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

Description

PROJECT SUMMARY ABSTRACTCairnSurgicalInca Dartmouth spin off companywill standardize supine breast MRI to streamline production of the Breast Cancer LocatorBCLas a cancer localization device for use in breast conserving surgeryBCStoieliminate wire localizationa moderately effectivesomewhat costly and certainly inconvenient procedure for patients and surgeonsand concomitantly toiireduce positive margin rates and subsequent re excision surgeriesa significant but unnecessary burden not only on patients but also on the cost of healthcareSpecificallystandardization of supine breast MRI will be achieved through aoptimization and use of standard body coils for breast imagingbdevelopment and testing of a body coil placement platform to minimize breast deformation and positioning inconsistencies during imagingand cdevelopment and testing of an abbreviated supine breast MRI protocol that can be added to a prone breast exam or used independentlyIn the proposed Phase I and IIFast Trackclinical studiesCairnSurgical will collaborate with Dartmouth researchers and clinicians at partnering institutions totest an adjustable body coil placement platform in a limited study ofvolunteers with varying breast cup sizes in MRI scanners from multiple vendorsconduct apatient study with a production ready version of the body coil placement platform to establish the viability of an abbreviated supine breast MRI protocol as an add on procedure to standard of care prone MRI in breast cancer patientsandevaluate the efficacy of the body coil placement platform in a limited multi center study involving remote clinical partnering sitesCairnSurgical will also develop and clinically validate information technologyITinfrastructure required for efficient transfer of medical images from hospital servers to CairnSurgical to enable BCL productionmanage work orders and generate unique patient identifiers to ensure traceability of the patient matched BCL deviceswhich are critical to widespread clinical adoption and commercial success of the BCL deviceQuality assurance and validation databoth clinical and non clinicalobtained from these studies will supportkregulatory filing for the body coil support platform as an accessory to the BCL devicePositive margin rates associated with contemporary BCS are highand cause significant strains on patients and the cost of breast healthcareMeta analyses of the impact of surgical margins on local recurrence also confirm that negative margins have a positive prognostic effectThusCairnSurgical is well positioned to develop and commercialize a potentially practice changing approach to BCS for accurate resection of breast cancers NarrativeDevelopment and standardization of supine breast MRI is proposed to enable commercial viability of the Breast Cancer LocatorBCLa surgical guidance device designed to improve the accuracy of cancer resection during breast conserving surgeryBCSIn this Fast Track projectCairnSurgical will test the feasibility of a body coil support platformtest efficacy of an abbreviated supine MRI protocol as an add on to standard of care prone breast MRI and establish imaging workflow efficiencies in single and multicenter settings