ST. PAUL, Minn.---- Cardiovascular Systems, Inc. , a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today reported financial results for its fiscal second quarter, ended December 31, 2018.
CSI’s second-quarter revenues were $60.2 million, an increase of $7.6 million, or 14.4%, from the second quarter of fiscal 2018. Gross profit margin remained healthy at 80.9%, but declined modestly compared to last year due to increased revenues from international distributors, and domestic sales of coronary balloons and peripheral guidewires.
Selling, general and administrative expenses increased 11.1% to $41.1 million due to increased investments to support international expansion. Research and development expenses increased 13.2% to $7.2 million as a result of planned new product development and patient enrollment costs in the ECLIPSE clinical trial.
Second-quarter net income was $0.5 million, or $0.01 per basic and diluted share, compared to a net loss of $0.4 million, or $0.01 per basic share, in the prior-year period. Adjusted EBITDA totaled $4.0 million.
Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, “We are driving market leading performance with orbital atherectomy and we are executing on our key growth initiatives to introduce new products and launch our business in new markets around the world.”
Distribution Partner OrbusNeich Launched Orbital Atherectomy in Several New Geographies
In November, CSI announced the first patient in Hong Kong was treated with the Diamondback 360® Coronary Orbital Atherectomy System (OAS), representing the first international coronary procedure as a result of the company’s distribution agreement with OrbusNeich.
In November, the first patients in Germany were treated with the Stealth 360® Peripheral OAS, representing the first commercial use of Peripheral OAS in Europe.
In January, the first patients in the United Arab Emirates were treated with the Diamondback 360® Coronary OAS, representing the first use of OAS in the Middle East.
Diamondback 360® Coronary OAS with Classic Crown and ViperWire Advance® FlexTip Guidewire Approved in Japan
On January 2, CSI announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) approved the Diamondback 360® Coronary OAS with Classic Crown (Classic Crown) and ViperWire Advance® Coronary Guidewire FlexTip (FlexTip).
Classic Crown is the market-leading coronary atherectomy device in the United States. Classic Crown utilizes a 1.25mm eccentrically mounted diamond-coated crown and a patented combination of centrifugal force and differential sanding to safely modify arterial calcium. This device now features GlideAssist®, which allows for tracking, easier removal and smoother repositioning of the device – particularly in challenging anatomies.
FlexTip is a unique new atherectomy guidewire with a nitinol core and shapeable stainless-steel tip for increased flexibility and kink-resistance, improved navigation, and reduced guidewire bias in complex coronary vessels.
Said Ward, “Continuous innovation in our core technology is a priority at CSI. With the simultaneous launch of Classic Crown, GlideAssist and FlexTip, physicians in Japan now have access to a full range of new technologies that will improve the quality of care for patients with complex and calcified coronary artery disease.”
First Patients in United States Treated with OrbusNeich Teleport® Microcatheter
In December, CSI announced that the first patients in the United States were treated using the OrbusNeich® Teleport Microcatheter (Teleport), which recently received U.S. Food and Drug Administration (FDA) 510(k) clearance.
Microcatheters are used to provide support and safe guidewire exchange during complex cardiovascular procedures. Teleport is a new generation microcatheter designed for deliverability and support, with a unique and robust tip designed to enable access in the most challenging lesions.
Said Ward, “We are committed to building a comprehensive cardiovascular company and leveraging our commercial footprint and clinical value to become the partner of choice in the revascularization of patients with complex peripheral and coronary artery disease. The clearance of the Teleport Microcatheter complements our emphasis on providing advanced solutions for the most difficult coronary and peripheral lesions.”
Company Updates Fiscal 2019 Guidance
Ward concluded, “Revenues grew 13.8% during the first half of fiscal 2019. Our key revenue drivers came in on plan; domestic atherectomy grew 10% and we added $4.2 million in new revenue from international distributors and the domestic sale of OrbusNeich angioplasty balloons and ZILIENT™ guidewires. We anticipate similar contributions from these drivers during the second half of fiscal 2019. As a result, we remain on track to achieve the midpoint of our fiscal 2019 revenue guidance range.
