Reyon Pharmaceutical announced today that the 'matrix-type combination hemostat (absorbable internal hemostatic device),' co-developed with T&R Biofab, has obtained domestic regulatory approval from the Ministry of Food and Drug Safety (MFDS). Consequently, Reyon Pharmaceutical will take charge of raw material supply and domestic sales for the combination hemostat.
The matrix-type combination hemostat is a product that combines Reyon Pharmaceutical's thrombin with T&R Biofab's extracellular matrix (ECM) material. It is known as a hemostatic medical device that rapidly stops bleeding from wounds caused by surgery or trauma and aids in tissue recovery. The product has been recognized for its high level of safety and quality by passing the evaluation for Class IV medical devices, the highest category in South Korea.
In particular, Reyon Pharmaceutical's thrombin is an enzyme protein involved in blood coagulation, acting to promote blood clotting by converting fibrinogen into fibrin in the blood. Since obtaining authorization to manufacture and sell thrombin in 1978, Reyon Pharmaceutical has served as the frontline production base for thrombin in South Korea and remains the only pharmaceutical company in the country to produce it to this day. Thrombin is well-known for delivering a definitive hemostatic effect with just a single application within seconds, utilizing natural fibrin.
T&R Biofab's ECM material is also fabricated from skin- and blood vessel-derived materials using its patented 'EER' technology. It features a multi-layered structure combining a non-contact layer that provides physical support and a contact layer that stops bleeding by absorbing and aggregating blood.
According to the 'Korean Medical Device Market Report' by Synex, a market research firm, the domestic hemostatic agent market size stood at approximately 270 billion KRW as of 2023 and is expected to see steady growth of over 10% annually. Through ongoing joint development with T&R Biofab, Reyon Pharmaceutical plans to expand its combination hemostat product portfolio in the future, thereby broadening its influence in both domestic and international hemostatic agent markets.
