European approval for device to help breast cancer surgeons

Endomag has gained CE Mark approval for its novel device which guides surgeons during breast cancer removal.

Regulators have given the green-light to Magseed, a minimally invasive breast market developed by the Cambridge firm. It will now be distributed across Europe, the Middle East and Africa by Sysmex, as part of a new five-year distribution deal for the company’s 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.

Eric Mayes, CEO of Endomag, said: “After the successful launch of Magseed in the US, where many of the top cancer centres are now using it routinely, we couldn’t wait to make it available across Europe. 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 over 25,000 breast cancer operations.

Ines Groener, Senior Vice President of Oncology, Sysmex: “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. 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.”

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