BioVentrix, pioneer of the Less Invasive Ventricular Enhancement™
(LIVE™) procedure for the treatment of heart failure, announced today
publication of baseline and 12-month comparative data demonstrating the
durability of its Revivent Myocardial Anchoring System in the first 11
patients treated with the device. Published in the European Journal
of Cardio-Thoracic Surgery (EJCTS)
, these patients sustained a mean
reduction in left ventricular end-systolic volume index (LVESVI), the
key prognostic measure for heart failure, to 43.9 mL/m2, well
below the 60mL/m2 threshold recently defined as providing a
survival benefit in heart failure patients.1,2 The Company
also announced that the number of heart failure centers trained to
perform the LIVE procedure has expanded to 20 leading centers throughout
Western Europe.

“The extent of volume reduction achieved, and more importantly
maintained at one year, using the Revivent System is comparable with,
and in some cases exceeds, the results achieved in multiple clinical
studies using a conventional surgical approach to reducing the volume of
the left ventricle,” said Andrew S. Wechsler, M.D., professor of
Cardiothoracic Surgery at Drexel University College of Medicine in
Philadelphia, Penn., U.S.A. “These results demonstrate that effective
volume reduction, using a less invasive approach, provides meaningful
clinical benefit to a previously untreated, fragile patient population.”

Data from a recent subgroup analysis of the National Institute of Health
(NIH)-sponsored Surgical Treatment for Ischemic Heart Failure (STICH)
studyconcluded that reducing the volume of the left
ventricle (LV) to less than 60mL/m2 provided a statistically
significant improvement in survival for patients suffering from HF2.
Since submission of data from the first 11-patients to EJCTS, an
additional 15 patients have reached the crucial one-year survival mark.
Combined these 26 patients treated with the Revivent System have
maintained a mean LVESVI of 57.4mL/m2 for one year following
the procedure, which represents a mean decrease of 33.5 percent.

The LIVE procedure is based upon a well-defined law of physics called
the law of LaPlace, which describes the relationship between the radius
and pressure of the LV, and the resulting LV wall tension. Increased
wall tension is the underlying cause of LV enlargement, worsening heart
failure symptoms and ultimately patient death. Conversely, reducing wall
tension prevents further LV enlargement and stops the progression of the
disease. The Revivent System is uniquely designed to reduce wall tension
by directly reducing the LV radius, which in turn decreases wall tension
and interrupts the ongoing destructive process of ischemic heart failure.

Phase I clinical trials, which led to CE-mark in November 2012, using
the Revivent System were conducted at four European sites. A second
broader phase now underway has brought system training to 20 additional
sites, including several prominent heart failure centers in Germany and

“We are gratified to see the rapid expansion of the LIVE procedure
across Europe, and the ease with which our clinicians are able to
complete the required training for use of the Revivent System,” said Ken
Miller, president and chief executive officer at BioVentrix, Inc. “We
are equally pleased with the interest from the scientific community in
our technology. Since our European product launch last November, the
Revivent System has been highlighted in four different oral abstract
presentations, all at prominent scientific meetings.”

About the Revivent System: A Less-Invasive Treatment for Heart
Failure Patients

The Revivent™ Myocardial Anchoring System addresses the safety concerns
of physicians about subjecting patients to invasive surgical
interventions on the heart’s left ventricle. The Revivent system, placed
using the LIVE™ procedure can be performed as a separate stand-alone
procedure, concurrent with other procedures (e.g., CABG or transcatheter
mitral valve procedures) or during other occasions when a sternotomy is
already employed. Neither a myocardial incision nor cardiopulmonary
bypass is required. Additionally, the Revivent system is deployed using
a straightforward, epicardial approach that can be completed in about
one hour.

About LIVE™: The World’s Only Reshaping, Restorative Left Ventricle

Less Invasive Ventricular Enhancement™ (LIVE™) therapy is an innovative
off-pump (i.e., beating heart) procedure that helps restore the left
ventricle’s intrinsic functional efficiency, rather than relying on a
surrogate pumping device or other invasive treatment. The only therapy
currently designed to restore optimal left ventricle size and function,
LIVE provides physician teams with a gentler surgical option that
enables them to more confidently treat heart failure patients who may
not tolerate left ventricle incisions. LIVE bridges a need in available
heart failure treatments, offering the potential for more consistent and
favorable surgical outcomes, while giving heart failure patients and
their families renewed hope for a more productive life.

About BioVentrix

BioVentrix, a privately held medical technology company headquartered in
San Ramon, Calif., is focused on developing and commercializing
minimally invasive as well as nonsurgical therapies for treating heart
failure (HF). The Revivent System received CE-mark in November 2012.

NOTE: The Revivent™ Myocardial Anchoring System requires regulatory
approval and is not yet commercially available in the United States.

1Wechsler, A., et al. Durability of epicardial
ventricular restoration without ventriculotomy. European Journal of
Cardio-Thoracic Surgery
(2013) 1–4. doi:10.1093/ejcts/ezt292

2Michler R et al. Insights from the STICH trial:
Change in left ventricular size after coronary artery bypass grafting
with and without surgical ventricular reconstruction. J of Thoracic
and Cardiovascular Surgery.
29 October 2012