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We develop, manufacture, and market innovative respiratory health products, including portable oxygen concentrators, or POCs, used to deliver supplemental long-term oxygen therapy to patients suffering from chronic respiratory conditions and the Simeox ® product for airway clearance treatment.
−Removed: Our proprietary Inogen One ® and Inogen Rove ® systems concentrate the air around the patient to offer a source of supplemental oxygen 24 hours a day, seven days a week with a battery and can be plugged into an outlet when at home, in a car, or in a public place with outlets available.
−Removed: While often used concomitantly with stationary oxygen concentrators and oxygen compressed gas tanks, our POCs are designed to reduce the patient’s reliance on stationary concentrators and scheduled deliveries of tanks with a finite supply of oxygen, thereby improving patient quality of life and fostering mobility.
−Removed: Our Simeox product is a technology-enabled airway clearance and mucus management device predominantly aimed at serving patients with bronchiectasis, which is a condition that presents as the lung's bronchi are damaged and widened in patients with cystic fibrosis, chronic obstructive pulmonary disease, or other chronic respiratory diseases.
+Added: In addition, we have started distributing the Inogen Voxi ® 5 stationary oxygen concentrator as well as the Aurora ® continuous positive airway pressure, or CPAP, masks in the United States.
+Added: Our proprietary Inogen One ® and Inogen Rove ® POC systems concentrate the air around the patient to offer a source of supplemental oxygen 24 hours a day, seven days a week with a battery and can be plugged into an outlet when at home, in a car, or in a public place with outlets available.
+Added: While often used together with stationary oxygen concentrators and oxygen compressed gas tanks, our POCs are designed to reduce the patient’s reliance on stationary concentrators and scheduled deliveries of tanks with a finite supply of oxygen, thereby improving patient quality of life and fostering mobility.
+Added: Our Simeox product is a technology-enabled mucus management device predominantly aimed at serving patients requiring airway clearance, such as those with bronchiectasis – a condition characterized by damaged and widened bronchi that can occur in patients with cystic fibrosis, chronic obstructive pulmonary disease, or COPD, or other chronic respiratory diseases.
+Added: The Voxi 5 stationary oxygen concentrator is used to provide continuous, long-term oxygen therapy to patients who need supplemental oxygen at home or in clinical settings.
+Added: The Aurora CPAP masks are used to deliver CPAP therapy through a separate device primarily for treating obstructive sleep apnea, or OSA.
Corporate history
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On September 14, 2023, we completed the acquisition of all of the issued and outstanding capital stock of Physio-Assist SAS, or Physio-Assist, and its wholly-owned subsidiary PhysioAssist GmbH.
+Added: On January 25, 2025, we entered into a Strategic Collaboration Agreement, or the Collaboration Agreement, with Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., or Yuwell.
+Added: The collaboration with Yuwell has broadened our product portfolio through distribution of certain respiratory products in the United States and select other territories, expanded and enhanced our innovation pipeline through research and development collaboration, and is working to accelerate the entry of our brand into the Chinese market.
+Added: Pursuant to the Collaboration Agreement, we have started distributing the Inogen Voxi 5 stationary oxygen concentrator as well as the Aurora CPAP masks in the United States, and Yuwell has commenced distributing certain POCs supplied by us in specified countries in the Asia-Pacific region.
Chronic obstructive pulmonary disease
We are focused on oxygen therapy and other opportunities in the global respiratory care market.
−Removed: We believe that our portable oxygen therapy solutions can help patients with chronic respiratory conditions, including patients with chronic obstructive pulmonary disease, or COPD.
+Added: We believe that our oxygen therapy solutions can help patients with chronic respiratory conditions, including patients with COPD.
COPD is a group of lung diseases including chronic bronchitis and emphysema.
−Removed: The main cause of COPD is smoking, but other factors like air pollution, secondhand smoke and dust, as well as fumes and chemicals can cause COPD.
+Added: The primary risk for developing COPD is smoking, but other factors, including air pollution, secondhand smoke, dust, fumes, and chemical exposures, are also associated with COPD.
There is currently no cure for COPD, and it is a progressive and debilitating disease that is characterized by a gradual loss of lung function and airflow limitation that is not fully reversible.
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COPD is a major cause of disability and the sixth leading cause of death according to the CDC.
−Removed: In terms of economic impact, the total economic cost from COPD in the United States was projected to be approximately $49 billion in 2020 with close to 925,000 COPD emergency department visits in 2020.
+Added: In terms of economic impact, the total annual economic cost from COPD in the United States was projected to be approximately $50 billion with nearly one million COPD emergency department visits each year.
A peer-reviewed article in the New England Journal of Medicine has stated that long-term oxygen therapy has been shown to help COPD patients who have severely low blood oxygen or hypoxemia.
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As COPD progresses into later stages, patients may need long-term oxygen therapy as part of their treatment.
−Removed: Other diseases including cystic fibrosis or congestive heart failure may lead to lower oxygen in the bloodstream and may also benefit from long-term oxygen therapy.
+Added: Other diseases including long term COVID-19 or congestive heart failure may lead to lower oxygen in the bloodstream and may also benefit from long-term oxygen therapy.
Oxygen therapy
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Additionally, patients must attach long, cumbersome tubing to their stationary concentrators to enable mobility within their homes.
−Removed: We believe the following factors have hindered the market acceptance of POCs:
−Removed: • to obtain POCs, many patients are dependent on home medical equipment providers, which may have significant investments in the physical distribution infrastructure to support the delivery model for stationary devices and therefore may be disincentivized to encourage adoption of POCs;
+Added: We believe that the adoption POCs by home medical equipment providers has progressed, although the following factors remain countervailing forces to the full market acceptance of POCs:
+Added: • to obtain POCs, many patients are dependent on home medical equipment providers, which may have significant investments in the physical distribution infrastructure to support the delivery model for stationary devices and tanks, and therefore may be disincentivized to encourage adoption of POCs;
• home medical equipment providers cannot easily convert their businesses to non-delivery models in oxygen due to low total reimbursement for oxygen therapy, capital expenditure constraints, investments that are spread across multiple product lines, and uncertainty around reimbursement rate changes;
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• constrained manufacturing costs of conventional POCs, driven by home medical equipment provider preference for products that have lower upfront equipment cost.
−Removed: Bronchiectasis
−Removed: We expanded our addressable market opportunity into the bronchiectasis market with the acquisition of Physio-Assist in September 2023.
+Added: With the launch of the Voxi 5, in addition to our existing Inogen at Home, stationary oxygen concentrator, we also provide devices to provide continuous, long-term oxygen therapy to patients who need supplemental oxygen at home or in clinical settings.
+Added: This can allow patients to use these stationary oxygen concentrators inside their home, while utilizing our POCs for ambulatory uses and activities outside their homes.
+Added: Airway clearance
+Added: We expanded our addressable market opportunity into the airway clearance market with the acquisition of Physio-Assist in September 2023.
Physio-Assist developed and manufactures Simeox, a technology-enabled airway clearance device with a proven efficacy and safety profile.
−Removed: Simeox has been on the market in Europe and several other markets since prior to the acquisition and was cleared in December 2024 by the FDA for use in the United States.
−Removed: The device is used to treat a condition in the lungs known as bronchiectasis, where the lung’s bronchi become damaged and widened.
+Added: Simeox has been on the market in Europe and several other markets since prior to the acquisition and was cleared in December 2024 by the Food and Drug Administration, or FDA, for use in the United States.
