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"Nurses are at the center of delivering a quality, compassionate patient care experience. AMN Healthcare is honored to recognize the exceptional service of nurses throughout the world this week," said Susan Salka, AMN Healthcare President and CEO.  "We are also very proud that some of the finest nurses in the country have or are currently working with the AMN team providing outstanding care for our clients. Their commitment to their profession and their advocacy for patients and their families is inspiring to us all." Per diem and travel nurses have always been an essential part of any effective healthcare system and are becoming increasingly important as the healthcare industry faces a growing nurse shortage and increased need for workforce flexibility. Research confirms that per diem and travel nurses provide quality of care that is equivalent to their permanent counterparts. The following four outstanding AMN travel nurses were chosen by a committee of AMN clients, clinicians and recruiters. These nurses showed an unwavering commitment to excellence in the nursing profession that goes far beyond their job requirements. The nominations were a testament to the high quality of nurses that AMN Healthcare has on assignment. The Innovation Award went to Jennifer Ordonez, RN BSN, an ICU Nurse on assignment in Palm Springs, CA, for her ongoing pursuit of personal and professional excellence through innovation and the advancement of patient care. As her nomination stated, "Jennifer goes beyond the care and comfort of the patient to provide life-changing care. This is the definition of excellence." The Passion Award for exemplifying the highest standards of professional excellence through leadership and extraordinary commitment to service throughout their healthcare community went to Allison Griffin, RN, BLS, CHEMO, PALS, PMD, a Pediatric Nurse on assignment in Boston, MA. Allison was selected because she "is able to impact the lives of the children and their families with her care and compassion in a meaningful way each and every day!" The Customer Focus Award for demonstrating an unwavering dedication to the improvement of patient care across all specialties and embodying the core values of the nursing profession in actions and words went to Sandra Shrago, RN, ACLS, BSN, an ICU Nurse on assignment at NewYork-Presbyterian/ Columbia University Medical Center in New York, NY. Sandra was nominated for this award because she "encompasses all that nursing should represent, going above and beyond what is standard, setting a bar for herself, for her care of others. Her amiable demeanor, warm smile and linguistic adeptness proves to be a pleasure and an asset." The Overall Commitment to Excellence Award for all of these qualities, and continually striving to improve patient care through education and innovation, displaying an unmatched passion for the profession was given to Sonia Washington, RN, ACLS, BLS, PALS, an ICU Nurse on assignment at Hilo Medical Center in Hilo, HI. "Sonia's respect of patients, families, physicians, and quick adaption to local culture make her shine," said Sonia's supervisors at Hilo Medical Center. "Sonia demonstrated the professional conduct and compassion our ICU Beacon Status department is known for and expects. Sonia has an outgoing personality, participates in our teamwork philosophy… and works above and beyond as a patient advocate." NewYork-Presbyterian NewYork-Presbyterian is one of the nation's most comprehensive, integrated academic healthcare delivery systems, whose organizations are dedicated to providing the highest quality, most compassionate care and service to patients in the New York metropolitan area, nationally, and throughout the globe. In collaboration with two renowned medical schools, Weill Cornell Medicine and Columbia University Medical Center, NewYork-Presbyterian is consistently recognized as a leader in medical education, groundbreaking research and innovative, patient-centered clinical care. For more information, visit www.nyp.org and on Facebook, Twitter and YouTube. Hilo Medical Center As the Big Island's leading provider of nationally recognized 4-star care, Hilo Medical Center (HMC) delivers a full range of services and programs. Our 20-acre campus consists of 276 beds located throughout the 137-bed acute hospital, 20-bed behavioral health unit and a 119-bed long-term care facility. We have over 1,000 employees and a medical staff comprised of 250 physicians, physician assistants and Advanced Practice Registered Nurses, representing 33 specialties. As a medical center, we have a network of nine outpatient clinics offering primary and specialty care. The hospital is a Level III Trauma Center which includes the second busiest emergency room in the state that provides 24-hour care to nearly 48,000 patients annually. In 2016, the Centers for Medicare & Medicaid Services (CMS) ranked HMC 4 stars for Overall Hospital Quality, putting our hospital in the top 20% in the nation, among the top 5 hospitals in the state, and named HMC the only 4-star hospital on Hawaii Island. Also in 2016, our Intensive Care Unit was designated as a bronze level for Beacon Award of Excellence – only the second ICU in the state to receive this designation. HMC received the 2016 American Heart Association Gold Plus Award for heart failure. HMC has also been recognized for quality long term care by Providigm for Quality Assurance & Performance Improvement Accredited Facility and Embracing Quality Award for the Prevention of Hospital Readmissions. Our long term care met the requirements for the American Health Care Association's Three Tier Level Quality Initiative Recognition Program. HMC ranks in the top 2% of hospitals in country and best in the state of Hawaii for preventing Hospital Acquired Conditions, according to CMS in 2015. The hospital is also a recipient of the 2015 Healthgrades Patient Safety Excellence Award™ and a past recipient of the Mountain Pacific Quality Health's Quality Achievement Award. HMC received the HIMSS Nicholas E. Davies Award for Excellence in 2015 for demonstrating EMR utilization to improve quality of care and financial management. We are part of the Hawaii Health Systems Corporation, a public entity established in 1996 by the State of Hawaii to fulfill the promise to provide quality, hometown healthcare. For more information, go to: www.hilomedicalcenter.org. About AMN Healthcare AMN Healthcare is the leader and innovator in healthcare workforce solutions and staffing services to healthcare facilities across the nation. The Company provides unparalleled access to the most comprehensive network of quality healthcare professionals through its innovative recruitment strategies and breadth of career opportunities. With insights and expertise, AMN Healthcare helps providers optimize their workforce to successfully reduce complexity, increase efficiency, and improve patient outcomes. AMN delivers managed services programs, healthcare executive search solutions, vendor management systems, recruitment process outsourcing, predictive modeling, medical coding and consulting, and other services. Clients include acute-care hospitals, community health centers and clinics, physician practice groups, retail and urgent care centers, home health facilities, and many other healthcare settings. For more information about AMN Healthcare, visit www.amnhealthcare.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/national-nurses-week-amn-healthcare-commitment-to-excellence-awards-recognize-importance-of-nurses-in-patient-care-300456603.html


Dr. Frank J. Overdyk, Chairman of the AAMI Foundation's National Coalition to Promote Continuous Monitoring of Patients on Opioids, outlined the critical role continuous monitoring plays in early detection of clinical deterioration on general floors. He highlighted proven strategies for successful implementation and cited key clinical and financial evidence for continuous monitoring, including reduced patient length of stay and fewer ICU days for patients transferred from EarlySense-equipped medical/surgical floors. "A significant percentage of in-hospital unplanned mortality is preventable, and early detection of clinical deterioration coupled with timely intervention helps prevent cardiac arrests and death," said Dr. Overdyk. "Hospitals that have implemented continuous monitoring have successfully reduced complications leading to cardiopulmonary arrest. It is clear that continuous monitoring is poised to become a standard of patient care, and ongoing dialogue regarding effective implementation strategies and best practices will further propel the global adoption of this standard." ISRRS, the largest international conference supporting rapid response systems across the globe, brought together clinicians and researchers from around the world to explore frontiers in rapid response, earlier detection of clinical deterioration, and using patient monitoring as a clinical support tool. Dr. Eyal Zimlichman, Chief Medical Officer of Israel's Sheba Medical Center, discussed emerging non-invasive monitoring technologies, presenting aggregated statistics from two U.S. hospitals that have used the EarlySense system to monitor approximately 10,000 patients. The data provides new insight regarding normal ranges of respiration rate and heart rate on general care floors, as well as maximal values, depending on age and comorbidities. "Contact-free continuous monitoring provides an opportunity for clinical teams to intervene in a timely manner, but must be implemented properly to avoid alarm fatigue," said Dr. Zimlichman. "Our findings point to the appropriate threshold settings to minimize alert fatigue on general care floors. Vitals statistics provided by continuous monitoring can significantly improve management of an alerting system, by incorporating demographic-dependent thresholds and trends." Approximately 2% of patients on general care floors, totaling about 240,000 patients per year, are admitted to ICUs or unexpectedly die[i] . Given that these unplanned events are typically preceded by hemodynamic antecedents in the 4-8 hour window prior to the event, early intervention can prevent such adverse events and patient deterioration. Dr. Zimlichman discussed several examples of successful continuous monitoring programs and lessons learned regarding workflow, involvement of multi-disciplinary project teams, and staff education and buy-in. For more information about these presentations, please contact Maayan.wenderow@earlysense.com. EarlySense provides contact-free, continuous monitoring solutions for the medical and consumer digital health markets. EarlySense's patented sensor and advanced algorithms monitor and analyze cardiac, respiratory and motion parameters. Used in hospitals and healthcare facilities worldwide, EarlySense assists clinicians in early detection of patient deterioration, helping to prevent adverse events, including code blues, preventable ICU transfers, patient falls and pressure ulcers. LIVE by EarlySense is the first home health and sleep monitor powered by medically-proven, contact-free, continuous monitoring technology. The company's OEM technology is also at the core of wellness and sleep products marketed by international partners including Samsung, Beurer and iFit. EarlySense was founded in 2004 and has offices in Waltham, MA, and Ramat Gan, Israel. For more information, please visit http://www.earlysense.com and http://www.livebyearlysense.com. i. Thierry Boulain et al. Patients Hospitalized in General Wards via the Emergency Department: Early Identification of Predisposing Factors for Death or Unexpected Intensive Care Unit Admission-A Historical Prospective. Emerg Med Int. 2014; 2014: 203747.