“In conjunction with our pre-announcement of second quarter revenue results on January 7, we narrowed our fiscal 2019 revenue expectations to a range of $243 million to $247 million from a range of $240 million to $250 million. Our gross margin and profitability expectations for fiscal 2019 remain consistent with the financial guidance we provided at our analyst day meeting on July 31, 2018.”
For the fiscal 2019 ending June 30, 2019, CSI anticipates:
Revenue in a range of $243 million to $247 million;
Gross profit as a percentage of revenues of about 80%;
Net loss equal to 1%-2% of revenue; and
Positive Adjusted EBITDA.
Conference Call Scheduled for Today at 3:30 p.m. CT (4:30 p.m. ET)
Cardiovascular Systems, Inc. will host a live conference call and webcast of its fiscal second-quarter results today, January 30, 2019, at 3:30 p.m. CT (4:30 p.m. ET). To access the call, dial (833) 241-7255 and enter the access number 7499798. Please dial in at least 10 minutes prior to the call. To access the live webcast, go to the events section of the company’s investor relations website, https://investors.csi360.com/events-and-presentations/events-calendar/default.aspx, and click on the webcast link.
Use of Non-GAAP Financial Measures
To supplement CSI's consolidated condensed financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), CSI uses certain non-GAAP financial measures in this release. Reconciliations of the non-GAAP financial measures used in this release to the most comparable U.S. GAAP measures for the respective periods can be found in tables later in this release immediately following the consolidated statements of operations. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for CSI's financial results prepared in accordance with GAAP.
About Peripheral Artery Disease (PAD)
As many as 18 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.
Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Stealth 360® and Diamondback 360® Peripheral Orbital Atherectomy Systems, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue — a critical factor in preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.
About Coronary Artery Disease (CAD)
CAD is a life-threatening condition and a leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the American Heart Association, 16.3 million people in the United States have been diagnosed with CAD, the most common form of heart disease. Heart disease claims more than 600,000 lives in the United States each year. According to estimates, significant arterial calcium is present in nearly 40% of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE).
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. The Stealth 360® Peripheral Orbital Atherectomy System (OAS) received CE Mark in October 2014. In March 2017, the company received PMDA approval in Japan for the Diamondback 360® Coronary OAS Micro Crown and reimbursement approval effective February 2018. Over 400,000 of CSI’s devices have been sold to leading institutions worldwide. For more information, visit the company’s website at www.csi360.com.
OrbusNeich® is a global pioneer in the provision of life-changing vascular solutions and offers an extensive portfolio of products that set industry benchmarks in vascular intervention. Current products include the world's first dual therapy stents, the COMBO® Plus and COMBO® Dual Therapy Stents, together with stents, balloons and microcatheters marketed under the names of Azule®, Scoreflex®, Sapphire® II, Sapphire® II PRO, Sapphire® II NC, Teleport® and Teleport® Control as well as products to treat peripheral artery disease: the Jade® and Scoreflex® PTA balloons. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Florida, USA; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to physicians in more than 60 countries. For more information, visit www.OrbusNeich.com.
Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding (i) CSI’s anticipated introduction of new products and launching its business in new markets around the world; (ii) the introduction of Classic Crown, GlideAssist and FlexTip in Japan; (iii) CSI’s commitment to building a comprehensive cardiovascular company and leveraging its commercial footprint and clinical value; (iv) revenue growth in the second half of fiscal 2019 and the factors driving such growth; and (v) anticipated revenue, gross profit, net loss and Adjusted EBITDA, are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, regulatory developments, clearances and approvals; approval of our products for distribution in countries outside of the United States; approval of products for reimbursement and the level of reimbursement in the U.S., Japan and other foreign countries; dependence on market growth; agreements with third parties to sell their products; the ability of OrbusNeich to successfully launch CSI products outside of the United States and Japan; our ability to maintain third-party supplier relationships and renew existing purchase agreements; our ability to maintain our relationship with our distribution partner in Japan and with OrbusNeich; the experience of physicians regarding the effectiveness and reliability of the products we sell; the reluctance of physicians, hospitals and other organizations to accept new products; the potential for unanticipated delays in enrolling medical centers and patients for clinical trials; actual clinical trial and study results; the impact of competitive products and pricing; unanticipated developments affecting our estimates regarding expenses, future revenues and capital requirements; the difficulty of successfully managing operating costs; our ability to manage our sales force strategy; our actual research and development efforts and needs; our ability to obtain and maintain intellectual property protection for product candidates; our actual financial resources and our ability to obtain additional financing; fluctuations in results and expenses based on new product introductions, sales mix, unanticipated warranty claims, and the timing of project expenditures; our ability to manage costs; investigations or litigation threatened or initiated against us; court rulings and future actions by the FDA and other regulatory bodies; the effects of hurricanes, flooding, and other natural disasters on our business; issues relating to our saline pump recall; the impact of federal corporate tax reform on our business, operations and financial statements; international trade developments; shutdowns of the U.S. federal government; general economic conditions; and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.
The Stealth 360® PAD System and Diamondback 360® PAD System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm. See the instructions for use for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.
Indications: The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Contraindications: The OAS is contraindicated when the ViperWire® guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.
Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated. See the instructions for use before performing Diamondback 360 Coronary OAS procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Three Months Ended
Six Months Ended
Basic earnings per share
Non-GAAP Financial Measures
To supplement CSI's consolidated condensed financial statements prepared in accordance with GAAP, CSI uses a non-GAAP financial measure referred to as "Adjusted EBITDA" in this release.
Reconciliations of this non-GAAP measure to the most comparable U.S. GAAP measure for the respective periods can be found in the following tables. In addition, an explanation of the manner in which CSI's management uses this measure to conduct and evaluate its business, the economic substance behind management's decision to use this measure, the substantive reasons why management believes that this measure provides useful information to investors, the material limitations associated with the use of this measure and the manner in which management compensates for those limitations is included following the reconciliation table.
Use and Economic Substance of Non-GAAP Financial Measures Used by CSI and Usefulness of Such Non-GAAP Financial Measures to Investors
CSI uses Adjusted EBITDA as a supplemental measure of performance and believes this measure facilitates operating performance comparisons from period to period and company to company by factoring out potential differences caused by depreciation and amortization expense and non-cash charges such as stock based compensation. CSI's management uses Adjusted EBITDA to analyze the underlying trends in CSI's business, assess the performance of CSI's core operations, establish operational goals and forecasts that are used to allocate resources and evaluate CSI's performance period over period and in relation to its competitors' operating results. Additionally, CSI's management is evaluated on the basis of Adjusted EBITDA when determining achievement of their incentive compensation performance targets.
CSI believes that presenting Adjusted EBITDA provides investors greater transparency to the information used by CSI's management for its financial and operational decision-making and allows investors to see CSI's results "through the eyes" of management. CSI also believes that providing this information better enables CSI's investors to understand CSI's operating performance and evaluate the methodology used by CSI's management to evaluate and measure such performance.
The following is an explanation of each of the items that management excluded from Adjusted EBITDA and the reasons for excluding each of these individual items:
Stock-based compensation. CSI excludes stock-based compensation expense from its non-GAAP financial measures primarily because such expense, while constituting an ongoing and recurring expense, is not an expense that requires cash settlement. CSI's management also believes that excluding this item from CSI's non-GAAP results is useful to investors to understand the application of stock-based compensation guidance and its impact on CSI's operational performance, liquidity and its ability to make additional investments in the company, and it allows for greater transparency to certain line items in CSI's financial statements.
