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So those are the same guys who got the FDA warning in 2005 ?
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2005/ucm075997.htm
Yep they are:
http://www.cmocro.com/company/INJEX+-+Equidyne+Systems,+Inc./index.html
Do we trust them now???
(And by the way, they are not Antares pharma competitor, you need to look in the wrinkle cosmetic market - doing a needle free injector (that cost $70) doe's not make them a competitor to another company who makes many type of injectors to OTHER applications)
Shareholder Newsletter 22/08/12
INJEX Pharma AG has successfully re-launched the needle free injection technology and obtained approvals in important markets
New beauty product SHIREEN will significantly contribute to profitable growth of the company
Dear Shareholder,
With a small team we completed the takeover of the entire worldwide business of INJEX Pharma GmbH. In February 2012, we merged all rights and assets into a corporate shell listed at the open market of the Frankfurt Stock Exchange. We started to set-up a strong professional team.
We managed to install a quality management system according to the ISO 13485 standard. Based on the higher performance level in quality management and product management we were able to speed up national registrations in several important countries. Today, the company has obtained CE Approval, FDA 510(k) registration, the Canadian medical device license, registration in Brazil and a couple of other markets. We also expect to get approval from China in the short term.
INJEX Pharma AG has signed exclusive agreements with dedicated partners worldwide. Some of them started already marketing and sales activities – others will start very soon after the national registration.
The INJEX30 system has moved into the focus of the pharmaceutical industry again. The research and development division of INJEX Pharma AG has some very promising projects in the pipeline and new funding will be used to build up a strong R&D team and to intensify R&D activities.
10 years ago, the market for needle free technology was small and a lot of companies failed to commercialize the technology. Today, this market is larger and has a very high potential. Also medication has changed. Today, the doses of drugs injected are much smaller and this opens up the market for needle free injection, which was limited by the dosage size 10 years ago.
With our new product SHIREEN we are entering the beauty market worldwide. The new poring method is an offer, in particular, to women, who are interested in the rejuvenation of their skin.. When the high priced anti-aging creams do not show any effects anymore, we have a new and innovative way to take care of the skin in a painless way. INJEX Pharma AG is starting in a high margin business on a global scale.
The company has a clear target – to become the worldwide market leader in needle free injection technology. The growth of market capitalization shall confirm our success in the near future. We are planning and we are in preparations to change to a segment with high transparency requirements (General Standard) at the Frankfurt Stock Exchange and to list the company in New York.
http://www.injex.de/newsletterarchiv
Having concentrated on the growth of the company in the past period, we will now - with the news about the Canadian registration and our first contract with an US Partner – move into the next phase and expect to present an interesting news flow to our shareholders.
INJEX Pharma AG and American Healthcare Products Inc. signed an exclusive distributor agreement to market needle-free syringe INJEX 30 in the West Coast States of USA
14:20 17.08.12
DGAP-News: INJEX Pharma AG / Key word(s): Contract
INJEX Pharma AG and American Healthcare Products Inc. signed an
exclusive distributor agreement to market needle-free syringe INJEX 30
in the West Coast States of USA
17.08.2012 / 14:15
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INJEX Pharma AG and American Healthcare Products Inc. signed an exclusive
distributor agreement to market needle-free syringe INJEX 30 in the West
Coast States of USA
INJEX Pharma AG ISIN: DE000A0STYL7
Berlin, 17 August 2012
Berlin - American Healthcare Products Inc., headquartered in California,
has been appointed as the exclusive distributor for USA West Coast states
to market INJEX 30 in Washington State, California, Arizona, Nevada and
Oregon. The agreement, includes a fixed minimum volume of 20,000 INJEX
systems in the first year, was signed and the first delivery of products
will start soon in August.
