{"success":true,"data":{"pressRelease":{"id":"166789","rtpr_id":"nGNXbxmNk9-20261012","ticker":"ORGO","exchange":"NASDAQ","all_tickers":["ORGO"],"title":"Organogenesis Announces Publication of Peer-Reviewed PREPARE Trial Results Demonstrating Clinical Benefit of PuraPly®AM for Hard-to-Heal Diabetic Foot Ulcers","author":"Globe Newswire","published_at":"2026-10-12T20:10:00.121Z","article_body":"CANTON, Mass., Oct. 12, 2026 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc.\n(Nasdaq: ORGO), a leading regenerative medicine company focused on product\nsolutions for the Advanced Wound Care and Surgical and Sports Medicine\nmarkets, today announced the publication of previously released\n(https://www.globenewswire.com/Tracker?data=UT6vCmBG4RY4blNNuDvWK07jzej20eV51PreBetsG27G8wxV83SJAjN8_-ggMHc-NrvmZmVjBaMel-fMUSjR4QO6J6pzSpM9oR-0X6AHvLZau767AnNKv4hqoSN2-INIQaKivF-aBxYwrt6sMCVAKsY54uiSmGeONOLlQzhuoZ_QWOulhZ_eihML0nt-5dv2232PrGLt2FlIpXFh6-pJsSkL5KyVJDPuTJt2HVoCM1iULTKU3mscI2CBWTo4kT1F)\nresults from PREPARE(1), a prospective, multicenter, randomized controlled\ntrial (RCT) evaluating PuraPly(®)AM (PCMP) plus standard of care (SoC)\ncompared to SoC alone in hard-to-heal diabetic foot ulcers (DFUs). The trial\nachieved its primary endpoint, and the results published in the Journal of\nWound Care\n(https://www.globenewswire.com/Tracker?data=2R0PudOfd-Hnh94C5uH-j6X1lvtu7oFwZbzRpoMUamLr64QHByVV_hRZHa83PoqBX4aSQaB5amI7uUwNln214IwSZdfaqQHsdxEkpiFC7ZL9I04dJ1F3ZM9KGKdA0PGzpaI7E6mrFYkNYKnRgf0ZI7R_J4tFfq64leowTCiUd1c=)\ndemonstrate statistically significant improvements in wound closure at 12\nweeks among patients treated with PuraPly(®)AM plus SoC, providing clinical\nevidence supporting the use of PuraPly(®)AM in one of the most costly and\ndifficult-to-treat chronic wound populations.\n\n\"The PREPARE study adds to our large and growing body of data for PuraPly AM,\nincluding real-world evidence from registry and comparative effectiveness\nstudies, and health economics and outcomes research,\" said Patrick Bilbo,\nChief Operating Officer of Organogenesis. \"We expect this evidence to form the\nbasis for future coverage decisions for PuraPly AM. Peer-reviewed data\ncontinues to differentiate us in a recalibrated market where Organogenesis is\ngaining share while competitors without comparable evidence are pivoting away\nfrom wound care or exiting the market altogether.\"\n\nAbout PuraPly(®)AM\n\nPuraPly(®)AM is a patent-protected native, cross-linked extracellular matrix\nscaffold with sustained antimicrobial effectiveness within the product to\nsupport wound healing as a protective barrier. PuraPly(®)AM is indicated for\nthe management of partial- and full-thickness wounds, including diabetic foot\nulcers, pressure injuries, venous leg ulcers, surgical wounds and traumatic\nwounds.\n\nAbout Organogenesis Holdings Inc.\n\nOrganogenesis Holdings Inc. is a leading regenerative medicine company focused\non the development, manufacture, and commercialization of solutions for the\nAdvanced Wound Care and Surgical and Sports Medicine markets. Organogenesis\noffers a comprehensive portfolio of innovative regenerative and tissue\nproducts to address patient needs across the continuum of care. For more\ninformation, visit www.organogenesis.com.\n\nForward-Looking Statements\n\nThis release contains forward-looking statements within the meaning of the\nPrivate Securities Litigation Reform Act of 1995. These forward-looking\nstatements relate to expectations or forecasts of future events.\nForward-looking statements may be identified by the use of words such as\n“future,” “plan,” “believe,” “intend,” “seek,”\n“anticipate,” “expect,” “outlook,” and “project” and other\nsimilar expressions that predict or indicate future events or trends or that\nare not statements of historical matters. Such forward-looking statements\ninclude statements relating to the Company’s expectations and beliefs\nregarding PuraPly AM’s inclusion in future coverage policies and\nopportunities for PuraPly AM to generate revenue for the Company.