Masimo SafetyNet Alert(tm) (Photo: Business Wire)

Masimo (MASI) – Get Masimo Corporation Report announced today the CE marking and launch in western Europe of Masimo SafetyNet Alert(tm), an arterial blood oxygen saturation monitoring and alert system designed for use at home. Masimo SafetyNet Alert uses Signal Extraction Technology (r), a wearable fingertip pulse-oximetry sensor, which communicates wirelessly with a companion Home Medical Hub app and a smartphone app. Masimo SafetyNet Alert monitors blood oxygen saturation (SpO 2) and pulse rate (PR) using clinically proven Masimo SET (r) Measure-through Motion and Low Perfusion(tm) pulse oximetry and perfusion index (Pi). The system sends alerts to other people if there are any drops in oxygen. It is designed to wake the person who has taken opioid overdose.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210829005026/en/

Masimo SafetyNet Alert(tm) (Photo: Business Wire)

Over 200 million people are monitored with Masimo SET (r) pulse oximetry in hospitals each year. 1 In hospitals, continuous Masimo SET (r) oxygen saturation monitoring has been shown to reduce harm associated with opioids in multiple clinical trials, including a 10-year study in which researchers at Dartmouth-Hitchcock Medical Center found that the use of Masimo SET (r)-based continuous patient surveillance monitoring resulted in zero opioid-related preventable deaths or brain damage in their post-surgical wards. The researchers also found there was a reduction in rapid rescue events by 60%, a reduction in ICU transfers by 50%, and an estimated $7 million annually in cost savings. 2-4

Opioids are powerful painkillers, and are commonly used as part of recovery after surgery and for patients with chronic pain, but they can also slow or stop one’s breathing, potentially leading to heart attack, brain damage, and even death. In 2020 the number of drug-related deaths recorded in England and Wales rose to 4,561, the highest since records began, and around half of these involved opioids. 5 Worldwide, that number is even worse, with an estimated more than 100,000 people dying from opioid overdose each year. People can experience opioid-induced respiratory depression (OIRD), regardless of whether they are taking prescription or nonprescription opioids. 6 Opioid addiction can occur at any time, even when a person is asleep. The risk of overdose-related death from opioids is higher for those who are taking opioids for the very first time, people who have COPD or sleep apnea, as well as those who take opioids together with alcohol or other sedatives. Masimo SafetyNet Alert helps to identify serious opioid overdoses before they cause lasting harm or even death by monitoring oxygen saturation levels, particularly while sleeping.

Masimo SafetyNet Alert leverages the same SET (r) pulse oximetry technology and a similar notification escalation policy used in hospitals to bring hospital-proven monitoring to the home setting. The system sends out escalating visual or audible alerts via the smartphone app and at Home Medical Hub station. These alerts are intended to notify the patient and anyone else nearby and prompt immediate action. To alert designated emergency contacts (such as family and friends) if oxygen levels drop, text messages are sent to them. They can then intervene or call Emergency Medical Services if necessary.

Masimo SafetyNet Alert presents the revolutionary Masimo SET(r) pulseoximetry that is used in hospitals all over the globe. SET (r) has been clinically proven to help care teams enhance patient safety and improve patient outcomes; in fact, more than 100 independent and objective studies have shown that Masimo SET (r) outperforms other pulse oximetry technologies during motion and low perfusion conditions, providing clinicians with increased sensitivity and specificity to make critical care decisions. 9

Dr. Mike Durkin is a Senior NHS Advisor on Patient Safety Policy & Leadership for the National Institute for Health Research, (NIHR), Imperial College Patient Safety Translational Research Centre. He stated, “Patients who have had surgery need pain relief with opioid drugs even after being discharged from hospital. These drugs can have serious side effects, especially if they are used to treat depression or breathing problems. If not treated immediately, it could lead to death or serious injury. It is possible to monitor the effects of opioids on the breathing. Patients should be able to monitor their oxygen levels at home and monitor vital signs. This will improve patient safety and help patients to recover at home.

Yvonne Gardner, mother of 21-year-old Parker Stewart, who died of an opioid overdose after taking only half of the prescribed dose of painkillers following a tonsillectomy, said, “I’ve had so many people call me personally and say, what would you do differently? My son is due for a tonsillectomy. Or my daughter is. They tell me: Make sure your doctor gives you monitors.”

