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 Oncology的使命是直接向病变组织提供改进的放射治疗， 从而保护健康组织。在NIH/NCI SBIR的支持下，该公司消除了疾病的局部复发 在胰腺癌患者身上取得了巨大的成功。据预测，胰腺癌很快将成为 在美国，这是一种常见的诊断癌症，没有显著的、有影响力的治疗方法。 然而，CivaTech已经开发出一种新型的、聚合物封装的、膜状辐射源，可以发射 仅在设备的一侧进行辐射- CivaSheet®。该定向源兼容开放式和 微创手术技术，并已获得FDA批准，可用作原发性或合并性癌症 疗法CivaSheet是一种生物可吸收、可植入的平面器械，可在初次植入时应用。 手术CivaSheet缩短了手术和放射治疗之间的时间，这对患者有益。 许多适应症的结果，特别是胰腺癌。此外，CivaSheet可以保护健康 在照射患病组织或肿瘤边缘的同时，这种屏蔽使CivaSheet能够被植入 靠近放射敏感结构而不会过量-这对腹部癌症来说是一个巨大的优势。 在临床试验中，患者正在从手术中恢复，没有器械的负面影响。 CivaTech Oncology已确认无辐射相关不良事件，无器械相关毒性。CivaSheet 与其他治疗相比， 放射治疗的形式，并有针对性的剂量测定胰腺癌。CivaSheet大大有利于这些 患者在初次手术时进行局部放射治疗，以防止局部 复发胰腺癌是一种侵袭性疾病，进展迅速，约有30%的局部 复发率在SBIR快速通道资助的过程中，CivaTech收集了临床证据， CivaSheet对胰腺癌患者的局部控制率为100%。 将对这些数据进行汇编，并与SOC患者的基于医院的结局进行比较，以完成 卫生经济分析。在保持生活质量的同时预防局部复发具有高度影响力 对于患者和医疗保健系统来说。 本IIB期提案要求为医疗保健经济分析和编制档案提供资金， 提交给医院的价值分析委员会，私人付款人和CMS。此外，该提案 旨在提供工程支持，以提高可制造性，并提高我们向客户提供产品的能力， 满足临床试验数据公布后的预期需求。CivaSheet是一个真正独特的 近距离放射治疗设备，有可能成为局部癌症的第一道防线， 数据来证明它可以大大降低手术切除肿瘤后的复发率。CivaTech 肿瘤学致力于使CivaSheet可用于改善胰腺癌患者的预后。