Reyon Pharmaceutical announced that the 'All-in-one absorbable internal hemostatic device,' co-developed with Ossgen, a specialized medical device company, has successfully obtained Class IV approval from the Ministry of Food and Drug Safety (MFDS), the highest regulatory category for medical devices.
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.
The newly approved hemostatic product is South Korea's first combination hemostat that merges Reyon Pharmaceutical's thrombin with Ossgen's collagen material. By consolidating the existing complex hemostasis process into a single product, it is evaluated to have improved the surgical environment and maximized convenience for medical staff. Furthermore, it significantly enhances patient safety by providing a stable and highly reproducible hemostatic environment.
Reyon Pharmaceutical holds the only regulatory authorization for thrombin in South Korea, and through this co-development, the company has secured exclusive domestic distribution and sales rights for the combination hemostat. This is viewed as a strategic move for Reyon Pharmaceutical to establish an overwhelming dominance in the thrombin-based hemostasis market.
Reyon Pharmaceutical is already supplying thrombin and selling related hemostatic products through partners such as Dalim Tissen and Phavis Pharmaceuticals. Additionally, the company has established a stable hemostatic lineup, having already passed the Class IV evaluation by the MFDS for an absorbable internal hemostatic device co-developed with T&R Biofab, which is currently awaiting launch. Securing exclusive rights to this Ossgen product is significant for expanding market share in the hemostatic agent market and diversifying the business structure of the thrombin segment.
An official from Reyon Pharmaceutical stated, "Based on this successful collaboration with Ossgen, we plan to conduct joint research and development between the two companies for convergence products not only in medical devices but also in various other fields." The official added, "We intend to expand the scope of thrombin applications into diverse convergence sectors to build a sustainable growth pipeline."
