Bactiguard Holding AB (publ) announced the launch of a clinical study to compare the BIP CVC with a non-coated standard catheter. Healthcare-associated infections (HAI) affect patients being treated in hospitals or other healthcare facilities across the globe and lead to more frequent use of antibiotics. In turn, this escalates the risk of antimicrobial resistance which is an acute global health issue considered to be one of the most important sustainability challenges in modern medicine.

One in ten patients worldwide are affected by HAI and it is often the medical devices used that cause the infections. Infections caused by central venous catheters are an increasingly serious clinical problem, especially for patients in intensive care. To gain additional clinical evidence of the efficacy of central venous catheters with Bactiguard's infection prevention coating, Bactiguard announced the launch of a clinical trial to compare the BIP C VC with a non-coatedstandard catheter.

The endpoints of the study will include, among others, catheters and thrombosis rate. The study will be performed at multiple sites in India and is under the supervision of primary investigator Dr. Yatin Metha, Medanta Hospital in New Dehli. The study has been approved by the local regulatory authorities DCGI (Drug Controller General of India).

It will be a randomized, controlled multi centre study that will be conducted over one year with the first patient enrolling in the first half of 2023. Important milestones and regular updates will be provided. The primary endpoint of the study will be the occurrence of central line associated blood stream infections following the definition by the CDC (US federal agency Centers for Disease Control and Prevention).