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In addition, Masimo's commercial exhibit attracted over 2,500anesthesiologists from the U.S. and around the world. Anesthesiologistsvisiting the commercial exhibit marveled at Masimo noninvasive hemoglobin(SpHb(TM)), the first-and-only technology capable of continuously monitoringhemoglobin status. Continuous monitoring of anemic status with Masimo SpHbmay allow clinicians to make earlier and better treatment decisions, such asdetecting blood loss earlier to initiate more timely transfusions in somepatients and avoiding unnecessary blood transfusions in others.
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Select Clinical Study Highlights
Continuous Pulse Ox Impacts Early Detection of Physiological Abnormalitiesin Post-Surgical Patients(1), a clinical evaluation led by Dr. George Blike atDartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, comparedclinical data, patient outcomes and nursing satisfaction before and afterimplementation of Masimo Patient SafetyNet(TM) -- a remote monitoring andwireless clinician notification system -- on a 36-bed post-surgical care unit.Findings during the three-month evaluation -- covering 2,587 total patientdays -- showed an 80 percent decrease in distress codes and rescueactivations, and a 50 percent decrease in ICU transfers for Masimo PatientSafetyNet system-monitored patients. Researchers concluded that, "the systemsupported the early identification of patients with sedation oranalgesia-induced respiratory depression," as well as the "early recognitionof other patterns of deterioration, including: poor heart rate control, acutebradycardia needing atropine, new onset A-fib, unrecognized obstructivepatterns of respiration like sleep apnea, and pulmonary complications such asfat emboli syndrome, pulmonary embolus and edema." In addition, researchersalso noted that the system rated high for up-time at 99.9995% and nursingsatisfaction, as identified by 'desire to keep vs. remove the system', at 5.5on a 6 point scale.
Do Pulse CO-Oximeter Measures of SpMet and SpO2 Correlate with Blood GasCO-Oximetry in Neonates?(2), a clinical study led by Dr. Mitchell R. Goldsteinat Loma Linda Children's Hospital in Loma Linda, California, evaluated whethermethemoglobin saturation (SpMet(TM)) could be successfully measured inneonates without compromise in oxygen saturation (SpO2) accuracy. Researcherscompared noninvasive SpMet and SpO2 measurements obtained from neonates usingthe Masimo Radical-7 Pulse CO-Oximeter and Rainbow R25-L disposable sensorwith MetHb and SaO2 measurements obtained from blood gas analysis using alaboratory CO-oximeter and found that the accuracy of SpMet (with a Bias of0.17, Standard Deviation of 0.92, and Average Root Mean Square of 0.93) andSpO2 (with a Bias of 1.4, Standard Deviation of 2.46, and Average Root MeanSquare of 2.86) was maintained and correlated with blood gas measurements.Researchers concluded that Masimo's multi-wavelength Pulse CO-Oximeter "cansimultaneously measure SpMet and SpO2 in neonates," and that "continuousmonitoring of MetHb allows better assessment of toxicity and helps identifythe need for ongoing treatment."
Ability of Pleth Variability Index to Non Invasively Predict theHemodynamic Effects of PEEP(3) -- led by Dr. Olivier Desebbe at Louis PradelHospital in Lyon-Bron, France, studied the ability of PVI to predict theeffects of positive end-expiratory pressure (PEEP) on cardiac index (CI) in 21mechanically-ventilated patients following cardiac surgery. The clinical teamrecorded mean arterial pressure (MAP), central venous pressure (CVP), cardiacindex (measured using pulmonary artery catheter), and PVI at three successivetidal volume settings (6, 8, and 10 ml/kg) under zero end-expiratory pressureand following adjunction of a PEEP, and found that successive zeroend-expiratory pressure induced significant changes in PVI, but not CVP orMAP. Findings also showed that "PVI was able to predict the hemodynamic effectof PEEP with 73% sensibility and 80% specificity." Researchers concluded thatPVI could allow clinicians to "optimize fluid loading noninvasively beforeadding PEEP for pulmonary reasons."
