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Strategies & Market Trends : Joe Copia's daytrades/investments and thoughts -- Ignore unavailable to you. Want to Upgrade?


To: Joe Copia who wrote (18202)7/22/1999 12:41:00 PM
From: Bouf  Read Replies (2) | Respond to of 25711
 
PCNA..cheap.....before consolidation and opening of Site on Aug 3!



To: Joe Copia who wrote (18202)7/22/1999 12:44:00 PM
From: blake roberts  Read Replies (2) | Respond to of 25711
 
truth hurts eh? maybe they knew it was a momo, but little did they know you kill them and the stock too with your short sales out of canada. you paying taxes on those canadian earnings joey?



To: Joe Copia who wrote (18202)7/22/1999 12:44:00 PM
From: Investor Clouseau  Read Replies (1) | Respond to of 25711
 
good news for blake?

(PR NEWSWIRE) New Female Incontinence Device Gains European Clearance with
New Female Incontinence Device Gains European Clearance with CE Mark

STEWARTVILLE, Minn., July 22 /PRNewswire/ -- Rochester Medical Corporation
(Nasdaq: ROCM) received notice this week that its FEMSOFT(R) Insert has
received regulatory clearance for marketing in Europe.
The FemSoft Insert is used to manage female stress urinary incontinence,
which is estimated to affect approximately 6.6 million U.S. women and a
similar number in Europe. It is a small, soft device that a women inserts
into her urethra. The latex-free device consists of a soft, thin, fluid
filled silicone sleeve. As a woman inserts the device, the soft liquid sleeve
easily slides into and conforms to her urethra forming an effective seal at
the neck of the bladder to prevent unintended urine leakage. It is removed
during regular bathroom visits where it is discarded and then replaced by a
fresh insert. Other options for management of female stress incontinence
include absorbent pads, surgery, and pelvic muscle strengthening techniques.
The Company's recently presented clinical study results show that its
FemSoft Insert is an effective and highly acceptable treatment option for
women with stress incontinence.
Rochester Medical Corporation President Anthony J. Conway said, "This is
excellent news. The CE Mark is issued by TUV Product Service after full
review of all Quality and Manufacturing Operations as well as Design History
Files (product validations, stability studies, risk analysis, biocompatibility
testing) and Clinical Study results. The mark gives us regulatory clearance
for marketing the FemSoft Insert in Europe and confirms compliance with the
ISO 9001/EN 46001 Quality System and the European Medical Device Directive."
The FemSoft Insert device is not currently available for sale. The U.S.
Food and Drug Administration (FDA) is currently reviewing the company's
pre-market approval (PMA) application.
"We anticipate receiving FDA clearance in time to begin a phased market
launch of the product before calendar year end," said Conway.
"Sales in Europe will follow market introduction in the U.S., but receipt
of the CE Mark at this time will allow selected European clinicians to start
gaining experience with the device in local populations while we continue
discussions with potential European distribution partners."
The immediately preceding document contains forward-looking statements
that involve risks and uncertainties. The FemSoft Insert has not been
authorized by the FDA for commercial sale, and the commercial success of the
FemSoft Insert is subject to the uncertainty of market acceptance of the
device. Other risks and uncertainties include the timing and results of FDA
review, the results of product evaluations, the timing of purchases by
customers, manufacturing capacity for both current and future products, the
results of clinical tests, the timing of clinical preference testing and
product instructions, as well as other risk factors listed from time to time
in the Company's SEC reports including, without limitation, the section
entitled "Risk Factors" in the Company's Annual Report on Form 10K (Part II,
Item 6) for the fiscal year ended September 30, 1998.

SOURCE Rochester Medical Corporation
-0- 07/22/99
/CONTACT: Brian J. Wierzbinski, Chief Financial Officer, 507-533-9604, or
Anthony J. Conway, Chief Executive Officer, 507-533-9600, both of Rochester
Medical Corporation; or General Inquiries, Craig Dickson, Analyst Inquiries,
Leslie Loyet, or Media Inquiries, Joyce Hanson, of The Financial Relations
Board, 312-266-7800/
(ROCM)

CO: Rochester Medical Corporation
ST: Minnesota
IN: MTC HEA
SU: PDT