Study Investigates the Ability of Masimo Noninvasive, Continuous Hemoglobin (SpHb®) to Provide Earlier Indication of Anemia and the Impact of Anemia on Patient Outcomes

Masimo (NASDAQ: MASI) announced today that in a study published in Injury, researchers used Masimo SpHb^® – noninvasive, continuous hemoglobin monitoring – to investigate possible delays in the detection of perioperative anemia assessed using invasive, intermittent laboratory hemoglobin values in elderly patients undergoing hip fracture surgery.¹ In addition, they investigated associations between a) this delay and cumulative perioperative time with anemia, monitored using SpHb, and b) patient outcomes (postoperative delirium and mortality or severe complications).

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Masimo Radical-7® with SpHb® (Photo: Business Wire)

Dr. Christopher G. Clemmesen and colleagues at Copenhagen University Hospital in Denmark sought to investigate the impact of anemia during surgery on patient outcomes – and whether noninvasive hemoglobin monitoring using Masimo SpHb might provide an earlier indication of perioperative anemia, as well as more effectively track total time with perioperative anemia, than traditional, intermittent invasive blood sampling. Data from 41 patients, aged 65 or older, undergoing surgery to repair hip fractures, were analyzed. Blood samples were taken as per standard hospital protocol, with transfusions triggered by a hemoglobin (Hb) value below 10 g/dL, which was also used to define anemia. Throughout surgery, SpHb, as well as oxygen saturation (SpO₂), perfusion index (Pi), and pulse rate (PR), were noninvasively monitored using Masimo Radical-7^® Pulse CO-Oximeters and rainbow^® sensors. The clinicians were blinded to data other than SpO₂ to prevent them from using SpHb or Pi values to guide transfusion or other clinical decisions.

The researchers found a mean delay in the detection of anemia (defined as the time lag between an SpHb value of 10 g/dL or less and a similarly low Hb value obtained through blood sampling) of 1.07 hours (± 2.84 hours). They found a significant association between median cumulative perioperative time with low SpHb (defined as SpHb below 10 g/dL for at least one minute) and postoperative delirium: 162 minutes for patients with delirium vs. 22 minutes for patients without (p = 0.034).

The researchers concluded, “In conclusion, we found a delay in transfusion threshold detection on average, and for some patients, the delay was substantial despite the study being done in an optimized perioperative setting in a specialized ward. Continuous monitoring with SpHb during the perioperative period revealed that some patients had Hb levels below the prescribed transfusion threshold for a prolonged period. Furthermore, we found a significant association between the presence of low SpHb and postoperative outcomes, and between the cumulated time with low SpHb and postoperative outcomes. ... Whether or not increased monitoring translates into improved patient outcomes will require further studies.”

Study co-author Dr. Nicolai B. Foss commented, “There can be a significant delay in perioperative detection of anemia in hip fracture patients, and the time spent anemic, as measured continuously by SpHb, was associated with poor outcomes in our study. We need continuous monitoring in order to identify and act on anemia in a timely manner to improve patient outcomes. We believe that future transfusion studies should include improved perioperative monitoring of hemoglobin to help identify anemia.”

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering among other factors: patient condition and laboratory diagnostic tests using blood samples.

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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.^5-7 Masimo SET^® is estimated to be used on more than 100 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 2019-20 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 Iris^® platform, and include Iris Gateway™, Patient SafetyNet, Replica™, Halo ION™, UniView™, and Doctella™. 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. Clemmesen CG, Palm H, and Foss NB5. Delay in detection and treatment of perioperative anemia in hip fracture surgery and its impact on postoperative outcomes. Injury (2019). https://doi.org/10.1016/j.injury.2019.09.001.
2. 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.
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 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.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. 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.
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 SpHb^®. 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 SpHb, 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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