Endomag received premarket approval from the FDA for its non-radioactive, dual-tracer for mapping out lymph nodes in breast cancer patients undergoing mastectomy, a week after raising $10 million in series C funding.
The company’s Magtrace liquid marker is designed to follow the route that cancer cells are most likely to take when they spread from the primary tumor, and is tracked with its magnetic Sentimag sensor. The Cambridge, U.K. and Austin, Texas-based Endomag hopes the approval will help U.S. hospitals reduce exposure to radioactive tracers.
“The Sentimag platform is the first and only non-radioactive solution approved in the U.S. that can perform lesion localization and sentinel node biopsy,” said Endomag CEO Eric Mayes in a statement.
“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.,” Mayes said. Magtrace will be exclusively distributed in North America by Leica Biosystems.
The tracer can be injected up to a week before surgery, and is filtered by sentinel lymph nodes without disrupting the rest of the nodes in the armpit.
“We’ve been watching this technology become established in Europe over the past few years, and have been eagerly awaiting its availability in the U.S.,” said principal study investigator Michael Alvarado, professor of surgery at the University of California, San Francisco.
“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,” Alvarado said, describing Endomag’s implantable magnetic seed surgery marker that recently received 510(k) clearance.
“Being able to carry out both seed localization and sentinel node biopsy with one instrument made this the only option for us,” he added.
Endomag’s series C funding, led by Draper Esprit, brought total investment in the company up to $22 million. The company plans to use the money to expand commercial activity.