PluroGen Therapeutics, Inc.
503 Broadleaf Way
Charlottesville, VA 22911
Tel: 443 994 0101
Fax: 410 990 9817
www.plurogen.com
503 Broadleaf Way
Charlottesville, VA 22911
Tel: 443 994 0101
Fax: 410 990 9817
www.plurogen.com
| News Release |
FOR IMMEDIATE RELEASE Contact: Neal G. Koller
President & CEO
30 September 2009 Board of Directors
443 994 0101
PLUROGEN RECEIVES FINAL OPINION OF APPROVABLE-FOR-SALE IN EUROPE
FOR LEAD BURN AND CHRONIC WOUND GEL
(Charlottesville, VA, 30 September 2009) – PluroGen Therapeutics, Inc. is pleased to announce that we
have received a final opinion of approvable-for-sale in Europe for our flagship burn and wound gel,
PluroGel® Silver Sulfadiazine.
Following-on to our News Release from 3 July 2009, in which we reported this preliminary opinion from the
European approving authority, PluroGen subsequently made the formal submission of the our European
medical device marketing application and now received notification that the scientific and clinical sections
are complete and acceptable as submitted.
The next step in the European approval process is the manufacturing facility inspection by the European
approving authority, which is now targeted for November 2009. Pending approval of the manufacturing
facility, PluroGen could be selling our flagship PluroGel® Silver Sulfadiazine in Europe by the end of the
year.
Commenting on this milestone achievement, Neal G. Koller, President & CEO of PluroGen, said “Plurogen
continues the strong forward progress and momentum it has now become so well known for. We are now
over the major hurdle in our drive to market, our drive to bring a terrific and critically needed product to
severe burn and chronic wound patients. This is an important achievement for all involved.”
About PluroGen Therapeutics, Inc.
PluroGen is a burn, wound and skin care company commercializing our multiple patent-protected
technology platforms, the 1st of which is our core gel technology that provides superior and differentiated
physical, bio-impact and multi-function benefits. Our multiple technology platforms are configurable to
deliver a wide variety of medicinal and beneficial compounds as protected and advanced therapeutic and
topical products for simple and complex skin care and burn and wound healing. PluroGen’s product
pipeline targets improved, protected therapies for the 6 areas of treatment in tissue management and
healing (cleansing, infection, pain, inflammation, tissue salvage, tissue regeneration).
PluroGen’s first gels, PluroGel® and ActiviGel™, are being used initially in skin and wound cleansing
products, for personal skin care products and for two branded topical antimicrobial products, PluroGel®
Barrier Gels and PluroGel® Barrier Dressings. PluroGel® / ActiviGel™ technology is currently in routine use
at the University of Virginia Medical Center, having shown superior results on more than 2,000 patients in
two different patient populations, severe burns and chronic wounds. The PluroGen management and
operational teams, Boards and Principal Investigators are recognized global clinical and commercial
leaders in PluroGen’s target markets of burn and wound care and in the life sciences industry.
For more information about PluroGen Therapeutics, Inc., visit the Company’s web site at www.plurogen.com.
Statements included in this press release that are not historical in nature are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act of 1995. The Company cautions readers that
forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to
differ materially and which are identified from time to time in the Company’s reports filed with the U.S.
Securities and Exchange Commission. PluroGen Therapeutics, Inc. claims the protection of the Safe Harbor for
forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Information included on PluroGen Therapeutics, Inc website is not incorporated herein by reference or otherwise.
© PluroGen Therapeutics, Inc. 2009
President & CEO
30 September 2009 Board of Directors
443 994 0101
PLUROGEN RECEIVES FINAL OPINION OF APPROVABLE-FOR-SALE IN EUROPE
FOR LEAD BURN AND CHRONIC WOUND GEL
(Charlottesville, VA, 30 September 2009) – PluroGen Therapeutics, Inc. is pleased to announce that we
have received a final opinion of approvable-for-sale in Europe for our flagship burn and wound gel,
PluroGel® Silver Sulfadiazine.
Following-on to our News Release from 3 July 2009, in which we reported this preliminary opinion from the
European approving authority, PluroGen subsequently made the formal submission of the our European
medical device marketing application and now received notification that the scientific and clinical sections
are complete and acceptable as submitted.
The next step in the European approval process is the manufacturing facility inspection by the European
approving authority, which is now targeted for November 2009. Pending approval of the manufacturing
facility, PluroGen could be selling our flagship PluroGel® Silver Sulfadiazine in Europe by the end of the
year.
Commenting on this milestone achievement, Neal G. Koller, President & CEO of PluroGen, said “Plurogen
continues the strong forward progress and momentum it has now become so well known for. We are now
over the major hurdle in our drive to market, our drive to bring a terrific and critically needed product to
severe burn and chronic wound patients. This is an important achievement for all involved.”
About PluroGen Therapeutics, Inc.
PluroGen is a burn, wound and skin care company commercializing our multiple patent-protected
technology platforms, the 1st of which is our core gel technology that provides superior and differentiated
physical, bio-impact and multi-function benefits. Our multiple technology platforms are configurable to
deliver a wide variety of medicinal and beneficial compounds as protected and advanced therapeutic and
topical products for simple and complex skin care and burn and wound healing. PluroGen’s product
pipeline targets improved, protected therapies for the 6 areas of treatment in tissue management and
healing (cleansing, infection, pain, inflammation, tissue salvage, tissue regeneration).
PluroGen’s first gels, PluroGel® and ActiviGel™, are being used initially in skin and wound cleansing
products, for personal skin care products and for two branded topical antimicrobial products, PluroGel®
Barrier Gels and PluroGel® Barrier Dressings. PluroGel® / ActiviGel™ technology is currently in routine use
at the University of Virginia Medical Center, having shown superior results on more than 2,000 patients in
two different patient populations, severe burns and chronic wounds. The PluroGen management and
operational teams, Boards and Principal Investigators are recognized global clinical and commercial
leaders in PluroGen’s target markets of burn and wound care and in the life sciences industry.
For more information about PluroGen Therapeutics, Inc., visit the Company’s web site at www.plurogen.com.
Statements included in this press release that are not historical in nature are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act of 1995. The Company cautions readers that
forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to
differ materially and which are identified from time to time in the Company’s reports filed with the U.S.
Securities and Exchange Commission. PluroGen Therapeutics, Inc. claims the protection of the Safe Harbor for
forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Information included on PluroGen Therapeutics, Inc website is not incorporated herein by reference or otherwise.
© PluroGen Therapeutics, Inc. 2009