Product approval opens door to China

The product approval for Bactiguard's foley catheters for infection prevention in China, has now been announced by China Food and Drug Administration (CFDA). This opens the door to one of the largest and fastest growing markets in the world.

”Finally a breakthrough for Bactiguard in China. We started the approval process with CFDA already in 2011, so we have been waiting for this approval for more than four years," says CEO Christian Kinch and continues: 

"Now we can seriously begin developing the world's largest market together with our Chinese partner Jian An who, together with us, have been waiting for this breakthrough".

China Food and Drug Administration (CFDA) has announced that it grants regulatory approval for Bactiguard’s foley catheter, Bactiguard Infection Protection Foley. This green light from CFDA is an important breakthrough for Bactiguard and opens one of the largest and fastest growing markets in the world. The Chinese market for foley catheters is estimated to be more than 50 million units per year and steadily growing.

Already in 2011 Bactiguard entered a distribution agreement with Chinese distributor Jian An Pharmaceutical, who has over 2,000 sales representatives and 5,000 hospital customers throughout China. After a long process to receive product approval, they now look forward to start developing the Chinese market:

"Bactiguard has a clinically proven solution for preventing healthcare associated infections, which has great potential in the Chinese market. We have the ambition to take a significant market share for foley catheters in China and are now ready to begin sales to Chinese hospitals", says Mr Zhangyi Zhan, CEO of Jian An Pharmaceutical.

Healthcare associated infections is a global problem and today the third largest cause of death in the Western world. In China, the problem is rapidly growing and a great challenge. Chinese representatives have expressed a strategy to reduce antibiotic use, which means that extensive efforts to reduce infections are required. Bactiguard’s infection protection solution therefore becomes a natural part of the prevention of healthcare associated infections.

This is information that Bactiguard Holding AB (publ) is required to publish in compliance with the Swedish Securities Market Act and/or the Financial Instruments Trading Act. The information was submitted for publication on 4 January 2016, at 08.00.

For further information, please contact:
Ulrika Berglund, Head of External Affairs, mobile: 46 708 800 407

About Bactiguard
Bactiguard is a Swedish medtech company with a mission of preventing healthcare associated infections, reducing the use of antibiotics and saving lives by developing and supplying infection prevention solutions for the healthcare industry. The company’s patented coating prevents healthcare associated infections by reducing bacterial adhesion and growth on medical devices. Bactiguard®-coated urinary catheters are market leading in the US and Japan, and in recent years the company has developed its own product portfolio of catheters for the urinary and respiratory tract and the blood stream. Bactiguard is currently in a strong expansion phase, focused on new markets in the Europe, Middle East, Asia, Latin America and Southern Africa. The company has market presence in some 50 countries and has about 60 employees. Its headquarters is located in Stockholm and production facilities in Sweden and Malaysia. Bactiguard is listed on Nasdaq Stockholm. Read more about Bactiguard at www.bactiguard.com

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About Us

Bactiguard is a Swedish medtech company with a global presence, offering a solution that prevents healthcare associated infections caused by medical devices. By preventing infections, we contribute to a reduced use of antibiotics and the spread of multi-resistant bacteria, which is a growing problem worldwide. We save lives, increase patient safety and significantly reduce the cost for the healthcare and society. Our technology is well-proven, safe and tissue friendly and consist of a thin layer of noble metals that prevents bacterial growth. The coating can be applied on almost all medical devices. Bactiguard-coated urinary catheters are market leading in the US and Japan and the company has also its own product portfolio consisting of foley catheters, central venous catheters and endotrachealtubes. Bactiguard is a growth company, focused on markets in Europe, Middle East, Asia and Latin America. The company has about 70 employees worldwide, mainly at the headquarters in Stockholm and the production facility in Malaysia and is listed on Nasdaq Stockholm. Read more about Bactiguard at www.bactiguard.com

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Quotes

Now we can seriously begin developing the world's largest market together with our Chinese partner Jian An who, together with us, have been waiting for this breakthrough
Christian Kinch; CEO Bactiguard
Bactiguard has a clinically proven solution for preventing healthcare associated infections, which has great potential in the Chinese market. We have the ambition to take a significant market share for Foley catheters in China and are now ready to begin sales to Chinese hospitals
Mr Zhangyi Zhan, CEO of Jian An Pharmaceutical.