0px 24px" class="Widget-module_outer__PBh8P HorizontalRule-module_outer__3UqSE"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%"><hr style="border-top-style:solid;border-top-width:3px;border-top-color:#a31f29"/></div></div><div id="outer" data-widget="heading-widget" style="background-color:transparent;padding:0px 24px 16px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Heading-module_container__uHf-4"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%"><h2><span style="font-family:"Roboto Slab"" class="__bold">CytexOrtho receives FDA greenlight for clinical trials into joint repair technology</span></h2></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p><span class="__bold" style="color:rgb(38,37,35)">Clinical stage medical device company CytexOrtho has announced approval from the US Food and Drug Administration (FDA) for its planned phase 1 clinical trial into orthopaedic joint preservation and repair. </span></p></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>The first-in-human study aims to assess the safety and efficacy of the company’s ReNew Hip Implant novel cartilage repair technology. There are plans to enrol up to 15 patients with hip disease that has resulted in the loss of articular cartilage integrity. The patients will be aged 14-55, and the nonrandomised, single-arm study will follow pain and functions ratings over 12 months pre-implementation and 60 months post-implementation.</p></div></div><div id="outer" data-widget="image-widget" style="background-color:transparent;padding:8px 24px 16px 24px;min-height:auto" class="Widget-module_outer__PBh8P"><div id="inner" class="Image-module_container__8raIv Image-module_container-noflex__-J1PG" style="border-radius:0px 0px 0px 0px;width:100%;min-height:auto"><picture class="Image-module_picture__gw1zY Image-module_loading__FfyPr"><source type="image/jpeg" srcSet="https://cdn.magloft.com/pdf-import/1144/images/img_13-2.jpg?optimizer=image&width=192 192w,https://cdn.magloft.com/pdf-import/1144/images/img_13-2.jpg?optimizer=image&width=384 384w,https://cdn.magloft.com/pdf-import/1144/images/img_13-2.jpg?optimizer=image&width=768 768w,https://cdn.magloft.com/pdf-import/1144/images/img_13-2.jpg?optimizer=image&width=1536 1536w" sizes="(min-width: 768px) 768px, 100vw"/><img src="https://cdn.magloft.com/pdf-import/1144/images/img_13-2.jpg?optimizer=image&width=768" srcSet="https://cdn.magloft.com/pdf-import/1144/images/img_13-2.jpg?optimizer=image&width=192 192w,https://cdn.magloft.com/pdf-import/1144/images/img_13-2.jpg?optimizer=image&width=384 384w,https://cdn.magloft.com/pdf-import/1144/images/img_13-2.jpg?optimizer=image&width=768 768w,https://cdn.magloft.com/pdf-import/1144/images/img_13-2.jpg?optimizer=image&width=1536 1536w" sizes="(min-width: 768px) 768px, 100vw" class="Image-module_image__w4slc" width="100%" height="557" decoding="async" alt="Image" style="height:auto;width:100%"/></picture></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>The ReNew technology uses a unique, highly porous and bioabsorbable device to mimic healthy cartilage, providing structural support and facilitating natural healing processes to start.</p></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>Farshid Guilak PhD, co-founder of CytexOrtho, professor of Orthopedic Surgery, and director of Research, Shriners Children’s – St. Louis, US added, “This investigational device exemption approval is backed up by of years of research and development showing success of the ReNew Hip Implant in pre-clinical animal studies. We believe our approach has the potential to address a significant unmet need in orthopaedics.”