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Celularity Receives Healthcare Common Procedure Coding System (HCPCS) Q Code Approval From the U.S. Centers for Medicare & Medicaid Services for Biovance 3L

Celularity Receives Healthcare Common Procedure Coding System (HCPCS) Q Code Approval From the U.S. Centers for Medicare & Medicaid Services for Biovance 3L

Celularity 获得美国医疗保险和医疗补助服务中心的 Biovance 3L 医疗保健通用程序编码系统 (HCPCS) Q 代码批准
GlobeNewswire ·  03/26 09:00

Nationally Established Q Code Will Further Support the Use of Biovance 3L by Physicians to Treat Wound Care Patients in Office Settings

全国制定的Q码将进一步支持医生在办公室环境中使用Biovance 3L治疗伤口护理患者

FLORHAM PARK, N.J., March 26, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) ("Celularity"), a regenerative medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a Healthcare Common Procedure Coding System (HCPCS) Q code for Biovance 3L, a tri-layer allograft derived from placental tissue intended for use as a biological membrane covering barrier or wrap that acts as a scaffold for restoration of functional tissue in partial- and full-thickness, acute and chronic wounds. The designated HCPCS Q code is Q4283 and is available starting April 1, 2024.

新泽西州弗洛勒姆公园,2024 年 3 月 26 日(GLOBE NEWSWIRE)— Celularity Inc. 纳斯达克股票代码:CELU)(“Celularity”)是一家开发胎盘衍生异基因细胞疗法和先进生物材料产品的再生医学公司,今天宣布,美国医疗保险和医疗补助服务中心(CMS)已授予Biovance 3L的医疗保健通用程序编码系统(HCPCS)Q码,Biovance 3L是一种源自胎盘组织的三层同种异体移植物,用作生物膜覆盖屏障或包裹,用作修复局部和全厚度、急性和慢性伤口中的功能组织的支架。指定的 HCPCS Q 代码为 Q4283,自 2024 年 4 月 1 日起上线。

"The HCPCS Q code approval by CMS further recognizes Biovance 3L as an important therapeutic option for the treatment of wounds," said Dr. Robert J. Hariri, M.D., Ph.D., Celularity CEO, chairman and founder. "The medical community has been rapidly adopting this product, and the HCPCS Q code approval paves the way for Biovance 3L to realize additional growth, enabling the potential to impact more lives. As one of our leading biomaterial products, we are excited about the potential impact this approval may have on Celularity's performance throughout the remainder of 2024 and beyond. We will continue to innovate in this important part of our business and look forward to providing future updates."

Celularity首席执行官、董事长兼创始人罗伯特·哈里里博士说:“CMS批准的HCPCSQ代码进一步认可Biovance 3L是治疗伤口的重要治疗选择。”“医学界一直在迅速采用该产品,HCPCS Q码批准为Biovance 3L实现额外增长铺平了道路,从而有可能影响更多生活。作为我们领先的生物材料产品之一,我们对该批准可能对Celularity在2024年剩余时间及以后的业绩产生的潜在影响感到兴奋。我们将继续在业务的这一重要部分进行创新,并期待提供未来的更新。”

The Healthcare Common Procedure Coding System (HCPCS) is produced by the Centers for Medicare and Medicaid Services (CMS). HCPCS is a group of standardized codes that represent medical procedures, supplies, products, and services. The codes are used to facilitate the processing of health insurance claims by Medicare and other insurers. The Q codes are established to identify drugs, biologicals, and medical equipment or services not identified by national HCPCS Level II codes but for which codes are needed for Medicare claims processing. HCPCS code modifiers are established internally by CMS to facilitate accurate Medicare claims processing.

医疗保健通用程序编码系统(HCPCS)由医疗保险和医疗补助服务中心(CMS)制定。HCPCS 是一组代表医疗程序、用品、产品和服务的标准化代码。这些守则用于促进医疗保险和其他保险公司处理健康保险索赔。Q代码的建立是为了识别药物、生物制剂和医疗设备或服务,这些药物、生物制品和医疗设备或服务未被国家HCPCS二级代码识别,但医疗保险索赔处理需要哪些代码。HCPCS 代码修改器由 CMS 内部建立,旨在促进准确的医疗保险索赔处理。

Biovance 3L's unique tri-layer membrane construction is designed for improved handling and ease of use as a covering, barrier, or wrap to surgical sites. The three-dimensional design provides more surface area, allows for suturing as required, and serves as a cell-friendly structure that promotes cell attachment within hours.

Biovance 3L 独特的三层膜结构旨在改善操作性并易于使用,可用作手术部位的覆盖物、屏障或包裹。三维设计可提供更大的表面积,允许根据需要进行缝合,并且是一种细胞友好结构,可在数小时内促进细胞附着。

About Celularity
Celularity Inc. (NASDAQ: CELU) is a regenerative medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Its therapeutic programs target aging-related diseases, including degenerative diseases, cancer, and immune disorders, using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. Celularity believes that, by harnessing the placenta's unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.

