Masimo SET® Pulse Oximetry: Superior Performance, Worldwide Presence, Immeasurable Impact

Masimo SET^® Is the Primary Pulse Oximetry at All 10 Top U.S. Hospitals, Monitors More Than 200 Million Patients a Year, and Has Been Shown to Have Unrivaled Accuracy and Reliability in More Than 100 Clinical Studies

Masimo (NASDAQ: MASI) Signal Extraction Technology^®, or SET^®, pulse oximetry – industry-leading, clinically proven, and used by top hospitals everywhere – continues to overcome the limitations of conventional pulse oximetry and offers unrivaled accuracy through ongoing innovation. As of 2024, Masimo’s foundational SET^® technology is now the primary pulse oximetry technology at all ten top U.S. hospitals,¹ and is used to monitor more than 200 million patients a year around the world.² With more than 100 studies demonstrating its ability to outperform other pulse oximetry technologies,³ SET^® measures with industry-best SpO₂ accuracy specifications⁴ – achieved with Masimo’s flagship RD SET^® sensors – through challenging conditions such as patient motion and low perfusion, across all patient populations, and on all skin tones. With decades of expertise, Masimo is now able to make SET^® available not only for traditional hospital bedside monitoring, but in tetherless sensors that promote freedom of movement, in wearable devices worn at home, in baby monitors, and in opioid overdose monitoring solutions – among many others.

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Masimo SET® Pulse Oximetry (Graphic: Business Wire)

Superior Performance

Masimo SET^® originated in Founder and CEO Joe Kiani’s desire to find a way to monitor the oxygen saturation of those most precious of patients – neonatal infants – accurately and reliably, even though their frequent movement and poor perfusion stymied traditional pulse oximetry. SET^® overcame those seemingly insurmountable obstacles, and Masimo’s continued innovation is driving significant accuracy and reliability milestones even today.

• Masimo SET^® is accurate during motion. Before Masimo SET^® pulse oximetry, false alarm rates were high,^5,6 often due to motion^7,8 and low perfusion.⁷ With Masimo SET^®, the rate of false alarms dropped by more than 80% and yet true alarm detection improved significantly.^7,8
• Masimo SET^® is accurate during low perfusion. A recent peer-reviewed study found that for Masimo SET^® SpO₂, A_RMS* accuracy was “1.37% in all subjects with normal perfusion and 1.64% in all subjects with low perfusion.”⁹
• Masimo SET^® is accurate on dark skin. A peer-reviewed publication using appropriately standardized sensor application sites demonstrated that Masimo RD SET sensors had only a 0.15% difference in bias between dark- and light-skinned subjects, which is not clinically significant because pulse oximeters only measure in whole numbers.¹⁰ Further analysis showed that RD SET accurately measured SpO₂ for both Black and White subjects not only when perfusion was normal but also during low perfusion.⁹

Improved Outcomes

With its breakthrough performance, Masimo SET^® made pulse oximetry a clinically useful tool. Prior to Masimo SET^®, not one study had shown that pulse oximetry led to better patient outcomes, despite its ubiquity.¹¹ Masimo SET^® has had, and continues to have, a significant impact not only on the lives of innumerable patients around the world, from young to old, as numerous studies have shown, but on clinician workflows, hospital finances, and even the health of our planet.

• Masimo SET^® saves lives. A study conducted over 10 years on general floor patients being monitored with Masimo SET^® while recovering from surgery found zero preventable deaths or brain damage from opioid-induced respiratory depression.¹² Another study has shown that use of SET^® led to an 80% reduction in the rate of retinopathy of prematurity (ROP, an eye disorder that can cause blindness in premature babies).¹³ Of particular note, in multiple studies, involving more than 300,000 newborns, use of SET^® as part of screening for critical congenital heart disease (CCHD) has been shown to significantly improve screening sensitivity.^14-23
• Masimo SET^® saves time. Studies have found that SET^® generates 86% fewer false alarms than competitor technologies⁸ and that use of SET^® to monitor general floor patients led to an approximately 60% reduction in rapid response team activations – without compromising patient safety.²⁴
• Masimo SET^® saves the environment. Use of Masimo SET^® as part of a sensor management strategy that leveraged Masimo’s unique replacement tape offering resulted in a 60% reduction in the volume of single-patient-use sensors.²⁵ And compared to traditional cable-based sensors, Masimo RD SET^® sensors produce 84% less waste.²⁶ Earlier this year, Masimo became the first pulse oximetry manufacturer to be recognized with the coveted “Greenhealth approved” sustainability seal of approval by Practice Greenhealth, for RD sensors.
• Masimo SET^® saves money. Masimo SET^® helped a hospital avoid $7 million in costs over 12 years through the use of a replacement tape sensor management strategy.²⁵ At another facility, use of Masimo SET^® to monitor med-surg patients helped clinicians reduce unplanned transfers to the ICU by approximately 50%.²⁴ And, our calculations have shown that use of Masimo SET^® and rainbow^® technologies could potentially save a 250-bed hospital over $4 million annually.²⁷

