Cairn Surgical has closed a $4.5m Series A2 financing round, as the company looks to advance its personalised device for breast cancer surgery.
Funds from the round, which was led by Shanghai-based private equity company Morningside Ventures, will be used to complete Cairn’s ongoing US pivotal trial and aid the commercialisation of the CE-marked device in certain European markets.
Cairn’s Breast Cancer Locator (BCL) device is a patient-specific tool used to reduce positive margins during breast cancer removal. The rate of positive surgical margins after breast cancer surgery varies but can reach as high as 20% in some cases. This primarily occurs due to limitations in current breast tumour localisation techniques, according to Cairn.
Improving the rate of successful margin removal can reduce costs and the need for further surgery, as well as improve physical appearance.
Cairn’s polymer device is printed to match the dimensions of the patient’s breast using MRI scans and the company’s Visualizer software tool. The surgeon then uses the locator to mark the projected edges of the cancer on the skin surface and places four bracketing wires through guiding ports.
The company treated the first patient in the US with its system as part of an ongoing pivotal study. The prospective, multi-centre, randomised trial will involve 448 women with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS) tumours.
The BCL is also being evaluated in a post-market clinical study in Europe, with the same primary endpoint.
Patients will be randomised to either Cairn’s BCL or standard wire localisation to guide surgery. The primary endpoint is a positive margin rate, with secondary endpoints that include the need for additional surgeries and cost of care, among others.
Cairn’s technology has already produced positive results in a study published in the Annals of Surgical Oncology, with the BCL accurately localising 18 out of 19 cancers.
Morningside Ventures investment adviser Mick Sawka said: “[Cairn’s] innovative image-derived guidance solution for breast cancer lumpectomy is showing great promise and progress and has shown outstanding clinical results in its European clinical trial. We are excited about its potential to significantly improve patient care, as well as reduce costs to the healthcare system.”
There are a range of digital solutions in the breast cancer surgery space. Lumicell’s surgical imaging tool combined with its optical imaging agent helps detect residual cancer in real time during lumpectomy surgery. With a Nobel Prize winner as one of its co-founders, the company received FDA approval in April this year.
Clarix Imaging has also developed a volumetric specimen imaging system, a point-of-care 3D imaging platform that provides margin visualisation in breast cancer surgeries. Previously backed by the National Institutes of Health, the company raised $10m in October 2023.
