INJEX Pharma AG received FDA clearance for the import and sale of the needle free injection technology INJEX 30 into the US Market
DGAP-News: INJEX Pharma AG / Key word(s): Regulatory Approval
INJEX Pharma AG received FDA clearance for the import and sale of the
needle free injection technology INJEX 30 into the US Market
30.05.2012 / 16:20
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INJEX Pharma AG received FDA clearance for the import and sale of the
needle free injection technology INJEX 30 into the US Market
INJEX Pharma AG ISIN: DE000A0STYL7
Berlin, 30. May 2012
The FDA had registered INJEX Pharma GmbH, Berlin, and INJEX Pharma US,
Miami, and given approval for the import and sale of INJEX 30 in the US
market. The condition was the registration by the FDA for INJEX Pharma GmbH
as manufacturer and exporter. This registration is now finalized.
The FDA 510(K) registration is based on the FDA 510(K) for the INJEX
system under Rösch Medizintechnik AG. INJEX Pharma GmbH is the new
registered manufacturer and exporter. The FDA 510(K) by Rösch AG was still
valid, but had to be reactivated by the new manufacturer. An important
milestone for INJEX Pharma AG began as a new startup company with worldwide
sales and marketing at the end of February 2012.
The management of the company will go on a road show in New York next week
and will present the new concept for worldwide sales and marketing to
investment groups on Wall Street. About 20 presentations are scheduled
right now.
According to Sylwin Grinman, President of INJEX Pharma USA
'USA/North America is a powerful market for any new and unique technology
that wants to establish itself in its respective market place. This needle
free injection system will create remarkable changes for all people.
Its applications are numerous and constantly emerging in areas of
dentistry, diabetes, cosmetic & beauty care, vaccines, ED dysfunction.
We have developed a new concept in the beauty & cosmetic industry with our
new line of SHIREEN, which will be used in wrinkle treatments. SHIREEN will
revolutionize the cosmetic market.
INJEX the needle free injection system is now a global commodity and it is
the beginning of a new era in medical device technology. It is simple, easy
to use and will fit perfectly into the American lifestyle.'
Contact:
Andy Rösch
CEO / Managing Director
INJEX Pharma AG
Buckower Damm 114
12349 Berlin
Tel.: 030/53096768
andy.roesch@injex.com
www.injex.com
Sylwin Grinman
Managing Director
INJEX Pharma USA
1922 NE 119 RD
North Miami Beach - FL - 33181
USA
Tel.: +1 786 512 196 3
sylwin@injex.com
press contact:
Maysmedia
Am Ideck 28
D-42781 Haan
0049-2129-343439
germany@maysmedia.de
End of Corporate News
---------------------------------------------------------------------
30.05.2012 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
172131 30.05.2012
DGAP-News: INJEX Pharma AG / Key word(s): Regulatory Approval
INJEX Pharma AG received FDA clearance for the import and sale of the
needle free injection technology INJEX 30 into the US Market
30.05.2012 / 16:20
---------------------------------------------------------------------
INJEX Pharma AG received FDA clearance for the import and sale of the
needle free injection technology INJEX 30 into the US Market
INJEX Pharma AG ISIN: DE000A0STYL7
Berlin, 30. May 2012
The FDA had registered INJEX Pharma GmbH, Berlin, and INJEX Pharma US,
Miami, and given approval for the import and sale of INJEX 30 in the US
market. The condition was the registration by the FDA for INJEX Pharma GmbH
as manufacturer and exporter. This registration is now finalized.
The FDA 510(K) registration is based on the FDA 510(K) for the INJEX
system under Rösch Medizintechnik AG. INJEX Pharma GmbH is the new
registered manufacturer and exporter. The FDA 510(K) by Rösch AG was still
valid, but had to be reactivated by the new manufacturer. An important
milestone for INJEX Pharma AG began as a new startup company with worldwide
sales and marketing at the end of February 2012.
The management of the company will go on a road show in New York next week
and will present the new concept for worldwide sales and marketing to
investment groups on Wall Street. About 20 presentations are scheduled
right now.
According to Sylwin Grinman, President of INJEX Pharma USA
'USA/North America is a powerful market for any new and unique technology
that wants to establish itself in its respective market place. This needle
free injection system will create remarkable changes for all people.
Its applications are numerous and constantly emerging in areas of
dentistry, diabetes, cosmetic & beauty care, vaccines, ED dysfunction.
We have developed a new concept in the beauty & cosmetic industry with our
new line of SHIREEN, which will be used in wrinkle treatments. SHIREEN will
revolutionize the cosmetic market.
INJEX the needle free injection system is now a global commodity and it is
the beginning of a new era in medical device technology. It is simple, easy
to use and will fit perfectly into the American lifestyle.'
Contact:
Andy Rösch
CEO / Managing Director
INJEX Pharma AG
Buckower Damm 114
12349 Berlin
Tel.: 030/53096768
andy.roesch@injex.com
www.injex.com
Sylwin Grinman
Managing Director
INJEX Pharma USA
1922 NE 119 RD
North Miami Beach - FL - 33181
USA
Tel.: +1 786 512 196 3
sylwin@injex.com
press contact:
Maysmedia
Am Ideck 28
D-42781 Haan
0049-2129-343439
germany@maysmedia.de
End of Corporate News
---------------------------------------------------------------------
30.05.2012 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
172131 30.05.2012