CELL PRESERVATION SERVICES INC — Department of Health and Human Services SBIR Phase I: 102

Description

The use of thermal therapies such as radio frequency ablationRFAor cryoablation to ablate tissue for the treatment of numerous diseases ranging from renal cancer to cardiac arrhythmias continues to grow in popularity and efficacyWhile several treatment options currently exist for renal cancerRCCanalysis of survival trends reveals that RCC has therd lowest improvement in overall survival sinceandltdecrease in the lastyearstrailing only pancreaticand bladdercancersWhile partial nephrectomy is currently one of the most common optionsan increasing number of older patients are now electing either heatRFAor freezingcryoablationas a preferred optiongiven their documented similar oncologic outcomes compared to partial nephrectomydue to the less invasive nature of the thermal percutaneous treatment andwhen patients are of advanced ageexhibit severe comorbidities such cardiovascular and pulmonary diseasesor have hereditary RCCBiopsy analysis is critical to defining and tracking the success of the treatment modalityThis Phase I application is formulated based on the advances in thermal ablation and its increasing applications in treating RCCCPSI Biotech is a medical device company that specializes in thermal ablation technology and has developed the Super Critical NitrogenSCNand Pressurized Sub cooled NitrogenPSNmedical devices now in pre clinical trialsGiven the increase in the use of thermal ablative technologies to treat a variety of diseases such as RCC coupled to the fact that CPSI has shown that using freezing and heat together in a dual thermal ablationDTAparadigm can be more effective than either heat or freezing alonewe propose to develop a unique percutaneous thermal probeQuadProbeRCCthat canafreezebheatcdeploy a thermosensor that is incorporated into the cryoprobe anddretrieve a biopsy of the targeted tissueThis multi functional probe will also be capable of performing DTA treatment of RCCSpecific Aims are the followingSADevelop QuadProbe RCC and test in non tissue systemsSATest the QuadProbe RCC in tissue engineered and in vivo modelsIf this project meets the Phase I feasibility criteriaPhase II will propose to further develop this probe technology platform enabling the administration of combinatorial drug ablation treatment paradigms including using thermal sensitizer designed to make freezingheat or DTA more effectiveThis platform will also enable the monitoring of target tissue temperature in real time without the need of multiple external thermal sensors which is the current state of the art for thermal ablation treatment paradigms This application proposes to develop a novel deployable multipoint temperature sensing dual thermal ablation probe and biopsy technology for the treatment of renal and other urologic cancers