ROME,
Aug. 28, 2016 /PRNewswire/ --
BackBeat Medical Inc. today announced the presentation of data
demonstrating a significant and sustained reduction in blood
pressure in patients with hypertension using the company's patented
cardiac pacing-based treatment. The focus of an oral late-breaking
clinical trial presentation by study investigator Petr Neuzil, M.D., Ph.D., at the European
Society of Cardiology's annual scientific meeting, ESC Congress, in
Rome, the data consisted of
detailed results from a multicenter clinical trial of
BackBeat's Programmable Hypertension Control (PHC)
therapy.
In the study that enrolled 35 hypertensive patients
indicated for implantation of a permanent dual-chamber pacemaker at
10 sites worldwide, participants received a pacemaker developed by
BackBeat, called the Moderato™, that incorporates the
company's proprietary PHC algorithm. During the first month of
treatment, only the standard pacing functions were activated to
allow estimation of the expected effect of participation in a study
on blood pressure. After the first month, 27 patients met the
strict study inclusion criteria at the end of the run-in period.
However, PHC therapy was successfully activated in all patients
with therapeutic benefit. In this study group that met all of
the study inclusion criteria, 24-hour ambulatory systolic
pressure significantly decreased by 11 mmHg immediately after PHC
activation and was maintained low during the study period. After
three months, ambulatory pressure had decreased by 10 mmHg from
pre-activation (p=0.004; 14 mmHg from baseline, p<0.001). Office
cuff pressure data were also collected on these patients and showed
an average reduction of 16mmHg from pre-activation levels
(p<0.001, 24 mmHg from baseline) after three months of therapy.
This effect was maintained in patients who have so far reached
later follow-up time points, with a significant reduction of 20
mmHg (p<0.001) from the pre-activation pressure after 12 months
of therapy and 21 mmHg (p=0.02) after 24 months.
"By reducing ventricle filling and modulating the
baroreflex response in hypertensive patients with a unique
algorithm in a standard pacemaker, we were able to quickly reduce
systolic blood pressure and sustain the response throughout the
three-month study period," said Dr. Neuzil, one of the study's
investigators and the head of the department of cardiology at Na
Homolce Hospital in Prague, Czech
Republic. "Additionally, these results have been maintained
in patients beyond two years following the activation of the
therapy. This is a highly differentiated approach to treating
hypertension that provides a significant reduction in blood
pressure with relatively no additional risk because the pacemaker
implants are already required for these patients. BackBeat's PHC
therapy has the potential to offer significant clinical benefits
and help address the known side effects and compliance challenges
associated with hypertension medications."
BackBeat's PHC algorithm reduces ventricular filing to
lower blood pressure while modulating the response of the
baroreflex to prevent activation of the autonomic nervous system.
This technology can be readily incorporated into marketed
pacemakers using standard leads and standard lead placement. It
also could be added to already implanted pacemakers as a software
download performed in the clinic. Hypertension affects over 70% of
pacemaker patients and is uncontrolled in approximately 38% of the
total pacemaker population. These patients could benefit
substantially from a potent hypertension therapy such as PHC that
could be included in their already necessary pacemaker.
Yuval Mika, Ph.D., CEO and
co-founder of BackBeat Medical, said, "PHC therapy potentially
represents an entirely new field of hypertension treatment that
will leverage the use of pacemakers for a significant new market
just as biventricular pacing has been used to treat heart failure.
Incorporating BackBeat's PHC pacing algorithm into standard
pacemakers would provide significant differentiation to increase
the commercial value of a combination pacemaker. Furthermore, it
could drive market share gains in the large population of the
patients who could benefit substantially from a hypertension
therapy that could be included in their pacemaker. With the data
from our study, we believe that this device-based treatment of
hypertension is now a reality, and we are actively pursuing plans
to make this therapy broadly available first for patients already
requiring pacemakers and, in the future, for other hypertensive
patients struggling to keep blood pressure under control despite
medication."
BackBeat is currently working to obtain regulatory
approval in Europe for PHC therapy
using data generated to date with BackBeat's Moderato™
device. In addition, the first patients have been enrolled in
another European BackBeat-sponsored 170-patient, randomized,
double-blind study designed to further investigate the benefit of
PHC therapy in hypertensive pacemaker patients. This study, which
will involve up to 30 clinical sites, will be used to drive
adoption and gain reimbursement in Europe as well as support future regulatory
approval of PHC therapy in the U.S. and other countries.
