SCL Group affiliate SCL Science announced on the 4th that it has obtained manufacturing approval from the Ministry of Food and Drug Safety (MFDS) for ‘Inoseal Plus DL,’ an absorbable internal hemostatic product.
Inoseal Plus DL is a grade 4 absorbable internal hemostatic product that applies biomimetic polymer platform technology, unlike existing products that utilize blood coagulation proteins. It reacts with various protein components in the blood to instantly form a physical hemostatic membrane and seal the bleeding site. It is an innovative product that effectively stops bleeding caused by blood coagulation disorders, overcoming the limitations of existing fibrin glue.
Unlike the existing grade 2 external use product Inoseal, Inoseal Plus DL can be used internally. Additionally, due to its high technical difficulty, it is expected to be sold at a price approximately 10 times higher than existing products.
The company completed clinical trials for Inoseal Plus DL in June last year and aims to obtain MFDS product approval within the first half of this year and start sales in the second half. Furthermore, it plans to pursue approval from the U.S. Food and Drug Administration (FDA) and CE marking certification from the European Community within the next 2 to 3 years.
A company official stated, “We will do our best to obtain product approval within the first half of the year, marking a milestone with the manufacturing approval of Inoseal Plus DL,” and added, “Once sales of the high value-added product Inoseal Plus DL begin, it will play a significant role in external growth and profitability improvement.”
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