LivaNova to Acquire ImThera Medical, Inc.
LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced it has entered into an agreement to acquire the remaining outstanding interests in ImThera Medical, Inc. (“ImThera”). Headquartered in San Diego, Calif., ImThera is a privately held company focused on neurostimulation for the treatment of obstructive sleep apnea (“OSA”). ImThera manufactures an implantable device that stimulates multiple tongue muscles via the hypoglossal nerve, which opens the airway while a patient is sleeping.
“The ImThera device is highly aligned with our existing Neuromodulation business, and we are extremely excited about the opportunity to optimize the technology and fold it into our universal platform. In the near term, we will focus on expanding ImThera’s current commercial presence in the European market, while advancing enrollment in a U.S. Food and Drug Administration (FDA) pivotal trial,” said Damien McDonald, LivaNova’s Chief Executive Officer. “The OSA market is large and growing, with many unmet needs. With our strong commercial capabilities and robust manufacturing, we look forward to bringing this innovative technology to the large patient population that has been unsuccessful with other treatments, allowing them to improve their quality of life.”
Patients with OSA can experience impaired daytime functionality, along with severe comorbidities such as heart failure and stroke. ImThera’s implantable device received CE Mark in 2012 and is indicated for patients with moderate to severe OSA who are unable or unwilling to use continuous positive airway pressure (“CPAP”) therapy. For these patients, the device is designed to reduce or eliminate sleep apnea, as demonstrated through clinical studies and its initial commercial use in Europe. Enrollment in a pivotal study is currently under way with the FDA to obtain premarket approval for the OSA implant.
“Adding ImThera and its obstructive sleep apnea device to our portfolio will strengthen our position as a leader in the field of neuromodulation,” said Jason Richey, LivaNova's President of North America and General Manager of the Neuromodulation business.
LivaNova has been an investor in ImThera since 2011 and has agreed to pay up to approximately $225 million to acquire the remaining outstanding interests of ImThera. Up-front costs are approximately $78 million with the balance paid on a schedule driven by regulatory and sales milestones. The deal is projected to be near-term accretive and is expected to close in early 2018 (subject to approvals and other customary closing conditions).
“ImThera Medical shares LivaNova’s mission to help patients live longer, better lives. We are proud of the accomplishments we have made in developing an effective CPAP alternative for individuals suffering from OSA. This acquisition will benefit healthcare providers, shareholders and most of all, the patients who are at the heart of everything we do,” said Marcelo Lima, ImThera’s Founder, President and Chief Executive Officer. “This is the culmination of several years of hard work by our team of dedicated professionals. We welcome the opportunity to become part of the LivaNova family and look forward to the continued evolution of our product.”
About ImThera Medical, Inc.
ImThera Medical is a global leader in neurostimulation for the treatment of obstructive sleep apnea. Headquartered in San Diego, ImThera was founded to improve the lives of patients suffering from the debilitating effects of OSA. ImThera’s sleep therapy product is comprised of an implanted small generator and multi-channel electrode lead, along with an external handheld remote control that can start, stop or pause therapy. ImThera collaborates with the world’s top scientists and medical experts in sleep medicine, and its product is commercially available in several countries outside the United States.
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.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe the Company’s future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," “could,” “seek,” “guidance,” “predict,” “potential,” “likely,” "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this press release are based on information presently available to LivaNova and assumptions that the Company believes to be reasonable, but are inherently uncertain. As a result, the Company’s actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company’s control. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning closing of the proposed acquisition of ImThera, entry into the OSA space, developing the ImThera device as an important growth platform, investing in the clinical studies, regulatory approvals, product enhancements and other steps needed to launch this device commercially in new markets, developing ImThera as a positive addition to the Company’s neuromodulation portfolio, offering patients the most advanced OSA therapy, offering a significant new therapy to patients with OSA, adding clinical study sites for ImThera’s implantable device, bringing a superior technology to market and anticipating that this transaction will meet all LivaNova long-term financial metrics and internal standards. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the Company’s business, including those described in the “Risk Factors” section of Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, the Registration Statement on Form S-4 and other documents filed from time to time with the United States Securities and Exchange Commission by LivaNova. LivaNova does not give any assurance (1) that LivaNova will achieve its expectations, or (2) concerning any result or the timing thereof.
All information in this press release is as of the date of its release. 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.
For more information, please visit www.livanova.com .
