Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
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.
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on OOZFIX.