NEXEL's DDT-IST review status as listed on the FDA ISTAND program official website (Source: NEXEL)

[by Kang, In Hyo] NEXEL, a Korean biotechnology venture, has successfully advanced through the U.S. Food and Drug Administration’s (FDA) Innovative Science and Technology Approaches for New Drugs (ISTAND) qualification program.

NEXEL announced on July 16 that the FDA has officially accepted the Letter of Intent (LOI) for ‘Cardiosight-S,’ its proprietary cardiac safety assessment platform based on human induced pluripotent stem cells (hiPSC)-derived cardiomyocytes.

The decision comes under the FDA’s Drug Development Tool (DDT) Qualification Program, which is administered pursuant to Section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The LOI, titled ‘Qualification of a standardized hiPSC-Derived Cardiomyocytes Platform for Regulatory Cardiac Safety Assessment,’ was submitted to the FDA in April 2026.

In particular, the explicit inclusion of NEXEL’s cardiomyocyte product, ‘Cardiosight-S,’ in this Letter of Intent (LOI) is regarded as a significant milestone, reflecting regulatory recognition of the platform’s technical validity and overall completeness. Additionally, the company is considered to have demonstrated both its technological capabilities and strategic differentiation by becoming the first in the world to enter the ISTAND program through a unique regulatory strategy tailored to hiPSC-derived cardiomyocytes, distinguishing itself from other developers in the field.

The ISTAND program is a system in which the FDA evaluates and qualifies ‘new tools’ that fall outside existing regulatory frameworks, including stem cells, organoids, organ-on-a-chip technologies, and artificial intelligence (AI), for use in drug development and regulatory review. Once a tool receives ‘official qualification’ through the program, it can be immediately adopted by pharmaceutical companies worldwide as official tools in the drug development and regulatory approval processes without the need for additional verification for its qualified context of use.

With the FDA's acceptance of the Letter of Intent (LOI), NEXEL has officially entered the ‘formal regulatory review process’ for its platform. The company’s next step is to prepare and submit a ‘Qualification Plan (QP)’ outlining detailed study designs and validation data. Along with the LOI acceptance, the FDA provided recommendations to be incorporated into the QP, which NEXEL will use to guide its data generation and submission strategy.

"The FDA’s acceptance of our LOI marks the 'world's first' 'hiPSC-derived cardiomyocyte-based platform' to enter the FDA's official qualification review process. It represents a major milestone demonstrating the maturity of our technology in the field of 'New Approach Methodologies (NAMs),' which have the potential to replace animal testing. We will continue to diligently advance the QP submission and subsequent consultation procedures," a NEXEL official said.

NEXEL is a biotechnology company specializing in hiPSC-based cell and organoid products, as well as novel drug evaluation platforms. Building on this latest achievement, the company plans to further expand collaboration with Korean and international partners and customers.

THEBIO Kang, In Hyo (zenith@thebionews.net)