Saadat Receives European CE Mark to Launch Aria, the First Portable Patient Monitor with Masimo rainbow SET Pulse CO-Oximetry Technology, at MEDICA
Incorporating Masimo’s Breakthrough Noninvasive Blood Constituent and Fluid Responsiveness Measurements, the Saadat Aria Debuts to European Market
Tehran, Iran and Irvine, California – November 16, 2010 – Saadat, international manufacturers of portable patient monitors, and Masimo (NASDAQ: MASI) jointly announce today CE Mark certification and the European launch of the Saadat Aria®—the first portable patient monitor with Masimo rainbow SET® Pulse CO-Oximetry™ technology for noninvasive physiological measurements. The integration of Masimo rainbow SET enables clinicians using the Aria monitor to immediately, noninvasively, and continuously measure multiple physiological parameters without invasive procedures—offering the ability to detect and treat anemia1, internal bleeding2, fluid responsiveness3, and other potentially life-threatening conditions on-the-spot, in real-time.
Aria is a cost-effective and lightweight (4.3” display weighing < 2lbs) detachable patient monitor that integrates some of the most advanced noninvasive patient monitoring capabilities available today—including Masimo rainbow SET, CAS NIBP, Phasein multi-gas analyzer, and the Saadat Multi-Module (SMM) for ECG, respiration, IBP, temperature, and cardiac output—for use as both a bedside and transport vital signs monitor throughout the entire care path. As the first-and-only technology platform to noninvasively and continuously measure total hemoglobin (SpHb®), oxygen content (SpOCTM), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®) and Pleth Variability Index (PVI®), in addition to the ‘gold-standard’ Measure-Through Motion and Low Perfusion performance of Masimo SET® oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate (PR), Masimo rainbow® SET provides detailed physiological data that helps clinicians to more rapidly assess patients and detect adverse conditions much earlier.
According to Reza Yaghoubzadeh, CEO of Saadat, “The novelty of Aria is its capacity to monitor vital patient parameters in all care areas and during transport. This of course would not have been possible without the integration of Masimo’s advanced rainbow SET technology platform, which provides a continuous stream of rich, reliable physiological measurements and hemodynamic data that significantly increases the amount of clinical intelligence available to medical staff—enabling more rapid and comprehensive patient assessments. We have enjoyed a strong relationship with Masimo over the years and look forward to extending our cooperation to improve patient care worldwide.”
Assessment of hemodynamic status is a critical aspect of evaluating, diagnosing, and directing therapy to manage the care of surgical and at-risk or critically-ill patients. However, hemodynamic monitoring has traditionally relied upon invasive, costly, intermittent, or unreliable methods to assist clinicians in maintaining critical blood, oxygen, and fluid levels to prevent irreversible damage and death. Masimo PVI offers a breakthrough for assessing hemodynamic status and is clinically-proven to help clinicians assess fluid responsiveness and improve fluid management to decrease patient risk. 4
In addition, published studies have shown that transfusion of just one or two units of blood significantly increases infection, pneumonia, sepsis, and mortality after surgery.5,6 These studies also suggest that transfusions and their associated risks could be "largely avoided" through implementation of better blood management techniques and "more appropriate indicators" for transfusions. Masimo SpHb is clinically-proven to reduce blood transfusions during surgery and may also help clinicians to immediately detect anemia and internal bleeding to help improve clinical decision-making.7
Masimo Founder and CEO, Joe Kiani, stated, “The limitations, costs, and delays associated with invasive hemodynamic monitoring and invasive blood sampling and laboratory analysis can compromise patient care. Incorporating Masimo rainbow SET into Saadat’s new Aria portable patient monitor means that clinicians have immediate and real-time access to vital data that can benefit patients at all points along the care path. This is truly a win for all—patients, clinicians, and healthcare systems.”
The compact Aria monitor easily slides into various docking stations and, offering network connectivity, VGA output, a recorder, and an extra battery, it plays the role of a full-size multi-parameter module—making it ideal for acute and general care floors, clinics, and home health care settings. Also offered as an OEM solution, Aria can be used in defibrillators, ventilators, and anesthesia machines—providing complete vital signs and core patient monitoring parameters in a variety of clinical settings.
