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Masimo Announces U.S. Release of softFlow® High-Flow Nasal Cannula Therapy

Innovative Nasal High-Flow Therapy Provides Respiratory Support for Patients with COVID-19 and Other Respiratory Conditions

Irvine, California , California - February 23, 2021 – Masimo (NASDAQ: MASI) today announced the U.S. introduction of softFlow®, innovative pulmonary care therapy which provides nasal high-flow warmed and humidified respiratory gases to spontaneously breathing patients. The technology, available on the softFlow 50, offers adult patients high-flow respiratory support through a soft nasal cannula by generating a consistent high flow of warm, humidified air or air/oxygen mixture.

Masimo softFlow

Masimo softFlow®

As the COVID-19 pandemic continues, increasing the number of patients suffering from respiratory conditions and requiring respiratory support, softFlow offers clinicians across the continuum of care an important tool to help in the treatment of spontaneously breathing patients. Capable of operating without an external compressed air supply, softFlow is designed for maximum versatility, with utility in settings throughout the hospital, long term-care facilities, and use at home. To reduce the risk of cross-contamination, softFlow uses a single-patient-use flow path from the internal mixing chamber to the patient and a bacterial/viral filter designed to filter contaminants from the air delivered to the patient.

The U.S. National Institutes of Health (NIH) and World Health Organization (WHO) have both suggested that the use of High-Flow Nasal Cannula (HFNC) therapy, like softFlow, is a viable option for providing respiratory support for select COVID-19 patients for whom conventional oxygen therapy may be insufficient.1 softFlow can provide patients suffering from COVID-19 or other respiratory conditions with higher flow rates of oxygen than conventional oxygen therapies. As a therapy, NIH concluded, "HFNC is preferred over Noninvasive Positive Pressure Ventilation (NIPPV) in patients with acute hypoxemic respiratory failure based on data from an unblinded clinical trial in patients without COVID-19 who had acute hypoxemic respiratory failure."2 The referenced study found a higher number of ventilator-free days (24 days) with HFNC than with conventional oxygen therapy (22 days) or NIPPV (19 days) (p=0.02). The researchers also found a lower 90-day mortality rate compared to conventional oxygen therapy or NIPPV.3

With softFlow, the airflow is consistently delivered through the nose, allowing patients to continue to eat, drink, and speak, which is difficult with mask-based forms of respiratory support. In addition, the softFlow 50 system provides warm, humidified gas into the patient's nose, to enhance comfort and aid in mucous clearance.4,5 With its ability to precisely deliver high respiratory gas flow rates well above those required for typical respiratory demand, clinicians can also take advantage of the high-flow rate to help limit the entrainment of room air (which can reduce the quantity of delivered inhaled oxygen).

The innovative integrated airflow generator of the softFlow technology and water reservoir attachment allow for continued HFNC treatment of recovering COVID-19 patients in the home and other care settings, without the need for a separate source for high-flow air like other devices. The device's simple, intuitive interface allows patients or their caregivers (who can lock settings) to easily customize the flow rate and humidification level.

First available in 2016, softFlow is now in use in numerous countries in Africa, Asia, and Europe.

Beijing Aerospace Changfeng Co., LTD, of China, noted, "We are very satisfied with the therapy successes we achieve with this device. We would like to emphasize the stable flow during inhalation and exhalation, which is generated by the powerful motor, which doesn’t need an external air source, as well as the resulting CO2 washing out. This fact opens up possibilities for [use as] a therapy for hypercapnic patients. Another very positive aspect of the device is the way it prevents condensation in the applicator by warming the entire tube system up to the nasal cannula. … All in all we are very satisfied with the handling of the device and the medical results."

Miguel Marina Barrio, Product Manager, Intensive Care Division, Hospital Hispania, Spain, added, "We already ordered 50 devices and we are very satisfied with the way softFlow performed. … In our opinion, the following points are very good: menu structure, product features, design, usability, manuals, delivery times. … The product quality, customer service, and type of packaging are particularly excellent."

Dr. Dalal Al Matrouk, Head of Anesthesia and ICU at Farwaniya Hospital, Ministry of Health, Kuwait, said, "We have deployed 10 units of Masimo softFlow to help our clinicians manage patients with COVID-19-induced respiratory problems. We realize that high-flow nasal therapy could potentially help avoid invasive mechanical ventilation and its associated risks of ventilator-induced lung injury and hospital-acquired pneumonia."

Joe Kiani, Founder and CEO of Masimo, said, "We believe softFlow provides clinicians with an important tool to help address the growing number of people with compromised respiratory function, whether in high-acuity or low-acuity settings, including at home. We're happy to now be able to offer this technology in the United States."

