Press Release

<< Back
LivaNova and MicroPort Announce the Approval of Rega Pacemakers by the China Food and Drug Administration

Marks first Chinese approval for the pacemakers manufactured by the companies’ joint venture

LONDON--(BUSINESS WIRE)--Sep. 27, 2017-- LivaNova PLC (NASDAQ:LIVN) (“LivaNova”) and MicroPort Scientific Corporation (HK:00853) (“MicroPort”), today announced that the companies’ Shanghai-based joint venture MicroPort Sorin Cardiac Rhythm Management Co. Ltd. (“MSC” or the “joint venture”) obtained approval for its family of RegaTM pacemakers from the China Food and Drug Administration.

Not only are Rega pacemakers the first manufactured by MSC, they are also China’s first domestically manufactured pacemakers that meet international standards. Measuring only eight cubic centimeters, Rega pacemakers are the smallest on the Chinese cardiac rhythm management (“CRM”) market. The devices feature advanced functions, such as a pacing mode that preserves intrinsic conduction, a dual sensor based response rate to exercise and sleep apnea monitoring.

“This is an important milestone achieved by MSC, our joint venture in China,” said Qiyi Luo, MicroPort’s Chief Technology Officer. “The release of Rega pacemakers will strengthen our local presence and expand our footprint in China.”

“The approval of Rega pacemakers represents a large opportunity within the rapidly growing, underpenetrated Chinese CRM market,” said Benoît Clinchamps, LivaNova’s Vice President and General Manager of its CRM business franchise. “China has more than one million bradycardia patients who can be treated with an implantable pacemaker, with an estimated 300,000 new cases annually. Due to the current high price of pacemakers in China, only about 80,000 patients are able to receive a pacemaker implant annually.”

”Rega pacemakers offer the Chinese patient a state-of-the-art technology at a significantly lower price than imported competing products,” said Li Wang, MSC’s Chief Executive Officer. “This is a game-changing value proposition for the Chinese patient.”

About MicroPort Sorin CRM Co. Ltd. (“MSC”)

MSC is a joint venture established in 2014 between LivaNova and MicroPort. Through MSC, the two companies are collaborating on the import, sale and service of LivaNova CRM devices in greater China, as well as on the development and manufacturing of local CRM products. MicroPort holds a 51 percent stake in the joint venture entity, while LivaNova holds the remaining 49 percent interest.

About MicroPort Scientific Corporation

MicroPort Scientific Corporation (“MicroPort”) is a leading medical device company publicly listed on the main board of Hong Kong (HK853). The Group focuses on innovating, manufacturing and marketing high-quality, and yet still affordable, high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one every 30 seconds in more than 2,000 major hospitals throughout China and more than 20 other countries, MicroPort maintains operations in a wide range of business segments, including Cardiovascular Devices, Orthopedic Devices, Electrophysiological Devices, Endovascular Devices, Neurovascular Devices, Surgical Management, Diabetes Care and Endocrinal Management, among others. MicroPort is dedicated to becoming a leading global enterprise capable of providing the best and most affordable medical products and technologies to patients throughout the world.

About LivaNova

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London and with a presence in more than 100 countries worldwide, the company employs more than 4,500 employees. LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm Management, with operating headquarters in Mirandola (Italy), Houston (U.S.A.) and Clamart (France), respectively.

For more information, please visit www.livanova.com.

Safe Harbor Statement

Certain statements in this press release, other than purely historical information, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements include, but are not limited to, LivaNova’s plans, objectives, strategies, prospects or future events and involve known and unknown risks that are difficult to predict. As a result, our performance, achievements or prospects may differ materially from those expressed or implied by these forward-looking statements. In some cases, you can identify forward-looking statements by the use of words such as "may," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or other similar words. Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties. Important factors that may cause actual results to differ include, but are not limited to: market acceptance and sales of our products; changes in coverage or reimbursement amounts, the presence or absence of intellectual property protection and potential patent infringement claims; maintaining compliance with government regulations; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future expenses and sales; and other risks detailed from time to time in our filings with the Securities and Exchange Commission ("SEC"). For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2016, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.

The Company does not undertake or assume any obligation to update publicly any of the forward-looking statements in this press release to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this press release.

Source: LivaNova PLC

LivaNova PLC Investor Relations and Media
Karen King, +1 (281) 228-7262
Vice President, Investor Relations & Corporate Communications
or
Deanna Wilke, +1 (281) 727-2764
Corporate External Communications Manager
corporate.communications@livanova.com