Administrative Supplement for the Evaluation of the novel, uni-directional, Pd-103 CivaSheet for Lung Cancer

母公司奖：R44 CA 217587新型单向Pd-103 CivaSheet治疗肺癌的临床评价 CivaTech Oncology的使命是直接为局部肿瘤提供改进的放射治疗。本公司已 开发了一种新型的，聚合物封装的，膜状辐射源，只在一侧发射辐射， 设备- CivaSheet®。这种定向源与开放式和微创手术技术兼容， FDA批准用作主要或联合癌症治疗。CivaSheet是一种生物可吸收植入物， 在初次手术时使用。CivaSheet缩短了手术和放射治疗之间的时间， 对患者有益。此外，CivaSheet可以屏蔽健康组织，同时照射病变组织或肿瘤 裕度这种屏蔽使CivaSheet能够被植入靠近辐射敏感结构，而不会过量- 对心脏和纵隔附近的癌症有巨大的优势。 CivaTech Oncology在病例研究中证实，CivaSheet在植入后不会移动， 可以为肺癌患者输送大量和有益剂量。CivaSheet极大地受益于这些患者， 在初次手术时进行局部放射治疗以防止局部复发， 关注肺癌患者。在SBIR快速通道家长资助期间，CivaSheet在肺部的安全性 癌症患者进行了演示，并定义了其使用的一般手术建议。 此外，SBIR快速通道父母补助金（R44 CA 217587）支持一项临床试验， 肺癌患者的肺叶切除术。植入CivaSheet的患者的局部复发率正在 评估并与20%的历史比率进行比较。作为研究的一部分，还监测了急性辐射毒性。 与其他形式的放射治疗相比，CivaSheet对相邻纵隔和心肌的辐射明显更少。 辐射输送，没有器械相关毒性的报道。 本行政补充申请旨在为临床用CivaSheets的生产和供应提供预算 试用。SBIR快速通道父母补助金预算假设CivaSheet将通过CMS和私人 付款人CivaSheet没有报销，这极大地影响了完成这项拟议工作的能力， 接触病人。有了这个行政补充，CivaTech Oncology将能够更快地完成 临床试验CivaSheet是一款真正独特的近距离放射治疗设备，有可能成为第一道防线 治疗局部癌症CivaTech Oncology致力于为癌症患者提供多个 迹象。

Parent Award: R44CA217587 Clinical Evaluation of the novel, Uni-directional Pd-103 CivaSheet for Lung Cancers CivaTech Oncology’s mission is to provide improved radiation therapy directly to localized tumors. The Company has developed a novel, polymer-encapsulated, membrane-like radiation source that emits radiation on only one side of the device – CivaSheet®. This directional source is compatible with open and minimally invasive surgical techniques and has FDA clearance to be used as primary or combined cancer therapy. CivaSheet is a bio-absorbable implant that can be applied at the time of the initial surgery. CivaSheet decreases the time between surgery and radiation therapy, which is a benefit to the patient. Additionally, CivaSheet can shield healthy tissues while irradiating the diseased tissue or tumor margin. This shielding enables CivaSheet to be implanted close to radiosensitive structures without overdosing them – a huge advantage for cancers near the heart and mediastinum. CivaTech Oncology has confirmed in case studies, that CivaSheet does not move after implantation and that a substantial and beneficial dose can be delivered for lung cancer patients. CivaSheet greatly benefits these patients by delivering localized radiation therapy at the time of initial surgery to protect against local recurrence, a significant concern for lung cancer patients. Over the course of the SBIR Fast Track Parent Grant, the safety of CivaSheet in lung cancer patients was demonstrated and general surgical recommendations for its use were defined. Additionally, the SBIR Fast Track Parent Grant (R44CA217587) supports a clinical trial to implant CivaSheet during sublobar resection of lung cancer patients. The rate of local recurrence in patients implanted with CivaSheet is being evaluated and compared to the historical rate of 20%. The acute radiation toxicity is also monitored as part of the study. CivaSheet delivers substantially less radiation to adjacent mediastinum and heart muscle compared to other forms of radiation delivery and no device related toxicity has been reported. This Administrative Supplement is requested to provide budget for the production and supply of CivaSheets for clinical trial use. The SBIR Fast Track Parent Grant budget assumed CivaSheet would be reimbursed through CMS and private payors. CivaSheet is not reimbursed and it is greatly impacting the ability to complete this proposed work and provide access to patients. With this Administrative Supplement, CivaTech Oncology will be able to more quickly complete the clinical trials. CivaSheet is a truly unique brachytherapy device that has the potential to become the first line of defense for localized cancer. CivaTech Oncology is committed to making CivaSheet available to cancer patients in multiple indications.