Tuesday, May 14, 2019
Masimo and Shenzhen Mindray Bio-Medical Electronics Co., Ltd. announced today that they have entered into a purchase and license agreement, under which Mindray will offer Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry – noninvasive, continuous measurement of oxygen saturation (SpO2), pulse rate (PR), and perfusion index (Pi) – in its monitoring devices. Mindray devices equipped with SET® will now be available in select countries in Europe, the Middle East, Russia and the Commonwealth of Independent States, and Asia-Pacific (excluding China), including Australia and India.
With the invention of Signal Extraction Technology® (SET®), Masimo established a new standard for pulse oximetry by introducing the ability to measure through motion and low perfusion. In a study comparing multiple pulse oximetry technologies, SET® was shown to demonstrate the highest sensitivity and specificity in identifying desaturation events and avoiding false desaturation events during these conditions.1 SET® has also opened up new frontiers in patient monitoring during challenging conditions: outcome studies have shown that SET®, combined with clinical assessment, has helped clinicians reduce retinopathy of prematurity (ROP) in neonates,2 improve critical congenital heart disease (CCHD) screening in newborns,3 and through continuous monitoring of patients in post-surgical wards, reduce ICU transfers and rapid response team activations.4-6 In all, over 100 independent and objective studies have shown that SET® outperforms other pulse oximetry technologies.7 Masimo continues to refine SET®, and recently announced that SpO2 accuracy specifications have now improved to 1.5% in conditions of motion and no motion for adult, pediatric, and infant patients (> 3 kg) with RD SET™ sensors. Now, the benefits of Masimo SET® are also available to clinicians using Mindray’s devices in many countries outside the United States, where Mindray has offered SET® pulse oximetry in devices from Datascope (which began offering SET® in 1998) since acquiring Datascope in 2008.
Mindray is a leading global provider of medical devices and solutions. Mindray’s products and services can be found in healthcare facilities in over 190 countries, and over 1.1 million Mindray monitors have been used or are in use across the world, representing the world’s third-largest patient monitoring market share. Patient monitors now available with integrated Masimo SET® pulse oximetry include the Mindray BeneVision N and BeneView T series for use in high-acuity environments and the ePM, iPM, and iMEC series for use in a variety of clinical scenarios, among other devices.
Jon Coleman, President of Worldwide Sales, Professional Services, and Medical Affairs, Masimo, commented, “We’re excited to enter into this agreement with Mindray, so that more patients, clinicians, and hospitals can benefit from the unmatched performance of Masimo SET® pulse oximetry.”
Yang Ting, General Manager of International Sales and Marketing, Patient Monitoring and Life Support, Mindray, said, “We are very happy to expand our cooperation with Masimo from North America to more regions, so that our customers will have access to the outstanding SpO2 technology from Masimo. It is a proof of our constant commitment to bringing advanced medical technologies to people in need, and making better healthcare more accessible for all.”
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.7 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 activations and costs.4-6 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 2018-19 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®, 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.
1. Shah N et al. Performance of Three New-Generation Pulse Oximeters During Motion and Low Perfusion in Volunteers. J Clin Anesth. 2012 Aug;24(5):385-91.
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 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.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6. 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.
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. Estimate: Masimo data on file.
Founded in 1991, Mindray is one of the leading global providers of medical devices and solutions. Firmly committed to our mission of “advance medical technologies to make healthcare more accessible,” Mindray is dedicated to innovation in the fields of Patient Monitoring & Life Support, In-Vitro Diagnostics, and Medical Imaging System. Mindray possesses a sound global R&D, marketing and service network. Inspired by the needs of customers, Mindray adopts advanced technologies and transforms them into accessible innovation, bringing healthcare within reach. While improving the quality of care, Mindray helps reduce its cost, making it more accessible to a larger part of humanity. Today, Mindray’s products and services can be found in healthcare facilities in over 190 countries and regions. In China, Mindray’s products and solutions can be found in over 110,000 medical institutions and 99% of Class A tertiary hospitals.
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 SET®. 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 SET®, 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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