BMEYE Receives CE Mark to Launch First Noninvasive Cardiovascular Monitor with Masimo Rainbow SET(R) Pulse CO-Oximetry(TM) Technology in Europe

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AMSTERDAM, and IRVINE, Calif., Jan. 21 /PRNewswire-FirstCall/ -- BMEYE B.V., the innovators of combined noninvasive, beat-to-beat blood pressure and cardiac output monitoring, and Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low-Perfusion pulse oximetry, jointly announce today CE Mark certification and the European launch of the BMEYE ccNexfin—the first noninvasive cardiovascular monitor with Masimo Rainbow SET Pulse CO-Oximetry technology.  The combination of two innovative noninvasive technologies—BMEYE for cardiovascular monitoring and Masimo Rainbow SET for hemoglobin and oxygen saturation monitoring—provides real-time, beat-to-beat measurements of cardiac, circulatory, and pulmonary parameters, which may enable clinicians to detect impending cardiovascular crisis before organ injury ensues.  

The ccNexfin with Masimo Rainbow SET offers some of the most advanced cardiovascular monitoring capabilities available today.  It utilizes a single sensor finger cuff (BMEYE) and finger sensor (Masimo Rainbow SET) to capture and continuously measure beat-to-beat blood pressure (sys/dia), mean arterial pressure (MAP), cardiac output (CO), stroke volume (SV), systemic vascular resistance (SVR), derivative of pressure (dP/dt), noninvasive hemoglobin (SpHb), oxygen saturation (SpO2), and perfusion index (PI).  This detailed data allows clinicians to predict and proactively address the early signs of hemodynamic instability during critical situations rather than reacting to late indicators and their effects.

"ccNexfin is a unique noninvasive, beat-to-beat, and user friendly cardiovascular monitor that delivers a patient's full hemodynamic profile based on real-time data," stated Rob de Ree, CEO of BMEYE.  "Masimo Rainbow SET Pulse CO-Oximetry plays an integral role in the delivery of this rich hemodynamic data stream by providing critical information about oxygen delivery at the tissue level, which is an essential component of accurate hemodynamic assessment."

Assessment of hemodynamic status is a cornerstone of critical care medicine, routinely used to evaluate, diagnose, and direct therapy to manage the care of at-risk and critically-ill patients.  Hemodynamic monitoring—the direct measurement of blood pressure inside the veins, heart and arteries in relation to cardiac output and systemic vascular resistance—allows clinicians to assess the cardiovascular system and identify early circulation changes that reflect small changes in the way the heart is working to deliver blood and oxygen to tissues and organs.  

Hemodynamic monitoring has traditionally relied upon invasive, costly, intermittent, or unreliable methods to assist clinicians in maintaining adequate oxygen delivery and tissue perfusion to prevent hypoxia and its irreversible damage. The integration of ccNexfin and Masimo Rainbow SET technologies into the emergency department, intensive care units, and anesthesiology care areas has the potential to facilitate earlier diagnosis and the delivery of protocol- and goal-directed therapies that improve patient safety and clinical outcomes.  

Masimo Founder and CEO, Joe Kiani, stated, "The risks and costs associated with invasive hemodynamic monitoring techniques leaves many high-risk patients underserved at a time when assessing hemodynamic stability is most needed.  The synergistic combination of BMEYE and Rainbow SET means that continuous, noninvasive hemodynamic monitoring can benefit more patients at all points along the care path."  

About BMEYE

BMEYE, a Dutch company based in Amsterdam, The Netherlands, develops innovative medical devices with broad application in clinical settings that require cardiovascular monitoring. Specifically, BMEYE produces patient monitors that noninvasively measure continuous blood pressure and cardiac output. BMEYE's mission: BMEYE is the premier provider and will set the standard of noninvasive, beat-to-beat, user-friendly cardiovascular monitoring systems, to improve patient care and reduce healthcare costs.

About Masimo

Masimo (NASDAQ: MASI) develops innovative 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 Masimo Rainbow SET® Pulse CO-Oximetry™, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb™), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI®, in addition to SpO2, pulse rate, and perfusion index (PI).  In 2009, Masimo introduced Masimo Rainbow SET® Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa).  Masimo's Rainbow platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.  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 our assumptions regarding the timing and market availability of ccNexfin with Masimo Rainbow SET, risks related to our assumptions that the integration of Masimo Rainbow SET with ccNexfin provides advanced noninvasive and continuous hemodynamic monitoring capabilities that have the potential to improve patient safety and outcomes by assisting in the delivery of protocolized, goal-directed therapies, risks related to our belief that the combination of Masimo Rainbow SET and ccNexfin will enable clinicians to detect impending cardiovascular crisis before organ injury ensues, 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.

Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57, Rad-9, Rad-8, Rad-5, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.

SOURCE Masimo; BMEYE B.V.