Millipede, Inc. is developing the IRIS Transcatheter Annuloplasty Ring System to treat severe mitral regurgitation
MARLBOROUGH, Mass. (Jan. 24, 2018) – Boston Scientific Corporation (NYSE: BSX) today announced it has closed an investment and entered into an acquisition option agreement with Millipede, Inc., a privatelyheld company that has developed the IRIS Transcatheter Annuloplasty Ring System for the treatment of severe mitral regurgitation (MR). Under the terms of the agreements, Boston Scientific has purchased a portion of the outstanding shares of Millipede along with newly issued shares of the company for a total consideration of $90M. Boston Scientific has the option to acquire the remaining shares of the company at any time prior to the completion of a first in human clinical study that meets certain parameters. Upon the completion of the clinical study, Millipede has the option to compel Boston Scientific to acquire the remaining shares of the company. Each company’s option period expires by the end of 2019. Completion of this acquisition would result in an additional $325M payment by Boston Scientific at closing with a further $125M becoming payable upon achievement of a commercial milestone.
MR is caused by a leaking mitral valve, which then causes blood to regurgitate from the left ventricle to the left atrium of the heart. Over time, the condition can lead to or accelerate heart failure and heart rhythm problems. Many patients with severe MR have compromised heart function and are not able to tolerate open-heart surgery to repair or replace the leaking valve. This large and currently underserved patient population could benefit from a fully-percutaneous transcatheter procedure that can repair the dilated mitral annulus and reduce regurgitation without undergoing surgery.
“Intervening with the least invasive approach at earlier stages of severe mitral regurgitation has the greatest opportunity to alter the natural history of the disease and the progression to heart failure,” said Professor Ian Meredith, AM, Executive Vice President and Global Chief Medical Officer, Boston Scientific. “We believe that restoring mitral annular dimensions via a transcatheter mitral annuloplasty ring will be a crucial component to effective, minimally invasive improvement of mitral valve function for appropriately-indicated patients.”
The Millipede IRIS annuloplasty ring, delivered via a transcatheter-transseptal delivery system, follows the standard surgical approach to repair and reduce the size of a dilated mitral annulus. The IRIS device is a complete ring designed to be used as a stand-alone device, or in combination with other technologies in patients with severe MR. The device is designed to be highly customizable to a specific patient’s anatomy and disease state, and is repositionable and retrievable to promote a high-quality outcome.
“We saw an opportunity to bring the gold-standard surgical approach to repairing the mitral valve to an underserved population of severe MR patients with transcatheter techniques, and are excited Boston Scientific
also sees the unique abilities of the IRIS transcatheter ring,” said Joe Cunningham, MD, Chairman of the Board, Millipede, Inc. and Managing Director of Santé Ventures.Millipede is based in Santa Rosa, California. It was founded in 2012 by majority investor Santé Ventures and Steve Bolling, MD, and has been led by CEO and Co-founder Randy Lashinski since 2014.
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 www.bostonscientific.com and connect on Twitter and Facebook.
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, expectations with respect to the Millipede transaction and technology, 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.
Trish Backes Media Relations
(651) 582-5887 (office)
Susie Lisa, CFA Investor Relations
(508) 683-5565 (office)