MARLBOROUGH, Mass. and
HERZLIYA, Israel, Oct. 8, 2015 /PRNewswire/ -- Boston
Scientific Corporation (NYSE: BSX) today announced that it has
closed on an additional round of financing with MValve Technologies
Ltd., a developer of a percutaneous mitral valve replacement
system, designed to work with the Boston Scientific
LOTUS™ Valve, creating a unique mitral regurgitation
(MR) treatment solution. Boston Scientific has provided the company
with funding since 2012 and has an exclusive option to acquire
MValve.
MValve Technologies plans to utilize the new financing, in part,
to fund a first-in-human clinical trial for the MValve docking
system for transcatheter mitral valve replacement (TMVR) in
patients with mitral regurgitation. The approach, in which the
Boston Scientific Lotus Valve is deployed inside the MValve docking
system, is designed to enable the treatment of mitral regurgitation
in a broad range of patients, and to improve long-term clinical
outcomes in this patient population. Both the dock and valve can be
repositioned and recaptured, enabling precise valve placement and
physician confidence prior to releasing.
Mitral regurgitation is the most common type of heart valve
disorder and occurs when the mitral valve does not close properly,
causing an abnormal reversal of blood to flow from the left
ventricle into the left atrium.
"The TMVR segment represents another significant growth
opportunity as we continue to build our Structural Heart
portfolio," said Kevin Ballinger,
senior vice president and president, Interventional Cardiology,
Boston Scientific. "This round of financing will support the
development of the MValve technology in anticipation of a
first-in-human clinical trial, and we are pleased to be continuing
our collaboration."
"MValve is proud of our truly novel technology, and we look
forward to continued development of this unique mitral system — a
system that we anticipate will finally provide physicians with a
transformative solution and offer patients the appropriate
treatment they deserve," said Dr. Maurice
Buchbinder, interventional cardiologist, founder and medical
director, MValve Technologies.
The MValve docking system is not available for sale.
About the Lotus Valve System
The Lotus Aortic Valve
System is a differentiated second-generation valve replacement
technology, consisting of a pre-loaded, stent-mounted tissue valve
prosthesis and catheter delivery system for guidance and
percutaneous placement of the valve. The low-profile delivery
system is designed to enable predictable and precise placement
associated with early valve function, as well as bi-directional
atraumatic repositioning and retrieval at any time prior to release
of the aortic valve implant. The device also features a unique
Adaptive Seal™ designed to minimize the incidence of paravalvular
regurgitation.
In the U.S., the Lotus Valve System is an investigational device
and not available for sale. It is CE marked in the European
Union.
About Boston Scientific
Boston Scientific transforms
lives through innovative medical solutions that improve the health
of patients around the world. As a global medical technology leader
for more than 35 years, we advance science for life by providing a
broad range of high performance solutions that address unmet
patient needs and reduce the cost of healthcare. For more
information, visit us at www.bostonscientific.com and connect on
Twitter or Facebook.
About MValve
MValve Technologies Ltd. is a privately
held corporation founded in 2011, with lead investment from Boston
Scientific corporation. MValve is dedicated to the development of
novel and minimally invasive technologies for transcatheter valve
replacement. The company operates from Herezeliya, Israel and San
Diego.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements may be identified by words like
"anticipate," "expect," "project," "believe," "plan," "estimate,"
"intend" and similar words. These forward-looking statements are
based on our beliefs, assumptions and estimates using information
available to us at the time and are not intended to be guarantees
of future events or performance. These forward-looking statements
include, among other things, statements regarding our business
plans, our collaboration with MValve Technologies Ltd., the
development and commercialization of a mitral system, and product
performance and impact. If our underlying assumptions turn out to
be incorrect, or if certain risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections expressed or implied by our forward-looking statements.
These factors, in some cases, have affected and in the future
(together with other factors) could affect our ability to implement
our business strategy and may cause actual results to differ
materially from those contemplated by the statements expressed in
this press release. As a result, readers are cautioned not to place
undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other
things: future economic, competitive, reimbursement and regulatory
conditions; new product introductions; demographic trends;
intellectual property; litigation; financial market conditions; and
future business decisions made by us and our competitors. All of
these factors are difficult or impossible to predict accurately and
many of them are beyond our control. For a further list and
description of these and other important risks and uncertainties
that may affect our future operations, see Part I, Item 1A – Risk
Factors in our most recent Annual Report on Form 10-K filed with
the Securities and Exchange Commission, which we may update in Part
II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we
have filed or will file hereafter. We disclaim any intention or
obligation to publicly update or revise any forward-looking
statements to reflect any change in our expectations or in events,
conditions or circumstances on which those expectations may be
based, or that may affect the likelihood that actual results will
differ from those contained in the forward-looking statements. This
cautionary statement is applicable to all forward-looking
statements contained in this document.
CONTACTS
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Media:
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Investors:
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Tom
Keppeler
|
Susie Lisa,
CFA
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508-683-6585
(office)
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508- 683-5565
(office)
|
Media
Relations
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Investor
Relations
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Boston Scientific
Corporation
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Boston Scientific
Corporation
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thomas.keppeler@bsci.com
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investor_relations@bsci.com
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SOURCE Boston Scientific Corporation