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

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Abstract Clarix Imaging, Corporation (Clarix) is focused on solving one of the largest problems in early stage breast cancer treatment, reoperations for positive margins. About 25% of the >200,000 patients who undergo lumpectomy in the US each year will face this additional procedure because current options for identifying positive margins intraoperatively are insufficient. Currently physicians rely on 2D specimen imaging for assessing margin status during surgery which cannot adequately represent the 3D margin morphology of the tumor. Therefore, Clarix is developing a novel volumetric specimen imager, VSI, device that yields fully 3D images of the specimen with isotropic resolution which can significantly improve margin assessment and provide precise guidance for directed cavity shaves before closing wound. In Phase I, we demonstrated the ability of our VSI patented algorithms to overcome long scan times of conventional 3D imagers that would disrupt surgical in a 20-case retrospective pilot study. In Phase II, we developed a robust prototype with hardware designed for user ease of use and safety, and software for user-friendly OR workflow integration. This transfer to manufacturing ready prototype was further validated in a large-scale 230 patient retrospective study. An initial FDA 510(k) application for the VSI device resulting from Phase II will be submitted in Q3 2019. We now propose four specific aims for a Phase IIB project that will help Clarix bridge the gap between technology development and commercialization as follows. Aim 1, “Develop Software for Further Improved Clinical Workflow and Radiology-Pathology Image Database” will further streamline integration into leading Electronic Medical Record systems, and a database will be developed which will pair VSI data and digital pathology records. Aim 2: “Develop Manufacturing Process for the VSI Device” for large scale manufacturing ability. Aim 3: “Prospective Phase II Clinical Trial” a multi-center single-arm 100 patient clinical trial will be conducted to preliminarily evaluate the ability of the VSI device to decrease positive margin rates to 10%. Aim 4: “Pivotal Randomized Clinical Trial” this 600 patient Phase III trial will be designed to definitively determine improvement in negative margins to 90%, demonstration of superiority over the current standard in this study will allow for specific FDA approval of FDA for margin assessment and widespread adoption. The 6,000 US hospitals and clinics performing lumpectomy are incentivized to adopt VSI under the ongoing movement toward value-based reimbursement, forming a ~$720M initial US installed-base. Our global market is estimated at ~$4B. At the conclusion of Phase IIB we will prove the commercial viability regionally, and then we will scale nationally and internationally.