Depreciation and amortization expense. CSI excludes depreciation and amortization expense from its non-GAAP financial measures primarily because such expenses, while constituting ongoing and recurring expenses, are not expenses that require cash settlement and are not used by CSI's management to assess the core profitability of CSI's business operations. CSI's management also believes that excluding these items from CSI's non-GAAP results is useful to investors to understand CSI's operational performance, liquidity and its ability to make additional investments in the company.
Material Limitations Associated with the Use of Non-GAAP Financial Measures and Manner in which CSI Compensates for these Limitations
Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for CSI's financial results prepared in accordance with GAAP. Some of the limitations associated with CSI's use of these non-GAAP financial measures are:
Items such as stock-based compensation do not directly affect CSI's cash flow position; however, such items reflect economic costs to CSI and are not reflected in CSI's "Adjusted EBITDA" and therefore these non-GAAP measures do not reflect the full economic effect of these items.
Non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles and therefore other companies may calculate similarly titled non-GAAP financial measures differently than CSI, limiting the usefulness of those measures for comparative purposes.
CSI's management exercises judgment in determining which types of charges or other items should be excluded from the non-GAAP financial measures CSI uses. CSI compensates for these limitations by relying primarily upon its GAAP results and using non-GAAP financial measures only supplementally. CSI provides full disclosure of each non-GAAP financial measure.