\nForward-looking statements with respect to the operations of the Company,\nstrategies, prospects, and other aspects of the business of the Company are\nbased on current expectations that are subject to known and unknown risks and\nuncertainties, which could cause actual results or outcomes to differ\nmaterially from expectations expressed or implied by such forward-looking\nstatements. These factors include, but are not limited to: (1) the impact of\ncoverage and reimbursement levels for PuraPly AM and the Company’s other\nproducts, particularly in light of CMS’ updated 2026 Medicare reimbursement\nand coverage changes; (2) the Company faces significant and continuing\ncompetition, which could adversely affect its business, results of operations\nand financial condition; (3) rapid technological change could cause the\nCompany’s products to become obsolete and if the Company does not enhance\nits product offerings through its research and development efforts, it may be\nunable to effectively compete; (4) to be commercially successful, the Company\nmust convince physicians that its products are safe and effective alternatives\nto existing treatments and that its products should be used in their\nprocedures; (5) the Company’s ability to raise funds; (6) the Company has\nincurred losses in the prior periods and may incur losses in the future; (7)\nchanges in applicable laws or regulations; (8) the possibility that the\nCompany may be adversely affected by other economic, business, and/or\ncompetitive factors; (9) the Company’s ability to maintain production or\nobtain supply of its products in sufficient quantities to meet demand; (10)\nthe Company’s ability to build out its Smithfield, Rhode Island facility on\ntime and on budget; (11) whether the Company is able to obtain regulatory\napproval for and successfully commercialize ReNu; and (12) other risks and\nuncertainties described in the Company’s filings with the Securities and\nExchange Commission, including Item 1A (Risk Factors) of the Company’s Form\n10-K for the year ended December 31, 2025 and its subsequently filed periodic\nreports. You are cautioned not to place undue reliance upon any\nforward-looking statements, which speak only as of the date made. Although it\nmay voluntarily do so from time to time, the Company undertakes no commitment\nto update or revise the forward-looking statements, whether as a result of new\ninformation, future events or otherwise, except as required by applicable\nsecurities laws.\n\n(1) Prospective, Randomized controlled trial assessing the Efficacy of a\nnative type 1 collagen extracellular matrix plus Polyhexamethylene biguanide\nAntimicrobial and standard of Care versus standard of Care alone in the\nManagement of hard-to-heal diabetic foot ulcers.\n\nContacts\nInvestor Inquiries: ICR Healthcare, Mike Piccinino, CFA, OrganoIR@westwicke.com\nPress and Media Inquiries: Cheston Turbyfill, cturbyfill@organo.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/9c2f551f-b7b2-403a-bf43-78f1889401e5)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXbxmNk9-20261012","title":"Organogenesis Announces Publication of Peer-Reviewed PREPARE Trial Results Demonstrating Clinical Benefit of PuraPly®AM for Hard-to-Heal Diabetic Foot Ulcers","author":"Globe Newswire","ticker":"ORGO","created":"2026-10-12T20:10:00.121Z","tickers":["ORGO"],"exchange":"NASDAQ","article_body":"CANTON, Mass., Oct. 12, 2026 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc.\n(Nasdaq: ORGO), a leading regenerative medicine company focused on product\nsolutions for the Advanced Wound Care and Surgical and Sports Medicine\nmarkets, today announced the publication of previously released\n(https://www.globenewswire.com/Tracker?data=UT6vCmBG4RY4blNNuDvWK07jzej20eV51PreBetsG27G8wxV83SJAjN8_-ggMHc-NrvmZmVjBaMel-fMUSjR4QO6J6pzSpM9oR-0X6AHvLZau767AnNKv4hqoSN2-INIQaKivF-aBxYwrt6sMCVAKsY54uiSmGeONOLlQzhuoZ_QWOulhZ_eihML0nt-5dv2232PrGLt2FlIpXFh6-pJsSkL5KyVJDPuTJt2HVoCM1iULTKU3mscI2CBWTo4kT1F)\nresults from PREPARE(1), a prospective, multicenter, randomized controlled\ntrial (RCT) evaluating PuraPly(®)AM (PCMP) plus standard of care (SoC)\ncompared to SoC alone in hard-to-heal diabetic foot ulcers (DFUs). The trial\nachieved its primary endpoint, and the results published in the Journal of\nWound Care\n(https://www.globenewswire.com/Tracker?data=2R0PudOfd-Hnh94C5uH-j6X1lvtu7oFwZbzRpoMUamLr64QHByVV_hRZHa83PoqBX4aSQaB5amI7uUwNln214IwSZdfaqQHsdxEkpiFC7ZL9I04dJ1F3ZM9KGKdA0PGzpaI7E6mrFYkNYKnRgf0ZI7R_J4tFfq64leowTCiUd1c=)\ndemonstrate statistically significant improvements in wound closure at 12\nweeks among patients treated with PuraPly(®)AM plus SoC, providing clinical\nevidence supporting the use of PuraPly(®)AM in one of the most costly and\ndifficult-to-treat chronic wound populations.