November 13, 2018
Masimo (NASDAQ: MASI) announced that a new consensus statement on postoperative anemia management was published in Anaesthesia by an international panel of clinicians specializing in patient blood management, which includes clear guidance on the use and benefits of noninvasive hemoglobin measurement.1 The statement, which discusses both spot-check and continuous measurement, references the Masimo Rad-67™ Pulse CO-Oximeter®, a spot-check device that measures noninvasive hemoglobin using Masimo SpHb®, as the example of noninvasive measurement.
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Masimo Rad-67™ with SpHb® (Photo: Business Wire)
The statement notes in part that “The use of non-invasive continuous haemoglobin monitoring devices instead of phlebotomy may reduce blood loss, pain and discomfort for the patient, but concerns about precision limit routine clinical use. Although the debate focuses on accuracy of a single check, the reliability of non-invasive haemoglobin monitoring devices for dynamic changes over time may permit detection of occult bleeding and response to therapy.”
In addition to this newest consensus statement, SpHb has recently received positive recognition from two other reputable institutions in the European anesthesiology community. Both the 2017 European Society of Anaesthesiology’s (ESA) Guidelines for the Management of Severe Perioperative Bleeding2 and the 2017 Italian Ministry of Health’s Blood Management Program Guidelines3 included noninvasive and continuous SpHb as a recommended tool for monitoring hemoglobin. Specifically, the ESA guidelines provided a strong recommendation that “continuous haemoglobin monitoring can be used as a trend monitor.”
SpHb is available on a variety of Masimo noninvasive spot-check and continuous monitoring devices, both portable and bedside, as well as through licensed third-party devices. For continuous monitoring, these include Masimo’s Rad-97™, Radical-7®, and Radius-7®. Noninvasive and continuous hemoglobin (SpHb) monitoring helps automate the patient’s hemoglobin status and provides real-time visibility to changes – or lack of changes – in hemoglobin between invasive blood samples. For spot-check SpHb measurement, Masimo Pronto® is available in addition to Rad-67. Next Generation SpHb, available on these devices outside the U.S., significantly advances noninvasive hemoglobin spot-checking with improved motion tolerance, faster time to display SpHb results, and enhanced field performance in low hemoglobin ranges.
Joe Kiani, Founder and CEO of Masimo, said, “We are happy to see growing recognition, from some of the world’s most renowned clinicians, institutions, and advisory bodies, of the utility and benefits of our noninvasive hemoglobin measurement technology. Studies on three continents have shown that continuous SpHb monitoring optimizes blood transfusion4-6 and in a trial with over 3,000 patients, continuous SpHb and PVi® were shown to reduce mortality 30 and 90 days after surgery.7 Never content, we continue to refine and improve SpHb and PVi, and look forward to bringing the advantages of Next Generation SpHb to additional markets and devices soon.”
Rad-67 with Next Generation SpHb has not received FDA clearance and is not available in the U.S.
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SpHb monitoring 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, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
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,8 improve CCHD screening in newborns,9 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response activations and costs.10-12 Masimo SET® is estimated to be used on more than 100 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 2018-19 U.S. News and World Report Best Hospitals Honor Roll.14 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/evidence/featured-studies/feature/.
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.
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.