Current News

Date Title
02/14/2012 Masimo Announces "Better Care" Program—A Hospital Risk-Share Program for Blood Transfusion Related Cost Reduction with
02/14/2012 Masimo Reports Fourth Quarter and Full Year 2011 Financial Results; Provides 2012 Financial Guidance
01/26/2012 Masimo to Report Fourth Quarter and Full Year 2011 Financial Results After Market Close on February 14, 2012
01/09/2012 Masimo Announces FDA Clearance and Full Market Release of the New Pronto-7™ for Noninvasive Total Hemoglobin Spot-Check Measurement, Along with SpO2, Pulse Rate, and Perfusion Index

 

Masimo Announces "Better Care" Program— A Hospital Risk-Share Program for Blood Transfusion Related Cost Reduction with SpHb®, and $30 SpHb Sensor Price

Better Care Program Enables Select Hospitals to Adopt SpHb Hospital-Wide to Improve Patient Outcomes with Guaranteed Savings

Irvine, California – February 14, 2012 – Masimo (NASDAQ: MASI) today announced that in line with its mission to "Improve Patient Outcomes and Reduce the Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications®," and its confidence that continuous noninvasive hemoglobin monitoring (SpHb®) will further the company's stated mission, Masimo is introducing a hospital-wide risk-share program for Blood Transfusion Related Cost Reduction (BTR-CR, pronounced "Better Care"). The Better Care Program guarantees blood transfusion related cost reductions will exceed the incremental price of SpHb sensors.

Joe Kiani, Founder and CEO of Masimo stated, "We understand that hospitals are doing their best to deliver quality care in an unprecedented time of reduced census, cost containment pressure, and increasing expense. Through our customers' and independent researchers' experience with SpHb, we are confident that SpHb will not only reduce mortality and morbidity, but will reduce cost dramatically. The Better Care Program allows a select number of hospitals to implement SpHb monitoring hospital-wide with the guaranteed protection that their costs will not increase. We hope the Better Care Program will not only provide improved patient care and dramatically lower costs, but will also represent a new model for other medical technology companies to help hospitals achieve their goal of better care, with lower cost guaranteed!"

Masimo's Better Care Risk-Share Program—Guarantees Hospital Savings from SpHb
Reducing cost of care is a central focus in every hospital today. Red blood cell transfusions and their related costs are one of the largest cost centers in every hospital, often 10 times the annual cost of SpO2 sensor purchases. Transfusions can save lives, but the evidence is clear that they also dramatically increase mortality and morbidity risk and cost. These facts underscore the need to transfuse only when necessary. Hemoglobin concentration is a primary indicator of the need for transfusion and invasive blood draws for laboratory hemoglobin determination are among the most common tests performed in hospitals, but they can only offer intermittent and often delayed results. Masimo SpHb has been shown to help clinicians reduce blood transfusions during surgery, as well as provide an early indication of hemoglobin drops in medical and surgical intensive care, obstetric, and general-floor patients—allowing lifesaving interventions. Results of a randomized controlled trial conducted by researchers at Massachusetts General Hospital and Harvard Medical School showed that Masimo SpHb helped anesthesiologists reduce the frequency of blood transfusion by 90% (from 0.1 to 0.01 units per patient) in 327 patients undergoing orthopedic surgery.1

In keeping with Masimo's mission to improve patient outcomes and reduce the cost of care, Masimo is proud to introduce its risk-share program for Blood Transfusion Related Cost Reduction. Masimo guarantees that when a hospital replaces its standard SpO2 adhesive sensors with Masimo rainbow® ReSposable SpHb Sensors and begins monitoring noninvasive hemoglobin (SpHb), pleth variability index (PVI®), and methemoglobin (SpMet®), in addition to Masimo SET SpO2, pulse rate, and perfusion index (PI), the incremental price paid for the rainbow sensors will be exceeded by a reduction in blood transfusion related costs.

If the documented blood transfusion-related costs in a hospital do not exceed the incremental price paid for Masimo rainbow® ReSposable Sensors beyond standard SpO2 sensor pricing, Masimo will provide a refund for the difference between the incremental price paid and the reduction in blood transfusion related costs (terms and conditions apply). The Better Care Program is available to the first 100 hospitals worldwide that qualify for the program. Interested hospitals should contact their Masimo sales representative or go online for further details and conditions at: www.masimo.com/bettercare.2

"Less than five percent of hospital costs are associated with the use of medical devices and disposables," stated Jon Coleman, President of Worldwide Sales, Marketing and Clinical Research at Masimo. "In contrast, blood is one of the largest cost centers in the hospital. Masimo is so confident that SpHb monitoring will result in a blood transfusion related cost reduction that we are willing to guarantee it with our new Better Care Risk-Share Program. We look forward to partnering with hospitals around the world to improve patient outcomes and decrease the cost of care with SpHb and our other rainbow® monitoring capabilities."

