Global Med Technologies(R), Inc. Receives FDA 510(K) Clearance For ElDorado Donor(TM)

Main Category: Medical Devices
Also Included In: IT / Internet / E-mail;  Blood / Hematology;  Regulatory Affairs / Drug Approvals
Article Date: 16 Feb 2008 - 0:00 PDT

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Global Med Technologies(R), Inc. (OTC Bulletin Board: GLOB), an international e-Health, medical information technology company, announced that the U.S. Food and Drug Administration has granted 510(k) clearance for ElDorado Donor(TM) a new blood management product produced by its Wyndgate Technologies(R) division ("Wyndgate"), paving the way for the Company to proceed marketing the product in the United States.

The ElDorado Donor release is the Company's next generation software and is intended as a comprehensive blood management software application created to provide for the information system needs of blood bank and donor centers. The software is designed to manage, automate, and control activities associated with donors, donor collections, testing, manufacturing, inventory, and distribution. ElDorado Donor was developed with scalability in mind and is designed to manage the system needs of diverse facilities, from small hospital blood banks to community blood centers, to regional and national centers. The release marks a new growth opportunity for the Company both domestically and internationally.

Utilizing an integrated modular configuration, ElDorado Donor is intended to offer functionality with flexibility to tailor features within the system to a facility's specific needs supporting process control from collection to distribution. The software was created for ease-of-use which includes drop down lists and easy access "find" forms. Wyndgate's At-a-Glance(TM) bars provide visual indications of the presence of relevant information offering quick and easy access to that information. ElDorado Donor is designed to support the industry standard for labeling (ISBT128), as well as the ABC Codabar blood product labeling standard.

ElDorado Donor includes safety checks for blood components, blood products, and other related supply items. Safety checks are performed throughout the system as part of the normal processing of donors, blood components, and other blood products. ElDorado Donor can provide extensive manufacturing controls that can be tailored for a specific site depending on its processes.

The blood management software was designed with guidance from Wyndgate's Technology Work Group ("TWG"), comprised of leading industry representatives from around the world. Throughout the ElDorado Donor development process, the TWG contributions assisted the Company in delivering a feature-rich and user-friendly solution.

Thomas F. Marcinek, President and Chief Operating Officer, commented, "We are delighted that ElDorado Donor has received FDA clearance for marketing. The Company has made a serious commitment to our customers by continuing to invest in innovations which help them meet their business and regulatory needs." Mr. Marcinek further commented, "Global Med is dedicated to providing solutions and services that help support and protect the public's health. We value the trust that our customers place in us, and their continued efforts to improve the safety of the blood supply. We believe that the introduction of ElDorado Donor brings us closer to our goal of becoming the world leader in blood management software and services."

About Global Med Technologies, Inc.

Global Med Technologies(R), Inc. is an international e-Health medical information technology company providing information management software products and services to the healthcare industry. Its Wyndgate Technologies(R) division is a leading supplier of information management systems to U.S. and international blood centers and hospital transfusion centers. Each year, Wyndgate's products and services manage more than eight million blood components, representing over 27% of the U.S. blood supply. Wyndgate's products are also being used in Canada and sub-Saharan Africa, and are being implemented in the Caribbean. Together, the Donor Doc(TM) interactive donor health history questionnaire, SafeTrace(R) donor management system, and the SafeTrace Tx(R) advanced transfusion management system, recently patented, provide Vein-to-Vein(R) tracking from donor collection to patient transfusion. Global Med's PeopleMed(R), Inc. subsidiary provides custom software validation, consulting and compliance solutions to hospitals and blood centers. PeopleMed's in-depth knowledge of Wyndgate's products and the blood banking industry results in cost-effective validation services, which leads to more efficient software implementations and upgrades for our customers.

This news release may include statements that constitute forward-looking statements, usually containing the words "believe," "estimate," "project," "expects" or similar expressions. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this news release.

Global Med Technologies, Inc.
http://www.globalmedtech.com