Smisson-Cartledge Biomedical, LLC Announces FDA 510(k) Market Clearance of ThermaCor 1200 Thermal Infusion System

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Smisson-Cartledge Biomedical LLC (SCB) announced today U.S. Food and Drug Administration (FDA) market clearance of their ThermaCor 1200 Infusion System, the first full range, portable normothermic infusion system. The ThermaCor 1200 Thermal Infusion System is indicated for use over a full range from slow feed to rapid, high flow infusion of: crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery; warmed fluid to re-warm patients after surgery or for hypothermia; and warmed fluid for irrigation in urology procedures.

Smisson-Cartledge Biomedical LLC (SCB) announced today U.S. Food and Drug Administration (FDA) market clearance of their ThermaCor 1200 Infusion System, the first full range, portable normothermic infusion system. SCB was funded in part by the U.S. Military for the expressed need to bring this state-of-the-art life-saving technology to our critically wounded soldiers and civilians suffering traumatic injuries or requiring extensive surgeries.

The ThermaCor 1200 Infusion System is a revolutionary full range, portable infusion system that is capable of delivering flow rates from 10 mL/Hour up to 1200 mL/Minute. This extensive delivery range can actually eliminate the need for several pumps making the ThermaCor 1200 a truly an All-in-One infusion system. The advanced thermal system incorporates a proprietary, super-efficient WaveformTM Heat Exchanger that enables the rapid warming of fluids to body temperature in an extremely compact, ease-to-use device. SCB has also integrated a proprietary ShurGardTM air trapping and elimination system that enables the system to run virtually continuously.    

"We are convinced that the ThermaCor 1200 Infusion System represents a breakthrough in rapid setup and safe delivery of a high flow of warm fluids (blood) to patients in need through a compact, ease-to-use device," commented David Field, President and CEO of SCB. "Our system, with its proprietary and unique one-latch loading, makes setup dramatically easier and faster than any similar device which is critical in the trauma and OR environments."

Dr. Richard Cartledge, Cardiovascular Surgeon and Co-Founder of the ThermaCor 1200, states that, "This exciting technology platform will enable more clinicians to safely and efficiently deliver normothermic (body temperature) fluids wherever and whenever it is needed."

"While our first device introduction is focused on controlled warming of fluids, our technology platform extends to rapid inline cooling of fluids for other applications such as heart attack and stroke patients," added Dr. Hugh Smisson III, Neurosurgeon and Co-Founder.

SCB is currently ramping up manufacturing and establishing the organizational structure to effectively commercialize the ThermaCor 1200 in 2nd Half of 2007 according to Calder Clay, Vice-President of Sales/Operations for SCB. "We are excited about delivering this new technology to the military and civilian patients that will benefit greatly from the development of this life saving technology."

About Smisson-Cartledge Biomedical, LLC

Smisson-Cartledge Biomedical LLC (SCB) is a medical device company focused on delivering a platform technology for providing temperature-controlled fluid therapies. The global market for efficiently delivering temperature controlled fluids is conservatively estimated as a multi-billion dollar opportunity.

Smisson-Cartledge Biomedical, LLC is located just outside of Atlanta, GA and is privately held. To learn more about the ThermaCor 1200, please go to .

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcome and benefit of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

Contact: Calder Clay, VP of Sales/Operations, 866-944-9992

ThermaCor1200, WaveForm and ShurGard are trademarks of Smisson-Cartledge Biomedical, LLC


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