New Studies Investigate the Accuracy of Noninvasive, Continuous Hemoglobin Monitoring with Masimo SpHb® on Neonates

(BUSINESS WIRE)-- Masimo (NASDAQ: MASI) today announced that in a study recently published in the Journal of Tropical Pediatrics, researchers evaluating Masimo SpHb^® (noninvasive, continuous hemoglobin monitoring) on neonatal patients concluded that the technology “offers reliable Hb [hemoglobin] values, which are comparable with the more traditional tHb [invasive venous blood sampling].”¹

Noting that “iatrogenic anemia caused by diagnostic blood sampling is a common problem in intensive care units,” especially in neonatal intensive care units (NICUs), and that diagnostic blood sampling also has implications for infection control and health care costs, Drs. Halil Kazanasmaz and Mahmut Demir at Harran University in Sanliurfa, Turkey sought to assess the efficacy of noninvasive, continuous hemoglobin monitoring with SpHb on neonates by comparing it to conventional tHb. To investigate this, they studied 310 neonatal patients in a level III NICU in Turkey. Immediately after patients had blood drawn for tHb analysis using a hematological laboratory analyzer, their SpHb values (alongside other noninvasive measurements) were recorded using a Masimo Radical-7^® Pulse CO-Oximeter^® with rainbow^® sensors placed on the neonate’s left foot.

Using Bland-Altman analysis, the researchers found a mean bias of 0.05 g/dL between tHb and SpHb, with limits of agreement of -1.85 and 1.96 g/dL. Based on the study results, they concluded, “In this study, it was found that the SpHb measurement method could yield reliable results similar to tHb measurement method in the newborns. It is thought that the SpHb method may have a complementary role in reducing unnecessary blood sampling and therefore iatrogenic anemia, especially in the newborns with anemia. Further clinical studies are needed to define the effectiveness of this measurement method in critically ill patients with circulatory disorders.”

In a similar study published earlier this year in the Journal of Clinical Neonatology, Drs. Ahmed Jamal and Biju John at Armed Forces Medical College in Pune, India, compared conventional laboratory hemoglobin to SpHb in 100 hemodynamically stable neonatal patients at a tertiary hospital in southern India.² To measure SpHb, they similarly used Radical-7 devices with rainbow^® sensors, but the sensors were placed on the babies’ wrists instead of the foot. Analyzing the paired Lab-Hb and SpHb data with Bland-Altman analysis, the researchers found “a good visual agreement between the Lab-Hb and SpHb values,” and calculated bias ± precision of 0.763 ± 1.349 g/dL. Drs. Jamal and John similarly concluded that SpHb is “an efficacious method of assessing Hb trend among neonates.”

In clinical studies with adult patients, continuous monitoring with SpHb as part of blood management programs has been shown to improve outcomes, such as reducing the percentage of patients receiving transfusions,³ reducing the units of red blood cells transfused per patient,^4-5 reducing the time to transfusion,⁶ reducing costs,⁷ and even reducing mortality 30 and 90 days after surgery by 33% and 29%, respectively.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.

Noninvasive, continuous SpHb for neonatal patients received CE marking in August 2019, and SpHb is now available for patients of all ages in CE marked countries. Noninvasive, continuous SpHb has received FDA clearance for patients > 3 kg but is not currently indicated for patients < 3 kg in the U.S.

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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. Kazanasmaz H, Demir M. The Comparison of Hemoglobin Values Measured by Blood and Continuous Non-Invasive Monitoring (SpHb) in Newborn Infants. J Trop. Pediatrics. 2020,0,1o-6. DOI: 10.1093/tropej/fmaa050.
2. Jamal A, John B. Efficacy of Noninvasive Hemoglobin Measurement by Pulse CO-Oximetry in Neonates. J Clin Neonatol. 2020;9:57-62.
3. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
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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