Novamed News - 500 Beiträge pro Seite

[Boto]

Hi Zusammen,

wollte einfach mal wieder Novamed ins Gespräch bringen. Würde mich freuen hier eine informative Runde zu gründen.

Gruß

[Boto]

Monday June 14, 8:20 am Eastern Time

Company Press Release

US Regulatory Status of Breast Implant Products

MINNEAPOLIS--(BUSINESS WIRE)--June 14, 1999--NovaMed, Inc. (OTCBB: NVMD -
news) sought today to clarify the status of all three company products now before the U.S.
Food and Drug Administration (FDA) for review.

The Company develops, manufacturers and markets breast implant products from facilities located in the US and Germany. Sales
to date have been generated internationally further to the European regulatory approval process Conformite European or CE
Mark. The NovaGold(TM) alternative fill and NovaSaline(TM) Pre-Filled obtained CE Mark`s in 1996 and since that time have
been sold in various countries outside of North America. The Company has to date sold approximately 10,000 devices in an
international market place valued at over $500 million annually and growing. The US market place constitutes half of the world
market. The cosmetic portion of that market, which accounts for approximately 80% of all breast implant surgeries, is entirely
dominated by the sale of saline filled breast implants, both inflatable and pre-filled. Admission to this market is very significant in
the Company`s measure of long term success. Accordingly, this year the Company has focused on obtained US FDA regulatory
clearance to market for its products.

The Company`s flagship product is the NovaGold(TM) pre-filled alternative gel breast implant. The product is filled with a
patented water based gel material and was originally developed in response to the demand for a replacement of silicone gel filled
implants. Sales outside of North America have met with resounding success when chosen over silicone gel filled implants. The
NovaGold(TM) appears to be more radiolucent than either silicone gel or saline and many times more viscous or natural feeling
than saline. Since the product is water based, NovaGold(TM) is designed to biocompatible, such that it would be harmlessly
excreted from the body in the event of leakage or rupture. The fill material is also osmotically balanced within the body, so that
fluctuations in implant volume should not occur over time.

The Company announced the submission of an application for an Investigative Device Exemption (IDE) for the NovaGold(TM) on
January 13, 1999. The IDE process requires that the Company conduct controlled clinical trials of the NovaGold(TM) breast
implant in the US. Clinical trials are expected to take between 18 months and two years. Once sufficient data has been collated,
the Company is then responsible for submitting a Pre-Market Approval (PMA) application containing the clinical information to the
FDA for an assessment of whether the data supports FDA clearance to market.

The Company is currently in the process of collecting additional data to support its application for an IDE and now anticipates,
subject to approval of the IDE from the FDA, to start enrolment for clinical trials in the third quarter of 1999.

The Company has also submitted two products, the NovaSaline(TM) Inflatable and the NovaSaline(TM) Pre-Filled breast implants
to the FDA pursuant to the 510k application process.

The 510k process requires a manufacturer to submit a formal application to the FDA for permission to market the product in the
United States. The submission includes the results of testing the product, design specifications and indications of use. The FDA
then has 90 days in which to determine whether the product is substantially equivalent to similar devices currently available. A
positive determination permits the FDA to clear the device for marketing. However, unlike most other devices cleared for market
to market through the 510k process, all saline filled breast implant manufacturers are required to conduct a Post-Market
Surveillance Clinical Study of the devices to evaluate safety and efficacy.

The NovaSaline(TM) Inflatable breast implant, which was developed for the US market, offers an alternative design to other
saline breast implants currently available in the U.S. market. Unlike other saline inflatable implants, the NovaSaline(TM) has a
unique one-piece self-sealing filling valve/patch assembly. This design eliminates the need for a physician to manually seal the
implant after filling, and also eliminates the straps associated with other saline breast implants. By incorporating the filling valve
and shell patch into a single system, there is only one fused area on the shell. The NovaSaline(TM) Inflatable requires a less
intrusive incision prior to placement than a pre-filled implant and enables the physician to fill individual implants to insure that an
equal balance is realized for each breast. Since, many patients approach physicians with complaints related to disproportionate
breast sizes.