News Article | May 9, 2017
Site: globenewswire.com

DANVERS, Mass., May 09, 2017 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced the debut of the 3rd Generation Impella CP heart pump at the Annual meeting of the Society for Cardiovascular and Angiography Interventions (SCAI 2017) in New Orleans, LA. The technology offers new features for optimal care during a percutaneous coronary intervention (PCI) in high-risk patients known as a Protected PCI, and for patients being treated with Impella in the intensive care unit (ICU). The 3rd Generation Impella CP is a member of the Impella family of heart pumps which have the unique ability to unload the heart and enable native heart recovery, potentially allowing patients to return home with their own hearts. As the world’s smallest heart pump, the Impella platform has supported more than 50,000 patients in the U.S. alone, and is the only Food and Drug Administration (FDA)-approved percutaneous ventricular assist device (pVAD) indicated as safe and effective for PCI in high-risk patients1 and patients with Acute Myocardial Infarction complicated by Cardiogenic Shock (AMICS)2. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/2c12e27d-b221-4a86-95d9-a2a8db4b4fac Higher flows and ability to maintain access to arteriotomy There are several new features on the Impella CP 3rd Generation that simplify patient management: “The ability to introduce the Impella device simply and swiftly even in the presence of challenging femoral or iliac arteries will be valuable for interventional cardiologists caring for high-risk patients during PCI and for those in cardiogenic shock,” explained Seth Bilazarian M.D., FACC, FSCAI, Chief Medical Officer of Abiomed and experienced interventional cardiologist. He continued, “Enhanced flows will be very useful, as will the new guide wire repositioning unit which expands the options for access site closure or device exchanges.” The ability to maintain access to the arteriotomy is particularly vital to the care of patients supported by the Impella device in the ICU long-term, such as those in cardiogenic shock. In addition, the Impella CP 3rd Generation heart pump offers fewer steps when flushing the system as part of standard maintenance. "It’s intuitive and user-friendly,” said Christiana Gartner, RN, a Nurse Educator and experienced ICU nurse with extensive Impella experience at Greenville Health System who had the opportunity to test features of the 3rd Generation CP. She continued, “It's a time saver; you don’t question what's coming next. This software will make it easier to take care of your patient in the ICU." Like all Impella heart pumps for the left side, the 3rd Generation CP® devices are designed for optimal positioning in the left ventricle and feature a flexible catheter, radiopaque marker, cannula shape and pigtail. The 3rd Generation Impella CP devices are now available in the U.S. Real-world data suggest improvement in outcomes, but also significant underuse of Impella Technology Since the Impella® platform received Pre-Market Approval (PMA) from the United States FDA for AMICS in April, 20162, Abiomed has continued tracking best practice data in the Impella Quality (IQ) Assurance Program, a real-world collection of clinical information derived from the treatment of patients with Impella devices since 2008. Results reveal that across sites using Impella devices to treat AMICS: “These additions to the Impella CP represent the continuous innovation and commitment to patients that you’ve known since Impella was first introduced nine years ago,” said Abiomed President, Chairman and Chief Executive Officer Michael R. Minogue. “We continue to believe that data-driven insights and clinical expertise, along with our 24x7 onsite and on-call support, can help hospitals improve patient outcomes and reduce costs.” The 3rd Generation Impella CP® heart pumps will be available for viewing at Booth # 404 beginning on May 10. During SCAI, we anticipate the opportunity to view three live cases that feature use of the Impella device. As part of the conference agenda, experienced users of Impella devices will also lead discussions on critical industry challenges including: The Impella 2.5®, Impella CP® and Impella 5.0® are FDA-approved heart pumps used to treat heart attack patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own hearts. The Impella 2.5 and Impella CP devices are also approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. Abiomed's right-side heart pump, the Impella RP® device, is approved to treat certain patients experiencing right heart failure. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com. The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries. ABOUT ABIOMED  Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com. This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.


News Article | May 9, 2017
Site: globenewswire.com

DANVERS, Mass., May 09, 2017 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced the debut of the 3rd Generation Impella CP heart pump at the Annual meeting of the Society for Cardiovascular and Angiography Interventions (SCAI 2017) in New Orleans, LA. The technology offers new features for optimal care during a percutaneous coronary intervention (PCI) in high-risk patients known as a Protected PCI, and for patients being treated with Impella in the intensive care unit (ICU). The 3rd Generation Impella CP is a member of the Impella family of heart pumps which have the unique ability to unload the heart and enable native heart recovery, potentially allowing patients to return home with their own hearts. As the world’s smallest heart pump, the Impella platform has supported more than 50,000 patients in the U.S. alone, and is the only Food and Drug Administration (FDA)-approved percutaneous ventricular assist device (pVAD) indicated as safe and effective for PCI in high-risk patients1 and patients with Acute Myocardial Infarction complicated by Cardiogenic Shock (AMICS)2. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/2c12e27d-b221-4a86-95d9-a2a8db4b4fac Higher flows and ability to maintain access to arteriotomy There are several new features on the Impella CP 3rd Generation that simplify patient management: “The ability to introduce the Impella device simply and swiftly even in the presence of challenging femoral or iliac arteries will be valuable for interventional cardiologists caring for high-risk patients during PCI and for those in cardiogenic shock,” explained Seth Bilazarian M.D., FACC, FSCAI, Chief Medical Officer of Abiomed and experienced interventional cardiologist. He continued, “Enhanced flows will be very useful, as will the new guide wire repositioning unit which expands the options for access site closure or device exchanges.” The ability to maintain access to the arteriotomy is particularly vital to the care of patients supported by the Impella device in the ICU long-term, such as those in cardiogenic shock. In addition, the Impella CP 3rd Generation heart pump offers fewer steps when flushing the system as part of standard maintenance. "It’s intuitive and user-friendly,” said Christiana Gartner, RN, a Nurse Educator and experienced ICU nurse with extensive Impella experience at Greenville Health System who had the opportunity to test features of the 3rd Generation CP. She continued, “It's a time saver; you don’t question what's coming next. This software will make it easier to take care of your patient in the ICU." Like all Impella heart pumps for the left side, the 3rd Generation CP® devices are designed for optimal positioning in the left ventricle and feature a flexible catheter, radiopaque marker, cannula shape and pigtail. The 3rd Generation Impella CP devices are now available in the U.S. Real-world data suggest improvement in outcomes, but also significant underuse of Impella Technology Since the Impella® platform received Pre-Market Approval (PMA) from the United States FDA for AMICS in April, 20162, Abiomed has continued tracking best practice data in the Impella Quality (IQ) Assurance Program, a real-world collection of clinical information derived from the treatment of patients with Impella devices since 2008. Results reveal that across sites using Impella devices to treat AMICS: “These additions to the Impella CP represent the continuous innovation and commitment to patients that you’ve known since Impella was first introduced nine years ago,” said Abiomed President, Chairman and Chief Executive Officer Michael R. Minogue. “We continue to believe that data-driven insights and clinical expertise, along with our 24x7 onsite and on-call support, can help hospitals improve patient outcomes and reduce costs.” The 3rd Generation Impella CP® heart pumps will be available for viewing at Booth # 404 beginning on May 10. During SCAI, we anticipate the opportunity to view three live cases that feature use of the Impella device. As part of the conference agenda, experienced users of Impella devices will also lead discussions on critical industry challenges including: The Impella 2.5®, Impella CP® and Impella 5.0® are FDA-approved heart pumps used to treat heart attack patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own hearts. The Impella 2.5 and Impella CP devices are also approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. Abiomed's right-side heart pump, the Impella RP® device, is approved to treat certain patients experiencing right heart failure. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com. The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries. ABOUT ABIOMED  Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com. This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.


