Augmenix said it won CE Mark approval in Europe for its TraceIT fiducial marker and TraceIT gel system radiology marking agents.
The products are part of Augmenix’s TraceIT line of absorbable hydrogels used to mark tissues with CT, MR, cone beam and ultrasound visibility. The line also includes TraceIT Tissue Marker, which won U.S. approval in 2013.
"At Augmenix, we are proud to introduce advanced hydrogel products that improve outcomes of radiotherapy by improving guidance to target organs and minimizing damage to adjacent organs," Augmenix CEO Amar Sawhney said in prepared remarks. "We hope that with these new markers radiotherapy may become an increasingly viable option to treat cancers of the bladder, liver and cervix and expand the market for radiotherapy overall while improving patient care and reducing healthcare costs."
In August, Augmenix raised $10.8 million in a Series D funding round to help bring its Space OAR hydrogel product to market. The product has not yet been approved in the U.S.