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Breast Cancer Locator

Award Number: R44CA210810
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2016
PERIOD OF PERFORMANCE END DATE: 07/31/2020

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Breast Cancer Locator - PROJECT SUMMARY/ABSTRACT: 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2018	CAIRNSURGICAL, INC.	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Cancer Cause and Prevention Research	000	4	2/6/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $969,868 )
2018	2018	CAIRNSURGICAL, INC.	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Cancer Cause and Prevention Research	000	4	7/19/2018	NON-COMPETING CONTINUATION	$968,273
2018	2018	CAIRNSURGICAL, INC.	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Cancer Cause and Prevention Research	001	4	8/21/2018	NON-COMPETING CONTINUATION	$1,595
														Subtotal = $969,868

Issue Date FY: 2017 ( Subtotal = $1,031,728 )
2017	2017	CAIRNSURGICAL LLC	8 LEDYARD LN	HANOVER	NH	03755	GRAFTON	USA	Cancer Cause and Prevention Research	000	2	7/19/2017	COMPETING CONTINUATION	$1,031,728
2017	2017	CAIRNSURGICAL LLC	8 LEDYARD LN	HANOVER	NH	03755	GRAFTON	USA	Cancer Cause and Prevention Research	002	3	9/26/2017	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,031,728
2017	2017	CAIRNSURGICAL LLC	8 LEDYARD LN	HANOVER	NH	03755	GRAFTON	USA	Cancer Cause and Prevention Research	001	2	9/26/2017	COMPETING CONTINUATION	-$1,031,728
														Subtotal = $1,031,728

Grand Total All Awards = $2,001,596

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Breast Cancer Locator

Award Number: R44CA210810

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2016

PERIOD OF PERFORMANCE END DATE: 07/31/2020

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