CairnSurgical, Inc. , an innovator dedicated to improving the precision of breast cancer surgery, today announced the treatment of the first patients in its European Post-Marketing Breast Cancer Clinical Trial Locator System . The first successful surgeries were performed at the Spital Zollikerberg in Zurich, Switzerland and at the Santa Chiara Hospital in Pisa. The BCL System was designed to improve the accuracy of breast-conserving surgery (lumpectomy) by providing an accurate guide to the shape, size and location of the tumor, thereby enabling the ability to achieve clear margins.
“We are thrilled to have achieved a negative surgical margin in our first use of BCL technology, with no detectable residual tumor after breast tumor removal. This is the result we were trying to achieve for each patient,” said Prof. Dr. Hisham Fansa, head of the Breast Center and head of the plastic surgery unit for Spital Zollikerberg, as well as co-principal investigator of the study. “We are excited to have more detailed 3D information about each tumor and a personalized surgical guide for each patient, which can help us make breast cancer surgeries more accurate, thus reducing the need for additional surgeries for our patients” .

The European Post-Marketing Surveillance Multi-Center Clinical Trial is being conducted in select European countries within customized MDR device guidelines. The study will be conducted in various European centres, including Santa Chiara Hospital, Spital Zollikerberg and Agaplesion Markus Krankenhaus in Frankfurt, Germany. The primary endpoint is the positive surgical margin rate, which is assessed by imaging and histological examination immediately postoperatively.

Currently, Breast Conserving Surgery (BCS) fails to completely remove the tumor in about 20 percent of cases, mainly because current tumor location techniques do not provide the information necessary to achieve accurate total removal of the tumor. A recent study of breast cancer shapes reveals that fewer than 20 percent of cancer cases are spherical in shape, 1 reducing or eliminating the usefulness of techniques for placing implants or wires at one of two central points within the breast cancer. purpose of identifying its dimensions, delimiting its area and margins.

The BCL System was designed to reduce positive margin rates and improve the three-step BCS process.

Initially, an MRI scan is done supine, with the breast in the surgical position, providing details of the size, shape, and location of the tumor. This imaging data is used to analyze the tumor and build a three-dimensional model that serves as the basis for two surgical tools.
A 3D printed form – the Breast Cancer Locator, or BCL TM – is manufactured to fit the patient's individual breast shape, with ports for various central and support wires to be placed under anesthesia in the operating room immediately prior to surgery. The wires guide the surgeon in identifying the area and margins of the tumor.
The surgeon receives an interactive 3D image of the breast tumor – the Visualizer TM – which can be manipulated during surgery. The Visualizer offers 360° views of the tumor and quantifies the minimum distance from the tumor to the skin and chest wall – information that provides a useful reference for the surgeon during the procedure.
“By customizing an individual patient breast and cancer guidance solution, in 3D and using supine MRI data, we enable precision medicine for breast cancer patients,” said Richard Barth, Jr., MD, Dartmouth -Hitchcock Medical Center, as well as Professor of Surgery, Geisel School of Medicine at Dartmouth, and co-founder of CairnSurgical. “With two ongoing multi-center clinical trials in the US and Europe, we are getting ever closer to the day when the BCL System will be accessible to surgeons who value precision and aim to reduce repeat surgeries for their patients.”

The US pivotal trial of the Breast Cancer Locator (BCL) System is currently enrolling patients and is designed to obtain FDA clearance and commercialization in the States. The multicenter, controlled, 1:1 randomized trial included 448 female patients treated at up to 25 centers. The primary endpoint is a positive surgical margin rate, which can be assessed immediately postoperatively. Other endpoints include sample volumes, rates of additional scrapings, rates of recurrence, cancer location rates, duration of surgery, and cost of treatment.

In two studies of the BCL System, published in the Annals of Surgical Oncology 2 and Surgical Oncology 3 , clear tumor margins were obtained in all 33 patients. The resection volumes were comparable to the optimal resection volumes determined by tumor modeling based on supine MRI. 2.3

About CairnSurgical

CairnSurgical, Inc. is developing patient-specific guides using state-of-the-art patient imaging data and 3D printing technologies commercially available in Europe and being studied in an ongoing pivotal trial in the United States. CairnSurgical's Breast Cancer Locator (BCL) System enables precise location and excision of tumors.

The Breast Cancer Locator is considered an investigational device in the United States and its use is restricted by US law to the investigational setting only.

1. Byrd BK, Krishnaswamy V, Gui J, et al. The shape of breast cancer. Breast Cancer Research and Treatment. 2020; 183: 403-410.
2. Barth RJ, Krishnaswamy V, Paulsen KD, et al. A patient-specific 3D-printed form accurately transfers supine MRI-derived tumor localization information to guide breast-conserving surgery. Ann Surg Oncol. 2017; 24(10): 2950-2956.
3. Barth RJ, Krishnaswamy V, Rooney T, et al. A pilot multi-institutional study to evaluate the accuracy of a supine MRI based guidance system, the Breast Cancer Locator™, in pazienti con cancro al seno palpabile. Surgical Oncology, Vol 44, Settembre 2022, 101843.

The original text of this announcement, written in the source language, is the official version which is authentic. Translations are offered solely for the convenience of the reader and must refer to the text in the original language, which is the only legally valid one.

Contacts
Michelle McAdam, Chronic Communications, Inc.
michelle@chronic-comm.com, (310) 902-1274

 

Source:businesswire.com

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