NEWTON, Mass.--(BUSINESS WIRE)--Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved its application for transitional pass-through (TPT) status for LUMISIGHT™ (pegulicianine) under the Medicare hospital outpatient prospective payment system (OPPS)..

马萨诸塞州牛顿市（商业新闻短讯）--Lumecell，Inc.，一家专注于开发用于手术过程中癌组织检测的创新荧光引导成像技术的私营公司，今天宣布，医疗保险和医疗补助服务中心（CMS）已批准其在医疗保险医院门诊预期支付系统（OPPS）下申请LUMISIGHT™（pegulicianine）的过渡通过（TPT）状态。。

The new Healthcare Common Procedure Coding System (HCPCS) drug TPT code (C9171 Injection, pegulicianine, 1 mg) may be used to bill CMS for LUMISIGHT when it is used in the treatment of Medicare beneficiaries in the hospital outpatient setting starting October 1, 2024.

自2024年10月1日起，新的医疗保健通用程序编码系统（HCPCS）药物TPT代码（C9171注射液，pegulicianine，1 mg）可用于在医院门诊治疗医疗保险受益人时为LUMISIGHT开具CMS账单。

The TPT payment is a mechanism created by the CMS to increase patient access to new and truly innovative technologies, such as LUMISIGHT, by facilitating adequate payment of new technologies. TPT will provide additional Medicare payment for LUMISIGHT for 2 to 3 years, and during this time, Medicare will collect and assess the data in consideration of future payments..

TPT支付是CMS创建的一种机制，通过促进新技术的充分支付，增加患者获得新的和真正创新的技术，如LUMISIGHT。TPT将为LUMISIGHT提供2至3年的额外医疗保险付款，在此期间，医疗保险将收集和评估数据，以考虑未来的付款。。

“We are proud that the country's largest payer for health care recognizes the importance of our truly innovative fluorescence-guided imaging technology,' said Howard Hechler, President and COO, “enhancing patient access to LUMISIGHT while helping surgeons to find cancer that might otherwise go undetected.”.

总裁兼首席运营官霍华德·赫克勒（HowardHechler）说：“我们感到骄傲的是，美国最大的医疗保健支付方认识到我们真正创新的荧光引导成像技术的重要性，同时帮助外科医生发现可能未被发现的癌症。”。

Up to 36% of patients with breast cancer have follow-up surgeries due to positive margins and 14% of patients with negative margins after lumpectomy have cancer remaining according to clinical studies.1 When LUMISIGHT is used with Lumicell DVS during lumpectomy, together referred to as LumiSystem™, surgeons can detect and resect residual breast cancer with 84% diagnostic accuracy as an adjunct to the procedure.2.

根据临床研究，高达36%的乳腺癌患者因切缘阳性而进行了随访手术，14%的乳房肿瘤切除术后切缘阴性的患者仍有癌症残留[1]。当LUMISIGHT在乳房肿瘤切除术中与Lumecell DVS一起使用时，被称为LumiSystem™，外科医生可以检测和切除残留的乳腺癌，诊断准确率为84%，作为手术的辅助手段。

LUMISIGHT (pegulicianine) received FDA approval in April of 2024 and will be commercially available in Q4 of this year.

LUMISIGHT（pegulicianine）于2024年4月获得FDA批准，将于今年第四季度上市。

About Lumicell Inc.

关于Lumecel Inc。

Lumicell is a privately held company focused on enabling a more complete resection of cancer by advancing the development and commercialization of its innovative fluorescence guided surgery technology. The company’s lead products are LUMISIGHT™ (pegulicianine) and Lumicell™ DVS which are designed for use in combination to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the standard of care.

Lumecell是一家私营公司，致力于通过推进其创新的荧光引导手术技术的开发和商业化，实现更完整的癌症切除。该公司的主导产品是LUMISIGHT™（pegulicianine）和Lumecell™DVS，它们被设计用于在最初的乳房肿瘤切除术过程中联合用于照射乳腺腔内的癌组织，作为护理标准的辅助手段。

Lumicell’s proprietary, pan-oncologic optical imaging agent, LUMISIGHT, is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit www.Lumicell.com and follow the company on Facebook, X, and LinkedIn..