News Article | May 10, 2017
Site: www.accesswire.com

BEDMINSTER, NJ / ACCESSWIRE / May 10, 2017 / CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today provided its corporate update for the first quarter ended March 31, 2017. CorMedix will host a conference call today, May 10, 2017, at 4:30 p.m. Eastern Time to discuss the Company's recent corporate developments and financial results. Khoso Baluch, Chief Executive Officer of CorMedix, said, "We are continuing to advance Neutrolin®, our broad-spectrum, non-antibiotic anti-infective solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, toward the U.S. and international markets. Our ongoing Phase 3 trial, LOCK-IT 100, continues to enroll patients with end-stage renal disease receiving hemodialysis through a central venous catheter, and an independent data safety and monitoring unanimously concluded it was safe to continue patient enrollment based on safety data from the first 279 patients. We currently anticipate exceeding our original enrollment target of 632 patients by the fourth quarter of 2017, and will continue to enroll additional patients until the requisite number of catheter-related bloodstream infections occur in this event-driven Phase 3 study. An interim efficacy analysis is currently anticipated by the end of the year, which would give us our first look into Neutrolin's potential to reduce catheter-related bloodstream infections in the study population." "In addition to advancing Neutrolin in the U.S., we were pleased to announce that we'd secured our first European commercial collaboration with Hemotech SAS to launch Neutrolin in France and French overseas territories. This enables CorMedix to leverage Hemotech's nearly 30 years of experience and significant presence, which includes 92% of all French dialysis organizations as well as major hospitals, where Neutrolin's CE Marking allows it to be marketed as a catheter lock solution for oncology and ICU patients with central venous catheters. We intend to pursue additional partnerships designed to further expand ex-U.S. sales of Neutrolin and begin augmenting our commercial presence in Europe. We expect to begin generating initial sales revenue over the quarters to come, which over time may partially offset our operational and clinical development costs in the U.S." Mr. Baluch continued, "CorMedix is committed to taking advantage of additional opportunities to generate value based on taurolidine, the active component of Neutrolin. A particular area of focus is in the medical device space, where taurolidine may be incorporated into various medical and surgical materials to confer antimicrobial or anti-inflammatory properties. Based on initial feasibility work, we are advancing preclinical studies for three product candidates: surgical meshes, suture materials, and hydrogels. We expect to develop and pursue FDA clearance for these potential products by the 510(k) pathway and will seek to establish development/commercial partnerships as these programs advance. A more robust 'R&D day' event will be scheduled within the coming months to discuss these and our ongoing oncology collaboration in greater detail." For the first quarter 2017, the Company recorded a net loss of $7.6 million, or $0.19 per share, compared with a net loss of $4.1 million, or $0.11 per share for the first quarter 2016. Operating expenses in the first quarter 2017 were $7.6 million, compared with $6.5 million in the fourth quarter of 2016. The increase was due to an increase in both R&D and G&A expense. Our cash used in operations in the first quarter 2017 was $6.8 million, compared with $6.5 million in the fourth quarter 2016. Cash was used primarily to conduct our Phase 3 study of Neutrolin, other R&D and related G&A activities. Our operating cash burn was funded primarily via drawdown of our cash on hand. Approximately $0.3 million was provided by the use of the Company's "At the Market" program during January 2017. CorMedix recently completed a public offering of common stock and warrants resulting in gross proceeds of $14 million, before deducting underwriting discounts and commissions and estimated offering expenses. The offering included the full exercise of underwriter H.C. Wainwright and Co.'s option to purchase additional shares of common stock and warrants from CorMedix. Mr. Baluch concluded, "We are dedicated to bringing Neutrolin to market, to help prevent potentially deadly catheter-related blood stream infections in already vulnerable patient populations in the U.S. and abroad. Our recent financing adds fuel to continue our U.S. pivotal clinical program, while in parallel, we're continuing to enhance our focus on driving additional value through European commercialization and advancement of our taurolidine-based therapeutic and medical device pipeline." Please call five minutes before the conference call is scheduled to begin. The live audio webcast will be accessible via the Events section of the CorMedix website. A replay of the teleconference will be available until 11:59 p.m. on May 17, 2017. CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin is currently in a Phase 3 clinical trial in patients undergoing chronic hemodialysis via a central venous catheter. The Company is planning to conduct its second Phase 3 clinical trial in patients with cancer receiving IV parenteral nutrition, chemotherapy and hydration via a chronic central venous catheter, subject to sufficient resources. If successful, the two pivotal studies may be submitted to the FDA for potential approval for both patient populations. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity upon U.S. approval. It is already a CE Marked product in Europe and other territories. For more information, visit: www.cormedix.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the timing and results of the planned interim efficacy analyses of the LOCK-IT 100 trial and the impact of those results on that trial; the cost, timing and results of the planned and ongoing Phase 3 trials for Neutrolin® in the U.S., including variances in the expected rate of CRBSI events, and the resources needed to commence and complete those trials; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; CorMedix's ability to obtain financing to support its research and development and clinical activities and operations; the risks associated with the launch of Neutrolin in new markets; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including the planned Phase 3 trial of Neutrolin in oncology patients and the marketing of Neutrolin in countries other than Europe; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's dependence on its collaborations and its license relationships; CorMedix's ability to maintain its listing on the NYSE MKT; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.


