Mitralign to Provide Update on Transcatheter Tricuspid Repair at TCT 2015

SCOUT study for percutaneous tricuspid repair to begin enrollment
in Q4

TEWKSBURY, Mass.–(BUSINESS WIRE)–Mitralign will present updates on its mitral and tricuspid valve repair
platform at the Transcatheter Cardiovascular Therapeutics (TCT)
conference Oct 11-15 in San Francisco. As a part of conference updates,
the company will also provide details on the SCOUT study utilizing its
TriAlignTM Tricuspid Percutaneous Valve Annuloplasty System
as part of an Early Feasibility Investigational Device Exemption (IDE)
approved by the FDA. The SCOUT study will be a multi-center U.S. study
and will commence patient enrollment in Q4 2015.

“We are excited to begin formal clinical investigation in the United
States with the TriAlign System to reinforce our position as the most
promising percutaneous tricuspid repair solution,” said Rick Geoffrion,
chief executive officer of Mitralign.

Mitralign is the only company to provide a direct percutaneous
annuloplasty system designed to treat both functional mitral
regurgitation (FMR) and tricuspid regurgitation (FTR) with the continued
advancement of its core technology. Both the Mitralign and TriAlign
Systems feature a customizable therapy solution in concert with an
extremely small footprint in the native anatomy. Neither the Mitralign
nor the TriAlign Systems are currently approved for sale or distribution.

“The patient population suffering from tricuspid regurgitation continues
to need an approved transcatheter repair solution and early experience
with the TriAlign System shows encouraging results,”
commented Rebecca Hahn, MD, Director of Interventional Echocardiography,
Columbia University Medical Center / New York Medical Center / New York
Presbyterian Hospital and Principal Investigator for the SCOUT study.
“Percutaneous repair for tricuspid regurgitation is the next horizon in
valve therapy.”

Updates on Mitralign’s percutaneous solutions will be available in their
booth, 2233, and also during a Mitralign sponsored symposium, A
Frontline Platform for Transcatheter Mitral and Tricuspid Repair
, on
October 13 from 1-2 PM in Moscone South, Lower Level, Exhibit Hall
Presentation Theater 3. The faculty includes Rebecca
T. Hahn
, MD, Azeem
Latib
, MD, Scott Lim, MD, Neil
E. Moat
, MD and Joachim Schofer, MD.

Additional data on the Mitralign and TriAlign Systems will be presented
at the ICI conference from December 13-15 in Tel Aviv, Israel, at
the Joint Interventional Meeting (JIM) from February 11-13, 2016 in
Milan, Italy and at the American College of Cardiology (ACC) Scientific
Sessions from April 2-4, 2016 in Chicago.

About Functional Mitral Regurgitation (FMR)
The mitral
valve
 controls blood flow from the left atrium to the left ventricle
of the heart, allowing blood to flow in one direction through the heart
and into the body. Functional Mitral Regurgitation (FMR) is the most
common valve disease and occurs when the left ventricle of the heart is
enlarged, called positive remodeling, and stretches the valve opening.
Subsequent to this remodeling, the valve leaflets are not able to come
together and close properly, allowing blood to flow, or regurgitate,
backwards into the atrium. Consequences can include heart failure or
serious rhythm problems called arrhythmias. An estimated four million
people in Europe and four million people in the United States have
significant mitral valve insufficiency, also known as mitral
regurgitation, with an annual incidence of 250,0001. If left
untreated, mitral regurgitation overloads the heart and can lead to or
accelerate heart failure.

About Tricuspid Regurgitation (TR)
Tricuspid regurgitation
occurs when the tricuspid valve fails to open and close properly,
causing blood to flow backwards into the right atrium. If left
untreated, TR can lead to heart enlargement and heart failure. In the
U.S. alone, there are an estimated 1.6 million patients suffering from TR2.
It is estimated that 50% of patients with mitral regurgitation have
moderate to severe tricuspid regurgitation3. TR is currently
undertreated by surgery. In the U.S. surgeons treat only 5,500 patients
per year, most of them in conjunction with left heart surgeries. When
treating the valves, surgeons choose repair 90% of the time versus
replacement (10%)4.

About Mitralign Inc.
Mitralign Inc. is the valve repair
company with the only direct transcatheter annuloplasty system designed
to treat both functional mitral regurgitation and tricuspid
regurgitation. The company is a venture-backed, medical innovation
company located near Boston, Massachusetts, USA. For more information,
visit www.mitralign.com.

1. Jamieson WR, Edwards FH, Schwartz M, et al. Ann Thorac Surg
1999;67:943-951
2. Stuge O., Liddicoat J., et al. JTCS
2006;132:1258-61
3. Argarwal et al. Circ Cardiovasc Interv
2009;2:565-573
4. RogersJH.Circulation2009:119: 2718-25

Contacts

Mitralign Inc.
David Schleifer, 617-869-6166
Director
of Marketing
dschleifer@mitralign.com