Drug intelligence / Profile preview

OOZFIX

Development stage
Phase 4
Lead developer
Theracion Biomedical
Modality
Transdermal Patches → Device-based Delivery → Drug Delivery Systems, Hydrogel Systems → Drug Delivery Systems
Administration
Topical
01

Overview

OOZFIX is an absorbable hemostatic powder consisting of polyelectrolyte complex polysaccharide (PECP), specifically a calcium-modified carboxymethyl starch with higher calcium ion content compared to existing powder-type products[1][2]. The product is designed to rapidly control bleeding through its high absorbency properties, which promote the clotting cascade[1].\n\n## Mechanism of Action\n\nThe hemostatic mechanism of OOZFIX works through multiple pathways:\n\n1. Blood absorption: The powder absorbs blood at the bleeding site, forming a barrier that enhances blood coagulation[3][5].\n2. Ionic assembly: OOZFIX contains an ionic assembly of carboxymethyl starch and calcium, which maintains its network structure after blood absorption due to the ionic assembly with Ca²⁺[5].\n3. Clotting promotion: The calcium ions in the structure facilitate hydrophilicity and blood coagulation with gelation during the later steps of hemostasis[5].\n\n## Product Specifications\n\nOOZFIX is available in several configurations:\n\n- Standard (Flexible type) models in 1g, 5g, and 7g volumes with 80mm working length\n- Laparoscopy (Straight type) models in 1g, 5g, and 7g volumes with 300mm working length[1]\n\nAll products are packaged as 5 packs per box and are sterilized using gamma-ray irradiation before being stored at room temperature[2].\n\n## Clinical Performance\n\nIn vivo studies have demonstrated that OOZFIX has:\n\n- Significantly improved hemostasis rate (78 ± 17 seconds) compared to Arista AH (182 ± 11 seconds)\n- Quick biodegradation (less than 3 weeks)\n- Reduced desorption properties[5]\n\nThe product has shown promising results in rat hepatic hemorrhage models, suggesting its effectiveness as a hemostatic agent for precise medical surgical treatments[5].\n\n## Regulatory Status\n\nAs of 2025, OOZFIX has achieved the following certifications:\n- KFDA: Approved\n- FDA: Completed in 2024\n- CE: Completed in 2025[1]\n\n## Manufacturer Information\n\nOOZFIX is developed and manufactured by Theracion Biomedical, a company based in Seongnam, Korea[1][2]. The company appears to specialize in hemostatic products, with OOZFIX being one of their flagship products alongside EndoStat, an endoscopic hemostatic powder[7].\n\nOOZFIX represents an advancement in hemostatic technology, offering healthcare providers a simple and effective solution for controlling bleeding during surgical procedures.

Brand names
OOZFIX

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