Statistically significant (p=0.0177) reduction in knee pain at six months

六个月时膝关节疼痛有统计学意义（p=0.0177）

Statistically significant (p<0.0001) maintenance of function at six months

六个月时功能维持有统计学意义（p<0.0001）

Transformational opportunity for Organogenesis to enter large and growing pain management market with innovative therapy

器官发生的转型机会，以创新疗法进入大型且不断增长的疼痛管理市场

Will address critical unmet medical need for all knee OA patients, including the most severe, if approved

如果获得批准，将解决所有膝关节OA患者（包括最严重的患者）尚未满足的关键医疗需求

CANTON, Mass., May 02, 2024 (GLOBE NEWSWIRE) -- 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 that its Phase 3 randomized control trial evaluating the safety and efficacy of ReNu, a cryopreserved amniotic suspension allograft (ASA), for the management of symptoms associated with knee osteoarthritis (OA) achieved its primary endpoint upon the analysis of positive top line data..

马萨诸塞州坎顿，2024年5月2日（环球通讯社）--Organogenesis Holdings Inc.（纳斯达克：ORGO）是一家领先的再生医学公司，专注于高级伤口护理以及外科和运动医学市场产品解决方案的开发，制造和商业化，今天宣布，其第三阶段随机对照试验评估了冷冻保存的羊膜悬浮同种异体移植物ReNu（ASA）治疗膝关节骨性关节炎（OA）相关症状的安全性和有效性，并在分析积极的顶线数据后达到了其主要终点。。

The study demonstrated a statistically significant reduction in knee OA pain at six months as assessed by the Western Ontario and McMaster Universities Arthritis Index pain scale compared with subjects treated with saline control. ReNu showed a favorable safety profile consistent with prior studies..

该研究表明，与用盐水对照治疗的受试者相比，西安大略省和麦克马斯特大学关节炎指数疼痛量表评估的膝关节OA疼痛在六个月时有统计学意义上的显着减轻。ReNu显示出与先前研究一致的良好安全性。。

“These top line results are a milestone achievement for Organogenesis,” said Gary S. Gillheeney, Sr., President and Chief Executive Officer of Organogenesis. “We look forward to sharing this compelling new evidence in our ongoing discussions with the FDA as we believe ReNu can provide clinically meaningful benefits where few non-surgical options exist.

器官发生总裁兼首席执行官加里·吉尔希尼（GaryS.Gillheeney）表示：“这些顶级结果是器官发生的里程碑式成就。”。“我们期待在与FDA的持续讨论中分享这一令人信服的新证据，因为我们相信ReNu可以在非手术选择很少的情况下提供临床上有意义的益处。

If approved, introducing Renu as an innovative pain management solution for the millions of patients suffering from knee OA represents a significant new addressable market opportunity for Organogenesis.”.

如果获得批准，引入Renu作为数百万膝关节OA患者的创新疼痛管理解决方案代表了器官发生的重要新的可寻址市场机会。”。

Knee OA is a degenerative joint disease that is estimated to affect nearly 31.1 million Americans and projected to grow to 34.4 million Americans by 2027. It is ranked among the most common causes of disability and poor quality of life, generally characterized by pain and functionality deficits. Up to 15 percent of knee OA patients are classified as severe (Kellgren-Lawrence [KL] grade 4).

膝关节OA是一种退行性关节疾病，估计会影响近3110万美国人，预计到2027年将增加到3440万美国人。它被列为残疾和生活质量差的最常见原因之一，通常以疼痛和功能缺陷为特征。高达15%的膝关节OA患者被归类为严重（Kellgren-Lawrence（KL）4级）。

End stage management of the disease in these patients is typically a total knee replacement when all other treatment options are exhausted..

当所有其他治疗选择都用尽时，这些患者的疾病终末期管理通常是全膝关节置换术。。

“To date, non-surgical treatment options for severe OA patients (KL 4) are limited—which represented approximately 30% of the enrolled patient population for this study,” said Adam B. Yanke, MD, PhD, Associate Professor of Orthopedics at Rush University Medical Center, a sports medicine and orthopedic surgeon and Co-Principal Investigator.

“迄今为止，严重OA患者（KL 4）的非手术治疗选择有限，约占本研究登记患者人数的30%，”拉什大学医学中心骨科副教授，运动医学和骨科外科医生兼联合首席研究员Adam B.Yanke博士说。

“These topline results provide statistically significant evidence that the use of ReNu is a safe, effective treatment option for knee OA patients, if approved.”.

“这些topline结果提供了统计学上显着的证据，表明如果获得批准，使用ReNu对膝关节OA患者是一种安全有效的治疗选择。”。

A total of 515 patients with moderate to severe symptomatic knee OA (KL severity grade 2 to grade 4) were randomized to receive a single intra-articular injection of either ReNu or saline control balanced across groups. Patients were randomized to receive ReNu (ASA) 2 mL diluted with 2 mL of saline or 4 mL saline control.

共有515名中度至重度症状性膝关节OA患者（KL严重程度2至4级）被随机分配接受单次关节内注射ReNu或生理盐水对照组。患者被随机分配接受用2 mL盐水或4 mL盐水对照稀释的2 mL ReNu（ASA）。

Statistically significant reductions in assessed knee pain (p=0.0177) were detected in the ReNu arm compared to the saline control arm six months after injection, and similar rates of adverse events were observed through 12 months of follow up. In addition to improving knee OA pain symptoms, ReNu maintained patient function compared to saline control (p < 0.0001)..

