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CairnSurgical - Helping Surgeons Remove Breast Cancer with Greater Precision

Imagine having been told you have breast cancer, and all the worry that comes with it. Then imagine that, after lumpectomy surgery and a short wait for the pathology results, you are told, “Sorry, we were not able to remove the entire cancer plus a margin of healthy tissue, so we need to operate again.” Unfortunately, this happens too often – it has been this way for about 20% of all patients since the advent of lumpectomy. The problem is not the skills of radiologists or surgeons, it is the inadequate tools and insufficient information that is provided to them.

CairnSurgical’s mission is to help surgeons remove breast cancer with more precision and improved clinical outcomes, thus also providing significant savings to the healthcare system. CairnSurgical has developed an image-derived, patient-specific, 3D printed surgical guidance solution, based on a patient’s breast MRI, that delivers improved clinical results for lumpectomy patients.

The difficulty of removing an entire breast tumor with clear margins is partly due to the fact that a tumor isn’t always spherical; tumors can be any shape and are often irregular. Additionally, the way tumors are shaped in a mammogram or a prone MRI are completely different from the way they are shaped when a patient is lying face-up on an operating table.

This is why a localization wire or seed in the center of a tumor is insufficient – the point in space at the end of a wire or the spot of a localization seed does not give a surgeon precise information about shape, size, and location of the tumor.

CairnSurgical’s Breast Cancer Locator changes the paradigm. Start with a supine MRI (patient lying face-up, the way she presents in the operating room), and work from there to deliver a comprehensive solution: a guidance device and an interactive visual model that surgeons can use to “see” and understand the dimensions and characteristics of the tumor in the supine position.

CairnSurgical receives the supine MRI data, analyzes it for the shape, size, and location of the tumor, then uses the analyses to design and build a 3D printed plastic form – the BCL – that is patient-specific for her tumor and her breast. The BCL fits on the breast at the start of surgery and has guidance cues that inform the surgeon how deep and how wide and what shape to excise. The company prints and ships the BCL device and sends an interactive model, the Visualizer, to the surgeon on a web link within 7-10 days – so there is no delay to surgery.

The CairnSurgical Breast Cancer Locator has been proven effective in pilot studies in the US and Europe. So far, in both palpable and non-palpable tumors, the BCL has enabled surgeons across multiple sites to achieve 100% success in removing the entire tumor plus a clear margin – no re-excisions, no added stress for patients, no added costs for hospitals and insurers from second surgeries.

CairnSurgical is currently conducting a randomized, prospective trial comparing the BCL to standard of care, and is implementing a limited commercial launch in Europe.

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