New Study Associates Masimo SpHb ® , Noninvasive and Continuous Hemoglobin Monitoring, as Part of Pediatric Patient Blood Management, with Reduced ICU Stays and Postoperative Transfusion

Masimo (NASDAQ: MASI) announced today the findings of an abstract recently presented at Euroanaesthesia 2020 in which Dr. Saraçoğlu and colleagues at Marmara University in Istanbul, Turkey investigated the efficacy of Masimo noninvasive and continuous hemoglobin monitoring, SpHb^®, as part of the transfusion management of pediatric patients undergoing major surgery.¹ The researchers found that use of SpHb was associated with decreased rate of postoperative transfusion, reduced length of ICU stay, and other improved outcomes.

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Noting that traditional methods of measuring hemoglobin and estimating blood loss as part of perioperative blood transfusion management are “time consuming” and may cause delays in decision making, the researchers sought to investigate whether use of a noninvasive, continuous method, Masimo SpHb, would have an impact on transfusion rates, morbidity, and mortality in pediatric patients undergoing craniosynostosis surgery. Pediatric patients aged 2-24 months were divided into a control group (n = 28), whose transfusion therapy was managed using intermittent blood gas analysis, and an experimental group (n = 27), whose transfusion therapy was managed using SpHb monitored with Masimo rainbow^® sensors connected to a Radical-7^® Pulse CO-Oximeter^®. In both groups, blood gas analysis was performed hourly during the perioperative period; in the SpHb group, when SpHb monitoring indicated a sudden decrease in hemoglobin, blood gas analysis was simultaneously performed.

The researchers calculated the following statistically significant (p < 0.05) results:

Outcome	Control Group	SpHb Group	P-value
Length of stay in ICU	55.43 hours ± 25.34 hours (48 hours median)	33.48 hours ± 12.25 hours (24 hours median)	0.001
Postoperative drainage	215.54 mL ± 93.1 mL	136.85 mL ± 62.27 mL	0.001
Postoperative red blood cell transfusion	179.02 mL ± 163.06 mL (145 mL)	102.69 mL ± 73.87 mL (105 mL)	0.033
Postoperative fresh frozen plasma transfusion	71.96 mL ± 94.95 mL (25 mL)	28.15 mL ± 64.35 mL (0 mL)	0.043
Perioperative crystalloid	396.79 mL ± 171.16 mL (350 mL)	462.59 mL ± 158.91 mL (500 mL)	0.048
First platelet level in ICU	270,821 ± 74,474	327,185 ± 104,644	0.025
Last lactate level in ICU	1.47 mmol/L ± 0.64 mmol/L (1.25 mmol/L)	1.18 mmol/L ± 0.63 mmol/L (0.9 mmol/L)	0.044

They found that the length of stay in the ICU was statistically significantly higher in the control group than the SpHb group. Postoperative drainage, red blood cell transfusion, and fresh frozen plasma transfusion in the ICU were also statistically significantly higher in the control group than the SpHb group. Lactate levels were higher in the SpHb group at the start of the operation, but higher in the control group at the end.

The researchers concluded, “Noninvasive continuous hemoglobin monitoring in major hemorrhagic surgeries in pediatric patients might be effective in reducing morbidity not only by reducing the amount of transfusion but also [by] leading to less metabolic and hemodynamic instability.”

In other clinical studies, conducted with adult patients, continuous monitoring with SpHb as part of patient blood management (PBM) programs has been found to improve outcomes, such as reducing the percentage of patients receiving transfusions,² reducing the units of red blood cells transfused per patient,^3-4 reducing the time to transfusion,⁵ reducing costs,⁶ and even reducing mortality 30 and 90 days after surgery by 33% and 29%, respectively.⁷ The evidence of SpHb’s impact on outcomes spans the globe, representing 6 countries on 4 different continents.^2-8 Today, SpHb technology supports clinicians in over 75 countries around the world.⁹

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.

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About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹⁰ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹¹ improve CCHD screening in newborns,¹² and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs^13-16 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁷ and is the primary pulse oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.¹⁸ Masimo continues to refine SET^® and in 2018, announced that SpO₂ accuracy on RD SET^® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO₂ values they rely on accurately reflect a patient’s physiological status. 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^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^® and Radius PPG™, portable devices like Rad-67™, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris Gateway^®, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Saraçoğlu A , Orhon Ergün M, Sakar M, Uyar E, Saçak B, Aykaç Z. The use of SpHb in pediatric patients undergoing major surgery associated with reduced morbidity. Proceedings from the Euroanaesthesia 2020 Annual Meeting. #5291.
2. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic 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 AM et al. The Value of Continuous Noninvasive Hemoglobin Monitoring in Intraoperative Blood Transfusion Practice During Abdominal Cancer Surgery. Open J Anesth. 2016;13-19.
6. Ribed-Sánchez B et al. 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.
7. Cros J et al. Continuous hemoglobin and plethysmography variability index monitoring can modify blood transfusion practice and is associated with lower mortality. J Clin Monit Comp. 3 Aug 2019. https://doi.org/10.1007/s10877-019-00367-z.
8. Merolle L et al. Postoperative patient blood management: transfusion appropriateness in cancer patients. Blood Transfus 2020; 18: 359-65 DOI 10.2450/2020.0048-20.
9. Masimo data on file.
10. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
11. 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.
12. 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.
13. Taenzer A 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.
14. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
15. McGrath S 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.
16. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
17. Estimate: Masimo data on file.
18. 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; risks related to COVID-19; 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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Contact information

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