{"id":817481,"date":"2025-02-25T08:11:51","date_gmt":"2025-02-25T13:11:51","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/"},"modified":"2025-02-25T08:11:51","modified_gmt":"2025-02-25T13:11:51","slug":"celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/","title":{"rendered":"Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft\u2122\u00a0Wound Care Products"},"content":{"rendered":"<h2>\nNatalin and Acelagraft\u2122\u00a0are the latest additions to Celularity\u2019s portfolio of HCT\/P 361\u00a0products for use in the treatment of partial and full thickness acute and chronic wounds<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p align=\"justify\">FLORHAM PARK, N.J., Feb.  25, 2025  (GLOBE NEWSWIRE) &#8212; Celularity Inc. (Nasdaq: CELU) (\u201cCelularity\u201d or the \u201cCompany\u201d), a regenerative and cellular medicine company, today announced that on December 19, 2024, it received recommendation letters from the US Food and Drug Administration, or FDA, Tissue Reference Group, or TRG,\u00a0in response to the Company\u2019s requests regarding its Natalin and Acelagraft\u2122 products confirming\u00a0that each product \u201cappears to meet all the criteria for regulation solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271.\u201d FDA\u2019s recommendations reflect that each meets the criteria to be regulated solely under section 361 (21 CRFR Part 1271.10(a)) as a human cell, tissue and cellular and tissue-based product, or HCT\/P, for given indication for use.<\/p>\n<p align=\"justify\">Natalin is a decellularized dehydrated amnion derived tri-layer graft and Acelagraft\u2122 is a decellularized dehydrated amnion derived bi-layer graft. Both Natalin and Acelagraft\u2122 are indicated for use in partial and full thickness acute and chronic wounds.<\/p>\n<p align=\"justify\">According to <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Ekd2tCTKbE_QmYvXaQ5_Anp7nILiRHh52s71-Vi7xJjNJO3SukmwoAfynRoiwxQ6gFgDKGif6tCCeFoSJhoB5Oik1FwziKwI_Qho8k8_BL1AkMoOr-vjdSnMRzzohuNfp6kFBOWj5ywp6atsJVbdUg==\" rel=\"nofollow\" target=\"_blank\">Nova One Advisor<\/a>, the 2024 global Biological Skin Substitutes market was $347.75 million and projected to grow at a compound annual growth rate, or CAGR, of 8.83% through 2034 to reach $810.50 million. The chronic wounds segment, which includes diabetic foot ulcers, pressure ulcers and venous leg ulcers,\u00a0is anticipated to grow at a 9.13% CAGR over the forecast period, the fastest of any segment. North America was the largest market accounting for 42.0% of the 2024 global market according to Nova One Advisor.<\/p>\n<p align=\"justify\">\u201cWe are extremely pleased to receive these TRG recommendation letters on important additions to our portfolio of human placental-derived biomaterials, which serves as a further testament to our commitment to innovate in the wound care sector and will further enable us to build on our commercial momentum,\u201d commented Dr. Robert Hariri, Chairman and CEO of Celularity.<\/p>\n<p align=\"justify\">\n        <strong>About the Tissue Reference Group<\/strong>\n      <\/p>\n<p align=\"justify\">The Tissue Reference Group, or TRG, is a working group within the FDA that responds to inquiries from manufacturers and\u00a0sponsors regarding their existing, investigational, or proposed products containing or consisting of HCT\/Ps. The TRG provides recommendation letters to inquiring\u00a0stakeholders concerning, among other things, the application of the criteria in 21 CFR 1271.10(a) to the regulation of human cells, tissues and cellular and tissue-based products, or HCT\/P, for given indication(s) for use and whether a submitted product appears to meet HCT\/P regulatory requirements. A TRG recommendation letter referencing Section 361 of the Public Health Service Act is used\u00a0by the Centers for Medicare and Medicaid Services, or CMS, and other agencies to confirm the regulatory status of an HCT\/P and that it meets the criteria for regulation solely under Section 361 of the Public Health Services Act, versus requiring premarket approval as a drug or biologic.\u00a0<\/p>\n<p align=\"justify\">\n        <strong>About Celularity<\/strong>\n      <\/p>\n<p align=\"justify\">Celularity Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta\u2019s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. For more information, visit www.celularity.com.<\/p>\n<p align=\"justify\">\n        <strong>Forward Looking Statements<\/strong><br \/>\n        <br \/>This press release includes \u201cforward-looking statements\u201d (as defined under Federal securities laws). All statements other than statements of historical facts are \u201cforward-looking statements,\u201d including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccan,\u201d \u201ccould,\u201d \u201cexpect,\u201d \u201cforecast,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cproject,\u201d \u201cshould,\u201d and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity\u2019s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption \u201cRisk Factors\u201d in Celularity\u2019s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on July 30, 2024, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity\u2019s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity\u2019s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.