Masimo Corporation

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New Study Shows Masimo SET(R) Pulse Oximetry Helps Yale-New Haven Children's Hospital Significantly Reduce Retinopathy of Prematurity in Newborns

IRVINE, CA -- (Marketwired) -- 05/15/14 -- Masimo (NASDAQ: MASI) today announced that a new study published in the Journal of Perinatology showed that after the neonatal intensive care unit (NICU) at Yale-New Haven Children's Hospital switched to Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, there was a 37% lower rate of severe retinopathy of prematurity (ROP), an eye disorder that can cause blindness in premature babies, and a 53% lower rate of ROP requiring surgery.(1)

According to the study, "In 2006, an internal review of NICU-specific outcomes revealed that rates of BPD and severe ROP in our VLBW population were above the 50th percentile for pooled data from level III and IV NICUs. These data combined with several published reports outlining safe and successful efforts aimed at reducing (bronchopulmonary dysplasia) BPD and ROP through limiting hyperoxia(2-4) resulted in the formation of the 'Oxidative Stress Initiative Committee.' The multidisciplinary committee was convened in January of 2007 and comprised physicians, neonatal nurse practitioners, physician assistants, registered nurses and respiratory therapists. A physician and nurse were identified to lead the initiative. Several steps were involved in this process including a detailed review of existing center-specific data and practices, discussion and analyses of relevant medical literature, creation of an evidence-based guideline, implementation of a new system for monitoring oxygen saturations and development and implementation of a unit-wide educational program."

In 2007, Yale-New Haven Children's Hospital launched an initiative to improve neonatal oxygen targeting. Researchers evaluated outcomes of newborns before and after the initiative. The pre-initiative period was Jan. 1, 2004 through Dec. 31, 2006. At the time, Yale-New Haven was using non-Masimo pulse oximeters in the NICU and an oxygen targeting range of 88% to 96%. The post-initiative period was Jan. 1, 2008 through Dec. 31, 2011, after Yale-New Haven had switched to Masimo SET® pulse oximetry "for its ability to more accurately measure SpO2 via algorithms and adaptive filters during episodes of motion or sever hypoxia."(5,6) The study also noted Masimo pulse oximeters "had the ability to generate histograms and temporal data, which proved vital" because it enabled researchers "to quantify, for set time intervals, the percentage of time each patient was spending within, above and below their target SpO2 range." In addition, the oxygen targeting range was revised to 85% to 93% with the goal of maintaining each infant within their desired range for at least 75% of the day, education was provided to staff members, and the approach to management of oxygen for newborns in the delivery room was also revised.

A total of 304 infants in the pre-initiative period were compared with 396 infants in the post-initiative period. The rates of severe ROP in the pre- vs. post-initiative period were 24.6% vs. 15.4% (p=0.006), a 37% reduction. The rates of severe ROP requiring surgery in the pre- vs. post-initiative period were 36.2% vs. 16.9% (p=0.0003), a 53% reduction. After adjusting for other factors, the post-initiative period was associated with significantly lower odds of severe ROP compared with the pre-initiative period (adjusted odds ratio 0.41, 95% confidence interval 0.24 vs. 0.72, P = 0.002); researchers reported similar findings for infants requiring corrective laser surgery (adjusted OR 0.31, 95% confidence interval 0.17 vs. 0.59, P = 0.0003).

"We were able to demonstrate a significant reduction in the incidence of severe ROP and ROP requiring laser surgery in our NICU that directly coincided with our effort to limit hyperoxia," researchers said. "We believe that introduction of Signal Extraction Technology was a major key to this success."

Lead researcher Dr. Matthew Bizzarro at the Division of Perinatal Medicine, Department of Pediatrics, Yale University School of Medicine, also said the histogram functionality of the Masimo devices allowed clinicians to objectively observe whether their patients were within their target oxygenation ranges over time. "It's a technology that's greatly improved the way we approach and treat these babies," Dr. Bizzarro said. "We find it an invaluable tool to better managing this patient population."

The Yale-Newhaven study results are similar to those reported by two other centers in a previously published study.(7) In the prior study, two separate NICUs that were staffed with the same physicians and nurses simultaneously changed their neonatal oxygen targeting range, and one of the centers switched from Nellcor to Masimo SET® pulse oximetry. In the first phase of the study, there was no decrease in severe ROP at the center using Nellcor pulse oximetry but there was a 58% reduction in severe ROP at the center using Masimo SET®. In the second phase of the study, the center still using Nellcor pulse oximetry switched to Masimo SET® and experienced a 54% reduction in severe ROP.