+Added: The device is used to assist in the removal of mucus from the lungs, a condition commonly associated with diseases such as bronchiectasis, in which the bronchi become damaged and widened.
Bronchiectasis is often present in cystic fibrosis and COPD patients.
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Simeox has expanded our product offering to serve COPD and other chronic respiratory disease patients who suffer from bronchiectasis with an innovative, non-invasive, and next generation airway clearance solution.
−Removed: We believe that Inogen can potentially access a large growing bronchiectasis market opportunity in the U.S.
−Removed: following receipt of 510(k) clearance for the Simeox 200 device in December 2024.
−Removed: We intend to commercialize Simeox through the purchase of the product initially, followed by recurring sales of device disposables.
−Removed: We will begin efforts to obtain reimbursement coverage in the first quarter of 2025 for the Simeox product in the U.S.
+Added: We believe that Simeox can potentially access a large growing airway clearance and bronchiectasis market opportunity in the U.S.
+Added: We have begun efforts to introduce the product into the U.S.
+Added: market through a limited market release and planned clinical trials intended to gather further clinical evidence to support the long-term potential of the product, including reimbursement coverage.
+Added: We intend to commercialize Simeox through the sale of the product initially, followed by recurring sales of device disposables.
+Added: Obstructive sleep apnea
+Added: We further expanded our addressable market opportunity with the launch of the Aurora masks for use with CPAP devices primarily for treating OSA.
+Added: The OSA market is large, well-established, and highly competitive, with demand driven by the high prevalence of undiagnosed and untreated OSA and continued growth in home-based diagnosis and therapy.
+Added: Our launch of the Aurora masks expands our participation in the OSA therapy ecosystem by complementing third-party CPAP devices with proprietary mask and accessory offerings, leveraging our existing distribution channels and customer relationships.
Business strategy
−Removed: We believe there is an opportunity to grow portable oxygen therapy usage and develop the market further to help patients with chronic conditions breathe better and help providers improve patient outcomes.
+Added: We believe there is an opportunity to grow portable oxygen therapy usage and develop the market further with innovative POCs and other respiratory products to help patients with chronic conditions breathe better and help providers improve patient outcomes.
Our strategy for expanding our business and growing the market includes:
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Enhance our business through innovation.
−Removed: We are committed to the ongoing innovation to meet the needs of patients, providers, and our business-to-business partners to manage lower blood oxygen and shortness-of-breath associated with COPD and other chronic conditions.
+Added: We are committed to ongoing innovation to meet the needs of patients, providers, and our business-to-business partners to manage the respiratory health issues associated with COPD and other chronic conditions.
+Added: We are committed to expanding our portfolio with additional products, such as Simeox, the Voxi 5 stationary oxygen concentrator, and Aurora CPAP masks to help meet these needs.
Support adoption of Inogen products through clinical evidence and key opinion leaders' advocacy .
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The KOLs are focused on advocating for the right therapy for patients and changing the behavior of prescribers.
−Removed: Our Inogen One and Inogen Rove portable oxygen systems provide patients who require long-term oxygen therapy with a reliable, lightweight solution that we believe allows patients the chance to remain ambulatory while managing the impact of their disease and eliminates dependence on both oxygen tanks and cylinders.
+Added: Portable oxygen concentrators
+Added: Our Inogen One and Inogen Rove portable oxygen systems provide patients who require long-term oxygen therapy with reliable, lightweight solutions that we believe allow patients the chance to remain ambulatory while managing the impact of their disease and eliminate dependence on both oxygen tanks and cylinders.
We have created a market leading portfolio of POCs.
−Removed: POC product features
We market our current portable product offerings, the Inogen Rove and Inogen One systems, as ambulatory solutions for long-term oxygen therapy.
The Inogen Rove 4 ® can operate up to 96 months when used for up to five hours per day, and the Inogen ® Rove 6 and the Inogen One G5 ® can operate up to 96 months when used for up to eight hours per day.
−Removed: The Inogen One G4 ® can operate up to 60 months when used for up to eleven hours per day.
Servicing of sieve beds, filters, and accessories can be performed by patients themselves for all of our current portable product offerings.
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Our Intelligent Delivery Technology is designed to provide effective levels of blood oxygen saturation during sleep and all other periods of rest and activity.
−Removed: We have also launched Inogen Connect, a wireless connectivity platform for the Inogen One G4, Inogen One G5, Inogen Rove 4 and Inogen Rove 6 consisting of a front-end mobile application for use by long-term oxygen therapy users and a back-end database portal for use by homecare providers.
+Added: We have also launched Inogen Connect, a wireless connectivity platform for the Inogen One and Rove POCs consisting of a front-end mobile application for use by patients and a back-end database portal for use by homecare providers.
The Inogen Connect application, or app, is compatible with Apple and Android platforms and includes patient features such as oxygen purity status, battery run time, product support functions, notification alerts, and remote software updates.
We believe features of the back-end database portal such as remote troubleshooting, equipment health checks, and a location tracker will drive operational efficiencies for home oxygen providers and lower the total cost of servicing oxygen therapy patients.
−Removed: We released our latest portable oxygen concentrator, Rove 4, in the U.S.
−Removed: and European Union in October 2024.
−Removed: The Inogen Rove 4 is among the lightest products on the market and has among the highest oxygen production capabilities.
+Added: The Inogen Rove 4 is our newest POC and is among the lightest products on the market and has among the highest oxygen production capabilities.
The performance parameters around our systems allow us to serve ambulatory long-term oxygen patients based on their clinical needs.
Our products enable us to address a patient’s particular clinical needs, as well as lifestyle and performance preferences.
−Removed: Stationary oxygen concentrator
+Added: Stationary oxygen concentrators
We market our own 5-liter stationary oxygen concentrator, the Inogen At Home, capable of delivering continuous flow of oxygen for the patients who require it.
The Inogen At Home is one of the smaller, quieter, and lower weight devices in this category.
−Removed: We also supply lower cost third-party manufactured stationary concentrators to our rental patients who require secondary sources of oxygen as a part of their CMS contract or to meet other clinical or payor requirements.
−Removed: Airway clearance
+Added: In 2025, we also introduced our Inogen Voxi 5 stationary oxygen concentrator through our collaboration with Yuwell.
+Added: We offer the Voxi to home oxygen providers as well as directly to patients through our direct to patient channel.
+Added: We believe the Voxi is a high-quality concentrator that we can offer at a competitive price.
+Added: We also supply the Voxi and other stationary concentrators to our rental patients who require secondary sources of oxygen as a part of their CMS contract or to meet other clinical or payor requirements.
+Added: Airway clearance devices
We added Simeox, an airway clearance device, to our portfolio through the acquisition of Physio-Assist in September 2023.
−Removed: Simeox has been commercialized in Europe and several other markets for several years and was recently cleared by the FDA for use in the United States in December 2024.
+Added: Simeox has been commercialized in Europe and several other markets for several years and was cleared by the FDA for use in the United States in December 2024.
Simeox uses an innovative technology of oscillating negative pressure to liquify mucus in the bronchi and help patients evacuate it by coughing and/or leveraging postural drainage.
A particular advantage of this technology is that it can be used by patients capable of generating productive cough, regardless of the body size, chest wall abnormalities or back pains.
−Removed: The efficacy and safety of Simeox has been demonstrated in 10 clinical trials.
−Removed: It is marketed in Europe under EU Medical Devices Directive 93/42/EEC, or MDD, regulations.
