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We are a global leader in digital health and cloud-connected medical devices.
−Removed: We design innovative solutions to treat and keep people out of the hospital, empowering them to live healthier, higher-quality lives.
−Removed: Our digital health technologies and cloud-connected medical devices transform care for people with sleep apnea, chronic obstructive pulmonary disease, or COPD, and other chronic diseases.
−Removed: Our comprehensive residential care software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice.
+Added: We design innovative technology to empower people to live happier, healthier lives.
+Added: Our artificial intelligence, or AI, powered digital health solutions, cloud-connected devices and intelligent software are designed to make home healthcare more personalized, accessible and effective.
By enabling better care, our products improve quality of life, reduce the impact of chronic disease, and lower costs for consumers and healthcare systems.
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CPAP systems deliver pressurized air, typically through a mask, to prevent collapse of the upper airway during sleep.
−Removed: Since the development of CPAP, we have expanded our business by developing or acquiring a number of innovative products and solutions for a broad range of respiratory disorders including technologies to be applied in medical and consumer products, ventilation devices, diagnostic products, mask systems for use in the hospital and home, headgear and other accessories, and dental devices.
+Added: Since the development of CPAP, we have expanded our business by developing or acquiring a number of innovative products and solutions for a broad range of sleep and related breathing health disorders including technologies to be applied in medical and consumer products, life support and ventilation devices, diagnostic products, mask systems for use in the hospital and home, headgear and other accessories, and dental devices.
In addition, we are a leading provider of cloud-based health applications, software and devices designed to provide connected care, enabling clinicians to manage more patients efficiently and effectively, as well as enabling and encouraging patients’ long-term adherence to and satisfaction with their therapy.
−Removed: We also provide management software that assists durable or home medical equipment (DME/HME) providers, and other long-term care providers operate more effectively and efficiently across various residential care settings.
+Added: In June 2026, we acquired Noctrix Health, LLC, or Noctrix, a company with an FDA De Novo classified medical device that treats restless legs syndrome.
+Added: The acquisition expands our clinical sleep health portfolio into an adjacent area of unmet
PART I Item 1
AND SUBSIDIARIES
−Removed: comprehensive set of software and services offerings, our software solutions enable providers to streamline workflow and deliver an improved patient experience across our existing vertical markets including HME and home infusion, facility-based organizations including skilled nursing, senior living, and life plan communities, home health and hospice providers, and to adjacent providers through a growing portfolio of value-added solutions with broad applicability.
−Removed: In May 2025, we acquired VirtuOx, a software-enabled independent diagnostic testing facility, or IDTF, and provider of technology solutions to facilitate in-home and remote testing services for sleep, respiratory, cardiac, and other health conditions across the United States, or U.S.
+Added: Noctrix will operate as a wholly owned subsidiary of Resmed.
+Added: Additional information regarding the transaction is included in Note 18 – Business Combinations and Divestitures of the Notes to Consolidated Financial Statements (Part II, Item 8).
+Added: Through our acquisition of VirtuOx in 2025, we operate a software-enabled independent diagnostic testing facility, or IDTF, that provides technology solutions to facilitate in-home and remote testing services for sleep, respiratory, cardiac, and other health conditions across the United States, or U.S.
This acquisition strengthens our position in the sleep and breathing health market by expanding our ability to offer end-to-end solutions, including home-based diagnostics and patient monitoring.
−Removed: VirtuOx will operate as a wholly owned subsidiary of Resmed.
−Removed: The acquisition is not material to our financial results.
−Removed: We employ more than 10,600 people and sell our products in more than 140 countries through a combination of wholly owned subsidiaries and independent distributors.
+Added: We also provide management software that assists providers to operate more effectively and efficiently across various residential care settings.
+Added: Through Brightree, we provide software solutions and services that enable durable or home medical equipment, or DME/HME, to automate clinical workflows, optimize billing and compliance, and drive patient engagement in the U.S.
+Added: Through MEDIFOX DAN, we provide a leading care management software platform which helps residential care providers in Germany to deliver and manager care more efficiently through integrated digital solutions.
+Added: Through the MatrixCare business as defined below, we provide similar care management software solutions for senior living, skilled nursing, life plan communities, home health, hospice and adjacent providers in the U.S.
+Added: Together, our software solutions support providers by improving workflow efficiency and patient experience through value-added solutions with broad applicability.
+Added: On June 30, 2026, we entered into a definitive agreement to sell our MatrixCare business for $490 million in an all-cash transaction, subject to certain closing adjustments.
+Added: The transaction includes MatrixCare and related software offerings historically sold under the MatrixCare brand, including Healthcare First, Citus, and home health and hospice solutions, collectively defined as the "MatrixCare business”.
+Added: The transaction is the result of portfolio optimization to sharpen our focus on our core growth areas of sleep, breathing and connected home-based healthcare.
+Added: The transaction is expected to close in the first quarter of fiscal year 2027.
+Added: Additional information regarding the transaction is included in Note 18 – Business Combinations and Divestitures of the Notes to Consolidated Financial Statements (Part II, Item 8).
+Added: We employ approximately 11,370 people and sell our products in more than 140 countries through a combination of wholly owned subsidiaries and independent distributors.
Our website address is www.resmed.com.
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Securities and Exchange Commission, or SEC.
−Removed: The SEC maintains an internet site, www.sec.gov, which contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.
+Added: The SEC maintains a website, www.sec.gov, which contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.
We also make available on our investor relations website, public financial information for which a report is not required to be filed with or furnished to the SEC.
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Ten CDIs on the ASX represent one share of our common stock on the NYSE.
−Removed: Since formation, we have grown organically through global expansion as well as by acquiring a number of businesses, including distributors, suppliers, developers of medical equipment and related technologies, and software solution providers.
+Added: Since formation, we have grown organically through global expansion as well as by acquiring a number of businesses, including distributors, suppliers, developers of medical equipment and related technologies, an independent diagnostic testing facility and software solution providers.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
Segment Information
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Financial information about our revenues from and assets located in foreign countries is also included in the notes to our consolidated financial statements.
−Removed: We are focused on sleep and related breathing health, both of which we believe are globally underpenetrated, and where we believe our products can improve patient outcomes, create efficiencies for our customers, help physicians and providers better manage chronic disease and reduce overall healthcare system costs.
+Added: We focus on sleep and related breathing health, both of which we believe are globally underpenetrated, and where we believe our products can improve patient outcomes, create efficiencies for our customers, help physicians and providers better manage chronic disease and reduce overall healthcare system costs.
Additionally, our software solutions are focused on those who provide residential care, which we believe is fragmented and underserved, and where we see significant opportunity to transform and significantly improve residential healthcare through a strategy of enabling better patient care, improving clinical decision support, and driving interoperability across residential care settings.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
Sleep and Breathing Health
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stage 1 is the lightest and stage 3 is the deepest.
−Removed: The upper airway has no rigid support and is held open by active contraction of upper airway muscles.
+Added: Quality sleep underpins almost all aspects of human health.
+Added: The upper airway has no rigid support and is held open by active contraction of upper airway muscles and tracheal traction by the lungs.
Normally, during REM sleep and deeper levels of non-REM sleep, upper airway muscles relax and the airway narrows.
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OSA has been recognized as a cause of hypertension and a significant comorbidity for heart disease, stroke, and type 2 diabetes.
+Added: Excessive daytime sleepiness or fatigue are hallmarks of OSA and can lead to headaches, poor mood, absenteeism, increased risk of motor vehicle accidents and exacerbate comorbidities associated with untreated OSA.
A long-term epidemiology study published in 2013 estimated that 26% of adults aged 30-70 have some form of obstructive sleep apnea.
−Removed: Another study published in Lancet Respiratory Medicine in 2019 estimated that mild to severe OSA impacts more than 936 million people worldwide, including 54 million Americans.
+Added: Another study published in Lancet Respiratory Medicine in 2019 estimated that mild to severe OSA impacts more than 936 million people worldwide, including 61 million Americans, per Lancet Respiratory Medicine in 2025.