'We are excited about the partnership with INJEX Pharma AG. With FDA 510K
approval for INJEX 30, we are very much convinced about the market
opportunities in the dental, diabetes and medical markets. INJEX is the
painless injection system and a safe alternative to the traditional needle
syringe and a solution for needle phobics. But above all INJEX is an
expression of the American way of life - basic rights of free choice for
patients - and INJEX - the needle-free injection system is the better
choice,' stated American Healthcare Products Inc. Managing Director Richard
Lim.
In October, American Healthcare Products Inc. will present and highlight
the INJEX 30 system and the needle-free treatments at the Annual Show of
the American Dental Association (ADA) to the American dentists.
'We are focused on our network opportunities and immediate market approach.
It's Time to market - we have the sales and marketing strategy in the
exclusive states prepared, the logistics built up and our long term
partners and customers integrated,' added Mr. Richard Lim.
'Together with American Healthcare Products Inc., we have a strong sales
and marketing partner, which has been established in the market,
experienced and has a first class network of institutions, associations and
clinics. This is fundamental for the sales opportunities and we are looking
forward to a successful market entry with our new partner in the US
market,' remarks Mr. Andy Rösch, CEO of INJEX Pharma AG.
Contact:
Andy Rösch
CEO
INJEX Pharma AG
Buckower Damm 114
12349 Berlin
Tel.: 0049-30-53096768
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
End of Corporate News
---------------------------------------------------------------------
17.08.2012 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
http://www.dgap.de/news/corporate/injex-pharma-and-american-healthcare-products-inc-signed-exclusive-distributor-agreement-market-needlefree-syringe-injex-the-west-coast-states-usa_42269_729684.htm
INJEX Pharma AG announces initial shipment of INJEX30 syringes without a needle to Canada
insert-text-here
New York Investment Groups Recommends Listing INJEX Pharma AG on NASDAQ
The financial roadshow of INJEX Pharma AG, Germany, was an excellent success. Feedback from the American financial community for the needle free injection technology has been great.
(PRWEB) June 20, 2012
The management of INJEX Pharma AG, a health care company based in Berlin, Germany, visited New York for a financial road show in the first week of June and presented the innovative products, INJEX and ROJEX, needle free and painless injection systems to selected investment groups.
The CEO, Mr. Andy Rösch and the Director for international sales, Mr. Sylwin Grinman, are convinced that the technology, which was introduced more than ten years ago, has great worldwide market potential today. We offer our worldwide network of distributors exclusive signed agreements. The start of marketing and sales in the US market is just ahead. At the end of May the company received the FDA 510(k) registration for marketing and sales of the INJEX products in the United States of America. This is an important milestone especially for the New York financial community.
INJEX Pharma AG impressed by presenting the beauty kit SHIREEN with the new Poring – Method for a soft wrinkle treatment. This new method combined with the SHIREEN Fluid has -big market potential and shall acquire the market between the skin creams and the injection method with different products.
Sylwin Grinman, INJEX Pharma USA in Miami says; “We will offer more as we plan for the future. We have an innovative concept, we are going new ways, entering new markets and are seeking new market potentials. INJEX for the medical markets and SHIREEN for the cosmetic markets will yield market share with our new marketing and sales concept. “
New York investment bankers recommended after the presentation a listing on the NASDAQ and offered their services to accompany INJEX Pharma AG. The CEO and the supervisory board will check the opportunities for such a listing with selected investment bankers in New York.
According to Andy Rösch, “This was a ground - breaking experience for our us to have the chance to present the company, the history and the future potential in New York. American bankers are focusing on the future and we were able to present and convince in a reliable manner. We are diversifying and entering new markets like the profitable cosmetic market. The proposal for a NASDAQ listing definitely amazed us . We want to take this American challenge, because this would be a huge opportunity for the company and the shareholders. Now we have to evaluate whether the company has all the basics to go this step. “
Georgina Fahrer
Injex Pharma
305 778 1489
Email Information
http://news.yahoo.com/york-investment-groups-recommends-listing-injex-pharma-ag-080312340.html
After the roadshow in NY they went straight to England for a meeting with investors, CEO told on a board of the social network XING and they got a further request for a meeting in Italy.