We believe hospitals can expect even greater savings beyond blood transfusion related costs by using SpHb and other rainbow® measurements to detect bleeding sooner and enable lifesaving interventions, reduce the number of blood draws and incidents of hospital-acquired anemia, optimize fluid management with PVI, and decrease the risk of dangerous methemoglobinemia with SpMet. In addition, we believe hospitals will also receive clinical and financial benefits from Masimo SET pulse oximetry, including reduced retinopathy of prematurity (ROP) in very low birth weight neonates, decreased sensor utilization, decreased arterial blood gas measurements, faster oxygen weaning time, and earlier detection of patient distress that helps to improve outcomes and lower the length of stay for post-surgical patients. The rainbow® ReSposable Sensor also provides the industry's best green solution with a dramatically lower carbon footprint.3

New Design Leads to $30 rainbow® SpHb ReSposable™ Sensor Price—Making SpHb Use Broadly Available
Thanks to recent enhancements to the rainbow® ReSposable design that increase the number of patient applications possible with the Reusable Optical Sensor (ROS™) component of the ReSposable System to 20 or more patients (from five previously), Masimo's internal cost savings can be extended to hospitals wishing to adopt SpHb more widely. The SpHb ReSposable Sensor System is now priced at just $30 USD per patient (based on reasonable committed sensor usage), which represents up to a 50% price reduction over previous pricing. Given that the SpHb ReSposable Sensor also provides Masimo SET® SpO2, pulse rate, perfusion index (PI), methemoglobin (SpMet), and pleth variability index (PVI) measurements, the new sensor pricing makes it possible for SpHb to become a new standard of care for all patients throughout the continuum of care.

1 Ehrenfeld J., Henneman J. "Impact of Continuous and Noninvasive Hemoglobin Monitoring on Intraoperative Blood Transfusions." American Society of Anesthesiologists, 2010 Annual Conference, October 18, 2010. Available online here.
2 This is not an offer. Participating in the guarantee requires a contract with agreed-upon terms and conditions.
3 Based on carbon footprint calculations validated by Carbonfund.org in November 2011.

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 demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements 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 required invasive procedures, 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). 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 noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET and Masimo rainbow SET technologies can be also 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 belief that SpHb enables hospitals to achieve significant patient care and financial impacts, risks related to our Better Care Risk Share Program and belief that the incremental price paid for the rainbow sensors will be exceeded by a reduction in blood transfusion related costs in every hospital, risks related to our belief that SpHb ReSposable sensor enhancements will deliver a 20:1 use ratio in all circumstances and applications, 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.

Media Contacts:
Dana Banks
Phone: (949) 297-7348
Email: dbanks@masimo.com

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, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57,Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.

 

Masimo Reports Fourth Quarter and Full Year 2011 Financial Results; Provides 2012 Financial Guidance

Q4 2011 Highlights (compared to Q4 2010):

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Total revenue, including royalties, rose 6% to $112.3 million.

 

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Product revenue rose 12% to $104.7 million.

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Shipped 34,400 Masimo SET® and Masimo rainbow® SET units.

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Masimo rainbow revenue rose 16% to $9.8 million.

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GAAP EPS was $0.23 versus $0.26 in the year-ago period. Excluding one-time items in Q4 2010, GAAP EPS declined 21% in Q4 2011, compared to adjusted EPS of $0.29 in Q4 2010.

Full Year 2011 Highlights (compared to 2010):

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Total revenue, including royalties, rose 8% to $439.0 million.

 

-

 

Product revenue rose 14% to $406.5 million.

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Shipped 148,200 Masimo SET® and Masimo rainbow® SET units, increasing worldwide installed base by 15%.

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Masimo rainbow revenue rose 4% to $34.1 million. Excluding the 2010 U.S. military order, rainbow revenue rose 18%.

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GAAP EPS was $1.05 versus $1.21 in 2010, which included a one-time net gain of $0.18. Excluding one-time items in 2010, GAAP EPS rose 2% in 2011 from $ 1.03.

Irvine, California, February 14, 2012 Masimo (NASDAQ: MASI) today announced its financial results for the fourth quarter and year ended December 31, 2011.

