SCL Science Completes Clinical Trial of InnoSeal Plus DL, an Internal Hemostasis Product

SCL Group affiliate SCL Science announced on the 13th that it has completed clinical trials for the absorbable internal hemostatic product 'Inoseal Plus DL.'

Unlike existing products that utilize blood coagulation proteins, Inoseal Plus DL is a Class 4 medical device absorbable internal hemostatic product based on a biomimetic polymer platform technology. It reacts with various protein components in the blood to instantly form a physical hemostatic membrane and seal the bleeding site. It is effective in stopping bleeding even in cases of bleeding disorders, overcoming the limitations of existing fibrin glue, and is expected by the company to be recognized as an innovative hemostatic product.

Hemostatic products are classified by medical device grade according to potential risk. Unlike Class 2 external hemostatic products, internal hemostatic products are high-risk Class 4 medical devices applied to bleeding sites within internal tissues. Class 4 internal hemostatic products, which have higher technical difficulty, are priced about 10 times higher than Class 2 products. SCL Science has a product lineup including Class 2 external hemostatic products ‘Inoseal’ and ‘Inoseal DL’ and Class 4 internal hemostatic products ‘Inoseal Plus’ and ‘Inoseal Plus DL.’

The clinical trial was a multi-center, single-blind, comparative, active-controlled, non-inferiority medical device confirmatory clinical trial, equivalent to a Phase 3 clinical trial for pharmaceuticals. It was conducted at Samsung Medical Center and the National Cancer Center, evaluating patients with continued exudative bleeding after primary hemostasis during liver resection surgery, comparing the test group with the control group (Tachosil).

The company confirmed the efficacy and safety of Inoseal Plus DL through the clinical trial. In the 3-minute hemostasis success rate evaluation, Inoseal Plus DL demonstrated non-inferiority compared to the control group. No adverse events (AE) or serious adverse events (SAE) related to the medical device were observed during the trial period.

A company representative stated, "In this clinical trial, Inoseal Plus DL showed high hemostatic performance, achieving a 100% success rate in 3-minute hemostasis," adding, "Based on the excellent clinical trial results, we will accelerate the application for product approval from the Ministry of Food and Drug Safety and aim for commercialization within this year."

Meanwhile, in February, SCL Science published a research paper related to Inoseal Plus DL in the prestigious international journal Advanced Healthcare Materials. Through this, they disclosed various non-clinical results including the structural characteristics, hemostasis, adhesion, and sealing properties of Inoseal Plus DL. Notably, it demonstrated superior hemostatic performance compared to existing hemostatic products in various animal models, attracting industry attention.