News Article | May 10, 2017
Site: marketersmedia.com

Completed independent Data and Safety Monitoring Board (DSMB) review for Phase 3 "LOCK-IT 100" study of Neutrolin® in hemodialysis patients; Enrollment on track to exceed original target of 632 patients by 4Q17 Currently in discussion with FDA regarding possible prospective changes to the LOCK-IT 100 trial protocol; FDA agreed to include interim efficacy analyses while the trial is ongoing Secured first European commercial collaboration with Hemotech SAS to launch and market Neutrolin in France and French overseas territories Raised $14 million in gross proceeds in a public offering of shares and warrants Demonstrated taurolidine effectiveness at killing emerging global health threat C. auris Advancing studies of taurolidine-infused antimicrobial medical materials: sutures, nanofiber meshes, hydrogels Conduct LOCK-IT 100 interim efficacy analysis, potentially in 4Q17 pending attainment of the requisite number of bloodstream infections in the study Complete enrollment for LOCK-IT 100 in 2Q18; Report top-line data in the second half of 2018 Host R&D day to discuss advances to taurolidine-based therapeutic and medical device pipeline in 3Q17 BEDMINSTER, NJ / ACCESSWIRE / May 10, 2017 / CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today provided its corporate update for the first quarter ended March 31, 2017. CorMedix will host a conference call today, May 10, 2017, at 4:30 p.m. Eastern Time to discuss the Company's recent corporate developments and financial results. Khoso Baluch, Chief Executive Officer of CorMedix, said, "We are continuing to advance Neutrolin®, our broad-spectrum, non-antibiotic anti-infective solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, toward the U.S. and international markets. Our ongoing Phase 3 trial, LOCK-IT 100, continues to enroll patients with end-stage renal disease receiving hemodialysis through a central venous catheter, and an independent data safety and monitoring unanimously concluded it was safe to continue patient enrollment based on safety data from the first 279 patients. We currently anticipate exceeding our original enrollment target of 632 patients by the fourth quarter of 2017, and will continue to enroll additional patients until the requisite number of catheter-related bloodstream infections occur in this event-driven Phase 3 study. An interim efficacy analysis is currently anticipated by the end of the year, which would give us our first look into Neutrolin's potential to reduce catheter-related bloodstream infections in the study population." "In addition to advancing Neutrolin in the U.S., we were pleased to announce that we'd secured our first European commercial collaboration with Hemotech SAS to launch Neutrolin in France and French overseas territories. This enables CorMedix to leverage Hemotech's nearly 30 years of experience and significant presence, which includes 92% of all French dialysis organizations as well as major hospitals, where Neutrolin's CE Marking allows it to be marketed as a catheter lock solution for oncology and ICU patients with central venous catheters. We intend to pursue additional partnerships designed to further expand ex-U.S. sales of Neutrolin and begin augmenting our commercial presence in Europe. We expect to begin generating initial sales revenue over the quarters to come, which over time may partially offset our operational and clinical development costs in the U.S." Mr. Baluch continued, "CorMedix is committed to taking advantage of additional opportunities to generate value based on taurolidine, the active component of Neutrolin. A particular area of focus is in the medical device space, where taurolidine may be incorporated into various medical and surgical materials to confer antimicrobial or anti-inflammatory properties. Based on initial feasibility work, we are advancing preclinical studies for three product candidates: surgical meshes, suture materials, and hydrogels. We expect to develop and pursue FDA clearance for these potential products by the 510(k) pathway and will seek to establish development/commercial partnerships as these programs advance. A more robust 'R&D day' event will be scheduled within the coming months to discuss these and our ongoing oncology collaboration in greater detail." For the first quarter 2017, the Company recorded a net loss of $7.6 million, or $0.19 per share, compared with a net loss of $4.1 million, or $0.11 per share for the first quarter 2016. Operating expenses in the first quarter 2017 were $7.6 million, compared with $6.5 million in the fourth quarter of 2016. The increase was due to an increase in both R&D and G&A expense. Our cash used in operations in the first quarter 2017 was $6.8 million, compared with $6.5 million in the fourth quarter 2016. Cash was used primarily to conduct our Phase 3 study of Neutrolin, other R&D and related G&A activities. Our operating cash burn was funded primarily via drawdown of our cash on hand. Approximately $0.3 million was provided by the use of the Company's "At the Market" program during January 2017. CorMedix recently completed a public offering of common stock and warrants resulting in gross proceeds of $14 million, before deducting underwriting discounts and commissions and estimated offering expenses. The offering included the full exercise of underwriter H.C. Wainwright and Co.'s option to purchase additional shares of common stock and warrants from CorMedix. Mr. Baluch concluded, "We are dedicated to bringing Neutrolin to market, to help prevent potentially deadly catheter-related blood stream infections in already vulnerable patient populations in the U.S. and abroad. Our recent financing adds fuel to continue our U.S. pivotal clinical program, while in parallel, we're continuing to enhance our focus on driving additional value through European commercialization and advancement of our taurolidine-based therapeutic and medical device pipeline." Please call five minutes before the conference call is scheduled to begin. The live audio webcast will be accessible via the Events section of the CorMedix website. A replay of the teleconference will be available until 11:59 p.m. on May 17, 2017. CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin is currently in a Phase 3 clinical trial in patients undergoing chronic hemodialysis via a central venous catheter. The Company is planning to conduct its second Phase 3 clinical trial in patients with cancer receiving IV parenteral nutrition, chemotherapy and hydration via a chronic central venous catheter, subject to sufficient resources. If successful, the two pivotal studies may be submitted to the FDA for potential approval for both patient populations. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity upon U.S. approval. It is already a CE Marked product in Europe and other territories. For more information, visit: www.cormedix.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the timing and results of the planned interim efficacy analyses of the LOCK-IT 100 trial and the impact of those results on that trial; the cost, timing and results of the planned and ongoing Phase 3 trials for Neutrolin® in the U.S., including variances in the expected rate of CRBSI events, and the resources needed to commence and complete those trials; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; CorMedix's ability to obtain financing to support its research and development and clinical activities and operations; the risks associated with the launch of Neutrolin in new markets; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including the planned Phase 3 trial of Neutrolin in oncology patients and the marketing of Neutrolin in countries other than Europe; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's dependence on its collaborations and its license relationships; CorMedix's ability to maintain its listing on the NYSE MKT; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. CORMEDIX INC. AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) CORMEDIX INC. AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) Proceeds from sale of common stock from at-the-market program Completed independent Data and Safety Monitoring Board (DSMB) review for Phase 3 "LOCK-IT 100" study of Neutrolin® in hemodialysis patients; Enrollment on track to exceed original target of 632 patients by 4Q17 Currently in discussion with FDA regarding possible prospective changes to the LOCK-IT 100 trial protocol; FDA agreed to include interim efficacy analyses while the trial is ongoing Secured first European commercial collaboration with Hemotech SAS to launch and market Neutrolin in France and French overseas territories Raised $14 million in gross proceeds in a public offering of shares and warrants Demonstrated taurolidine effectiveness at killing emerging global health threat C. auris Advancing studies of taurolidine-infused antimicrobial medical materials: sutures, nanofiber meshes, hydrogels Conduct LOCK-IT 100 interim efficacy analysis, potentially in 4Q17 pending attainment of the requisite number of bloodstream infections in the study Complete enrollment for LOCK-IT 100 in 2Q18; Report top-line data in the second half of 2018 Host R&D day to discuss advances to taurolidine-based therapeutic and medical device pipeline in 3Q17 BEDMINSTER, NJ / ACCESSWIRE / May 10, 2017 / CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today provided its corporate update for the first quarter ended March 31, 2017. CorMedix will host a conference call today, May 10, 2017, at 4:30 p.m. Eastern Time to discuss the Company's recent corporate developments and financial results. Khoso Baluch, Chief Executive Officer of CorMedix, said, "We are continuing to advance Neutrolin®, our broad-spectrum, non-antibiotic anti-infective solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, toward the U.S. and international markets. Our ongoing Phase 3 trial, LOCK-IT 100, continues to enroll patients with end-stage renal disease receiving hemodialysis through a central venous catheter, and an independent data safety and monitoring unanimously concluded it was safe to continue patient enrollment based on safety data from the first 279 patients. We currently anticipate exceeding our original enrollment target of 632 patients by the fourth quarter of 2017, and will continue to enroll additional patients until the requisite number of catheter-related bloodstream infections occur in this event-driven Phase 3 study. An interim efficacy analysis is currently anticipated by the end of the year, which would give us our first look into Neutrolin's potential to reduce catheter-related bloodstream infections in the study population." "In addition to advancing Neutrolin in the U.S., we were pleased to announce that we'd secured our first European commercial collaboration with Hemotech SAS to launch Neutrolin in France and French overseas territories. This enables CorMedix to leverage Hemotech's nearly 30 years of experience and significant presence, which includes 92% of all French dialysis organizations as well as major hospitals, where Neutrolin's CE Marking allows it to be marketed as a catheter lock solution for oncology and ICU patients with central venous catheters. We intend to pursue additional partnerships designed to further expand ex-U.S. sales of Neutrolin and begin augmenting our commercial presence in Europe. We expect to begin generating initial sales revenue over the quarters to come, which over time may partially offset our operational and clinical development costs in the U.S." Mr. Baluch continued, "CorMedix is committed to taking advantage of additional opportunities to generate value based on taurolidine, the active component of Neutrolin. A particular area of focus is in the medical device space, where taurolidine may be incorporated into various medical and surgical materials to confer antimicrobial or anti-inflammatory properties. Based on initial feasibility work, we are advancing preclinical studies for three product candidates: surgical meshes, suture materials, and hydrogels. We expect to develop and pursue FDA clearance for these potential products by the 510(k) pathway and will seek to establish development/commercial partnerships as these programs advance. A more robust 'R&D day' event will be scheduled within the coming months to discuss these and our ongoing oncology collaboration in greater detail." For the first quarter 2017, the Company recorded a net loss of $7.6 million, or $0.19 per share, compared with a net loss of $4.1 million, or $0.11 per share for the first quarter 2016. Operating expenses in the first quarter 2017 were $7.6 million, compared with $6.5 million in the fourth quarter of 2016. The increase was due to an increase in both R&D and G&A expense. Our cash used in operations in the first quarter 2017 was $6.8 million, compared with $6.5 million in the fourth quarter 2016. Cash was used primarily to conduct our Phase 3 study of Neutrolin, other R&D and related G&A activities. Our operating cash burn was funded primarily via drawdown of our cash on hand. Approximately $0.3 million was provided by the use of the Company's "At the Market" program during January 2017. CorMedix recently completed a public offering of common stock and warrants resulting in gross proceeds of $14 million, before deducting underwriting discounts and commissions and estimated offering expenses. The offering included the full exercise of underwriter H.C. Wainwright and Co.'s option to purchase additional shares of common stock and warrants from CorMedix. Mr. Baluch concluded, "We are dedicated to bringing Neutrolin to market, to help prevent potentially deadly catheter-related blood stream infections in already vulnerable patient populations in the U.S. and abroad. Our recent financing adds fuel to continue our U.S. pivotal clinical program, while in parallel, we're continuing to enhance our focus on driving additional value through European commercialization and advancement of our taurolidine-based therapeutic and medical device pipeline." Please call five minutes before the conference call is scheduled to begin. The live audio webcast will be accessible via the Events section of the CorMedix website. A replay of the teleconference will be available until 11:59 p.m. on May 17, 2017. CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin is currently in a Phase 3 clinical trial in patients undergoing chronic hemodialysis via a central venous catheter. The Company is planning to conduct its second Phase 3 clinical trial in patients with cancer receiving IV parenteral nutrition, chemotherapy and hydration via a chronic central venous catheter, subject to sufficient resources. If successful, the two pivotal studies may be submitted to the FDA for potential approval for both patient populations. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity upon U.S. approval. It is already a CE Marked product in Europe and other territories. For more information, visit: www.cormedix.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the timing and results of the planned interim efficacy analyses of the LOCK-IT 100 trial and the impact of those results on that trial; the cost, timing and results of the planned and ongoing Phase 3 trials for Neutrolin® in the U.S., including variances in the expected rate of CRBSI events, and the resources needed to commence and complete those trials; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; CorMedix's ability to obtain financing to support its research and development and clinical activities and operations; the risks associated with the launch of Neutrolin in new markets; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including the planned Phase 3 trial of Neutrolin in oncology patients and the marketing of Neutrolin in countries other than Europe; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's dependence on its collaborations and its license relationships; CorMedix's ability to maintain its listing on the NYSE MKT; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. CORMEDIX INC. AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) CORMEDIX INC. AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) Proceeds from sale of common stock from at-the-market program


