T&R Biofab announced on the 13th that it has received permission for domestic sales of a powder-type hemostatic agent product from the Ministry of Food and Drug Safety.
This hemostatic agent is a hemostatic used directly in the body and is a Class 4 medical device that must meet high levels of safety and quality.
T&R Biofab's powder-type hemostatic agent is composed of a mixed solution made up of low-toxicity absorbable pig gelatin powder, hemostatic powder containing thrombin that induces blood coagulation to prevent bleeding, protein extracts, and polyvinylpyrrolidone, processed by a patented method. When mixed, the gelatin powder absorbs and coagulates blood to perform a hemostatic action, and the thrombin, a hemostatic active substance in the product, assists in converting fibrinogen in the blood into fibrin, the company explained.
A company official noted, "Our product shows superior performance in tissue regeneration, adhesion, and hemostatic performance compared to existing products, including vascular-derived extracellular matrix (VdECM), which is the core material of hemostatic agents. We have a price competitiveness advantage as we manufacture low-toxicity products using our own technology, and we expect that this product will become a key item that drives the company's sales in the future."
T&R Biofab plans to pursue approval for a matrix-type hemostatic agent soon.
According to the 'Domestic Medical Device Market Report' by Synex, the domestic hemostatic agent market is estimated to be worth 270 billion won as of 2023 and is expected to grow steadily at an average annual rate of about 10% due to increases in laparoscopic and endoscopic surgeries. T&R Biofab aims to replace imported hemostatic products, which currently account for about 77% of the domestic hemostatic agent market, with local products such as powder-type and matrix-type hemostatic agents.