Masimo's total fourth quarter revenue, including royalties, rose 6% to $112.3 million, compared to $105.6 million for the fourth quarter of 2010. Fourth quarter 2011 product revenue rose 12% to $104.7 million, compared to $93.8 million for the fourth quarter of 2010. For the fourth quarter of 2011, the company's worldwide end-user business grew 17% and represented 86% of product revenue. OEM sales, which represented the remaining 14% of product revenue, declined 12% in the fourth quarter of 2011, compared to the same period in 2010. Revenue from Masimo rainbow product sales rose 16% to $9.8 million in the fourth quarter, compared to $8.4 million for the fourth quarter of 2010.

Net income for the fourth quarter was $13.8 million, or $0.23 per diluted share, compared to reported net income of $16.1 million, or $0.26 per diluted share, in the fourth quarter of 2010. Excluding one-time expenses in the year-ago period, Masimo's adjusted net income and adjusted earnings per share for the fourth quarter of 2010 were $17.5 million and $0.29, respectively.

For 2011, Masimo's total revenue rose 8% to $439.0 million, compared to $405.4 million in 2010. The company's product revenue rose 14% to $406.5 million, compared to $356.4 million in 2010. Revenue from Masimo rainbow products rose 4% to $34.1 million, compared to $32.9 million in 2010. Excluding the $4.0 million U.S. military order in 2010 that did not repeat in 2011, rainbow revenue grew by18%. Royalty revenue declined from $49.0 million in 2010 to $32.5 million in 2011.

Masimo's net income for 2011 was $63.7 million, or $1.05 per diluted share, compared to 2010 net income of $73.5 million, or $1.21 per diluted share, which included $0.18 from the net of a one-time gain related to $30.8 million in antitrust proceeds from Covidien and offset by $14.7 million in one-time expenses. Excluding one-time items in 2010, Masimo's 2010 adjusted net income and adjusted earnings per share were $62.5 million and $1.03, respectively.

During the fourth quarter, the company shipped approximately 34,400 Masimo SET pulse oximetry and Masimo rainbow SET Pulse CO-Oximetry units, excluding handheld units, down 18% compared to approximately 41,800 in the same prior-year period. For 2011, Masimo shipped approximately 148,200 Masimo SET pulse oximetry and Masimo rainbow SET Pulse CO-Oximetry units, excluding handheld units, down 2% compared to approximately 153,200 in 2010. Masimo estimates its worldwide installed base as of December 31, 2011 to be 979,000 units, up 15% from 855,000 units as of January 1, 2011.

Joe Kiani, Chairman and Chief Executive Officer of Masimo, said, "Masimo finished 2011 with a 12% rise in fourth quarter product revenue, including 17% growth in our direct business. Strong double-digit sales growth in our U.S. acute care channel and international business, as well as a 16% increase in rainbow revenue, drove our product revenue performance in the quarter. We also grew our worldwide installed base by 15%, expanding our global reach and demonstrating the continuing demand for our superior Masimo SET pulse oximetry and rainbow SET Pulse CO-Oximetry technology."

As of December 31, 2011, cash and cash equivalents were $129.9 million, compared to $88.3 million as of January 1, 2011. During the fourth quarter, the company used approximately $36 million in cash to purchase approximately 1.8 million shares of its common stock under a stock repurchase program authorized by the Board of Directors in mid-2011.

2012 Financial Guidance
Masimo expects fiscal 2012 total revenue to be approximately $483 million, including product revenue of $455 million and royalty revenue of $28 million. Included within the 2012 product revenue guidance is a rainbow revenue expectation of $45 million. The company expects fiscal 2012 GAAP earnings per share to be $1.20. Each of the components of Masimo's guidance set forth above is an estimate only and actual performance could differ.

