Masimo Announces Bridge™

Drug-free Neurostimulation Device Reduces the Symptoms of Opioid Withdrawal

IRVINE, Calif.–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) today announced Bridge™, an opioid withdrawal solution that uses neuromodulation to aid in the reduction of symptoms associated with opioid withdrawal. Bridge, which has been granted an FDA De Novo classification, is the first evidence-based, drug-free, non-surgical device of its kind.

Opioid withdrawal is often accompanied by painful, often severe flu-like symptoms lasting for up to two weeks, making voluntary discontinuation by opioid users a long, challenging process. For many patients with opioid-use disorder (OUD), fear of the physical and psychological effects of withdrawal can be a barrier to even attempting to seek treatment. It has been estimated that less than 20% of the more than two million people suffering from OUD in the United States are receiving treatment.¹

By aiding in the reduction of withdrawal symptoms, Bridge can help patients with OUD successfully transition away from opioids into an appropriate treatment program, helping them safely address their disorder. 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 adult OUD patients, it was shown that 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

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. These electrical impulses to the cranial nerves have been found to reduce heightened neuron activity,³ which is associated with opioid withdrawal symptoms. Bridge can be easily applied by a healthcare professional in a simple, non-surgical, in-office procedure, and its use doesn’t interfere with normal daily activities such as work or school.

Joe Kiani, Founder and CEO of Masimo, said, “The opioid epidemic continues to impact millions of people around the world. Unassisted withdrawal from long-term use can be lengthy, extremely unpleasant, and there is a high risk of relapse. Effectively helping to reduce opioid withdrawal symptoms, which is what Bridge has been shown to do, is a critical first step toward successful illicit opioid cessation and treatment. This is the first tool that we are introducing to help with the opioid epidemic. We are committed to doing what we can to help reduce opioid-related deaths.”

Opioid use (including prescription opioids and heroin) kills many people in the U.S. each year. From 1999 to 2018, opioids were involved in more than 446,000 deaths,⁴ approximately 232,000 of which were the result of overdoses related to prescription opioids.⁵ In 2018, the most recent year for which data is available, approximately 47,000 deaths involved opioids, almost 15,000 of which involved prescription opioids.⁴

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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 and reduce the cost of care. 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.⁶ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁷ improve CCHD screening in newborns,⁸ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^9-11 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹² and is the primary pulse oximetry at 9 of the top 10 hospitals according to the 2019-20 U.S. News and World Report Best Hospitals Honor Roll.¹³ 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 Iris^® platform, and include Iris Gateway^®, Patient SafetyNet, Replica™, Halo ION™, UniView™, 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. https://www.drugabuse.gov/publications/research-reports/medications-to-treat-opioid-addiction/overview
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. Babygirija R et al. Percutaneous Electrical Nerve Field Stimulation Modulates Central Pain Pathways and Attenuates Post-inflammatory Visceral and Somatic Hyperalgesia in Rats. Neuroscience 356 (2017) 11-21.
4. Wilson N et al. Drug and Opioid-Involved Overdose Deaths — United States, 2017–2018. MMWR Morb Mortal Wkly Rep 2020;69:290–297. DOI: http://dx.doi.org/10.15585/mmwr.mm6911a4.
5. https://www.cdc.gov/drugoverdose/data/prescribing/overview.html.
6. 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.
7. 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.
8. 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.
9. Taenzer AH 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.
10. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
11. McGrath SP 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.
12. Estimate: Masimo data on file.
13. 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 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 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 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.

Contacts

Masimo
Evan Lamb

949-396-3376

elamb@masimo.com