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LOS ANGELES, CA / ACCESS Newswire / February 13, 2026 / Nature Cell, led by Chairman Jeong-Chan Ra and specializing in adult stem cell biotechnology, announced that its U.S. subsidiary, Nature Cell America Inc., has entered into a Scientific Advisory Agreement with Professor Gregg L. Semenza of Johns Hopkins University School of Medicine, recipient of the 2019 Nobel Prize in Physiology or Medicine.
Professor Semenza was awarded the Nobel Prize for his groundbreaking research on how cells respond and adapt to low-oxygen conditions. He identified the Hypoxia-Inducible Factor (HIF) signaling pathway and demonstrated its central role in angiogenesis, cellular survival, metabolic regulation, and tumor development. His discoveries have significantly advanced the understanding of ischemic diseases and cancer biology. He currently serves as a faculty member at Johns Hopkins University School of Medicine.
Under this agreement, Professor Semenza will advise Nature Cell America Inc. on the U.S. clinical development and FDA approval strategy for Vascostem CLI, the company’s investigational therapy for Critical Limb Ischemia (CLI). Advisory activities will include optimizing treatment approaches based on ischemic disease mechanisms, strengthening the scientific rationale linking HIF signaling pathways to cell therapy, enhancing Chemistry, Manufacturing, and Controls (CMC) documentation, and providing strategic guidance on U.S. FDA regulatory processes.
Vascostem CLI is being developed as a single-administration therapy consisting of 500 million cells per dose. Upon commercialization in the United States, the anticipated treatment price is expected to exceed $50,000. Critical Limb Ischemia is a severe and life-threatening condition, associated with an estimated one-year mortality rate of 20-25%, and represents a substantial unmet medical need.
Nature Cell intends to file for U.S. Investigational New Drug (IND) approval and seek Regenerative Medicine Advanced Therapy (RMAT) designation in the first half of 2026, with plans to initiate clinical trials in the latter half of the year. Subject to meeting accelerated approval criteria, the company aims to expedite development with a target U.S. market launch in 2029.
Forward-Looking Statement: This press release includes forward-looking statements related to development timelines, regulatory submissions, potential accelerated approval, and commercialization plans. Actual outcomes may differ depending on regulatory decisions and other factors.
Contact: Biostar Public Relations & Marketing Department
02-6978-9209
SOURCE: Nature Cell
View the original press release on ACCESS Newswire
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