“Without SET^®, there would be no rainbow^® SpHb^® or ORi™, no Hospital Automation™ products like Root^®, Patient SafetyNet™, or Radius VSM™, and no telemonitoring solutions like Masimo SafetyNet^® or Masimo W1^®, among so many other achievements,” said Joe Kiani. “Masimo was established precisely to address the limitations of noninvasive monitoring – problems people thought were unsolvable until Masimo’s inventions! We are honored to be the choice of all top ten hospitals in the U.S, but we are far from satisfied. We are committed to continuously building on our legacy of breakthrough innovation and improving the lives of people everywhere.”

Learn more about Masimo SET^® at https://professional.masimo.com/technology/co-oximetry/masimo-set-pulse-oximetry/.

@Masimo | #Masimo

*A_RMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- A_RMS of the reference measurements in a controlled study.

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. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, 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.³ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹³ improve CCHD screening in newborns,^14-23 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^12,24 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,² and is the primary pulse oximetry at all 10 top U.S. hospitals as ranked in the 2024 Newsweek World’s Best Hospitals listing.¹ 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^®, Radius PPG^®, and Radius VSM™, 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^® and the Masimo W1^® Medical Watch. Masimo hospital and home 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^®. Its growing portfolio of health and wellness solutions includes Radius Tº^® and Masimo W1 Sport. 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/.

RPVi has not received FDA 510(k) 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. As ranked in the 2024 Newsweek World’s Best Hospitals listing, available here: https://www.newsweek.com/rankings/worlds-best-hospitals-2024/united-states
2. Estimate: Masimo data on file.
3. 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.
4. Masimo RD SET Sensor Instructions for Use: LAB-10131D posted on https://techdocs.masimo.com/.
5. Lawless ST. Crying wolf: false alarms in a pediatric intensive care unit. Crit Care Med. 1994 Jun;22(6):981-5.
6. Tsien CL, Fackler JC. Poor prognosis for existing monitors in the intensive care unit. Crit Care Med. 1997 Apr;25(4):614-9.
7. Shah N et al. J Clin Anesth. 2012 Aug;24(5):385-91.
8. Hay W et al. J Perinatol. 2002;360–366.
9. Sharma V, Barker S, Sorci R, Park L, Wilson W. Racial effects on Masimo pulse oximetry: impact of low perfusion index. J Clin Monit Comput. 19 Jan 2024.
10. Barker SJ, Wilson WC. Racial effects on Masimo pulse oximetry: a laboratory study. J Clin Monit Comput. 2023 Apr;37(2):567-574.
11. de-Wahl Granelli A et al. Screening for duct-dependent congenital heart disease with pulse oximetry: A critical evaluation of strategies to maximize sensitivity. Acta Paediatri. 2005;94:1590-1596.
12. 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. 2021; 17(8):557-561. DOI: 10.1097/PTS.0000000000000696.
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. Slitine N, et al. Pulse Oximetry and Congenital Heart Disease Screening: Results of the First Pilot Study in Morocco. Int J Neonatal Screen 6(53). 30 June 2020.
16. 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.
17. Ewer AK et al. Pulse Oximetry Screening for Congenital Heart Defects in Newborn Infants (Pulseox): A Test Accuracy Study. Lancet. 2011 Aug 27;378(9793):785-94.
18. de-Wahl Granelli A et al. Noninvasive Peripheral Perfusion Index as a Possible Tool for Screening for Critical Left Heart Obstruction. Acta Paediatr 2007; 96(10): 1455-9.
19. Meberg A et al. First Day of Life Pulse Oximetry Screening to Detect Congenital Heart Defects. J Pediatr 2008; 152:761-5.
20. Schena F et al. Perfusion Index and Pulse Oximetry Screening for Congenital Heart Defects. J Pediatr. 2017 Apr;183:74-79.
21. Hamilçıkan S, Can E. Critical Congenital Heart Disease Screening With a Pulse Oximetry in Neonates. J Perinat Med. 2018 Feb 23;46(2):203-207.
22. Jawin V et al. Beyond Critical Congenital Heart Disease: Newborn Screening Using Pulse Oximetry for Neonatal Sepsis and Respiratory Diseases in a Middle-Income Country. PLoS One. 2015; 10(9): e0137580.
23. Gunaratne CR, Hewage I, Fonseka A, Thennakoon S. Comparison of pulse oximetry screening versus routine clinical examination in detecting critical congenital heart disease in newborns. Sri Lanka J Child Health, 2021; 50(1): 04-11.
24. 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.
25. Palmer, A. Biomed Instrum Technol. 2021. 55(2):59-62.
26. Masimo data on file.
27. Estimate: Masimo data on file.

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^®. 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^®, 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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