关于 Celularity
Celularity Inc. (NASDAQ: CELU) 是一家再生医学公司,开发和商业化先进的生物材料产品和异基因、冷冻保存、胎盘衍生的细胞疗法,全部源自产后胎盘。其治疗计划针对与衰老相关的疾病,包括退行性疾病、癌症和免疫障碍,使用间充质样粘附基质细胞(MLASC)、用CAR(CAR T细胞)设计的T细胞以及转基因和未改造的自然杀伤(NK)细胞。Celularity认为,通过利用胎盘的独特生物学和现成可用性,它可以开发治疗解决方案,以满足全球对有效、可获得和负担得起的疗法的重大未满足的需求。

Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of The U.S. Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts are "forward-looking statements," including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "can," "contemplate," "continue," "could," "estimate," "expect," "forecast," "intends," "may," "might," "outlook," "plan," "possible," "potential," "predict," "project," "seek," "should," "strive," "target," "will," "would" and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. The forward-looking statements in this press release include , without limitation, the ability of physicians to utilize Biovance 3L for the treatment of wound care patients in office settings, the timing for reimbursement to commence, the effectiveness of Biovance 3L as a treatment option for wounds, the impact of Biovance 3L on patient lives, the adoption of Biovance 3L by the medical community, the ability of Celularity to meet physician demand and its impact on Celularity's performance throughout the remainder of 2024 and beyond, and Celularity's ability to innovate its biomaterials business, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: Celularity's liquidity situation; the volatility in Celularity's stock price; inherent risks in biotechnological development, including with respect to the development of novel biomaterial therapies; ; along with those risk factors set forth under the caption "Risk Factors" in Celularity's annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31, 2023, 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's 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's views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

前瞻性陈述
本新闻稿包括 “前瞻性陈述”,其含义是 这个 1995 年美国私人证券诉讼改革法案,以及经修订的 1933 年《美国证券法》第 27A 条和经修订的 1934 年《美国证券交易法》第 21E 条的定义。 除历史事实陈述以外的所有陈述均为 “前瞻性陈述”,包括与未来事件有关的陈述。在某些情况下,您可以使用 “预测”、“相信”、“可以”、“考虑”、“继续”、“可能”、“估计”、“预期”、“预测”、“打算”、“可能”、“展望”、“展望”、“计划”、“可能”、“潜在”、“预测”、“项目”、“寻求”、“应该”、“应该”、“应该”、“应该”、“”、“应该”、“”、“应该”、“”、“应该”、“”、“应该”、“” “应该” 等术语来识别前瞻性陈述努力”、“目标”、“意愿”、“将” 以及此类术语或其他类似术语的否定词语以及其他具有相似含义的词语或术语。本新闻稿中的前瞻性陈述包括但不限于医生在办公室使用Biovance 3L治疗伤口护理患者的能力、开始报销的时机、Biovance 3L作为伤口治疗选择的有效性、Biovance 3L对患者生活的影响、医学界对Biovance 3L的采用、Celularity满足医生需求的能力及其对患者的影响 Celularity 在 2024 年剩余时间及以后的表现,以及 Celularity 的能力创新其生物材料业务等。许多因素可能导致实际业绩与这些前瞻性陈述中描述的结果存在重大差异,包括但不限于:Celularity的流动性状况;Celularity股价的波动;生物技术发展的固有风险,包括与开发新型生物材料疗法有关的风险;以及Celularity向美国证券交易委员会提交的10-K表年度报告中 “风险因素” 标题下列出的风险因素(SEC) 于 2023 年 3 月 31 日提交,以及向美国证券交易委员会提交的其他文件秒。如果这些风险中有任何一项成为现实或基本假设被证明不正确,则实际结果可能与这些前瞻性陈述所暗示的结果存在重大差异。可能还有Celularity目前不知道的其他风险,或者Celularity目前认为这些风险并不重要,也可能导致实际业绩与前瞻性陈述中包含的结果有所不同。此外,这些前瞻性陈述反映了Celularity当前对未来事件的预期、计划或预测,以及截至本通讯发布之日的观点。随后的事件和事态发展可能会导致评估发生变化。因此,不应依赖前瞻性陈述来代表Celularity自其后任何日期以来的观点,除非适用的证券法另有要求,否则Celularity没有义务更新前瞻性陈述以反映本文发布之日之后的事件或情况,无论是由于新信息、未来事件还是其他原因造成的。

Investor Contact:
Carlos Ramirez
Senior Vice President, Celularity Inc.
Carlos.ramirez@celularity.com

投资者联系人:
卡洛斯·拉米雷斯
Celularity Inc. 高级副总裁
Carlos.ramirez@celularity.com

Media Contacts:
Ali Nagy / Michaela Fawcett
KCSA Strategic Communications
anagy@kcsa.com / mfawcett@kcsa.com

媒体联系人:
Ali Nagy /Michaela Fawcett
KCSA 战略传播
anagy@kcsa.com / mfawcett@kcsa.com


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