So news ahead about the results of all the meetings, probably.
Roadshow in NY finished - news about it soon
CEO told in a German social network called XING:
Today a roadshow will end, held in New York to present the Injex Pharma AG to investores and analysts.
The resonance was outstanding and will be significant for the company.
They will summarize the results at the weekend and will report about it in an announcement at the beginning of next week.
Looking forward to ...
Cheers and have a good day!
Makrolon by Bayer for INJEX
Have a read: http://plastics.bayer.com/plastics/emea/en/product/makrolon/application_areas/docId-943/InjexTM_needle-free_injection_system.html
The global market for drug delivery devices is forecast to exceed $22 billion by 2017 with a Compounded Annual Growth Rate (CAGR) of 4% from 2010 to 2017.
http://reports.pr-inside.com/drug-delivery-device-market-to-r3212197.htm
Dax equity shares on Friday, the deep red Injex Pharma AG has had a good rise. The first signs are already on the management of the company going in the next week in New York on a road show and wants to convince American investors in the new global marketing concept. There are advised about 20 presentations.
Hi-Tech Plastics for the vial produced by Bayer
http://www.bayer.de/
http://www.makrolon.com/bms/db-rsc/makroloncmsr6.nsf/id/home_en
Source of the following media: http://www.azom.com/news.aspx?newsID=13652
Bayer MaterialScience Demonstrate Makrolon Polycarbonate Usage in Medical Applications
Published on September 9, 2008 at 10:15 PM
Bayer MaterialScience’s Makrolon® polycarbonate is ideal for use in medical applications, where global trends are driving demand for plastics and materials with superior properties.
INJEX system – a needle-free system INJEX™
“Global trends - such as the preference for self-medication, minimally-invasive treatment and surgery, and emerging areas such as genetics and biotechnology – are driving demand for increasingly innovative medical products,” noted Dr. Markus Steilemann, Vice President of Consumer Products & Medical, for Bayer MaterialScience’s Polycarbonates Business Unit in Asia Pacific.
“Because of the stringent requirements set by the medical industry for such applications, Makrolon®’s ability to withstand high heat and impact, as well as it transparent and aesthetic appeal, make it the material of choice for an extremely versatile range of medical applications,” he explained. Makrolon® can be sterilised with superheated steam, high-energy radiation, or ethylene oxide. It can also be sterilised by laser without discolouring or turning yellow - a problem common to other plastics. All Bayer’s materials used in medical technology comply with US-Pharmacopeia standard Class VI and ISO 10993-1.
“In China, Bayer MaterialScience’s extensive experience collaborating with medical device manufacturers globally, coupled with our local presence and technical support, ensure that we are in a good position to support the needs of medical device manufacturers in China,” Dr. Steilemann said. Citing the example of how Bayer MaterialScience can help its customers ensure better time-to-market for their products, Dr Steilemann explained: “We are able to provide binding assurances regarding the consistency of the relevant formulations and the stability of supply, as well as (the US) FDA-maintained quality of our material. This means that the regulatory approval time needed for goods produced in Asia can be decreased.”
At the MEDTEC 2008 exhibition in Shanghai, the company showcased injection-molded micro forceps which comprise eight moving components made with Makrolon® Rx 2530. The forceps measure only a few millimetres in length and width, and Makrolon® ’s excellent mechanical properties, outstanding strength, stiffness and toughness, together with its good photoconductivity, make the highly-transparent polycarbonate ideal for precise medical use.
Another exhibit featured was a needle-free system called INJEX™ that allows injections to be self-administered painlessly. With the INJEX™ system, drugs are injected into the skin through pressure-resistant ampoules when high air pressure is applied briefly. The INJEX™ system is made with Makrolon® Rx1805, and benefits from the material’s resistance to gamma-ray sterilization and to stress cracking, as well as its superior transparency.
In addition, Bayer’s experts demonstrated Makrolon®’s ability to withstand tough conditions during sterilisation.