Of those impacted globally, it was estimated that more than 424 million would have moderate to severe sleep apnea.
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Studies have shown that sleep apnea is present in approximately 83% of patients with drug-resistant hypertension, approximately 77% of patients with obesity, approximately 76% of patients with chronic heart failure, and approximately 72% of patients with type 2 diabetes.
−Removed: A study presented at the European Respiratory Society (ERS) International Congress in 2021 and later published in CHEST in 2022 found that using PAP therapy as directed can significantly increase sleep apnea patients’ chances of living longer.
−Removed: The study concluded that people with obstructive sleep apnea who started and continued PAP therapy were 39% more likely to survive over a three-year period than OSA patients who did not.
−Removed: Researchers found that the survival rate gap remained significant when accounting for patients’ ages, overall health, other pre-existing conditions, and causes of death.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: A systematic review and meta-analysis published in Lancet Respiratory Medicine in 2025 (Benjafield et al.), which evaluated evidence from randomized controlled trials and confounder-adjusted non-randomized studies, found that PAP therapy was associated with a 37% reduction in all-cause mortality and a 54% reduction in cardiovascular mortality compared with no PAP therapy.
+Added: These findings are consistent with earlier research presented at the European Respiratory Society (ERS) International Congress in 2021 and subsequently published in CHEST in 2022, which found that patients with obstructive sleep apnea who initiated and continued PAP therapy were 39% more likely to survive over a three-year period than patients who did not receive PAP therapy.
+Added: Researchers found that the survival rate gap remained significant when accounting for patients’ ages, overall health, socioeconomic status and pre-existing conditions.
Sleep-Disordered Breathing and Obstructive Sleep Apnea.
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studies have linked OSA to increased occurrences of traffic and workplace accidents.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
Generally, an individual seeking treatment for the symptoms of OSA is referred by a general practitioner to a sleep specialist for further evaluation.
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Patient compliance has been a major factor in the effectiveness of CPAP treatment.
−Removed: Early generations of CPAP units provided limited patient comfort and convenience.
+Added: Early generations of CPAP units provided limited patient comfort and
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
Patients experienced soreness from the repeated use of nasal masks and had difficulty falling asleep with the CPAP device operating at the prescribed pressure.
In recent years, we have developed product innovations to improve patient comfort and compliance.
−Removed: These include more comfortable patient interface systems;
−Removed: delay timers that gradually increase air pressure allowing the patient to fall asleep more easily;
−Removed: bilevel air devices, including our AirCurve 11 Series devices, which provide different air pressures for inhalation and exhalation;
−Removed: heated humidification systems to make the airflow more comfortable;
−Removed: and auto-titration devices that modulate the average pressure delivered during the night.
−Removed: We also offer myAir, a patient engagement application that provides sleep data and a daily score based on a user's previous night’s data to improve compliance.
+Added: These include more comfortable patient interface systems, delay timers that gradually increase air pressure allowing the patient to fall asleep more easily, bilevel air devices, including our AirCurve 11 Series devices which provide different air pressures for inhalation and exhalation, heated humidification systems to make the airflow more comfortable, and auto-titration devices that modulate the average pressure delivered during the night.
+Added: We also offer myAir, an application that aims to help improve patient comfort and long-term CPAP compliance by providing personalized coaching, daily therapy insights, and tools that support patients throughout their sleep therapy journey.
+Added: The new Smart Comfort feature within myAir recommends personalized therapy comfort settings, such as ramp time and pressure relief, helping reduce trial and error and making it easier for patients to adapt to therapy.
Breathing Health
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We also provide data management systems designed to improve the management of patients by care providers.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
Chronic Obstructive Pulmonary Disease.
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COPD includes diseases such as emphysema and chronic bronchitis.
−Removed: A recent study based on recent epidemiology data estimates that there are approximately 480 million people worldwide who suffer from COPD, the world’s third leading cause of death.
+Added: A study in 2022 based on epidemiology data estimated that there were approximately 480 million people worldwide who suffer from COPD and a separate study in 2025 identified that COPD is the world’s third leading cause of death.
Patients with COPD can have different clinical presentations.
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An estimated 90% of patients with OHS also have OSA.
−Removed: In patients with OHS, positive airway therapy, with either CPAP or NIV, has been shown to effectively treat upper airway obstruction and reverse daytime respiratory failure as well as reduce the work of breathing and improve respiratory drive.
+Added: In patients with OHS, positive airway therapy,
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: with either CPAP or NIV, has been shown to effectively treat upper airway obstruction and reverse daytime respiratory failure as well as reduce the work of breathing and improve respiratory drive.
Neuromuscular Disease.
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These providers face increasing operational and compliance complexities due to factors such as evolving reimbursement frameworks, workforce constraints, and demographic shifts.
−Removed: Our Residential Care Software offerings are designed to support customers in addressing these challenges by helping providers perform analytics, manage documentation and implement new
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
−Removed: reimbursement requirements as well as more effectively transfer data as patients move between different care settings.
+Added: Our Residential Care Software offerings are designed to support customers in addressing these challenges by helping providers perform analytics, manage documentation and implement new reimbursement requirements as well as more effectively transfer data as patients move between different care settings.
Our Residential Care Software platforms include capabilities for billing and business management, electronic medical records, revenue cycle management, operational analytics, patient engagement, and workforce management.
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We envision a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home.
−Removed: We believe the sleep and breathing treatments will continue to grow due to a number of factors, including increasing awareness of OSA, CSA and COPD;
+Added: We believe the demand for sleep and breathing treatments will continue to grow due to a number of factors, including increasing awareness of OSA, CSA and COPD;
improved understanding of the role of sleep apnea treatment in the management of adjacent pathologies;
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We aim to continue differentiating our products by integrating artificial‑intelligence and machine‑learning, or AI and ML, algorithms to further enhance therapy performance and user experience.
−Removed: Sleep is becoming a more important aspect of our customers' lives, and we intend to drive higher rates of screening, diagnosis, and therapy adoption through simpler care pathways.
−Removed: In April 2025, we made our home sleep apnea test, NightOwl, available across the U.S., providing a simplified, accurate, and efficient way to diagnose OSA from the comfort of an individual’s home.
−Removed: In May 2025, we acquired VirtuOx, an IDTF, to expand our ability to partner with healthcare providers to help streamline the diagnostic process, while expanding collaboration with home medical equipment providers to efficiently support patients to start treatment.
+Added: Sleep is becoming increasingly recognized as an important aspect of our lives, and we intend to drive higher rates of screening, diagnosis, and therapy adoption through simpler care pathways.
+Added: In 2025, we made our home sleep apnea test, NightOwl, available across the U.S., where supply permitted, providing a simplified, accurate, and efficient way to diagnose OSA from the comfort of an individual’s home.
+Added: In 2025, we also acquired VirtuOx, an independent diagnostic testing facility, to expand our ability to partner with healthcare providers and to help streamline the diagnostic process, while expanding collaboration with home medical equipment providers to efficiently support patients to start treatment.
• Accelerate Market Growth through Awareness.
We continue to expand our existing educational activities to increase awareness of sleep apnea, COPD, and other clinical conditions that can be treated with our industry-leading solutions.
−Removed: These activities target both the population predisposed to sleep apnea and medical specialists, such as pulmonologists, sleep medicine specialists, primary care physicians, cardiologists, neurologists, and other medical subspecialists who treat these conditions and their associated comorbidities.
+Added: These activities target both the population predisposed to sleep apnea and medical specialists, such as pulmonologists, sleep medicine specialists, primary care physicians, cardiologists, neurologists, and other
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: medical subspecialists who treat these conditions and their associated comorbidities.
We target special interest groups, including the National Stroke Association, the American Heart Association, COPD Foundation, and the National Sleep Foundation, to further increase awareness of the relationship between OSA, COPD, neuromuscular disease, and comorbidities such as cardiac disease, diabetes, hypertension, and obesity.