Pulse Oximeter Perfusion Index as a Predictor for the Effect ofllio-Inguinal Block(4), a prospective clinical study led by Dr. AKI Uemura atthe Tsukuba University Hospital in Ibaraki, Japan, examined whether changes inPerfusion Index (PI) reflect the effect of llio-inguinal block in 18 children(mean age 32 months) during inguinal herniorrhaphy. Patients receivingllio-inguinal blocks were divided into two groups according to theconcentration of Ropivacaine received (0.25% or 0.5%), and monitored usingelectrocardiography, noninvasive blood pressure, and two Masimo SET Radicalpulse oximeters placed on both the left and right side limb. The clinicalteam recorded PI, blood pressure, heart rate, end-tidal CO2, end-tidal Sevo%,and respiratory rate for all patients and found that PI on the block side wassignificantly elevated when compared to the non-block side. Researchersconcluded that "PI value is a useful, objective, and noninvasive method toevaluate the effect of llio-inguinal block in pediatric patients."
In addition, there were nine other clinical studies(5-13) presentedvalidating the accuracy, reliability, and clinical value of Masimo SET PulseOximetry and Rainbow SET Pulse CO-Oximetry -- the first-and-only technologyplatform to noninvasively measure blood constituents and fluid responsivenessthat previously required invasive procedures, including: noninvasive &continuous total hemoglobin (SpHb), oxygen content (SpOC(TM)),carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)) and Pleth VariabilityIndex (PVI), in addition to the 'Gold Standard'measure-through-motion-and-low-perfusion performance of Masimo SET OxygenSaturation (SpO2), Pulse Rate (PR) and Perfusion Index (PI).
Michael O'Reilly, MD, Masimo Executive Vice President of Medical Affairs,stated; "The 13 new studies presented at ASA this year add to the growing bodyof evidence showing that the use of Masimo SET pulse oximetry and MasimoRainbow SET Pulse CO-Oximetry improves patient safety and outcomes."
About Masimo
Masimo (Nasdaq: MASI) develops innovative monitoring technologies thatsignificantly improve patient care -- helping solve "unsolvable" problems. In1995, the company debuted Measure-Through-Motion-and-Low-Perfusion pulseoximetry, known as Masimo SET, which virtually eliminated false alarms andincreased pulse oximetry's ability to detect life-threatening events. Morethan 100 independent and objective studies demonstrate Masimo SET provides themost reliable SpO2 and pulse rate measurements even under the most challengingclinical conditions, including patient motion and low peripheral perfusion.In 2005, Masimo introduced Masimo Rainbow SET, a breakthrough noninvasiveblood constituent monitoring platform that can measure many blood constituentsthat previously required invasive procedures. Masimo Rainbow SET continuouslyand noninvasively measures total hemoglobin (SpHb(TM)), oxygen content(SpOC(TM)), carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)), andPVI(TM), in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusionindex (PI), allowing early detection and treatment of potentiallylife-threatening conditions. Founded in 1989, Masimo has the mission of"Improving Patient Outcomes and Reducing Cost of Care by Taking NoninvasiveMonitoring to New Sites and Applications." Additional information about Masimoand its products may be found at http://www.masimo.com.
Forward Looking Statements
This press release includes forward-looking statements as defined inSection 27A of the Securities Act of 1933 and Section 21E of the SecuritiesExchange Act of 1934, in connection with the Private Securities LitigationReform Act of 1995. These forward-looking statements are based on currentexpectations about future events affecting us and are subject to risks anduncertainties, all of which are difficult to predict and many of which arebeyond our control and could cause our actual results to differ materially andadversely from those expressed in our forward-looking statements as a resultof various risk factors, including, but not limited to: risks related to ourbelief that the applications of Masimo Rainbow SET technologies described inthe foregoing clinical studies will deliver a sufficient level of clinicalimprovement over alternative measurement capabilities to allow for rapidadoption of the technology, and risks related to our assumptions regarding therepeatability of clinical results at other hospitals and healthcare settings,and risks related to our assumptions regarding timing or commercialavailability of SpHb, as well as other factors discussed in the "Risk Factors"section of our Quarterly Report on Form 10-Q for the fiscal quarter ended June28, 2008, filed with the Securities and Exchange Commission ("SEC") on August5, 2008, which may be obtained for free at the SEC's website athttp://www.sec.gov. Although we believe that the expectations reflected in ourforward-looking statements are reasonable, we do not know whether ourexpectations will prove correct. All forward-looking statements included inthis press release are expressly qualified in their entirety by the foregoingcautionary statements. You are cautioned not to place undue reliance on theseforward-looking statements, which speak only as of today's date. We do notundertake any obligation to update, amend or clarify these forward-lookingstatements or the "Risk Factors" contained in our Quarterly Report on Form10-Q for the fiscal quarter ended June 28, 2008, whether as a result of newinformation, future events or otherwise, except as may be required under theapplicable securities laws.
