Health Canada provides COVID-19 Interim Order approval for Bactiguard’s TempSensor catheter

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Health Canada has approved Bactiguard’s urinary catheter with temperature sensor for infection prevention through an Interim Order. The approval is driven by COVID-19, as Bactiguard’s catheters can reduce the risk of secondary infections for critically ill patients.

“Many critically ill COVID-19 patients require a urinary catheter with integrated temperature monitoring. The ICU treatment period can be 14 days or more, which means patients will require an indwelling urinary catheter for a long period of time. Each day with a catheter increases the risk of acquiring catheter-associated urinary tract infection (CAUTI) and any secondary bacterial infection in these patients could worsen an already serious condition. With Bactiguard's catheter, this risk is significantly reduced”, says Dr. Stefan Grass, Chief Medical Officer and deputy CEO at Bactiguard.

“The global COVID-19 pandemic we now experience has highlighted the urgent need for infection prevention. The pressure on healthcare in general, and the ICUs in particular, is enormous. Therefore, we are very pleased to be able to offer ICU patients better protection against secondary infections in the form of Bactiguard coated urinary catheters with temperature monitoring”, says Maik Rehfeldt, CEO of HANSAmed.

The Bactiguard technology reduces microbial adhesion to medical devices, which in turn reduces the risk of device-related infections. Clinical studies show a significant reduction of catheter-associated urinary tract infections by 35-90 %1-2, when using Bactiguard's catheters. The ICU treatment period for critically ill COVID-19 patients is often 14 days or longer, and each day with a standard catheter increases the risk of acquiring CAUTI.

For further information, please contact:
Stefan Grass, Chief Medical Officer, mobile: +46 70 727 24 48
George Cugini, Director Business Development, HANSAmed mobile: +1 416-574-0423

1.  Lederer et al. 2014; Multicenter Cohort Study to Assess the Impact of a Silver-Alloy and Hydrogel-Coated Urinary Catheter on Symptomatic Catheter-Associated Urinary Tract Infections.
2.  Aljohi AA, Hassan HE, Gupta RK. The efficacy of noble metal alloy urinary catheters in reducing catheter-associated uri­nary tract infection. Urol Ann 2016;8:423-9.

About HANSAmed Limited 
Established in 1996, HANSAmed Limited is a specialty pharmaceutical and medical device distributor serving the needs of the Canadian dental professional community while focusing on meeting the specialized education and product-related needs of oral and maxillofacial surgeons, periodontists, general practitioners, and hygienists.

Health Canada licences include DEL, MDEL, and NHP to import, wholesale and distribute drug and medical devices as well as the ability to package and re-label. In recent years, HANSAmed has expanded its services to include medical practitioners and is investing in the growth of this channel with a portfolio of new specialty products. For more information:

About Bactiguard
Bactiguard is a Swedish medical device company with a mission to save lives. To achieve this mission, we develop and supply infection prevention solutions which reduce the risk of infections and the use of antibiotics. This way, we save significant costs for healthcare and the society at large.

The Bactiguard technology is based on a thin noble metal alloy coating that prevents bacterial adhesion and biofilm formation on medical devices. Bactiguard offers the technology through licence agreements and our BIP (Bactiguard Infection Protection) portfolio of products. Urinary catheters with Bactiguard's coating are market leaders in the USA and Japan through our licensing partner BD.

Bactiguard's product portfolio also includes Hydrocyn® aqua, a non-alcoholic product line for wound care and disinfection. Hydrocyn effectively kills viruses, bacteria and fungi while being biocompatible, pH neutral and tissue friendly. The active ingredient hypochlorous acid is the same substance as the body's immune cells use in their defence against infectious organisms.

Bactiguard is in a strong expansion phase in the markets in Europe, China, India and the Middle East through our own product portfolio and by establishing licensing deals in new therapy areas.

Bactiguard has about 180 employees around the world. Its headquarters and one of three production facilities are located in Stockholm, the other two in Malaysia. Bactiguard is listed on Nasdaq Stockholm.
Read more about Bactiguard