The programs also support our efforts to inform the community of the dangers of sleep apnea with regard to occupational health and safety, especially in the transport industry.
+Added: We also continue to broaden access to sleep health education through strategic partnerships.
+Added: For example, our collaboration with ŌURA helps connect individuals who experience nighttime breathing disturbances identified through Oura Ring insights with our educational resources and a sleep assessment to understand more about sleep health.
+Added: The partnership also provides pathways to healthcare providers and discussion guides to help encourage earlier evaluation and care for sleep-related conditions.
We have helped establish a center for clinical care and medical research at the University of California, San Diego, in the fields of sleep apnea and COPD.
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Our evolution is designed to capitalize on key macro trends, including the enhanced spotlight on sleep apnea due to pharmaceuticals and consumer technology.
−Removed: Through our brand leadership and expertise, we are positioned to serve large, unmet needs in insomnia, COPD and other respiratory and related conditions.
+Added: Through our brand leadership and expertise, we are positioned to serve large, unmet needs in insomnia, COPD and other respiratory and sleep-related conditions.
Research supported by Resmed has demonstrated that the addition of non-invasive ventilation to patients with severe COPD who are receiving oxygen therapy provides meaningful clinical benefits to the patient and the broader healthcare system.
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We maintain close working relationships with prominent physicians to explore new medical applications for our products and technology.
−Removed: • I nvest in an Integrated, Intelligent Digital‑Health Ecosystem Delivered at Home.
+Added: In June 2026, we expanded our clinical sleep health portfolio through the acquisition of Noctrix, a medical device company developing clinically validated wearable therapeutics for chronic neurological disorders, including restless legs syndrome.
+Added: • Invest in an Integrated, Intelligent Digital‑Health Ecosystem Delivered at Home.
Digital enablement is central to our strategy.
Our secure cloud-based digital health applications, along with our devices, are designed to provide connected care to improve patient outcomes and efficiencies for our customers, allowing fewer professionals to manage more patients and empowering patients to track their own health outcomes.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
−Removed: leverage our installed base of more than 30 million patients using cloud‑connected devices on AirView and over 10 million patients registered to our myAir platform to enable personalized, efficient and data‑driven care.
+Added: We can leverage our installed base of more than 35 million patients using cloud‑connected devices on AirView and over 12 million patients registered to our myAir platform to enable personalized, efficient and data‑driven care.
Our own efforts to drive increased therapy adoption, as well as increased adoption through use of wearables with sleep monitoring functionality, will allow us to further build upon our data advantage.
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Today, our Residential Care Software solutions support residential care providers serving more than 180 million individual patient accounts.
+Added: On June 30, 2026, we entered into a definitive agreement to sell our MatrixCare business, reflecting our ongoing commitment to focus on businesses that directly support our sleep health, breathing health, and connected home-based healthcare strategy.
Our portfolio of products includes devices, diagnostic products, mask systems, headgear and other accessories, dental devices, and cloud-based software and informatics solutions.
For purposes of the following discussion, we generally refer to our air flow generators and ventilators collectively as devices.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
We produce cloud-connected CPAP, automatic positive airway pressure, or APAP, bilevel, adaptive servo-ventilation, or ASV, and HFT devices that deliver positive airway pressure through a patient interface, either a mask or cannula.
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Devices in total accounted for approximately 51%, 52%, and 52% of our net revenues in fiscal years 2026, 2025, and 2024, respectively.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
The tables below provide an illustrative selection of devices, as known by our trademarks.
+Added: For purposes of this report, we group certain products into categories to facilitate the presentation of our product portfolio.
+Added: These categories are organizational groupings and do not necessarily reflect the regulatory classification, intended use or specific therapeutic indications of individual products across all care settings in all countries.
CPAP, APAP & BILEVEL
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Other features include the availability of remote software updates so users can enjoy the latest version of these tools every night.
−Removed: The prior generation of these devices, called AirSense™ 10, is the most widely used series of CPAP and APAP machines, each designed to deliver high-quality therapy for a better night’s sleep.
+Added: The prior generation of these devices, called AirSense™ 10, was one of the most widely used series of CPAP and APAP machines, each designed to deliver high-quality therapy for a better night’s sleep.
All AirSense machines include a built-in humidifier, Climate Control Auto setting to provide breathing comfort, AutoRamp™ with sleep onset detection and can be used with myAir™, an online support program and app that helps users track their therapy.
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Stellar 100 and 150 Resmed Stellar™ 100 and 150 ventilators are suitable for invasive and non-invasive ventilation, either at home or in a healthcare setting.
−Removed: They are not a life support ventilator.
+Added: They are not life support ventilators.
Stellar 150 also includes iVAPS™ (intelligent Volume-Assured Pressure Support) technology to adjust to changing respiratory needs.
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With both invasive and non-invasive options, they offer a lightweight design, exceptional battery life and adaptive technologies to provide greater mobility and peace of mind.
−Removed: AirCurve 10 ST-A Resmed AirCurve™ 10 ST-A is designed for people with respiratory conditions that affect breathing such as restrictive lung disorders, severe COPD and hypoventilation.
+Added: PRODUCTS DESCRIPTION
+Added: AirCurve Platform Resmed AirCurve™ devices are designed for people with respiratory conditions that affect breathing such as restrictive lung disorders, severe COPD and hypoventilation.
It combines user-friendly controls, an intuitive interface and automatic features to make ventilation therapy effective, comfortable and hassle-free.
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Masks, diagnostic products and accessories together accounted for approximately 37%, 36%, and 35% of our net revenues in fiscal years 2026, 2025, and 2024, respectively.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
Mask systems are one of the most important elements of sleep apnea treatment systems.
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CATEGORY DESCRIPTION
−Removed: Minimalist AirFit F40, AirFit F30, AirFit P10, and AirFit N30 minimalist masks feature our lightest, lowest profile designs.
+Added: Minimalist AirFit F40, AirFit P10, and AirFit N30 minimalist masks feature our lightest, lowest profile designs.
The features of these masks are focused on minimizing contact with the patient’s face to reduce red marks and irritation.
−Removed: Freedom AirFit N30i, AirFit X30i, AirFit P30i, and AirFit F30i freedom masks, which feature top-of-head tubing design allowing flexibility to easily switch sleep positions.
−Removed: Ultra Soft The AirTouch N30i, AirTouch F20 and AirTouch N20 masks feature soft and breathable materials designed to enhance CPAP mask comfort.
+Added: Freedom AirFit N30i, AirFit X30i, AirFit P30i, AirFit F30i and AirTouch F30i freedom masks, which feature top-of-head tubing design allowing flexibility to easily switch sleep positions.
+Added: Ultra Soft The AirTouch N30i, AirTouch F30i, AirTouch F20 and AirTouch N20 masks feature soft and breathable materials designed to enhance CPAP mask comfort.
Universal Fit AirFit F20 and AirFit N20 masks are designed to fit a wide range of faces due to the InfinitySeal silicone cushion that adapts to unique facial contours, which increases comfort, improves fit and reduces leakage.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
Diagnostic Products
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ApneaLink Air A portable diagnostic device that measures oximetry, respiratory effort, pulse, nasal flow and snoring.
−Removed: It works with AirView Diagnostics to provide comprehensive diagnostic solution to clinicians.
+Added: It works with AirView Diagnostics to provide a comprehensive diagnostic solution to clinicians.
NightOwl A portable, cloud-connected, fully disposable diagnostic device that measures AHI based on derived peripheral arterial tone, actigraphy, and oximetry over several nights.
A comprehensive sleep lab solution that treats a range of patients, designed to support comfortable, uninterrupted sleep for effective titration.
−Removed: Connected Solutions and Other Products
+Added: Connected Solutions
We have a suite of products that are designed to allow fewer professionals to manage more patients and empower patients to track their own health outcomes.
−Removed: We are expanding our cloud-based patient management and engagement platforms, such as AirView and other systems used by providers, enabling remote monitoring, over-the-air trouble shooting, changing of device settings, as well as automated patient coaching through a text, email, or interactive voice phone call and myAir, a patient engagement application that provides sleep data, a daily score based on a user's previous night’s data and coaching for patients.
