SBIR-STTR Award

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, 3D 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 4) distances from the anterior tumor edge to breast surface and the posterior tumor edge to the chest wall. In the proposed Phase 1 studies, CainSurgical will collaborate with Dartmouth clinicians and researchers to 1) develop and validate BCL model creation software, 2) optimize BCL manufacturing and sterilization processes, and 3) test the feasibility of BCL in surgical cases of 10 patients with palpable breast cancer. The positive margin rates associated with contemporary BCS are high (~22%-42%)9-13, 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.

Public Health Relevance Statement:
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 10-patient clinical trial.

Project Terms:
3D Print; Algorithms; Anterior; arm; Award; base; Breast; Breast-Conserving Surgery; Businesses; Caring; Chest wall structure; Clinical; Clinical Trials; commercialization; Complex; Computer software; cost; Cues; Data; design; Development; Devices; Enrollment; Excision; experience; Feasibility Studies; Fellowship; Funding; Goals; Health Care Costs; Healthcare; image guided; image guided intervention; improved; Ink; innovation; Institution; Intellectual Property; interstitial; Investments; Licensing; Light; Location; Magnetic Resonance Imaging; malignant breast neoplasm; Malignant Neoplasms; Mammary Gland Parenchyma; Mediation; Medical; Medicare; meetings; Meta-Analysis; Modeling; novel therapeutics; Operative Surgical Procedures; Outcome; Palpable; Palpation; Patients; payment; Performance; Phase; phase 1 study; phase 2 study; Positioning Attribute; Printing; Procedures; Process; prognostic; Randomized; Recurrence; Research Personnel; Resected; Rights; Risk; Site; Small Business Innovation Research Grant; standard of care; Sterilization; Surface; Surgeon; Surgical incisions; Surgical margins; System; Technology; Testing; Time; tumor; United States National Institutes of Health

CairnSurgical LLC, a Dartmouth spin-off company, will optimize and test multi-site clinical 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 surgeons - 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, 3D 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 4) distances from the anterior tumor edge to breast surface and the posterior tumor edge to the chest wall. In the proposed Phase II studies, CairnSurgical will collaborate with Dartmouth researchers and surgeons at four partnering institutions to 1) improve BCL model creation process efficiency by eliminating the need for optical scanning and clinically validate the approach in a 10- patient study at Dartmouth, 2) develop BCLPlanner software to streamline BCL creation and quality assurance processes, and optimize BCL production, packaging and delivery to achieve manufacturing and scale-up efficiencies, and 3) test the feasibility of BCL at four distant clinical sites in approximately 12 patients with palpable breast cancers. Quality assurance and validation data (both clinical and non-clinical) obtained from these studies will support 510(k) regulatory filing for the BCL device. Positive margin rates associated with contemporary BCS are high (~22%-42%)9-13, and cause significant strains on patients and the cost of breast healthcare. Meta-analyses of the impact of surgical margins on local recurrence also confirm that negative margins have 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.

Public Health Relevance Statement:
Narrative: A surgical guidance device, Breast Cancer Locator (BCL), is proposed for improving accuracy of cancer resection during breast conserving surgeries (BCS). In this phase II project CairnSurgical will continue the development of BCL technology, manufacturing and sterilization processes and test its feasibility in a multi- center setting.

Project Terms:
3D Print; Anterior; arm; base; Breast; Breast-Conserving Surgery; Chest wall structure; Clinical; Clinical Research; clinical research site; Clinical Trials; Collaborations; commercialization; Complex; Computer software; Computers; cost; Cost Analysis; Cues; Data; Data Analyses; Development; Devices; Distant; Dyes; Enrollment; Excision; experience; Funding; Future; Health Care Costs; Healthcare; Image; image guided; image guided intervention; improved; Injection of therapeutic agent; Ink; innovation; Institution; interstitial; Investments; Localized Malignant Neoplasm; Location; Magnetic Resonance Imaging; malignant breast neoplasm; Malignant Neoplasms; Mammary Gland Parenchyma; manufacturing scale-up; Marketing; Medical; Meta-Analysis; Modeling; Multi-Institutional Clinical Trial; novel therapeutics; Operative Surgical Procedures; Optics; Outcome; Pain; Palpable; Patients; Performance; Phase; phase 2 study; Positioning Attribute; pre-clinical; Preparation; Printing; Procedures; Process; process optimization; Production; prognostic; Progress Reports; quality assurance; Randomized; Recurrence; research clinical testing; Research Infrastructure; Research Personnel; Resected; Scanning; Schedule; Series; Site; software development; Specific qualifier value; standard of care; Sterilization; success; Supination; Surface; Surgeon; Surgical incisions; Surgical margins; System; Technology; Testing; Time; Training; tumor; United States National Institutes of Health; Validation