注射后6个月，与生理盐水对照组相比，ReNu组评估膝关节疼痛的统计学显着降低（p=0.0177），并且在12个月的随访中观察到类似的不良事件发生率。除了改善膝关节OA疼痛症状外，与生理盐水对照组相比，ReNu还维持了患者的功能（p<0.0001）。。

“ReNu is supported by a robust and growing volume of scientific evidence,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “Based on the positive results of this pivotal trial along with our accumulated safety and efficacy data, we now plan to request a meeting with the FDA to discuss the clinical data requirements for a Biologics License Application filing.

器官发生首席运营官帕特里克·比尔博（PatrickBilbo）表示：“ReNu得到了强有力且不断增长的科学证据的支持。“基于这项关键试验的积极结果以及我们积累的安全性和有效性数据，我们现在计划与FDA举行会议，讨论生物制剂许可证申请备案的临床数据要求。

We look forward to having an update to share later this year and to initiating further studies to expand the potential clinical indications of ReNu.”.

我们期待着在今年晚些时候分享最新信息，并启动进一步的研究，以扩大ReNu的潜在临床适应症。”。

Complete analysis of the Phase 3 prospective, double-blind, multicenter, saline-controlled, parallel group clinical trial is expected in May. A second multi-center clinical trial for ReNu is actively enrolling with full enrollment expected this year, ahead of earlier expectations.

预计5月将对3期前瞻性，双盲，多中心，盐水对照，平行组临床试验进行完整分析。第二项针对ReNu的多中心临床试验正在积极招募，预计今年将全面招募，提前于早些时候的预期。

About ReNu®

关于ReNu®

ReNu is a cryopreserved, amniotic suspension allograft (ASA) developed for the management of symptomatic knee osteoarthritis. ReNu consists of amniotic fluid cells and micronized amniotic membrane and contains cellular, growth factor, and extracellular matrix components. ReNu received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Knee OA in 2021..

ReNu是一种冷冻保存的羊膜悬浮同种异体移植物（ASA），用于治疗症状性膝骨关节炎。ReNu由羊水细胞和微粉化羊膜组成，含有细胞，生长因子和细胞外基质成分。ReNu于2021年获得了FDA膝关节OA再生医学高级治疗（RMAT）的指定。。

About Organogenesis Holdings Inc.

关于Organogenesis Holdings Inc。

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..

Organogenesis Holdings Inc.是一家领先的再生医学公司，专注于高级伤口护理以及外科和运动医学市场解决方案的开发，制造和商业化。器官发生提供了一系列创新再生产品，以满足患者在整个护理过程中的需求。。

Forward-Looking Statements

前瞻性声明

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our ReNu product. 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 “forecast,” “intend,” “if approved,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的前瞻性声明，包括有关我们ReNu产品的声明。这些前瞻性陈述涉及对未来事件的预期或预测。前瞻性陈述可以通过使用诸如“预测”、“打算”、“如果批准”、“寻求”、“目标”、“预期”、“相信”、“预期”、“估计”、“计划”、“展望”和“项目”等词语以及其他预测或指示未来事件或趋势或非历史事项陈述的类似表达来识别。

These statements concern, and these risks and uncertainties include, among others: the risks and uncertainties inherent in clinical development; that interim results are not necessarily indicative of final results; that other clinical trials of ReNu may produce different results; the likelihood and timing of possible regulatory approval and commercial launch of ReNu; determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to develop or commercialize ReNu; ongoing regulatory obligations and oversight impacting ReNu; unforeseen safety issues resulting from the administration of ReNu in patients; competing products and product candidates that may be superior to our products and product candidates; uncertainty of market acceptance and commercial success of ReNu and the impact of studies (whether conducted by us or others and whether mandated or voluntary) on the commercial success of ReNu; our ability to manufacture and manage supply components for ReNu; the availability and extent of reimbursement of ReNu from third-party payers, including private payer healthcare and insurance programs and government programs such as Medicare and.

这些陈述涉及，这些风险和不确定性包括：临床开发固有的风险和不确定性；中期结果不一定代表最终结果；ReNu的其他临床试验可能会产生不同的结果；ReNu可能获得监管部门批准和商业启动的可能性和时间；监管和行政政府部门的决定可能会延迟或限制我们开发ReNu或将其商业化的能力；影响ReNu的持续监管义务和监督；患者服用ReNu导致的不可预见的安全问题；可能优于我们的产品和候选产品的竞争产品和候选产品；ReNu的市场接受度和商业成功的不确定性以及研究（无论是由我们还是其他人进行的，无论是强制性的还是自愿的）对ReNu商业成功的影响；我们为ReNu制造和管理供应部件的能力；第三方付款人偿还ReNu的可用性和程度，包括私人付款人医疗保健和保险计划以及政府计划，如医疗保险和。

Investor Inquiries: ICR Westwicke Mike Piccinino, CFA OrganoIR@westwicke.com Press and Media Inquiries: Organogenesis communications@organo.com

投资者咨询：ICR Westwicke Mike Piccinino，CFAOrganoIR@westwicke.com新闻和媒体查询：器官发生communications@organo.com