In Response to Blood Shortages Due to COVID-19, Masimo Offers Licenses for rainbow^® Noninvasive Blood Constituent Monitoring, Including Total Hemoglobin, SpHb^®, at No Additional Charge During the Coronavirus Pandemic

rainbow^® Can Help Masimo Customers Better Manage Blood Supplies with SpHb^® and Monitor Patients Receiving iNO Therapy with SpMet^®

Masimo (NASDAQ: MASI) today announced that, in response to current worldwide blood shortages driven by the coronavirus pandemic, it is making rainbow^® licenses available for no additional charge to hospitals where rainbow^®-ready devices are already in use. The Masimo rainbow^® platform allows for the noninvasive and continuous monitoring of 12 parameters, including hemoglobin (SpHb^®), oxyhemoglobin (SpO2), and methemoglobin (SpMet^®). Once rainbow^® is enabled, hospitals can purchase RD rainbow^® sensors at discounted prices during this pandemic. The program is available globally and is planned to continue until the pandemic subsides.

Masimo RD rainbow SET ^® Sensor

SpHb provides real-time visibility to changes, or lack of changes, in hemoglobin between invasive blood samples – and has been shown to help clinicians improve patient blood management. In multiple outcome studies, SpHb has been shown to help clinicians reduce blood transfusions.^1-4 SpHb is available on a variety of Masimo Pulse CO-Oximeters^®, including the Root^® Patient Monitoring and Connectivity Platform, Radical-7^®, and Rad-97^®, as well as patient monitors from 25 other patient monitoring manufacturers, including Dräger and Philips.

"Our goal is to make the biggest difference we can during this challenging time. This is our third initiative in the past four days to help clinicians deal with COVID-19. Many hospitals have seen the value of rainbow^®, and we hope every hospital can now benefit from proven rainbow^® noninvasive blood constituent monitoring technology," said Joe Kiani, Founder and CEO of Masimo.

One of the many burdens COVID-19 is placing on health systems around the world is a shortage of blood products, as hospitals rush to treat an extraordinary surge of patients – at the same time that many blood drives have been cancelled. Therefore, hospitals are needing to manage blood supplies as efficiently and conservatively as possible. A growing body of evidence from around the world has shown that Masimo SpHb may help clinicians reduce unnecessary blood transfusions in both low- and high-blood-loss surgeries:

• A randomized trial of 327 patients undergoing elective orthopedic surgery found that the use of continuous, noninvasive hemoglobin monitoring with SpHb reduced the rate of transfusions by 87% when compared to standard care without continuous, noninvasive hemoglobin monitoring.¹
• A prospective cohort study of 106 neurosurgical patients found that adding SpHb monitoring to standard-of-care blood management resulted in decreased blood utilization in high-blood-loss neurosurgery by 41%, while also decreasing time to transfusion when indicated by 41 minutes.²
• A study of 100 patients undergoing abdominal cancer surgery found that SpHb monitoring decreased blood utilization by 39%, while facilitating earlier transfusions when indicated by 33 minutes.³
• A study of 237 patients undergoing hip trauma surgery found that continuous SpHb monitoring during high-blood-loss surgery reduced the percentage of patients needing blood transfusions by 7% and number of transfused units per patient by 13%.⁴

In addition to SpHb, the rainbow^® family of advanced noninvasive parameters includes SpMet, which helps clinicians noninvasively and continuously monitor methemoglobin levels in the blood.⁵ Elevated methemoglobin levels can be caused by inhaled nitric oxide (iNO) therapy,^6-7 which is currently being investigated as a potential treatment for lung complications associated with COVID-19. By allowing clinicians to monitor methemoglobin levels, SpMet may be an important monitoring tool during iNO therapy.

SpHb and SpMet are 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 and laboratory diagnostic tests using blood samples.

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1. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014
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. Study Protocol: The transfusion threshold of 10g/dL was predetermined by the study protocol and may not be appropriate for all patients. The blood sampling technique was the same for patients in both the control and the test group. Arterial blood was drawn from a 20-gauge radial artery cannula into 2mL ethylenediaminetetraacetic acid collection tubes, thoroughly mixed, then sent immediately to the central lab for analysis by a hematology analyzer. The reference laboratory device used for hemoglobin measurements in the study was a Coulter GEN-S Hematology Analyzer.
3. 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.
4. 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.
5. Annabi E et al. Severe Methemoglobinemia Detected by Pulse Oximetry. Anesth Analg. 2009 Mar;108(3):898-9.
6. Riou Y et al. Pediatric Research. 1998. 43, 295-295.
7. U.S. Food & Drug, Consumer Updates, Benzocaine and Babies: Not a Good Mix.
8. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at https://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
9. 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.
10. 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.
11. 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.
12. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
13. 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.
14. Estimate: Masimo data on file.
15. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

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