LivaNova PLC Investor Relations and Media
Karen King, +1 (281) 228-7262
Vice President, Investor Relations & Corporate Communications
Deanna Wilke, +1 (281) 727-2764
Corporate External Communications Manager
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Lehman Brothers Treasury Announces Plans for Partial Wind-Down14.12.2018 20:41 | Tiedote
Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Kramer Levin Naftalis & Frankel LLP, announced that LBT is planning a final cash distribution to its creditors. Professional holders of eligible notes will have the option to retain their investment by electing to receive substitute notes of one (or a few) series. Such election shall take place through a solicitation process. As a consequence, LBT will be able to reduce the number of series of notes outstanding from more than 3,700 to one or a few. Noteholders electing to receive substitute notes will be afforded the same economic entitlement to distributions received by LBT from Lehman Brothers Holdings Inc. (“LBHI”) through the substitute notes. The substitute notes will be denominated in U.S. dollars and future distributions will be made in U.S. dollars only. Noteholders who are not professional investors, or hold notes that are not eligible for substitution, or do not elect to receive substitut
Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma in Combination with AVD14.12.2018 20:00 | Tiedote
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the extension of the marketing authorization of ADCETRIS (brentuximab vedotin) and recommended its approval in combination with AVD in adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma. ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma. ADCETRIS is currently not approved as a therapy for previously untreated Hodgkin lymphoma in Europe. “For a large number of previously untreated Hodgkin lymphoma patients diagnosed with Stage IV disease, progression will occur with current treatments, highlighting a true unmet need in this population,” said Anna Sureda, M.D., Ph.D., Head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme, Institut Català d'Oncologia - Hospital Duran i Reynals. “In the ECHELON-1 cl
Diamond CBD, POTN Subsidiary, Enters the $46 Billion Coffee Market With the Release of Premium Line of CBD-Infused Coffee & Tea K-Kup Capsules14.12.2018 18:42 | Tiedote
Diamond CBD Inc., wholly owned subsidiary of PotNetwork Holdings, Inc. (OTC Pink: POTN), a leader in hemp extraction and innovative CBD products for the wellness market, enters the Coffee segment, an industry expected to reach revenues of $46 Billion in 2018. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181214005308/en/ Experience a cup of Chill (Photo: Business Wire) Produced in accordance with a universal K-Cup design, these pods fit in almost all modern single cup coffee makers, making it an easily integrated enhancement to any environment, delivering 25mgs of CBD in a tasty favorite beverage at less than $5 per cup. This new line of premium Chill Coffee Capsules was recently added to the Company’s broad range of cannabinoid and natural hemp products. Each box comes with 4 individual capsules in original chill coffee, decaf chill coffee, chill black tea, and chill green tea flavors. The unit price for each box is $10.00
Henley & Partners Enlarges Executive Committee to Manage Expansion and Growth14.12.2018 17:00 | Tiedote
Residence- and citizenship-by-investment programs have firmly established themselves over the past few years as the new frontier in terms of freedom, flexibility, and future-readiness, both for the countries issuing these programs and for the individual investors participating in them. The societal and economic value these programs generate is undisputed. The investment migration industry as a whole is currently grossing roughly USD 18 billion per year, with an expectation that it will hit the USD 20 billion mark very soon. Foreign direct investment (FDI) is now considered the lifeblood of economic growth for many developing and recovering smaller countries around the world. As such, the number of investment migration programs has been increasing rapidly, from just a handful of programs in the 1980s and 1990s to over 100 countries that now have investment migration provisions in their laws. There are more than 60 active programs today, with Moldova and Montenegro — both fast-growing Eu
Vargatef® plus docetaxel could be an option after failure of immunotherapy in lung cancer14.12.2018 12:07 | Tiedote
Boehringer Ingelheim announced today the first interim results of VARGADO, an ongoing non-interventional study in routine clinical practice in Germany evaluating the efficacy and safety of Vargatef® (nintedanib) and docetaxel in patients with stage III/IV locally advanced or metastatic non-small cell lung cancer (NSCLC) of adenocarcinoma histology. The study consists of three cohorts, two of which allow for prior treatment with immune checkpoint inhibitors (ICIs) either in combination with chemotherapy in the first-line or as monotherapy in the second-line of treatment. The interim results from Cohort B (first-line chemotherapy, second-line immune checkpoint inhibitors, third-line Vargatef® plus docetaxel) were presented today at ESMO Immuno-Oncology Congress 2018 in Geneva.1 Despite a limited sample size, the VARGADO study adds to the body of evidence for nintedanib in lung adenocarcinoma following pre-treatment with chemotherapy and ICIs.1,3 The addition of nintedanib to docetaxel ha
Alps Electric to Exhibit at CES 2019 as Alps Alpine for the First Time14.12.2018 10:58 | Tiedote
Japanese comprehensive electronic components manufacturer Alps Electric Co., Ltd. (TOKYO:6770) (Ota-ku, Tokyo; President: Toshihiro Kuriyama) will exhibit at CES 2019, to open at the Las Vegas Convention and World Trade Center in Las Vegas, Nevada, in the United States on January 8. Alps Electric will be taking part as a new company, Alps Alpine Co., Ltd., for the first time. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181213006022/en/ Alps Alpine's new touch input device for automotive (Graphic: Business Wire) At CES 2019, an exposition of cutting-edge technologies brought together from around the world, Alps Electric will present a variety of technologies in response to the major trends in automotive development referred to as “CASE”—namely connected cars, autonomous driving, sharing and services, and electric vehicles. Making its first appearance at the show as a new company following its business integration with subs
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme