Australian listed medical imaging company Imagion Biosystems (ASX: IBX) has received approval as a breakthrough device for its breast cancer detection technology from the US Food and Drug Administration.
The approval, which gives priority to communications between Imagion and the FDA to speed the development process, is a major step forward for the company, according to executive chairman, Bob Proulx.
He said: “Qualifying as a breakthrough device…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.”
MagSense is a new non-radioactive and safe diagnostic imaging technology that combines biotechnology and nanotechnology to detect cancer and other diseases.
Specialized MagSense nanoparticles are coated with tumour targeting antibodies and can be administered by simple intravenous injection.
Weak, but highly sensitive magnetic fields are used to locate the nanoparticles which only bind to the targeted tumour cells.
Proulx told the company’s annual general meeting in May that the company was making tremendous progress in its aggressive development plans, though these had been forced to be changed during the year.
“We have to remember that our MagSense technology is a whole new way to detect tumours and like most things disruptive to a current paradigm, if it were easy it would have been done before.
“We are the first to be developing a targeted bio-safe imaging technology.”
The company is now planning with the FDA the clinical sites to undertake its first in-human studies.
Picture: Imagion Biosystems/ MagSense
Subscribe to our free @AuManufacturing newsletter here.