This will complement the engagement with the U.S. FDA’s Center for Devices & Radiological Health Payor Communication Task Force.
Vancouver, British Columbia--(Newsfile Corp. - March 24, 2021) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) (“Izotropic” or the “Company”), 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 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
ON BEHALF OF THE BOARD
For investor relations inquiries contact:
James Berard
Email: jberard@izocorp.com
Cell: 778-228-2314
Toll Free: 1-833-IZOCORP ext.1
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.
Additional information about Izotropic Corporation can be found on its website at izocorp.com and by reviewing its profile on SEDAR at sedar.com
Forward Looking Statements
This document may contain statements that are “Forward-Looking Statements,” which are based upon the current estimates, assumptions, projections and expectations of the company’s management, business, and its knowledge of the relevant market and economic environment in which it operates. The Company has tried, where possible, to identify such information and statements by using words such as “anticipate,” “believe,” “envision,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate” and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words. These statements are not guarantees of performance and involve risks and uncertainties that are difficult to control or predict, and as such they may cause future results of the company’s activity to differ significantly from the content and implications of such statements. Forward-Looking Statements are pertinent only as of the date on which they are made, and the company undertakes no obligation to update or revise any Forward-Looking Statements to reflect new information or the occurrence of future events or circumstances unless otherwise required to do so by law. Neither the company nor its shareholders, officers and consultants, shall be liable for any action and the results of any action taken by any person based on the information contained herein, including without limitation the purchase or sale of company securities. Nothing in this document should be deemed to be medical or other advice of any kind.
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