Contact Information: CONTACT: Medcool, Inc. Jeffrey M. Arnold 781-237-6210
Medcool Inc. Receives FDA Clearance for Its RapidCool (TM) System
Medical Device Provides Rapid Non-Invasive Hypothermia Therapy
| Source: MedCool
WELLESLEY, MA--(Marketwire - July 30, 2007) - Medcool Inc. of Wellesley, MA, an emerging
provider of non-invasive systems for therapeutic hypothermia and
temperature management, announced today that its RapidCool™ System has
received 510(K) clearance by the FDA to be marketed in U.S. for temperature
reduction therapy.
The RapidCool System is indicated for use for "temperature reduction in
patients where clinically indicated, e.g. in hyperthermic patients, and for
monitoring of patient temperature."
The RapidCool System uses an innovative and patented disposable helmet that
directs agitated cold water to the scalp, plus more standard body and neck
pads, to rapidly cool the head and body of patients for whom cooling is
indicated. The system rapidly reduces head and body temperature to a set
point in the range of 32-37 degrees C, is non-invasive and does not
interfere with cardiac catheterization and other hospital procedures.
A growing body of research indicates that mild hypothermia, in the range of
32-34 degrees C, could potentially have a protective effect, reducing
damage from cardiac arrest, stroke, brain injury, and other traumatic
events. Rapid cooling is believed to be important in reducing injury to
the brain following these events. The recent cover article in Newsweek
describes the evolving use of hypothermia following cardiac arrest
(http://www.msnbc.msn.com/id/19751440/site/newsweek/).
"We are very pleased to be cleared for marketing in the U.S.," said Joe
Caruso, Medcool CEO, "and are actively looking for strategic and
distribution partners for this unique technology."
The Company's helmet design makes use of the fact that the body responds to
decreasing temperature by increasing blood flow to the scalp while reducing
blood flow to the periphery. As a result, the RapidCool System is capable
of high rates of cooling compared to standard non-invasive cooling systems
-- and directs most of its cooling to the head where it is most needed.
About Medcool
Medcool, Inc. is a medical products company based in Wellesley,
Massachusetts, that develops and manufactures non-invasive, proprietary
therapeutic temperature reduction solutions for emergency medicine and
intensive care applications including potentially following brain injury,
cardiac arrest or stroke.
Copyright© 2007. Medcool, Inc. All rights reserved.