CSI uses and detailed reconciliations of each non-GAAP measure to its most directly comparable GAAP measure. CSI encourages investors to review these reconciliations. CSI qualifies its use of non-GAAP financial measures with cautionary statements as set forth above.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190130005031/en/
Cardiovascular Systems, Inc.
Source: Cardiovascular Systems, Inc.
View this news release online at:
ST 。明尼苏达州，保罗。-----Cardiovascular Systems , Inc .，一家为外周和冠状动脉疾病患者开发和商业化创新介入治疗系统的医疗器械公司，今天公布了截至2018年12月31日的第二财季财务业绩。
销售、总务及管理费用增加11.1%至4110万美元，原因是支持国际扩张的投资增加。研发费用增加13.2%至720万美元，原因是计划在 ECLIPSE 临床试验中开发新产品和患者注册费用。
第二季度净利润为50万美元，即基本和摊薄后的每股0.01美元，而上年同期净亏损40万美元，即基本每股0.01美元。调整后 EBITDA 总计为400万美元。
CSI 董事长、总裁兼首席执行官 Scott Ward 表示：“我们正在用轨道无动脉切除技术推动市场领先的表现，我们正在实施关键的增长计划，以引进新产品，并在全球新市场推出我们的业务。”
分销合作伙伴 OrbusNeich 在几个新的地理区域启动了轨道横竖术
去年11月， CSI 宣布香港的第一位患者接受了 Diamondback 360®冠状 Orbital 直立手术系统( OAS )的治疗，这是该公司与 OrbusNeich 签订经销协议后的第一个国际冠状动脉手术。
11月，德国的第一例患者接受了隐形360®周边 OAS 治疗，这是欧洲首次在商业上使用周边 OAS 。
今年1月，阿拉伯联合酋长国的第一批患者接受了 Diamondback 360®冠状 OAS 治疗，这是首次在中东使用 OAS 。
Diamondback 360®带经典皇冠和 ViperWire Advance ® FlexTip 向导的冠状动脉成形术已在日本获得批准
1月2日， CSI 宣布，日本卫生、劳动和福利部（ MHLW ）批准了带经典皇冠（经典皇冠）和 ViperWire Advance ®冠状动脉导引线 FlexTip （ FlexTip ）的 Diamondback 360®冠状动脉成形术。
经典皇冠是市场领先的冠状动脉造瘘设备在美国。经典皇冠利用一个1.25毫米偏心安装金刚石涂层冠和专利组合离心力和差动砂光安全地修改动脉钙。该设备现在具有 GlideAssistant ®，可以跟踪、更轻松地移除和更平滑地重新定位该设备，尤其是在具有挑战性的解剖结构中。
沃德说：“我们核心技术的持续创新是 CSI 的优先事项。随着 Classic Crown 、 GlideAssistant 和 FlexTip 的同时推出，日本的医生现在可以获得一系列新技术，这些新技术将提高复杂钙化冠状动脉疾病患者的护理质量。”
美国第一例接受 OrbusNeich Teleport ®微导管治疗的患者
去年12月， CSI 宣布，美国第一批患者使用 OrbusNeich ® Teleport 微导管（ Teleport ）进行治疗，该导管最近获得了美国食品药品监督管理局（Food and Drug Administration）（ FDA ）510（ k ）的许可。
Ward 说，“我们致力于建设一家综合心血管公司，并利用我们的商业足迹和临床价值，成为复杂外周和冠状动脉疾病患者血运重建的首选合作伙伴。Teleport 微导管的清除补充了我们对为最困难的冠状动脉和外周病变提供先进解决方案的重视。”
沃德得出结论：“2019年上半年收入增长13.8%。我们的主要收入驱动因素是按计划进行的；国内动脉内膜切除术增长了10%，我们从国际分销商和 OrbusNeich 血管成形术气球和 ZiLIENT ™导尿管的国内销售中增加了420万美元的新收入。我们预计，这些驱动因素将在2019年下半年做出类似贡献。因此，我们仍有望实现2019年财政收入指引区间的中点。
