MELBOURNE, Australia, April 4, 2018 /PRNewswire/ -- Imagion Biosystems Limited (ASX:IBX), a company dedicated to improvinghealthcare through the earlier detection of cancer, is pleased to provide an update on recent communications with the U.S Food and Drug Administration (FDA) regarding its plans for clinical development of MagSense™ technology.
"We are very happy with the feedback we received and the level of engaged dialog with the FDA in our Pre-Submission process," said Bob Proulx, Executive Chairman of Imagion Biosystems. "This communication gives us confidence that our clinical development plan is on solid ground and in sync with the expected regulatory requirements."
Key next steps in the development process required before first-in-human testing include:
About Imagion Biosystems
Imagion Biosystems is at the crossroads of biotechnology and nanotechnology. Its novel bioimaging and nanomagnetic detection systems have been developed specifically to detect cancer earlier and with higher specificity than is currently possible. With MagSense™ technology, the company has the potential to optimize patient care and reduce mortality rates across various cancer indications. Imagion Biosystems listed on the Australian Securities Exchange (ASX) in June 2017. For further information please visit www.imagionbiosystems.com
View original content:http://www.prnewswire.com/news-releases/imagion-biosystems-reports-progress-on-regulatory-pathway-300624053.html
SOURCE Imagion Biosystems
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