The Company announced on June 7, 1999 that the FDA had completed the scientific review portion of its 510(k) application for
the NovaSaline(TM) Inflatable breast implant. The final step in the process of obtaining FDA clearance to market the product in
the US is a FDA inspection of the Company`s Minneapolis manufacturing facility, methods and controls to ensure compliance with
FDA approved manufacturing standards. The company is preparing its manufacturing facility for this inspection and expects to be
ready by September 1999. US sales of the product are anticipated before the end of 1999.

Unlike the NovaSaline(TM) Inflatable, the NovaSaline(TM) Pre-Filled is finished with sterile saline at the point of manufacture,
packaged, sealed and terminally sterilized prior to delivery for implant surgery. One benefit of the NovaSaline(TM) Pre-Filled
implant, like the NovaSaline(TM) Inflatable, is that it is saline filled. Should the implant rupture, only salt water is released into the
body and the deflation immediately recognized. Another advantage of the NovaSaline(TM) Pre-Filled is that the physician cannot
introduce substances into the device during surgery. Physicians have independently added steroids and other antibiotics into
inflatable prostheses in the past. Since the device is sold pre-filled, sealed, and sterilized, the risk of microbial contamination during
surgery is significantly diminished.

The Company announced the submission of the NovaSaline(TM) Pre-Filled to the FDA for review on June 10,1999. Clearance to
market, according to the 510(k) time frame, is anticipated by September of 1999. The Company thereafter anticipates sales of the
product in the US.

This release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Securities Litigation
Reform Act of 1995. Forward-looking statements involve the known and unknown risks and uncertainties that may cause the
company`s actual results in future periods to differ materially from that which is anticipated.

[Boto]

Monday June 21, 8:11 am Eastern Time

Company Press Release

NovaMed and IKB Deutsche Industriebank AG
Announce Government Guaranteed Funding for New
Production Facility in Germany

MINNEAPOLIS and DUSSELDORF, Germany--(BUSINESS WIRE)--June 21,
1999--NovaMed, Inc. (OTCBB.NVMD) and IKB Deutsche Industriebank AG (IKB.GR) announced today an agreement with
the state government of North Rhine Westphalia to a financing arrangement consisting of government guaranteed loans and grants
totaling DM22,300,000 marks (approximately US$12.7 million) for the purpose of constructing a new production facility in
Duisburg, Germany.

NovaMed, which manufactures breast implants, disclosed that its product sales in less than the first six months of 1999 have
accounted for 75% of the volume of sales made in all of 1998, and this upward sales trend is expected to continue.

The increased demand for NovaMed`s breast implant products, stems from the success of direct sales and new international
distribution arrangements which have necessitated plans to expand production facilities in Europe. Since NovaMed currently
manufactures from leased facilities in Germany, the decision was made to apply for government funding guarantees that would
enable the Company to construct a new manufacturing facility in Germany that could meet the anticipated demand. Agreement
with the Ministry of the Economy for the state of North Rhine Westphalia and the City of Duisburg in conjunction with IKB AG
has made this expansion possible.

The terms of the financing are to include DM17,408,000 in long term fixed rate government guaranteed loans provided by IKG AG
(approximately US$10.2 million) and a non repayable grant of DM4,496,000 (approximately US$2.5 million) provided by the state
government of North Rhine Westphalia. The City of Duisburg has set aside 4,000 square meters of land -- to be purchased by the
Company at a below market sale price -- that lies within a 25,000 square meter area designated as a technology park. The
Company has the further option of purchasing an additional 8,000 square meters of contiguous land for development as the
Company grows. The Company anticipates building a 20,000 square foot research & development and manufacturing facility on
the site.

IKB Deutsche Industriebank AG provides a variety of banking services that focus on promoting small and medium sized business
ventures. IKB offers medium and long term credit, as well as other forms of financing. IKB has several offices in Germany, an
office in Luxembourg and representative offices in London, Paris and Hong Kong.

NovaMed develops, manufactures and markets breast implant products worldwide. The flagship product is the NovaGold(tm)
alternative fill breast implant that utilizes a PVP hydrogel filling material which offers certain design characteristics not presently
available with other fill materials. The Company currently manufactures and markets its products from facilities in Minneapolis,
Minnesota and Monheim, Germany.

