New Study Finds Continuous, Noninvasive Hemoglobin Monitoring Using Masimo SpHB May Reduce Intraoperative Red Blood Cell Transfusion

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today that in a new study recently presented at the World Congress of Anesthesiologists (WCA) in Hong Kong, researchers concluded that continuous and noninvasive hemoglobin monitoring using Masimo SpHb^® may reduce excessive intraoperative red blood cell (RBC) transfusion.¹

“This is the third study, published by different researchers on three continents (US2, Egypt3, and now Japan1), that has shown that in addition to other clinical tools, SpHb may be used to help clinicians make informed transfusion decisions during different types of surgery*”

In a retrospective review of 371 patients who underwent intraoperative RBC transfusions between 2012 and 2014 at Fukushima Medical University in Japan, Dr. Imaizumi and colleagues compared 94 patients who had noninvasive hemoglobin measurements to 277 patients who did not (the control group). The total transfusion volumes and transfusion volume per 1 g of blood loss were determined for each group.

Comparing the groups, researchers noted that “a significantly lower mean RBC transfusion volume per 1 g of blood loss was observed in the SpHb group compared with the [control] group (SpHb group, 0.9 ± 1.0 ml/g blood loss vs [control] group, 2.4 ± 5.9 ml/g blood loss, p < 0.01).” They also observed that there was “no significant difference…in the average RBC transfusion volume (SpHb group, 815 ± 819 ml vs. [control] group, 785 ± 773 ml, p=0.75), or the preoperative hemoglobin concentration (SpHb group, 10.4 ± 1.9 g/dL vs. [control] group, 10.2 ± 2.4 g/dL, p=0.27) between the groups.” According to results from this abstract, the authors concluded that “SpHb measurements are associated with reducing excessive intraoperative RBC transfusion.”

“This is the third study, published by different researchers on three continents (US², Egypt³, and now Japan¹), that has shown that in addition to other clinical tools, SpHb may be used to help clinicians make informed transfusion decisions during different types of surgery*,” stated Dr. Steven Barker, Ph.D., M.D., Chief Science Officer, Masimo.

SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samplings – when the SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing; when the SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing and the clinician may otherwise think hemoglobin is stable. SpHb with laboratory diagnostic test may thus help clinicians make more timely and informed decisions, and has been shown to help clinicians provide more timely blood transfusions* and reduce blood transfusions in cases such as neurosurgery and orthopedic surgery.^2,3

Last week Masimo announced that in response to the Zika virus and its potential impact on the availability of blood products, Masimo has created a special program to dramatically reduce the cost of and increase access to Masimo’s SpHb solutions, as SpHb has been shown to help clinicians reduce blood transfusions in both low and high blood loss surgery. This special program will be available wherever the blood supply is affected by the Zika virus.

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*Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References

1. Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may reduce excessive intraoperative RBC transfusion. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR607.
2. Ehrenfeld JM et al. J Blood Disorders Transf. 2014. 5:9. 2.
3. Awada WN et al. J Clin Monit Comput. 2015 Feb 4.

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^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. 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. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

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 SpHb^® and the availability of Masimo’s special program for SpHb solutions. 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 SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; 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.