Masimo Announces CE Marking Of Rad-97 Pulse CO-Oximeter

NEUCHATEL, Switzerland--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today the CE marking of the Rad-97^™ Pulse CO-Oximeter^®. Rad-97 offers the same Measure-through Motion and Low Perfusion™ SET^® pulse oximetry and upgradeable rainbow SET™ technology as the Radical-7^® Pulse CO-Oximeter – in a versatile standalone monitor configuration.

“Rad-97 brings our core SET® and rainbow® technologies to a compact new design, which will allow broader applications in many new settings, including low-resource countries and homes”

Rad-97 features a high-resolution 1080p HD color display with user-friendly multi-touch navigation, similar to Root^® and Radical-7, allowing clinicians to easily customize the device to best suit their monitoring needs. Users can also rapidly configure the device to accommodate different patient populations using customizable profiles. Rad-97 provides both built-in wireless connectivity, via Wi-Fi and Bluetooth^®, and built-in wired options, including Ethernet, USB, and Nurse Call Interface connections. A rechargeable battery lasting seven hours allows Rad-97 to be used in situations where portability or extended operation without access to power are needed.

In select markets outside the United States, Rad-97 will be available with an optional camera, which will be used in conjunction with Masimo Patient SafetyNet™*. The camera includes a high resolution, high-frame rate video feed, as well as audio, to the Patient SafetyNet view-station. The system will be able to use the hospital’s existing IT network and to provide additional viewing of images in the same care area. Through Rad-97, it will be possible to connect other devices a patient may be using, such as glucometers and scales, to Patient SafetyNet and to remotely allow for interaction between clinicians and patients or other clinicians.

Like Radical-7, Rad-97 features Measure-through Motion and Low Perfusion pulse oximetry (SpO₂), pulse rate (PR), and perfusion index (PI). Clinicians can add other monitoring solutions such as the rainbow SET measurements total hemoglobin (SpHb^®), methemoglobin (SpMet^®), acoustic respiration rate (RRa^®), carboxyhemoglobin (SpCO^®), and oxygen content (SpOC™). In select markets outside the United States, additional parameters such as Oxygen Reserve Index™ (ORi™) and respiration rate from the pleth (RRp™) are available, making Rad-97 the smallest Masimo bedside device currently capable of monitoring the full rainbow SET platform.

“Rad-97 brings our core SET^® and rainbow^® technologies to a compact new design, which will allow broader applications in many new settings, including low-resource countries and homes,” said Joe Kiani, Founder and CEO of Masimo. “We’ve engineered Rad-97 to take advantage of the latest advances in adaptability and connectivity, packaging Masimo’s industry-leading noninvasive technology in a cost-effective monitor that will make it more accessible and useful to clinicians and patients than ever.”

ORi and RRp parameters and the camera feature do not have 510(k) clearance and are not available in the U.S.

@MasimoInnovates | #Masimo

*The use of the trademark SafetyNet is under license from University HealthSystem Consortium.

About Masimo

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 by taking noninvasive monitoring to new sites and applications. 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^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. 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®), and more recently, Pleth Variability Index (PVI^®) and 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. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

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’s Rad-97™ Pulse CO-Oximeter^®. 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 Rad-97 Pulse CO-Oximeter, 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.