What You Should Know
- Flosonics Medical secured a major development contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
- Awarded under BARDA’s Burn and Blast Medical Countermeasures program (Contract No. 75A50126C00006), the agreement includes initial funding of approximately $15 million, with a total potential value of up to ~$70 million if all milestones and options are exercised.
- Funds the development of FloPredict, an AI-enabled software algorithm designed to detect internal bleeding and hemorrhage following acute traumatic injury and mass casualty events (including blast scenarios and nuclear detonations).
- Integrates directly with FloPatch, Flosonics’ FDA-cleared, wireless, wearable Doppler ultrasound device worn on the neck to assess carotid blood flow and real-time hemodynamic changes.
- FloPatch has already been deployed across more than 13,000 patients in 30+ U.S. hospitals, primarily supporting bedside fluid resuscitation decisions in sepsis, shock, and hypotension workflows.
Extending Wearable Doppler Ultrasound to Mass Casualty Triage
The federal funding will support the development of FloPredict, an artificial intelligence software enhancement for the company’s FDA-cleared FloPatch device. FloPatch is a wireless, adhesive Doppler ultrasound sensor applied directly over the carotid artery to capture real-time blood flow dynamics. To date, the device has been deployed across more than 30 U.S. hospitals on over 13,000 patients, primarily guiding fluid resuscitation decisions for critical care conditions such as sepsis, septic shock, and severe hypotension.
Under the BARDA agreement, Flosonics will develop machine learning algorithms within FloPredict to analyze real-time Doppler waveforms and flag early hemodynamic indicators of internal hemorrhage. The initiative aims to strengthen emergency preparedness and triage capabilities for high-consequence mass casualty events, including blast trauma and potential nuclear detonations where medical personnel and diagnostic resources are severely constrained.
Key capabilities targeted by the collaboration include:
- Pre-Decompensation Hemorrhage Alerts: AI models designed to detect subtle changes in arterial flow time and velocity profiles that precede clinical shock.
- Rapid Bedside Triage: Enables non-specialist frontline clinicians and first responders to obtain objective hemodynamic data within seconds without waiting for bulky imaging equipment or invasive arterial lines.
- Optimized Resource Allocation: Helps triage teams identify which trauma victims require immediate surgical intervention or blood transfusions during mass casualty surges.
