SADDLE BROOK, N.J.–(BUSINESS
WIRE)–CircuLite®, Inc. today announced that it has received a grant from
the Cardiovascular Medical Research and Education Fund, Inc. (CMREF) to fund
the development of a right-heart circulatory support system based upon
CircuLites Synergy® Micro-pump for the treatment of right heart failure due to
pulmonary arterial hypertension (PAH) and other causes. The Synergy system
includes a micro-blood pump the size of a AA battery that can be implanted
superficially in a “pacemaker-like” pocket. Synergy is the first and smallest
surgically implanted device designed for partial circulatory support (up to
4.25L/min) in patients with heart failure. CircuLite is currently conducting a
clinical trial with Synergy in patients with Class IIIB/early Class IV heart
failure at multiple centers in Europe, aimed
at achieving CE Mark.

CMREF has awarded CircuLite approximately $950,000 to
support ongoing work to modify the design of its existing Synergy system so
that it can be used to provide circulatory support for a failing right heart,
and to conduct two in vivo research studies required to support the systems
eventual clinical use. CircuLite is also exploring whether Synergy can be used
under Humanitarian Use Designation in the US to provide right-heart support
in high-risk PAH patients.

“Synergy was originally designed to supplement the native
pumping capacity of the left side of the heart, but the uniquely small pump and
4.25L/min of flow may make the system ideally suited for right-side support,”
said Paul Southworth, President and Chief Executive Officer of CircuLite. “The
ongoing CE Mark study has shown that providing supplemental flow with Synergy
unloads the left ventricle and improves hemodynamics, which can translate into
important improvements in functional status and quality of life. We believe
that modifying Synergy for right-heart support could be similarly beneficial
and we look forward to further progressing our development of a right-heart
system to address the needs of patients with PAH.”

“The issue with trying to use traditional left ventricular
assist devices for right-heart support is that these significantly larger pumps
generate flow rates that may be too high for patients with PAH,” said Daniel
Burkhoff, M.D., Ph.D., Chief Medical Officer of CircuLite. “Furthermore, the
invasive implantation procedure for traditional LVADs is less than ideal for
these very sick patients. Our belief is that only minimal modifications would
need to be made to the current Synergy system to optimize it for use as a
right-heart support system, and the already less-invasive implantation
techniques can be adapted in order to provide a new treatment option for
patients who currently have nowhere else to turn.”

About Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension is abnormally high blood pressure in the
arteries of the lungs and it is a rare, progressive and fatal disease for which
there remains a significant unmet medical need. In cases where the cause is
unknown (idiopathic), the condition is rare with an estimated incidence of 1-2
cases per million or approximately 600 new cases per-year in the United States.
PAH causes the right side of the heart to work harder than normal and enlarge
over time, making it less efficient at pumping blood to the lungs to pick up
oxygen. While there are seven approved medical therapies for PAH in the US, none have
been clinically shown to significantly affect long-term mortality, halt
progression or cause regression of the disease. Patients with advanced-stage
disease are typically treated with intravenous prostacyclin or with a
percutaneous interventional cardiovascular procedure called atrial septostomy.
The only other possible treatment for patients who do not respond to standard
medical care is bilateral lung transplantation.

About Synergy®

The Synergy® Micro-pump represents a new approach to mechanical circulatory
support that is designed to transform chronic heart failure management by
providing a less-invasive, elective treatment option for patients before their
disease state becomes emergent. Synergy is the first implantable system
designed to provide partial circulatory support for long-term use in millions
of unserved patients that have NYHA Class IIIb/early Class IV heart failure.

CircuLites patented micro-pump provides up to 4.25L/min of
flow, which increases total cardiac output, offloads the heart, allowing it to
rest, and potentially enables beneficial recovery of heart function. The size
of a AA battery, the device is small enough to be implanted subcutaneously in a
“pacemaker-like” pocket through a minimally invasive procedure.

About CircuLite®

CircuLite is transforming heart failure treatment with the development of
minimally-invasive devices for long-term partial circulatory support. By
enabling a proactive and lower-risk treatment approach by supplementing a
patients native pumping capacity, CircuLite has the potential to improve the
quality of life for millions of chronic heart failure patients and their
families. CircuLites pipeline is lead by the Synergy® Micro-pump, the worlds
smallest implantable blood pump, currently in a CE Mark clinical trial.
Next-generation Synergy micro-pumps include an endovascular system, a
fully-implantable system and a pediatric system. For more information on
CircuLite and the Synergy Micro-pump devices, visit our website at www.CircuLite.net.

CAUTION: Investigational Device. Limited by Federal Law to
Investigational Use Only.

Posted by Sean Fenske, Editor-in-Chief, MDT