REFLEXION MEDICAL, INC. — Department of Health and Human Services SBIR Phase I: 102

Description

Project Summary Ablative radiotherapy is an effective way to non invasively destroy a tumorThis high dose treatmenthoweverrequires precise targetingwhich is complicated by the fact that tumors in the body move with respirationThere are a variety of technologies that implement tumor tracking to achieve ablative radiotherapy in the bodyHoweverthese are limited to treating just a few lesions in a patient due to the complexity and invasiveness of the necessary motion management techniquesThereforepatients that present with later stage disease with more than a few metastatic sitesi emore thanlesionsare not feasibly treatable with ablative radiotherapyRefleXion Medical is developing the first universal method for direct real time targeting of tumors based on biological guidanceUtilizing positron emission tomographyPETemissions from the patientthis new technique allows for continuous and automatic dose conformation to multiple lesionsenabling dose escalation to the target sand toxicity reduction to sensitive tissuesThe concept has been proven with the development of the first prototype machineThis proposal has four specific aimsAimsandare to validate the reproducibility and robustness of the treatment approachAimsandare to develop a quality assuranceQAdevice that can measure the performance of biology guided radiotherapyBgRTand perform end to end tests to validate that planning goals can be accurately achieved in patient like phantomsSuccess of these aims will mitigate clinical risks and enable commercialization of the first biology guided radiotherapyBgRTsystem Narrative After cancer has metastasizedthere are very few options other than systemic treatmentslike chemotherapyRadiosurgerywhich is a highly effective outpatient procedure for ablating a tumoris no longer an option for the patient due to the complexity of treating multiple lesions in the body without a way to precisely track their locations during treatmentIn this projectRefleXion Medical aims to develop the first radiotherapy system that uses the gold standard cancer imaging modalitypositron emission tomographyPETto non invasively track multiple tumors simultaneouslyenabling biology guided radiotherapyBgRTfor advanced stage cancer patients