Esteemed Society Recommends the Use of Continuous Hemoglobin Monitoring as Part of Patient Blood Management to Improve Patient Outcomes

Masimo (NASDAQ: MASI) announced today the conclusions of a whitepaper published by the Society for the Advancement of Patient Blood Management (SABM) which highlights the importance of continuous hemoglobin (Hgb) monitoring to improve patient outcomes in critical care and perioperative settings.¹ The authors of the publication concluded that “continuous Hgb monitoring devices provide highly valuable real-time trending data that can assist clinicians in making timelier decisions.”

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Masimo Root® Monitor and rainbow® SpHb® Sensor (Graphic: Business Wire)

Founded in 2001, SABM is recognized as a key educational resource for Patient Blood Management (PBM). The society defines PBM as the timely application of evidence-based medical and surgical concepts designed to maintain Hgb concentration, optimize hemostasis and minimize blood loss in an effort to improve patient outcomes. To that end, the SABM whitepaper reviews over 10 years of peer-reviewed publications on continuous hemoglobin in making its conclusion. The whitepaper notes that “having continuous access to Hgb levels in real-time offers a clear advantage over the traditional measurement methods as it enables the clinicians to detect changes in Hgb levels quickly and adjust the clinical management strategies accordingly.”

Masimo offers noninvasive and continuous hemoglobin monitoring, SpHb^®, as part of its rainbow^® Pulse CO-Oximetry platform. To display SpHb trends, Masimo rainbow^® sensors can connect to a variety of Masimo Pulse CO-Oximeters^®, including patient monitors available or in development from more than 20 other Masimo OEM Partners. For details, visit masimo.com/oem/partners. By utilizing multiple wavelengths of light, SpHb provides real-time visibility to changes, or lack of changes, in hemoglobin between invasive blood samples.

Continuous hemoglobin monitoring with SpHb as part of PBM programs has been found to improve outcomes in both high- and low- blood loss surgeries, 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 This evidence of SpHb’s impact on outcomes spans the globe, representing 6 countries on 4 different continents.^2-8

One of the key references cited by the whitepaper is the recent SABM Administrative and Clinical Standards for PBM Programs (5^th edition). These standards recommend the “use of noninvasive hemoglobin and other laboratory measurements” as part of a strategy to reduce phlebotomy blood loss.⁹ Similarly, the latest pediatric standards from SABM (4^th edition) recommend that “noninvasive techniques are used for monitoring of blood gases, hemoglobin and other analytes whenever possible.”¹⁰

Sherri Ozawa, RN, President of SABM, commented, “We believe that comprehensive patient blood management will be the global standard of care. The evidence shows that patient outcomes are better when a patient’s own blood is well managed and unnecessary transfusions are avoided. Clinicians need access to timely information that allows them to make better informed decisions, such as the information provided by noninvasive hemoglobin technology.”

The SABM whitepaper also discusses the role of pleth variability index (PVi^®) as part of PBM. PVi is a continuous, noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. It is a measure of the dynamic changes in perfusion index that occur during the respiratory cycle. The authors note that “combining such a measure with noninvasive Hgb monitoring can yield a more comprehensive picture of the hemodynamic and circulatory status of the patients.” More than 100 independent studies have demonstrated the utility of PVi as an indicator of fluid responsiveness.¹¹

Dr. William Wilson, Chief Medical Officer of Masimo, stated, “Anesthesiologists and critical care physicians have long recognized the importance of dynamic measures of intravascular volume and fluid responsiveness. With the combination of PVi and SpHb, clinicians have a wealth of information at the bedside accessible through something as ubiquitous as a pulse oximetry sensor.”

Joe Kiani, Founder and CEO of Masimo, commented, “Since the launch of SpHb in 2008, we have seen over 75 countries adopt this technology and numerous publications noting its positive impact on outcomes. SABM is recognized as the premier provider of professional education in patient blood management. It’s great to see SABM recommend the use of SpHb and PVi to help improve patient outcomes.”

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.

The accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure, and device-related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi.

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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, reduce the cost of care, and take noninvasive monitoring to new sites and applications. 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.¹² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹³ improve CCHD screening in newborns,¹⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^15-18 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2021-22 U.S. News and World Report Best Hospitals Honor Roll.²⁰ 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, iSirona™, 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. Society for the Advancement of Blood Management (SABM). Improvement of Patient Outcomes with Hemoglobin Monitoring in the Critical Care and Perioperative Setting. Publications. 2021, January. https://sabm.org/wp-content/uploads/SABM-HbMonitoringWhitepaper.pdf
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, Marraccini C, Di Bartolomeo E, Montella M, Pertinhez T, Baricchi R, Bonini A. Postoperative patient blood management: transfusion appropriateness in cancer patients. Blood Transfus 2020; 18: 359-65 DOI 10.2450/2020.0048-20.
9. Society for the Advancement of Blood Management (SABM). SABM Administrative and Clinical Standards for Patient Blood Management Programs 5th Edition. Publications. 2019. https://sabm.org/wp-content/uploads/SABM-Standards-20196.pdf
10. Goobie SM, Gallagher T, Gross I, Shander A. Society for the advancement of blood management administrative and clinical standards for patient blood management programs. 4th edition (pediatric version). Paediatr Anaesth. 2019 Mar;29(3):231-236. doi: 10.1111/pan.13574. PMID: 30609198.
11. Published clinical studies on PVi, with varying results and outcomes, can be found on our website at http://www.masimo.com/evidence/pulse-oximetry/pvi. Studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
12. 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.
13. 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.
14. 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.
15. 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.
16. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
17. 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.
18. 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.
19. Estimate: Masimo data on file.
20. 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^® and PVi^®. 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 and PVi, 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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