This release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Securities Litigation
Reform Act of 1995. Forward-looking statements involve the known and unknown risks and uncertainties that may cause the
company`s actual results in future periods to differ materially from that which is anticipated.

[Boardspecht9]

ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE ENTE

[seph]

Gibt es wirklich nicht mehr fundierte Meinungen zu diesem Wert oder steckt da nur heiße Luft dahinter die schon kalt geworden ist?

[Wallstreet-Trad]

Tja, seph, ne gute Frage.......!

[Boto]

Hi Zusammen,

nach meinem Wissenstand, seit diesem Jahr, sieht es folgend aus: Die Produkte sind in Europa zugelassen, in Amerika fehlt noch die FDA-Zulassung, haben dann strategischen Deal mit amerikanischen Konkurenten abgeschlossen, darauf hin ist der Kurs von 1 E auf 1,8 gestiegen und hält sich zwischen 1,6 und 1,75. Bauen jetzt eine neue Produktionsstätte im Ruhrgebiet, haben eurpäische Fördergelder erhalten. Ich denke, wie auch schon von palladiumbroker erwähnt, wenn die FDA-Zulassung kommt, Zeitraum zwischen 3 Monate und 1 Jahr, wird sich da schon einiges ergeben. Die Story hängt von der Zulassung ab, positiv ist die Gleichmäßigkeit, wie sie derzeit gehandelt wird. Kein allzu großes auf und ab. Einfach abwarten........

[Boto]

neueste nachricht. gehen derzeit auf die 1.40 zu, heute schon -9%.

Company Press Release

NovaMed Files Form 10-SB With SEC To Be
Fully-Reporting Company

MINNEAPOLIS--(BUSINESS WIRE)--Aug. 4, 1999--NovaMed, Inc. (OTCBB: NVMD - news) has filed a Form 10-SB with
the Securities and Exchange Commission as the initial submission in the process of becoming a fully reporting company pursuant to
the Exchange Act of 1934 and recent rulings from the National Association of Securities Dealers (NASD).

Once the Form 10-SB has been accepted for review by the SEC, absent any comment from the SEC as to the adequacy of the
submission, the Form 10-SB is declared effective by operation of law within 60 days. When it is declared effective by the SEC,
through operation of law or after response to comments, NovaMed, Inc. will be considered a fully reporting company. The
company`s Form 10-SB will be retrievable at the SEC web site at www.sec.gov shortly.

NovaMed develops, manufactures and markets breast implant products worldwide. The company`s flagship product is the
NovaGold(TM) alternative fill breast implant that utilizes a PVP hydrogel filling material which offers certain beneficial design
characteristics not presently available with other fill materials. The company has also developed a line of saline filled products
(NovaSaline(TM)), which are expected, subject to compliance with Food and Drug Administration clearance procedures, to be
introduced into the U.S. market before the end of this year. The company currently manufactures and markets its products from
facilities in Minneapolis, Minnesota and Monheim, Germany.

This release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Securities Litigation
Reform Act of 1995. Forward-looking statements involve the known and unknown risks and uncertainties that may cause the
company`s actual results in future periods to differ materially from that which is anticipated.

[Vivaldi]

übrigens ist Novamed letzte Woche vom www.stocksearchers.de Börsenbrief empfohlen worden!!

Vivaldi

[Boto]

hallo vivaldi,

kennst Du die Gründe für den Kursverlust der letzten Tage.

biba boto

[Boto]

hallo leute,

irgendwas ist da los, heute startet novamed mit einem verlust auf 1.10€, habe mal etwas recherchiert und folgendes gefunden:

eine empfehlung von europacific:
http://www.eupac.de/heiss/empfehlungen/hei_nvmd.htm

und noch ein text von denen:

NovaMed

Die Mitteilungen des Unternehmens beweisen, daß die Entwicklung in den letzten Monaten
sehr positiv verlaufen ist.

(Wir zitieren aus einer Pressemeldung der NovaMed Inc.).

