CAMBRIDGE, England--(BUSINESS WIRE)--Endomag, the surgical guidance company, announced that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for Magtrace, the first non-radioactive, dual-tracer for lymphatic mapping in patients with breast cancer undergoing a mastectomy. Magtrace is a liquid marker designed to follow the route that cancer cells are most likely to take when they spread from the primary tumour.

Magtrace will help U.S. hospitals reduce their reliance on radioactive tracers and, along with Magseed, allows surgeons to perform both lesion localisation and sentinel node biopsy with the Sentimag platform, both incredibly important operations for breast cancer patients with thousands performed every week.

According to the American Cancer Society, approximately 266,000 new cases of invasive breast cancer and 65,000 cases of carcinoma in situ (the earliest form of breast cancer) will be found in the United States this year - a figure expected to double by 2030. Thankfully, if breast cancer is caught at an early stage, 99% of patients are likely to be alive five years after diagnosis, however, surgery is generally still needed.
For those affected, the gold-standard of treatment is to remove the tumour surgically and determine whether the cancer has spread to other parts of the body with a lymphatic mapping procedure. Typically, this involves the use of radioactive drugs and blue dyes, which are limited in their availability, can cause scheduling delays and are considered to be very painful and uncomfortable for patients. Magtrace is a non-radioactive alternative that has been developed to improve this process for both patients and surgeons.

Unlike existing methods, Magtrace can be injected up to a week before surgery as the tracer is optimally sized; both small enough to move rapidly through breast, yet big enough to be filtered by the first draining or ‘sentinel’ lymph nodes, the ones most likely to carry cancer. The collection of Magtrace in these nodes allows the surgeon to accurately target them for removal, without disrupting the rest of the nodes in the armpit. This is critical in determining the tumour stage and deciding on the patient’s best treatment pathway.

Prof Michael Alvarado, Professor of Surgery from UCSF and Principal Investigator for the US Magtrace trial, said: “We’ve been watching this technology become established in Europe over the past few years, and have been eagerly awaiting its availability in the US. During the SentimagIC trial I was impressed with how easy the technique was to learn, how intuitive the system was to use, and ultimately, as Principal Investigator for the trial, that our clinical outcomes matched the results that have been seen in the numerous European trials of Magtrace.

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