Masimo Partners with Penington Institute to Raise Awareness of Harm from Prescription Opioid Overdose

(BUSINESS WIRE) -- To mark International Overdose Awareness Day (IOAD) on August 31, Masimo (NASDAQ: MASI), a global medical technology company, announced today its commitment to raising awareness of the risks of overdose from prescription opioids, even when used as directed.

In December 2016, following a routine tonsillectomy, healthy, 21-year-old Parker Stewart took just half of his prescribed dose of opioids and suffered from opioid overdose in his sleep. Tragically, he never woke up. This could have been prevented. His mother, Yvonne Gardner, pleads, “I wish I had known it was a problem – I didn’t know it could happen. I Googled a lot of stuff before the surgery – but I never Googled ‘tonsillectomy fatalities,’ because you just don’t think that such a routine surgery would end up this way.”

Parker’s story is just one example of a preventable death from opioid overdose that happens tens of thousands of times each year around the world.¹ Awareness and education are important to helping prevent others. In honor of IOAD, Masimo is launching an educational website, www.OpioidSafety.org, which shares information about the potential side effects of prescription opioid painkillers, who is at risk, and how to protect yourself. Furthermore, Masimo, in partnership with the Penington Institute – the founder of IOAD – has committed to funding comprehensive research and reporting on the prevalence and impact of prescription and non-prescription opioid overdoses. The reports will be made publicly available at no charge, with the first report, focused on the UK, expected to be available in 2022.

In the latest figures for 2020, published by the UK Office for National Statistics (ONS), drug-related deaths recorded in England and Wales reached the highest levels since records began in 1993. Of the 2,263 deaths recorded, approximately half involved opioids.² Already known to be highly addictive, opioids also have serious side effects, including slowed or stopped breathing – which can lead to cardiac arrest, brain damage, or death.³ Harm can occur even when opioids are taken as prescribed.⁴

Opioid painkillers are prescribed for pain relief and are commonly used by patients during and after surgery, as well as by those experiencing chronic pain. Opioid prescriptions have increased steadily in the UK, with over 50 million opioid prescriptions written in the UK last year alone.² Importantly, about 30% of those taking a prescription opioid painkiller don’t realize they’re taking an opioid.⁵ Last year, more people died from opioids than car accidents.⁶

Dr. Mike Durkin, a Senior NHS Advisor on Patient Safety Policy and Leadership for the National Institute for Health Research (NIHR) Imperial College Patient Safety Translational Research Centre, said, “Prescription opioids are a cornerstone of pain relief for millions of people recovering from injury or managing medical conditions. However, these treatments can pose serious risks to a person’s health if not monitored continuously, and sometimes result in tragic consequences, including loss of life. It is therefore vital that patients prescribed opioid painkillers have a better understanding of their side effects, and are educated on how to protect themselves, including the role of oxygen saturation (SpO₂) monitoring.”

John Ryan, CEO of the Penington Institute, a leader in public health and safety, and immediate past President of London-based Harm Reduction International, said, “Opioid overdose is a complex problem driven by multiple reasons, and as a result, the true scale is not fully reported or understood. However, just because a problem is underreported, it doesn’t mean it doesn’t exist. With incidences of opioid deaths continuing to increase year-on-year, there is an urgent need for better research into treatment and care involving opioids to identify current gaps in care and to help protect people from avoidable harm.”

Joe Kiani, Founder and CEO of Masimo, said, “Too many lives are being lost. Many people immediately assume that an overdose is connected only to the use of illicit drugs or taking more opioids than prescribed. In fact, Parker Stewart took only half the prescribed dose and still died from opioid overdose. We need to prevent harm for anyone taking opioids, including those taking prescription opioids as directed by their healthcare professional for chronic pain or for postoperative or acute pain. We have an obligation to drive education and innovation to eliminate preventable deaths.”

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About International Overdose Awareness Day

International Overdose Awareness Day (August 31) is the world’s largest annual campaign to end overdose, remembering those who have died and acknowledge the grief of the family and friends left behind. The campaign, which originated in Australia, raises awareness of overdose, which is one of the world’s worst public health crises, and stimulates action and discussion about evidence-based overdose prevention and drug policy. International Overdose Awareness Day spreads the message about the tragedy of drug overdose death and that drug overdose is preventable.

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, reduce the cost of care, and take noninvasive monitoring to new sites and applications. 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.^10-13 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁴ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2021-22 U.S. News and World Report Best Hospitals Honor Roll.¹⁵ 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 Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica™, Halo ION™, UniView^®, UniView :60™, and Masimo SafetyNet™. 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. Opioid Overdose. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/opioid-overdose.

2. BMJ Newsroom (2020). Vastly differing opioid prescribing patterns in England even in similarly deprived areas. Available at: https://www.bmj.com/company/newsroom/vastly-differing-opioid-prescribing-patterns-in-england-even-in-similarly-deprived-areas/.

3. Prescription Opioid Data. CDC Injury Center. Centers for Disease Control and Prevention.

4. Levy N. An international multidisciplinary consensus statement on the prevention of opioid-related harm in adult surgical patients. Anaesthesia. 2021;76:520–536.

5. National Safety Council. Prescription opioid pain killer public opinion poll. October 2017. https://www.cdc.gov/drugoverdose/deaths/prescription/index.html

6. Odds of Dying - Data Details. National Safety Council; Injury Facts, 4 Mar. 2021, injuryfacts.nsc.org/all-injuries/preventable-death-overview/odds-of-dying/data-details.

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. Taenzer A 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.

11. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

12. 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.

13. 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. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.

14. Estimate: Masimo data on file.

15. 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 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, 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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