Die Bilanz per 31.12.98 zeigt, daß sich das Umsatzergebnis von US-$ 1,01 Mio auf US-$ 1,26
gesteigert hat. Im gleichen Zeitraum konnten durch eine entsprechende Optimierung der
Produktion die Verluste von US-$ 1,09 Mio überproportional auf US-$ 213.000 gesenkt
werden. Die Schulden des Unternehmens von US-$ 3,5 Mio wurden durch den Verkauf von
Aktienbeständen auf 0 reduziert.

Der weltgrößte Hersteller und Vertreiber von Brustimplantaten Inamed Corp. hat mit NovaMed
einen Kooperationsvertrag abgeschlossen. Für das Recht, NovaMed Implantate zu
verkaufen, zahlt Inamed US-$ 10,0 Mio an NovaMed. Dieses Recht gilt weltweit für alle
Länder außer den USA und Deutschland. Die geschätzten Kosten für die Zulassung der
NovaMed Produkte in den USA betragen dagegen nur US-$ 3,0 Mio und können mit diesen
Einkünften leicht beglichen werden.

Inamed hat sich vertraglich außerdem dazu verpflichtet, stufenweise in den nächsten drei
Jahren Implantate von NovaMed für DM 25,0 Mio pro Jahr zu erwerben.

Dazu kommen die Umsätze in den USA, sobald die FDA Genehmigungen vorliegen, die den
Umsatz durch die Joint Venture Aktivitäten verdoppeln werden. Das kann zusammen mit allen
beschriebenen Einkünften zu einem Umsatzergebnis von DM 50,0 Mio pro Jahr führen. Die
erste Zulassung für den amerikanischen Markt wird von NovaMed für das Ende der
kommenden Woche erwartet.

Zusätzlich zu diesen positiven Ausblicken kommt die Genehmigung von staatlichen
Zuschüssen und zinsgünstigen Krediten durch das Land Nord-Rhein-Westfalen in Höhe von
DM 22,3 Mio. Das bedeutet, daß NovaMed schon im Sommer 1999 mit dem Bau einer neuen
Produktionsstätte in Duisburg beginnen kann, die ab Frühjahr 2.000 die gestiegenen Umsätze
weltweit bedienen kann.

Der Börsenkurs der NovaMed hat sich in den vergangenen Monaten von US-$ 1,15 auf US-$
2,0 befestigt und an täglicher Liquidität gewonnen. Diese Kurssteigerung ist trotz der massiven
Verkäufe erfolgt, die täglich den Markt belasteten. Diese Verkäufe wurden von Altaktionären
der Firma veranlaßt, deren Unternehmensmantel die NovaMed erworben hatte, um möglichst
schnell eine Börsennotierung zu erreichen. Die Gesamtanzahl der verkauften NovaMed
Aktien durch diese Altaktionäre belief sich auf 3 Mio Stück und dennoch konnte ein
Kursanstieg verzeichnet werden. Bis auf einen Restbestand von 200.000 Aktien sind diese
Verkäufe jetzt abgeschlossen und wir erwarten den Durchbruch der NovaMed Aktie über die
US-$ 2,00 Linie binnen der nächsten Wochen. Die nächste Widerstandslinie liegt bei US-$
2,50.

Wir sind der festen Überzeugung, daß die NovaMed Aktie in einem Zeitraum von 6-12
Monaten das Kursniveau der Inamed von derzeit US-$ 15,0 und der Mentor von aktuell US-$
16,0 erreichen kann. Beachtenswert ist, daß beide Firmen doppelt soviel Aktien ausgegeben
haben wie NovaMed.

Wir sehen NovaMed als den kommenden Marktführer in dem beschriebenen Marktsegment.
Das einzigartige Produkt NovaGold als Flaggschiff der Produktfamilie hat allein in Deutschland
einen Marktanteil von 30 % errungen, obwohl in der Bundesrepublik Silikonimplantate noch
erlaubt sind. Nicht auszudenken ist der Umsatzschub für NovaMed in den USA sobald
NovaGold oder andere Produkte dort verkauft werden. Der Gesamtmarkt für Implantate in den
USA beträgt mehr als US-$ 200 Mio pro Jahr.