News Article | May 10, 2017
Site: globenewswire.com

SAN CLEMENTE, Calif., May 10, 2017 (GLOBE NEWSWIRE) -- ICU Medical, Inc. (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy and critical care applications, today announced financial results for the quarter ended March 31, 2017. First quarter 2017 revenue was $247.7 million, compared to $89.9 million in the same period last year. GAAP gross profit for the first quarter of 2017 was $88.9 million, as compared to $49.2 million in the same period last year.  GAAP gross margin for the first quarter of 2017 was 36%, as compared to 55% in the same period last year.  GAAP net income for the first quarter of 2017 was $55.9 million, or $2.86 per diluted share, as compared to GAAP net income of $18.2 million, or $1.08 per diluted share, for the first quarter of 2016, which were both adjusted from the previously announced adoption of  FASB ASU 2016-09, Improvements to Employee Share-based Payment Accounting, effective January 1, 2016. Adjusted net sales for the first quarter of 2017 was $248.1 million. Adjusted gross profit for the first quarter of 2017 was $111.0 million.  Adjusted gross margin for the first quarter of 2017 was 45%.  Adjusted diluted earnings per share for the first quarter of 2017 were $1.68 as compared to $1.26 for the first quarter of 2016. Also, adjusted EBITDA was $50.1 million for the first quarter of 2017 as compared to $32.7 million for the first quarter of 2016. Adjusted net sales, adjusted gross profit, adjusted gross margin, adjusted diluted earnings per share and adjusted EBITDA are measures calculated and presented on the basis of methodologies other than in accordance with GAAP.  Please refer to the Use of Non-GAAP Financial Information following the financial statements herein for further discussion and reconciliations of these measures to GAAP measures. Vivek Jain, ICU Medical's Chief Executive Officer, said, "Revenues were in-line with our expectations and our adjusted EBITDA and adjusted earnings per share were slightly ahead of our expectations due to minor discrete accounting and tax benefits. Integration activities are progressing as planned.” Revenues by market segment for the three months ended March 31, 2017 and 2016 were as follows (in millions): The following market segment results for the first quarter of 2017 includes our legacy business and our Hospira Infusion Systems business from the point of closing of the acquisition, which was February 3, 2017, through the end of the first quarter of 2017. The Company ended the first quarter of 2017 with a strong balance sheet. As of March 31, 2017, cash and cash equivalents totaled $201.9 million, working capital was $725.9 million and long-term debt obligations of $75 million. The Company will host a conference call to discuss first quarter 2017 financial results today at 4:30 p.m. EDT (1:30 p.m. PDT).   The call can be accessed at (800) 936-9761, international (408) 774-4587, conference ID 13657052. The conference call will be simultaneously available by webcast, which can be accessed by going to the Company's website at www.icumed.com, clicking on the Investors tab, clicking on the Webcast icon and following the prompts. The webcast will also be available by replay. ICU Medical, Inc. (Nasdaq:ICUI) develops, manufactures and sells innovative medical devices used in vascular therapy, and critical care applications. ICU Medical's product portfolio includes IV smart pumps, sets, connectors, closed transfer devices for hazardous drugs, cardiac monitoring systems, along with pain management and safety software technology designed to help meet clinical, safety and workflow goals. ICU Medical is headquartered in San Clemente, California. More information about ICU Medical, Inc. can be found at www.icumed.com. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as ''will,'' ''expect,'' ''believe,'' ''could,'' ''would,'' ''estimate,'' ''continue,'' ''build,'' ''expand'' or the negative thereof or comparable terminology, and may include (without limitation) information regarding the Company's expectations, goals or intentions regarding the future, and our recently completed acquisition of the Hospira infusion systems business. These forward-looking statements are based on management's current expectations, estimates, forecasts and projections about the Company and assumptions management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to, decreased demand for the Company's products, decreased free cash flow, the inability to recapture conversion delays or part/resource shortages on anticipated timing, or at all, changes in product mix, increased competition from competitors, lack of continued growth or improving efficiencies, unexpected changes in the Company's arrangements with its largest customers and the Company’s ability to meet expectations regarding the integration of the Hospira infusion systems business. Future results are subject to risks and uncertainties, including the risk factors, and other risks and uncertainties, described in the Company's filings with the Securities and Exchange Commission, which include those in the Annual Report on Form 10-K for the year ended December 31, 2016 and our subsequent filings. Forward-looking statements contained in this press release are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise. ______________________________________________________ (1) December 31, 2016 balances were derived from audited consolidated financial statements. Use of Non-GAAP Financial Information This press release contains financial measures that are not calculated in accordance with U.S. generally accepted accounting principles ("GAAP").  The non-GAAP financial measures should be considered supplemental to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.  There are material limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may not be comparable to similarly titled non-GAAP financial measures used by other companies, including peer companies.  Our management believes that the non-GAAP data provides useful supplemental information to management and investors regarding our performance and facilitates a more meaningful comparison of results of operations between current and prior periods.  We use non-GAAP financial measures in addition to and in conjunction with GAAP financial measures to analyze and assess the overall performance of our business, in making financial, operating and planning decisions, and in determining executive incentive compensation.  The non-GAAP financial measures included in this press release are adjusted net sales, adjusted gross profit, adjusted gross profit margin, adjusted EBITDA and adjusted diluted earnings per share ("Adjusted Diluted EPS"). Adjusted net sales includes/excludes the following items from net sales: Excludes contract manufacturing revenue:  We manufacture certain products for Pfizer at cost in accordance with a manufacturing services agreement.  We do not include the contract manufacturing revenue in our adjusted net sales as the revenue under this agreement was negotiated contemporaneously with our acquisition of Hospira from Pfizer and is not indicative of a normal market transaction. Includes ICU intercompany sales to Hospira: We include intercompany sales to Hospira for inventory that we previously sold to Hospira, which remained on the opening balance sheet of Hospira after its acquisition by ICU. Adjusted gross profit excludes the following from gross profit: Adjustment to reverse the cost recognition related to the purchase accounting write-up of inventory to fair market value: The inventory step-up represents the expense recognition of fair value adjustments in excess of the historical cost basis of inventory obtained through acquisition, these charges are outside of our normal operations and are excluded. Adjusted gross profit margin is calculated using the adjusted gross profit as a percentage of the adjusted net sales as determined above. Adjusted EBITDA excludes the following items from net income: Interest, net:  We exclude interest in deriving adjusted EBITDA as interest can vary significantly among companies depending on a company's level of income generating instruments and/or level of debt. Intangible asset amortization expense:  We do not acquire businesses or capitalize certain patent costs on a predictable cycle.  The amount of purchase price allocated to intangible assets and the term of amortization can vary significantly and are unique to each acquisition.  Capitalized patent costs can vary significantly based on our current level of development activities.  We believe that excluding amortization of intangible assets provides the users of our financial statements with a consistent basis for comparison across accounting periods. Depreciation expense:  We exclude depreciation expense in deriving adjusted EBITDA because companies utilize productive assets of different ages and the depreciable lives can vary significantly resulting in considerable variability in depreciation  expense among companies. Stock compensation expense:  Stock-based compensation is generally fixed at the time the stock-based instrument is granted and amortized over a period of several years.  The value of stock options is determined using a complex formula that incorporates factors, such as market volatility, that are beyond our control.  The value of our restricted stock awards is determined using the grant date stock price, which may not be indicative of our operational performance over the expense period.  Additionally, in order to establish the fair value of performance-based stock awards, which are currently an element of our ongoing stock-based compensation, we are required to apply judgment to estimate the probability of the extent to which performance objectives will be achieved.  Based on the above factors, we believe it is useful to exclude stock-based compensation in order to better understand our operating performance. Restructuring and strategic transaction:  We incur restructuring and strategic transaction charges that result from events, which arise from unforeseen circumstances and/or often occur outside of the ordinary course of our ongoing business.  Although these events are reflected in our GAAP financial statements, these unique transactions may limit the comparability of our ongoing operations with prior and future periods. Bargain purchase gain:  We may incur a bargain purchase gain on certain acquisitions if the fair market value of the identifiable assets acquired and liabilities assumed, net of deferred taxes exceeds the total consideration paid.  We exclude such gains as they are related to acquisitions and have no direct correlation to the operation of our ongoing business. Adjusted Diluted EPS excludes from diluted EPS, net of tax, interest, net, intangible asset amortization expense, stock compensation expense, restructuring and strategic transaction, and bargain purchase gain, which was tax free.  We apply our GAAP consolidated effective tax rate to our non-GAAP financial measures, other than when the underlying item has a materially different tax treatment. From time to time in the future, there may be other items that we may exclude if we believe that doing so is consistent with the goal of providing useful information to investors and management. The following tables reconcile our GAAP and non-GAAP financial measures:


