Through the filing of a Pre-Submission with the U.S. Food and...

Through the filing of a Pre-Submission with the U.S. Food and Drug Administration (FDA), MedTech company Imagion Biosystems (ASX:IBX) has taken its first step towards gaining approval to commence its first-in-human study into its non-invasive, non-radioactive imaging technology MagSense, for staging HER2 breast cancer.

This comes only weeks after Imagion’s MagSense Systems gained “Breakthrough Device” designation from the FDA, a factor that will help expedite communication between the company and the FDA for this approval process.

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”.

Achieving Breakthrough Device status in itself was a major development that resulted in Imagion’s shares increasing more than 150% under record volumes.

FDA status paves way for accelerated communications
Based on FDA’s previous guidance, the company has filed a Pre-Submission with the agency in anticipation of filing for an investigational device exemption (IDE), a US regulatory requirement for human studies with medical devices.

In 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.

Proulx went on to explain that while the designation does not change the compliance requirements, it should improve the speed with which the company receives feedback from the agency, as well as reducing the risk of disruptions to its 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 the company can address specific questions related to the IDE.

The company’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.

The MagSense test for the staging of HER2 breast cancer aims to eliminate the unnecessary surgeries and concomitant morbidity resulting from the current standard of care biopsy procedure.