正调整 EBITDA 。
心血管系统公司将于今天（2019年1月30日）下午3:30（美国东部时间下午4:30）举办一次关于其第二财季业绩的电话会议和网络直播。若要接通电话，请拨(833)241-7255，输入电话号码7499798。请在通话前至少10分钟拨打电话.要访问现场网络直播，请访问公司投资者关系网站的活动部分 https://investors 。csi360。com / events-and-presents / events-call / default 。然后点击网播链接。
非 GAAP 财务措施的使用
为了补充 CSI 根据美国公认会计原则（一般公认会计原则（GAAP））编制的合并简明财务报表， CSI 在本新闻稿中使用了某些非非一般公认会计原则（non-GAAP）财务指标。本新闻稿中使用的非非一般公认会计原则（non-GAAP）财务指标与各时期最具可比性的美国一般公认会计原则（GAAP）财务指标的对账，请参见合并运营报表后的本新闻稿后面的表格。非 GAAP 财务指标作为分析工具具有局限性，不应单独考虑或代替 CSI 根据一般公认会计原则（GAAP）编制的财务业绩。
外周动脉疾病( PAD )
多达1800万美国人，大多数超过65岁，患有 PAD ，这是由周围动脉斑块积累减少血流。症状包括行走时或休息时的腿部疼痛。如果不进行治疗， PAD 会导致严重的疼痛、不动、不愈合的伤口，最终导致肢体截肢。随着糖尿病和肥胖等风险因素的增加， PAD 的患病率以两位数的速度增长。
数百万患有 PAD 的患者可以通过使用隐形360®和 Diamondback 360®外周 Orbital At直立系统（ CSI 开发和制造的微创导管系统）的轨道动脉切除术治疗获益。这些系统使用的钻石覆盖冠，附着在轨道轴，其中砂掉斑块，同时保存健康的血管组织-一个关键因素，防止再次发生。球状血管成形术和支架治疗硬钙化病变有明显的缺点.干细胞容易骨折和高复发率，治疗硬钙化病变往往导致血管损伤和次优结果。
关于冠状动脉疾病( CAD )
冠心病是一种威胁生命的疾病，是美国男性和女性死亡的主要原因。当一种叫做斑块的脂肪物质在动脉的壁上堆积时，就会发生 CAD 。斑块的积聚导致动脉硬化和狭窄（动脉粥样硬化），减少血流。如果一个人患有下列一种或多种疾病，冠心病的风险就会增加：高血压、胆固醇异常、糖尿病或早期心脏病家族史。据美国心脏协会统计，美国有1630万人被诊断为冠心病，这是最常见的心脏病。心脏病每年在美国有超过60万人的生命。据估计，近40%接受经皮冠状动脉介入治疗（ PCI ）的患者存在明显的动脉钙质。当使用传统疗法时，大量钙会导致不良的结果和更高的治疗成本，包括死亡和重大心脏不良事件（ MACE ）的显著增加。
总部设在圣路易斯的心血管系统公司。明尼苏达州的保罗。是一家专注于开发和商业化治疗血管和冠心病创新解决方案的医疗器械公司。该公司的 Orbital 动脉直立系统在几分钟的治疗时间内治疗整个腿部和心脏的动脉血管钙化和纤维性斑块，并解决与现有外科、导管和药物治疗方案相关的许多限制。2007年8月，美国食品和药物管理局批准在外周动脉使用 Diamondback Orbital 动脉导管系统510( k )。2013年10月，公司获得 FDA 批准在冠状动脉使用 Diamondback Orbital 动脉粥样硬化系统。隐形360®外围轨道直立系统( OAS )于2014年10月获得 CE 标志。2017年3月，公司收到日本 PMDA 关于 Diamondback 360®冠状 OAS MicroCrown 的批文，并于2018年2月生效的报销批文。超过40万台 CSI 的设备已销往全球领先的机构。有关更多信息，请访问公司网站 www.csi360.com 。
OrbusNeich ®是提供改变生命的血管解决方案的全球先驱，提供广泛的产品组合，为血管干预设定行业基准。目前的产品包括世界上第一个双治疗支架、 COMBO ® Plus 和 COMBO ®双治疗支架，以及以 Azule ®、 Scorecflex ®、 Sapphire ® II 、 Sapphire ® II PRO 、 Sapphire ® II NC 的名义销售的支架、球囊和微导管，Teleport ®和 Teleport ® Control 以及治疗外周动脉疾病的产品： Jade ®和 Scoflex ® PTA 气球。OrbusNeich 总部位于香港，在中国深圳、美国弗洛里达州的劳德代尔堡、荷兰的 Hoevelaken 和日本的东京均有业务。OrbusNeich 为60多个国家的医生提供医疗设备。有关详细信息，请访问 www.OrbusNeich.com 。