+Added: We are expanding our cloud-based patient management and engagement platforms, such as AirView and other systems used by providers, enabling remote monitoring, over-the-air trouble shooting, changing of device settings, as well as automated patient coaching through a text, email, or interactive voice phone call and myAir, an application that aims to help improve patient comfort and long-term CPAP compliance by providing personalized coaching, daily therapy insights, and tools that support patients throughout their sleep therapy journey.
PRODUCTS DESCRIPTION
2 unchanged sentences
myAir A personalized therapy management application for patients with sleep apnea providing support, education and troubleshooting tools for increased patient engagement and improved compliance.
−Removed: Connectivity Module A module providing a seamless cellular connection between our compatible ventilation devices (e.g., Astral, Stellar) and our AirView™ system.
+Added: Smart Comfort, launched in early 2026 to select new myAir users, is the first FDA-cleared AI-enabled medical device that recommends personalized comfort settings to help patients with OSA start and stay on CPAP therapy.
+Added: Connectivity Module A module providing a seamless cellular connection between our compatible life support and ventilation devices (e.g., Astral, Stellar) and our AirView™ system.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: Other Products
+Added: In June 2026, we acquired Noctrix, a company with an FDA De Novo classified medical device that treats restless legs syndrome.
+Added: The acquisition expands our clinical sleep health portfolio into an adjacent area.
+Added: PRODUCTS DESCRIPTION
+Added: Nidra Platform An FDA De Novo classified wearable neurostimulation device that delivers tonic motor activation therapy to reduce symptoms of restless legs syndrome and improve sleep quality in adults with moderate-to-severe restless legs syndrome who are refractory to medication.
Residential Care Software Products
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Product Development and Clinical Trials
−Removed: We have a strong track record of innovation in the sleep and breathing health markets.
−Removed: In 1989, we introduced our first CPAP device.
−Removed: Since then, we have been committed to an ongoing program of product advancement and development.
+Added: We have a strong track record of innovation in sleep and breathing health solutions.
+Added: Since introducing our first CPAP device in 1989, we have been committed to an ongoing program of product advancement and development.
Currently, our product development and clinical trial efforts are focused on not only improving our current product offerings and usability, but also expanding into new digital product applications.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
We continually seek to identify new applications of our technology for significant unmet medical needs.
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Studies have established a clinical association between untreated sleep apnea and systemic hypertension, diabetes, coronary artery disease, stroke, atrial fibrillation, chronic heart failure, and mortality.
−Removed: Across the sleep and breathing health platforms, we support clinical trials in many countries including the U.S., Canada, Germany, France, the United Kingdom, Switzerland, Netherlands, Spain, Portugal, Sweden, Denmark, Iceland, Argentina, Chile, China, Republic of Korea, Japan, Malaysia, Singapore, and Australia to develop new clinical applications for our technology.
+Added: Across the sleep and breathing health platforms, we support clinical trials in many countries including the U.S., Canada, Germany, France, the United Kingdom, Switzerland, Netherlands, Spain, Portugal, Sweden, Iceland, Argentina, Chile, China, Japan, Malaysia, Singapore, and Australia to develop new clinical applications for our technology.
We also continue to support some of the largest sleep apnea studies in history by performing advanced statistical analyses on millions of real-world, de-identified, clinical data points collected through our cloud-connected devices and patient engagement tools.
3 unchanged sentences
New product ideas are also identified by our marketing staff, direct sales force, and clinicians.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
Sales and Marketing
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See Note 13 – Segment Information of the Notes to Consolidated Financial Statements (Part II, Item 8) for financial information about our geographic areas.
−Removed: United States, Canada, and Latin America.
−Removed: Our products are typically purchased by a HME provider who then sells the products to the patient.
+Added: United States, Canada, and Latin America or "Americas".
+Added: Our products are typically purchased by an HME provider who then sells the products to the patient.
The decision to purchase our products, as opposed to those of our competitors, is made or influenced by one or more of the following individuals or organizations:
−Removed: prescribing practitioners;
−Removed: HME providers;
−Removed: insurers (both private and public);
−Removed: and patients.
−Removed: In the U.S., Canada, and Latin America, our sales and marketing activities are conducted through a field sales organization made up of regional territory representatives, program development specialists and regional sales directors.
−Removed: Our field sales organization markets and sells products to HME provider branch locations throughout the U.S., Canada, and Latin America.
+Added: prescribing practitioners, HME providers, insurers (both private and public), and patients.
+Added: In the Americas, our sales and marketing activities are conducted through a field sales organization made up of regional territory representatives, program development specialists and regional sales directors.
+Added: Our field sales organization markets and sells products to HME provider branch locations throughout the Americas.
We also directly educate physicians and sleep clinics about our products.
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The HME provider, in consultation with the referring practitioner, will assist the patient in selecting the equipment, fit the patient with the appropriate mask and set the device pressure to the prescribed level.
+Added: Combined Europe, Asia, and other markets or "Rest of World".
+Added: We market our products in most major countries in Rest of World geographies.
+Added: We have wholly owned subsidiaries in Australia, Austria, China, Czech Republic, Denmark, Finland, France, Germany, India, Ireland, Japan, Korea, Netherlands, New Zealand, Norway, Poland, Sweden, Switzerland, Taiwan, Thailand, and the United Kingdom.
+Added: We use a combination of our direct sales force and independent distributors to sell our products in Rest of World regions.
+Added: We select independent distributors in each country based on their knowledge of respiratory medicine and a commitment to treatment of sleep apnea with our therapy.
+Added: In countries where we sell our products directly, a local senior manager is responsible for direct national sales.
+Added: In many countries, we sell our products to HME providers or hospitals who then sell the products to the patients.
+Added: In Germany, Australia, New Zealand, and South Korea, we also operate home healthcare businesses, providing products and services directly to patients through a vertically integrated network.
+Added: Residential Care Software.
Our Residential Care Software solutions are sold to providers of healthcare in various residential care settings.
8 unchanged sentences
Our MatrixCare management solutions are primarily sold through direct sales, and ancillary solutions are sold both through direct sales and channel sellers.
−Removed: Combined Europe, Asia, and other markets.
−Removed: We market our products in most major countries in combined Europe, Asia and other geographies.
−Removed: We have wholly owned subsidiaries in Australia, Austria, China, Czech Republic, Denmark, Finland, France, Germany, India, Ireland, Japan, Korea, Netherlands, New Zealand, Norway, Poland, Sweden, Switzerland, Taiwan, Thailand, and the United Kingdom.
−Removed: We use a combination of our direct sales force and independent distributors to sell our products in combined Europe, Asia, and other regions.
−Removed: We select independent distributors in each country based on their knowledge of respiratory medicine and a commitment to treatment of sleep apnea with our therapy.
−Removed: In countries where we sell our products directly, a local senior manager is responsible for direct national sales.
−Removed: In many countries, we sell our products to HME providers or hospitals who then sell the products to the patients.
−Removed: In Germany, Australia, New
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
−Removed: Zealand, and South Korea, we also operate home healthcare businesses, providing products and services directly to patients through a vertically integrated network.
−Removed: We only sell our Residential Care Software products in the U.S.
+Added: We develop, market, and sell our MEDIFOX DAN care management and related digital solutions to providers in Germany, including home care organizations, care home operators, youth care providers, and therapy practices;
+Added: we also provide e-learning content directly to caregiving relatives.
+Added: Core software functionality covers invoicing, EHR and staff rostering, augmented by integrated solutions such as AI-based workflow automation, e-learning for nurses, and revenue cycle management.
+Added: Our MEDIFOX DAN solutions are primarily sold through direct sales, enabled by digital lead generation and self-service capabilities, depending on customer segment and solution.
Manufacturing
2 unchanged sentences
Of the numerous raw materials, parts and components purchased for our therapeutic and diagnostic sleep disorder products, many are available from multiple vendors.
