SAN DIEGO, Feb. 3 /PRNewswire/ -- BeneChill, Inc. (www.benechill.com) today announced the start of the PRINCE (Pre-Resuscitation Intra-Nasal Cooling Effectiveness) study. This randomized study will determine whether intra-nasal cooling using BeneChill's RhinoChill device during resuscitation increases patient resuscitation and survival rates.
The PRINCE study is being conducted as a post-market approval study in Europe. The company received CE marking for the RhinoChill system in 2007.
The non-invasive, portable, and easy-to-use RhinoChill Device is used without external power for rapid therapeutic patient cooling. This system uses a nasal catheter to deliver a proprietary inert coolant to the nasal cavity to reduce temperature in clinically indicated conditions. Current uses of cooling technologies include ischemic events such as cardiac arrest, stroke, and traumatic brain injury. Unlike other cooling devices, the RhinoChill device is easily utilized in emergency field settings.
As part of the upcoming study, patients will receive either advanced cardiac life support measures (ACLS) alone or ACLS supplemented by intra-nasal cooling. The study will be conducted in Belgium, Germany, Italy and Sweden over the next 6-9 months.
"Out-of-hospital cardiac arrest is a significant cause of death," said BeneChill founder/CEO Denise Barbut, MD MRCP. "Mild hypothermia induced after resuscitation from cardiac arrest has been shown to improve survival in humans. Given that our team previously demonstrated the cooling efficacy of our technology in clinical trials around the globe, the PRINCE study is the next logical step."
BeneChill COO Allan Rozenberg, PhD, noted at today's announcement: "Earlier initiation of cooling in animals has a great impact on their survival. In randomized pig studies, for example, we've seen dramatically higher survival rates when intra-nasal cooling has been initiated during resuscitation."
"The RhinoChill Device uses the nasal cavity for cooling," Dr. Rozenberg stressed, noting "This is advantageous since the nasal cavity allows easy access into the body, is in close proximity to the brain, and is a natural heat exchanger."
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, non-invasive cooling for use in the field. The RhinoChill System is an investigational device in the United States, and is limited by US law to investigational use only.
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