本新闻稿中的某些声明是1995年《私人证券诉讼改革法案》含义内的前瞻性声明，是在安全港的保护下提供的，用于该法案提供的前瞻性声明。例如，在本新闻稿中有关以下内容的声明： CSI 预期将推出新产品，并在全球新市场开展业务；引入经典皇冠GlideAssistant 和 FlexTip 在日本的业务；( iii ) CSI 致力于建立一家综合心血管公司，并充分利用其商业足迹和临床价值；( iv )2019年下半年的收入增长和推动这一增长的因素；( v )预期收入、毛利、净亏损和经调整的 EBITDA 为前瞻性报表。这些声明涉及可能导致结果与预期结果存在重大差异的风险和不确定性，包括但不限于监管发展。批准和批准；批准我们的产品在美国以外的国家分销；批准偿还产品和偿还水平。日本和其他外国；依赖市场增长；与第三方达成协议销售其产品； OrbusNeich 在美国和日本以外成功推出 CSI 产品的能力；我们维持第三方供应商关系和更新现有采购协议的能力；我们维持与我们在日本和 OrbusNeich 的分销合作伙伴关系的能力；医生关于我们销售产品的有效性和可靠性的经验；医生、医院和其他组织不愿接受新产品；在注册医疗中心和患者进行临床试验方面出现意外延迟的可能性；实际临床试验和研究结果；竞争产品和定价的影响；意外发展未来收入和资本要求；成功管理运营成本的难度；我们管理销售团队战略的能力；我们的实际研发努力和需求；我们获取和维护产品候选者知识产权保护的能力；我们的实际财政资源和获得额外融资的能力；基于新产品介绍、销售组合、意外担保索赔和项目支出时间的结果和支出的波动；我们管理成本的能力；我们面临或发起的调查或诉讼； FDA 和其他监管机构的法院裁决和未来行动；飓风、洪水的影响，以及其他对我们业务的自然灾害；与我们的盐水泵召回有关的问题；联邦公司税改革对我们的业务、运营和财务报表的影响；国际贸易发展；美国联邦政府的关闭；一般经济状况；以及 CSI 向美国证券交易委员会定期提交的报告中详列的其他因素，包括最新的10-K报表表格年度报告和随后的10-Q 季报。CSI 鼓励您在评估本新闻稿中包含的前瞻性声明时，仔细考虑所有这些风险、不确定性和其他因素。由于这些事项、事实变化、未实现的假设或其他情况， CSI 的实际结果可能与本新闻稿中前瞻性陈述中讨论的预期结果存在重大差异。本新闻稿中的前瞻性陈述仅在本新闻稿发布之日作出， CSI 不承担更新声明以反映后续事件或情况的义务。
隐形360® PAD 系统和 Diamondback 360® PAD 系统是经皮眼眶动脉切除术系统，用于治疗周围动脉闭塞性动脉粥样硬化症患者和人工动静脉透析瘘管的狭窄材料。这些系统被禁止用于冠状动脉、旁路移植物、支架或血栓或解剖部位。虽然不良事件的发生率很少，但可能发生的潜在事件包括：疼痛，低血压， CVA / TIA ，死亡，解剖，穿孔，远端栓塞，血栓形成，血尿，突然或急性血管关闭，或动脉痉挛。有关程序、适应症、禁忌症、警告、注意事项、潜在不良事件等详细信息，请参见使用说明。有关更多信息，请致电 CSI ，电话：1-877-274-0901和/或咨询 CSI 网站 www.csi360.com 。
适应症： Diamondback 360®冠状动脉支架系统（ OAS ）是一种经皮轨道动脉直肠切除术系统，用于在冠状动脉疾病（ CAD ）患者中提供支架，这些患者可接受 PTCA 或支架，因为冠状动脉病变严重钙化。
禁忌：当 ViperWire ®导丝不能穿过冠状动脉病变或目标病变位于旁路移植物或支架内时，禁止使用 OAS 。当病人不适合接受旁路手术、血管成形术或动脉切除治疗，或有血栓的血管造影证据，或只有一个开放血管，或有血管造影证据表明在治疗场所和孕妇或儿童有重大解剖时， OAS 是禁忌的。
警告/预防措施：对过度扭曲的血管或分叉进行治疗可能导致血管损伤； OAS 仅在严重钙化病变中进行评估。在治疗右冠状动脉和环曲动脉病变时，可能需要临时起搏导线；应将现场外科手术备份作为临床考虑因素；射血分数( EF )低于25%的患者未进行评估。有关程序、适应症、禁忌症、警告、预防措施和潜在不良事件的详细信息，请参见实施 Diamondback 360冠状动脉造影程序前的使用说明。有关更多信息，请致电 CSI ，电话：1-877-274-0901和/或咨询 CSI 网站 www.csi360.com 。