+Added: The efficacy and safety of Simeox has been demonstrated in numerous clinical trials.
+Added: It is marketed in Europe under the transitional provisions of the EU Medical Devices Regulation 2017/745, or MDR.
+Added: In November 2025, we launched the Aurora CPAP masks in the U.S.
+Added: through our collaboration with Yuwell.
+Added: The Aurora CPAP masks are high-performing masks designed for patients with OSA.
+Added: A more extensive launch of these products is planned in 2026 as we focus on market development.
Domestic sales and marketing
In the United States, we market and distribute our products directly to consumers through a wide variety of direct-to-consumer sales and marketing strategies, including consumer advertising, an inside sales staff, and a physician referral model.
−Removed: Of the $218.5 million of our 2024 revenue derived from the United States, approximately 38.2% represented sales to traditional home medical equipment providers, distributors (including our private label collaborator) and resellers, 35.7% represented direct-to-consumer sales, and 26.1% represented direct-to-consumer rentals.
+Added: Of the $209.8 million of our 2025 revenue derived from the United States, approximately 45.1% represented sales to traditional home medical equipment providers, distributors (including our private label collaborator) and resellers;
+Added: 29.5% represented direct-to-consumer sales;
+Added: and 25.4% represented direct-to-consumer rentals.
We believe we were the first oxygen therapy manufacturer to employ a direct-to-consumer marketing strategy, meaning we advertise directly to patients, process their physician paperwork, and provide clinical support as needed.
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To pursue a direct-to-consumer rental strategy, our manufacturing competitors would need to meet national accreditation and state-by-state licensing requirements and secure Medicare billing privileges as well as compete with the home medical equipment providers to whom many of our manufacturing competitors sell across their entire homecare businesses.
−Removed: Our direct-to-consumer sales and marketing efforts are focused on generating awareness and demand for our Inogen One, Inogen Rove and Inogen At Home systems among patients, physicians and other clinicians, and third-party payors.
+Added: Our direct-to-consumer sales and marketing efforts are focused on generating awareness and demand for our Inogen products among patients, physicians and other clinicians, and third-party payors.
Our direct-to-consumer rental marketing efforts are focused on informing prescribers of the benefits of our products in order to serve patients earlier at the point of diagnosis and prescription while capturing a higher proportion of the life-time value of prescribed oxygen therapy.
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In addition to generating consumer demand, we believe our products can create value for our business partners by either creating a retail sale opportunity for them or by reducing the need for costly home deliveries associated with the delivery model for oxygen tanks.
−Removed: As of December 31, 2024, we employed 356 people in the United States and Europe in our Sales and Marketing organization.
+Added: As of December 31, 2025, we employed 314 people in the United States in our Sales and Marketing organization.
International
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For international sales, we sell to and bill the distributor or house accounts directly, leaving the patient billing, support, and clinical setup to the local provider.
−Removed: As of December 31, 2024, we had 333 people located in the United States who focused on selling our products and providing service and support to distributors and house accounts worldwide and 23 in-house and contract employees and independent employees located in Europe who provided sales and customer support services to a portion of our international customers.
−Removed: No single international customer and no single foreign country represented more than 10% of our total revenue in 2024, 2023 or 2022.
+Added: As of December 31, 2025, we had 19 in-house and contract employees and independent employees located in Europe who provided sales and customer support services to a portion of our international customers.
+Added: No international customer and no foreign country represented more than 10% of our total revenue in 2025, 2024, or 2023.
Our wholly-owned subsidiary, Inogen Europe B.V.
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Also, in support of our European operations, we produce our Inogen Rove 6 concentrators and perform related repair activities using a contract manufacturer, Foxconn, located in the Czech Republic to improve our ability to efficiently service our European customers.
−Removed: Physio-Assist sells its Simeox product throughout Europe and several other markets and manufactures the product in its Montpelier, France location.
+Added: Physio-Assist sells our Simeox product throughout Europe and several other markets and manufactures the product in our Montpelier, France location.
Concentration of customers
We primarily sell our products to traditional home medical equipment providers, distributors, and resellers in the United States and in foreign countries on a credit basis.
−Removed: We also sell our products direct-to-consumers on a primarily prepayment basis.
+Added: We also sell our products direct-to-consumers primarily on a prepayment basis.
+Added: One customer represented more than 10% of our total revenue for the twelve months ended December 31, 2025.
+Added: No customer represented more than 10% of our net accounts receivable balance as of December 31, 2025.
+Added: No customer represented more than 10% of our total revenue for the twelve months ended December 31, 2024.
One customer represented more than 10% of our net accounts receivable balance with a net accounts receivable balance of $3.3 million as of December 31, 2024.
−Removed: One customer represented more than 10% of our financing receivable balance with a balance of $6.5 million as of December 31, 2024.
−Removed: Two customers each represented more than 10% of our net accounts receivable balance with net accounts receivable balances of $8.6 million and $5.0 million, respectively, as of December 31, 2023.
−Removed: We rent products directly to consumers for insurance reimbursement, which resulted in a customer concentration relating to Medicare’s service reimbursement programs.
+Added: We also rent products directly to consumers for insurance reimbursement, and collect payment from private insurance payers, patients, or through Medicare’s service reimbursement programs.
Medicare’s service reimbursement programs accounted for 61.9%, 56.3% and 67.7% of rental revenue in 2025, 2024 and 2023, respectively, and accounted for 9.5%, 9.5% and 13.7% of total revenue for 2025, 2024 and 2023, respectively.
−Removed: Accounts receivable balances relating to Medicare’s service reimbursement programs (including held and unbilled receivables, net of allowances) amounted to $1.1 million or 3.7% of total net accounts receivable as of December 31, 2024 compared to $2.1 million, or 4.9%, of total accounts receivable as of December 31, 2023.
+Added: Accounts receivable balances relating to Medicare’s service reimbursement programs (including held and unbilled receivables, net of allowances) amounted to $1.4 million, or 3.6%, of total net accounts receivable as of December 31, 2025, compared to $1.1 million, or 3.7%, of total net accounts receivable as of December 31, 2024.
Customer support
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We provide our patients with a dedicated 24/7 hotline, allowing direct access to our customer service representatives who can handle product-related questions.
−Removed: Additionally, clinical staff is on call 24/7 and available to patients whenever needed by the patient or the customer service representative.
−Removed: Our rental intake staff supports patients who wish to use their rental insurance benefits to receive our products and services.
+Added: Additionally, clinical staff are available to patients whenever needed by the patient or the customer service representative.
+Added: Our rental intake staff supports patients who wish to use their insurance benefits to receive our products and services.
Our dedicated billing services team is available to answer patient questions regarding invoicing, reimbursement, and account status during normal business hours.
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For the year ended December 31, 2025, approximately 61.9% of our rental revenue was derived from Medicare’s traditional fee-for-service reimbursement programs.
−Removed: Medicare revenue, including patient co-insurance and deductible obligations, represented 9.5% of our total revenue in the year ended December 31, 2024 and 13.7% of our total revenue in the year ended December 31, 2023.
For additional discussion of the impact of Medicare on our business, see “Risk Factors” herein.
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We have been developing and refining the manufacturing of our oxygen concentrator systems since 2004.
−Removed: While nearly all of our manufacturing and assembly processes were originally outsourced, assembly of the compressors, sieve beds, and concentrators were brought in-house in order to improve quality control and reduce cost.