Lumecell专有的泛肿瘤光学成像剂LUMISIGHT也在探索各种实体瘤适应症的进一步发展。有关更多信息，请访问www.lumecell.com，并在Facebook、X和LinkedIn上关注该公司。。

Indications for Use

使用指示

LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery..

光学成像剂LUMISIGHT和荧光成像设备Lumecell DVS适用于乳腺癌成人的荧光成像，作为在乳房肿瘤切除术中切除主要标本后切除腔内癌组织的术中检测辅助手段。。

Important Safety Information

重要安全信息

What is LUMISIGHT (pegulicianine) and Lumicell DVS?

什么是LUMISIGHT（pegulicianine）和Lumicell DVS？

LUMISIGHT (pegulicianine), an optical fluorescence imaging agent, and Lumicell DVS, an imaging device, are used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure.

LUMISIGHT（pegulicianine）是一种光学荧光成像剂，Lumecell DVS是一种成像设备，用于成人乳腺癌患者，以帮助在肿瘤切除术中切除主要标本后检测手术部位残留的任何癌组织。

What is the most important information I should know about LUMISIGHT?

关于LUMISIGHT，我应该知道的最重要的信息是什么？

Hypersensitivity Reactions: LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG).

超敏反应：LUMISIGHT可能引起严重的超敏反应，包括过敏反应。在临床研究中，有4/726（0.6%）的患者发生了过敏反应。如果你对聚乙二醇（PEG）或造影剂或含有聚乙二醇（PEG）的产品有过敏反应史，请告诉你的医生。

Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy..

您的医疗保健提供者应在使用LUMISIGHT期间提供紧急复苏药物、设备和训练有素的人员。医疗保健提供者应监测所有患者的超敏反应，如果怀疑有患者，应立即停止注射并开始适当的治疗。。

What are the most common side effects of LUMISIGHT?

LUMISIGHT最常见的副作用是什么？

The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.

最常见的副作用（≥1%）包括过敏和尿液颜色异常。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning.

鼓励您向FDA报告处方药的负面副作用。访问MedWatch或致电1-800-FDA-1088。请参阅完整的处方信息，包括盒装警告。

What additional important information I should know about LUMISIGHT and Lumicell DVS?

关于LUMISIGHT和Lumecell DVS，我还应该了解哪些其他重要信息？

Adjunctive use: Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures.

辅助用途：Lumecell DVS用作肿块切除术的一部分，不能替代标准的护理程序和病理学。在进行任何手术之前，您的医疗保健提供者必须接受正确使用Lumecell DVS和保乳手术的培训。

Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.

误诊风险：手术中没有信号并不排除癌症。此外，在非癌组织中可能会看到阳性信号。

Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity who have received LUMISIGHT.

用于前哨淋巴结定位的染料的干扰：您的医疗保健提供者应该在对接受LUMISIGHT的乳房肿瘤切除术腔进行成像之前避免使用染料。

Tissue perforation or damage: During the procedure, your healthcare provider should avoid excessive pressure or torque with the Lumicell DVS handheld probe while inside the cavity as it can cause tissue perforation or damage.

组织穿孔或损伤：在手术过程中，您的医疗保健提供者应避免在腔内使用Lumecell DVS手持式探头产生过大的压力或扭矩，因为它可能导致组织穿孔或损伤。

Infection risk: To avoid infection risk, the reusable Lumicell DVS handheld probe and cables should be properly and completely disinfected and reprocessed after each use by your healthcare provider. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover.

感染风险：为避免感染风险，可重复使用的Lumecell DVS手持探头和电缆应在您的医疗保健提供者每次使用后进行适当彻底的消毒和再处理。您的医疗保健提供者还应确保正确使用无菌一次性探针盖。

Eye discomfort: Your healthcare provider should avoid direct eye exposure to Lumicell DVS handheld light probe as it may cause pain.

眼睛不适：您的医疗保健提供者应避免直接接触Lumecell DVS手持式光探头，因为它可能会引起疼痛。

Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use. For complete product information, visit www.LumiSystem.com.

请参阅LUMISIGHT处方信息，包括盒装警告和Lumecell DVS使用说明。有关完整的产品信息，请访问www.LumiSystem.com。

1 Dupont, et al., Ann Surg 2021; 273(5): 876-881

1杜邦等人，Ann Surg 2021；273（5）：876-881

2 Smith, et al., NEJM Evidence 2023; 2(7)

2 Smith等人，NEJM证据2023；2（7）

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