CRII News out: FDA approval earlier this week now European approval today
Its the FIRST Personal laser medical device approved by the FDA to replace steel needles and lancets in order for diabetes patients to monitor themselves for blood glucose. And its nearly painless.
This is a HUGE market folks.
CRII trading around $3 a share/
CHMD who markets this unit trades at $12...both great stocks.
Each unit sells for approx $2k... will be lowered to $1k soon with an even more compact model
100 MILLION Diabetics world wide.
If only 500K or .5% buys the unit(Meaning 99.5% of the diabetic population doesn't need to buy it)
We are looking at a $1 BILLION DOLLAR + market
No competition. Huge Market.
And the stock trades only at $15 mil market cap.
See the potential?
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Friday December 11, 8:02 am Eastern Time
Company Press Release
SOURCE: Cell Robotics International, Inc.
Cell Robotics Receives CE Mark to Market the Lasette in Europe
ISO-9001 Certification for Cell Robotics and European Certification (CE Mark) for the Lasette has
been granted.
ALBUQUERQUE, N.M., Dec. 11 /PRNewswire/ -- Cell Robotics International, Inc. (OTC
Bulletin Board: CRII - news), a manufacturer and marketer of medical
and scientific laser devices, today announced that it has received ISO 9001 and EN46001
certification by ISO qualifying agency, TUV Essen. The award of this
certification insures that Cell Robotics' products meet quality standards that have been accepted by
over 100 countries and thousands of organizations throughout
the world. ISO 9001 standards span 20 quality components of management, engineering,
manufacturing, marketing and customer service. EN46001certification is a
European requirement for medical devices.
Receiving the ISO Certification was the final step for obtaining the CE Mark for the Lasette™, laser
skin perforator. In addition, the Lasette must be tested against
the stringent European standards for safety. The testing was completed and the data submitted in
September 1998. The CE Mark was granted in December. The
CE Mark is required for medical products to be shipped to and marketed in a number of countries,
including all of Europe, Brazil, Argentina, Australia, New
Zealand, South Korea and some other smaller countries. Receiving the CE mark allows Cell
Robotics to immediately sell to the listed countries.
Ronald K. Lohrding, Ph.D., chairman and chief executive officer of Cell Robotics, commented, ''We
were very pleased that the FDA cleared the Lasette for home
use on December 7, 1998; now the CE Mark opens up the even larger markets of Europe and other
important countries. Customer response to the FDA home-use
clearance has been far beyond our expectations and has inundated the Chronimed customer 800
number.'' Dr. Lohrding continued, ''In addition, the response from
the national media in regard to the FDA's approval of the Lasette for home use has been
astounding.''
Diabetes is a chronic disease that has no cure and is a leading cause of death worldwide. According
to the International Diabetes Institute,
www.idi.org.au/golbal.htn by 2000 there will be the following numbers of people with diabetes by
region: 16.9 million in North America, 23.7 million in Europe,
51.2 million in Asia and 12.6 million in Latin America. These statistics illustrate how important the
CE Mark is to Cell Robotics' and Chronimed's Lasette marketing
efforts.
Lasette is marketed and distributed by Chronimed, Inc.,(Nasdaq: CHMD - news) a leading
integrated healthcare company specializing in products for people with
chronic health conditions, such as diabetes, AIDS and organ transplants. Lasette product information
is available through Chronimed at (800) 866-1633 or via
e-mail (Lasette@chronimed.com).
In addition to the Lasette, Cell Robotics International, Inc. manufactures, markets, and distributes
scientific and medical laser devices. These devices include the In
Vitro Fertilization (IVF) Workstation, designed to improve human fertility, and the Cell Robotics
Workstation, a research instrument that incorporates the
LaserTweezers® and LaserScissors™ for manipulating and cutting cells and chromosomes.
Additional information is available on the Cell Robotics Web Site at
www.cellrobotics.com, by e-mail at crii@cellrobotics.com., or by telephone at (505) 343-1131.
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-DavidCG |