−Removed: We also purchase uniquely configured components from various suppliers, including some who are single-source suppliers for us.
+Added: We also purchase uniquely configured components from
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: various suppliers, including some who are single-source suppliers for us.
Any reduction or halt in supply from one of these suppliers could limit our ability to manufacture our products or devices until a replacement supplier is found and qualified.
5 unchanged sentences
Further, we source many components and materials for our products from and manufacture our products in various countries.
−Removed: Changes to trade policy, including tariff measures introduced in February 2025, may drive new inflation risks in our supply chain for these components and materials.
+Added: Changes to global trade policy, including the imposition, modification, or expansion of tariffs and other trade measures, may drive new inflation risks in our supply chain for these components and materials.
On April 5, 2025, U.S.
Customs and Border Protection issued a Notice of Implementation confirming that current tariff relief for products like ours continues.
−Removed: The current impact of global tariffs is dynamic, however.
−Removed: If reciprocal tariffs go into widespread effect, they could have a material impact on our business and financial statements through interruption of supply chains, increases in our costs as our suppliers deal with an uncertain global trade environment or an increase or disruption of global shipping.
−Removed: Our quality management system is based upon the requirements of ISO 13485, Food and Drug Administration, or FDA, Quality System Regulation, or QSR, being replaced by the new FDA Quality Management System Regulation, or QMSR, effective February 2, 2026, European Medical Device Regulation, or MDR, the Medical Device Directive (93/42/EEC) and other applicable regulations for the markets in which we sell.
+Added: The current impact of global tariffs is dynamic, however, new or increased tariffs, reciprocal tariffs, or other disruptions to global trade could have a material impact on our business and financial results through interruption of supply chains, increases in our costs or reduction in the availability of key inputs as our suppliers deal with an uncertain global trade environment, increases in transportation costs, or disruption of global shipping.
+Added: Our quality management system is based upon the requirements of ISO 13485, Food and Drug Administration, or FDA, Quality Management System Regulation, or QMSR, European Medical Device Regulation, or MDR, the Medical Device Directive (93/42/EEC) and other applicable regulations for the markets in which we sell.
Our main manufacturing sites are certified to ISO 13485 and are audited at regular intervals by a Notified Body.
5 unchanged sentences
Sydney, Australia;
−Removed: Chatsworth, California;
−Removed: Calabasas, California;
+Added: Chatsworth, California, Calabasas, California (beginning in fiscal year 2027);
Johor Bahru, Malaysia;
3 unchanged sentences
Refer to Item 2 for additional details on these properties.
−Removed: We will continue to expand and balance volume across our network to meet scale, cost, resilience, and environmental performance objectives, and to meet the needs of customers and patients.
+Added: We will continue to expand and balance production volume across our network to meet scale, cost, resilience, and environmental performance objectives, and to meet the needs of customers and patients.
Third-Party Coverage and Reimbursement
2 unchanged sentences
While we do not generally receive direct payments for our products from payors in other countries, our success largely depends on the ability of patients to obtain coverage and our customers to obtain adequate reimbursement from those payors.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
In the U.S., our products are purchased primarily by HME providers, health systems, or sleep clinics, who invoice third-party payors directly for reimbursement.
1 unchanged sentence
These payors may deny coverage and reimbursement if they determine that specific defined coverage criteria are not met or that a device is not used in accordance with certain covered treatment methods, or is experimental, or not deemed reasonable and necessary.
−Removed: Additionally, our recent acquisition of VirtuOx will now require us to bill both commercial and governmental payors in the U.S.
−Removed: for diagnostic testing and interpretation services.
+Added: Additionally, in the U.S., our acquisitions of VirtuOx and Noctrix require us to bill both commercial and governmental payors.
As an IDTF, VirtuOx is subject to various enrollment, coverage and billing requirements by Medicare, state Medicaid Programs, other governmental payors, and commercial health insurance plans.
Payors may deny coverage and reimbursement for VirtuOx’s services if they determine that specific defined coverage criteria are not met or that the services are not medically necessary.
−Removed: VirtuOx experiences frequent government payor audits and while we believe that our billing is appropriate, such audits incur business expenses and decisions may not always be favorable.
+Added: VirtuOx experiences frequent government payor audits and while we believe that our billing is appropriate, such audits incur
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: business expenses and decisions may not always be favorable.
+Added: Similarly, Noctrix is a durable medical equipment, or DME supplier for purposes of distributing their products and as such, is also subject to enrollment, coverage and billing requirements by Medicare, state Medicaid Programs, other governmental payors, and commercial health insurance plans.
+Added: Payors may deny coverage for Noctrix devices if they determine that coverage criteria are not met or that the device and related services are not medically necessary.
+Added: Further, as a newly-cleared medical device, Noctrix has not yet achieved a national or local coverage determination with the Medicare Program, meaning that individual Medicare administrative contractors may determine coverage on a case by case basis.
The long-term trend towards cost-containment, through managed healthcare, or other legislative proposals to reform healthcare, could control or significantly influence the purchase of healthcare services and products and could result in lower prices for our products and services.
10 unchanged sentences
The last round of competitive bid contracts lapsed, effective January 1, 2019.
−Removed: CMS then removed 13 product categories, including CPAP and respiratory assist devices (or bilevel devices), from the Round 2021 Competitive Bidding Program competition.
−Removed: As a result, these products are currently subject to a temporary gap period during which any Medicare-enrolled DMEPOS suppliers may furnish DMEPOS items and services to patients.
−Removed: Payment for Medicare-enrolled DMEPOS suppliers in former CBAs is based on 100% of the single payment amount, for the CBA increased by the projected percentage change in the Consumer Price Index for all Urban Consumers (CPI-U) from January 2023 to January 2024.
−Removed: The temporary gap period for all DMEPOS CBPs has recently ended with the announcement of new regulations reinstating competitive bidding in the U.S.
−Removed: As a consequence, we expect that CMS will initiate the next round of the DMEPOS Competitive Bidding Program after the agency completes the formal public notice and comment rulemaking process.
−Removed: For items furnished in non-CBAs, fees are based on fully-adjusted rates per the applicable methodology under Code of Federal Regulations Title 42 414.210 (g).
+Added: CMS then removed 13 product categories, including CPAP and respiratory assist devices (or bilevel devices), from the Round 2021 Competitive Bidding Program process.
+Added: The DMEPOS Competitive Bidding Program (CBP) remains in a temporary gap period following the expiration of Round 2021 contracts for off-the-shelf (OTS) back braces and OTS knee braces on December 31, 2023.
+Added: On July 2, 2025, CMS released a proposed rule covering, in part, DMEPOS Competitive Bidding Program Updates.
+Added: A final rule implementing the proposed changes was displayed in the Federal Register on November 28, 2025.
+Added: Following the 2026 final rule and related program implementation activities, CMS is currently preparing for Round 2028, which is structured as a nationwide Remote Item Delivery (RID) Competitive Bidding Program covering seven (7) specified product categories.
+Added: During the temporary gap period, fee schedule amounts for competitively bid items and services furnished in former competitive bidding areas are based on 100% of the applicable single payment amount, adjusted for inflation as specified by CMS, while fee schedule amounts for such items and services furnished in areas outside former competitive bidding areas continue to be based on fully adjusted fee schedule amounts determined in accordance with the methodology set forth in 42 C.F.R.
+Added: § 414.210(g).
+Added: The upcoming Round 2028 does not include CPAP or other respiratory or sleep-assist devices, however, future changes to the CBP or applicable reimbursement policies could affect our business in the U.S.
Other legislative changes have been proposed and adopted since the Affordable Care Act (ACA) was enacted.
5 unchanged sentences
The sequestration order covers all payments for services with dates of service on or after July 1, 2022.
−Removed: On March 9, 2024, President Biden signed the Consolidated Appropriations Act, 2024,
+Added: On March 9, 2024, President Biden signed the Consolidated Appropriations Act, 2024, which included a 2.93% update to the CY 2024 Physician Fee Schedule (PFS) Conversion Factor (CF) for dates of service March 9 through December 31, 2024.