News Article | May 10, 2017
Site: globenewswire.com

SAN CLEMENTE, Calif., May 10, 2017 (GLOBE NEWSWIRE) -- ICU Medical, Inc. (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy and critical care applications, today announced financial results for the quarter ended March 31, 2017. First quarter 2017 revenue was $247.7 million, compared to $89.9 million in the same period last year. GAAP gross profit for the first quarter of 2017 was $88.9 million, as compared to $49.2 million in the same period last year.  GAAP gross margin for the first quarter of 2017 was 36%, as compared to 55% in the same period last year.  GAAP net income for the first quarter of 2017 was $55.9 million, or $2.86 per diluted share, as compared to GAAP net income of $18.2 million, or $1.08 per diluted share, for the first quarter of 2016, which were both adjusted from the previously announced adoption of  FASB ASU 2016-09, Improvements to Employee Share-based Payment Accounting, effective January 1, 2016. Adjusted net sales for the first quarter of 2017 was $248.1 million. Adjusted gross profit for the first quarter of 2017 was $111.0 million.  Adjusted gross margin for the first quarter of 2017 was 45%.  Adjusted diluted earnings per share for the first quarter of 2017 were $1.68 as compared to $1.26 for the first quarter of 2016. Also, adjusted EBITDA was $50.1 million for the first quarter of 2017 as compared to $32.7 million for the first quarter of 2016. Adjusted net sales, adjusted gross profit, adjusted gross margin, adjusted diluted earnings per share and adjusted EBITDA are measures calculated and presented on the basis of methodologies other than in accordance with GAAP.  Please refer to the Use of Non-GAAP Financial Information following the financial statements herein for further discussion and reconciliations of these measures to GAAP measures. Vivek Jain, ICU Medical's Chief Executive Officer, said, "Revenues were in-line with our expectations and our adjusted EBITDA and adjusted earnings per share were slightly ahead of our expectations due to minor discrete accounting and tax benefits. Integration activities are progressing as planned.” Revenues by market segment for the three months ended March 31, 2017 and 2016 were as follows (in millions): The following market segment results for the first quarter of 2017 includes our legacy business and our Hospira Infusion Systems business from the point of closing of the acquisition, which was February 3, 2017, through the end of the first quarter of 2017. The Company ended the first quarter of 2017 with a strong balance sheet. As of March 31, 2017, cash and cash equivalents totaled $201.9 million, working capital was $725.9 million and long-term debt obligations of $75 million. The Company will host a conference call to discuss first quarter 2017 financial results today at 4:30 p.m. EDT (1:30 p.m. PDT).   The call can be accessed at (800) 936-9761, international (408) 774-4587, conference ID 13657052. The conference call will be simultaneously available by webcast, which can be accessed by going to the Company's website at www.icumed.com, clicking on the Investors tab, clicking on the Webcast icon and following the prompts. The webcast will also be available by replay. ICU Medical, Inc. (Nasdaq:ICUI) develops, manufactures and sells innovative medical devices used in vascular therapy, and critical care applications. ICU Medical's product portfolio includes IV smart pumps, sets, connectors, closed transfer devices for hazardous drugs, cardiac monitoring systems, along with pain management and safety software technology designed to help meet clinical, safety and workflow goals. ICU Medical is headquartered in San Clemente, California. More information about ICU Medical, Inc. can be found at www.icumed.com. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as ''will,'' ''expect,'' ''believe,'' ''could,'' ''would,'' ''estimate,'' ''continue,'' ''build,'' ''expand'' or the negative thereof or comparable terminology, and may include (without limitation) information regarding the Company's expectations, goals or intentions regarding the future, and our recently completed acquisition of the Hospira infusion systems business. These forward-looking statements are based on management's current expectations, estimates, forecasts and projections about the Company and assumptions management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to, decreased demand for the Company's products, decreased free cash flow, the inability to recapture conversion delays or part/resource shortages on anticipated timing, or at all, changes in product mix, increased competition from competitors, lack of continued growth or improving efficiencies, unexpected changes in the Company's arrangements with its largest customers and the Company’s ability to meet expectations regarding the integration of the Hospira infusion systems business. Future results are subject to risks and uncertainties, including the risk factors, and other risks and uncertainties, described in the Company's filings with the Securities and Exchange Commission, which include those in the Annual Report on Form 10-K for the year ended December 31, 2016 and our subsequent filings. Forward-looking statements contained in this press release are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise. ______________________________________________________ (1) December 31, 2016 balances were derived from audited consolidated financial statements. Use of Non-GAAP Financial Information This press release contains financial measures that are not calculated in accordance with U.S. generally accepted accounting principles ("GAAP").  The non-GAAP financial measures should be considered supplemental to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.  There are material limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may not be comparable to similarly titled non-GAAP financial measures used by other companies, including peer companies.  Our management believes that the non-GAAP data provides useful supplemental information to management and investors regarding our performance and facilitates a more meaningful comparison of results of operations between current and prior periods.  We use non-GAAP financial measures in addition to and in conjunction with GAAP financial measures to analyze and assess the overall performance of our business, in making financial, operating and planning decisions, and in determining executive incentive compensation.  The non-GAAP financial measures included in this press release are adjusted net sales, adjusted gross profit, adjusted gross profit margin, adjusted EBITDA and adjusted diluted earnings per share ("Adjusted Diluted EPS"). Adjusted net sales includes/excludes the following items from net sales: Excludes contract manufacturing revenue:  We manufacture certain products for Pfizer at cost in accordance with a manufacturing services agreement.  We do not include the contract manufacturing revenue in our adjusted net sales as the revenue under this agreement was negotiated contemporaneously with our acquisition of Hospira from Pfizer and is not indicative of a normal market transaction. Includes ICU intercompany sales to Hospira: We include intercompany sales to Hospira for inventory that we previously sold to Hospira, which remained on the opening balance sheet of Hospira after its acquisition by ICU. Adjusted gross profit excludes the following from gross profit: Adjustment to reverse the cost recognition related to the purchase accounting write-up of inventory to fair market value: The inventory step-up represents the expense recognition of fair value adjustments in excess of the historical cost basis of inventory obtained through acquisition, these charges are outside of our normal operations and are excluded. Adjusted gross profit margin is calculated using the adjusted gross profit as a percentage of the adjusted net sales as determined above. Adjusted EBITDA excludes the following items from net income: Interest, net:  We exclude interest in deriving adjusted EBITDA as interest can vary significantly among companies depending on a company's level of income generating instruments and/or level of debt. Intangible asset amortization expense:  We do not acquire businesses or capitalize certain patent costs on a predictable cycle.  The amount of purchase price allocated to intangible assets and the term of amortization can vary significantly and are unique to each acquisition.  Capitalized patent costs can vary significantly based on our current level of development activities.  We believe that excluding amortization of intangible assets provides the users of our financial statements with a consistent basis for comparison across accounting periods. Depreciation expense:  We exclude depreciation expense in deriving adjusted EBITDA because companies utilize productive assets of different ages and the depreciable lives can vary significantly resulting in considerable variability in depreciation  expense among companies. Stock compensation expense:  Stock-based compensation is generally fixed at the time the stock-based instrument is granted and amortized over a period of several years.  The value of stock options is determined using a complex formula that incorporates factors, such as market volatility, that are beyond our control.  The value of our restricted stock awards is determined using the grant date stock price, which may not be indicative of our operational performance over the expense period.  Additionally, in order to establish the fair value of performance-based stock awards, which are currently an element of our ongoing stock-based compensation, we are required to apply judgment to estimate the probability of the extent to which performance objectives will be achieved.  Based on the above factors, we believe it is useful to exclude stock-based compensation in order to better understand our operating performance. Restructuring and strategic transaction:  We incur restructuring and strategic transaction charges that result from events, which arise from unforeseen circumstances and/or often occur outside of the ordinary course of our ongoing business.  Although these events are reflected in our GAAP financial statements, these unique transactions may limit the comparability of our ongoing operations with prior and future periods. Bargain purchase gain:  We may incur a bargain purchase gain on certain acquisitions if the fair market value of the identifiable assets acquired and liabilities assumed, net of deferred taxes exceeds the total consideration paid.  We exclude such gains as they are related to acquisitions and have no direct correlation to the operation of our ongoing business. Adjusted Diluted EPS excludes from diluted EPS, net of tax, interest, net, intangible asset amortization expense, stock compensation expense, restructuring and strategic transaction, and bargain purchase gain, which was tax free.  We apply our GAAP consolidated effective tax rate to our non-GAAP financial measures, other than when the underlying item has a materially different tax treatment. From time to time in the future, there may be other items that we may exclude if we believe that doing so is consistent with the goal of providing useful information to investors and management. The following tables reconcile our GAAP and non-GAAP financial measures:


