Healthcare Industry News: transcatheter
News Release - October 8, 2015
Boston Scientific Announces Additional Investment And Right To Acquire MValve TechnologiesInvestment continues alliance for percutaneous mitral valve replacement established in 2012
MARLBOROUGH, Mass. and HERZLIYA, Israel, Oct. 8, 2015 -- (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (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.
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.
Source: Boston Scientific
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