+Added: This replaced the 1.25% update provided by the Consolidated Appropriations Act of 2023.
+Added: On November 1, 2024, CMS issued a rule finalizing changes for Medicare payments under the PFS and other
PART I Item 1
AND SUBSIDIARIES
−Removed: which included a 2.93% update to the CY 2024 Physician Fee Schedule (PFS) Conversion Factor (CF) for dates of service March 9 through December 31, 2024.
−Removed: This replaced the 1.25% update provided by the Consolidated Appropriations Act of 2023.
−Removed: On November 1, 2024, CMS issued a rule finalizing changes for Medicare payments under the PFS and other Medicare Part B policies, effective on or after January 1, 2025.
+Added: Medicare Part B policies, effective on or after January 1, 2025.
Under this final rule, the average payment rates under the PFS would be reduced by 2.93% in CY 2025, removing the temporary increase in payment for CY 2024.
1 unchanged sentence
As discussed immediately below, however, the One Big Beautiful Bill Act includes a 1-year, 2.5% increase to the PFS for 2026, which temporarily addresses the 2025 payment cuts.
−Removed: Most recently, on July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act (the Bill), which among other things, cuts federal Medicaid funding by $930 billion over ten years but provides reimbursement rate increases for providers.
+Added: On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act (the Bill), which among other things, cuts federal Medicaid funding by $930 billion over ten years but provides reimbursement rate increases for providers.
Notably, however, the Bill is projected to increase the federal deficit, which may lead to mandatory Medicare cuts and reduction in payments to providers in the future.
2 unchanged sentences
Specifically, the proposed rule would remove in its entirety the current 30% disability rating for veterans exhibiting excessive daytime sleepiness and instead replacing it with a 10% disability rating for veterans with a sleep apnea diagnosis with incomplete relief (as determined by a sleep study) with treatment including a CPAP machine, and further, remove the automatic 50% disability rating for veterans with a documented need for a CPAP machine (50% disability would instead require that the veteran have a sleep apnea diagnosis with ineffective treatment, as determined by a sleep study, or who is unable to use treatment due to comorbid conditions, without end-organ damage).
−Removed: The VA has not yet changed its ratings criteria but it could happen in calendar year 2025.
If the changes are implemented, veterans who were rated for sleep apnea before the change in criteria will be grandfathered and retain their rating.
However, all veterans filing new claims on and after the change in ratings criteria would be evaluated under the new criteria.
−Removed: The VA has not yet adopted these changes to the disability ratings system for sleep apnea but should this proposal, or another similar proposal to limit disability ratings be adopted, fewer veterans may pursue treatment of sleep apnea using CPAP or more veterans would claim ineffective treatment with CPAP to obtain a higher rating.
+Added: The VA has not yet finalized these proposed revisions, and the current rating criteria remains in effect, but should this proposal, or another similar proposal to limit disability ratings be adopted, fewer veterans may pursue treatment of sleep apnea using CPAP or more veterans would claim ineffective treatment with CPAP to obtain a higher rating.
+Added: The VA may finalize, modify, or withdraw the proposed revisions through a future final rule, the timing and substance of which remain uncertain.
The legislative landscape is complex and changes with the influence of one party or the other.
15 unchanged sentences
We compete in various geographies, each with different competitors, and some of our competitors are affiliates of our customers, which may make it difficult to compete with them.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
Our primary Sleep and Breathing Health competitors include Philips BV;
4 unchanged sentences
React Health Corporation;
−Removed: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd, and Lowenstein Medical SE & Co.
+Added: Jiangsu Yuyue
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: Medical Equipment & Supply Co., Ltd, and Lowenstein Medical SE & Co.
KG plus regional and new-entrant manufacturers.
3 unchanged sentences
Injectable weight loss drugs have been approved for treatment of OSA in patients with obesity and moderate to severe OSA and are being marketed by physicians and to consumers.
−Removed: Oral versions of these drugs are reportedly under development and may be approved for the treatment of OSA.
+Added: Oral versions of these drugs are also under development and may be approved for the treatment of OSA.
The development of new or innovative drugs, procedures, devices, or alternative therapies by others could result in our products becoming obsolete or noncompetitive, which would harm our revenues and financial condition.
21 unchanged sentences
Government Regulations
−Removed: Our products are subject to extensive regulation particularly as to safety, efficacy and adherence to FDA QSR, and related manufacturing standards.
+Added: Our products are subject to extensive regulation particularly as to safety, efficacy and adherence to FDA QMSR, and related manufacturing standards.
Medical device products are subject to rigorous FDA and other governmental agency regulations in the U.S.
2 unchanged sentences
are safe and effective for their intended use.
−Removed: In addition, the FDA is authorized to establish special controls to
+Added: In addition, the FDA is authorized to establish special controls to provide reasonable assurance of the safety and effectiveness of most devices.
+Added: Non-compliance with applicable requirements can result in import detentions, fines, civil and administrative penalties, injunctions, suspensions or losses of
PART I Item 1
AND SUBSIDIARIES
−Removed: provide reasonable assurance of the safety and effectiveness of most devices.
−Removed: Non-compliance with applicable requirements can result in import detentions, fines, civil and administrative penalties, injunctions, suspensions or losses of regulatory approvals, recall or seizure of products, operating restrictions, refusal of the government to approve product export applications or allow us to enter into supply contracts, and criminal prosecution.
+Added: regulatory approvals, recall or seizure of products, operating restrictions, refusal of the government to approve product export applications or allow us to enter into supply contracts, and criminal prosecution.
Unless an exemption applies, the FDA requires that a manufacturer introducing a new medical device, certain modifications thereof, or a new indication for use of an existing medical device obtain either a Section 510(k) premarket notification clearance, a premarket approval, or PMA, or a de novo approval, and pay a user fee, before introducing it into the U.S.
22 unchanged sentences
As a medical device manufacturer, all of our manufacturing facilities are subject to inspection on a routine basis by the FDA.
−Removed: We are required to adhere to applicable regulations setting forth detailed cGMP requirements, as set forth in the QSR, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all phases of the design and manufacturing process.
+Added: We are required to adhere to applicable regulations setting forth detailed cGMP requirements, as set forth in the QMSR, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all phases of the design and manufacturing process.
Noncompliance with these standards can result in, among other things, fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspension of production, refusal of the government to grant clearance or approval of devices, withdrawal of marketing approvals and criminal prosecutions.
We believe that our design, manufacturing and quality control procedures comply with the FDA’s regulatory requirements.
−Removed: We must also comply with post-market surveillance regulations, including medical device reporting or MDR requirements which require that we review and report to the FDA any incident in which our products may have caused or contributed to
+Added: We must also comply with post-market surveillance regulations, including medical device reporting or MDR requirements which require that we review and report to the FDA any incident in which our products may have caused or contributed to a death or serious injury.
+Added: We must also report any incident in which our product has malfunctioned if that malfunction would likely cause or contribute to a death or serious injury if it were to recur.
PART I Item 1
AND SUBSIDIARIES
−Removed: a death or serious injury.
−Removed: We must also report any incident in which our product has malfunctioned if that malfunction would likely cause or contribute to a death or serious injury if it were to recur.
Labeling and promotional activities are subject to scrutiny by the FDA and, in certain circumstances, by the Federal Trade Commission.
23 unchanged sentences
AND SUBSIDIARIES
−Removed: On April 5, 2017, the European Parliament passed the MDR, which repeals and replaces the MDD.
−Removed: Unlike directives, which must be implemented into the national laws of the EEA member states, the regulations would be directly applicable (i.e., without the need for adoption of EEA member State laws implementing them) in all EEA member states and are intended to eliminate current differences in the regulation of medical devices among EEA member States.
−Removed: The MDR, among other things, is intended to establish a uniform, transparent, predictable and sustainable regulatory framework across the EEA for medical devices and ensure a high level of safety and health while supporting innovation.
