PIPELINE
Medical Device Development Pipeline
Medical device development pipeline and regulatory and launch milestones based on Lynk Solutec’s proprietary LYNKCOAT coating platform.
Development, regulatory and launch milestones are reported separately by product and market. Planned timelines may change as development progresses.
Product
Discovery
Validation
Biological Safety / Performance
Regulatory Approval
Mass Production
Regulatory Status / Planned Launch
Key Highlights
Common
Anti-Fog Solution for Endoscopes
C.E.V. · CleanView (anti-adhesion)
Korea Class I
FDA Class II
Discovery
Validation
Biological Safety / Performance
Regulatory Approval
Mass Production
Mass Production in Progress
Regulatory Status / Planned Launch
Korea
Completed
FDA
Q3 2027
Key highlights
Supplied to hospitals and the Korea Racing Authority; PPS pilot procurement in progress
Common
Medical Lubricant
Lubricious coating
Korea Class II
FDA Class I
Discovery
Validation
Biological Safety / Performance
Regulatory Approval
Mass Production
Regulatory Process in Progress
Regulatory Status / Planned Launch
Korea
Q4 2026
FDA
Completed
Key highlights
Medical device compatibility validation and regulatory preparation in progress
Ophthalmology
Other Non-Absorbable Sutures
Suture for ptosis surgery (anti-adhesion)
Korea Class III
FDA Class I
Discovery
Validation
Biological Safety / Performance
Regulatory Approval
Mass Production
Regulatory Stage Completed
Regulatory Status / Planned Launch
Korea
Q3 2027
FDA
Completed
Key highlights
Designated as a rare medical device; exclusively manufactured in Korea
Ophthalmology
Lacrimal Drainage Silicone Tube
For treatment of lacrimal obstruction (lubricious coating)
Korea Class II
Discovery
Validation
Biological Safety / Performance
Regulatory Approval
Mass Production
Validation
Regulatory Status / Planned Launch
Korea
Q4 2027
FDA
Q4 2028
Key highlights
Co-developed with Prof. Jin Sook Yoon and Prof. Jae Sang Ko at Yonsei University Health System
Urology
Ureteral Stent
For treatment of urinary stones and strictures (anti-adhesion)
Korea Class III
FDA Class II
Discovery
Validation
Biological Safety / Performance
Regulatory Approval
Mass Production
Safety / Performance Completed
Regulatory Status / Planned Launch
Korea
Q3 2027
FDA
Q1 2028
Key highlights
Superior anti-adhesion performance compared with global products Licensing discussions with Boston Scientific
Urology
General-Purpose Tube Catheter
Combined lubricious and anti-adhesion coating
Korea Class II
FDA Class II
Discovery
Validation
Biological Safety / Performance
Regulatory Approval
Mass Production
Safety / Performance Completed
Regulatory Status / Planned Launch
Korea
Q4 2026
FDA
Q4 2027
Key highlights
MOU secured with a distributor Core product with the widest global usage network
Gastroenterology
Pancreatic & Biliary Stent
Coating to prevent biliary stricture
Korea Class III
FDA Class II
Discovery
Validation
Biological Safety / Performance
Regulatory Approval
Mass Production
Discovery
Regulatory Status / Planned Launch
Korea
Q3 2027
FDA
Q1 2028
Key highlights
Technology licensing with Taewoong Medical Technology fees generated from optimization of biliary stent coatings
Common
Central Venous Catheter
Antithrombotic coating for thrombosis and infection prevention
Korea Class III
FDA Class II
Discovery
Validation
Biological Safety / Performance
Regulatory Approval
Mass Production
Discovery
Regulatory Status / Planned Launch
Korea
Q2 2028
FDA
Safety Evaluation
Key highlights
Co-developed with Prof. Jung-Hoon Park at Asan Medical Center High-risk product category for thrombosis and infection (annual market: 27 million units)