News Article | May 10, 2017
Site: globenewswire.com

SAN CLEMENTE, Calif., May 10, 2017 (GLOBE NEWSWIRE) -- ICU Medical, Inc. (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy and critical care applications, today announced financial results for the quarter ended March 31, 2017. First quarter 2017 revenue was $247.7 million, compared to $89.9 million in the same period last year. GAAP gross profit for the first quarter of 2017 was $88.9 million, as compared to $49.2 million in the same period last year.  GAAP gross margin for the first quarter of 2017 was 36%, as compared to 55% in the same period last year.  GAAP net income for the first quarter of 2017 was $55.9 million, or $2.86 per diluted share, as compared to GAAP net income of $18.2 million, or $1.08 per diluted share, for the first quarter of 2016, which were both adjusted from the previously announced adoption of  FASB ASU 2016-09, Improvements to Employee Share-based Payment Accounting, effective January 1, 2016. Adjusted net sales for the first quarter of 2017 was $248.1 million. Adjusted gross profit for the first quarter of 2017 was $111.0 million.  Adjusted gross margin for the first quarter of 2017 was 45%.  Adjusted diluted earnings per share for the first quarter of 2017 were $1.68 as compared to $1.26 for the first quarter of 2016. Also, adjusted EBITDA was $50.1 million for the first quarter of 2017 as compared to $32.7 million for the first quarter of 2016. Adjusted net sales, adjusted gross profit, adjusted gross margin, adjusted diluted earnings per share and adjusted EBITDA are measures calculated and presented on the basis of methodologies other than in accordance with GAAP.  Please refer to the Use of Non-GAAP Financial Information following the financial statements herein for further discussion and reconciliations of these measures to GAAP measures. Vivek Jain, ICU Medical's Chief Executive Officer, said, "Revenues were in-line with our expectations and our adjusted EBITDA and adjusted earnings per share were slightly ahead of our expectations due to minor discrete accounting and tax benefits. Integration activities are progressing as planned.” Revenues by market segment for the three months ended March 31, 2017 and 2016 were as follows (in millions): The following market segment results for the first quarter of 2017 includes our legacy business and our Hospira Infusion Systems business from the point of closing of the acquisition, which was February 3, 2017, through the end of the first quarter of 2017. The Company ended the first quarter of 2017 with a strong balance sheet. As of March 31, 2017, cash and cash equivalents totaled $201.9 million, working capital was $725.9 million and long-term debt obligations of $75 million. The Company will host a conference call to discuss first quarter 2017 financial results today at 4:30 p.m. EDT (1:30 p.m. PDT).   The call can be accessed at (800) 936-9761, international (408) 774-4587, conference ID 13657052. The conference call will be simultaneously available by webcast, which can be accessed by going to the Company's website at www.icumed.com, clicking on the Investors tab, clicking on the Webcast icon and following the prompts. The webcast will also be available by replay. ICU Medical, Inc. (Nasdaq:ICUI) develops, manufactures and sells innovative medical devices used in vascular therapy, and critical care applications. ICU Medical's product portfolio includes IV smart pumps, sets, connectors, closed transfer devices for hazardous drugs, cardiac monitoring systems, along with pain management and safety software technology designed to help meet clinical, safety and workflow goals. ICU Medical is headquartered in San Clemente, California. More information about ICU Medical, Inc. can be found at www.icumed.com. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as ''will,'' ''expect,'' ''believe,'' ''could,'' ''would,'' ''estimate,'' ''continue,'' ''build,'' ''expand'' or the negative thereof or comparable terminology, and may include (without limitation) information regarding the Company's expectations, goals or intentions regarding the future, and our recently completed acquisition of the Hospira infusion systems business. These forward-looking statements are based on management's current expectations, estimates, forecasts and projections about the Company and assumptions management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to, decreased demand for the Company's products, decreased free cash flow, the inability to recapture conversion delays or part/resource shortages on anticipated timing, or at all, changes in product mix, increased competition from competitors, lack of continued growth or improving efficiencies, unexpected changes in the Company's arrangements with its largest customers and the Company’s ability to meet expectations regarding the integration of the Hospira infusion systems business. Future results are subject to risks and uncertainties, including the risk factors, and other risks and uncertainties, described in the Company's filings with the Securities and Exchange Commission, which include those in the Annual Report on Form 10-K for the year ended December 31, 2016 and our subsequent filings. Forward-looking statements contained in this press release are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise. ______________________________________________________ (1) December 31, 2016 balances were derived from audited consolidated financial statements. Use of Non-GAAP Financial Information This press release contains financial measures that are not calculated in accordance with U.S. generally accepted accounting principles ("GAAP").  The non-GAAP financial measures should be considered supplemental to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.  There are material limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may not be comparable to similarly titled non-GAAP financial measures used by other companies, including peer companies.  Our management believes that the non-GAAP data provides useful supplemental information to management and investors regarding our performance and facilitates a more meaningful comparison of results of operations between current and prior periods.  We use non-GAAP financial measures in addition to and in conjunction with GAAP financial measures to analyze and assess the overall performance of our business, in making financial, operating and planning decisions, and in determining executive incentive compensation.  The non-GAAP financial measures included in this press release are adjusted net sales, adjusted gross profit, adjusted gross profit margin, adjusted EBITDA and adjusted diluted earnings per share ("Adjusted Diluted EPS"). Adjusted net sales includes/excludes the following items from net sales: Excludes contract manufacturing revenue:  We manufacture certain products for Pfizer at cost in accordance with a manufacturing services agreement.  We do not include the contract manufacturing revenue in our adjusted net sales as the revenue under this agreement was negotiated contemporaneously with our acquisition of Hospira from Pfizer and is not indicative of a normal market transaction. Includes ICU intercompany sales to Hospira: We include intercompany sales to Hospira for inventory that we previously sold to Hospira, which remained on the opening balance sheet of Hospira after its acquisition by ICU. Adjusted gross profit excludes the following from gross profit: Adjustment to reverse the cost recognition related to the purchase accounting write-up of inventory to fair market value: The inventory step-up represents the expense recognition of fair value adjustments in excess of the historical cost basis of inventory obtained through acquisition, these charges are outside of our normal operations and are excluded. Adjusted gross profit margin is calculated using the adjusted gross profit as a percentage of the adjusted net sales as determined above. Adjusted EBITDA excludes the following items from net income: Interest, net:  We exclude interest in deriving adjusted EBITDA as interest can vary significantly among companies depending on a company's level of income generating instruments and/or level of debt. Intangible asset amortization expense:  We do not acquire businesses or capitalize certain patent costs on a predictable cycle.  The amount of purchase price allocated to intangible assets and the term of amortization can vary significantly and are unique to each acquisition.  Capitalized patent costs can vary significantly based on our current level of development activities.  We believe that excluding amortization of intangible assets provides the users of our financial statements with a consistent basis for comparison across accounting periods. Depreciation expense:  We exclude depreciation expense in deriving adjusted EBITDA because companies utilize productive assets of different ages and the depreciable lives can vary significantly resulting in considerable variability in depreciation  expense among companies. Stock compensation expense:  Stock-based compensation is generally fixed at the time the stock-based instrument is granted and amortized over a period of several years.  The value of stock options is determined using a complex formula that incorporates factors, such as market volatility, that are beyond our control.  The value of our restricted stock awards is determined using the grant date stock price, which may not be indicative of our operational performance over the expense period.  Additionally, in order to establish the fair value of performance-based stock awards, which are currently an element of our ongoing stock-based compensation, we are required to apply judgment to estimate the probability of the extent to which performance objectives will be achieved.  Based on the above factors, we believe it is useful to exclude stock-based compensation in order to better understand our operating performance. Restructuring and strategic transaction:  We incur restructuring and strategic transaction charges that result from events, which arise from unforeseen circumstances and/or often occur outside of the ordinary course of our ongoing business.  Although these events are reflected in our GAAP financial statements, these unique transactions may limit the comparability of our ongoing operations with prior and future periods. Bargain purchase gain:  We may incur a bargain purchase gain on certain acquisitions if the fair market value of the identifiable assets acquired and liabilities assumed, net of deferred taxes exceeds the total consideration paid.  We exclude such gains as they are related to acquisitions and have no direct correlation to the operation of our ongoing business. Adjusted Diluted EPS excludes from diluted EPS, net of tax, interest, net, intangible asset amortization expense, stock compensation expense, restructuring and strategic transaction, and bargain purchase gain, which was tax free.  We apply our GAAP consolidated effective tax rate to our non-GAAP financial measures, other than when the underlying item has a materially different tax treatment. From time to time in the future, there may be other items that we may exclude if we believe that doing so is consistent with the goal of providing useful information to investors and management. The following tables reconcile our GAAP and non-GAAP financial measures:


