VoltMed, Inc. — Department of Health and Human Services SBIR Phase I: 102

Description

Brain tumors are the second leading cause of cancer related deaths in people under the age ofwith Glioblastoma MultiformeGBMbeing the most aggressive and considered incurable with conventional therapiesIrreversible ElectroporationIREis a minimally invasive technique invented by DrRafael DavalosCo PIfor non thermalenergy based ablation of inoperable tumorsIRE uses a series of low energyunipolar pulsed electric fieldswhich are applied through electrodesmminserted into the tumorDrsDavalosVoltMed Co Founderand ArenaPIVoltMed Co Foundersubstantially improved the IRE technique by inventing high frequency irreversible electroporationH FIRETMa patented waveform technology that implements bipolar bursts of electrical energy with individual pulse durations that are two orders of magnitude shortersthan those in IREH FIREimproves the safety of IRE procedures and enables non thermal ablation of GBMWe have demonstrated that H FIRETMunlike IREcan be performed without the need for neuroparalyticsis more predictable by mitigating tissue heterogeneitiesand produces tumor cell specific ablationAdditionallyH FIRETM can transiently disrupt the BBB beyond the tumor marginenabling effective and precise delivery of molecules that are normally blocked from entry by the BBBH FIRETM can be used to ablate the bulk of GBM tumors as well as infiltrative cells beyond the tumor margin under MRI guidanceIn the current proposalwe will develop the H FIRETM technology through Phasepreclinical studiesfollowing industry standard FDA Design Controlsculminating in the submission of an IDE proposal to the FDAThe Specific Aims of this PhaseSBIR application areSpecific AimFinalize concept and design for construction of design control MRI compatibleelectrode prototypes for H FIRETM deviceMilestonesAFabricate an IDE H FIRETM systemthat can produceVs biphasic pulses as well as an MRI compatible probeBVerifyand validate device functionalityin support of IDEksubmissionSpecific AimConduct a proof of concept study to determine the safety and efficacy of H FIREinvivoin canine patientsMilestonesADemonstrate that H FIREis safe when used in vivoandBDemonstrate that H FIRETM is efficacious in the treatment of tumor in vivoSuccessful completion of the proposed studies will lead to the development of an IDE device whichcan be tested in early feasibility human studies to treat GBMThe resulting data will be used todesign clinical trials for safety and efficacy in support of our planned regulatoryksubmission to the FDAwith the long term goal of market commercialization Brain tumors are the second leading cause of cancer related deaths in people under the age ofwith Glioblastoma Multiforme being the most aggressive and considered incurable with conventional therapiesHFIRETM is a patented waveform technology that implements shortsbipolar bursts of electrical energy with individual pulse durationsand can be performed without the need for neuroparalyticsis more predictable by mitigating tissue heterogeneitiesand produces tumor cell specific ablationIn the current proposalwe will develop the H FIRETM technology through Phasepreclinical studiesfollowing industry standard FDA Design Controlsculminating in the submission of an IDE proposal to the FDAwith the long term goal of testing in early feasibility human studies to treat GBM