+Added: While nearly all of our manufacturing and assembly processes were originally outsourced, assembly of the compressors, sieve beds, and concentrators were brought in-house to improve quality control and reduce cost.
In support of our European sales, we use a contract manufacturer located in the Czech Republic to manufacture high-volume products and perform product repairs to improve delivery to our European accounts.
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We also manufacture the Simeox device in a leased facility in Montpelier, France.
−Removed: We use lean manufacturing practices to maximize manufacturing efficiency and eliminate waste.
+Added: We use lean manufacturing practices to maximize manufacturing efficiency and reduce waste.
We rely on third-party manufacturers to supply components of our products.
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For additional discussion of potential risks related to our manufacturing and raw materials, please see the risk factor entitled “ Reduction or interruption in our supply of components and products may adversely affect our manufacturing operations and related product sales.”
−Removed: We currently manufacture our oxygen concentrators in a leased building in Plano, Texas and have a design facility at our Corporate Headquarters in Goleta, California, that we have registered with the Food and Drug Administration, or FDA, and maintain a Quality Management system for which we have obtained International Standards Organization, or ISO, 13485 certification.
+Added: We currently manufacture our oxygen concentrators in a leased building in Plano, Texas and have a design facility at our location in Goleta, California, that we have registered with the FDA and maintain a Quality Management system for which we have obtained International Standards Organization, or ISO, 13485 certification.
We also manufacture the Simeox device in a leased facility in Montpelier, France.
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Our Quality Assurance and Regulatory Affairs departments oversee quality management by tracking component, device, and organization performance and by training team members outside the Quality Assurance and Regulatory Affairs departments to become competent users of our Quality Management system.
−Removed: By measuring component performance, communicating daily with the production group and our suppliers, and reviewing customer complaints, our Quality Assurance department, through the use of our corrective action program, drives and documents continuous performance improvement of our suppliers and internal departments.
+Added: By measuring component performance, communicating daily with the production group and our suppliers, and reviewing customer complaints, our Quality Assurance department, using our corrective action program, drives and documents continuous performance improvement of our suppliers and internal departments.
Our Regulatory Affairs department also trains internal quality auditors to audit our adherence to the Quality Management system.
Our Quality Management system has been certified to ISO 13485:2016 by BSI, a notified body.
−Removed: In addition, we continue to operate the quality management system of Physio Assist as we move to fully integrate the systems, with its system also certified to ISO 13485:2016 by IMQ, its notified body.
−Removed: As of December 31, 2024, we had 187 employees in operations, manufacturing, quality assurance, manufacturing engineering and repair in the United States.
+Added: In addition, we continue to operate the quality management system of Physio Assist as we move to fully integrate the systems, which is also certified to ISO 13485:2016 by IMQ, its notified body.
+Added: As of December 31, 2025, we had 178 employees in operations, manufacturing, quality assurance, manufacturing engineering, and repair.
Research and development
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As of December 31, 2025, our research and development staff included 29 engineers and scientists with expertise in air separation, compressors, pneumatics, electronics, embedded software, mechanical design, sensor, automation, connectivity, digital health, and manufacturing automation.
−Removed: The team is augmented with expertise and resources of our third-party partners specialized in medical device development.
+Added: The team is augmented with expertise and resources of our third-party partners specializing in medical device development.
Our current research and development efforts are focused primarily on increasing functionality, improving design for ease-of-use, and reducing the total cost of ownership of our products, as well as developing our next-generation oxygen concentrators and further developing the Simeox product line.
We have leveraged our 96 issued patents and intend to continue to seek ways to innovate to develop products and functionality improvements that enhance patient quality of life and to reduce costs through manufacturing and design improvements.
−Removed: The long-term oxygen therapy market is a highly competitive industry.
+Added: The long-term oxygen therapy market, as well as the broader respiratory market, is highly competitive.
We compete with a number of manufacturers and distributors of POCs, as well as providers of other long-term oxygen therapy solutions such as home delivery of oxygen tanks or cylinders, stationary concentrators, transfilling concentrators, and liquid oxygen.
Some of our competitors are large, well-capitalized companies with greater resources and other advantages than we have.
−Removed: Our significant manufacturing competitors are Caire Medical (a subsidiary of NGK Spark Plug), DeVilbiss Healthcare (a subsidiary of Drive Medical), O2 Concepts, Precision Medical, Gas Control Equipment (a subsidiary of Colfax), Nidek Medical, 3B Medical, SysMed, iRhythm Technologies, Inc., and Belluscura.
+Added: Our significant manufacturing competitors are Rhythm Healthcare, Caire Medical (a subsidiary of NGK Spark Plug Co., Ltd.), Drive DeVilbiss Healthcare, O2 Concepts, React Health, Nidek Medical Products, Precision Medical, 3B Medical, SysMed, Inc., and GCE Healthcare.
Respironics (a subsidiary of Koninklijke Philips N.V.) announced in early 2024 that it was leaving the U.S.
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For example, some major competitors have implemented direct-to-consumer sales models, which may increase their competitiveness and sales to patients, and we have recently seen the cost per generated lead trend higher than historical averages that may in part be due to increased competition.
−Removed: However, the strategies of these major competitors are currently limited to direct-to-consumer sales and do not include direct-to-consumer rentals where they would be responsible to meet national accreditation and state-by-state licensing requirements and secure Medicare billing privileges.
−Removed: Manufacturing companies compete for sales to providers primarily on the basis of price, quality/reliability, financing, bundling, product features, and service.
+Added: However, the strategies of these major competitors are currently limited to direct-to-consumer sales and do not include direct-to-consumer rentals where they would be responsible for meeting national accreditation and state-by-state licensing requirements and securing Medicare billing privileges.
+Added: Manufacturing companies compete for sales to providers primarily on the basis of price, quality/reliability, financing, product features, and service.
For many years, Lincare, Inc.
(a subsidiary of the Linde Group), Apria Healthcare, Inc., AdaptHealth Corp., Rotech Healthcare, Inc., and Viemed Healthcare, Inc.
−Removed: have been among the market leaders in providing respiratory therapy products, while the remaining market is serviced by local providers.
−Removed: Because of reimbursement reductions, we expect more industry consolidation and volatility in ordering patterns based on how providers are restructuring their businesses and their access to capital.
−Removed: In addition, providers may reduce or eliminate purchases from us due to our increased focus on building out a prescriber sales team and pursuing rentals directly, which could be in competition with our providers in the United States.
−Removed: Respiratory therapy providers compete primarily on the basis of product features and service, rather than price, since reimbursement levels are established by Medicare and Medicaid, or by the individual determinations of private payors.
+Added: have been among the market leaders in providing respiratory therapy products, while the remaining market is serviced by local or regional providers.
+Added: Because of actual and potential reimbursement restrictions and reductions, we expect more industry consolidation and volatility in ordering patterns based on how providers are restructuring their businesses and their access to capital.
+Added: In addition, providers may reduce or eliminate purchases from us due to our focus on maintaining a prescriber sales team and pursuing rentals directly, which could be in competition with our providers in the United States.
+Added: Respiratory therapy providers compete primarily based on product features and service, rather than price, since reimbursement levels are established by Medicare and Medicaid, or by the individual determinations of private payors.
Government regulation
−Removed: Inogen's products, including the Inogen One and Rove systems, Inogen At Home systems, Simeox, and related accessories, are medical devices subject to extensive and ongoing regulation by the FDA, as well as other federal and state regulatory bodies in the United States and comparable authorities in other countries.
