Masimo Renews $1,000,000 Guarantee that Masimo SET® Will Outperform All Covidien Nellcor™ Pulse Oximeters

IRVINE, Calif., May 30, 2013 /PRNewswire/ -- Masimo (NASDAQ: MASI), the inventor of measure-through motion and low perfusion pulse oximetry today renewed its $1,000,000 (USD) guarantee that Masimo SET^® Pulse Oximetry and rainbow^® Pulse CO-Oximetry™ will outperform all Nellcor™ pulse oximeters, including the three that Covidien recently announced have received FDA 510(k) clearance with motion claims.^1,2 This offer is available only to hospitals whose goal is to upgrade their pulse oximetry hospital-wide to the new standard. Important details, conditions, and qualifications for the guarantee are available at http://www.masimo.com/1millionrules.htm.³

"Masimo has always stood for the truth," stated Joe Kiani, Founder and CEO of Masimo.  "Covidien's recent announcements appear to be an attempt to create an impression that Nellcor products are clinically equivalent, or even superior, to Masimo's products. In fact, the performance of Nellcor pulse oximeters has not changed since 2006 when they introduced the version of their technology that is still the same today, after the U.S. Court of Appeals for the Federal Circuit directed the Federal District Court in Los Angeles to enjoin the Nellcor pulse oximeter that infringed Masimo's breakthrough measure-through motion patents. All studies we are aware of show that the current Nellcor technology does not match the performance of Masimo SET^® technology during challenging motion conditions. We hope this $1,000,000 guarantee sends a clear message to clinicians, biomedical engineers, materials management, and hospital administrators to look to the objective evidence when they are interested in improving pulse oximetry performance."

Dr. Michael O'Reilly, Chief Medical Officer for Masimo, stated: "The ability of Masimo SET^® to detect oxygen saturation changes (sensitivity) and avoid false alarms (specificity) is proven by more than 100 independent and objective studies, internal studies, and thousands of clinical evaluations. Most importantly, only Masimo SET^® pulse oximetry has been shown to improve patient outcomes by helping clinicians reduce retinopathy of prematurity,⁴ screen newborns for critical congenital heart disease (CCHD),^5,6 reduce ventilator weaning time,⁷ and save lives while reducing rapid response activations and intensive care unit transfers on the general floor."⁸

Dr. O'Reilly continued: "Since we introduced Masimo SET^®, we have converted more than 2,600 hospitals worldwide. Yet, in the same period, fewer than one in 100 hospitals have switched from Masimo, and to the best of our knowledge, none did so due to performance.  We understand that hospital conversions to a new technology require time and effort. We are so confident in the performance of Masimo technology and the difference it will make in the care of patients that we are willing to assure care providers that their time and efforts will not be wasted with our $1,000,000 guarantee."

Dr. Peter Cox, Clinical Director, Critical Care Medicine & Associate Chief Physician, Department of Critical Care Medicine at the Hospital for Sick Children in Toronto, stated:  "Recently published reports support the notion that Masimo SET^® pulse oximetry outperforms Nellcor pulse oximetry during motion and low perfusion conditions. Measure-through motion and low perfusion performance can be validated by changing the true arterial oxygen saturation during motion and low perfusion conditions. In the recently published study of SpO₂ accuracy in both machine- and volunteer-generated motion, Masimo SET^® had 97% sensitivity and 95% specificity while the Nellcor N-600 had 57% sensitivity and 72% specificity."⁹

Dr. Anne Granelli—lead author on one of the largest published CCHD studies to date, liaison to the U.S. Department of Health and Human Services Secretary's Advisory Committee on Heritable Diseases in Newborns and Children (SACHDNC) workgroup, and author of an award-winning doctoral thesis in this field—stated: "While working at one of the two centers in Sweden that performed pediatric cardiac surgery, I found a significant difference, when compared simultaneously with blood gas, between Masimo SET^® and all other pulse oximetry technologies we used on cyanotic children in the PICU and pediatric cardiac ward. We were not aware of the significant difference between oximeters before this clinical study. And, as a result, we upgraded all our pulse oximeters to Masimo SET^®."

Dr. Kenneth Rothfield, Chairman of Anesthesiology at Saint Agnes Hospital in Baltimore, stated: "In my 20 years' experience, I have used other pulse oximeters that claimed to tolerate motion, but this is easier said than done. When a patient's life hangs in the balance, a pulse oximeter that cannot measure despite motion and low perfusion is useless—and that can have dangerous consequences. That's one of the many reasons my hospital switched from Nellcor to Masimo SET^®. Masimo SET^® doesn't just tolerate motion, it measures through it – accurately and consistently."

Background

On May 20, 2013, Covidien announced FDA 510(k) clearance with motion claims for three Nellcor^™ pulse oximeters and stated they are the "first company to receive FDA 510(k) clearance for a motion-tolerant bedside pulse oximeter portfolio that is compliant with ISO 80601-2-61," a new pulse oximetry testing standard.¹ On May 28, 2013, Covidien announced that "Nellcor Pulse Oximeters Receive FDA 510(k) Clearance with Labeling for Use in Newborn Screening for Critical Congenital Heart Disease."²

Covidien's announcements may cause confusion because:

1.    Covidien did not disclose the specific motion claims for Nellcor pulse oximeters, and Covidien has not changed the motion performance of Nellcor pulse oximeters
The terms "motion claims" and "motion-tolerant" were not defined by Covidien and their test methods and results were not disclosed. However, any changes by Covidien in motion claims do not mean there have been any changes in motion performance. The motion performance of Nellcor pulse oximeters has not changed since 2006, when Nellcor introduced the N-600 and 06 circuit board, and then the N-600x, after U.S. courts found that previous Nellcor pulse oximeters infringed on multiple Masimo patents. The two Nellcor pulse oximeters introduced in 2012, the Bedside Monitoring System and Bedside Respiratory Monitoring Systems, share pulse oximetry technology with the 06/N-600/N-600x.

