CA-MASIMO

Masimo  (NASDAQ: MASI) announced today the findings of a recently published study in which researchers evaluated the utility of Masimo noninvasive and continuous hemoglobin (SpHb^® ) in reducing the number of unnecessary blood transfusions, thus reducing costs and improving quality of care.¹

In the study, Dr. Ribed-Sánchez and colleagues at HM Hospitales, ETSII-Universidad Nacional de Educaíon a Distancia (UNED), and CEU San Pablo University in Spain compared the transfusion outcomes of two groups of patients undergoing hip trauma surgery: those whose hemoglobin levels were measured using traditional invasive blood draws and those whose levels were monitored continuously using Masimo SpHb. The researchers’ goal was to determine whether there was a difference in the percentage of patients transfused and the number of units transfused per patient between the two groups. 115 control group patients had hemoglobin levels intermittently checked through invasive blood draws and laboratory analysis. 122 experimental group patients had hemoglobin levels monitored continuously with Masimo Radical-7^® Pulse CO-Oximeters^® with SpHb.

The researchers found a decrease in the percentage of patients receiving a transfusion from 48.7% in the control group to 45.1% in the experimental (SpHb) group, a 7.4% reduction. The number of units transfused per patient dropped from 1.322 to 1.156, a 12.56% decrease. Based on the average cost of a unit of blood in Spain and taking sensor cost into account, they calculated that on an annual and national level, the reduction could lead to an estimated savings of 1.756 million euros and 13,500 fewer units of blood transfused.

The researchers concluded, “Constant monitoring of the value of hemoglobin during surgeries with significant blood loss significantly reduces blood transfusions. Based on the reduction of transfusions by using this measurement technology, health facilities can significantly reduce their costs while improving quality of care.”

Joe Kiani, Founder and CEO of Masimo, commented, “This is the fifth SpHb study showing a reduction in blood transfusion,^1-5 which is not only expensive, but associated with mortality. In fact, all six of the clinical outcome studies on SpHb that we are aware of to date have been positive.⁶ In addition to blood transfusion reduction, three of the studies showed faster time to transfusion for patients who needed it.”^3,5,7

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

@MasimoInnovates  | #Masimo

References

1. Ribed-Sánchez B, González-Gaya C, Varea-Díaz S, Corbacho-Fabregat C, Pérez-Otoyza J, and Belda-Iniesta C. Economic Analysis of the Reduction of Blood Transfusions during Surgical Procedures While Continuous Hemoglobin Monitoring is Used. Sensors . 2018, 18, 1367; doi:10.3390/s18051367.
2. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf . 2014. 5:9. 2.
3. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
4. Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may reduce excessive intraoperative RBC transfusion. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR607.
5. Kamal A et al. The Value of Continuous Noninvasive Hemoglobin Monitoring in Intraoperative Blood Transfusion Practice during Abdominal Cancer Surgery. Open Journal of Anesthesiology, 6, 13-19. DOI: 10.4236/ojanes.2016.63003
6. Published clinical studies and abstracts on Masimo SpHb can be found at http://www.masimo.com/evidence/pulse-co-oximetry/sphb/ .
7. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

About Masimo

Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹ improve CCHD screening in newborns,² and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.^3,4,5 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,⁶ and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.⁷ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^® ), oxygen content (SpOC™), carboxyhemoglobin (SpCO^® ), methemoglobin (SpMet^® ), Pleth Variability Index (PVi^® ), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO₂ , pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root^® , an intuitive patient monitoring and connectivity platform with the Masimo Open Connect^® (MOC-9^® ) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7^® wearable patient monitor, iSpO₂ ^® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com . Published clinical studies on Masimo products can be found at http://www2.masimo.com/evidence/featured-studies/feature/ .

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter . Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety . 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview .

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 include, among others, statements regarding the potential effectiveness of Masimo SpHb^® . 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 repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; 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 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.

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Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com

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