@MasimoInnovates || #Masimo

The softFlow 50 is FDA cleared for use in hospital and long-term care facilities. Home use is being made available in the US under the FDA Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the COVID-19 Public Health Emergency.

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 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.6 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,7 improve CCHD screening in newborns,8 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.9-12 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,13 and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.14 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, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView :60™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. https://www.who.int/docs/default-source/coronaviruse/clinical-management-of-novel-cov.pdf
  2. https://www.covid19treatmentguidelines.nih.gov/critical-care/oxygenation-and-ventilation/
  3. Frat JP, Thille AW, Mercat A, et al. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015;372(23):2185-2196. Available at: https://www.ncbi.nlm.nih.gov/pubmed/25981908.
  4. Hasani A et al. Chron Respir Dis 5, no. 2 (2008): 81-86.
  5. Roca O et al. Respir Care 55, no. 4 (2010): 408-413.
  6. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at https://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
  7. 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.
  8. 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.
  9. 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.
  10. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  11. 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.
  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. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
  13. Estimate: Masimo data on file.
  14. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements: Masimo
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 softFlow®. 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 softFlow, 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.

Media Contact: Masimo
Evan Lamb
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

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Masimo Announces Full Market Release of Masimo SafetyNet-OPEN™

Easy-to-Implement Solution Helps Businesses, Schools, and Other Organizations Reopen Responsibly and Stay Open Safely During Infectious Illnesses

Irvine, California , California - February 15, 2021 – Masimo (NASDAQ: MASI) today announced the full market release of Masimo SafetyNet-OPEN™, a web and mobile app solution that helps businesses, schools, and other organizations screen, trace, and manage users as they face COVID-19 and other infectious illnesses, such as seasonal flu. SafetyNet-OPEN not only helps organizations bring their people back to the workplace responsibly, but stay open safely. Tailored for each organization’s safety protocols and needs, SafetyNet-OPEN is capable of covering all stages of back-to-work management, including risk screening, exposure contact tracing, and recovery management.

Masimo SafetyNet-OPEN™

Masimo SafetyNet-OPEN™

As a global leader in noninvasive patient monitoring technologies and advanced connectivity and automation solutions, Masimo is uniquely positioned to provide organizations with the tools to assist them in staying open safely. Trusted by leading hospitals to monitor more than 200 million patients each year,1 Masimo, in the first phase of the COVID-19 pandemic, developed the Masimo SafetyNet™ remote patient management solution, now in use at hospitals around the world, to help keep patients and frontline workers safe. SafetyNet-OPEN builds on SafetyNet by scaling this patient management to the level of entire organizations, no matter the size. When escalation of care is needed, SafetyNet-OPEN can even integrate clinical monitoring using Masimo SafetyNet, in partnership with the organization's health care provider or local hospital.

Masimo SafetyNet-OPEN helps organizations identify those who are most at risk of COVID-19 or other infectious viruses, trace possible exposure to limit the spread of the virus, and monitor users' vital signs, including temperature, to help detect the onset of fever, and arterial oxygen saturation, for signs of dangerous deterioration. Based on answers to daily questions and physiological data from connected monitoring devices, users receive a personalized daily risk score, automating directives to stay home, get tested, or seek treatment, configured according to each organization’s safety protocols, back-to-work procedures, and changing local health authority guidelines.

Flexible and versatile, the Masimo SafetyNet-OPEN system can be augmented with additional components to offer more advanced management of the organization's users. To help screen potentially infected users, results from on-site testing, implemented in coordination with a trusted lab partner, can be securely stored and taken into account in risk scoring and assessment. To improve contact tracing, SafetyNet-OPEN can be customized with proximity wristbands or with the Radius T°™ wearable continuous thermometer for both temperature measurement and proximity analysis, to help track users' exposure to those who may be at risk, including time spent in close contact. And when care escalation may be needed, the organization, in collaboration with a trusted clinical partner, can easily incorporate vital signs data into SafetyNet-OPEN, to monitor impacted users as their risk level rises or during recovery from COVID-19, flu, or another illness. Data can be collected from the Radius T° continuous thermometer (to help track fever), the Radius PPG™ wearable continuous pulse oximeter, and other monitoring devices.

For businesses, schools, and organizations both large and small, Masimo SafetyNet-OPEN is easy and fast to implement, with no desktop software to install and with a dedicated Masimo support team to ensure seamless rollout. A web-based workforce management dashboard provides a clear picture of every team member's status – who's at risk, who's recovering, who's cleared to work, proximity violations, etc. – helping organizations efficiently and safely manage their teams during COVID-19 and beyond. Every aspect, from the daily risk-assessment questions, to the rules of the algorithm that determines risk scores, to group assignments for contact tracing, and more, can be easily customized. Furthermore, SafetyNet-OPEN is designed to ensure user data is secure.