Juhl A., Naqvi S., Aregbeyen O., Shander A. "Noninvasive and Continuous Hemoglobin Monitoring in an Intensive Care Unit Patient with low Hemoglobin." Society for the Advancement of Blood Management (SABM) Annual Meeting. September 24, 2010.
2 Prith P, Torp K, et al. Real Time Hemoglobin Monitoring During Liver Transplantation. A Case Report. Society for the Advancement of Blood Management (SABM) Annual Meeting. September 24, 2010.
3Zimmerman M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf B., Wiesenack C. "Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically-ventilated Patients Undergoing Major Surgery." European Journal of Anaesthesiology June 2010;27(6):555-61. Available online here.
4Forget P.; Lois F.; De Kock M. "Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management." Anesthesia & Analgesia. August 2010. Available online here.
5Bernard AC et al. Intraoperative transfusion of 1U to 2U of packed red blood cells is associated with increased 30-day mortality, surgical site infection, pneumonia, and sepsis in general surgery patients. Journal of the American College of Surgeons. 2009;208:931-937. Available online here.
6Surgenor SD et al, for the Northern New England Cardiovascular Disease Study Group. The Association of Perioperative Red Blood Cell Transfusions and Decreased Long-Term Survival After Cardiac Surgery. Anesthesia & Analgesia 2009; 108:1741-1746. Available online here.
7Ehrenfeld J., Henneman J. "Impact of Continuous and Noninvasive Hemoglobin Monitoring on Intraoperative Blood Transfusions." American Society of Anesthesiologists, 2010 Annual Conference, October 18, 2010. Available online here.
# # #
Saadat is the global provider of high quality and cost effective patient monitoring systems accompanying patients throughout the care path and monitoring vital signs at the bedside and during transport. The company was founded in 1998 with the goal of improving patient care by providing a complete and cost effective solution that monitors patients in all care areas including the Ambulance, Emergency Room, ICU, CCU, NICU, Operating and Recovery Room. Saadat monitors integrate high end modules including Masimo Rainbow, CAS NIBP and Phasein multi-gas analyzer along with the Saadat advanced Multi-Module (SMM) for ECG, Respiration, IBP, Temperature, and Cardiac Output. Additional information about Saadat and its products may be found at www.saadatco.com
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow® SET Pulse CO-OximetryTM technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOCTM), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow Acoustic MonitoringTM, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo’s rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET and Masimo rainbow SET technologies can be also found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcomes and Reducing Cost of Care … by Taking Noninvasive Monitoring to New Sites and Applications®." Additional information about Masimo and its products may be found at www.masimo.com.
Forward Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to::risks related to assumptions regarding clinical applications for the Aria monitor and repeatability of clinical results; risks related to the belief that integrating Masimo rainbow SET will allow clinicians to immediately, noninvasively, and continuously measure multiple physiological parameters in all patients, under all clinical conditions; risks related to the belief that Masimo rainbow SET provides detailed physiological data on-the-spot, in real-time to help clinicians more rapidly assess patients and detect and treat adverse conditions much earlier, including anemia, internal bleeding, fluid responsiveness; risks related to the belief that the ability to noninvasively and continuously trend a patient's hemoglobin level with Masimo SpHb offers a breakthrough in blood management and patient safety that may help clinicians to reduce blood transfusions and improve clinical decision-making; as well as other factors discussed in the “Risk Factors” section of our most recent reports filed with the Securities and Exchange Commission (“SEC”), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these forward-looking statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Ali Noorali Dana Banks
Saadat Co. Masimo Corporation
Phone: +60 12 9715667 Phone: (949) 297-7348
Email: firstname.lastname@example.org Email: email@example.com
Saadat, Aria, and Saadat advanced Multi-Module (SMM) are trademarks or registered trademarks of Saadat Co.
Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care… by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57,Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, and SEDLine are trademarks or registered trademarks of Masimo Corporation..