<\/p>\n<p align=\"justify\">Carlos Ramirez<br \/>Senior Vice President, Celularity Inc.<br \/>Carlos.ramirez@celularity.com<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM4Mzk2NyM2NzQ2Nzc0IzIyMDUwMDk=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/NjQ4Y2UyZTYtNjE1Mi00NGY0LWEwNWMtODc1ZDUzNmU5M2MzLTEyMTY1NjI=\/tiny\/Celularity-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Natalin and Acelagraft\u2122\u00a0are the latest additions to Celularity\u2019s portfolio of HCT\/P 361\u00a0products for use in the treatment of partial and full thickness acute and chronic wounds FLORHAM PARK, N.J., Feb. 25, 2025 (GLOBE NEWSWIRE) &#8212; Celularity Inc. (Nasdaq: CELU) (\u201cCelularity\u201d or the \u201cCompany\u201d), a regenerative and cellular medicine company, today announced that on December 19, 2024, it received recommendation letters from the US Food and Drug Administration, or FDA, Tissue Reference Group, or TRG,\u00a0in response to the Company\u2019s requests regarding its Natalin and Acelagraft\u2122 products confirming\u00a0that each product \u201cappears to meet all the criteria for regulation solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271.\u201d FDA\u2019s recommendations reflect that each meets the criteria &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft\u2122\u00a0Wound Care Products&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-817481","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft\u2122\u00a0Wound Care Products - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft\u2122\u00a0Wound Care Products - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Natalin and Acelagraft\u2122\u00a0are the latest additions to Celularity\u2019s portfolio of HCT\/P 361\u00a0products for use in the treatment of partial and full thickness acute and chronic wounds FLORHAM PARK, N.J., Feb. 25, 2025 (GLOBE NEWSWIRE) &#8212; Celularity Inc. (Nasdaq: CELU) (\u201cCelularity\u201d or the \u201cCompany\u201d), a regenerative and cellular medicine company, today announced that on December 19, 2024, it received recommendation letters from the US Food and Drug Administration, or FDA, Tissue Reference Group, or TRG,\u00a0in response to the Company\u2019s requests regarding its Natalin and Acelagraft\u2122 products confirming\u00a0that each product \u201cappears to meet all the criteria for regulation solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271.\u201d FDA\u2019s recommendations reflect that each meets the criteria &hellip; Continue reading &quot;Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft\u2122\u00a0Wound Care Products&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-02-25T13:11:51+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM4Mzk2NyM2NzQ2Nzc0IzIyMDUwMDk=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft\u2122\u00a0Wound Care Products\",\"datePublished\":\"2025-02-25T13:11:51+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\\\/\"},\"wordCount\":879,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTM4Mzk2NyM2NzQ2Nzc0IzIyMDUwMDk=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\\\/\",\"name\":\"Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft\u2122\u00a0Wound Care Products - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/","og_locale":"en_US","og_type":"article","og_title":"Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft\u2122\u00a0Wound Care Products - Market Newsdesk","og_description":"Natalin and Acelagraft\u2122\u00a0are the latest additions to Celularity\u2019s portfolio of HCT\/P 361\u00a0products for use in the treatment of partial and full thickness acute and chronic wounds FLORHAM PARK, N.J., Feb. 25, 2025 (GLOBE NEWSWIRE) &#8212; Celularity Inc. (Nasdaq: CELU) (\u201cCelularity\u201d or the \u201cCompany\u201d), a regenerative and cellular medicine company, today announced that on December 19, 2024, it received recommendation letters from the US Food and Drug Administration, or FDA, Tissue Reference Group, or TRG,\u00a0in response to the Company\u2019s requests regarding its Natalin and Acelagraft\u2122 products confirming\u00a0that each product \u201cappears to meet all the criteria for regulation solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271.\u201d FDA\u2019s recommendations reflect that each meets the criteria &hellip; Continue reading \"Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft\u2122\u00a0Wound Care Products\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/","og_site_name":"Market Newsdesk","article_published_time":"2025-02-25T13:11:51+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM4Mzk2NyM2NzQ2Nzc0IzIyMDUwMDk=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft\u2122\u00a0Wound Care Products","datePublished":"2025-02-25T13:11:51+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/"},"wordCount":879,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM4Mzk2NyM2NzQ2Nzc0IzIyMDUwMDk=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/celularity-receives-fda-tissue-reference-group-recommendation-letters-for-its-natalin-and-acelagraft-wound-care-products\/","name":"Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft\u2122\u00a0Wound Care Products - 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