New Intra-Arrest Cooling Method May Save More Brains During Cardiac Arrest

-Study Unveiled at AHA Late Breaking 'Best of Best' Presentation Shows
Survival Benefit-

ORLANDO, Fla., Nov. 15 /PRNewswire/ -- The first randomized intra-arrest
cooling study performed using a novel intra-nasal cooling method showed much
faster and earlier cooling in treated patients and significantly higher
neurologically intact survival - to - discharge rate in many patients. The
Pre-Resuscitation Intra-Nasal Cooling Effectiveness (PRINCE) study involved
200 patients and was conducted by 15 Emergency Medical Systems (EMS) in
Belgium, Germany, Italy, Czech Republic and Sweden. The aim was to determine
safety and efficacy of intra-nasal cooling during ongoing resuscitation of
cardiac arrest patients even before the return of circulation (ROSC).

The study was conducted using RhinoChill(TM), a non-invasive nasal catheter
that sprays a rapidly evaporating coolant liquid into the nasal cavity. This
large cavity is a heat exchanger and lies right under the brain.

The trial was designed to determine the safety and effectiveness of early
cooling initiated at the site of the arrest. The RhinoChill(TM) technology
enabled cooling to start much earlier than is possible with conventional
methods used in a hospital setting and focuses on the brain. "The brain is
the organ that dies first so the closer to the time of arrest the brain is
cooled, the more of it is rescued," said Denise Barbut, M.D, founder and CEO
of BeneChill, the company that makes RhinoChill. "The brain is the organ that
controls the heart, much like a puppet on a string," she added.

Additional endpoints included cooling rates, time to achieve target
temperature, ease of use in the field, ROSC rates, survival and neurologically
intact survival. EMS personnel recruited adults over 18 years old who were in
cardiac arrest and not hospitalized during resuscitation. All patients who
were deemed eligible for advance cardiac life support (ACLS) were included as
long as the arrest was witnessed and cardiopulmonary resuscitation (CPR) was
initiated within 20 minutes of collapse.

The results of the study included:
-- Cooling was initiated 23 minutes following arrest and lowered brain
temperature (tympanic) (34.2 degrees C vs. 35.5 degrees C) and body
(core) temperature (35.1 degrees C vs. 35.8 degrees C) significantly
by
ER arrival.
-- Time to target tympanic temperature of 34 degrees was three hours
faster
and time to target core temperature was two hours faster in patients
cooled intra-nasally in the field compared to those receiving hospital
cooling alone.
-- Survival to discharge was higher in treated patients admitted to
hospital (46.7% vs 31%) and significantly higher in those in whom CPR
was initiated within 10 minutes of collapse, irrespective of rhythm
(59.1% vs 29.4%).
-- Neurologically intact survival to discharge was higher in treated
patients admitted to the hospital (36.7% vs 21.4%) and significantly
higher in those in whom CPR was initiated within 10 minutes of
collapse,
irrespective of rhythm (45.5% vs 17.6%).

-- Intra-nasal cooling with RhinoChill was feasible and safe during an
arrest. Nasal discoloration was the most commonly reported adverse
event occurring in 13 patients. This resolved spontaneously in all
patients who were successfully resuscitated.

Maaret Castren, M.D, Ph.D of the Department of Clinical Science and Education,
Karolinska Institute, Stockholm, Sweden and the Department of Emergency
Medicine, Sodersjukhuset and PRINCE lead investigator noted, "In this study,
early cooling of the brain combined with early CPR favorably affected
outcomes, irrespective of rhythm. We believe that this study demonstrates
that making every attempt to initiate both CPR and intra-arrest cooling as
early as possible in the resuscitation process should be adopted."

The EMS teams also noted that the portability of the device and ease of use
meant that cooling could be administered in the field by non-specialized
medical personnel. This also is useful in the hospital setting where the
patient can be transported around with on-going cooling.

Dr. Castren presented the findings in Orlando, FL on Sunday, November 15
during the American Heart Association's Resuscitation Science Symposium "Best
of the Best" presentations.

The sponsor of the study is BeneChill, a privately held medical device company
which develops novel, rapid cooling systems to improve survival and brain
function after cardiac arrest and other forms of brain ischemia. Its lead
product, RhinoChill, which was used in the PRINCE study, can be administered
quickly and close to the brain using a nasal catheter that delivers a rapidly
evaporating coolant. RhinoChill will be marketed in Europe in early 2010 and
currently is not available in the US.

SOURCE BeneChill

Lynn Rubenson, +1-858-922-9201 (mobile), lrubensol@sbcglobal.com