Masimo Announces CE Marking of Neonatal Indication for Noninvasive, Continuous Hemoglobin Monitoring (SpHb®)

Masimo (NASDAQ: MASI) announced today the CE marking of SpHb^®, noninvasive and continuous hemoglobin monitoring, for neonatal and infant patients (< 3 kg). With this clearance, the benefits of SpHb are available for patients of all ages in CE mark countries. SpHb for neonates and infants is provided on rainbow^® sensors, which allow clinicians to simultaneously measure multiple additional noninvasive parameters alongside SpHb, including oxygen saturation (SpO₂) and methemoglobin (SpMet^®).

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Masimo Root® with SpHb® and PVi® (Photo: Business Wire)

Because of their small size, neonates and infants have less blood than older patients. In addition, their lack of bone marrow density makes them far less capable than adults of generating new red blood cells for approximately the first eight months of life. Current invasive methodologies for measuring hemoglobin can only provide intermittent, delayed results. By providing a continuous, noninvasive measurement, SpHb allows clinicians to more closely monitor neonatal hemoglobin status in real time by tracking the stability, or instability, of a patient’s hemoglobin trend, providing visibility into changes, or lack of changes, in hemoglobin between invasive blood samples.

On adult patients, continuous monitoring with SpHb has been found to improve outcomes, such as reducing the percentage of patients receiving transfusions,¹ reducing the units of red blood cells transfused per patient,^2-3 reducing the time to transfusion,⁴ reducing costs,⁵ and even reducing mortality 30 days after surgery.⁶

In addition to hemoglobin, rainbow^® sensors monitor SpO₂ using Masimo SET^® Measure-through Motion and Low Perfusion™ technology, which has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.⁷ Crucially for newborn health, SET^® has been shown to help clinicians reduce severe retinopathy of prematurity in neonates⁸ and in multiple studies, including the largest critical congenital heart disease (CCHD) study to date, to improve CCHD screening in newborns.^9-10

The rainbow^® family of advanced noninvasive measurements also allows clinicians to use the same single sensor to monitor another physiological parameter particularly important to neonatal care: methemoglobin, using SpMet. SpMet helps clinicians noninvasively and continuously monitor methemoglobin levels in the blood.¹¹ In neonates and infants, inhaled nitric oxide (iNO) therapy and even topical anesthetics containing benzocaine or prilocaine can cause elevated levels of methemoglobin.^12-13

Joe Kiani, Founder and CEO of Masimo, said, “We are thrilled to be able to bring the power of noninvasive hemoglobin monitoring with SpHb to the youngest, most fragile patients of all. We have long been dedicated to helping improve the lives of neonatal and infant patients, and this latest clearance significantly furthers that mission. SpHb is already used to monitor adult patients in more than 75 countries. We look forward to witnessing the impact that SpHb will now be able to have on neonatal and infant patients.”

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 has received FDA clearance for patients >3 kg but is not currently indicated for patients <3 kg in the US.

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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.⁷ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁸ improve CCHD screening in newborns,⁹ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^14-16 Masimo SET^® is estimated to be used on more than 100 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 listed in the 2018-19 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 Iris^® platform, and include Iris Gateway™, Patient SafetyNet, Replica™, Halo ION™, UniView™, and Doctella™. 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. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
2. 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.
3. 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.
4. 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.
5. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.
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. 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.
8. 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.
9. 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.
10. Zhao et al. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54.
11. Annabi EH et al. Anesth Analg. 2009 Mar;108(3):898-9.
12. Riou Y et al. Pediatric Research. 1998. 43, 295-295.
13. U.S. Food & Drug, Consumer Updates, Benzocaine and Babies: Not a Good Mix.
14. 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.
15. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
16. 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.
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; 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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