InnoTherapy, Effective Hemostatic Agent for Patients with Blood Coagulation Disorders... "Consecutive Publications in International Journals"

[Asia Economy Reporter Hyunseok Yoo] InnoTherapy announced on the 4th that the results of a multicenter clinical study proving the safety and efficacy of the absorbable internal hemostatic product ‘InnoSEAL Plus’ have been published in the international academic journal ‘Annals of Surgical Treatment and Research (ASTR).’

Earlier in March, InnoTherapy introduced the new mechanism results of InnoSEAL Plus, which can also be used for patients with blood coagulation disorders, in the world-renowned journal ‘Science Advances.’ This paper represents a step forward from the exploratory trial results to confirmatory trial results. It is significant in that it demonstrated the hemostatic efficacy and safety of InnoSEAL Plus through a comparative clinical trial with ‘Tachosil,’ a professional pharmaceutical product widely used globally, including in Korea.

In the confirmatory trial, ‘liver resection patients’ were targeted, with Tachosil used as the control product. The 3-minute and 10-minute hemostasis success rates, rebleeding rates, hemostasis time, and adverse reactions were evaluated. Clinical results showed that InnoSEAL Plus demonstrated 100% efficacy in the 3-minute hemostasis success rate test, proving hemostatic effects equal to or greater than Tachosil (98%). It also achieved a 100% success rate at 10 minutes, with no rebleeding or adverse reactions observed.

As an absorbable hemostatic agent, InnoSEAL Plus is expected to be a strong competitor to fibrin glue, which currently dominates the surgical hemostatic agent market, and a game-changer that will elevate the industrial level of domestic medical device therapeutic materials.

InnoTherapy already obtained approval from the Ministry of Food and Drug Safety in 2019 for InnoSEAL Plus as a Class 4 medical device. Based on this academic paper on the new mechanism and clinical effects, negotiations are currently underway with the Health Insurance Review and Assessment Service regarding insurance reimbursement for therapeutic materials.

In the medical field, as various surgical methods develop, the role of therapeutic materials such as hemostatic agents is becoming increasingly important. InnoSEAL Plus is a rare product among domestic Class 4 medical devices that has been approved through confirmatory clinical trials as the world’s first new material.

Domestic medical devices have faced practical barriers due to relatively insufficient clinical evidence because of the short accumulation period of clinical data, resulting in less appropriate evaluation compared to overseas products. Consequently, the market has increasingly been formed around imported products and copy products.

A company official stated, “As a developer of new materials and a leading player driving the growth of the domestic medical device therapeutic materials market, InnoTherapy has thoroughly prepared all the clinical trials required by relevant authorities and proven them through academic papers,” adding, “If InnoSEAL Plus receives a reasonable evaluation for its scientific evidence, it will be a positive opportunity to advance the domestic medical device market, which currently remains at the stage of imported and copy product development.”

He continued, “Compared to Tachosil, the fibrin glue product that dominates the hemostatic agent market, InnoSEAL Plus has a different new mechanism and is an effective hemostatic agent even for patients with blood coagulation disorders, so it is expected to lead not only the domestic but also the overseas hemostatic agent markets.”