SAN DIEGO, Jan. 15 /PRNewswire/ -- BeneChill, Inc., today announced it has received CE Marking for the commercial sale of the RhinoChill System in European Union member countries. The RhinoChill System is a battery-operated, non-invasive, portable, and easy-to-use medical device for rapid therapeutic patient cooling.
"This is an important step for BeneChill," said Denise Barbut, MD, who is founder and CEO of BeneChill. "We've spent the past three years developing RhinoChill. Clinical trials in Europe and elsewhere have demonstrated that RhinoChill decreases temperature in patients requiring cooling therapy. We are very pleased with this market clearance, which will provide medical personnel within the European Union with a user-friendly tool to cool patients rapidly and non-invasively."
The RhinoChill System uses a nasal catheter to deliver a proprietary inert coolant to the nasal cavity to reduce patient temperature. Therapeutic hypothermia (reducing patient temperature to approximately 33 degrees C or 91 degrees F) has been shown to improve survival and neurologic outcome after cardiac arrest. The American Heart Association and the International Liaison Committee on Resuscitation recommend the use of therapeutic hypothermia in comatose survivors of cardiac arrest. Other possible uses of therapeutic hypothermia include stroke and traumatic brain injury.
The RhinoChill System is designed to overcome limitations of other temperature reduction technologies by enabling early and rapid initiation of patient cooling. The battery-operated RhinoChill System does not require a refrigeration unit -- a drawback associated with all existing hypothermia devices.
"RhinoChill is a unique approach to patient cooling," stated BeneChill COO Allan Rozenberg, PhD, at today's announcement. "RhinoChill uses the nasal cavity, which is the body's natural heat exchanger and is in close proximity to the brain."
Dr. Rozenberg also noted that using the nasal cavity enables treatment by non-specialized medical personnel using non-sterile technique in any surrounding, including ambulances, military rescue operations and emergency rooms, as well as general hospital environments.
BeneChill is a venture capital funded medical device company based in San Diego, CA. The company is developing products in the therapeutic hypothermia arena with a focus on rapid and non-invasive cooling in the field. The technology has been used in Europe in cardiac arrest patients. For more information about BeneChill, please visit http://www.BeneChill.com.
The RhinoChill System is an investigational device in the United States. The device is limited by United States law to investigational use only.
|SOURCE BeneChill, Inc.|
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