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

Description

PROJECT SUMMARY ABSTRACT CairnSurgical LLC a Dartmouth spin off company will optimize and test the feasibility of a new image guided intervention device the Breast Cancer Locator BCL in breast conserving surgery BCS to i eliminate wire localization a moderately effective somewhat costly and certainly inconvenient procedure for patients and concomitantly to ii reduce positive margin rates and subsequent re excision surgeries a significant but unnecessary burden not only on patients but also on the cost of healthcare Specifically BCL is a patient specific D printed device that allows accurate clinical transfer of multiple surgical cues not available through other competing technologies currently available including i a tumor silhouette projected on the breast surface as viewed from the incision site ii an intra operatively placed wire that defines a direct path to the tumor from the incision site iii interstitial inking of the maximum tumor extents using an innovative system of access ports and distances from the anterior tumor edge to breast surface and the posterior tumor edge to the chest wall In the proposed Phase studies CainSurgical will collaborate with Dartmouth clinicians and researchers to develop and validate BCL model creation software optimize BCL manufacturing and sterilization processes and test the feasibility of BCL in surgical cases of patients with palpable breast cancer The positive margin rates associated with contemporary BCS are high and currently represent significant strains on patients and the cost of breast healthcare Meta analysis of the impact of surgical margins on local recurrence also confirms that margin status has a positive prognostic effect Thus CairnSurgical is well positioned to explore and commercially develop a potentially practice changing approach to BCS for accurate resection of breast cancers Narrative A surgical guidance device Breast Cancer Locator BCL is proposed for improving accuracy of cancer resection during breast conserving surgeries BCS In this project CairnSurgical will develop and validate BCL software manufacturing and sterilization processes and test its feasibility in a patient clinical trial