Masimo (NASDAQ: MASI) announced today the findings of a study published in the Journal of Pain & Relief in which Dr. Jacques Chelly and colleagues at the University of Pittsburgh investigated the utility of Masimo Bridge^®, an auricular field nerve stimulator, in reducing postoperative opioid requirements in patients undergoing kidney donor surgery.¹ The researchers found that use of Bridge was associated with significant reductions in opioid use at 24 hours and pain at 24 and 48 hours after surgery, concluding that Bridge “may represent a complementary approach to minimize the postoperative requirement for opioid[s].”

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Masimo Bridge® (Photo: Business Wire)

Noting that opioids are still considered to be required after kidney donor surgery, in spite of their “established serious side effects including respiratory depression, postoperative nausea and vomiting” and that they “expose the donors to an unnecessary risk of opioid use disorder,” the researchers sought to evaluate whether the technique of percutaneous nerve field stimulation might provide benefit during the postoperative period. To evaluate this, they enrolled 20 patients undergoing kidney donor surgery, divided into two groups of 10. Both groups underwent the same enhanced recovery after surgery (ERAS) protocol based on a multimodal analgesic approach. The primary endpoint was opioid requirement, measured as oral morphine equivalent (OME), 24 hours after surgery. They also evaluated pain (on a 0 to 10 scale) 24 and 48 hours after surgery. In the experimental group (n=10), Masimo Bridge was fitted on patients in the post-anesthesia care unit.

The researchers found that, compared to the control group (n=10), the patients in the Bridge group had a 75.4% reduction in OME (8.3 ± 9.6 mg vs. 33.5 ± 37.3 mg, p = 0.03) and a 58.3% reduction in pain (2.5 ± 2.0 vs. 6 ± 1.4, p < 0.001) at 24 hours. At 48 hours, they had a 16.1% reduction in OME (22.4 ± 19.5 mg vs 26.7 ± 21.9 mg, p = 0.33) and a 73.3% reduction in pain (1.6 ± 1.6 vs. 6.0 ± 2.8, p = 0.0004). There was no difference in non-opioid analgesic use between the two groups. “Tolerability” of the Bridge device was reported as “excellent” by 78% of participants.

The researchers concluded, “This study suggests that the NSS-2 [Masimo] Bridge device may be of significant value in controlling postoperative opioid consumption and pain. This is especially interesting in the context of the current opioid epidemic and associated risk of opioid use disorder (OUD) in surgical patients. However, a prospective randomized placebo control design is required to confirm our findings.”

Masimo Bridge, the first evidence-based, drug-free, non-surgical device of its kind, has been cleared by the FDA for use in the treatment of clinical symptoms associated with opioid withdrawal, but is not currently FDA-cleared for postoperative pain management. The solution consists of a wearable, single-patient-use, percutaneous neurostimulator, fitted behind the ear, which applies gentle electrical impulses to branches of the cranial nerves around the ear. By using neuromodulation to aid in the reduction of withdrawal symptoms, Bridge may help patients with OUD successfully transition into a treatment program. In clinical testing, Bridge was found to reduce opioid withdrawal symptoms within 15-30 minutes and provide continuous relief for as long as it was applied, which can be up to 120 hours per device, allowing opioids to leave the body. In a study of 73 adults with OUD, it was shown that opioid withdrawal symptoms (such as increases in resting pulse rate, sweating, restlessness, bone or joint aches, tremors, and anxiety) were reduced by 85% after the first hour of using the device and 97% after 5 days of use (measured using the clinical opiate withdrawal scale).²

Study author Dr. Chelly commented, “Auriculotherapy is an ancient technique that has been used for centuries to treat pain. However, it requires long and specialized training and experience to be used effectively on patients. The Bridge device, by contrast, provides similar therapy but requires only limited training. Bridge offers the possibility of allowing many more patients to benefit from auriculotherapy, especially at a time when the use of opioids is so controversial.”

Joe Kiani, Founder and CEO of Masimo, said, “With FDA clearance, we have been marketing Bridge for opioid withdrawal for over a year and have seen amazing success stories. With this new promising study from UPMC, we will now work towards getting Bridge cleared for postoperative pain treatment worldwide. Last year, over 83,000 people died in the US alone from drug overdoses, with almost 63,000 of them killed by opioids, many of them from prescription opioids used post surgery.³ While we hope that with our FDA-pending, breakthrough-designated Masimo SafetyNet™ opioid solution, we will catch opioid overdoses early enough to save lives, it would be best if we can avoid the unnecessary use of opioids altogether. We hope additional studies will confirm that Bridge can help reduce the use of opioids.”

@Masimo | #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.⁴ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁵ improve CCHD screening in newborns,⁶and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^7-10 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹¹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.¹² Masimo continues to refine SET^® and in 2018, announced that SpO₂ accuracy on RD SET^® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO₂ values they rely on accurately reflect a patient’s physiological status. 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^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^® and Radius PPG™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica™, Halo ION™, UniView^®, UniView :60™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Monroe AL, Planinsic RM, Tevar A, Chelly JE. Auricular field nerve stimulation using the NSS-2 Bridge® device as an alternative to opioids following kidney donor surgery. J Pain Relief. 2021. 10:365.
2. Miranda A, Taca A. Neuromodulation with percutaneous electrical nerve field stimulation is associated with reduction in signs and symptoms of opioid withdrawal: a multisite, retrospective assessment. Am J Drug Alcohol Abuse. 2017 Mar 16;1-8.
3. Provisional Drug Overdoes Death Counts. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
4. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
5. 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.
6. 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;Jan 8;338.
7. Taenzer A 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.
8. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
9. McGrath S 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.
10. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
11. Estimate: Masimo data on file.
12. 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 Bridge^® and Masimo’s plan to obtain additional FDA clearance for Masimo Bridge. 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 that a prospective randomized placebo control design is unable to confirm the findings in the new study from UPMC; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Bridge, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks of not gaining FDA clearance or marketing approvals for its product candidates, including Masimo Bridge; risks related to COVID-19; 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.

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