AtriCure Enters Into Definitive Agreement to Acquire SentreHEART


2019-08-13 11:36:00 BioSpace


AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, today announced that it has entered into a definitive agreement to acquire SentreHEART, Inc., a privately held developer of percutaneous left atrial appendage management solutions. The company also announced updated full year 2019 guidance. Under the terms of the agreement to acquire SentreHEART, the transaction consideration consists of an upfront payment of approximately $40 million in cash and AtriCure common stock, plus additional contingent consideration based on the achievement of certain clinical and reimbursement milestones over the next several years, all of which are value-creating events. Of the contingent consideration, $140 million is based on milestones related to the aMAZE™ IDE clinical trial, including PMA approval, and $120 million is based on a milestone related to reimbursement for the therapy involving SentreHEART devices. All contingent consideration would be payable in a combination of cash and stock. “We believe that SentreHEART is a strategic addition to AtriCure, significantly expanding our addressable markets with a product designed for electrophysiologists,” said Michael Carrel, President and Chief Executive Officer of AtriCure. “With our pursuit of labeling based on the aMAZE Trial, we are deepening our commitment to provide the broadest possible offering of ablation and left atrial appendage management solutions to our customers and their patients.” Mr. Carrel continued, “This transaction combines two companies dedicated to solving the challenges associated with Afib. We are confident that SentreHEART complements our current product portfolio and intellectual property, augments our commitment to clinical science with the aMAZE Trial, and will leverage our growing commercial channel into the electrophysiology market. We believe that upon FDA approval, use of the LARIAT® device will continue to advance AtriCure’s competitive position in the market.” SentreHEART was founded in 2005 and is based in Redwood City, California. The company’s technology is currently being studied in the aMAZE Trial, an FDA-approved, prospective, multicenter, randomized controlled trial evaluating the LARIAT Suture Delivery Device for LAA closure adjunctive to Pulmonary Vein Isolation (PVI) catheter ablation for the treatment of persistent and longstanding persistent Afib. The objective of the aMAZE Trial is to demonstrate that the LARIAT device for LAA closure, plus a PVI ablation, will lead to a reduced incidence of recurrent Afib compared to PVI alone, with a high safety profile. The aMAZE Trial is expected to enroll up to 600 total patients at 65 sites with one-year follow up. Primary endpoint measures are freedom from episodes of Afib greater than 30 seconds at one-year post treatment. More information about the aMAZE Trial can be found at: To date, 535 patients have been enrolled in the trial, with full enrollment anticipated in early 2020. Subject to customary closing conditions, the transaction is expected to close in the next several days. AtriCure shareholder approval is not required. 2019 and Future Outlook AtriCure projects total revenue for 2019 to be in the range of $224.5 million to $228.5 million, which includes minimal contribution from SentreHEART, and reflects approximately 11% to 13% organic growth. Revenue contribution from the SentreHEART business is expected to be nominal until after completion of the aMAZE Trial and PMA approval. For 2019, AtriCure now expects adjusted EBITDA, a non-GAAP measure, to be a loss due to integration and operating costs resulting from the transaction. Full-year adjusted EBITDA loss is expected to be in the range of $7 million to $9 million, excluding acquisition costs. This adjusted EBITDA loss translates into an adjusted loss per share between $1.07 and $1.14. For 2020, the company expects to have an adjusted EBITDA loss of less than $10 million, as investments shift from completing the aMAZE Trial to preparing for FDA approval. Adjusted EBITDA and adjusted loss per share are non-GAAP measures. A discussion of non-GAAP financial measures and reconciliations regarding non-GAAP financial measures to their respective GAAP financial measures is provided later in this press release. “We have a strong balance sheet, which has been reinforced by our credit facility with Silicon Valley Bank. As a result, we believe that we can support both the upfront payment and ongoing investments in the combined business with minimal shareholder dilution,” said Andy Wade, Senior Vice President and Chief Financial Officer. “While this transaction will impact short and medium-term profitability, we do not need to raise additional capital to finish the aMAZE Trial or support post-trial commercialization efforts.” About AtriCure, Inc. AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first and only medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely sold LAA management devices worldwide. About SentreHEART, Inc. SentreHEART is a privately-owned medical device company based in Redwood City, California. Founded in 2005, SentreHEART has developed innovative technology for remote delivery of suture for closure of anatomic structures including the LAA. The company is committed to clinical evidence development and is currently sponsoring the FDA-approved prospective, multi-center, randomized controlled trial known as the aMAZE Trial.
