Masimo and Mdoloris Announce Masimo Open Connect™ (MOC) Partnership for the Root® Patient Monitoring and Connectivity Hub

Masimo (NASDAQ: MASI) and Mdoloris Medical Systems announced today a Masimo Open Connect™ (MOC) partnership for the Root^® Open Architecture Patient Monitoring and Connectivity Hub, in which Mdoloris is developing and will commercialize their Analgesia Nociception Index (ANI^®) technology for Root.

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Masimo’s unique approach to medical technology integration through MOC partnerships is expected to address some major barriers to new technology adoption in patient monitoring. Root’s open architecture and built-in connectivity enable third-party companies to determine themselves whether to pursue an integrated product. They can then independently develop, obtain regulatory approvals, and commercialize their own external MOC-9 module or Masimo Open Connect Control (MOC-C^TM) App for Root using Masimo’s MOC software development kit (SDK). Masimo’s engineering team supports MOC partner development as needed and Masimo’s commercial team helps increase awareness of the availability of MOC-9 modules and MOC-C Apps from MOC partners. In turn, MOC partners use their existing distribution channels to sell their MOC-9 module or MOC-C App to Masimo customers already using Root, as well as offering the MOC-9 module or MOC-C App for Root to their potential customers as an additional option to implement their technology.

Pain relief is a major concern of all developed countries while pain assessment has historically been subjective, time-consuming due to its manual nature, and intermittent. To address these limitations, Mdoloris has developed ANI technology to provide an objective, noninvasive, and continuous way to automatically monitor the pain level of patients. Use of the ANI may help clinicians improve pain assessment and through it, patient care and pain management with more objective and precise drug administration.

“We are proud to announce our first MOC partnership and expect Root’s advanced patient monitoring and versatile connectivity options will be strengthened through MOC development and the addition of innovative new technologies such as ANI from Mdoloris," said Joe Kiani, Founder and CEO of Masimo. “We believe that Root with Masimo Open Connect can do for patient monitoring what the PC did for computing: speed up the patient monitoring innovation cycle, reduce the cost of patient monitoring, and prolong the useful life of the equipment hospitals invest in.”

“We consider Masimo to be the most innovative company in the patient monitoring space, so it is a pleasure to announce our MOC partnership. We share Masimo’s vision of improving patient outcomes and reducing the cost of care and believe Root offers a unique and compelling solution to implement our ANI technology,” said Fabien Pagniez, Founder and CEO of Mdoloris Medical Systems.

The ANI MOC-9 module for Root will be available for preview in the Mdoloris exhibit booth at the European Society of Anaesthesiology in Geneva, Switzerland, June 3 to 5, 2017.

ANI has not received 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates | #Masimo

About Mdoloris Medical Systems

Mdoloris (www.mdoloris.com), a medical devices manufacturer, was created in June 2010 out of 23 years of academic research performed in Lille University hospital, France. It has an international representation in more than 58 countries and a scientific, technical and medical acknowledgement. Mdoloris has developed so far three products, all able to continuously assess the pain level of patients (The ANI technology for patients older than two years old, the NIPE technology for neonates, the PTA technology for pets). Its innovative technologies provide clinical added values for clinicians that are not able to communicate with their patients in order to personalize pain medications and avoid known side effects due to over / under dosage of such drugs.

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^® 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 including 16 of the top 20 hospitals listed in the 2016-17 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^®), 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, 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.

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

ORi has not received 510(k) clearance and is not available for sale in the United States.

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 Open Connect. 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 Open Connect, contribute to positive clinical outcomes and patient safety; 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.

Potential MOC Partners Contact:
http://www.masimo.com/home/signal-extraction-pulse-oximetry/masimo-set-monitors/root/moc-9-web-form/

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Contact information

Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com
or
Mdoloris
Antoine Szczypa
Antoine.szczypa@mdoloris.com