Conference Call
Masimo will hold a conference call today at 1:30 p.m. PT (4:30 p.m. ET) to discuss the results. A live webcast of the conference call will be available online from the investor relations page of the company's corporate website at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 758-3929 for international callers. The reservation code for both dial-in numbers is 42982286. After the live webcast, the call will be available on Masimo's website through March 14, 2012. In addition, a telephonic replay of the call will be available through February 28, 2012. The replay dial-in numbers are (800) 585-8367 for domestic callers and +1 (855) 859-2056 for international callers. Please use reservation code 42982286

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 demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements 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 required invasive procedures, 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). 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 noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET and Masimo rainbow SET technologies can also 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 Outcomes 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
All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements including, in particular, the statements about our financial condition, results of operations and business generally; expectations regarding our ability to design and deliver innovative new noninvasive technologies; demand for our technologies; and expectations for total revenue, royalty revenue and product revenue, including rainbow revenue, and GAAP earnings per share, for the full fiscal year 2012. These forward-looking statements are based on management's current expectations and beliefs and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control and could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to, those related to: our dependence on Masimo SET and Masimo rainbow SET products and technologies for substantially all of our revenue; any failure in protecting our intellectual property exposure to competitors' assertions of intellectual property claims; the highly competitive nature of the markets in which we sell our products and technologies; any failure to continue developing innovative products and technologies; the lack of acceptance of any of our current or future products and technologies; obtaining regulatory approval of our current and future products and technologies; the risk that the implementation of our international realignment will not continue to produce anticipated operational and financial benefits, including a continued lower effective tax rate; the loss of our customers; the failure to retain and recruit senior management; product liability claims exposure; a failure to obtain expected returns from the amount of intangible assets we have recorded; the maintenance of our brand; the impact of the decline in the worldwide credit markets on us and our customers; the amount and type of equity awards that we may grant to employees and service providers in the future; and other factors discussed in the "Risk Factors" section of our most recent periodic reports filed with the Securities and Exchange Commission ("SEC"), including our most recent Form 10-K and Form 10-Q, all of which you may obtain for free on 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. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Investor Contact: Sheree Aronson

 

Media Contact: Dana Banks

Vice President, Investor Relations, Masimo Corporation

 

Manager, Public Relations, Masimo Corporation

(949) 297-7043

 

(949) 297-7348

saronson@masimo.com

 

dbanks@masimo.com

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, Rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57,Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, and SEDLine are trademarks or registered trademarks of Masimo Corporation.

 

 

 

 

Masimo to Report Fourth Quarter and Full Year 2011 Financial Results After Market Close on February 14, 2012

Conference call and webcast to begin at 1:30 p.m. PT (4:30 p.m. ET)

IRVINE, Calif., January 26, 2012 -- Masimo (NASDAQ: MASI) announced today that it will release fourth quarter and full year financial results for the period ended December 31, 2011, after the market closes on February 14,  2012. The conference call to review the results will begin at 1:30 p.m. PT (4:30 p.m. ET) and will be hosted by Joe Kiani, Chairman and Chief Executive Officer, and Mark P. de Raad, Executive Vice President and Chief Financial Officer.

A live webcast of the conference call will be available online from the investor relations page of the company's corporate website at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 758-3929 for international callers. The reservation code for both dial-in numbers is 42982286. After the live webcast, the call will be available on Masimo's website through March 14, 2012. In addition, a telephonic replay of the call will be available through February 28, 2012. The replay dial-in numbers are (800) 585-8367 for domestic callers and +1 (855) 859-2056 for international callers. Please use reservation code 42982286.


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 demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements 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 required invasive procedures, 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).  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 noninvasive and continuous monitoring of acoustic respiration rate (RRa™).  Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.  In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices.  Masimo SET and Masimo rainbow SET technologies can be also 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 Outcomes 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.


Investor Contact:
Sheree Aronson
Vice President, Investor Relations
Masimo Corporation
(949) 297-7043
saronson@masimo.com

Media Contact:
Dana Banks
Manager, Public Relations
Masimo Corporation
(949) 297-7348
dbanks@masimo.com

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, Rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57,Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, and SEDLine  are trademarks or registered trademarks of Masimo Corporation.

 

Masimo Announces FDA Clearance and Full Market Release of the New Pronto-7™ for Noninvasive Total Hemoglobin Spot-Check Measurement, Along with SpO2, Pulse Rate, and Perfusion Index

Irvine, California – January 9, 2012 – Masimo (NASDAQ: MASI) today announced FDA 510(k) clearance and full market commercial launch of the Masimo Pronto-7®—a palm-sized handheld device designed for quick and easy noninvasive spot-checking of total hemoglobin (SpHb®), SpO2, pulse rate, and perfusion index.

Hailed as a "potential game-changing technology," Dr. Andrew J. Schuman—adjunct assistant professor of pediatrics at Dartmouth Medical School, contributing editor for Contemporary Pediatrics, and a practicing pediatrician in New Hampshire, who reviewed the device prior to FDA clearance—says that the new Pronto-7 is so innovative it has the "potential for significantly improving pediatric practice."