+Added: Inogen's products, including the Inogen One and Rove systems, Inogen At Home systems, Simeox, Voxi, Aurora, and related accessories, are medical devices subject to extensive and ongoing regulation by the FDA, as well as other federal and state regulatory bodies in the United States and comparable authorities in other countries.
The FDA regulations govern the following activities that we perform, or that are performed on our behalf, to ensure that medical products distributed domestically or exported internationally are safe and effective for their intended uses:
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FDA’s classification of medical devices and pre-market clearance and approval requirements
−Removed: FDA classifies medical devices into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent of control needed to ensure safety and effectiveness.
+Added: FDA classifies medical devices into one of three classes—Class I, Class II, or Class III—depending on the degree of risk and the extent of control needed to ensure safety and effectiveness.
Most Class I devices and some Class II devices are exempt from pre-market review requirements.
2 unchanged sentences
In addition to the general controls, Class II devices are subject to “special controls,” such as performance standards and guidance documents, as identified in the classification regulation for the device type.
−Removed: Class III devices require FDA approval of a pre-market approval application, or PMA, demonstrating reasonable assurance of safety and effectiveness of the device, prior to commercial distribution.
+Added: Class III devices require FDA's pre-market approval, or PMA, demonstrating reasonable assurance of safety and effectiveness of the device, prior to commercial distribution.
Class III devices are those deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting, or implantable devices.
4 unchanged sentences
When a 510(k) clearance is required, we must submit a pre-market notification to the FDA demonstrating that our proposed device is substantially equivalent to a legally marketed predicate device.
−Removed: By law, FDA is supposed to make a decision on a 510(k) within 90 calendar days of accepting the submission for review;
+Added: By law, FDA is supposed to decide on a 510(k) within 90 calendar days of accepting the submission for review;
however, as a practical matter, clearance often takes significantly longer.
7 unchanged sentences
We obtained 510(k) clearance for the Simeox airway clearance system on December 23, 2024.
+Added: Yuwell, as the registration holder, obtained the 510(k) clearances for the Voxi and Aurora products.
De Novo authorization pathway
−Removed: The De Novo authorization pathway, also referred to as “Evaluation of Automatic Class III Designation”, entails a request to the FDA to classify novel devices of low to moderate risk t into Class II or Class I.
−Removed: De Novo authorization is intended as a potential pathway for devices for which the 510(k) process is not an available pathway because there is no legally marketed predicate device to which to claim substantial equivalence.
+Added: The De Novo authorization pathway, also referred to as “Evaluation of Automatic Class III Designation”, entails a request to the FDA to classify novel devices of low to moderate risk into Class II or Class I.
+Added: De Novo authorization is intended as a potential pathway for devices for which the 510(k) process is not an available pathway because there is no legally marketed predicate device on which to claim substantial equivalence.
FDA review of a De Novo application may lead the FDA to authorize marketing of the device and classify it as either a Class I or II device, which can then serve as a predicate device for future 510(k) pre-market notification submissions.
1 unchanged sentence
A pre-market approval application must be submitted to the FDA if the device cannot be cleared or authorized through the 510(k) or De Novo process.
−Removed: The pre-market approval application process is more demanding than the 510(k) pre-market notification process.
−Removed: A pre-market approval application must be supported by extensive data, generally including but not limited to, technical information, preclinical testing, clinical trials, manufacturing information, and labeling to demonstrate reasonable assurance of safety and effectiveness of the device.
−Removed: After a pre-market approval application is submitted and the FDA determines that the application is sufficiently complete to permit a substantive review, the FDA will accept the application for review.
−Removed: The FDA has 180 days to review an “accepted” pre-market approval application, although the review of an application generally occurs over a significantly longer period of time and can take up to several years.
+Added: The PMA process is more demanding than the 510(k) pre-market notification process.
+Added: A PMA application must be supported by extensive data, generally including but not limited to, technical information, preclinical testing, clinical trials, manufacturing information, and labeling to demonstrate reasonable assurance of safety and effectiveness of the device.
+Added: After a PMA application is submitted and the FDA determines that the application is sufficiently complete to permit a substantive review, the FDA will accept the application for review.
+Added: The FDA has 180 days to review an “accepted” PMA application, although the review generally occurs over a significantly longer period of time and can take up to several years.
During this review period, the FDA may request additional information or clarification of the information already provided.
Also, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device.
−Removed: In addition, the FDA will conduct a preapproval inspection of the manufacturing facility to ensure compliance with quality system regulations.
+Added: In addition, the FDA will conduct a pre-approval inspection of the manufacturing facility to ensure compliance with quality system regulations.
Clinical trials
−Removed: Clinical trials are almost always required to support pre-market approval and are sometimes required for 510(k) clearance and De Novo authorization.
+Added: Clinical trials are almost always required to support PMA devices, and are sometimes required for 510(k) clearance and De Novo authorization devices.
In the United States, these trials generally require submission of an application for an Investigational Device Exemption, or IDE, to the FDA.
4 unchanged sentences
Even if a trial is completed, the results of clinical testing may not demonstrate the safety and efficacy of the device, may be equivocal or may otherwise not be sufficient to obtain approval or clearance of the product.
−Removed: We have sponsored clinical studies and real-world data analyses that recently resulted in several publications in the areas of the following:
+Added: We have sponsored clinical studies and real-world data analyses that have resulted in several publications in the following areas:
use of POCs, impact of oxygen treatment modality and patient mobility on mortality and healthcare resource utilization, as well as the impact of ventilatory support in addition to oxygen therapy on exercise tolerance in patients with COPD.
We have also sponsored clinical studies on the Simeox device through Physio-Assist both prior to and since the acquisition.
−Removed: We continue to invest in clinical research activities to support new product development, as well as expansion of the uses of its products and services.
+Added: We continue to invest in clinical research activities to support product development, as well as expansion of the uses of our products and services.
Pervasive and ongoing regulation by the FDA and foreign agencies
10 unchanged sentences
The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination.
−Removed: We have modified various aspects of our Inogen One systems since receiving regulatory clearance, but we believe that new 510(k) clearances are not required for these modifications.
+Added: We have modified various aspects of our Inogen systems since receiving regulatory clearance, but we believe that new 510(k) clearances are not required for these modifications.
If the FDA disagrees with our determination not to seek a new 510(k) clearance, the FDA may retroactively require us to seek 510(k) clearance or pre-market approval.
4 unchanged sentences
As a medical device manufacturer, our manufacturing facilities are subject to periodic inspections and audits by the FDA, certain other regulatory agencies and authorities, and our notified body.
−Removed: We have been periodically audited by these organizations and none have identified any major observations with our manufacturing facilities or Good Manufacturing Policies.
+Added: We have been periodically audited by these organizations and none has identified any major observations with our manufacturing facilities or Good Manufacturing Policies.
International sales of medical devices are subject to foreign government regulations and registration, which may vary substantially from country to country.
3 unchanged sentences
In April 2009, we became an accredited Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Medicare supplier by the Accreditation Commission for Health Care for our Goleta, California facility for Home/Durable Medical Equipment Services for oxygen equipment and supplies.
−Removed: Our Medicare accreditation must be renewed every three years by passing an on-site inspection.
+Added: Our Medicare accreditation must be renewed every three years by passing an on-site inspection, and starting in 2026, on an annual basis when our current accreditations expire.
Our current accreditation with Medicare is due to expire in May 2027.