Wir raten deshalb dazu, die Aktie mindestens bis zu dem Zeitpunkt zu halten, zu dem die
Genehmigungen für die klinischen Tests in den USA vorliegen.

Wir sind auch der Meinung, daß andere bedeutende Unternehmen aus dem Medizinbereich
an NovaMed sehr interessiert sind. Da eine Übernahme von NovaMed nicht auszuschließen
ist, kann es in der Folge zu dramatischen Kursanstiegen kommen". (Übertragung der
Pressemitteilung der NovaMed Inc.)

(Der Herausgeber dieses Börsenbriefes (Euro Pacific) und Mitarbeiter der
Euro Pacific halten Aktienbestände in diesem Wert)


zusätzlich noch produktbeschreibung von novagold:

http://www.novagold.com/

also was meint ihr zur neuesten information von sec?

biba boto

[seph]

Na hört sich doch gut an.
Übrigens, gibt es zu dem Wert ein Börsenkürzel?

[Boto]

Hi seph,

unter jahoo finance nvmd, hier in d ist die wkn 915510.

[dicom1]

hallo leute,
kann jemand übersetzen, ich verstehe nur einen teil.

NovaMed Files Form 10-SB With SEC To Be Fully-Reporting Company

BusinessWire, Wednesday, August 04, 1999 at 08:22

MINNEAPOLIS--(BUSINESS WIRE)--Aug. 4, 1999--NovaMed, Inc. (OTCBB:NVMD) has filed a Form 10-SB with the Securities and Exchange
Commission as the initial submission in the process of becoming a
fully reporting company pursuant to the Exchange Act of 1934 and
recent rulings from the National Association of Securities Dealers
(NASD).
Once the Form 10-SB has been accepted for review by the SEC,
absent any comment from the SEC as to the adequacy of the submission,
the Form 10-SB is declared effective by operation of law within 60
days. When it is declared effective by the SEC, through operation of
law or after response to comments, NovaMed, Inc. will be considered a
fully reporting company. The company`s Form 10-SB will be retrievable
at the SEC web site at www.sec.gov shortly.
NovaMed develops, manufactures and markets breast implant
products worldwide. The company`s flagship product is the NovaGold(TM)
alternative fill breast implant that utilizes a PVP hydrogel filling
material which offers certain beneficial design characteristics not
presently available with other fill materials. The company has also
developed a line of saline filled products (NovaSaline(TM)), which are
expected, subject to compliance with Food and Drug Administration
clearance procedures, to be introduced into the U.S. market before the
end of this year. The company currently manufactures and markets its
products from facilities in Minneapolis, Minnesota and Monheim,
Germany.
This release contains forward-looking statements that are made
pursuant to the safe harbor provisions of the Securities Litigation
Reform Act of 1995. Forward-looking statements involve the known and
unknown risks and uncertainties that may cause the company`s actual
results in future periods to differ materially from that which is
anticipated.


CONTACT: Martin E. Janis & Company, Chicago
Hal Schweig
312/943-1100
or
NovaMed, Inc., Minneapolis
Corporate:
Ruairidh Campbell, President
612/378-1437

KEYWORD: MINNESOTA
INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICINE PHARMACEUTICAL

Today`s News On The Net - Business Wire`s full file on the Internet
with Hyperlinks to your home page.
URL: http://www.businesswire.com

[Octopus]

Phantombild des ersten Novamed-Aktionärs !!!!!!

[Octopus]

Die wirklichen Gründe dafür, warum der Kurs der Novamed fällt:





ENTE bei seiner Lieblingbeschäftigung !!!!

[Boardspecht9]

Wirklich ein äußerst informativer Beitrag. Unglaublich geschmackvoll!!
Danke Octopus.

[Boardspecht9]

Baut die ENTE in Duisburch jezz´die Tittenfabrik , ja oder nein?
Gestehe Du Schurke!!

[Boardspecht9]

Happ´gehört, die ENTE will jezz mit seine Bude EURO-PACIFIC anne Börse gehn.
Tut da jemand watt näheres wissen?