Masimo kondigt CE-markering aan voor RAS-45 sensor voor rainbow Acoustic Monitoring® van ademfrequentie

NEUCHATEL, Zwitserland–(BUSINESS WIRE)– Masimo (NASDAQ: MASI) heeft vandaag de CE-markering aangekondigd van de RAS-45, een akoestische ademhalingssensor voor rainbow Acoustic Monitoring ^® (RAM ^™) van de ademhalingsfrequentie (RRa ^®) voor eenmalig gebruik voor volwassenen en kinderen.

Continue monitoring van de ademhalingsfrequentie is vooral belangrijk voor postoperatieve patiënten die patiëntgecontroleerde pijnstilling krijgen. De Patient Safety Foundation (APSF) en The Joint Commission bevelen continue oxygenatie en ventilatie monitoring aan voor alle patiënten die opioïde pijnstilling krijgen. ^1,2 RAM doet een niet-invasieve en continue meting van de ademhalingsfrequentie met behulp van een innovatieve zelfklevende sensor met een geïntegreerde akoestische transducer, zoals Masimo’s RAS-125c en nu RAS-45, die wordt toegepast op de nek van de patiënt.

Masimo Announces CE Marking for RAS-45 Sensor for rainbow Acoustic Monitoring® of Respiration Rate

NEUCHATEL, Switzerland–(BUSINESS WIRE)– Masimo (NASDAQ: MASI) announced today the CE Marking of RAS-45, a single-use adult and pediatric acoustic respiration sensor for rainbow Acoustic Monitoring ^® (RAM ^™) of respiration rate (RRa ^®).

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Masimo Root with rainbow Acoustic Monitoring (RAM) of Respiration Rate (RRa) with RAS-45 Sensor (Photo: Business Wire)

Continuous monitoring of respiration rate is especially important for post-surgical patients receiving patient-controlled analgesia for pain management. The Anesthesia Patient Safety Foundation (APSF) and The Joint Commission recommend continuous oxygenation and ventilation monitoring for all patients receiving opioid-based pain medications. ^1,2 RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer, such as Masimo’s RAS-125c and now RAS-45, that is applied to the patient’s neck. Using acoustic signal processing that leverages Masimo’s breakthrough Signal Extraction Technology (SET ^®), the respiratory signal is separated and processed to display continuous acoustic respiration rate (RRa). RRa has been shown to be accurate, easy-to-use, and reliable, and to enhance patient compliance. ^3,4 RRa may facilitate earlier detection of respiratory compromise and patient distress, offering a breakthrough in patient safety for post-surgical patients and for procedures requiring conscious sedation. ⁴

RAS-45 is designed to facilitate placement on and improve attachment to the neck, but with a smaller adhesive profile than the RAS-125c. It is flexible and uses a transparent adhesive. Like the RAS-125c, it operates with Masimo MX technology boards to measure RRa and display the acoustic respiration wave form. RAS-45 maintains the same performance parameters, range, and accuracy specifications as RAS-125c. Both sensors are for patients who weigh more than 10 kg.

Joe Kiani, Founder and CEO of Masimo, commented, “RAM harnesses the power of our breakthrough signal processing technology, using Masimo SET ^® and rainbow ^® technologies, and applies those achievements to a respiratory measurement derived from the sound of breathing. Studies have found that RAM RRa is more sensitive to detecting respiratory pause ⁵ and yet easier for clinicians and patients to use.” ³

@MasimoInnovates | #Masimo

References

1 Stoelting, RK et al. APSF newsletter. 2011. www.apsf.org.

2 The Joint Commission Sentinel Event Alert. Issue 49, August 8, 2012. www.jointcomission.org.

3 Macknet MR et al. Anesthesiology. 2007;107:A84 (abstract).

4 Goudra BG et al. Open J Anesthesiol. 2013;3:74-79.

5 Ramsay MAE et al. Anesthesia-analgesia. 2013:117:1.

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 SpO ₂, 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 RAM™, RRa ^®, and RAS-45. 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 RAM, RRa, and RAS-45, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; 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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Contacts

Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com