VisCardia Announces First Implant of the VisONE System for Treating Heart Failure

VisCardia Inc., a privately held medical device developer, announced
today the first implant of the VisONE® implantable system for heart
failure, and the commencement of its VisONE Heart Failure pilot study in

The VisONE implantable system delivers VisCardia’s proprietary
Asymptomatic Diaphragmatic Stimulation (ADS) therapy to improve cardiac
function. By electrically stimulating the diaphragm in an asymptomatic
manner, transient intrathoracic pressures gaited to cardiac activity are
applied against the cardiac walls, improving both cardiac filling and
output. “Our preclinical and early feasibility studies demonstrated ADS
improves acute hemodynamic parameters and chronic left ventricular
ejection fraction, while remaining asymptomatic and with no adverse
effects. With our newly developed implantable VisONE system, we intend
to demonstrate ADS benefits the majority of moderate heart failure
patients with reduced ejection fraction,” said Peter Bauer, VisCardia’s
President and CEO.

“During this 12-month pilot study, we are optimistic VisONE will deliver
comparable benefits as those observed during our ADS feasibility
studies,” said Paul Erne, M.D., Professor Emeritus of Cardiology at the
University Hospital of Basel and former Head of Cardiology at the
Kantonsspital of Lucerne, Switzerland.

The implant took place at the Heart Institute, Kyiv, Ukraine, under the
leadership of Institute Director Professor Borys Todurov, M.D., Ph.D.,
and Principal Investigator Dr. Vitaliy Demyanchuk, M.D., Ph.D. The
patient, a 53-year-old male with a reduced ejection fraction of 17%,
remained in symptomatic heart failure despite an optimally titrated
medical regimen, and had no alternative treatment options. General
Surgeon Dr. Oleksandr Plehutsa, M.D., Ph.D., who performed the
laparoscopic implant, stated, “The practicality and expediency of this
novel and minimally invasive approach reduces critical anesthesia times
for this delicate heart failure population, enabling a quicker recovery
versus established medical device therapies.” Furthermore, Dr. Todurov
added, “We are excited at the potential of this therapy to address a
significant gap in clinical care. Our center will be actively and
methodically studying its impact on heart failure.”

Echocardiographic data will be analyzed at the University Hospital of
Zurich under the direction of Professor Felix Tanner, M.D., with
statistical analysis performed at the Robertson Centre for Biostatistics
in Glasgow under the guidance of Professor John Cleland, M.D. Michael
Mirro, M.D., VisCardia’s Director of Medical Affairs, commented, “Given
the promising evidence to date, it is exciting to see two recognized
groups engaged in studying this new therapy with the proper clinical
rigor of a multicenter study used by prominent heart centers.”

About VisONE® ADS Therapy

ADS therapy utilizes a medical device with electrodes, implanted using a
minimally invasive laparoscopic surgical procedure, to deliver
electrical pulses to precise areas of the diaphragm. The therapy is
non-invasively adjusted and programmed using an external programmer to
improve hemodynamic benefit and eliminate undesired stimulatory side

About VisCardia

VisCardia, based in Portland, OR, is developing a novel implantable
device therapy for treating heart failure, a condition that afflicts 10
million patients in the U.S. and Europe. To learn more about VisCardia,

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