\n\n\"The PREPARE study adds to our large and growing body of data for PuraPly AM,\nincluding real-world evidence from registry and comparative effectiveness\nstudies, and health economics and outcomes research,\" said Patrick Bilbo,\nChief Operating Officer of Organogenesis. \"We expect this evidence to form the\nbasis for future coverage decisions for PuraPly AM. Peer-reviewed data\ncontinues to differentiate us in a recalibrated market where Organogenesis is\ngaining share while competitors without comparable evidence are pivoting away\nfrom wound care or exiting the market altogether.\"\n\nAbout PuraPly(®)AM\n\nPuraPly(®)AM is a patent-protected native, cross-linked extracellular matrix\nscaffold with sustained antimicrobial effectiveness within the product to\nsupport wound healing as a protective barrier. PuraPly(®)AM is indicated for\nthe management of partial- and full-thickness wounds, including diabetic foot\nulcers, pressure injuries, venous leg ulcers, surgical wounds and traumatic\nwounds.\n\nAbout Organogenesis Holdings Inc.\n\nOrganogenesis Holdings Inc. is a leading regenerative medicine company focused\non the development, manufacture, and commercialization of solutions for the\nAdvanced Wound Care and Surgical and Sports Medicine markets. Organogenesis\noffers a comprehensive portfolio of innovative regenerative and tissue\nproducts to address patient needs across the continuum of care. For more\ninformation, visit www.organogenesis.com.\n\nForward-Looking Statements\n\nThis release contains forward-looking statements within the meaning of the\nPrivate Securities Litigation Reform Act of 1995. These forward-looking\nstatements relate to expectations or forecasts of future events.\nForward-looking statements may be identified by the use of words such as\n“future,” “plan,” “believe,” “intend,” “seek,”\n“anticipate,” “expect,” “outlook,” and “project” and other\nsimilar expressions that predict or indicate future events or trends or that\nare not statements of historical matters. Such forward-looking statements\ninclude statements relating to the Company’s expectations and beliefs\nregarding PuraPly AM’s inclusion in future coverage policies and\nopportunities for PuraPly AM to generate revenue for the Company.\nForward-looking statements with respect to the operations of the Company,\nstrategies, prospects, and other aspects of the business of the Company are\nbased on current expectations that are subject to known and unknown risks and\nuncertainties, which could cause actual results or outcomes to differ\nmaterially from expectations expressed or implied by such forward-looking\nstatements. These factors include, but are not limited to: (1) the impact of\ncoverage and reimbursement levels for PuraPly AM and the Company’s other\nproducts, particularly in light of CMS’ updated 2026 Medicare reimbursement\nand coverage changes; (2) the Company faces significant and continuing\ncompetition, which could adversely affect its business, results of operations\nand financial condition; (3) rapid technological change could cause the\nCompany’s products to become obsolete and if the Company does not enhance\nits product offerings through its research and development efforts, it may be\nunable to effectively compete; (4) to be commercially successful, the Company\nmust convince physicians that its products are safe and effective alternatives\nto existing treatments and that its products should be used in their\nprocedures; (5) the Company’s ability to raise funds; (6) the Company has\nincurred losses in the prior periods and may incur losses in the future; (7)\nchanges in applicable laws or regulations; (8) the possibility that the\nCompany may be adversely affected by other economic, business, and/or\ncompetitive factors; (9) the Company’s ability to maintain production or\nobtain supply of its products in sufficient quantities to meet demand; (10)\nthe Company’s ability to build out its Smithfield, Rhode Island facility on\ntime and on budget; (11) whether the Company is able to obtain regulatory\napproval for and successfully commercialize ReNu; and (12) other risks and\nuncertainties described in the Company’s filings with the Securities and\nExchange Commission, including Item 1A (Risk Factors) of the Company’s Form\n10-K for the year ended December 31, 2025 and its subsequently filed periodic\nreports. You are cautioned not to place undue reliance upon any\nforward-looking statements, which speak only as of the date made. Although it\nmay voluntarily do so from time to time, the Company undertakes no commitment\nto update or revise the forward-looking statements, whether as a result of new\ninformation, future events or otherwise, except as required by applicable\nsecurities laws.