About
Patient Life Saving
Innovative Therapeutic
Solution
Achieving human health and happiness through
the development of innovative therapeutic products
A global leader creating new markets
by providing unmet medical solutions
based on polymer technology
Leadership
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.
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
-
Eunhye LeeCTO
Ph.D
Senior Post-Doc, Sanford Burnham Medical Research Institute
GIST, MS & Ph.D.
-
Ziv HaskalCMO MD
Boston University School of Medicine(MD)
Univ. of Virginia Medical School, Prof.
J&J, Pfizer, Boston Scientific, Medtronic
-
Joo Ha HwangCMA
MD,Ph.D
Professor of Gastroenterology, Stanford Univ., School of Medicine
Univ. of Washington, College of Engineering, Ph.D.
Univ. of Chicago, College of Medicine, MD
-
Jong Ho MoonSAB
MD,Ph.D
President of SoonChunHyang Univ., Bucheon Hospital
Professor of Gastroenterology
-
Man-Deuk KimSAB
MD,Ph.D, FSIR
Professor of Radiology, Severance Hospital
-
Yasuaki AraiSAB
MD,Ph.D
JP National Cancer Center Hospital Director
-
Yuji OkunoSAB
MD,Ph.D
Okuno Clinic Chief Director
-
Siddharth A. PadiaSAB
MD
President of Radiology, UCLA
History
-
202503
Central IRB approval for Nexsphere-F
03FDA Breakthrough Device Designation for Nexsphere-F
02Japan PMDA approval
-
202411
US FDA Clearance for Nexpowder(LGIB)
08KOSDAQ listing
012023New health technology approval by National Evidence-based Healthcare Collaborating Agency (NECA)
11CE- MDER certification (Nexpowder)
02Approval of IND(Korea) for Nexsphere-F
-
202212
Singapore HSA approval for Nexpowder
11World-class Product of Korea 2022 (Nexpowder)
10Canada Health Clearance for Nexpowder
09US FDA Clearance for Nexpowder
06MDSAP Registration
-
2021042020
Reimbursement approval by National Health Insurance, Korea (Nexpowder)
12Korea Innovative medical device company designation by Ministry of Health and Welfare (MOHW)
10First shipment to Medtronic (Nexpower)
09US FDA 510k submission for Nexpowder
07Global supply and distribution agreement with Medtronic (Nexpowder)
04CE certification (Nexsphere)
-
201911
Innovative icon company designation by Korea Credit Guarantee Fund (KODIT)
06Quality Collaboration Agreement with Medtronic
06Relocation of new corporate building in Songdo
06Medical device manufacture approval by Ministry of Food and Drug Satefy (MFDS) (Nexsphere)
01New health technology approval by National Evidence-based Healthcare Collaborating Agency (NECA)
-
201812
CE certification (Nexpowder)
012015Medical device manufacture approval by MFDS (Nexpowder)
07Certification of venture company/Establishment of R&D Center
062014GMP certification by MFDS
08Establishment of NEXTBIOMEDICAL CO., LTD.