Dr. Richard Carmona, MD, MPH, 17th Surgeon General of the United States and Distinguished Professor of Public Health at the University of Arizona Mel and Enid Zuckerman College of Public Health, said, "One of Masimo SafetyNet-OPEN's greatest strengths is its great versatility and customizability, which gives it enormous potential to provide utility in so many settings. As a former Surgeon General I can see tremendous application across a number of federal agencies whose day-to-day operation and 24/7 capability we all depend upon. At the University of Arizona, where I lead the effort to safely reopen our campuses, we've been involved in numerous initiatives examining how COVID-19 affects social groups – for example, the effects of asymptomatic carriers, and how to prevent 'superspreader' events. SafetyNet-OPEN's risk assessment and mitigation tools, which can be fine-tuned to accommodate our evolving understanding of the disease, are ideal for better understanding and coping with such a complex challenge."

Claremont McKenna College President Hiram E. Chodosh, JD, said, "We are grateful to Masimo for the pilot use of its SafetyNet-OPEN tools, which we believe provide yet another important way for us to strengthen the health and safety capabilities of our college campus and the broader community."

Dr. Mark Ferris, MSc, MRCGP, MFOM, Occupational Physician, UK, commented, "Over the last year, we have gained considerable knowledge about COVID-19 and how best to control it. It is clear that to protect our colleagues or students, their families, our workplaces, and the wider community, we need to combine as many strategies as possible. These include the provision of accurate information, physical distancing, masks, ventilation, hygiene precautions, testing and monitoring, contact tracing, and supported isolation. The Masimo SafetyNet-OPEN solution offers a vital way to help organizations apply this combined strategy."

Filmmaker Mark Kassen, Co-Founder and Executive Chairman of Like Minded Media Ventures, added, "We are all anxious to get back to work but without Masimo SafetyNet-OPEN, which we used during its limited market release, we never would have felt safe and secure enough to ask our cast and crew to come back to set."

Dr. Oscar San Román Orozco, MD, COVID-19 Clinic, University Health System, Universidad Autonoma de Queretaro, Mexico, explained, "Public Health interventions never work in silos, because pandemics don’t just affect one sector. To overcome the challenges that COVID-19 has given us, we need a robust systematic approach that involves intersectoral, evidence-based interventions and technology. Masimo SafetyNet-OPEN provides employers and university leaders with the necessary tools to make their communities feel safe through an organized, controlled, and monitored strategy. We might not eradicate the disease soon, but we can control it by segmenting work and social groups based on their risk, monitoring these social bubbles using a robust screening and contact tracing method, and trusting in new intersectoral approaches and technologies. These will allow us to delimit the viral propagation and maintain tight control in case any individual gets infected."

Joe Kiani, Founder and CEO of Masimo, said, "As the COVID-19 pandemic continues, organizations around the world are struggling with the immense challenge of balancing the health and safety of employees, students, and members with the economic and educational needs of their communities. Masimo has developed numerous technologies to help patients and clinicians stay safe during the pandemic. With SafetyNet-OPEN, we've combined our decades of expertise in patient monitoring with our latest innovations in automation and connectivity to help organizations confront this challenge and better manage future ones."

@MasimoInnovates || #Masimo

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 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.2 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,3 improve CCHD screening in newborns,4 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.5-8 Masimo SET® 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 listed in the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.9 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®, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. Estimate: Masimo data on file.
  2. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at https://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
  3. 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.
  4. 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.
  5. 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.
  6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  7. 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.
  8. 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.
  9. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements: Masimo
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 SafetyNet-OPEN™, Radius T°™, and Radius PPG™. 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-OPEN, Radius T°, and Radius PPG, 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.

Media Contact: Masimo
Evan Lamb
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

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Masimo Expands Suite of Advanced Measurements Through Acquisition of UK-Based LiDCO Group Plc

Leading Provider of Hemodynamic Monitoring Becomes Masimo Subsidiary

Irvine, California , California - February 2, 2021 – Masimo (NASDAQ: MASI) today announced that it has successfully completed the acquisition of the LiDCO Group Plc, a leading provider of advanced hemodynamic monitoring solutions (LiDCO). The Company completed the acquisition of 100% of LiDCO on February 2, 2021.

LiDCO was founded in 1991, launched its first product in 1999, and began trading on the AIM submarket of the London Stock Exchange in 2001. On January 11, 2021, LiDCO was de-listed from AIM and will be re-registered by Masimo as a UK-based private subsidiary.

