Overview

Brava Diagnostics has an exclusive, worldwide license to a high-sensitivity point-of-care platform for the acute care market. The Company is seeking financing to fund diagnostic product development for rapid multiplex tests for emergency medicine and critical care. Our first point-of-care product will be a high-sensitivity troponin test for diagnosis of heart attack.

The Need

Emergency physicians need precise lab results, ideally within 15 minutes, to guide treatment or safe discharge for patients with chest pain. New guidelines from the European Society of Cardiology (ESC) and the American College of Cardiology (ACC) are driving the shift to high-sensitivity troponin assays (hs-cTn). Central lab tests suffer from turnaround time of more than an hour (high quality, but slow results). Point-of-care (POC) assays are widely used, but the, care team must compromise performance for speed (lower quality, but fast results). Neither lab nor POC tests meet the need.

Our Solution

Brava can fill this large market gap with a high-sensitivity troponin test that delivers lab-quality performance at the point-of-care in 15 minutes. Our evanescent planar waveguide technology is a different approach to POC diagnostics that enables a low-cost instrument and high margin consumable cartridges. The platform enables precise measurements at very low concentrations. MBio developed the core technology over ten years and has commercialized products outside of human health, significantly de-risking product development. Brava will build on these accomplishments by adapting the instrument for the healthcare market, developing in vitro diagnostic assays and executing clinical trials.

Cardiac Markers

Our first products will help in the diagnosis and management of heart attack and heart failure in the emergency department.

Sepsis

Sepsis is the most expensive condition treated in hospitals. Brava tests will help stage patients and inform treatment.

Platform Technology

Our multiplex technology enables rapid, quantitative measurement of very low concentrations of  proteins from whole blood.

Key Investment Drivers

Market OpportunityBrava’s Superior TechnologyCompetitive Advantages
The market for cardiac markers will reach $2.45 billion by 2025. The POC segment will reach $806 million by 2025.

European and US guidelines are driving a shift to high-sensitivity troponin assays to improve diagnosis of heart attack and to discharge low-risk patients safely.
Our evanescent planar waveguide platform delivers lab-quality results at the point-of-care.
• Whole blood sample
• Simple test procedure
• Results in <15 minutes compared to >1 hour from the central lab.
Limitations of current POC methods prevent achieving metrics in the guidelines.
Meets American College of Cardiology and European Society of Cardiology guidelines for sensitivity and precision.
• Sensitivity at pg/mL concentrations
• Precision CV <10% at the 99th percentile of the reference population

Experienced Management Team

The executive team is comprised of accomplished veterans of the diagnostics industry, with deep experience ranging from start-up to multi-national companies.

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