Real-time volumetric specimen imager for 3D intra-operative lumpectomy margin assessment

Project Summary We propose to develop a novel volumetric specimen imagerVSIsystem for significantly reducing breast lumpectomy s reoperation rate and improving cosmetic outcomesAmong the annual performance of andgtlumpectomies in the USaboutof patients need reoperationswhen post surgery pathology examination revealspositive marginindicating incomplete tumor removal in initial surgeryCurrently physicians rely either onD intra operative specimen imagingwhich has onlysensitivity for positive margin detectionor on randomly shaving additional cavity tissues at all marginsleading tohigher excision volume and worse cosmetic outcomeWe propose a robust VSI system that yields fullyD images of the specimen with isotropicsubm resolutionand workflow streamlining software applications which can significantly improve margin assessment and enable precisely image guided shave marginUniquely enabled by a proprietary algorithm invented by Clarix foundersthe VSI provides superior image quality meeting clinical requirements and significant imaging acceleration for seamless workflow integrationInyearswe plan to introduce the VSI based solution as the new standard of care for lumpectomywhich is expected to lower the reoperation rate to andltwhile reducing excision volume bythereby considerably reducing healthcare costs and patient inconvenience while improving cosmetic outcomesWe have successfully achieved all Aims in Phase I studywhich includeto verify that image quality requirements can be met by a calibrated VSI prototypeto verify that scan time requirements can be met by optimizing VSI parametersandto verify that VSI hassensitivity and specificity for assessing lumpectomy marginsIn our Phase II studywe hypothesize that an optimizedmanufacture ready VSI prototype can meet technicalworkflowand regulatory requirements for clinical applicationand can result in substantially improved margin assessment accuracy and breast tissue conservationThe Specific Aims areto optimize VSI device for robust image acquisition in ORto create VSI software for seamless OR workflow integrationandto conduct clinical VSI validation for enhancing margin assessment accuracy and reducing cavity shave margin volumeCurrentlyhospitals and clinics performing lumpectomy in the US form a $M installed baseWe will focus our in house talent on the core software and configuration designWe will partner with experienced specialists for regulatory compliant engineering designand with leading research hospitals for clinical studyOur Phase I success has attracted investors such as Softbank for assisting to obtain FDAkclearance withinyearsAfter proving the commercial viability regionallywe will obtain further venture financing to scale nationally and internationally Narrative Currentlyof patients receiving lumpectomy need reoperations due to positive margins undetected during initial surgeryWe propose to develop a robustreal timeD imaging device with software that can accurately identify positive margins during the surgeryallowing surgeons to immediately remove additional cancerous tissues and thus significantly reducing reoperation rateimproving cosmetic outcomesand lowering healthcare cost