About Hypertension
Hypertension (HTN), or high blood pressure, affects an
estimated 75 million American adults (1 in 3) according to the CDC
and over 1 billion adults globally according to the WHO. HTN is one
of the most important factors contributing to cardiovascular
morbidity and mortality, accounting for over 9.4 million global
deaths annually. Unacceptably high blood pressure is defined as
systolic pressure >140 mmHg in the absence of other
cardiovascular risk factors, or >130 mmHg in the presence of
other risk factors. Cardiovascular risk doubles for every 10 mmHg
increase in systolic blood pressure, and mortality rate is doubled
with an increase of 20 mmHg in systolic blood pressure.
Hypertension increases dramatically with age from 7.3% for ages
18-39 to 65% for ages 60+. The estimated direct and indirect
yearly cost of hypertension in the U.S. is $46.6 billion. Medications are frequently
effective in controlling blood pressure but require daily strict
compliance by patients and can cause side effects that make them
difficult for patients to tolerate. Only 54% of U.S. HTN patients
have their high blood pressure under control (CDC). Further, data
from the NIH's landmark Systolic Blood Pressure Intervention Trial
(SPRINT) published in 2015 show that more aggressive treatment to
achieve a target systolic pressure of 120 millimeters of
mercury (mm Hg), reduced rates of cardiovascular events, such as
heart attack and heart failure, as well as stroke, by almost a
third and the risk of death by almost a quarter, as compared to the
target systolic pressure of 140 mm Hg.
About Pacemakers
Pacemakers are permanent implants that directly stimulate,
or "pace," the heart. Indications for
permanent pacing include the following: symptomatic sick
sinus syndrome, including symptomatic sinus bradycardia,
tachycardia-bradycardia syndrome, atrial fibrillation with sinus
node dysfunction, chronotropic incompetence (inability to increase
the heart rate to match a level of exercise) and various degrees of
conductance block between the atrium and the ventricle. The annual
value of the global pacemaker market is approximately $4.2B with more than 1 million pacemaker
procedures performed worldwide every year. While pacemaker prices
have generally been in decline with the exception of new
MRI-compatible devices, the introduction of new features, like
MRI-compatible pacemakers, resulted in significant increases in
device selling price. Furthermore, the introduction of new
therapeutic capabilities in pacemakers, like biventricular pacing
for the treatment of heart failure, resulted in a significant
increase in device price. The addition of features and additional
therapeutic capabilities can also affect market share by providing
competitive advantages and product differentiation to first movers.
It is estimated that more than 70% of the patients that are
indicated for the implant of a pacemaker have hypertension. The
main reason may be attributed to the average age of the pacemaker
patient population being 73 years old and the dramatic increase in
the prevalence of hypertension in people over 60 years old.
Hypertension is uncontrolled in approximately 55% of these people
(approximately 38% of the total pacemaker population). These
patients could benefit substantially from a hypertension therapy
like PHC that could be included in their already necessary
pacemaker.
About BackBeat Medical
BackBeat Medical Inc. is a medical technology company
founded in 2010 to develop novel cardiac stimulation-based
therapies for hypertension and heart failure. BackBeat has
developed a patented cardiac pacing-based treatment for
hypertension (HTN) called programmable hypertension control (PHC)
therapy. PHC is comprised of proprietary pacing algorithms that can
be readily incorporated into standard pacemakers using standard
leads and standard lead placement and thus has broad applicability.
PHC offers a new potent device-based HTN therapeutic alternative
potentially opening up a large market to treat HTN patients,
particularly HTN patients who already have or require a pacemaker.
Clinical results generated to date using BackBeat's own Moderato™
pacemaker incorporating PHC algorithms demonstrate that this
therapy has a substantial and sustained therapeutic effect on blood
pressure as determined by both in-office cuff measurements (average
reduction of 24 mmHg from baseline) and 24-hour ambulatory
measurements (average reduction of 14 mmHg from baseline) with
clinical follow up extending up to two years.
Media
Contacts:
David Schull or
Todd Davenport,
Ph.D.
Russo Partners, LLC
(212)
845-4271
(212)
845-4235
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
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SOURCE BackBeat Medical Inc.