2.    Covidien is not the first company to receive FDA 510(k) clearance for a pulse oximeter with motion claims while complying with ISO standards
Masimo was the first company to receive FDA 510(k) clearance with measure-through motion claims in 1998 and measure-through motion and low perfusion claims in 1999, and has always been in compliance with ISO standards. While the ISO standard 9919 is still in effect, compliance with the new ISO 80601 standard will be required by the FDA for all new FDA 510(k) submissions for pulse oximeters after June 30, 2013. The new ISO standard will also apply to CE marked products in 2014. The new ISO standard does not change how a pulse oximeter is tested under motion and low perfusion. 

3.    Covidien did not disclose the specific labeling for screening newborns for CCHD, and only Masimo SET^® pulse oximetry has been proven in large studies to have high enough sensitivity and specificity to allow the clinical community to recommend CCHD screening 
Any decisions on which pulse oximeter to use for newborn screening for CCHD screening should be made with protection of the patient and family as the highest priority. To maximize the effectiveness of newborn screening that is often performed in moving babies, use of pulse oximetry that can actually measure through motion is important to minimize both false negatives (failing to indicate a baby should receive diagnostic testing) and false positives (indicating a baby should receive diagnostic testing when they do not). After a thorough review, the CCHD workgroup that published the 2011 screening recommendations relied upon two independent, published studies,^5,6 which included nearly 60,000 newborn subjects and exclusively used Masimo SET^® pulse oximeters. The CCHD workgroup stated, "On the basis of new data from the large population-based screening activities in Sweden (Granelli) and England (Ewer), the work group developed a recommendation for screening that was based on what was shown to be effective in those studies." In contrast to the evidence for Masimo SET^®, Masimo is unaware of any large studies using Nellcor pulse oximetry to screen newborns for CCHD that demonstrate similar effectiveness as shown by Drs. Granelli and Ewer. In fact, Covidien cites three studies using Nellcor pulse oximeters for newborn screening for CCHD with questionable results and/or negative conclusions.^10,11,12

4.    Masimo SET^® pulse oximetry provides clinically superior performance compared to Nellcor pulse oximetry during motion and is the only pulse oximetry shown to help clinicians improve patient outcomes. 
Masimo SET^® pulse oximeter technology takes venous blood movement into the assumption of the measurement and utilizes patented and proprietary algorithms to identify the venous blood signal, isolate it, and using five parallel algorithms including adaptive filtering, extract the arterial signal during all conditions, including motion and low perfusion. A video example of Masimo SET^® and Nellcor motion performance during desaturation and resaturation can be viewed here. A video of Masimo SET^® and Nellcor motion performance during low perfusion can be viewed here. Masimo representatives can easily show the motion performance of both Masimo SET^® and Nellcor pulse oximeters in a side-by-side demonstration. In addition, Masimo strongly encourages scientific, side-by-side evaluations with automated data collection on patients. 

1      http://investor.covidien.com/phoenix.zhtml?c=207592&p=irol-newsArticle&ID=1821990&highlight=
2      http://investor.covidien.com/phoenix.zhtml?c=207592&p=irol-newsArticle&ID=1824373&highlight=
3      http://www.masimo.com/1millionrules.htm
4      Castillo A, et al. Acta Paediatr. 2011 Feb.;100(2):188-92.
5      de-Wahl Granelli A., et al. BMJ. 2009 Jan 8;338.
6      Ewer A, et al.  Health Technol Assess. 2012;16(2):1-184.
7      Durbin, et al.  Critical Care Medicine. 2002 Aug.;30(8): 1735 to 1740.
8      Taenzer A, et al. Anesthesiology, 2010 Feb;112(2):282-7.
9      Shah N, et al. J Clinical Anaesthesia. 2012 Auog;24(5):385-91.
10    Sendelbach DM, et al.  Pediatrics. 2008 Oct. 122(4): p. e815-20.
11    Walsh, W. J Perinatol, 2011 Feb. 31(2): p. 125-9.
12    Reich, JD, et al. J Pediatr, 2003 Mar. 142(3):p. 268-72.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET^®, which virtually eliminated false alarms and increased pulse oximetry's ability to help clinicians detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET^® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow ^® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb^®), oxygen content (SpOC^™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), PVI^®, and perfusion index (PI), in addition to measure-through motion SpO₂, and pulse rate. In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow^® Acoustic Monitoring^™, the first-ever commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo SET^® and Masimo rainbow^® technologies also can be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care … by Taking Noninvasive Monitoring to New Sites and Applications^®." Additional information about Masimo and its products may be found at www.masimo.com.

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 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 published studies, internal clinical studies and side-by-side clinical evaluations; 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 forward-looking 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.

Media Contacts:
Mike Drummond
Masimo Corporation
(949) 297-7434
[email protected]

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