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FDA Clears MD Scientific, LLC's Tight Glucose Control Software


6/20/2006 12:54:43 PM

CHARLOTTE, N.C., June 20 /PRNewswire/ -- MD Scientific, LLC (MD Scientific), announces Food and Drug Administration clearance to market EndoTool(TM) Glucose Management System. EndoTool(TM) is an intravenous insulin dose calculator, designed for critical care applications where tight blood glucose control is desirable.

According to the Centers for Disease Control and Prevention in Atlanta, each year over 2 million patients acquire infections in U.S. hospitals, resulting in 90,000 deaths and costing an estimated $50 billion in medical charges. High blood glucose levels compromise the immune system and leave patients vulnerable to infections. Controlling blood glucose for patients in critical care has been shown to reduce infections and death.

"Since 2003, the MD Scientific team has been focused on giving physicians and nursing staff the tools needed to control blood glucose," states Shade Mecum, President of Charlotte, NC-based MD Scientific. "This FDA clearance is a testimony to the hard work and steadfast vision of our team."

The role of uncontrolled blood glucose in infection rates is well documented and a nation-wide effort by the Center for Medicare and Medicaid Services (CMS) and the Center for Disease Control and Prevention (CDC) has targeted controlling glucose as one improvement to prevent complications caused by surgical infections and cardiovascular surgeries. The risks of infection secondary to uncontrolled blood glucose are high for patients with diabetes and higher for patients without diabetes.

The EndoTool(TM) Glucose Management System is a solution to the problem of how to effectively and safely control blood glucose for critically ill patients after surgery. EndoTool(TM) has been operating in thirteen intensive care units and operating rooms with over 100,000 insulin dose calculations annually. The software leads to prompt control of the glucose level and has a hypoglycemia incidence of less than 0.1% of total calculated doses administered.

The software is HIPPA compliant, provides printed and digital records, is user friendly, reduces physician work load, requires no calculations by nurses, allows for local control of many parameters, can provide medical director directed transition to subcutaneous insulin orders, and is associated with an incidence of hypoglycemia well below all published reports of tight glycemic control protocols.

The software runs on any PC or server with Windows 2000 or higher operating system and is provided under license from MD Scientific. On-site installation, in-service, and 24/7 technical support is included in the license fee.

"Blood glucose management has been outstanding with this software, infection incidence has dropped dramatically, and this computer system approach has been well received by the staff and is easy to use," says Joseph Cook, MD, Chief of Thoracic and Cardiovascular Surgery, Carolinas Medical Center, Charlotte, NC.

About MD SCIENTIFIC

Founded in September 2003, MD Scientific has two distinct market offerings - development and commercialization of a drug for the prevention of acute renal failure and implementation of a software application to calculate insulin dosage for critically ill patients with elevated blood glucose. For more information about the company, EndoTool and other offerings, please visit www.mdscientific.com.

MD Scientific, LLC

CONTACT: Winn Maddrey for MD Scientific, LLC, +1-704-344-9191, orcellular, +1-704-905-2912, or wmaddrey@blueninepartners.com



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