VANCOUVER, BC – March 4, 2021 – Izotropic Corporation (“Izotropic”) (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3), a company developing high-resolution 3D dedicated breast CT imaging technology for the earlier detection, diagnosis, and treatment of breast cancers, is pleased that the American Medical Association (AMA) has released six Category III CPT billing codes for Breast CT technology.
The AMA issuance of these initial insurance billing codes spotlights dedicated breast CT as a promising emerging technology. It is an important development and step in the reimbursement process and aligns with Izotropic’s activities in working with payors to secure future coverage.
Izotropic’s imaging technology is based on technology from Dr. John M. Boone’s laboratory at UC Davis, with prototype devices used in a number of fully-funded clinical trials, the results of which have been published in peer-reviewed literature. Izotropic is now engaged with key payors in the USA to define their acceptance criteria and the timelines involved in obtaining coverage for breast CT. Payors may use Dr. Boone’s historic and ongoing breast CT imaging clinical trial data in addition to Izotropic’s future clinical data to support insurance coverage decisions.
Izotropic continues to work towards commercializing its breast CT imaging technology for the earlier detection, diagnosis, and treatment of breast cancers. The AMA issuance of these initial insurance billing codes is one more positive step along that path.
ON BEHALF OF THE BOARD
Robert Thast, CEO
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Background: Category III CPT Codes Defined
Category III CPT codes are temporary codes for emerging technologies and are used to facilitate data collection and track performance. These codes usually remain active for five years. The main difference between a Category I and a Category III code application is that a Category III code application does not require FDA approval/clearance or proven clinical efficacy.
A Category III code needs to satisfy specific criteria. The procedure or service must be currently or recently performed in humans. Also, the procedure or service has to meet at least one of the following additional criteria (“The CPT Approval Process”):
- Supported by at least one CPT or Health Care Professionals Advisory Committee (HCPAC, whose members represent qualified non-physician healthcare professionals) society that would use this procedure or service
- Actual or potential clinical efficacy supported by peer-reviewed literature
- At least one institutional review board (IRB) approved protocol of a study
- A description of a current and ongoing United States trial outlining the efficacy
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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