VANCOUVER, BC - TheNewswire - March 24, 2021 - Izotropic Corporation (“Izotropic” or the “Company”) (CNSX:IZO.CN) (OTC:IZOZF) (FSE:1R3), a company commercializing true 3D, dedicated breast CT imaging technology for the earlier detection of breast cancers, is pleased to announce it has partnered with EXCITE International (EXCITE), a global network of payors, health systems, patients, scientists, and end-users, to prepare for future commercial adoption of the IZOview. This will complement the engagement with the U.S. FDA’s Center for Devices & Radiological Health Payor Communication Task Force. With this EXCITE partnership, Izotropic will engage with EXCITE’s global network to align the device, clinical trial design, and regulatory strategy with potential payor groups, methodologists, and expert end-users. The aim is to integrate all of the inputs from various groups to increase potential breadth and speed of adoption upon regulatory approval. The expectation is for this work to be completed before the end of the calendar year.
Executive Vice President of Commercial Operations and incoming CEO, Dr. John McGraw, stated, “EXCITE offers real-time access to key opinion leaders, scientists and payor groups in North America and Europe. By engaging with internationally recognized key-stakeholders early on, just as we did with the FDA Pre-Submission, we’re de-risking our regulatory and commercialization plans and ensuring that we’re compliant and can deliver the appropriate clinical evidence needed to support adoption in a given patient population. Simply put, the partnership with EXCITE should increase the likelihood of rapid adoption of the IZOview Breast CT system.”
Founder and CEO of EXCITE, Dr. Leslie Levin, explained the network’s process and how it impacts adoption: “EXCITE offers early direct engagement with experts and payers through early technology review, protocol development, and clinical trial execution. This allows companies to anticipate and meet the downstream expectations of these important stakeholders. EXCITE is selective in only taking on potentially impactful technologies that offer improved patient outcomes and/or health system efficiencies. IZOview clearly offers promise across this spectrum.”
EXCITE recognizes the current process of evidence development late in the lifecycle is responsible for high payor rejection rates of FDA-approved technologies. The EXCITE process addresses this issue through early engagement. Dr. Levin stated, “Offering these early insights continues to provide companies with an understanding of expectations of key stakeholders early enough to allow them to develop strategies that meet their expectations and, in so doing, mitigate the risk of downstream rejection. The EXCITE approach also de-risks investments into technology development.”
Dr. Levin has experience in cancer immunology, biochemistry research, practice experience as an academic medical oncologist and has participated in numerous cancer-related clinical trials, published over 60 original papers, and led the development of evidence at the policy interface with EXCITE.
More information on Excite International and how they lower investment risk can be found at https://www.exciteinternational.com/site/clinical-trial-development-and-execution
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About Izotropic Corporation
Izotropic Corporation is commercializing dedicated breast CT imaging technology for the earlier detection, diagnosis and treatment of breast cancers. Extensive preliminary studies have found that breast CT may be able to routinely detect small breast tumors in the 3-5 mm size range. The median size of breast cancer found using mammography is approximately 11 mm. Routine detection of 3 mm lesions would result in 1.5 year earlier detection over mammography.
The initial indication for use for breast CT as a diagnostic device has been confirmed. Forthcoming business objectives include identifying additional indications for use, development of accessories, and additional products, all aimed at making breast CT an indispensable tool for improving the outcomes of breast cancer.
Forward Looking Statements
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