+Added: Regulation (EU) 2017/745 on medical devices (MDR) became applicable in the EU on May 26, 2021, repealing and replacing Directive 93/42/EEC (MDD).
+Added: Unlike the MDD, which had to be implemented into the national laws of the EEA member states, the MDR is directly applicable in all EEA member states, without the need for implementing national legislation, thus eliminating previously existing differences in the regulation of medical devices among EEA member states.
+Added: The MDR is intended to establish a uniform, transparent, predictable, and sustainable regulatory framework across the EEA for medical devices and ensure a high level of safety and health while supporting innovation.
Regulation (EU) 2017/746 (IVDR), applicable as of May 26, 2022, provides for the regulatory framework applicable to in vitro diagnostic medical devices.
−Removed: The MDR was meant to become applicable three years after publication (in May 2020).
−Removed: However, on April 23, 2020, to allow EEA national authorities, notified bodies, manufacturers and other actors to focus fully on urgent priorities related to the COVID-19 pandemic, the European Council and Parliament adopted Regulation 2020/561, postponing the date of application of the MDR by one year.
−Removed: The MDR thus became applicable on May 26, 2021.
−Removed: The MDR transitional provisions allow the placing on the market of devices with a CE Certificate issued in accordance with the MDD until May 26, 2024, under certain conditions.
−Removed: Moreover, the MDR provides that the following medical devices with a CE Certificate issued in accordance with the MDD may continue to be made available on the market or put into service until May 26, 2025.
−Removed: • Devices placed on the market in compliance with the MDD prior to May 26, 2021;
−Removed: • Devices placed on the market after May 26, 2021, benefiting from the described MDR transitional provisions.
−Removed: The European Commission further extended provision of the MDR and IVDR through Regulation (EU) 2023/607, whereby manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC.
−Removed: Moreover, the deletion of the ‘sell off’ date in the MDR and the IVDR aims to prevent unnecessary disposal of safe devices.
−Removed: These provisions extend the transition period of devices through to December 31, 2027 or December 31, 2028 depending on device risk classification.
−Removed: The MDR, among other things:
−Removed: • strengthens the rules on placing devices on the market and reinforces surveillance once they are available;
−Removed: • establishes explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;
−Removed: • improves the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;
−Removed: • sets up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU;
−Removed: • strengthens rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.
−Removed: We have received certification at several locations, including Sydney, Australia;
−Removed: San Diego, California;
−Removed: and Lyon, France.
−Removed: We continue to transition our certification profile to meet the new MDR requirements.
+Added: The MDR provides for a transitional regime that currently allows devices with a CE Certificate issued in accordance with the MDD to be placed on the market until December 31, 2027 or December 31, 2028, depending on device risk classification, provided that such devices satisfy certain conditions.
Other Regulatory Bodies
3 unchanged sentences
The government has interpreted these laws broadly to apply to the marketing and sales activities of manufacturers and distributors like us.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
The federal Anti-Kickback Statute is a criminal statute that prohibits, among other things, persons or entities from knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, in cash or in kind, in exchange for or to induce either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid.
10 unchanged sentences
Private suits filed under the civil False Claims Act, known as qui tam actions, can be brought by individuals on behalf of the government.
−Removed: These individuals may share in any amounts paid by the entity to the government in fines, judgement, or settlement.
+Added: These individuals may share in any amounts paid by the entity to the government in fines, judgment, or settlement.
The federal Civil Monetary Penalties Law prohibits, among other things, the offering or transferring of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of items or services reimbursable by Medicare or a state healthcare program, unless an exception applies.
−Removed: As a medical device manufacturer, the beneficiary inducement prohibition under the Civil Monetary Penalties Law did not directly apply to us (unless we engaged in activities that influenced a Medicare or Medicaid beneficiary to select a particular provider, practitioner or supplier);
−Removed: however, following our acquisition of VirtuOx, a Medicare supplier, we will be directly subject to the beneficiary inducement prohibition if we provide any remuneration to a Medicare or Medicaid beneficiary that is intended to or that we should know would be likely to influence that beneficiary to select VirtuOx as their supplier.
+Added: As a medical device manufacturer, the beneficiary inducement prohibition under the Civil Monetary Penalties Law did not directly apply to us (unless we engaged in activities that
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: influenced a Medicare or Medicaid beneficiary to select a particular provider, practitioner or supplier);
+Added: however, following our acquisitions of VirtuOx and Noctrix, both Medicare suppliers, we are directly subject to the beneficiary inducement prohibition if we provide any remuneration to a Medicare or Medicaid beneficiary that is intended to or that we should know would be likely to influence that beneficiary to select VirtuOx or Noctrix as their supplier.
The Federal Physician Self-Referral Law, or the Stark Law, 42 U.S.C.
5 unchanged sentences
However, we will need to monitor our VirtuOx offerings in the future and if we choose to offer any DHS, we will be subject to the Stark Law.
+Added: Noctrix, on the other hand, is a DME supplier and DME is categorically classified as DHS;
+Added: therefore, the Stark Law applies directly to Noctrix and its relationships with referring physicians.
+Added: Notably, Noctrix is a one-product DME supplier and therefore other pertinent limitations that might potentially be applicable to us by owning a DME supplier (e.g., Medicare CPAP Payment Prohibition) do not apply.
Additionally, there has been a recent trend of increased federal and state regulation of payments and transfers of value provided to healthcare professionals or entities.
−Removed: The federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, biologicals, and medical devices or supplies that require premarket approval by or notification to the FDA, and for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, to report annually to CMS information related to (i) payments and other transfers of value to teaching hospitals, physicians (as defined by statute) and, as of 2022, physician
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
−Removed: assistants, nurse practitioners and other practitioners, and (ii) ownership and investment interests held by such providers and their immediate family members.
+Added: The federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, biologicals, and medical devices or supplies that require premarket approval by or notification to the FDA, and for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, to report annually to CMS information related to (i) payments and other transfers of value to teaching hospitals, physicians (as defined by statute) and, as of 2022, physician assistants, nurse practitioners and other practitioners, and (ii) ownership and investment interests held by such providers and their immediate family members.
Applicable manufacturers are required to submit annual reports to CMS.
13 unchanged sentences
Most of the conduct chargeable under the FCPA will also constitute crimes under other laws, such as the U.S.
−Removed: wire fraud statute and the SEC’s civil enforcement authority.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: statute and the SEC’s civil enforcement authority.
Foreign laws prohibiting bribery of a government official will also continue to apply.
8 unchanged sentences
In some of our operations, such as those involving our cloud-based software digital health applications, we are a business associate under HIPAA, requiring us to comply with the terms of the business associate agreements we have with our covered entity customers.
−Removed: Additionally, by virtue of our acquisition of VirtuOx, and expanded efforts to reach patients seeking treatment, we are also subject to the rules applicable to a covered entity.
−Removed: Therefore, we are required to comply with
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
−Removed: the HIPAA Security Rule, Breach Notification Rule and certain provisions of the HIPAA Privacy Rule.
+Added: Additionally, by virtue of our acquisitions of VirtuOx and Noctrix, and expanded efforts to reach patients seeking treatment, we are also subject to the rules applicable to a covered entity.
+Added: Therefore, we are required to comply with the HIPAA Security Rule, Breach Notification Rule and the HIPAA Privacy Rule.
We are limited by HIPAA with respect to our use and disclosure of protected health information created or received and could potentially face significant civil and criminal penalties if the Department of Health and Human Services Office for Civil Rights (OCR), or any state Attorney General, were to determine that we failed to comply with the applicable HIPAA standards.
13 unchanged sentences
We also may be required to implement additional practices or processes or otherwise invest our resources to comply with these and other regulations.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
In addition, the European Union General Data Protection Regulation, or GDPR, went into effect in May 2018.
8 unchanged sentences
Failure to comply with the requirements of GDPR and the applicable national data protection and marketing laws of the EEA member states may result in fines of up to €20 million or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties as well as individual claims for compensation.
