Endomag Receives CE Mark Approval for Magseed Breast Cancer Localization Technology

Endomag, a surgical guidance company, has received CE Mark approval for Magseed, a minimally invasive breast marker used to accurately guide surgeons during breast cancer removal. Magseed will be distributed throughout Europe, the Middle East, and Africa (EMEA) by Sysmex as part of a new five-year distribution deal for the Sentimag surgical guidance platform.
 
Magseed allows a radiologist to accurately mark the tumour site with a seed, smaller than a grain of rice, up to 30 days before surgery. It only takes a few minutes to put it in and, once implanted, it’s set firmly in place and cannot be dislodged before surgery. The patient is free to return home and carry out normal day-to-day activities, which significantly improves the patient experience.
 
In the operating theatre the surgeon uses the Sentimag to accurately locate the tumour before making an incision. This frees the surgeon to select the best approach, reducing the invasiveness of the surgery and possibly providing a better cosmetic outcome. Once inside, knowing its precise location helps ensure all of the tumour is removed.
 
“After the successful launch of Magseed in the U.S., where many of the top cancer centres are now using it routinely, we couldn’t wait to make it available across Europe,” said Eric Mayes, CEO of Endomag. “Sysmex’s experience with the Sentimag and Sienna system makes it an ideal partner for Magseed, and Sysmex has demonstrated its ability to successfully launch and grow sales of our products across the EMEA region. Together, we can now offer the first radiation-free surgical guidance platform for both lesion localisation and sentinel node biopsy using a single instrument.”
 
Endomag and Symex’s partnership dates from 2013 and the launch of Sentimag in EMEA. The Sentimag platform is the first to offer radiation-free surgical guidance for both localising and staging breast cancer. Since that time both companies have invested in numerous clinical trials that have shown the technique to be as effective as the current gold standard. The system now has an installed base of over 130 systems across EMEA and has been used in more than 25,000 breast cancer operations.
 
“We’re pleased to extend our partnership with Endomag, which has proven its ability to successfully address genuine unmet needs. Our commitment to another five years demonstrates our confidence in Endomag and the Sentimag platform,” said Ines Groener, senior vice president of oncology at Sysmex. “We are delighted with this opportunity to introduce Magseed. We will now be able to deliver a safer, more efficient workflow for cancer centres that we believe will help them be more efficient and more effective. This is perfectly in line with our mission of shaping the advancement of healthcare for the benefit of patients and our clients alike.”

Breast cancer is the most common form of cancer in women, with 1.7 million new cases of breast cancer globally every year, and is expected to double by 2030. Due to a rise in national screening programs and an increase in public awareness, breast cancer is being diagnosed and treated at an earlier stage meaning that the tumours are smaller, less defined and harder to feel, with as many as 50 percent of all breast tumours impalpable at the time of diagnosis. In these cases, a technique called ‘wire localization’ is typically used by surgeons to locate the tumour.
 
Although widely used, wire localization commonly causes complications: It involves inserting a hookwire into the tumour on the morning of surgery. The wire protrudes from the patient’s breast and great care must be taken to avoid dislodging or moving the wire before surgery, creating additional stresses for the patient. If the wire should move, there’s no way for the surgeon to know, and they must assume it’s in the right place and remove the tissue around the tip of the wire. On average, the wire will have migrated in one in four patients and parts of the tumour will be left in the breast and require a second procedure or additional treatment to remove it. Additionally, there is a risk of infection due to the wire protruding from the skin, so the placement of the wire must be done on the same day as surgery. These issues result in unnecessary anxiety for patients, delays to the surgical lists and fewer patients being treated as a consequence.
 
Alternatively, newer techniques such as radioseed localization involve placement of small radio-labelled (iodine-125 or palladium-103) metal seeds within the breast lesion, enabling precise localisation of cancerous tissue up to five days ahead of surgery. The use of radioactive components during breast surgery is subject to strict nuclear regulatory requirements and close monitoring/tracking procedures to ensure that the seeds are handled appropriately and not lost during operations.
 
Magseed is smaller than a grain of rice and can be placed into the tumour for up to 30 days, allowing the patient to return home ahead of surgery. Once implanted, the seed is not easily dislodged and patients are not restricted in movement or activity. On the day of surgery, patients aren’t subjected to a localization procedure and can instead go straight to the operating room. During surgery, the seed is detected with the Sentimag probe to guide accurate removal of the tumor, maximizing the amount of healthy tissue left behind. Unlike radioactive alternatives that involve strict regulatory oversight and complex logistics, the Magseed technique can be widely adopted by any hospital, regardless of size.
 
Endomag is a pioneer in the use of magnetism for minimally-invasive surgical guidance. Founded as a spin-out from the University of Houston and the University College London (UCL) in 2007, Endomag’s clinical platform uses magnetic fields to power diagnostic and therapeutic devices. The company has sales in over 30 countries worldwide and is headquartered in Cambridge, United Kingdom.
 
Sysmex Corporation is a world leader in clinical laboratory systemisation, providing solutions for laboratory diagnostics, laboratory automation and clinical information systems. Serving customers for close on 50 years, its mission is to shape the advancement of healthcare by delivering technological leadership in diagnostic science and information tools that make a genuine difference to the health of people worldwide. More recently, Sysmex has been focusing on improving cancer management. The company provides targeted solutions to improve the cancer management workflow—from screening, through diagnostics, surgery and postoperative treatment and support. The company, headquartered in Kobe, Japan, has subsidiaries in North America, Latin America, Europe, China and Asia Pacific and employs about 8,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange.