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RESPeRATE - FDA Clears
Breakthrough Therapeutic Breathing Device To Lower Blood Pressure
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Millions of Americans with high
blood pressure can now benefit from over-the-counter availability of innovative
medical device from InterCure
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PRINCETON, NJ — July 17, 2002 –
Millions of Americans with high blood pressure can now benefit from the first
non-drug medical device clinically proven to reduce high blood pressure without
side effects. InterCure, Inc. today announced that the device, RESPeRATE™, has
received clearance from the Food and Drug Administration (FDA) for
over-the-counter distribution.
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The interactive, device-guided
breathing technology used in RESPeRATE is based upon the established scientific
evidence that certain breathing exercises, when performed routinely, can lower
blood pressure. These therapeutic breathing exercises are difficult to perform
properly without the interactive, personalized coaching that RESPeRATE provides.
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RESPeRATE has been clinically
validated to significantly lower blood pressure by an average of 14 mmHg
systolic and 9 mmHg diastolic after 8 weeks of routine use (15 minutes per day,
3-4 times per week). Average reductions are even greater for older patients and
patients with higher baseline blood pressure. These reductions are in addition
to reductions achieved with other therapies.
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“RESPeRATE offers an important new
option, in fact, a whole new therapeutic class for the adjunctive treatment of
high blood pressure,” said Dr. Henry Black, chairman of the Department of
Preventive Medicine at Rush-Presbyterian St. Luke’s Medical Center in Chicago
and member of InterCure’s Scientific Advisory Board. “Physicians and patients
have long been searching for an additional effective non-drug therapy, and
RESPeRATE is a real breakthrough. It will have a major impact on how high blood
pressure is treated."
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RESPeRATE, about the size of a
paperback book, is battery operated and can be used anywhere. Users place an
elastic belt with a respiration sensor around their torso, above the clothing,
and wear standard headphones. RESPeRATE automatically analyzes the user’s
breathing rate and pattern and then interactively guides the user through a
therapeutic breathing exercise that effortlessly slows the breathing from a
normal rate of 14 to 18 breaths per minute to the “therapeutic zone” of less
than 10 breaths per minute with prolonged exhalation. While breathing returns to
normal after each session, the beneficial effects on the blood pressure
accumulate and a significant and sustained reduction in blood pressure can be
achieved with regular use.
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“We are thrilled to be announcing
FDA clearance to sell RESPeRATE over the counter. Now the tens of millions of
people suffering from high blood pressure have easy access to this remarkable
therapy,” said Paul Sheils, president and CEO of InterCure. “Patients finally
have a nondrug, no-side-effects treatment option to lower their blood pressure
that’s easy and pleasant to use and can be incorporated safely into their
existing hypertension therapies.”
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About InterCure, Inc.
InterCure is a medical technology company pioneering the application of
interactive device-guided breathing therapies to some of the world’s most
widespread and costly cardiovascular and pulmonary diseases. The Company has
already developed and received regulatory approval for its hypertension product,
RESPeRATE, and is expanding into congestive heart failure (CHF), asthma and
chronic obstructive pulmonary disease (COPD).
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InterCure was founded in 1996 by
Benjamin Gavish, Ph.D. and Erez Gavish. The company has offices in Lod, Israel
and Princeton, NJ. InterCure is guided by a team of experienced executives and a
world-class scientific board, including past presidents of the American,
European and International Societies of Hypertension.
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Resperate listing at FDA site.
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