#South Korea #Seoul #hair health #LISCure #Mobiome

LISCure BioSciences Secures Pioneering FDA NDI Notification for Hair Health Probiotic Mobiome®

On September 9, 2025, LISCure BioSciences, a pioneering company in the biotechnology sector, announced an important milestone that is set to reshape the hair health industry. They have successfully received the world's first New Dietary Ingredient (NDI) notification from the U.S. Food and Drug Administration (FDA) for their exceptional product, Mobiome®. This innovative hair health probiotic has not only gained recognition from the FDA but had also been previously validated by the Korean Ministry of Food and Drug Safety (MFDS) as a functional ingredient, after extensive scientific evaluation through both preclinical and clinical studies.

Validation of Efficacy and Safety

The scientific validation supporting Mobiome® is impressive, demonstrating multiple modes of action critical for hair health. Significant findings from clinical trials revealed that Mobiome® enhances antioxidant activity, reduces inflammation, stimulates hair follicle cell proliferation, and effectively regulates the hair follicle cell cycle. Participants in these trials reported statistically significant improvements, specifically in hair gloss and elasticity, along with notable consumer satisfaction regarding texture, split ends, dryness, and overall damage levels.

These results underscore Mobiome®'s potential as a breakthrough product in the hair care sector, establishing it as a scientifically-backed solution for individuals seeking hair health enhancement.

Rigorous FDA NDI Notification Process

The pathway to receiving the FDA's NDI notification involved navigating one of the most stringent evaluation processes globally. This comprehensive examination required LISCure to present extensive evidence supporting Mobiome®’s safety and efficacy, including its characteristics, toxicological safety, gastrointestinal survivability, and functional validation data. An NDI status marks a significant credential for companies aspiring to enhance their footprint within the expansive global dietary supplement market.

Expansion Plans Post FDA Approval

With the NDI notification from the FDA, LISCure has fortified its competitive stature not only in South Korea but also in key global markets. Hwa-sup Chin, CEO of LISCure, noted, “The FDA acceptance of the NDI notification for Mobiome® allows us to propel our expansion ambitions in North America, Europe, and crucial Asian markets.” This bold statement outlines LISCure's future growth trajectory, indicating plans to broaden its presence on the international scene.

In addition to Mobiome®, LISCure is keenly developing a range of other functional ingredients. Their ongoing projects target critical health areas, including body fat reduction, joint health, cognitive improvement, and support for kidney health. These new initiatives are poised to further solidify LISCure's reputation for innovation within the nutraceutical landscape.

Advancements in Pharmaceuticals

While committing to dietary supplements, LISCure is concurrently driving advancements in its core pharmaceutical business. Significant programs include the Brain Shuttle Platform ExoPN-101 and LB-P8, a therapeutic candidate for Primary Sclerosing Cholangitis (PSC) that has been granted both FDA Orphan Drug Designation and Fast Track Designation, now progressing into Phase 2 clinical trials in the U.S. Furthermore, LB-P2D, an immuno-oncology candidate backed by promising preclinical data, is moving toward clinical testing.

By harmonizing efforts across both pharmaceutical advancements and functional health products, LISCure aims to foster sustainable growth and deliver impactful health solutions on a global scale.

Conclusion

LISCure BioSciences stands as a testament to innovation and scientific integrity within the health sector. The pioneering achievement of securing the FDA's NDI notification for Mobiome® lays a strong foundation for the company’s aspirations, ensuring that it remains at the forefront of addressing health concerns related to hair vitality. Through continued research, partnerships, and development of groundbreaking products, LISCure is poised not only to transform individual health but also to contribute significantly to the global landscape of health and wellness.