Hemex Health

Hemex Health

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Private Company

Total funding raised: $5M

Overview

Hemex Health is a private, commercial-stage diagnostics company with its Gazelle platform already deployed in over 40 countries, though not yet cleared for sale in the United States. The portable, battery-powered platform integrates microchip electrophoresis and fluorescent immunoassay (FIA) technologies to provide quantitative results for hemoglobin variants and ferritin levels in minutes. The company recently received FDA Breakthrough Device Designation for its Hb Variant Test, signaling significant regulatory progress and potential for U.S. market entry. Its core mission is to address the vast unmet need for accessible, point-of-care testing for inherited blood disorders and anemia worldwide.

HematologyGenetic DisordersAnemia

Technology Platform

The Gazelle platform integrates paper-based microchip electrophoresis and fluorescent immunoassay (FIA) technologies into a portable, battery-powered point-of-care device. It uses AI-driven algorithms for automated result interpretation and is designed for a expandable menu of quantitative blood tests.

Funding History

3
Total raised:$5M
Grant$500K
Series A$3M
Seed$1.5M

Opportunities

The massive global unmet need for point-of-care testing for sickle cell disease and iron deficiency anemia, particularly in low-resource settings, represents a vast addressable market.
Recent FDA Breakthrough Device Designation accelerates the pathway to enter the high-value U.S.
market, while the platform's expandable design allows for future growth into new test areas.

Risk Factors

Key risks include failure to secure FDA clearance for U.S.
market entry, intensifying competition in the point-of-care diagnostics space, and execution challenges in scaling manufacturing and distributor networks globally.
Funding requirements for regulatory processes and R&D also present an ongoing risk.

Competitive Landscape

Hemex competes in the point-of-care hematology diagnostics space. For sickle cell, competitors range from lab-based HPLC systems to other POC devices like the Sickle SCAN™ (BioMedomics) and HemoTypeSC™ (Silver Lake Research). In ferritin testing, it competes with central lab immunoassays and a few other POC quantitative ferritin devices. Gazelle's key differentiators are its quantitative results, multi-test platform capability, and proven ruggedness for low-resource settings.