Masimo Announces Distribution of Rad-57® Pulse CO-Oximeters® by The Jeffrey Lee Williams Foundation to First Responders

Masimo (NASDAQ: MASI) announced today that The Jeffrey Lee Williams Foundation has distributed 20 Masimo Rad-57® Pulse CO-Oximeters® to EMS departments in York County, South Carolina, with the majority going to Piedmont Medical Center EMS. The Foundation purchases equipment that assists in monitoring for the presence of carbon monoxide (CO) and donates it to the community and local fire and first response agencies. The Rad-57s were awarded to the departments at an event on November 6.

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The Jeffrey Lee Williams Foundation Presents Masimo Rad-57® Pulse CO-Oximeters® to Members of the Piedmont Medical Center EMS (York County, South Carolina) (Photo: Business Wire)

The Jeffrey Lee Williams Foundation was founded in 2013 to honor the tragic loss of Jeannie Williams’ son Jeffrey at the age of 11 to CO poisoning. Its mission is to help prevent CO poisoning by facilitating the distribution and placement of equipment to detect and monitor for CO. Currently, the Foundation is working in York County to sponsor the distribution of 2,000 CO alarms among all 18 fire districts in York County for installation in residential homes, the distribution of 45 “always-on” CO monitors among fire departments and EMS departments, and the distribution of the 20 Masimo Rad-57s to first responders and EMS departments.

CO poisoning is a leading cause of unintentional poisoning deaths in the United States.1 In addition, just one severe CO exposure event nearly doubles the risk of premature death, and consistent CO exposure may cause long-term heart and brain damage.2,3 Even mild levels of CO circulating in the blood rob the heart and brain of oxygen, which can cause mental confusion, leading to poor decision making and increasing the risk of heart disease or stroke – two conditions that account for nearly 50% of on-duty firefighter deaths.4,5

Rad-57 provides oxygen saturation, pulse rate, and perfusion index measurements using SET® Measure-through Motion and Low Perfusion™ pulse oximetry. In addition, it includes SpCO®, a noninvasive rainbow® parameter, to measure the amount of carboxyhemoglobin in red blood cells; carboxyhemoglobin forms after exposure to CO. Noninvasive SpCO monitoring may lead to the identification of elevated CO levels that might otherwise go undetected in front-line settings.

Amber Williams, Co-founder of The Jeffrey Lee Williams Foundation, South Carolina, “We are thrilled to offer Piedmont Medical Center EMS and two other rescue squads the Rad-57s! These devices will provide quick, noninvasive, objective data to responders to assist in the identification and treatment of CO exposure in our community.”

Jeannie Williams, Co-founder, added, “Thank you Masimo for your support as we work to help others in Jeffrey’s memory.”

Joe Kiani, Founder and CEO of Masimo, said, “We are saddened by the loss of life due to CO poisoning and delighted to help support The Jeffrey Lee Williams Foundation’s important work. We hope that Rad-57 and SpCO technology can help to identify elevated CO levels in York County EMS responders, firefighters, and civilians.”

SpCO is intended to be used to monitor CO levels in the blood and is not intended to be used as the sole basis for making diagnosis or treatment decisions related to carbon monoxide poisoning. SpCO monitoring is not intended to replace laboratory blood testing; blood samples should be analyzed by laboratory instruments prior to clinical decision making.

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References

1. Carbon Monoxide Exposures, United States, 2000-2009. Morbidity and Mortality Weekly Report. Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6030a2.htm.
2. Hampson NB et al. Increased long-term mortality among survivors of acute carbon monoxide poisoning. Crit Care Med. 2009; 37(6):1941-47.
3. Bledsoe BE. The heart dangers of CO: Understanding cardiovascular risks to responders from CO exposure. J Emerg Med Svcs. 2007; 32:54-59.
4. Jakubowski G. The Invisible Incidents: How to respond to CO alarms. FireRescue Magazine. 2004; 22(11):52-55.
5. Bledsoe BE. The Perils of CO. FireRescue Magazine. September 2005.

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,1 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.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 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/cpub/clinical-evidence.htm.

ORi 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. 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.
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;338.
3. 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.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. 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.
6. Estimate: Masimo data on file.
7. 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 Rad-57® Pulse CO-Oximeter® and SpCO®. 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 Rad-57 Pulse CO-Oximeter and SpCO, 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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