\n\n(1) Prospective, Randomized controlled trial assessing the Efficacy of a\nnative type 1 collagen extracellular matrix plus Polyhexamethylene biguanide\nAntimicrobial and standard of Care versus standard of Care alone in the\nManagement of hard-to-heal diabetic foot ulcers.\n\nContacts\nInvestor Inquiries: ICR Healthcare, Mike Piccinino, CFA, OrganoIR@westwicke.com\nPress and Media Inquiries: Cheston Turbyfill, cturbyfill@organo.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/9c2f551f-b7b2-403a-bf43-78f1889401e5)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-12T20:10:00.160565974Z","server_sent_at_ms":1791835800160},"received_at":"2026-10-12T20:10:00.290Z","source_url":null},"analysis":{"id":"155128","press_release_id":"166789","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["results were previously released; publication is incremental rather than new data","commercial benefit contingent on future payer coverage decisions amid CMS 2026 reimbursement changes"],"eventType":"clinical_trial","narrative":"Organogenesis announced peer-reviewed publication of PREPARE trial results for PuraPly AM in the Journal of Wound Care.\n\nThe randomized controlled trial met its primary endpoint, showing statistically significant improvements in 12-week wound closure for hard-to-heal diabetic foot ulcers versus standard of care alone.\n\nManagement expects the data to support future coverage decisions, which matter given CMS's updated 2026 Medicare reimbursement changes.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Peer-reviewed PREPARE data strengthens PuraPly AM's coverage-case in a recalibrated wound-care market."},"keyFigures":{"drugName":"PuraPly AM (PCMP)","phaseOfTrial":"Prospective, multicenter randomized controlled trial","customDimensions":{"endpoint":"primary endpoint achieved","timepoint":"wound closure at 12 weeks"}},"quotedText":"We expect this evidence to form the basis for future coverage decisions for PuraPly AM.","namedEntities":{"people":[{"name":"Patrick Bilbo","role":"Chief Operating Officer"},{"name":"Mike Piccinino","role":"Investor relations contact, ICR Healthcare"},{"name":"Cheston Turbyfill","role":"Press and media contact"}],"products":["PuraPly AM","ReNu"],"companies":[{"name":"Organogenesis Holdings Inc.","ticker":"ORGO"},{"name":"Journal of Wound Care","relationship":"publisher of peer-reviewed results"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Publication of previously released PREPARE trial results in a peer-reviewed journal; no new clinical data disclosed. Incremental support for reimbursement/coverage decisions rather than a market-moving event."},"tickerRelevance":{"others":[],"primary":"ORGO"},"globalImportance":20,"audienceRelevance":15,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"peer-reviewed publication of previously released data","sectorWeight":"moderate — reimbursement-relevant but no new results"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Organogenesis announced peer-reviewed publication of PREPARE trial results for PuraPly AM in the Journal of Wound Care.\n\nThe randomized controlled trial met its primary endpoint, showing statistically significant improvements in 12-week wound closure for hard-to-heal diabetic foot ulcers versus standard of care alone.\n\nManagement expects the data to support future coverage decisions, which matter given CMS's updated 2026 Medicare reimbursement changes.","key_figures":{"drugName":"PuraPly AM (PCMP)","phaseOfTrial":"Prospective, multicenter randomized controlled trial","customDimensions":{"endpoint":"primary endpoint achieved","timepoint":"wound closure at 12 weeks"}},"named_entities":{"people":[{"name":"Patrick Bilbo","role":"Chief Operating Officer"},{"name":"Mike Piccinino","role":"Investor relations contact, ICR Healthcare"},{"name":"Cheston Turbyfill","role":"Press and media contact"}],"products":["PuraPly AM","ReNu"],"companies":[{"name":"Organogenesis Holdings Inc.","ticker":"ORGO"},{"name":"Journal of Wound Care","relationship":"publisher of peer-reviewed results"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-12T20:10:04.833Z","global_importance":20,"audience_relevance":15,"importance_components":{"tickerTier":"small-cap","eventGravity":"peer-reviewed publication of previously released data","sectorWeight":"moderate — reimbursement-relevant but no new results"}},"durationMs":4528,"modelName":"glm-5.3-flashx"}}