Saudi Arabia Ministry of Health and Masimo Announce Automation of National Neonatal CCHD Screening Process Using Masimo Technology

Recently at Arab Health 2019, the Saudi Arabia Ministry of Health (MOH) and Masimo (NASDAQ: MASI) jointly announced the implementation of an automation solution designed to streamline the process of critical congenital heart disease (CCHD) screening of newborns using Masimo SET^®, the first automation of its kind worldwide. This latest phase in Saudi Arabia’s national CCHD screening program, which began in 2016 as part of the Vision 2030 plan addressing improvements in healthcare and other areas, automates the collection and storage of screening data, helping to make the process both more efficient and more accurate.

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In 2016, Saudi Arabia implemented a mandatory CCHD screening program for all newborns using the Masimo Eve™ Newborn Screening Application on Radical-7^® Pulse CO-Oximeters^® with SET^® Measure-through Motion and Low Perfusion™ pulse oximetry technology. Over 100 independent and objective studies have shown SET^® to outperform other pulse oximetry technologies.¹ Crucially for newborn health, studies – including the largest CCHD screening study to date – have shown that SET^® combined with clinical assessment significantly improved CCHD screening sensitivity.^2-3 With its ability to accurately measure through motion and low perfusion, alongside its performance in outcome studies, SET^® stands out as the most proven and established choice of pulse oximetry technology for clinicians and policy makers hoping to implement CCHD screening processes. Since the program began in 2016, more than 600,000 Saudi Arabian newborns have been screened using SET^®, Radical-7, and Eve.

In 2018, Eve on Rad-97™ Pulse CO-Oximeters was added to the program. Masimo SET^®, coupled with Eve to streamline the screening process, and now with Rad-97 and automated data collection and aggregation, provides a powerful and the only automated CCHD solution of its kind available worldwide. Last year alone 72 newborns were referred for CHD diagnosis and heart surgery to save their lives, as a result of positive screening results. The screenings are carried out at 200 medical centers operated by the MOH, with a further 170 private hospitals adopting the screening process in late 2018. By 2020, it is estimated that 550,000 newborns annually will be screened in Saudi Arabia.

Dr. Fahad A. Al Aql, advisor to the MOH responsible for implementing the CCHD screening program, commented, “We are thrilled to be able to announce that in 2018 alone, widespread use of our national CCHD screening protocol, facilitated by Masimo technology, caught 72 instances of CHD that might otherwise have gone undetected. Now, in this next phase, which we plan to implement nationwide by February, we are augmenting our screening program with additional technology – making it the only automated solution that uses Rad-97 and Eve – that we believe will make the process faster, easier for clinicians to perform, and less prone to error. Patient identification can be quickly accomplished through barcode wristband scanning, and the results, calculated by Eve, will be collected and uploaded to central EMRs automatically, without the need for manual transcription. More efficient, more accurate healthcare is a cornerstone of Vision 2030. With the support of His Excellency the Minister of Health, Dr. Tawfiq Al Rabiah, we are looking forward to continuing to advance the forefront of healthcare in Saudi Arabia with this implementation.”

Eve, available on Radical-7 and Rad-97, combines the power of Masimo SET^® pulse oximetry with an automated pre- to post-ductal synchronization algorithm designed to reduce calculation errors during CCHD screening. In addition, Eve simplifies the CCHD screening process by providing visual instructions, animations, and a detailed, easy-to-interpret display of screening results. Saudi Arabia’s automation solution uses Masimo Iris Gateway™ to record and transmit screening results, labeled with unique patient identifiers for both mother and newborn, from Rad-97 and Radical-7 devices to hospital and national electronic medical record (EMR) systems, for efficient, accurate electronic charting and data aggregation in a unified, central health repository.

CCHD affects approximately 2.5 to 3 newborns per 1000 live births⁴ and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage.⁵ In a study of 39,821 infants, CCHD screening sensitivity increased from 63% with physical exam alone to 83% with physical exam and Masimo SET^® pulse oximetry.² In a study of 122,738 infants – the largest CCHD screening study to date – CCHD screening sensitivity increased from 77% to 93% with the combined use of Masimo SET^® and clinical assessment.³

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About Masimo

Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁶ improve CCHD screening in newborns,² and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response activations and costs.^7-9 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,¹⁰ 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.¹¹ 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^®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO₂, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root^®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect^® (MOC-9^®) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7^® wearable patient monitor, iSpO₂ ^® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/evidence/featured-studies/feature/.

Eve has not obtained FDA clearance and is not available in the United States. Radical-7 and Rad-97 have obtained FDA clearance and are available, without Eve, in the United States.
ORi has not received FDA clearance and is not available for sale in the United States.
The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
References
1.			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.
2.			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.
3.			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.
4.			Hoffman JL et al. The incidence of congenital heart disease. J Am Coll Cardiol. 2002;39(12):1890-1900.
5.			2011 Legislative Report; State of Maryland, Department of Health and Mental Hygiene, State Advisory Council on Hereditary and Congenital Disorders. Recommendations on Implementation of Screening for Critical Congenital Heart Disease in Newborns. Page 7.
6.			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.
7.			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.
8.			Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
9.			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.
10.			Estimate: Masimo data on file.
11.			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 SET^®, Radical-7^®, Rad-97™, and Eve™. 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 SET^®, Radical-7, Rad-97, and Eve, 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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Contact information

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