</p></div></div></div></div></div><div class="_slug__share-button__ettip"><hr/></div></div></div><div id="ControlBar" class="_slug__control-bar__Jj4LE"><div class="WrapAutoHide-module_navigation__9sdQy WrapAutoHide-module_visible__UN7GD"><div class="ControlBar-module_toc-wrapper__AF5eD"><div class="ControlBar-module_toc__mKXnp"><div class="ControlBar-module_white-blur__TGapK"><div class="ControlBar-module_toc-slider__i9fv1"></div></div><div class="ControlBar-module_control-bar__9Zqak"><button class=""><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none"><path d="M13.8287 19C13.5367 19 13.2467 18.873 13.0487 18.627L8.22066 12.627C7.92266 12.256 7.92666 11.726 8.23166 11.36L13.2317 5.35998C13.5847 4.93598 14.2157 4.87898 14.6407 5.23198C15.0647 5.58498 15.1217 6.21598 14.7677 6.63998L10.2927 12.011L14.6077 17.373C14.9537 17.803 14.8857 18.433 14.4547 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announced approval from the US Food and Drug Administration (FDA) for its planned phase 1 clinical trial into orthopaedic joint preservation and repair.","image":"https://cdn.magloft.com/pdf-import/1144/images/img_13-2.jpg","cover":"https://cdn.magloft.com/publication-14882/screenshots/articles/269252.jpg?ts=1731322444","date":1731283200000,"unlockType":"free","categories":[],"pdfPageId":"KblVL2OrIcD8","visible":true,"showOnToc":true,"bookmark":false,"position":23,"publicationId":14882,"pwaOptinId":null,"seoDescription":"Clinical stage medical device company CytexOrtho has announced approval from the US Food and Drug Administration (FDA) for its planned phase 1 clinical trial into orthopaedic joint preservation and repair.","classificationIds":[],"pwaSubscriptionIds":[],"source":"typeloft2","trending":false,"html":"\u003cpage-widget padding=\"16 0 24 0\"\u003e\u003cparagraph-widget padding=\"0 24 0 24\"\u003eApprovals\u003c/paragraph-widget\u003e\u003chorizontal-rule-widget padding=\"0 24 0 24\" color=\"#a31f29\"\u003e\u003c/horizontal-rule-widget\u003e\u003cheading-widget padding=\"0 24 16 24\" type=\"h2\"\u003e\u003cspan style=\"font-family: \u0026quot;Roboto Slab\u0026quot;;\" class=\"__bold\"\u003eCytexOrtho receives FDA greenlight for clinical trials into joint repair technology\u003c/span\u003e\u003c/heading-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003e\u003cspan class=\"__bold\" style=\"color: rgb(38,37,35)\"\u003eClinical stage medical device company CytexOrtho has announced approval from the US Food and Drug Administration (FDA) for its planned phase 1 clinical trial into orthopaedic joint preservation and repair. \u003c/span\u003e\u003c/paragraph-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003eThe first-in-human study aims to assess the safety and efficacy of the company’s ReNew Hip Implant novel cartilage repair technology. There are plans to enrol up to 15 patients with hip disease that has resulted in the loss of articular cartilage integrity. The patients will be aged 14-55, and the nonrandomised, single-arm study will follow pain and functions ratings over 12 months pre-implementation and 60 months post-implementation.\u003c/paragraph-widget\u003e\u003cimage-widget padding=\"8 24 16 24\" aspect-ratio=\"0.7258805513016845\" magnify-label=\"center\" source=\"https://cdn.magloft.com/pdf-import/1144/images/img_13-2.jpg#image/jpeg\"\u003e\u003c/image-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003eThe ReNew technology uses a unique, highly porous and bioabsorbable device to mimic healthy cartilage, providing structural support and facilitating natural healing processes to start.\u003c/paragraph-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003eFarshid Guilak PhD, co-founder of CytexOrtho, professor of Orthopedic Surgery, and director of Research, Shriners Children’s – St. Louis, US added, “This investigational device exemption approval is backed up by of years of research and development showing success of the ReNew Hip Implant in pre-clinical animal studies. We believe our approach has the potential to address a significant unmet need in orthopaedics.”\u003c/paragraph-widget\u003e\u003c/page-widget\u003e","keywordPhrase":"FDA ","articleAssets":[{"url":"https://cdn.magloft.com/reader/fonts/roboto-slab.css","extension":"css","contentType":"text/css"},{"url":"https://cdn.magloft.com/reader/fonts/open-sans.css","extension":"css","contentType":"text/css"},{"url":"https://cdn.magloft.com/pdf-import/1144/images/img_13-2.jpg","extension":"jpeg","contentType":"image/jpeg"}]},"publicationId":14882},"__N_SSG":true},"page":"/domains/[domain]/articles/[slug]","query":{"domain":"www.pharmafocus.com","slug":"cytex-ortho-receives-fda-greenlight-for-clinical-trials-into-join"},"buildId":"U1LT7ce93wR6IyWFJCllT","isFallback":false,"gsp":true,"scriptLoader":[]}</script></body></html>