Joe Kiani, Founder and CEO of Masimo, said, “30 years ago, we had the dream of improving patient outcomes and reducing the cost of care by taking noninvasive monitoring to new sites and applications. Our measure-through motion and low pulse oximetry are now available at home to monitor opioid users. This is fulfilling a dream I never had. With Masimo SafetyNet alert, I hope that tens of thousands more lives will be saved from opioid overdose each year.

Masimo SafetyNet Alert has not received FDA 510(k) clearance and is not available for sale in the United States.

@Masimo | #Masimo

About Masimo

Masimo (MASI) – Get Masimo Corporation Report 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 and reduce costs. We also aim to expand non-invasive monitoring to new locations and applications. Masimo SET (r) Measure-through Motion and Low Perfusion(tm) pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies. 9 Masimo SET (r) has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates, 10 improve CCHD screening in newborns, 11 and, when used for continuous monitoring with Masimo Patient SafetyNet(tm) in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs. 2-4,12 Masimo SET (r) is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world, 1 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. 13 Masimo continues to refine SET (r) and in 2018, announced that SpO 2 accuracy on RD SET (r) sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO 2 values they rely on accurately reflect a patient’s physiological status. In 2005, Masimo introduced rainbow (r) Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb (r)), oxygen content (SpOC(tm)), carboxyhemoglobin (SpCO (r)), methemoglobin (SpMet (r)), Pleth Variability Index (PVi (r)), RPVi(tm) (rainbow (r) PVi), and Oxygen Reserve Index (ORi(tm)). In 2013, Masimo introduced the Root (r) 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 (r) Brain Function Monitoring, O3 (r) Regional Oximetry, and ISA(tm) Capnography with NomoLine (r) sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters (r) includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7 (r) and Radius PPG(tm), portable devices like Rad-67 (r), fingertip pulse oximeters like MightySat (r) Rx, and devices available for use both in the hospital and at home, such as Rad-97 (r). Masimo hospital automation and connectivity solutions are centered around the Masimo Hospital Automation(tm) platform, and include Iris (r) Gateway, iSirona(tm), Patient SafetyNet, Replica(tm), Halo ION(tm), UniView (r), UniView : 60(tm), and Masimo SafetyNet(tm). 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. University HealthSystem Consortium has licensed the use of the trademark Patient SafetyNet.

References

  1. Estimate: Masimo data on file.
  2. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  3. McGrath S et al. Surveillance Monitoring Management of General Care Units: Strategy and Design. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7): 293-302.
  4. McGrath S et al. Inpatient Respiratory Arrest as Associated with Sedative and analgesic Medication: Effect of Continuous Monitoring on Patient Mortality, Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
  5. Office for National Statistics. (2021) Deaths related to drug poisoning in England and Wales: 2020 registrations. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsrelatedtodrugpoisoninginenglandandwales/2020. Last accessed August 2021.
  6. Opioid Overdose. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/opioid-overdose.
  7. Gupta K et al. Curr Opin Anaesthesiol. 2018;31(1): 110-119.
  8. Subramani Y et al. Br J Anaesth. 2017;119(5): 885-899.
  9. Published clinical studies on pulse oximetry and the benefits of Masimo SET (r) can be found on our website at http://www.masimo.com. Comparative studies are independent and objective studies that include abstracts from scientific meetings or peer-reviewed journal articles.
  10. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO 2 Technology. Acta Paediatr. 2011 Feb;100(2): 188-92.
  11. 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.
  12. Taenzer A et al. A before-and-after comparison study on the impact of pulse oximetry surveillance upon rescue events and transfer to ICUs. Anesthesiology. 2010: 112(2): 282-287.
  13. 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 statements about the effectiveness of Masimo SafetyNet Alert ™. 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 SafetyNet Alert, 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. We believe our forward-looking statements to be reasonable. However, we don’t know if our expectations will prove true. This press release contains forward-looking statements that are qualified by the foregoing cautionary remarks. These forward-looking statements are only valid as of today and should not be relied upon. These forward-looking statements and the “Risk Factors”, contained in the most recent SEC reports, are subject to change, clarification, or amendment, as required by applicable securities laws.

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