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Imagion Biosystems Initiates Regulatory Communications for First-In-Human Study

Imagion Biosystems Limited, an Australian biotechnology company dedicated to improving healthcare through the earlier detection of cancer, has filed for a Pre-Submission with the U.S. Food and Drug Administration (FDA), the first step in gaining approval to commence its first-in-human study.

Communications with the FDA’s Centre for Devices and Radiology Health (CDRH) follow from the recent notification that Imagion’s MagSense System and Test for staging HER2 breast cancer have been designated as a “Breakthrough Device”.

Based on FDA’s previous guidance, Imagion has filed a Pre-Submission with the agency in anticipation of filing for an investigational device exemption (IDE), a U.S. regulatory requirement for human studies with medical devices. Through the submission Imagion has requested a “sprint” discussion, a facility within the Breakthrough Device program 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 Bob Proulx, Executive Chairman. “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.”

Following a brief review of the Pre-Submission by the FDA, Imagion will be able to schedule a meeting wherein both the reviewers within the agency and Imagion can address specific questions related to the IDE.

On July 18th, 2019, Imagion announced the Breakthrough Device designation for the MagSense System and Test for staging HER2 breast cancer. To qualify for Breakthrough Device status a product must be considered to “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions”.

Imagion’s early feasibility, first-in-human study is a critical milestone in the development of the company’s non-radioactive imaging technology which provides a non-surgical solution to identify the progression or stage of HER2 breast cancer metastases. Operationally, the company is focused on the manufacturing of nanoparticles to be used in the study, and contracting the clinical site, in preparation for commencement of the study. [APBN]