Masimo SET® significantly reduces false alarms (specificity) and accurately detects true alarms (sensitivity)(8,9) that can help clinicians identify a deteriorating patient. Most importantly, Masimo SET® pulse oximetry has been clinically proven to improve patient outcomes by helping clinicians reduce retinopathy of prematurity (ROP)(10) in neonates, screen newborns for critical congenital heart disease (CCHD),(11,12) reduce ventilator weaning time and arterial blood gas measurements in the ICU,(13) and save lives and costs while reducing rapid response activations and intensive care unit transfers on the general floor.(9) It is estimated that Masimo SET® helps clinicians monitor more than 100 million patients each year and is the primary pulse oximetry technology for eight of the top 10 hospitals on the U.S. News & World Report Best Hospitals Honor Roll (2013-2014).

"We are very happy to see yet another study showing that when a hospital NICU switches to Masimo SET pulse oximetry, they significantly reduce severe ROP and ROP requiring surgery," said Dr. Augusto Sola, Vice President of Neonatal Medical Affairs for Masimo. "Severe ROP and ROP-related blindness due to excessive supplemental oxygen unnecessarily harms one of society's most vulnerable patient populations, and as this study shows, can be drastically curtailed with the proper use of the right technology."

In babies born at full gestation, the blood vessels in the eye are fully developed. However, babies born prematurely often have abnormal blood vessel development in the retina of the eye, called ROP. These premature babies also often have lungs that are not fully developed, requiring the administration of supplemental oxygen in the NICU. Clinicians monitor oxygen saturation levels in the blood (SpO2) with pulse oximetry to help titrate the supplemental oxygen levels up and down to try and avoid periods of not enough oxygen in the blood (hypoxemia), which can lead to higher mortality, and too much oxygen in the blood (hyperoxia), which can exacerbate ROP. If pulse oximeters cannot accurately measure SpO2 during conditions of motion and low perfusion, which are common in the NICU, suboptimal oxygen titration can occur.

1 Bizzarro MJ, Li FY, Katz K, Shabanova V, Ehrenkranz RA, Bhandari V. Temporal quantification of oxygen saturation ranges: an effort to reduce hyperoxia in the neonatal intensive care unit. Journal of Perinatology (2014) 34, 33-38; doi:10.1038/jp.2013.122; published online 26 September 2013
2 Deulofeut R, Critz A, Adams-Chapman I, Sola A. Avoiding hyperoxia in infants < or = 1250 g is associated with improved short- and long-term outcomes. J Perinatol 2006; 26: 700-705.
3 Castillo A, Sola A, Baquero H, Neira F, Alvis R, Deulofeut R et al. Pulse oxygen saturation levels and arterial oxygen tension values in newborns receiving oxygen therapy in the neonatal intensive care unit: is 85 to 93% an acceptable range? Pediatrics 2008; 121: 882-889.
4 Vandveen DK, Mansfield TA, Eichenwald EC. Lower oxygen saturation alarm. Limits decrease the severity of retinopathy of prematurity. J AAPOS 2006; 10: 445-448.
5 Barker SJ. Motion-resistant pulse oximetry: a comparison of new and old models. Anesth Analg 2002; 95: 967-972.
6 Hay WW, Rodden DJ, Collins SM, Melara DL, Hale KA, Fashaw LM. Reliability of conventional and new pulse oximetry in neonatal patients. J Perinatol 2002; 22: 360-366.
7 Castillo AR, Deulofeut R, Sola A. Clinical Practice and SpO2 Technology in the Prevention of ROP in VLBW Infants. Presented at Pediatric Academic Societies Annual Meeting May 5-8, 2007.
8 Shah N, Ragaswamy HB, Govindugari K, Estanol L "Performance of Three New-Generation Pulse Oximeters during Motion and Low Perfusion in Volunteers" .J Clin Anesth. 2012 Aug;24(5):385-91.
9 Taenzer, Andreas H.; Pyke, Joshua B.; McGrath, Susan P.; Blike, George T. "Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-and-After Concurrence Study." Anesthesiology, February 2010, Vol. 112, Issue 2. Available online here.
10 Castillo A, et al. Acta Paediatr. 2011 Feb.;100(2):188-92.
11 de-Wahl Granelli A., et al. BMJ. 2009 Jan 8;338.
12 Ewer A, et al. Health Technol Assess. 2012;16(2):1-184.
13 Durbin, et al. Critical Care Medicine. 2002 Aug.;30(8): 1735 to 1740.

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 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 SET® 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 Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). 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 belief that Masimo SET® provides real-time results for all patients to help clinicians to more rapidly assess, diagnose, and treat every patient; risks related to our assumptions regarding the repeatability of clinical results; 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.

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation.

Media Contacts:
Mike Drummond
Masimo
(949) 297-7434
Email: mdrummond@masimo.com

Source: Masimo

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