HLB Cell, Next-Generation Hemostatic Agent 'BleeFix' Clinical Success "Targeting Approval by Year-End"

[Financial News] HLB Life Science's subsidiary HLB Cell announced on the 27th that the next-generation surgical hemostatic agent 'BleeFix(BleeFix®)' has proven to be equal or superior to existing hemostatic agents in a confirmatory clinical trial equivalent to phase 3, confirming 'non-inferiority' and succeeding in the clinical trial. This achievement was made three years after starting the confirmatory clinical trial.
This clinical trial was a multicenter, randomized, single-blind, active-controlled non-inferiority comparative trial conducted on 134 patients who continued to have exudative bleeding even after primary hemostasis following liver resection. The interim analysis showed a 'hemostasis success rate within 5 minutes' of 98.5%, significantly proving non-inferiority. Particularly, the efficacy evaluation was conducted by independent third-party evaluators to ensure objectivity and reliability of the assessment.
BleeFix is the first domestic hemostatic agent with an 'anti-adhesion' function that not only has a hemostatic effect but also prevents adhesion between tissues after surgery. Its main components are biopolymers such as hyaluronic acid, which react with moisture to form a fast and strong adhesive gel when applied to the bleeding site. At the same time, it absorbs plasma, concentrating platelets and blood cells at the boundary of the bleeding site to promote hemostasis, featuring a dual mechanism. In powder form, it is highly convenient for use in laparoscopic surgeries, which have been rapidly increasing recently.
HLB Cell plans to apply for product approval of BleeFix to the Ministry of Food and Drug Safety in the third and fourth quarters and aims to obtain approval by the end of the year. Following this, they plan to list it for insurance coverage with the Health Insurance Review and Assessment Service and begin full-scale sales from mid-next year. Additionally, they plan to expand the use of BleeFix beyond surgical use to emergency, military, and trauma hemostatic agents. To this end, they are planning additional clinical trials for various indications.
Doohun Lee, CEO of HLB Cell, said, "BleeFix is a next-generation hemostatic agent that can surpass the limitations of existing hemostatic agents," adding, "We expect it to become Best-in-Class in the powder hemostatic agent sector within a few years."
Meanwhile, according to the 2024 Synex Market Report, the domestic topical hemostatic agent market is expected to grow at an average annual growth rate of 10%, reaching approximately 461.7 billion KRW by 2028. This is analyzed to be due to the increase in surgical cases, aging population, expansion of robotic surgeries, and growing demand for trauma patient treatment, leading to a full-scale expansion of demand centered on absorbable hemostatic agents.
dschoi@fnnews.com Doosun Choi Reporter