Clinical evaluation of the novel, uni-directional, Pd-103 CivaSheet for Pancreatic Cancers

CivaTech Oncology s mission is to provide improved radiation therapy directly to localized tumorsThe Company has developed a novelpolymer encapsulatedmembrane like radiation source that emits radiation on only one side of the devicethe CivaSheetThis directional source is compatible with open and minimally invasive surgical techniques and has FDA clearance to be used as primary or combined cancer therapyThe CivaSheet is a partially bio absorbable implant that can be applied at the time of the initial surgeryThe CivaSheet decreases the time between surgery and radiation therapywhich is a benefit to the patientAdditionallythe CivaSheet can shield healthy tissues while irradiating the diseased tissue or tumor marginThis shielding enables the CivaSheet to be implanted close to radiosensitive structures without overdosing thema huge advantage for cancers in the abdomenIn Phase ICivaTech Oncology will confirm the CivaSheet does not move after implantation and that excellent dosimetry can be achievedThe CivaSheet will be implanted during the Whipple procedure for pancreas resectiona standard of care procedure for resectable pancreatic patientsThe CivaSheet will benefit these patients by delivering radiation therapy at the time of initial surgery to minimize delay in the treatmentPancreatic cancer is an aggressive disease that progresses quicklyFaster treatment cycles are ideal for cancer types that proliferate quicklyIn Phase Ithe safety of CivaSheet and general recommendations for its use in this patient population will be assessedA Clinical Evaluation Team will review the clinical trial protocolsplans for implantssample dosimetry that can be achieved andeventuallyeach patient case to evaluate device related eventsThe Clinical Evaluation Team will agree with Physicians on site to continue treating patients in Phase IIThe Phase II will consist of two concurrent clinical trials exploring the use of the CivaSheet as monotherapy or boost therapy in resectable pancreatic cancer patientsThe rate of local recurrence in patients implanted with CivaSheet will be compared to the current rate ofAdditionallythe quality of lifepainand mortality in each patient will be monitoredCivaSheet will reduce the radiation delivered to adjacent duodenumstomachand liver and should result in fewer side effectsAdditionallyit will provide a conformal dosereduce the risk for infectionand possibly reduce treatment related side effectsThe Clinical Evaluation Team will review each patient case to discuss patient specific differences impacting the device to increase knowledge and benefit future surgical proceduresCivaSheet is a truly unique brachytherapy device that has the potential to become the first line of defense for localized cancerCivaTech Oncology is committed to making the CivaSheet available to cancer patients in multiple indications