The product approval for Bactiguard’s central venous catheters has been announced by the Indian Ministry of Health & Family Welfare. This provides new opportunities for Bactiguard in providing effective infection prevention in one of the largest and fastest growing markets in the world.
The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health & Family Welfare, has announced the regulatory approval of Bactiguard’s central venous catheters for infection prevention (BIP CVC).
”We are very pleased with this relatively rapid product approval, which means that we expand our product portfolio in India and can offer effective infection prevention for the most vulnerable patients. The problem of healthcare associated infections is huge and India is the largest consumer of antibiotics in the world, which has led to a high level of multi-resistant bacteria. This means that there is an urgent need for preventive solutions”, says Cecilia Edström, SVP Sales & New Business.
Bactiguard has earlier received product approval for its infection preventive urinary catheters (BIP Foley) and sales in India started in 2015. In parallel, a clinical study, involving 1 000 patients in total, at six prestigious hospitals in different regions of the country is being conducted. The regulatory approval for BIP CVC, a class III product with higher safety requirements than for BIP Foley, which is a class IIb product, is unconditional and there are no requirements for post approval clinical trials.
Central venous catheters with antimicrobial coatings have gained increasing importance, given the escalating costs associated with hospital acquired infections, particularly in ICUs where patients are critically ill and CVCs are frequently used in their treatment.
This information is information that Bactiguard Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below 2017-08-30, at. 08.00
For further information, please contact:
Cecilia Edström, SVP Sales and New business, cell phone: +46 72 226 23 28