(1) Continuous Pulse Ox Impacts Early Detection of PhysiologicalAbnormalities in Post-Surgical Patients. George Blike, M.D., Jean Avery, R.N.,Melanie Mastanduno, R.N., Klaus Christoffersen, Ph.D., Susan McGrath, Ph.D.Quality & Patient Safety, Dartmouth-Hitchcock Medical Center, Lebanon, NH.
(2) Do Pulse CO-Oximeter Measures of SpMet and SpO2 Correlate with BloodGas CO-Oximetry in Neonates. Mitchell R. Goldstein, M.D., Daniel Saesim, M.D.,Mark Macknet, M.D., Martin Allard, M.D., Ricardo Peverini, M.D. NeonatalMedicine, Loma Linda University Children's Hospital, Loma Linda, California.
(3) Ability of Pleth Variability Index to Non Invasively Predict theHemodynamic Effects of PEEP. Olivier Desebbe, M.D., Cecile Boucau, R.D.,Pascal Rosamel, M.D., Jean-Jacques Lehot, M.D., Ph.D., Maxime Cannesson, M.D.Department of Anesthesiology, Louis Pradel Hospital, Lyon-Bron, France.
(4) Pulse Oximeter Perfusion Index as a Predictor for the Effect ofllio-Inguinal Block. Aki Uemura, M.D., Ph.D., Masahiro Yagihara, M.D.,Masayuki Miyabe, M.D., Ph.D. Anestheiology, Tsukuba University, Ibaraki,Japan.
(5) Ability of PVI to detect preload changes in ortho liver transplant.Christopher Wray, M.D., Jack Buckley, M.D., Derek Kwan, B.S., Tayeba Maktabi,Aman Mahajan, M.D., Ph.D. Anesthesiology, David Geffen School of Medicine,UCLA, Los Angeles, California.
(6) PVI A non invasive device for fluid responsiveness. Olivier Desebbe,M.D., Cecile Boucau, R.D., Pascal Rosamel, M.D., Jean-Jacques Lehot, M.D.,Ph.D., Maxime Cannesson, M.D. Department of Anesthesiology, Louis PradelHospital, Lyon-Bron, France.
(7) Impact of PEEP on PI and PVI. Nitin K. Shah, M.D., Darin V. Allred,M.D., Laverne Estanol, M.S., Fine Brian, B.S., Ghandi Vipal, B.S.Anesthesiology, Long Beach VAHS, Long Beach, California.
(8) Impact of lower extreminity nerve blockade on PI and PVI. Darin V.Allred, M.D., Nitin K. Shah, M.D., Laverne Estanol, M.S. Anesthesiology,University of California Irvine, Orange, California.
(9) Perfusion Index via finger and toe. Hiroyuki Sumikura, M.D., Ph.D.,Yayoi Ohashi, M.D., Ph.D., Yasuyuki Suzuki, M.D., Youichi Kondo, M.D.,Hirokazu Sakai, M.D. Obstetric Anesthesia, National Center for Child Healthand Development, Tokyo, Japan.
(10) Effect of Servoflurane on peripherial PI. Anne Laffargue, M.D.,Bruno Marciniak, M.D., Anne Hebrard, M.D., Caroline Petyt, M.D., ReneeKrivosic-Horber, M.D. Pole de'Anethesie Reanimation, Jeanne de Flandre, CHRU,Lille, France.
(11) Prolocaine induced Methemoglobinemia. Peter Soeding, M.D., MatthiasDeppe, Hartmut Gehring, M.D., Ph.D. Anesthesiology, University of Luebeck,Lubeck, Schleswig-Holstein, Germany.
(12) Second hand smoke in children. Branden E. Yee, B.A., Iqbal M. Ahmed,M.D., Raghu Idupuganti, D.O., Douglas Brugge, Ph.D., M.S., Roman Schumann,M.D. Anesthesia, Tufts Medical Center, Boston, MA.
(13) Estimation of respiration dependent PaO2 Oscillations. MarcBodenstein, M.D., Stephan Boehme, John Graybeal, M.D., Hemei Wang, Ph.D.,Klaus Markstaller, M.D., Ph.D. Department of Anesthesiology, JohannesGutenber-University, Mainz, Rhineland-Palatinate, Germany.
Masimo, SET, Signal Extraction Technology, Improving Outcomes and ReducingCost 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 orregistered trademarks of Masimo Corporation.Contact: Dana Banks Masimo Corporation 949-297-7348
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