News Article | May 10, 2017
Site: globenewswire.com

SAN CLEMENTE, Calif., May 10, 2017 (GLOBE NEWSWIRE) -- ICU Medical, Inc. (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy and critical care applications, today announced financial results for the quarter ended March 31, 2017. First quarter 2017 revenue was $247.7 million, compared to $89.9 million in the same period last year. GAAP gross profit for the first quarter of 2017 was $88.9 million, as compared to $49.2 million in the same period last year.  GAAP gross margin for the first quarter of 2017 was 36%, as compared to 55% in the same period last year.  GAAP net income for the first quarter of 2017 was $55.9 million, or $2.86 per diluted share, as compared to GAAP net income of $18.2 million, or $1.08 per diluted share, for the first quarter of 2016, which were both adjusted from the previously announced adoption of  FASB ASU 2016-09, Improvements to Employee Share-based Payment Accounting, effective January 1, 2016. Adjusted net sales for the first quarter of 2017 was $248.1 million. Adjusted gross profit for the first quarter of 2017 was $111.0 million.  Adjusted gross margin for the first quarter of 2017 was 45%.  Adjusted diluted earnings per share for the first quarter of 2017 were $1.68 as compared to $1.26 for the first quarter of 2016. Also, adjusted EBITDA was $50.1 million for the first quarter of 2017 as compared to $32.7 million for the first quarter of 2016. Adjusted net sales, adjusted gross profit, adjusted gross margin, adjusted diluted earnings per share and adjusted EBITDA are measures calculated and presented on the basis of methodologies other than in accordance with GAAP.  Please refer to the Use of Non-GAAP Financial Information following the financial statements herein for further discussion and reconciliations of these measures to GAAP measures. Vivek Jain, ICU Medical's Chief Executive Officer, said, "Revenues were in-line with our expectations and our adjusted EBITDA and adjusted earnings per share were slightly ahead of our expectations due to minor discrete accounting and tax benefits. Integration activities are progressing as planned.” Revenues by market segment for the three months ended March 31, 2017 and 2016 were as follows (in millions): The following market segment results for the first quarter of 2017 includes our legacy business and our Hospira Infusion Systems business from the point of closing of the acquisition, which was February 3, 2017, through the end of the first quarter of 2017. The Company ended the first quarter of 2017 with a strong balance sheet. As of March 31, 2017, cash and cash equivalents totaled $201.9 million, working capital was $725.9 million and long-term debt obligations of $75 million. The Company will host a conference call to discuss first quarter 2017 financial results today at 4:30 p.m. EDT (1:30 p.m. PDT).   The call can be accessed at (800) 936-9761, international (408) 774-4587, conference ID 13657052. The conference call will be simultaneously available by webcast, which can be accessed by going to the Company's website at www.icumed.com, clicking on the Investors tab, clicking on the Webcast icon and following the prompts. The webcast will also be available by replay. ICU Medical, Inc. (Nasdaq:ICUI) develops, manufactures and sells innovative medical devices used in vascular therapy, and critical care applications. ICU Medical's product portfolio includes IV smart pumps, sets, connectors, closed transfer devices for hazardous drugs, cardiac monitoring systems, along with pain management and safety software technology designed to help meet clinical, safety and workflow goals. ICU Medical is headquartered in San Clemente, California. More information about ICU Medical, Inc. can be found at www.icumed.com. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as ''will,'' ''expect,'' ''believe,'' ''could,'' ''would,'' ''estimate,'' ''continue,'' ''build,'' ''expand'' or the negative thereof or comparable terminology, and may include (without limitation) information regarding the Company's expectations, goals or intentions regarding the future, and our recently completed acquisition of the Hospira infusion systems business. These forward-looking statements are based on management's current expectations, estimates, forecasts and projections about the Company and assumptions management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to, decreased demand for the Company's products, decreased free cash flow, the inability to recapture conversion delays or part/resource shortages on anticipated timing, or at all, changes in product mix, increased competition from competitors, lack of continued growth or improving efficiencies, unexpected changes in the Company's arrangements with its largest customers and the Company’s ability to meet expectations regarding the integration of the Hospira infusion systems business. Future results are subject to risks and uncertainties, including the risk factors, and other risks and uncertainties, described in the Company's filings with the Securities and Exchange Commission, which include those in the Annual Report on Form 10-K for the year ended December 31, 2016 and our subsequent filings. Forward-looking statements contained in this press release are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise. ______________________________________________________ (1) December 31, 2016 balances were derived from audited consolidated financial statements. Use of Non-GAAP Financial Information This press release contains financial measures that are not calculated in accordance with U.S. generally accepted accounting principles ("GAAP").  The non-GAAP financial measures should be considered supplemental to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.  There are material limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may not be comparable to similarly titled non-GAAP financial measures used by other companies, including peer companies.  Our management believes that the non-GAAP data provides useful supplemental information to management and investors regarding our performance and facilitates a more meaningful comparison of results of operations between current and prior periods.  We use non-GAAP financial measures in addition to and in conjunction with GAAP financial measures to analyze and assess the overall performance of our business, in making financial, operating and planning decisions, and in determining executive incentive compensation.  The non-GAAP financial measures included in this press release are adjusted net sales, adjusted gross profit, adjusted gross profit margin, adjusted EBITDA and adjusted diluted earnings per share ("Adjusted Diluted EPS"). Adjusted net sales includes/excludes the following items from net sales: Excludes contract manufacturing revenue:  We manufacture certain products for Pfizer at cost in accordance with a manufacturing services agreement.  We do not include the contract manufacturing revenue in our adjusted net sales as the revenue under this agreement was negotiated contemporaneously with our acquisition of Hospira from Pfizer and is not indicative of a normal market transaction. Includes ICU intercompany sales to Hospira: We include intercompany sales to Hospira for inventory that we previously sold to Hospira, which remained on the opening balance sheet of Hospira after its acquisition by ICU. Adjusted gross profit excludes the following from gross profit: Adjustment to reverse the cost recognition related to the purchase accounting write-up of inventory to fair market value: The inventory step-up represents the expense recognition of fair value adjustments in excess of the historical cost basis of inventory obtained through acquisition, these charges are outside of our normal operations and are excluded. Adjusted gross profit margin is calculated using the adjusted gross profit as a percentage of the adjusted net sales as determined above. Adjusted EBITDA excludes the following items from net income: Interest, net:  We exclude interest in deriving adjusted EBITDA as interest can vary significantly among companies depending on a company's level of income generating instruments and/or level of debt. Intangible asset amortization expense:  We do not acquire businesses or capitalize certain patent costs on a predictable cycle.  The amount of purchase price allocated to intangible assets and the term of amortization can vary significantly and are unique to each acquisition.  Capitalized patent costs can vary significantly based on our current level of development activities.  We believe that excluding amortization of intangible assets provides the users of our financial statements with a consistent basis for comparison across accounting periods. Depreciation expense:  We exclude depreciation expense in deriving adjusted EBITDA because companies utilize productive assets of different ages and the depreciable lives can vary significantly resulting in considerable variability in depreciation  expense among companies. Stock compensation expense:  Stock-based compensation is generally fixed at the time the stock-based instrument is granted and amortized over a period of several years.  The value of stock options is determined using a complex formula that incorporates factors, such as market volatility, that are beyond our control.  The value of our restricted stock awards is determined using the grant date stock price, which may not be indicative of our operational performance over the expense period.  Additionally, in order to establish the fair value of performance-based stock awards, which are currently an element of our ongoing stock-based compensation, we are required to apply judgment to estimate the probability of the extent to which performance objectives will be achieved.  Based on the above factors, we believe it is useful to exclude stock-based compensation in order to better understand our operating performance. Restructuring and strategic transaction:  We incur restructuring and strategic transaction charges that result from events, which arise from unforeseen circumstances and/or often occur outside of the ordinary course of our ongoing business.  Although these events are reflected in our GAAP financial statements, these unique transactions may limit the comparability of our ongoing operations with prior and future periods. Bargain purchase gain:  We may incur a bargain purchase gain on certain acquisitions if the fair market value of the identifiable assets acquired and liabilities assumed, net of deferred taxes exceeds the total consideration paid.  We exclude such gains as they are related to acquisitions and have no direct correlation to the operation of our ongoing business. Adjusted Diluted EPS excludes from diluted EPS, net of tax, interest, net, intangible asset amortization expense, stock compensation expense, restructuring and strategic transaction, and bargain purchase gain, which was tax free.  We apply our GAAP consolidated effective tax rate to our non-GAAP financial measures, other than when the underlying item has a materially different tax treatment. From time to time in the future, there may be other items that we may exclude if we believe that doing so is consistent with the goal of providing useful information to investors and management. The following tables reconcile our GAAP and non-GAAP financial measures:

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