{"id":949324,"date":"2026-04-06T20:04:59","date_gmt":"2026-04-07T00:04:59","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/organogenesis-achieves-primary-endpoint-in-randomized-controlled-trial-of-puraplyam\/"},"modified":"2026-04-06T20:04:59","modified_gmt":"2026-04-07T00:04:59","slug":"organogenesis-achieves-primary-endpoint-in-randomized-controlled-trial-of-puraplyam","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/organogenesis-achieves-primary-endpoint-in-randomized-controlled-trial-of-puraplyam\/","title":{"rendered":"Organogenesis Achieves Primary Endpoint in Randomized Controlled Trial of PuraPly\u00aeAM"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li style=\"margin-bottom:8pt\">Statistically significant (p&lt;0.0477) DFU wound closure at 12 weeks<\/li>\n<li style=\"margin-bottom:8pt\">RCT compared PuraPly\u00aeAM plus standard of care to standard of care alone<\/li>\n<li style=\"margin-bottom:8pt\">Results strengthen existing clinical evidence supporting future coverage\n<\/li>\n<\/ul>\n<p>CANTON, Mass., April  06, 2026  (GLOBE NEWSWIRE) &#8212; Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the completion of a randomized controlled trial (RCT) evaluating PuraPly\u00aeAM plus standard of care (SOC) versus SOC alone in the management of non-healing diabetic foot ulcers (DFUs).<\/p>\n<p>The prospective, multi-center, randomized controlled trial of 170 patients evaluated the safety and efficacy of PuraPly\u00ae AM plus SOC. The trial achieved its primary endpoint, demonstrating statistically significant wound closure at 12 weeks, compared to SOC alone (p &lt; 0.0477). These findings further demonstrate the clinical effectiveness of PuraPly\u00aeAM in the management of DFUs expanding the body of evidence supporting its use. Organogenesis plans to publish the study results soon in a peer-reviewed journal.<\/p>\n<p>\u201cWe are pleased to report primary endpoint achievement in this important study underscoring the clinical efficacy of PuraPly\u00aeAM in the management of non-healing DFUs,\u201d said Patrick Bilbo, Chief Operating Officer of Organogenesis. \u201cThese wounds pose a significant burden to patients and are extremely costly to our healthcare system. We believe publication of these impactful results will strongly support PuraPly\u00ae AM\u2019s inclusion in future coverage policies, underscoring its critical role in the healing paradigm.\u201d<\/p>\n<p>PuraPly\u00ae AM is a patent-protected product that is differentiated among all skin substitutes by combining a native, cross-linked collagen matrix with polyhexamethylene biguanide (PHMB) antimicrobial to manage bioburden within the product and support healing.<\/p>\n<p>\n        <strong>About Organogenesis Holdings Inc.<\/strong>\u00a0<br \/>Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=HfgPtxGXp8XgK-zPwdpUuYtwZYvJOe8OkSe97Wp-SaAIlJVU2pT1005cC-eLUh1c1MFFLp-39qv9lJIfoUZxqbEgGWjN7RrVJ8K4o_DEXtpyxYMCU_1gFUnWiDt1TQUhjH7BpAy6tR8HmHTGxoXF2oRdEAhORFZi90hBL5kdV1JyUxc0e1pOa9xAD5tvwK9t3MlyKFPJ3hGciZbcW-k3TSL1Pj2wLX2bEcjz5J41yf5sOZgpkcK4GeULUD8sBGxt31m4pEuFFY0RWkS2Rtlf-g==\" rel=\"nofollow\" target=\"_blank\">www.organogenesis.com<\/a>.<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong>\n      <\/p>\n<p>This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as \u201cfuture,\u201d \u201cplan,\u201d \u201cbelieve,\u201d \u201cintend,\u201d \u201cseek,\u201d \u201canticipate,\u201d \u201cexpect,\u201d \u201coutlook,\u201d and \u201cproject\u201d and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to the Company\u2019s expectations and beliefs regarding PuraPly AM\u2019s inclusion in future coverage policies and opportunities for PuraPly AM to generate revenue for the Company. Forward-looking statements with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of coverage and reimbursement levels for PuraPly AM and the Company\u2019s other products, particularly in light of CMS\u2019 updated 2026 Medicare reimbursement and coverage changes; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company\u2019s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company\u2019s ability to raise funds to expand its business; (6) the Company has incurred losses in the prior periods and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and\/or competitive factors; (9) the Company\u2019s ability to maintain production or obtain supply of its products in sufficient quantities to meet demand; (10) the Company\u2019s ability to build out its Smithfield, Rhode Island facility on time and on budget; (11) whether the Company is able to obtain regulatory approval for and successfully commercialize ReNu; and (12) other risks and uncertainties described in the Company\u2019s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company\u2019s Form 10-K for the year ended December 31, 2025 and its subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY4NDk0NiM3NTIyMTI4IzIwOTk0MDg=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/MjlkNzczZjEtMjk1YS00ZTlhLWI2YTgtMWRjODNjYjgyZjE1LTExMTA5NzktMjAyNi0wNC0wNi1lbg==\/tiny\/Organogenesis-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\">\n<pre>Investor Inquiries: ICR Healthcare Mike Piccinino, CFA OrganoIR@westwicke.com\r\nPress and Media Inquiries: Organogenesis Communications@organo.com<\/pre>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Statistically significant (p&lt;0.0477) DFU wound closure at 12 weeks RCT compared PuraPly\u00aeAM plus standard of care to standard of care alone Results strengthen existing clinical evidence supporting future coverage CANTON, Mass., April 06, 2026 (GLOBE NEWSWIRE) &#8212; Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the completion of a randomized controlled trial (RCT) evaluating PuraPly\u00aeAM plus standard of care (SOC) versus SOC alone in the management of non-healing diabetic foot ulcers (DFUs). The prospective, multi-center, randomized controlled trial of 170 patients evaluated the safety and efficacy of PuraPly\u00ae AM plus SOC. The trial achieved its &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/organogenesis-achieves-primary-endpoint-in-randomized-controlled-trial-of-puraplyam\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Organogenesis Achieves Primary Endpoint in Randomized Controlled Trial of PuraPly\u00aeAM&#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-949324","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Organogenesis Achieves Primary Endpoint in Randomized Controlled Trial of PuraPly\u00aeAM - 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\/organogenesis-achieves-primary-endpoint-in-randomized-controlled-trial-of-puraplyam\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Organogenesis Achieves Primary Endpoint in Randomized Controlled Trial of PuraPly\u00aeAM - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Statistically significant (p&lt;0.0477) DFU wound closure at 12 weeks RCT compared PuraPly\u00aeAM plus standard of care to standard of care alone Results strengthen existing clinical evidence supporting future coverage CANTON, Mass., April 06, 2026 (GLOBE NEWSWIRE) &#8212; Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the completion of a randomized controlled trial (RCT) evaluating PuraPly\u00aeAM plus standard of care (SOC) versus SOC alone in the management of non-healing diabetic foot ulcers (DFUs). The prospective, multi-center, randomized controlled trial of 170 patients evaluated the safety and efficacy of PuraPly\u00ae AM plus SOC. 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