Izotropic Corporation (CSE: IZO) has announced its regulatory strategy for the United States and European Union to introduce IzoView as a diagnostic device for patients with dense breast tissue.
The regulatory pathway involves conducting a pre-market authorization clinical study with an estimated 400 patients at a cost of US$3.5 million. The company is currently finalizing a pre-submission and plans to submit to the U.S. Food and Drug Administration (FDA) within the next six to eight weeks.
The strategy positions the IzoView Breast CT as a diagnostic imaging device to be used alongside digital breast tomosynthesis for patients with dense breast tissue. Izotropic is investing significant resources in regulatory preparation to secure market approval for IzoView. The study design aligns with FDA expectations and new U.S. government-mandated breast density notifications for breast cancer screening patients.
Upon receiving formal acceptance from the FDA, Izotropic will confirm timelines and costs for long-term debt funding or non-dilutive options to execute the study and prepare for commercialization. The company, headquartered in Vancouver, focuses on developing and commercializing the Izotropic Breast Imaging System for proprietary diagnostic products for breast cancer.
Shares of Izotropic Corp. (CSE: IZO) have risen by 11.76% to C$0.095 as of 9:43 am ET. Investors can join the discussion on the Izotropic Corp. Bullboard investor forum to keep updated on the stock’s performance. It is important to note that the information provided in this article is for informational purposes only and should not be considered as investment advice. For full disclaimer information, please refer to the provided link.
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