EMIT Corporation Receives FDA 510(k) Clearance for HypothermX(TM) Blood and Fluid Warmer.
HOUSTON, May 26 2011 /PRNewswire/ — EMIT Corporation announced today that it has received U.S. Food and Drug Administration 510(k) clearance to market the HypothermX(TM) HX100 device. The HypothermX(TM) HX100 device is a patent protected portable fluid warming device designed to warm intravenous fluids, blood or blood products infused into a patient to prevent or treat trauma, environmental, procedure related, or induced hypothermia. Heating is accomplished via a flameless hydrocarbon combustion process.
“HypothermX((TM)) HX100 is the first truly light weight (< 3.0 lbs), portable, long-term (>4 hours continuous use) solution to offer actual therapeutic warming in the field for injured patients. HypothermX((TM)) HX100 is capable of warming up to 5 liters of saline introduced at 15 degrees C and 15 units of packed red blood cells introduced at 5 degrees C to 38 degrees C +/- 3 degrees C with an infusion rate between 50 ml/min and 200 ml/min and ambient conditions between 0 degrees C and 40 degrees C. The system has numerous safety features and provides the user with the ability to temporarily silence alarms based on operational needs,” stated Mr. Sheldon, EMIT Corporation Founder, Chairman & CEO.
“Our market clearance represents a significant milestone for the company and we will begin an aggressive sales and marketing campaign in the military and civilian market sectors this quarter,” said Mr. Sheldon Mr. Sheldon went on to say that “hypothermia continues to plague the military and civilian first responder markets and our device will result in life saving interventions at the point of injury.”
About EMIT Corporation
EMIT Corporation is focused on the design, development, manufacture, and sale of devices and related products for the treatment and prevention of hypothermia. The HypothermX(TM) HX100 and ancillary products were invented by Charles Cox, Jr., MD and Brijesh Gill, MD and exclusively licensed from The University of Texas Health Science Center at Houston and The University of Texas at Austin following nearly $4.0 million of research and development funding provided by the United States Army Telemedicine and Advanced Technology Research Center. EMIT Corporation raised an additional $2.4 million from CitareTx Investment Partners, a Texas based medical device investment fund and business incubator, also founded and managed by Mr. Sheldon.
Contact: Jeffery J. Sheldon – Founder, Chairman & CEO, EMIT Corporation, +1-281-984-7355, , or fax, +1-281-984-7374, or mobile, +1-832-455-3173, email@example.com
SOURCE EMIT Corporation