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

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.CivaTech Oncology has developed a membrane-like brachytherapy device – CivaSheet® – that is truly customizable to a specific patient’s condition and offers a novel unidirectional option to shield healthy tissue. CivaSheet brachytherapy has been shown to minimize exposure of healthy tissue to radiation, thus reducing treatment-induced side effects while potentially delivering a higher dose of radiation to the target tissues compared to external beam or other forms of radiation treatment. CivaSheet has not gained reimbursement pathways as anticipated during the Parent Grant’s budget. In this Administrative Supplement, we request additional funds to support the use of CivaSheet for lung cancer patients.