−Removed: Further, the UK GDPR also provides for significant data protection fines up to the greater of £17.5 million or 4% of global turnover.
+Added: Further, the UK GDPR also provides for significant data protection fines up to the greater of approximately £18 million or 4% of global turnover.
In addition, EEA member states and the UK may modify or impose additional conditions to be able to transmit electronic marketing communications.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
Numerous other state, federal and foreign laws, including consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality and security of patient health information and other personal information.
7 unchanged sentences
Compliance with these and any other applicable privacy and data security laws and regulations is a rigorous and time-intensive process, and we may be required to implement additional mechanisms to comply with the new data protection rules.
−Removed: With respect to VirtuOx, for instance, we will need to meet HIPAA's requirements for covered entities and support this additional privacy function.
+Added: With respect to VirtuOx and Noctrix, for instance, we will need to meet HIPAA's requirements for covered entities and support this additional privacy function.
If we fail to comply with any such laws or regulations, we may face significant fines and penalties that could adversely affect our business, financial condition and results of operations, damage our reputation and customers’ trust.
5 unchanged sentences
Despite the lack of comprehensive legislation, federal regulators are continuing to pursue AI-related enforcement actions under existing federal laws.
−Removed: For example, the Securities and Exchange Commission has pursued several enforcement actions against companies that are alleged to have made false or misleading statements about their AI capabilities, referred to as AI washing, in violation of the Securities Exchange Act.
+Added: For example, the Securities and Exchange Commission has pursued several enforcement actions against companies that are alleged to have made false or misleading statements about their AI capabilities, referred
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: to as AI washing, in violation of the Securities Exchange Act.
In addition to existing federal laws, federal regulators have also issued guidance concerning the use, development, or deployment of AI.
12 unchanged sentences
Numerous other countries have adopted or are considering similar frameworks to regulate the use, development, or deployment of AI.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
We intend to continue to monitor developments regarding the use of AI that could be relevant to our products and services, and comply with all applicable laws regarding the use, development, or deployment of AI.
4 unchanged sentences
Our culture is designed to unlock the potential, skills, engagement and creativity of our people.
−Removed: Our Code of Business Conduct & Ethics, values and ethical business practices and policies directly impact workplace behavior and communication, and address discrimination and harassment, health and safety, and employee engagement, supporting talent attraction, retention, and development.
+Added: Our Code of Business Conduct & Ethics, values and ethical business practices and policies support workplace behavior and communication, including discrimination and harassment prevention, health and safety, and employee engagement, talent attraction, retention, and development.
Our board of directors and its committees provide general oversight on a range of our human capital management efforts.
1 unchanged sentence
As of June 30, 2026, we had approximately 11,370 employees, of which approximately 4,590 were employed in cost of sales activities including areas such as warehousing and manufacturing, 2,300 in research and development and 4,480 in sales, marketing and administration.
−Removed: Of our employees, approximately 3,250 (31%) were located in the U.S., Canada and Latin America, 3,250 (31%) in Asia, 1,570 (14%) in Australia and 2,530 (24%) in Europe.
+Added: Of our employees, approximately 3,490 (31%) were located in the Americas, 3,560 (31%) in Asia, 1,650 (15%) in Australia and 2,670 (23%) in Europe.
We believe that the success of our business will depend, in part, on our ability to attract and retain qualified personnel that represent the world we live in, in every way.
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Our dedication drives transformation in our patients' healthcare, improving lives globally.
−Removed: Our social sustainability team focuses on people practices, developing solutions and programs that enhance our business and brand success.
−Removed: Our objectives during this year focused on product design and raising awareness through discussions on accessibility design for our products.
−Removed: We also expanded global mentorship opportunities and offered quarterly micro-learnings on many topics.
−Removed: Additionally, our team broadened its outreach efforts, collaborating with employee resource groups, or ERGs, and global site leaders to create a global giving program supporting science, technology, engineering, and mathematics, or STEM, health, and sleep awareness initiatives.
+Added: We focus on people practices, developing solutions and programs that enhance our business and brand success.
+Added: Our objectives during this year focused on product design and raising awareness
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: through discussions on accessibility design for our products.
+Added: Additionally, we continued to expand outreach efforts, collaborating with employee resource groups, or ERGs, and global site leaders to create a global giving program supporting science, technology, engineering, and mathematics, or STEM, health, and sleep awareness initiatives.
Employee Resource Groups.
We continue to place a high value on initiatives that create community, learning and volunteer opportunities for our employees.
−Removed: Our global network comprises nineteen employee-driven ERGs that are instrumental in advancing the success of our patients and employees.
−Removed: On average, we host one event per week, accessible to all employees on a purely voluntary basis to encourage learning and community involvement.
+Added: Our global network comprises employee-driven ERGs that are instrumental in advancing the success of our patients and employees.
+Added: Events are accessible to all employees on a purely voluntary basis to encourage learning and community involvement.
Learning and Development of Inclusion Values.
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We offer various resources for leaders to leverage in their workshops and sessions.
−Removed: Over the past year, we sustained and expanded the reach of our global mentorship initiatives and launched a reverse mentorship program fostering intergenerational learning with work and technology.
−Removed: We also delivered enterprise-wide trainings and quarterly learning sessions.
Strategic Inclusive Development.
−Removed: Every year, employees apply or are nominated by their leaders to sit on our global council that advises on, and promotes, our inclusion efforts.
+Added: Employees apply or are nominated by their leaders to sit on our global council that advises on, and promotes, our inclusion efforts.
The council aims to share developments and gather feedback from representatives across a wide representation of functions and office locations.
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Leadership Engagement.
−Removed: E ach ERG is supported by one to two Executives that serve as a network of champions and help kick off events, attend, advertise, and share learnings with their wider teams.
−Removed: They meet collectively every quarter to share impressions, give feedback, and provide ideas on the goal of developing our people.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
+Added: ERGs are supported by Executives that serve as a network of champions and help kick off events, attend, advertise, and share learnings with their wider teams.
+Added: They meet collectively to share impressions, give feedback, and provide ideas on the goal of developing our people.
Community Outreach & Giving Back.
−Removed: This year, we expanded our community support efforts by designing a giving program to better track and report our efforts, ensuring we provide meaningful support to the communities surrounding our offices.
+Added: This year, we continued strengthening our community support efforts by designing a giving program to better track and report our efforts, ensuring we provide meaningful support to the communities surrounding our offices.
Sourcing and Recruiting.
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Our annual and long-term incentives are linked directly to business performance and outcomes, as well as shareholder value creation.
−Removed: We offer an employee stock purchase plan globally, as well as recognition rewards catered to localized market practices.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: employee stock purchase plan globally, as well as recognition rewards catered to localized market practices.
Eligibility for non-salary benefits such as salary continuance, life insurance, retirement, health insurance, and other benefits, are also aligned to local regulations and practices.
Employee Health and Safety
−Removed: We believe that maintaining a physically safe, and mentally healthy, working environment is essential in supporting our people to deliver their best work.
+Added: We believe that a physically safe, and mentally healthy, working environment helps our people deliver their best work.
We employ global standards to provide the framework for our locally compliant, integrated and effective health and safety management systems which enable the capability, autonomy & accountability of the leaders to manage local sites.
6 unchanged sentences
We are committed to improving the quality of life of our employees and their families.
−Removed: Our health and wellbeing programs differ by country and may include company-sponsored health insurance, retirement savings plans, sleep apnea screening
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
−Removed: and treatment, smoking cessation, gym membership discounts, seasonal flu vaccinations, mental health assistance, and many other programs to drive healthy behaviors and awareness.
+Added: Our health and wellbeing programs differ by country and may include company-sponsored health insurance, retirement savings plans, sleep apnea screening and treatment, smoking cessation, gym membership discounts, seasonal flu vaccinations, mental health assistance, and many other programs to drive healthy behaviors and awareness.
Additionally, we have implemented a company-wide Resmed Day - taken at the employee's election - for our people to focus on mental, social and physical health.
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.