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