"The Pronto-7 is a potentially game-changing device because it can help healthcare providers expedite the diagnosis and treatment of anemia in children and adolescents," continued Dr. Schuman. Not only does it represent an exciting medical advancement in point-of-care testing, but it also provides pediatricians with a high-tech alternative to painful venipuncture or finger stick blood sampling that, until now, has been the only way to measure hemoglobin levels in our young patients. Parents and pediatricians will also appreciate our new ability to screen without the scream! Most would agree that the best preventative healthcare is provided both quietly as well as painlessly."

With FDA 510(k) clearance and full commercial availability of the new Pronto-7 device, which includes expanded sensor size options to accommodate a wider range of finger sizes and the addition of a Max Sensitivity Mode, clinicians throughout the United States will be able to quickly and conveniently measure total hemoglobin, SpO2, pulse rate, and perfusion index— without removing a drop of blood.

pronto-7Masimo Pronto-7 has already received several notable industry accolades, including the 2011 GOLD Medical Design Excellence Award, 2011 TechAmerica High-Tech Innovation Award, and the 2011 iF Product Design Award. And in 2010, the Pronto-7 was named to the World Health Organization's (WHO) List of Innovative Medical Technologies that Address Global Health Concerns and Needs.

Hemoglobin is one of the most commonly ordered tests in both hospital and non-hospital settings because it is critical to assessing blood loss. However, current testing requires a painful needle stick for the patient, time-consuming blood draws for the clinician, and typically provides delayed results. The Pronto-7 offers a breakthrough solution for measuring hemoglobin in less than one minute—without the needles, risk of blood contamination, hazardous medical waste, laboratory analysis, and patient discomfort associated with traditional blood tests. With dimensions of just 13 cm x 7.2 cm x 2.5 cm (5.1" x 2.8" x 1") and weight of 296 grams (10.5 ounces), the palm-sized Pronto-7 puts the power of noninvasive hemoglobin spot-check testing, along with SpO2, pulse rate, and perfusion index, into any clinician's hands in various clinical settings, including physician offices, hospitals, and clinics. Because of the device's embedded 802.11 b/g and Bluetooth communication capability, wireless printing or emailing of test results is enabled and future upgrades will allow for wireless transmission to electronic health record (EHR) systems.

Thomas A. Murray, III, MD, an obstetrician/gynecologist in Salem, Massachusetts, says: "As one of the first users of the prototype Pronto-7, I was impressed with its ease of use right from the start. In a general ob/gyn office, anemia is a common disorder and the Pronto-7 allows me to accurately measure my patients' hemoglobin levels noninvasively, conveniently, and quickly—right here on-the-spot in my office. My patients used to cringe at the idea of a finger stick and love that Pronto-7 is noninvasive. It is also much safer for my staff as there is no possibility of a needle stick injury or blood exposure. I have found the Pronto-7 to be very useful in my practice."

Masimo is the first company to commercially introduce continuous and spot-check noninvasive total hemoglobin devices. Prior to the introduction of the Pronto-7, Masimo received U.S. FDA 510(k) and CE mark clearance and first introduced the ability to noninvasively and continuously measure total hemoglobin (SpHb) in 2008 using its Radical-7 bedside Pulse CO-Oximeter. In 2009, Masimo launched Pronto®—its first handheld noninvasive spot-check device for point-of-care hemoglobin, SpO2, and pulse rate testing—worldwide. And in 2010, Medicare reimbursement was added for transcutaneous hemoglobin measurement in the United States.

Masimo Founder and CEO, Joe Kiani, stated: "Full market release of Pronto-7 will enable clinicians to better care for and assess their patients. We agree with the physicians and industry experts who call the Pronto-7 a game-changing technology. And we are proud to deliver this medical first—completely noninvasive total hemoglobin, SpO2, pulse rate, and perfusion index measurements available in the palm of your hand—which offers healthcare providers around the world the opportunity to transform the way and amount of time it takes to deliver the right care, at the right time to patients."

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 demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements 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 required invasive procedures, 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). 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 noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET and Masimo rainbow SET technologies can be also 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 of the repeatability of clinical results obtained using the new Masimo Pronto-7 and noninvasive sensor sizes, risks related to our belief that the Pronto-7 enables quick and easy noninvasive spot-checking of hemoglobin (SpHb®), SpO2, pulse rate, and perfusion index at the point-of-care for all patients, 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.

Media Contacts:
Dana Banks
Phone: (949) 297-7348
Email: dbanks@masimo.com
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, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57,Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.