- Izotropic (CSE:IZO) reveals it is pursuing a regulatory strategy in the United States and European Union to launch IzoView as a diagnostic device in patients with dense breast tissue
- The path towards regulation will review a pre-market authorization clinical study with an estimated population of 400 patients and a cost of US$3.5million
- The company is completing a pre-submission and expects to file with the U.S. Food and Drug Administration in the next six to eight weeks
- Shares of Izotropic Corp. are up 11.76 per cent to C$0.095 as of 9:43 am ET
Izotropic (CSE:IZO) reveals it is pursuing a regulatory strategy in the United States and European Union to launch IzoView as a diagnostic device in patients with dense breast tissue.
In a news release, the company stated the path towards regulation will review a pre-market authorization clinical study with an estimated population of 400 patients and a cost of US$3.5 million.
Izotropic stated it is also now completing a pre-submission and expects to file with the U.S. Food and Drug Administration (FDA) in the next six to eight weeks.
The strategy positions the IzoView Breast CT for market entry as a diagnostic imaging device to be used in conjunction with digital breast tomosynthesis and is intended for use in patients with dense breast tissue.
“Izotropic has invested considerable time and capital in the filing and regulatory preparation stages aimed at securing market approval or clearance for IzoView in the U.S,” Robert Thast, CEO of Izotropic, said in a statement. “The current clinical study design selected for IzoView as a contrast-enhanced diagnostic device adjunctive to Digital Breast Tomosynthesis for patients with dense breast tissue is in line with the expectations of the FDA and supported by the new U.S. government-mandated breast density notifications for patients undergoing breast cancer screening.”
After receipt of formal acceptance from the FDA, the company will be able to confirm and finalize timelines and costs in order to complete long-term debt funding related to milestones or non-dilutive options to execute the study and prepare for commercialization.
Izotropic has its headquarters out of Vancouver and is focused on the development and commercialization of the Izotropic Breast Imaging System for application in proprietary diagnostic products for breast cancer.
Shares of Izotropic Corp. (CSE:IZO) are up 11.76 per cent to C$0.095 as of 9:43 am ET.
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