Commitment to China’s medical device manufacturing industry
Dr Steilemann said Bayer MaterialSciences aims to strengthen its ability to provide highly-tailored solutions to local customers in the medical industry. “In addition to ensuring the reliable supply of high quality product, we also are placing significant emphasis on supporting our customers with technical solutions in colour selection and measurement,” said Dr. Steilemann. “With our extensive medical and technological expertise, our local teams can anticipate our customers' needs and are able to offer specific professional advice and expertise, whether in supporting material trials or regulatory documentation,” he said.
Supported by local production capacity at the Bayer Integrated Site Shanghai, and technical support at Bayer’s Polymer Reseach and Development Center ( PRDC) in Shanghai- Bayer brings its rich global experience with customers around the world to a local level, to ensure that local needs are always met. The company’s Colour Competence Centre (CCC) and Customer Interface Centre (CIC) provide platforms where customers can take full advantage of Bayer’s professional solutions, including optimising production process and products as well as colour-selection and measurement.
“Domestic customers are eager and well-prepared to grow their businesses and markets, and we are ready by their side when it comes to materials and services concerning medical grade polycarbonates. We are confident that our efforts, together with local government support, will ensure a bright future for China’s medical device market,” concluded Dr. Steilemann.
Movies about Injex Part I: What is it and how to use it
introduction to INJEX
INJEX 30 Injection
Tutorial on the Injex System
How to Operate INJEX with Vials
FDA clearance received for the import and sale of the needle free injection technology INJEX 30 into the US Market
source: http://de.finance.yahoo.com/nachrichten/dgap-news-injex-pharma-ag-142207887.html
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 (Xetra: 529140 - Nachrichten) 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 (Frankfurt: A0DKRK - Nachrichten) 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 (Euronext: ALITS.NX - Nachrichten) 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
The method brings SHIREEN-Poring through the applying of hyaluronic back through the pores of the skin to the magic of youthful beauty. Hyaluronic acid is a natural fountain of youth for the skin. But with age the body produces less and less of this precious substance - the result, the skin reveals our age. Stop it! In order to counteract this, hyaluronic acid is generated by pressure from the SHIREEN PoreJet Poring with our specially developed tip, gently placed in the top layers of skin and then spread evenly with targeted massages. The skin is soft from the inside filled and smoothed. The great advantage of this method of skin rejuvenation with SHIREEN: The effect of the treatment is immediately visible and made ??a lasting effect. The skin is able to store larger amounts of moisture, the tension increases and the formation of collagen & elastin is stimulated. The needle-free wrinkle reduction by hyaluronic suitable for the first, superficial wrinkles and aging in the face, back and hand Dekolletté area.Änderungen rückgängig machen
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Healthy Smiles Introduces Injex Needleless Local Anaesthesia
insert-text-here
the thread does so to the right format
thank you very interesting am looking forward to the presentation next week in the usa
insert-text-here
The total needle-free delivery market is expected to grow rapidly
http://www.visiongain.com/Press_Release/141/The-total-needle-free-delivery-market-is-expected-to-grow-rapidly-as-more-opportunities-arise-from-new-technology-and-emerging-economies
What would you prefer?
beauty treatment with needle:
Homepages of Injex in different countries:
www.injex.de
www.injex.com
www.injex.us
www.injex.info
www.injex.com.au/
www.safeinject.com.br
www.injex.cc
www.injex.co.il
www.injex.co.il/ru
www.injex.kr/index.php
www.injexuk.com
INJEX Pharma AG announces FDA clearance to market and sell their needle free injection system in the USA.
http://news.yahoo.com/injex-pharma-ag-announces-fda-clearance-market-sell-071644108.html
The innovative method for reducing wrinkles gently and completely needle-free
is a milestone. I think this will come out on top...
Video will be available in english next week:
http://www.injex.com/fight-wrinkles-injex
German Video:
http://www.injex.de/shireen-bei-beauty-trends
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