@MasimoInnovates || #Masimo

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 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.1 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates3 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs4-7 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,8 and is the primary pulse oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.9 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®, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at https://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. 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.
3. 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.
4. 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.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6. 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.
7. 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.
8. Estimate: Masimo data on file.
9. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

About LiDCO
LiDCO is a supplier of noninvasive and minimally invasive hemodynamic equipment used to monitor the amount of blood flowing around the body and ensure that vital organs are adequately oxygenated. Clinical studies show that optimizing the hemodynamic status of high-risk patients produces better outcomes and reduced hospital stay. Since launching our first product in 1999, LiDCO has been committed to improving patient outcomes whilst providing excellent customer service. Dedicated to making a difference.

Forward-Looking Statements: Masimo
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, those related to Masimo’s proposed acquisition of the Connected Care Business from NantHealth (the "Acquisition"), and 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 achieving the conditions to closing the Acquisition and risks regarding the integration of assets acquired from NantHealth; 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; 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.

Media Contact: Masimo
Evan Lamb
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

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Masimo Announces the iSirona™ Connectivity Hub

Irvine, California – January 19, 2021 – Masimo (NASDAQ: MASI) today announced the global launch of iSirona™, a compact, versatile connectivity hub designed to maximize interoperability across the continuum of care. The iSirona hub offers an efficient way to physically connect up to six medical devices at the bedside and automatically route the data to the Masimo Hospital Automation™ platform, a vendor-agnostic connectivity solution for EMR integration, surveillance monitoring, alarm management, mobile notifications, smart displays, and analytics. Supplemented by iSirona, Masimo Root® – a powerful, versatile, multimodal patient monitoring and connectivity solution combining numerous advanced measurements with sophisticated expansion capabilities – helps ensure that whatever the source, all patient data can be accurately and efficiently captured and presented to clinicians in the most suitable ways.

patient hand equiped with ORi next to Masimo Root Device

Masimo iSirona™ and the Hospital Automation™ Platform

iSirona, Root, and the Hospital Automation platform are already compatible with an ever growing list of more than 500 medical devices. With its focus on versatility and compatibility, iSirona is particularly valuable as an easy but robust way for hospitals to connect almost all medical devices, regardless of brand – helping reduce the time spent manually charting patient data and instances of transcription errors while promoting efficient workflows by giving clinicians access to patient data wherever, whenever, and however they want to see it.

With its compact and fan-less design, iSirona is ideal for connecting multiple patient monitors, anesthesia machines, pumps, and other medical devices in operating rooms and ICUs where space is often restricted. The included multi-slotted mounting bracket allows iSirona to be fixed in a room or mounted directly to a mobile medical device (such as a ventilator) to provide connectivity wherever the medical device is used. The onboard rechargeable battery and local storage allow the iSirona to continue operating and buffering data for up to two hours in the event of a power outage or loss of network connectivity, helping reduce potential loss of data during emergencies and ensuring data continuity during patient transport. With software-configurable USB and Bluetooth® connections, iSirona is designed to integrate today's physical medical devices and support wireless and wearable devices in the future, as well as provide utility in both high- and low-acuity areas throughout the hospital.

In addition to iSirona and Root, the Hospital Automation platform encompasses a variety of components that together provide a holistic, end-to-end hospital data automation solution that aggregates high-fidelity parametric data, waveforms, and alarms from Masimo and third-party devices. For example, clinicians can surveil and remotely monitor patients from a central location, as well as view alarms, using Masimo Patient SafetyNet™. With Masimo Replica™, real-time monitoring data and alarm notifications can be relayed to mobile devices, reaching clinicians wherever they are – even beyond the hospital. Masimo UniView™ brings together data from multiple devices on an enlarged display that can be tailored for each patient case, helping ensure that data is visualized for clinical teams as usefully as possible. And Masimo Iris Analytics™ transforms data into richly detailed, customizable patient and even hospital-wide reports.

Joe Kiani, Founder and CEO of Masimo, said, "We believe that Masimo's Hospital Automation platform is the most customizable, versatile, and future-focused connectivity solution on the market. We continue to deepen our understanding of what data clinicians most want to have at their fingertips and how, in the ideal hospital of tomorrow, it will be available to them – and to develop monitoring, display, automation, notification, and reporting solutions that best address these needs now. iSirona, the latest member of the Hospital Automation family, makes it easier than ever to add connectivity wherever it's needed – bringing offline data online, smoothing workflows, and ultimately, helping clinicians improve patient care."

@Masimo || #Masimo

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 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.1 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,2 improve CCHD screening in newborns,3 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.4-7 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,8 and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.9 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®, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at https://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. 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.
  3. 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.
  4. 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.
  5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  6. 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.
  7. 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.
  8. Estimate: Masimo data on file.
  9. 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 iSirona™, Hospital Automation™, and Root®. 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 iSirona, Hospital Automation, and Root, 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.

Media Contact
Evan Lamb
Phone: (949) 396-3376
Email: elamb@masimo.com

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