18 July 2019
As reported in Biotech Daily
Imagion says the US Food and Drug Administration has granted ‘breakthrough device designation’ for its Magsense HER2 breast cancer staging test.
Imagion said devices that provided a more effective treatment of a human disease or condition and either represent a breakthrough technology, address an application for which there are no alternatives, offer advantages over alternatives or are in the best interests of the patients, qualify for breakthrough device designation.
The company said the designation was designed “to expedite and improve communications between a device manufacturer and the agency during device development and throughout the review process and provides priority review”.
The company said it was in discussions with the FDA on clinical study sites for a first-in-human study of the Magsense HER2 breast cancer test to eliminate unnecessary surgeries and concomitant morbidity from current biopsy procedures.
Imagion executive chairman Bob Proulx said, “the FDA’s designation of our Magsense technology and HER2 test as a breakthrough device is a significant step in our clinical development program”.
“Qualifying as a breakthrough device will allow us to expedite our dialog with the Agency and validates that our Magsense technology is not just another medical device but … could improve the standard of care for staging HER2 breast cancer,” Mr Proulx said.
Imagion was up 3.1 cents or 155 percent to 5.1 cents with 190.7 million shares traded.