Imagion Biosystems (ASX:IBX) says it has filed pre-submission with the US Food and Drug Administration (FDA), the first step in gaining approval to commence its first-in-human study.
The company said the communication with the FDA’s Center for Devices and Radiological Health (CDRH) follows the recent notification that its MagSense System and Test for staging HER2 breast cancer have been designated as a 'Breakthrough Device'.
It added it has filed the pre-submission in anticipation of filing for an investigational device exemption (IDE), a US regulatory requirement for human studies with medical devices, requesting a 'sprint' discussion that is intended to expedite communication.
“The recent Breakthrough Device designation by the FDA has been very timely, allowing us to request an expedited review of our submission,” said executive chairman Bob Proulx. “While the designation does not change the compliance requirements, we expect it will improve the speed with which we receive feedback from the agency and reduce the risk of disruptions to our plans for undertaking a first-in-human study.”
The company said early feasibility and a first-in-human study is a critical milestone in the development of its non-radioactive imaging technology that provides a potential non-surgical solution to identify the progression or stage of HER2 breast cancer metastases.