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Izotropic Corp. C.IZO

Alternate Symbol(s):  IZOZF

Izotropic Corp is a Canada based company. It is engaged in the development and commercialization of the Izotropic Breast Imaging System for application in proprietary diagnostic products for breast cancer.


CSE:IZO - Post by User

Post by lscfaon Jan 01, 2024 10:37pm
189 Views
Post# 35806500

fins on sedar

fins on sedarThe Company filed a modified pre-submission application with the FDA in September 2023 and met with the FDA October 25th 2023 to discuss the Company’s intent to transition from a Class III approval pathway, to a Class II 510(k) market clearance pathway. Discussions have been ongoing since the October 25th , 2023 meeting and the Company is now awaiting guidance from the FDA in respect to this application. During the past 6 months, the Company has been in discussions with several industry related entities about sublicensing certain IzoView applications, global marketing arrangements, partnering, merging, collaboration arrangements, manufacturing and funding. If an agreement is reached involving sublicensing and partnering, non-dilutive capital will be an important condition. Presently, all but one of the entities the Company is in discussions with are awaiting a decision from the FDA, before working to finalize an agreement. With formal guidance from the FDA, the Company intends to complete its go to market plans, work to finalize agreements with one or more strategic partners, ready for manufacturing and secure capital to fund next steps.
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