Commercializing CivaSheet for Pancreatic Cancer Patients

将 CivaSheet 商业化用于胰腺癌患者

• 批准号: 10684454
• 负责人: Kristy Perez
• 金额: $ 186.48万
• 依托单位: CIVATECH ONCOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-13 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10684454
• 关键词: Abdomen; Address; Adverse event; Affect; American; Automation; Award; Awareness; Blood Vessels; Brachytherapy; Brachytherapy Seeds; COVID-19 pandemic effects; Caring; Clinical; Clinical Trials; Conduct Clinical Trials; Cost Analysis; Data; Data Analyses; Devices; Diagnosis; Discipline of Nuclear Medicine; Disease; Disease Progression; Dose; Duodenum; Electromagnetic Energy; Eligibility Determination; Encapsulated; Engineering; Excision; Funding; Generations; Goals; Grant; Health; Healthcare Systems; Hospitals; Implant; Industry; Kidney; Liver; Local Therapy; Localized Disease; Localized Malignant Neoplasm; Malignant Neoplasms; Malignant neoplasm of pancreas; Marketing; Membrane; Microinvasive; Mission; Neutrons; North Carolina; Nuclear Reactors; Oncology; Operative Surgical Procedures; Organ; Outcome; Overdose; Palladium 103; Pancreas; Patients; Phase; Phase I/II Clinical Trial; Physics; Polymers; Privatization; Process; Production; Publications; Quality of life; Radiation; Radiation Dose Unit; Radiation Tolerance; Radiation therapy; Radioactive; Recurrence; Recurrent disease; Request for Proposals; Resected; Retroperitoneal Space; Shapes; Side; Small Business Innovation Research Grant; Source; Stomach; Structure; Surgical margins; Survival Rate; System; Techniques; Testing; Time; Tissues; Toxic effect; United States; United States National Institutes of Health; Universities; Vendor; Work; cancer diagnosis; combination cancer therapy; commercialization; cost; cost outcomes; disorder control; dosimetry; economic evaluation; economic outcome; health care economics; health economics; improved; improved outcome; innovation; manufacturability; manufacture; manufacturing capabilities; manufacturing process; manufacturing scale-up; manufacturing systems; microchip; minimally invasive; novel; pancreatic cancer patients; prevent; professor; programs; radiation delivery; screening; seal; success; tumor

CivaTech Oncology’s mission is to provide improved radiation therapy directly to diseased tissues while sparing healthy tissues. With NIH/NCI SBIR support, the Company has eliminated local recurrence of disease in pancreatic cancer patients – a huge success. Pancreatic cancer is predicted to soon become the most commonly diagnosed cancer in the US and there are no significant, impactful therapies making a difference. However, CivaTech 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, implantable planar device 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 outcomes for many indications, in particular, for pancreatic cancer. 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 in the abdomen. In clinical trials, patients are recovering from their surgical procedures without negative effects from the device. CivaTech Oncology has confirmed no radiation related adverse events, no device-related toxicity. CivaSheet delivers substantially less radiation to adjacent duodenum, stomach, liver, and kidneys compared to other forms of radiation delivery and has targeted dosimetry for pancreatic cancer. CivaSheet greatly benefits these patients by delivering localized radiation therapy at the time of initial surgery to protect against local recurrence. Pancreatic cancer is an aggressive disease that progresses quickly and has about 30% local recurrence rates. Over the course of the SBIR Fast Track Grant, CivaTech has collected clinical evidence that the CivaSheet is highly effective and has a 100% local control rate for pancreatic cancer patients. These data will be compiled and compared to hospital-based outcomes for SOC patients to complete a healthcare economic analysis. Preventing local recurrence while maintaining quality of life is highly impactful for patients and for the healthcare system. This Phase IIB proposal requests funds for the healthcare economic analysis and compiling a dossier that will be presented to hospitals’ value analysis committees, private payors, and CMS. Additionally, this proposal aims to provide engineering support to increase manufacturability and improve our ability to supply products to meet the projected demand following the publication of our clinical trial data. CivaSheet is a truly unique brachytherapy device that has the potential to become the first line of defense for localized cancer and has data to demonstrate it can substantially reduce recurrence rates after a surgical tumor removal. CivaTech Oncology is committed to making CivaSheet available to improve outcomes of pancreatic cancer patients.

Civatech肿瘤学的使命是直接向解剖组织提供改进的放射治疗 保留健康的组织。在NIH/NCI SBIR的支持下，该公司消除了局部疾病的复发 在胰腺癌患者中 - 取得了巨大成功。预计胰腺癌很快成为最大的 通常在美国被诊断出癌症，没有明显的影响疗法有所作为。 但是，Civatech开发了一种新颖的聚合物封装，膜状辐射源，发出 设备的一侧仅辐射 - civasheet®。此定向源与开放和 微创手术技术，并具有FDA清除率可用作癌症或联合癌症 治疗。 Civasheet是一种可生物吸收的，可植入的平面设备，可以在初始时应用 外科手术。 Civasheet减少了手术和放射疗法之间的时间，这对 胰腺癌的许多迹象的结果。此外，Civasheet可以屏蔽健康 组织同时照射解剖的组织或肿瘤边缘。这种屏蔽使得civasheet植入 接近放射线敏感的结构而不会过量服用 - 对于腹部的癌症来说，这是一个巨大的优势。 在临床试验中，患者正在从其外科手术中恢复，而没有对设备产生负面影响。 Civatech肿瘤学证实没有相关的广告事件，没有与设备有关的毒性。 Civasheet 与其他 辐射递送的形式，已针对胰腺癌的剂量测定法。 Civasheet极大地受益 患者在初次手术时提供局部放射治疗以防止局部 复发。胰腺癌是一种侵略性疾病，迅速发展，本地约30％ 复发率。在SBIR快速拨款的过程中，Civatech收集了临床证据 Civasheet非常有效，胰腺癌患者具有100％的局部控制率。 这些数据将进行编译，并将其与基于医院的结果进行比较，以使SOC患者完成 医疗保健经济分析。在维持生活质量的同时防止当地复发具有很高的影响力 适用于患者和医疗保健系统。 此阶段IIB提案要求资金进行医疗保健经济分析，并汇编档案 呈现给医院的价值分析委员会，私人付款人和CMS。此外，此提案 旨在提供工程支持以增加制造业并提高我们提供产品的能力 出版我们的临床试验数据后，满足预计需求。 Civasheet是一个真正独特的 近距离放射疗法有可能成为局部癌症的第一道防线，并且具有 数据以证明其可以大大降低手术肿瘤后的复发率。 Civatech 肿瘤学致力于使Civasheet可用，以改善胰腺癌患者的预后。