"The FDA’s designation of our MagSense technology and HER2 test as a breakthrough device is a significant step in our clinical development program"
NEW YORK--Manhattan Scientifics Inc.’s former wholly-owned subsidiary that was initially funded by MHTX, Imagion Biosystems Ltd (ASX:IBX) over a nine-year period has received confirmation from the Food and Drug Administration (FDA) that the MagSense System and Test for staging HER2 breast cancer has qualified for and been granted designation as a breakthrough device. The cancer diagnostic technology further develops the early work of physicist Edward R. Flynn, PhD.
Manhattan Scientifics owns 64 million IBX shares. Imagion Biosystems traded 140 million shares yesterday to a high of AU$0.075 and closed with a gain of approximately 200% over its previous close.
Imagion has confirmed that it is currently discussing with the FDA and clinical study sites to undertake a first-in-human study of the MagSense HER2 Test.
“The FDA’s designation of our MagSense technology and HER2 test as a breakthrough device is a significant step in our clinical development program,” said Bob Proulx, executive chairman of Imagion. “Qualifying as a breakthrough device will allow us to expedite our dialogue with the agency and validates that our MagSense technology is not just another medical device but, indeed, represents a transformative opportunity for healthcare and could improve the standard of care for staging HER2 breast cancer,” Mr Proulx added.
Manhattan Scientifics Inc. (www.mhtx.com) is focused on commercialization of disruptive technologies in the nano medicine space.
This press release contains forward-looking statements, which are subject to a number of risks, assumptions and uncertainties that could cause the Company's actual results to differ materially from those projected in such forward-looking statements. Management at Manhattan Scientifics believes that purchase of its shares should be considered to be at the high end of the risk spectrum. Forward-looking statements speak only as of the date made and are not guarantees of future performance. We undertake no obligation to publicly update or revise any forward-looking statements.