TFDA APPROVES CEMMA’s AND LIPOCOAT’S COATED ANTIFOULING CENTRAL VENOUS CATHETER

Taipei, Taiwan / Enschede, The Netherlands – May 28, 2025 – CEMMA Medical and LipoCoat proudly announce medical device approval of their co-developed coated antifouling central venous catheter (CVC) by the Taiwan Food and Drug Administration (TFDA).This regulatory milestone marks a significant advancement in the fight against healthcare-associated infections (HAIs), particularly catheter-related bloodstream infections (CRBSIs), which are among the most lethal HAIs. This milestone is the culmination of the collaboration announced in early in 2022 between LipoCoat and CEMMA Medical (and its Taiwan-based medical device manufacturer Eline Medical).

A Revolutionary Leap in Infection Prevention
The approved catheter features a LipoCoat’s lipid-based and biomimicking coating that is antifouling towards clinically relevant pathogens and limit their biofilm formation. Unlike traditional antimicrobial coatings, this hydrophilic, by nature inspired, non-toxic, and non-antibiotic coating is poised to reduce the risk of CRBSI without contributing to antimicrobial resistance (AMR). “This is not just another coated device,” said Jasper van Weerd, CEO of LipoCoat. “It’s a step toward sustainable infection control – one that is passive, safe-by-design and built on a nature-inspired foundation.”

Clinical Impact and Global Ambitions
As the first central venous catheter to feature LipoCoat’s lipid-coating platform, the device provides a unique solution for critical care settings, particularly intensive care units where catheter use is both routine and high-risk. Following TFDA approval, CEMMA Medical plans to launch the catheter in Taiwan in the coming months. Meanwhile, preparations are underway for regulatory filings in Europe and North America, signaling the beginning of global expansion.

A Model for Cross-Border Innovation
“This milestone highlights what’s possible when expertise from different corners of the world comes together,” said a representative from CEMMA Medical. “Through CEMMA’s strength in manufacturing and LipoCoat’s deep knowledge in surface technologies, we’ve co-developed a product designed with patient safety at its core.” This reflects a shared commitment to advancing biomedical innovation and delivering better patient outcomes across global markets.

Cemma Medical Public Relations: cemmatw@cemma.com.tw
LipoCoat Media Relations: info@lipocoat.com