−Removed: Several states require that durable medical equipment providers be licensed in order to sell products to patients in that state.
+Added: Several states require that durable medical equipment providers be licensed to sell products to patients in that state.
Certain of these states require that durable medical equipment providers maintain an in-state location.
13 unchanged sentences
Non-compliance with the Federal Anti-Kickback Statute can result in cancellation of our provider numbers and exclusion from Medicare, Medicaid, or other federal healthcare programs, restrictions on our ability to operate in certain jurisdictions, as well as civil and criminal penalties, any of which could have an adverse effect on our business and results of operations.
−Removed: Federal law also includes the Physician Self-Referral Law, commonly known as the “Stark Law,” which prohibits a physician from referring a patient to an entity with which the physician (or an immediate family member of the physician) has a financial relationship, for the furnishing of certain designated health services for which payment may be made by Medicare or Medicaid, unless an exception applies.
−Removed: Violation of the Stark Law could result in denial of payment, disgorgement of reimbursements received under a non-compliant arrangement, civil penalties and fees, and exclusion from Medicare, Medicaid or other federal healthcare programs.
−Removed: Although we believe that we have structured our provider arrangements to comply with current Stark Law requirements, regulatory authorities may determine otherwise.
−Removed: Additionally, regulations issued for the Federal Anti-Kickback Statute and the Stark Law have undergone significant revisions, and it is reasonable to assume that revisions will occur in the future.
−Removed: While we have attempted to operate in compliance with these laws and regulations, our arrangements may ultimately be found to be not in compliance with applicable federal law.
+Added: Federal law also includes the Physician Self-Referral Law, commonly known as the “Stark Law,” which prohibits physicians from referring patients for certain designated health services payable by Medicare or Medicaid to an entity with which the physician, or an immediate family member, has a financial relationship, unless an applicable exception is satisfied.
+Added: Violations of the Stark Law may result in denial of payment, required refunds of amounts received under non-compliant arrangements, civil monetary penalties, and exclusion from participation in Medicare, Medicaid, or other federal healthcare programs.
+Added: While we believe our provider arrangements are structured to comply with applicable Stark Law requirements, there can be no assurance that regulatory authorities will not reach a different conclusion.
+Added: Additionally, regulations implementing Federal Anti-Kickback Statute and the Stark Law have undergone significant revisions in recent years and may be further amended or reinterpreted in the future.
+Added: Although we seek to structure and operate our arrangements in compliance with these evolving requirements, such arrangements could be determined by regulatory authorities to be non-compliant with applicable federal law.
Federal False Claims Act
−Removed: The Federal False Claims Act, as amended, or the False Claims Act, provides that the federal government, and under certain circumstances a private party or whistleblower, may bring claims against a person who knowingly presents or causes to be presented a false or fraudulent request for payment to the federal government or uses a false statement or false record to get a claim approved.
−Removed: Violations of the False Claims Act can result in penalties up to $28,619 for each claim, plus three times the amount of damages that the federal government sustained.
−Removed: Moreover, a claim including items or services resulting from a violation of the Federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.
+Added: The Federal False Claims Act, as amended, or the False Claims Act, permits the federal government, and in certain circumstances private parties acting as whistleblowers, to bring actions against any person who knowingly presents, or causes to be presented, a false or fraudulent claim for payment to the federal government, or who knowingly uses a false statement or record to obtain approval of such a claim.
+Added: Violations of the False Claims Act may result in significant civil monetary penalties on a per-claim basis, treble damages, and other remedies.
+Added: In addition, claims for items or services resulting from a violation of the Federal Anti-Kickback Statute may constitute false or fraudulent claims under the False Claims Act.
The Company is not aware of any pending claims against it under the False Claims Act.
Civil monetary penalties law
−Removed: The Federal Civil Monetary Penalties Law grants authority to the U.S.
−Removed: Department of Health & Human Services Office of Inspector General, or OIG, to seek civil monetary penalties, or CMPs, against an individual or entity based on a wide variety of conduct including violations of the Anti-Kickback Statute, Stark Law, and False Claims Act.
−Removed: An entity that offers to or transfers remuneration to any individual eligible for benefits under Medicare or Medicaid that such entity knows or should know is likely to influence such individual to order or receive from a particular provider, practitioner, or supplier any Medicare or Medicaid payable item or service may be liable for CMPs.
−Removed: We sometimes offer customers various discounts and other financial incentives in connection with the sales of our products.
−Removed: While we have processes in place to manage our discount and incentive programs, the federal government may find that our marketing activities violate the law.
−Removed: If we are found to be in non-compliance, we could be subject to CMPs of up to $50,000 for each wrongful act and exclusion from Medicare, Medicaid and other federal healthcare programs.
−Removed: In addition, to the extent we are found to not be in compliance, we may be required to curtail or restructure our operations.
−Removed: Any penalties, damages, fines, exclusions, curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results.
+Added: The Federal Civil Monetary Penalties Law authorizes the U.S.
+Added: Department of Health & Human Services Office of Inspector General, or OIG, to impose civil monetary penalties, or CMPs, against individuals or entities for a broad range of conduct, including violations of the Federal Anti-Kickback Statute, the Stark Law, and the False Claims Act.
+Added: An entity may be subject to CMPs if it offers to or transfers remuneration to any individual eligible for benefits under Medicare or Medicaid that the entity knows or should know is likely to influence such individual's selection of a particular provider, practitioner, or supplier of Medicare or Medicaid payable items or services.
+Added: We from time to time offer customers discounts and other financial incentives in connection with the sale of our products.
+Added: Although we maintain processes designed to structure and manage these programs in compliance with applicable law, regulatory authorities may determine our marketing or pricing arrangements violate federal healthcare law.
+Added: If we are found to be non-compliant, we could be subject to significant CMPs, exclusion from participation in Medicare, Medicaid and other federal healthcare programs, and may be required to curtail, modify, or restructure aspects of our operations.
+Added: Any such penalties, exclusions, or operational changes could adversely affect our business, financial condition, and results of operations.
State fraud and abuse provisions
−Removed: Many states have also adopted anti-kickback and self-referral laws similar and statutes similar to the Federal Anti-Kickback Statute and False Claims Act that apply to DMEPOS suppliers regardless of the payor source, and violations of such laws could result in fines, penalties and restrictions on our ability to operate in these jurisdictions.
+Added: Many states have adopted anti-kickback, self-referral, and false claims laws that are similar to the Federal Anti-Kickback Statute and Federal False Claims Act and that apply to DMEPOS suppliers regardless of the payor source.
+Added: Violations of these state laws may result in civil or criminal penalties, fines, or restrictions on our ability to operate in affected jurisdictions.
The Company is not aware of any pending claims against it under such state laws.
−Removed: The Health Insurance Portability and Accountability Act of 1996, or HIPAA, established uniform standards governing the conduct of certain electronic healthcare transactions and protecting the security and privacy of individually identifiable health information maintained or transmitted by most healthcare providers, health plans and healthcare clearinghouses, which are referred to as “covered entities.” Among the standards that have been promulgated under HIPAA’s regulations:
−Removed: the Standards for Privacy of Individually Identifiable Health Information, which restrict the use and disclosure of certain individually identifiable health information, the Standards for Electronic Transactions, which establish standards for common healthcare transactions, such as claims information, plan eligibility, payment information and the use of electronic signatures, the Security Standards, which require covered entities to implement and maintain certain security measures to safeguard certain electronic health information, including the adoption of administrative, physical and technical safeguards to protect such information, and the Breach Notification Standards, which establish standards for notification in the event of a breach of unsecured individually identifiable health information.