AtriCure , Inc .( Nasdaq : ATRC ),一家领先的心房颤动( Afib )和左房附属物( LAA )治疗创新企业,今天宣布,该公司已签订最终协议,收购 SentreHEART , Inc .,一家私人持有的经皮左房附属物管理解决方案开发商。公司还公布了最新的2019年全年指导意见。 根据收购 SentreHEART 的协议条款,交易对价包括约4,000万美元现金和 AtriCure 普通股的预付款,以及基于未来几年实现某些临床和偿付里程碑的额外或有对价。所有这些都是创造价值的事件。在或有对价中,1.4亿美元基于与包括上市前批准(PMA)批准在内的 aMAZE ™ IDE 临床试验相关的里程碑,1.2亿美元基于与涉及 SentreHEART 设备的治疗补偿相关的里程碑。所有或然代价将以现金及股份之组合支付。 AtriCure 总裁兼首席执行官迈克尔•卡尔( Michael Carrel )表示:“我们认为 SentreHEART 是 AtriCure 的战略补充,通过为电生理专家设计的产品,大大拓展了我们的目标市场。”“随着我们在 MAZE 试验基础上对标签的追求,我们正在深化我们的承诺,为我们的客户和患者提供尽可能广泛的消融和左房附属物管理解决方案。” Carrel 先生继续说,“本次交易合并了两家致力于解决 Afib 相关挑战的公司。我们相信 SentreHEART 补充了我们目前的产品组合和知识产权,通过 MAZE 试验增强了我们对临床科学的承诺,并将利用我们不断增长的商业渠道进入电生理市场。我们相信,经 FDA 批准, LARIAT ®设备的使用将继续提升 AtriCure 在市场上的竞争地位。” SentreHEART 成立于2005年,总部位于加州红木城。该公司的技术目前正在进行 aMAZE 试验研究,这是一项 FDA 批准的、前瞻性的、多中心的随机对照试验,评估 LARIAT 缝合器的 LARIAT 缝合器,用于肺动脉静脉隔离( PVI )导管消融治疗持续性和持续性 Afib 。aMAZE 试验的目的是证明 LARIAT 关闭装置,加上 PVI 消融,将导致复发性 Afib 的发生率比单纯 PVI 低,安全性高。预计阿马泽试验将在65个地点招募至多600名患者,并进行为期一年的随访。主要的终点指标是治疗后一年内免于超过30秒的 Afib 发作。有关 aMAZE 试验的更多信息,请参见: https://amatterial 。com / en /。到目前为止,共有535名患者参加了试验,预计将于2020年初全部纳入试验。 根据惯例成交条件,预计交易将在未来几天内完成。不需要 AtriCure 股东批准。 2019年及未来展望 AtriCure 预计2019年的总收入在2.245亿至2.285亿美元之间,其中包括 SentreHEART 的最低贡献,并反映了约11%至13%的有机增长。SentreHEART 业务的收入贡献预计在 MAZE 试验和上市前批准(PMA)批准完成之前是名义的。 对于2019年, AtriCure 现在预计调整后的 EBITDA (非非一般公认会计原则(non-GAAP)衡量指标)将是由于整合和交易导致的运营成本造成的损失。全年经调整 EBITDA 亏损预计在700万至900万美元之间,不包括收购成本。此经调整 EBITDA 亏损转化为每股1.07元至1.14元的经调整亏损。2020年,随着投资从完成 aMAZE 试验转向准备 FDA 批准,公司预计调整后的 EBITDA 损失将低于1,000万美元。调整后的 EBITDA 和调整后的每股亏损是非非一般公认会计原则(non-GAAP)措施。关于非 GAAP 财务指标的讨论和非非一般公认会计原则(non-GAAP)财务指标与各自一般公认会计原则(GAAP)财务指标的对账,将在本新闻稿后面提供。 “我们拥有强大的资产负债表,我们与硅谷银行( Silicon Valley Bank )的信贷安排加强了这一点。因此,我们认为,我们可以支持对合并后业务的前期支付和持续投资,并将股东稀释到最低限度,”高级副总裁兼首席财务官 Andy Wade 表示。“虽然这笔交易将影响短期和中期盈利能力,但我们不需要筹集额外资金来完成 MAZE 试验或支持试验后商业化努力。” 关于 AtriCure 公司。 AtriCure , Inc .为治疗 Afib 及相关条件提供创新技术。Afib 影响全球3300万人。全球的电子生理学家和心胸外科医生使用 AtriCure 技术治疗 Afib 和减少 Afib 相关并发症。AtriCure 的 Isolator ® Synergy ™消融系统是首个获得 FDA 批准用于治疗持续性 Afib 的医疗设备。AtriCure 的 AtriClip Left Atral Appendage ( LAA )独家系统产品是全球销售最广泛的 LAA 管理设备。 关于 SentreHEART 公司。 SentreHEART 是一家私人拥有的医疗设备公司,总部设在加利福尼亚州的 Redwood 市。SentreHEART 成立于2005年,开发了创新的技术,远程提供缝合缝合封闭的解剖结构,包括 LAA 。公司致力于临床证据的开发,目前正在赞助 FDA 批准的前瞻性、多中心、随机对照试验,称为 aMAZE 试验。