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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

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.
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Publication:PR Newswire
Geographic Code:1USA
Date:Dec 17, 1998
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