−Removed: In 2009, Congress passed the American Recovery and Reinvestment Act of 2009, or ARRA, which included sweeping changes to HIPAA, including an expansion of HIPAA’s privacy and security standards.
−Removed: ARRA includes the Health Information Technology for Economic and Clinical Health, or HITECH, which, among other things, made HIPAA’s privacy and security standards directly applicable to business associates of covered entities.
−Removed: A business associate is a person or entity that performs certain functions or activities on behalf of a covered entity that involve the use or disclosure of protected health information in connection with recognized healthcare operations activities.
−Removed: As a result, business associates are subject to significant civil and criminal penalties for failure to comply with applicable standards.
−Removed: HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney fees and costs associated with pursuing federal civil actions.
−Removed: In addition to federal regulations issued under HIPAA, some states have enacted privacy and security statutes or regulations that, in some cases, are more stringent than those issued under HIPAA.
−Removed: In those cases, it may be necessary to modify our planned operations and procedures to comply with the more stringent state laws.
−Removed: If we fail to comply with applicable state laws and regulations, we could be subject to additional sanctions.
−Removed: Any liability from failure to comply with the requirements of HIPAA, HITECH or state privacy and security statutes or regulations could adversely affect our financial condition.
−Removed: The costs of complying with privacy and security related legal and regulatory requirements are burdensome and could have a material adverse effect on our results or operations.
+Added: Certain states also impose additional requirements on medical device manufacturers, including mandates to implement compliance programs, restrictions on marketing practices, and obligations to track and report gifts, compensation, and other remuneration provided to healthcare professionals.
+Added: The Health Insurance Portability and Accountability Act of 1996, or HIPAA, established uniform standards governing certain electronic healthcare transactions and the privacy and security of individually identifiable health information maintained or transmitted by healthcare providers, health plans, and healthcare clearinghouses, known as “covered entities.” Regulations promulgated under HIPAA include standards governing the use and disclosure of protected health information, requirements for electronic healthcare transactions such as claims, eligibility, and payment information, security standards requiring administrative, physical, and technical safeguards to protect electronic health information, and breach notification requirements applicable in the event of unauthorized access to unsecured protected health information.
+Added: In 2009, Congress passed the American Recovery and Reinvestment Act of 2009, or ARRA, which included the Health Information Technology for Economic and Clinical Health, or HITECH.
+Added: HITECH expanded HIPAA’s privacy and security standards and made certain provisions directly applicable to business associates, defined as persons or entities that perform functions or activities on behalf of covered entities involving the use or disclosure of protected health information.
+Added: As a result, business associates are subject to civil and criminal penalties for noncompliance.
+Added: HITECH also increased the potential penalties for violations and authorized state attorneys general to bring civil actions in federal court to enforce HIPAA requirements and seek damages, injunctions, and related costs.
+Added: In addition to HIPAA and HITECH, many states have enacted privacy and security laws that, in some cases, impose requirements more stringent than federal standards.
+Added: Compliance with these state laws may require us to modify our operations, policies, or procedures.
+Added: Failure to comply with applicable privacy and security requirements could subject us to enforcement actions, penalties, or other sanctions and could adversely affect our business, financial condition, or results of operations.
+Added: In addition, the costs associated with compliance with evolving privacy and data security laws and regulations may be significant and could have a material adverse effect on our results or operations.
Physician Payments Sunshine Act
−Removed: In addition, there has been a recent trend of increased federal and state regulation of payments made to physicians and other healthcare providers.
−Removed: The Physician Payments Sunshine Act, enacted as part of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, imposed public reporting requirements on medical device manufacturers for payments or other transfers of value made by them to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
−Removed: The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act enacted in 2018, extended the reporting and transparency requirements under the Physician Payments Sunshine Act to physician assistants, nurse practitioners and other mid-level practitioners, with reporting requirements going into effect in 2022 for payments made in 2021.
−Removed: Failure to submit required ownership and investment interest information may result in civil monetary penalties of up to an aggregate of $211,000 per year (or up to an aggregate of $1.4 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported in an annual submission.
−Removed: Certain states also mandate implementation of compliance programs, impose restrictions on device manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians and other healthcare professionals.
−Removed: The Patient Protection and Affordable Care Act also requires healthcare providers to voluntarily report and return an identified Medicare or Medicaid overpayment within 60 days after identifying the overpayment.
−Removed: Failure to repay the overpayment within 60 days will result in the claim being considered a “false claim” and the healthcare provider will be subject to False Claims Act liability.
+Added: In addition, federal and state governments have increased regulation and transparency requirements related to payments and other transfers of value made to physicians and other healthcare professionals.
+Added: The Physician Payments Sunshine Act, enacted as part of the Patient Protection and Affordable Care Act, and later amended, requires medical device manufacturers to publicly report certain payments or other transfers of value made to physicians, other prescribers, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
+Added: Failure to comply with applicable reporting requirements may result in significant civil monetary penalties.
+Added: The Patient Protection and Affordable Care Act further requires healthcare providers to report and return identified Medicare or Medicaid overpayments within 60 days of identification.
+Added: Failure to timely report and return such overpayments may cause the related claims to be considered as false or fraudulent claims, subjecting the provider to liability under the False Claims Act.
International regulation
−Removed: International sales of medical devices are subject to foreign governmental regulations, which vary substantially from country to country.
−Removed: The time required to obtain clearance or approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may be different.
−Removed: In the European Union, medical devices are regulated by the European Union Medical Devices Regulation (EU) 2017/745, or MDR, which became applicable on May 26, 2021 and replaced the EU MDD, with the EU MDD still applying to certain products that were approved under that process.
−Removed: The MDR and its associated guidance documents and harmonized standards to regulate the design, manufacture, clinical trials, labeling and adverse event reporting for medical devices.
−Removed: Devices that comply with the requirements of the MDR will be entitled to bear the European Conformity Marking, or CE Mark, indicating that the device conforms to the essential requirements of the MDR and, accordingly, can be commercially distributed throughout the Member States of the European Union, and additional Members States of the European Economic Area, or EEA, (i.e ., Norway, Lichtenstein and Iceland).
−Removed: The method of assessing conformity under the MDR varies depending on the type and class of the product, but normally involves a combination of self-assessment by the manufacturer and a third-party assessment by a notified body, an independent and neutral institution designated by a Member State country to conduct the conformity assessment.
−Removed: This third-party assessment may consist of an audit of the manufacturer’s quality system by reference to ISO 13485, review of technical documentation, and specific testing of the manufacturer’s device.
−Removed: Such an assessment may be required in order for a manufacturer to commercially distribute the product throughout the EEA.
−Removed: We have completed the necessary conformity assessment procedure required to allow us to affix the CE Mark to our oxygen therapy products and to commercialize our devices in the EEA, through the EU MDD and MDR processes.
−Removed: Our ISO 13485 certification was first issued on April 21, 2005, and our EC-Certificate was first issued on March 16, 2007.
−Removed: We received the CE Mark for our oxygen therapy products under the MDR on December 12, 2022.
−Removed: Following the United Kingdom’s exit from the European Union, known as “Brexit”, the MDR does not apply in the United Kingdom (except for Northern Ireland, which under the Northern Ireland Protocol is bound by certain EU laws).
