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Masimo Announces FDA Clearance and Worldwide Release of NomoLine™ Capnography Sampling Lines

MASI | November 27, 2017

Masimo Announces FDA Clearance and Worldwide Release of NomoLine™ Capnography Sampling Lines

Includes U.S. Release of NomoLine Airway Adapter Sets for Neonatal and Infant Patients

Masimo (NASDAQ:MASI) announced today FDA clearance and U.S. release of the full family of NomoLine™ capnography sampling lines. NomoLine sampling lines are available in more than 40 configurations of airway adapter sets and cannulas for use in a variety of clinical scenarios, including for intubated and non-intubated patients in both low and high humidity applications, for all patient populations, including neonatal patients. NomoLine capnography sampling lines are compatible with both Masimo and third-party OEM NomoLine monitors and enable hassle-free sidestream capnography and gas monitoring.

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171127005267/en/

Masimo Root® Patient Monitoring and Connectivity Platform with NomoLine™ Capnography (Photo: Business Wire)

NomoLine “no moisture” sampling technology eliminates many common problems associated with conventional sidestream gas sampling line systems. Incorporating a unique, patented polymer, NomoLine allows water in the sampling line to continuously evaporate into the surrounding air, while leaving oxygen, carbon dioxide, and anesthetic gases unaffected. This technology eliminates the need for water traps and issues related to their handling, as well as enabling extended monitoring time in high-humidity applications, reducing the volume of disposables and the cost and waste associated with them.

NomoLine technology is designed for low-flow applications, with a very low sampling rate of 50 ml/min, supporting use on patients with low tidal volumes and high breath rates, common characteristics of neonatal patients. With functionality in any orientation, NomoLine provides a variety of sampling line options including nasal, nasal/oral, oxygen delivery, single nasal prong, and airway adapter sets. Soft, ergonomically curved cannulas help provide greater patient comfort.

NomoLine sampling lines are compatible with NomoLine ISA™ capnography modules, including ISA CO₂, ISA AX+, and ISA OR+ for multigas monitoring. ISA modules are available on the expandable Masimo Root^® Patient Monitoring and Connectivity Platform through Root’s Masimo Open Connect™ (MOC-9™) ports, as well as on more than 70 OEM monitors, including those from Spacelabs, Schiller, Ortivus, Siare, and Edan. In addition, the Rad-97™ Pulse CO-Oximeter^® is now available with an integrated module allowing direct connection to NomoLine sampling lines.

“With NomoLine, we’ve developed innovative moisture-wicking technology – and then applied that breakthrough to an entire line of cannulas, including neonatal airway adapter sets. Masimo continues to automate noninvasive monitoring with solutions such as NomoLine that are reliable and easy to use,” said Joe Kiani, Founder and CEO of Masimo.

Rad-97 and neonatal NomoLine and ISA products are currently available in the United States only.

@MasimoInnovates | #Masimo

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. 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,¹ improve CCHD screening in newborns,² and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.^3,4,5 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,⁶ and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.⁷ 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/cpub/clinical-evidence.htm.

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.

References

1. 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.

2. 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;338.

3. 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.

4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

5. 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.

6. Estimate: Masimo data on file.

7. 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 NomoLine™ capnography. 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 NomoLine, 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.