We propose to develop a novel volumetric specimen imager (VSI) system for significantly reducing breast lumpectomy?s reoperation rate and improving cosmetic outcomes. Among the annual performance of >200,000 lumpectomies in the US, about 25% of patients need reoperations, when post-surgery pathology examination reveals ?positive margin?, indicating incomplete tumor removal in initial surgery. Currently physicians rely either on 2D intra-operative specimen imaging, which has only ~53% sensitivity for positive margin detection, or on randomly shaving additional cavity tissues at all margins, leading to 50% higher excision volume and worse cosmetic outcome. We propose a robust VSI system that yields fully-3D images of the specimen with isotropic, sub-100m resolution, and workflow-streamlining software applications which can significantly improve margin assessment and enable precisely image-guided shave margin. Uniquely enabled by a proprietary algorithm invented by Clarix founders, the VSI provides superior image quality meeting clinical requirements and significant imaging acceleration for seamless workflow integration. In 4-5 years, we plan to introduce the VSI-based solution as the new standard of care for lumpectomy, which is expected to lower the reoperation rate to <10% while reducing excision volume by 30%, thereby considerably reducing healthcare costs and patient inconvenience while improving cosmetic outcomes. We have successfully achieved all Aims in Phase I study, which include (1) to verify that image-quality requirements can be met by a calibrated VSI prototype, (2) to verify that scan-time requirements can be met by optimizing VSI parameters, and (3) to verify that VSI has 90% sensitivity and specificity for assessing lumpectomy margins. In our Phase II study, we hypothesize that an optimized, manufacture-ready VSI prototype can meet technical, workflow, and regulatory requirements for clinical application, and can result in substantially improved margin-assessment accuracy and breast-tissue conservation.
The Specific Aims are: (1) to optimize VSI device for robust image acquisition in OR, (2) to create VSI software for seamless OR workflow integration, and (3) to conduct clinical VSI validation for enhancing margin-assessment accuracy and reducing cavity shave-margin volume. Currently 6,000 hospitals and clinics performing lumpectomy in the US form a $720M installed-base. We will focus our in-house talent on the core software and configuration design. We will partner with experienced specialists for regulatory-compliant engineering design, and with leading research hospitals for clinical study. Our Phase I success has attracted investors such as Softbank for assisting to obtain FDA 510(k) clearance within 2 years. After proving the commercial viability regionally, we will obtain further venture financing to scale nationally and internationally.
Currently 25% of patients receiving lumpectomy need reoperations due to positive margins undetected during initial surgery. We propose to develop a robust, real-time 3D imaging device with software that can accurately identify positive margins during the surgery, allowing surgeons to immediately remove additional cancerous tissues and thus significantly reducing reoperation rate, improving cosmetic outcomes, and lowering healthcare cost.
