Market Overview

Breast Cancer Device Receives FDA Approval

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The first non-radioactive, dual-tracer for sentinel lymph node biopsy
approved in the U.S.

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.

After 18 months of using the Sentimag platform with Magseed for lesion
localization, we're really excited to add the sentinel node biopsy
capability with Magtrace. Being able to carry out both seed localization
and sentinel node biopsy with one instrument, made this the only option
for us. Magtrace and Magseed not only help to reduce the hospital staff
and patients from exposure to radioactivity, they also offer us
flexibility and so many more options when deciding on how to approach
our breast cancer patients."

Eric Mayes, CEO at Endomag, said: "This achievement
demonstrates our team's ability to innovate for the benefit of
clinicians and their patients. The Sentimag® platform is the first and
only non-radioactive solution approved in the U.S. that can perform
lesion localisation and sentinel node
biopsy. The addition of Magtrace to the platform offers clinicians
greater options and more flexibility when treating their patients and
will help transform the way breast cancer is treated in the U.S."

Magtrace will be exclusively distributed in North America by Leica
Biosystems – the breast health specialist with world-renowned brands
such as Mammotome, Hydromark and Neoprobe – the current market leader
for sentinel lymph node biopsy. The Sentimag platform can help hospitals
to reduce their reliance on radioactive tracers, reduce the exposure of
their staff and patients to radioactivity and become the new standard in
breast cancer treatment.

If you would like to know more, register for our upcoming Magtrace
Webinar: https://bit.ly/2n0eUbx

For more information on Endomag and their recent announcements, visit www.endomag.com

ENDS

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