InnoTherapy Receives Top European CE Certification for Hemostatic Agent... "Full-Scale Global Expansion"

[Asia Economy Reporter Hyunseok Yoo] InnoTherapy is targeting the global market by obtaining the highest European CE class certification for its hemostatic agent developed with domestic technology.

InnoTherapy announced on the 30th that its hemostatic product, InnoSeal, has acquired the highest European CE certification, Class III.

InnoSeal is the first product developed with an independent new mechanism applicable even to patients with blood coagulation disorders. Following approval from the U.S. Food and Drug Administration (FDA), it has received European CE certification, gaining international recognition for its efficacy and safety.

This allows sales in the United States as well as in 33 EU member countries that recognize CE certification, enabling full-scale entry into the global market and expected expansion of sales.

This highest CE class certification is the result achieved three years after InnoTherapy began certification in 2018 with its self-developed material. Recently, due to safety issues with medical device products, the European CE certification guidelines have been strengthened under the Medical Device Regulation (MDR). The requirements for clinical evidence to obtain approval for Class III products, the highest class, have become very stringent.

During the CE certification process for InnoSeal, a thorough review of numerous clinical results conducted in Korea and East Asia was a key focus. Based on this, InnoSeal has been recognized for its efficacy, safety, and excellence in quality management systems, attracting attention.

Lee Moonsu, CEO of InnoTherapy, stated, “With this certification, we plan to begin full-scale sales in 33 countries including EU member states,” adding, “Recently, we also succeeded in signing a contract with a Group Purchasing Organization (GPO) in the U.S. this year, securing opportunities to enter large hospitals.” He further added, “We will accelerate global market expansion through European sales contracts and contribute to performance growth.”