非 GAAP 财务指标
为了补充 CSI 根据一般公认会计原则（GAAP）编制的合并简明财务报表， CSI 在本新闻稿中使用了一种非非一般公认会计原则（non-GAAP）财务指标，称为“调整 EBITDA ”。
CSI 采用的非 GAAP 财务指标的使用与经济实质及非 GAAP 财务指标对投资者的有用性
CSI 将调整后的 EBITDA 作为业绩的补充衡量指标，并认为该衡量指标通过排除折旧摊销费用和股票薪酬等非现金费用带来的潜在差异，促进了各期和公司对公司的经营业绩比较。CSI 的管理层使用经调整的 EBITDA 分析 CSI 业务的潜在趋势，评估 CSI 核心运营的业绩，制定用于分配资源和评估 CSI 在一段时间内的业绩周期以及与竞争对手经营业绩相关的运营目标和预测。此外， CSI 管理层在确定其激励薪酬业绩目标实现情况时，根据调整后的 EBITDA 进行评估。
中证证券认为，列报经调整的 EBITDA 为投资者提供了更大的透明度，使投资者能够更好地了解中证证券管理层在财务和运营决策方面所使用的信息，并使投资者能够“通过管理层的眼睛”看到中证证券的业绩。中证证券还认为，提供这些信息更好地使中证证券的投资者能够了解中证证券的经营业绩，并评估中证证券管理层用于评估和衡量此类业绩的方法。
以下为管理层不计入经调整 EBITDA 的各项项目的说明及不计入各单项项目的原因：
股份补偿。CSI 将基于股票的补偿费用排除在其非非一般公认会计原则（non-GAAP）财务指标之外，主要是因为此类费用虽然构成持续和经常性费用，但不是需要现金结算的费用。CSI 的管理层还认为，将本项目排除在 CSI 非非一般公认会计原则（non-GAAP）业绩之外，对于投资者了解基于股票的薪酬指导的应用及其对 CSI 的运营业绩、流动性及其对公司进行额外投资的能力的影响非常有用。它允许 CSI 财务报表中某些行项目具有更大的透明度。
折旧及摊销费用。CSI 将折旧和摊销费用排除在其非非一般公认会计原则（non-GAAP）财务指标之外，主要是因为此类费用虽然构成持续和经常性费用，但不是需要现金结算的费用，也不是 CSI 管理层用于评估 CSI 业务运营的核心盈利能力的费用。CSI 的管理层还认为，将这些项目排除在 CSI 非非一般公认会计原则（non-GAAP）业绩之外，对于投资者了解 CSI 的经营业绩、流动性及其对公司进行额外投资的能力是有用的。
与使用非 GAAP 财务措施相关的实质性限制和 CSI 对这些限制进行补偿的方式
非 GAAP 财务指标作为分析工具具有局限性，不应单独考虑或代替 CSI 根据一般公认会计原则（GAAP）编制的财务业绩。与 CSI 使用这些非非一般公认会计原则（non-GAAP）财务指标相关的一些限制是：
股票补偿等项目不直接影响 CSI 的现金流状况，但是，这些项目反映了 CSI 的经济成本，不反映在 CSI 的“调整后 EBITDA ”中，因此这些非非一般公认会计原则（non-GAAP）措施不反映这些项目的全部经济影响。
非 GAAP 财务指标不是基于任何一套全面的会计规则或原则，因此其他公司可以计算类似标题的非非一般公认会计原则（non-GAAP）财务指标不同于 CSI ，限制了这些指标的用途比较。
CSI 的管理层在确定哪些类型的收费或其他项目应排除在非非一般公认会计原则（non-GAAP）财务指标 CSI 使用之外时作出判断。CSI 通过主要依赖其非一般公认会计原则（non-GAAP）结果和仅补充使用非一般公认会计原则（GAAP）财务指标来补偿这些限制。CSI 提供了每个非非一般公认会计原则（non-GAAP）财务指标的完整披露。
CSI 使用和详细核对每个非非一般公认会计原则（non-GAAP）措施，以其最直接可比的一般公认会计原则（GAAP）措施。CSI 鼓励投资者审查这些对账。CSI 有资格使用非非一般公认会计原则（non-GAAP）财务措施，并有上述警告声明。
查看 businesswire 上的源代码。com : https://www.businesswire.com/news/home/20190130050031/en/
j 。nielsen @ csi360.com
马特。sullivan @ padillaco.com