Vancouver, British Columbia–(Newsfile Corp. – January 5, 2021) – Izotropic Corporation (CSE: IZO) (OTC Pink: IZOZF) (FSE: 1R3) (“Izotropic” or the “Company“) is pleased to provide an update on corporate and commercialization progress and its positioning for 2021.
Izotropic achieved important milestones in 2020 and added experienced medical device executives and key thought leaders in the medical device sector to its team that continue to provide valuable contributions to product development, regulatory, and commercialization initiatives. With clear objectives and sufficient capital to execute, the Company looks forward to sustaining its progress through 2021, and will be providing quarterly updates as it continues to create value for our shareholders.
As well as planning for the initial indication for use of breast CT as a diagnostic device, Izotropic has identified additional indications for use for breast CT and plans to develop accessories and additional products, all aimed at making breast CT an indispensable tool for improving the outcomes of breast cancer.
Izotropic Breast CT Technology
Extensive preliminary studies at UC Davis have found that breast CT may be able to routinely detect tumors in the 3 to 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 with breast CT .
A 2019 study on breast CT demonstrated that cancerous or malignant masses were more clearly visualized on contrast-enhanced breast CT than both mammography and tomosynthesis .
A 2020 study on mortality rates due to cancer treatment delays showed that every month delayed in cancer treatment can raise risk of death by around 10% .
Patents and IP
The Company’s exclusive licensing agreement with the Regents of the University of California currently covers a portfolio of 10 (ten) U.S and international patents and patent applications.
U.S. patent representation is led by Henry Daley, Ph.D., partner at Venable LLP law firm in Washington DC. In addition to a Doctor of Law degree, Mr. Daley holds a Ph.D. in physics and specializes in patent prosecution and intellectual property.
The Company continues to file and prosecute U.S. and international patents and expects additional IP developments and announcements in 2021.
In Q4 2020, the Company completed a pre-submission meeting with the FDA. Feedback and considerations resulting from this meeting are now being integrated into commercialization planning.
The Company will engage with additional jurisdictions in 2021.
In moving forward with its clinical study plans, the Company has begun discussions with targeted U.S. hospitals for clinical study partners.
Izotropic is active in participating in the FDA’s Center for Devices & Radiological Health Payor Communication Task Force program, and initial progress will be reported before the end of Q1 2021.
Approximately $20M in U.S. government grants has been invested in Breast CT product development and clinical trials at UC Davis. The Company is in a unique position to use this trial data in discussions with insurance payers to demonstrate patient benefits for insurance coverage of breast CT.
Capital and Value-Added Incentives
Izotropic raised approximately $6M CND in calendar Q4 2020, and is well positioned to execute business and commercialization objectives in 2021.
In addition to equity financing, Izotropic is eligible for additional grants in the U.S. and Canada, including the Canadian SR&ED, a capital reimbursement program. Incentive facilities are being pursued that will help maximize R&D spending and support the development of additional products.
ON BEHALF OF THE BOARD
Chief Executive Officer
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1. Breast CT Scanner for Earlier Cancer Detection
2. Conspicuity of suspicious breast lesions on contrast enhanced breast CT compared to digital breast tomosynthesis and mammography
Shadi Aminololama-Shakeri, Craig K. Abbey, Javier E López, Andrew M Hernandez, Peymon Gazi, John M Boone, and Karen K Lindfors
The British Journal of Radiology 2019 92:1097
3. Every Month Delayed in Cancer Treatment Can Raise Risk of Death by Around 10%
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
This document may contain forward-looking statements that are based on the Company’s expectations, estimates and projections regarding its business and the economic environment in which it operates. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to control or predict. Therefore, actual outcomes and results may differ materially from those expressed in these forward-looking statements and readers should not place undue reliance on such statements. Statements speak only as of the date on which they are made and the Company undertakes no obligation to update them publicly to reflect new information or the occurrence of future events or circumstances, unless otherwise required to do so by law.
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