Company

  • About

About

Patient Life Saving
Innovative Therapeutic
Solution

  • First-In-Class

    Developing innovative therapeutic products

    • Endoscopic hemostasis + Prevention
    • Musculoskeletal embolization for pain control of osteoarthritis,
      sports injuries & tendonitis
  • Ready-to-global

    Global system

    • US FDA & CE-MDR approval
    • QMS & Regulatory capabilities
    • Global distribution agreement with Medtronic
  • Standard-of-care

    Creating new markets

    • Create and dominate a new market
    • Market expansion as a standard-of-care
Mission

Achieving human health and happiness through
the development of innovative therapeutic products

Vision

A global leader creating new markets
by providing unmet medical solutions
based on polymer technology

Leadership

Don Haeng Lee CEO

MD, Ph.D.

“Lead the development & commercialization of innovative therapeutics by resolving the unmet clinical needs experienced as a physician”

Accomplishments

2005~Now
Professor of Gastroenterology, Inha Univ. Hospital
2010~2013
Director, National Gastroenterology Efficacy Evaluation Center
2013~2021
Director, Institute of Biomedical Research, Inha Univ Hospital
2014~Now
CEO, NEXTBIOMEDICAL CO., LTD.

Vice President, Korean Society of Gastrointestinal Endoscopy
Vice President, Korean Interventional Medical Devices Society
External Cooperation Officer, Korean Innovative Medical Technology Society
Director, Korea Medical Device Development Fund

Education

1982~1988
Yonsei University, Bachelor of Medicine
1992~1995
Yonsei University, MS in Internal Medicine
1997~2001
Yonsei University, Ph.D. in Internal Medicine
Don Haeng Lee CEO

MD, Ph.D.

“Lead the development & commercialization of innovative therapeutics by resolving the unmet clinical needs experienced as a physician”

Accomplishments

2005~Now
Professor of Gastroenterology, Inha Univ. Hospital
2010~2013
Director, National Gastroenterology Efficacy Evaluation Center
2013~2021
Director, Institute of Biomedical Research, Inha Univ Hospital
2014~Now
CEO, NEXTBIOMEDICAL CO., LTD.

CEO, NEXTBIOMEDICAL CO., LTD.
Vice President, Korean Society of Gastrointestinal Endoscopy
Vice President, Korean Interventional Medical Devices Society
External Cooperation Officer, Korean Innovative Medical Technology Society
Director, Korea Medical Device Development Fund

Education

1982~1988
Yonsei University, Bachelor of Medicine
1992~1995
Yonsei University, MS in Internal Medicine
1997~2001
Yonsei University, Ph.D. in Internal Medicine

History

  • 2025
    03

    Central IRB approval for Nexsphere-F

    03

    FDA Breakthrough Device Designation for Nexsphere-F

    02

    Japan PMDA approval

  • 2024
    11

    US FDA Clearance for Nexpowder(LGIB)

    08

    KOSDAQ listing

    01

    New health technology approval by National Evidence-based Healthcare Collaborating Agency (NECA)

    2023
    11

    CE- MDER certification (Nexpowder)

    02

    Approval of IND(Korea) for Nexsphere-F

  • 2022
    12

    Singapore HSA approval for Nexpowder

    11

    World-class Product of Korea 2022 (Nexpowder)

    10

    Canada Health Clearance for Nexpowder

    09

    US FDA Clearance for Nexpowder

    06

    MDSAP Registration

  • 2021
    04

    Reimbursement approval by National Health Insurance, Korea (Nexpowder)

    2020
    12

    Korea Innovative medical device company designation by Ministry of Health and Welfare (MOHW)

    10

    First shipment to Medtronic (Nexpower)

    09

    US FDA 510k submission for Nexpowder

    07

    Global supply and distribution agreement with Medtronic (Nexpowder)

    04

    CE certification (Nexsphere)

  • 2019
    11

    Innovative icon company designation by Korea Credit Guarantee Fund (KODIT)

    06

    Quality Collaboration Agreement with Medtronic

    06

    Relocation of new corporate building in Songdo

    06

    Medical device manufacture approval by Ministry of Food and Drug Satefy (MFDS) (Nexsphere)

    01

    New health technology approval by National Evidence-based Healthcare Collaborating Agency (NECA)

  • 2018
    12

    CE certification (Nexpowder)

    01

    Medical device manufacture approval by MFDS (Nexpowder)

    2015
    07

    Certification of venture company/Establishment of R&D Center

    06

    GMP certification by MFDS

    2014
    08

    Establishment of NEXTBIOMEDICAL CO., LTD.