Izotropic Corporation is pursuing a regulatory strategy to introduce IzoView, a breast CT imaging system, in the U.S. and EU markets. This initiative targets the diagnosis of breast cancer in patients with dense breast tissue, a condition linked to a higher risk of developing breast cancer. The company's strategy involves a Pre-Market Authorization (PMA) clinical study in the U.S., requiring a sample population of 400 patients and an estimated cost of $3.5M USD. The study aims to demonstrate the superiority of combining digital breast tomosynthesis (DBT) with Contrast-Enhanced Breast CT over DBT alone for detecting breast cancer in women with dense breasts.
In the EU, Izotropic is seeking market approval under the CE Mark pathway, leveraging U.S. clinical data to potentially expedite commercialization. The company is engaging with a notified body to assess the conformity of IzoView under EU legislation, with the schedule for CE Marking to be finalized post-negotiations.
IzoView offers a comfortable imaging experience without the need for breast compression, producing high-resolution 3D images that allow radiologists to examine the breast from any angle. This technology is particularly beneficial for patients with dense breast tissue, where traditional imaging methods may obscure abnormalities.
Izotropic's efforts are supported by the FDA's recent mandate requiring U.S. screening facilities to inform women about their breast density, highlighting the importance of advanced diagnostic tools like IzoView. The company's U.S. patent portfolio includes the only patent to measure breast density using the Breast CT modality, underscoring its commitment to improving breast cancer diagnostics.
Despite challenges, including financial constraints and regulatory hurdles, Izotropic is determined to advance IzoView's development and commercialization. The company's CEO, Robert Thast, expressed confidence in the regulatory approach and approval pathways identified for both the U.S. and EU markets, emphasizing the potential of IzoView to enhance the accuracy of breast cancer diagnosis globally.
