Just in:
Thursday, Dec 17 1998 10:29AM EST
-Preview-
(PR Wires) DJ: Chronimed's Personal Lasette Product Receives FDA Safety
DJ: Chronimed's Personal Lasette Product Receives FDA Safety Nod, and Lasette
Obtains CE Mark for International Markets
Consumer Lasette Model Meets Safety Standards of Professional Model
MINNEAPOLIS, Dec. 17 /PRNewswire/ -- Chronimed Inc. (Nasdaq: CHMD),
announced today that the Food and Drug Administration (FDA) has granted
clearance to market and sell the second-generation of the Lasette(TM) laser
finger perforator system -- the smaller, more portable personal model still
in development and specifically designed for consumer use. Developed by
Cell Robotics International, Inc. (OTC Bulletin Board: CRII), and
exclusively distributed by Chronimed, Lasette laser technology products
allow for obtaining a capillary blood sample in a nearly painless manner for
glucose testing. The currently available professional Lasette model,
designed for use by healthcare professionals in clinical and institutional
settings, received FDA clearance last week for at-home use by consumers,
with prescription and proper training. As announced on December 8, the
Lasette is the first medical laser device ever to receive FDA clearance for
consumer use. Today's announcement is an additional FDA notification that
the personal Lasette model, expected to be available in mid-1999, meets the
same safety and efficacy standards of the professional Lasette model.
The Lasette has also recently been granted the CE Mark, a medical device
safety standard established by the European Community and required for
medical product marketing and shipment in certain international markets. On
December 11, Cell Robotics announced their ISO 9001 certification, ensuring
that Lasette products meet international quality standards, as well as their
EN46001 certification, a European requirement for medical devices. ISO
certification is required for obtaining the CE Mark. The Lasette can now be
marketed throughout Europe and in several countries including Brazil,
Argentina, New Zealand, and South Korea, among others.
"We are pleased to be working with Cell Robotics on these unique products,
and we congratulate them on their recent certifications. Together, we are
providing healthcare professionals and consumers with innovative technology
to aid in the treatment of diabetes," said Steven A. Crees, Senior Vice
President of Diagnostic Products at Chronimed.
Diabetes is a chronic health condition that has no cure and is a leading
cause of death worldwide. According to the American Diabetes Association,
there are 15.7 million people in the U.S., or 5.9 percent of the nation's
population, who have diabetes. Each day approximately 2,200 people are
diagnosed with diabetes. Worldwide, there are more than 100 million people
with diabetes.
Chronimed has exclusive worldwide rights to market and sell the Lasette
laser technology products through its development and distribution agreement
with Cell Robotics. The agreement grants Chronimed rights to market and
sell the Lasette(TM) laser finger perforator system and all future
generation products developed using Lasette(TM) laser technologies, as well
as worldwide manufacturing rights of the disposable finger shield
components.
Lasette technology utilizes a laser beam that penetrates the skin to obtain
a capillary blood sample, instead of traditional steel lancets that tear the
skin. In addition to minimizing immediate and residual pain, the Lasette
eliminates accidental needle sticks, reduces cross contamination, eliminates
sharps disposal, and can be used for testing glucose with any standard blood
glucose meter. All Lasette products for use by consumers require a doctor's
prescription and proper training.
Cell Robotics International, Inc., based in Albuquerque, New Mexico, is a
manufacturer, marketer and distributor of scientific and medical laser
devices. Formed in 1988 as part of a scientific group from Los Alamos
National Laboratory, Cell Robotics is the developer of the Lasette and other
medical laser devices.
Chronimed Inc. is a leading integrated healthcare company specializing in
diagnostic products, specialty pharmacy services, and disease management for
people with chronic health conditions. The Company develops, manufactures,
markets, and distributes pharmaceuticals, medical diagnostic products, and
provides specialized patient management services nationwide for people with
long-term chronic conditions such as HIV/AIDS, diabetes, organ transplants,
and diseases treated with injectable medications. Chronimed works directly
with patients, providers, and payors to improve clinical and cost-of-care
outcomes. Chronimed's web site address is chronimed.com
For more information about the Lasette, please call the toll-free hotline:
800-866-1633.
As a cautionary note to investors, certain matters discussed in this press
release are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such matters involve risks and
uncertainties that may cause actual results to differ materially, including
the following: changes in economic conditions; general competitive factors;
the Company's ability to execute its sales and marketing plans; changes in
the status of managed care contracts; and the risks described from time to
time in the Company's SEC reports.
/CONTACT: Investor Inquiries, Paul S. Dunn, 612-979-3942, Media Inquiries,
Maggie P. Knack, 612-979-3830, both of Chronimed Inc., or Dealer & Consumer
Inquiries, 800-866-1633, Fax 800-307-3334, or E-mail Lasette@chronimed.com,
to receive product information/
10:12 EST
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