CAIRNSURGICAL, INC. — Department of Health and Human Services SBIR Phase II: 101

Description

PROJECT SUMMARY ABSTRACTCairnSurgical LLCa Dartmouth spin off companywill optimize and test multi site clinical feasibility of a new image guided intervention devicethe Breast Cancer LocatorBCLin 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 healthcareSpecificallyBCL is a patient specificD printed device that allows accurate clinical transfer of multiple surgical cues not available through other competing technologies currently availableincluding ia tumor silhouette projected on the breast surface as viewed from the incision siteiian intra operatively placed wire that defines a direct path to the tumor from the incision siteiiiinterstitial inking of the maximum tumor extents using an innovative system of access portsanddistances from the anterior tumor edge to breast surface and the posterior tumor edge to the chest wallIn the proposed Phase II studiesCairnSurgical will collaborate with Dartmouth researchers and surgeons at four partnering institutions toimprove BCL model creation process efficiency by eliminating the need for optical scanning and clinically validate the approach in apatient study at Dartmouthdevelop BCLPlanner software to streamline BCL creation and quality assurance processesand optimize BCL productionpackaging and delivery to achieve manufacturing and scale up efficienciesandtest the feasibility of BCL at four distant clinical sites in approximatelypatients with palpable breast cancersQuality assurance and validation databoth clinical and non clinicalobtained from these studies will supportkregulatory filing for 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 explore and commercially develop a potentially practice changing approach to BCS for accurate resection of breast cancers