FloBio

FloBio

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Private Company

Total funding raised: $3.9M

Overview

FloBio is developing a first-of-its-kind, fluidic-based point-of-care diagnostic platform to transform the management of bleeding and clotting disorders. Its core technology simulates in-vivo clot formation under flow, providing a multiplex, functional assessment of platelet and fibrin activity in whole blood within 10-15 minutes. The company's initial focus is on detecting and quantifying Direct Oral Anticoagulants (DOACs) to guide reversal strategies, addressing a critical unmet need in emergency medicine. With FDA Breakthrough Device Designation for its bleeding risk test, FloBio is positioned to enter a significant market driven by the growing safety concerns and costs associated with blood thinners.

HematologyEmergency MedicineCritical Care

Technology Platform

A patented, fluidic-based point-of-care diagnostic platform that simulates in-vivo clot formation under hemodynamic flow. It performs dynamic, multiplex evaluation of whole blood to assess platelet and fibrin function in real-time (10-15 minutes) via a table-top analyzer and disposable cartridge.

Funding History

5
Total raised:$3.9M
Grant$413K
Grant$1.2M
Seed$1.8M
Grant$252K

Opportunities

The massive and growing use of DOACs, coupled with the lack of rapid POC tests, creates a critical unmet need.
The platform's adaptability allows for a portfolio of tests addressing various hemostasis abnormalities beyond DOACs, such as trauma-induced coagulopathy and platelet disorders.
Hospital drives for cost-effective care and blood product stewardship align perfectly with the value proposition of rapid, guided decision-making.

Risk Factors

The company must successfully transition its complex research platform into a robust, manufacturable, and user-friendly IVD product and prove its clinical utility in pivotal trials.
As a pre-revenue startup, it faces significant financing risk to fund development and commercialization.
It will also need to displace established standard tests and compete with larger, well-resourced diagnostic companies in a cost-sensitive hospital market.

Competitive Landscape

FloBio competes in the POC coagulation testing market against large, established players like Roche (CoaguChek), Abbott, and Werfen, which offer tests like PT/INR and ACT, but not functional, multiplex assays under flow. It also faces potential competition from other startups developing novel coagulation diagnostics. Its key differentiation is the simulation of physiological flow to provide a more comprehensive, functional assessment of hemostasis in a single rapid test.