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Highlights
- Dr. Kyle J. Myers and Dr. Alicia Toledano lead regulatory and clinical strategy for IzoView.
- Mr. John DeLucia ensures smooth FDA interactions and regulatory compliance for Izotropic.
- IzoView, a breast CT imaging system, targets underserved patients with dense breast tissue.
Izotropic Corporation, a forward-thinking medical device company (CSE:IZO), continues to make significant strides in the fight against breast cancer. The company is commercializing innovative imaging products to improve the screening, diagnosis, and treatment of breast cancer. Recently, Izotropic announced the addition of three prominent experts in the field, Dr. Kyle J. Myers, Dr. Alicia Toledano, and Mr. John DeLucia, to provide key consulting services in the company's regulatory division.
These experts are set to support the company’s crucial goal of advancing IzoView, an imaging device designed to enhance breast cancer screening for women with dense breast tissue. IzoView is a dedicated breast CT imaging system, specifically designed as an adjunct to digital breast tomosynthesis (DBT, or 3D mammography), offering a revolutionary approach to screening asymptomatic women who have dense breasts. This population, currently underserved by the existing standard-of-care imaging techniques, comprises approximately 50% of women in the U.S. undergoing breast cancer screening.
Dr. Myers and Dr. Toledano, supported by Izotropic’s core team, were instrumental in the development of the company’s regulatory strategy and clinical study design, which were recently presented in the company’s pre-submission to the U.S. Food and Drug Administration (FDA). Their expertise in medical imaging and regulatory affairs is pivotal in guiding the pathway to FDA approval for IzoView.
Dr. Myers, with an impressive career in medical imaging, previously served as the Director of the Division of Imaging, Diagnostics, and Software Reliability at the FDA. Her extensive work in the field includes developing evaluation methods for emerging imaging systems, 3D breast imaging technologies, and software tools. Her experience will be invaluable in ensuring IzoView’s clinical studies meet FDA standards and effectively demonstrate the device’s benefits for women with dense breasts. Dr. Myers holds a doctorate in optical sciences from the University of Arizona and is a member of the National Academy of Engineering.
Dr. Toledano, an expert in clinical study design and regulatory affairs, will play a crucial role in refining IzoView’s clinical trial strategies and ensuring the regulatory submission is seamless. She will work closely with the management team and other advisors to ensure that all FDA requirements are met in the most efficient and timely manner.
Additionally, Mr. John DeLucia, a seasoned regulatory consultant, will represent Izotropic during pre-submission discussions with the FDA. His role will ensure that the company’s proposals, documentation, filings, and communications align with the FDA's stringent regulatory compliance processes. His expertise is crucial in navigating the complexities of FDA interactions and ensuring that the company’s submission is complete and coherent.
