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Hema Biologics

Hema Biologics

Louisville, United States· Est.
hemabio.com
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Private Company

Funding information not available

Overview

HEMA Biologics is a private, commercial-stage biotech company founded in 2012 and headquartered in Louisville, Kentucky. Its primary achievement is the FDA approval of SEVENFACT, the first new inhibitor bypassing agent for hemophilia in over two decades, positioning it in the niche but critical hemophilia with inhibitors market. The company operates with a therapeutics business model, generating early revenue from this single commercial product while potentially exploring other rare bleeding disorders. Its strategy includes patient engagement through digital tools like an educational app and support for investigator-initiated research.

HematologyRare Bleeding Disorders

Technology Platform

Recombinant protein production using transgenic rabbits for the expression of coagulation Factor VIIa.

Funding History

1
GrantUndisclosed

Opportunities

SEVENFACT is the first new inhibitor bypassing agent approved in over two decades, offering a new treatment option in a stable but high-value niche market.
The company can leverage investigator-initiated research to generate real-world evidence and explore potential label expansions within rare bleeding disorders.

Risk Factors

The company is heavily reliant on the commercial success of a single product in a market dominated by large, established competitors.
It also faces inherent risks related to the safety profile of its product (thrombotic events) and the complexities of pricing and reimbursement in the hemophilia space.

Competitive Landscape

SEVENFACT competes directly with Novo Nordisk's NovoSeven® RT (rFVIIa) and Takeda's FEIBA® (aPCC) in the hemophilia inhibitor bypassing agent market. These competitors have long-standing relationships, extensive clinical data, and large commercial infrastructures, presenting a significant barrier to market entry and share capture.

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