Atossa Therapeutics Inc (NASDAQ:ATOS) has announced its support for the SMART study, a new Phase 2 clinical trial aimed at validating an innovative artificial intelligence-driven breast cancer risk assessment model.
The study will enrol 70,000 women in Sweden following their regularly scheduled bi-annual mammogram.
The Profound AI Model, a proprietary algorithm, will analyze mammogram results and additional assessment data to determine each participant’s risk of developing breast cancer within the next two years.
Approximately 20% of participants identified as high risk will be divided into an intervention arm and a control arm to measure the model's predictive power.
"The SMART study will be the largest prospective clinical trial in the history of medicine that is intended to test if individualized, risk-based breast cancer screening is superior to current practice," said Dr Per Hall, Professor of Epidemiology at Karolinska Institutet, Stockholm, Sweden, and Principal Investigator of the SMART clinical trial.
"The breast cancer risk models that are widely used today are simply not effective, in large part because they fail to consider the individual woman."
Atossa’s CEO, Steven Quay, emphasized the study's significance: "Atossa is proud to help sponsor this groundbreaking study. Validating the Profound AI Risk model for therapeutic purposes will allow us to leverage the algorithm for the planned SMART 2 study."