−Removed: The medical device legislative framework in the United Kingdom is set out in the Medical Devices Regulations 2002, as amended.
−Removed: These Regulations are based on the previous medical device directives of the EU (including the MDD) but have been amended so that they function properly now the United Kingdom is no longer part of the European Union.
−Removed: The Medical Devices Regulations 2002 have introduced several changes including (but not limited to) replacing the CE mark with a UK Conformity Assessed, or UKCA, marking (although CE marks will be recognized potentially up until June 2030), requiring manufacturers outside of the United Kingdom to appoint a “UK Responsible Person” if they place devices on the Great Britain market and more wide-ranging UK device registration requirements.
−Removed: Inogen has sold products in Canada since 2006 when we obtained our Medical Device License after obtaining appropriate licensure, accreditation, and meeting ISO Standard 13485.
−Removed: As of January 1, 2019, Health Canada implemented the Medical Device Single Audit Program as the sole mechanism for manufacturers to demonstrate compliance with the quality management system requirements of the Medical Device Regulations, replacing the Canadian Medical Devices Conformity Assessment System program.
−Removed: In Australia, we must appoint an agent sponsor who will interact on our behalf with the Therapeutics Goods Administration, or TGA.
−Removed: We must also prepare a technical file and declaration of conformity to essential requirements under Australian law, provide evidence of CE Marking of the device and submit this information via our agent sponsor to the TGA in a Medical Device Application.
+Added: International sales of medical devices are subject to extensive and varying foreign regulatory requirements, which differ significantly by jurisdiction.
+Added: The time required to obtain regulatory clearance or approval outside the United States may be longer or shorter than that required for FDA clearance or approval, and applicable standards, processes, and compliance obligations may differ materially.
+Added: In the European Union, medical devices are regulated by the European Union Medical Devices Regulation (EU) 2017/745, or MDR, which became applicable on May 26, 2021 and replaced the former Medical Devices Directive, or EU MDD, subject to certain transitional provisions for legacy devices.
+Added: The MDR and related guidance and harmonized standards govern, among other things, the device design, manufacture, clinical evaluation, labeling, post-market surveillance, and adverse event reporting.
+Added: Devices that comply with MDR requirements may bear the European Conformity Marking, or CE Mark, permitting commercial distribution throughout the Member States of the European Union and additional countries of the European Economic Area, or EEA, (i.e ., Norway, Lichtenstein and Iceland).
+Added: Conformity assessment under the MDR varies based on device classification and typically involves a combination of manufacturer self-assessment and third-party review by a notified body, an independent and neutral institution designated by a Member State country to conduct the conformity assessment.
+Added: This third-party assessment may include an audit of the manufacturer’s quality management system by reference to ISO 13485, review of technical documentation, and, in some cases, product testing.
+Added: We have completed the necessary conformity assessment procedure required to allow us to affix the CE Mark to our oxygen therapy products and to commercialize them in the EEA.
+Added: Our ISO 13485 certification was first issued on April 21, 2005, our original EC Certificate was issued on March 16, 2007, and we CE Marked our oxygen therapy products under the MDR on December 12, 2022.
+Added: Our Simeox product is CE Marked under the EU MDD but benefits from the applicable transition provisions of the MDR, meaning it can be placed on the EEA market until December 31, 2028, provided we continue to satisfy the MDR transitional provisions.
+Added: Following the United Kingdom’s exit from the European Union, known as “Brexit”, the MDR does not apply in Great Britain, although it continues to apply in Northern Ireland under the Northern Ireland Protocol.
+Added: Medical devices in Great Britain are regulated under the Medical Devices Regulations 2002, as amended.
+Added: These regulations are largely based on the former EU directives, but modified to operate independently of EU law.
+Added: The UK regulatory framework contains certain Great Britain-specific requirements, including the introduction of the UK Conformity Assessed, or UKCA, marking (although CE marks will be recognized potentially up until June 2030 or later (subject to further consultation)) the requirement for manufacturers located outside the United Kingdom to appoint a “UK Responsible Person”, and expanded device registration obligations.
+Added: We have sold products in Canada since 2006 following receipt of our Medical Device License and satisfaction of applicable licensure, accreditation, and ISO Standard 13485 requirements.
+Added: As of January 1, 2019, Health Canada implemented the Medical Device Single Audit Program, or MDSAP, as the sole mechanism for demonstrating compliance with Canadian quality management system requirements, replacing the prior Canadian Medical Devices Conformity Assessment System program.
+Added: In Australia, we are required to appoint a local sponsor to interface with the Therapeutics Goods Administration, or TGA.
+Added: Compliance requires preparation of technical documentation, a declaration of conformity to Australian essential principles, and submission of supporting evidence, including CE Marking, through the appointed sponsor.
On June 4, 2007, we received our Certificate for Inclusion of a Medical Device in Australia.
Foreign Corrupt Practices Act
−Removed: Also, the U.S.
−Removed: Foreign Corrupt Practices Act and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries from making improper payments to foreign officials.
−Removed: We cannot assure you that our internal control policies and procedures will protect us from reckless or negligent acts committed by our employees, manufacturers, distributors, partners, collaborators or agents.
−Removed: Violations of these laws, or allegations of such violations, could result in legal fees, fines, penalties or prosecution and have a negative impact on our business, results of operations and reputation.
+Added: In addition, the U.S.
+Added: Foreign Corrupt Practices Act and similar anti-bribery and anti-corruption laws in other jurisdictions generally prohibit companies and their intermediaries from offering, promising, or making improper payments or other things of value to foreign government officials.
+Added: While we maintain policies and procedures designed to promote compliance with these laws, we cannot provide assurance that such controls will prevent or detect improper conduct by our employees or third parties acting on our behalf, including manufacturers, distributors, partners, collaborators or agents.
+Added: Violations of these laws, or allegations of such violations, could result in significant legal expenses, fines, penalties, criminal or civil sanctions, and could adversely affect our business, results of operations, and reputation.
Intellectual property
−Removed: We believe that to maintain a competitive advantage, we must develop and preserve the proprietary aspect of our technologies.
−Removed: We rely on a combination of patent, trademark, trade secret and other intellectual property laws, non-disclosure agreements and other measures to protect our proprietary rights.
−Removed: Currently, we require our employees, public accountants, consultants and advisors to execute non-disclosure agreements in connection with their employment, consulting or advisory relationships with us, where appropriate.
−Removed: We also require our employees, consultants and advisors with whom we expect to work on our current or future products to agree to disclose and assign to us all inventions conceived during the workday, developed using our property or related to our business.
−Removed: Despite any measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects of our systems, sell counterfeit versions of our products, or obtain and use information that we regard as proprietary.
+Added: We believe that maintaining a competitive advantage depends in part on our ability to develop and preserve the proprietary aspect of our technologies.
+Added: We rely on a combination of patent, trademark, trade secret, and other intellectual property laws, as well as confidentiality agreements and other contractual and operational measures, to protect our proprietary rights.
+Added: We generally require employees, consultants, advisors, and certain third parties to enter into non-disclosure agreements in connection with their employment or engagement, as appropriate.
+Added: In addition, we require our employees, consultants, and advisors involved in the development of our current or future products to agree to disclose and assign to us inventions conceived during the course of their work, developed using our resources, or related to our business.
+Added: Despite these measures, unauthorized parties may attempt to copy or reverse-engineer aspects of our technologies, manufacture or sell counterfeit products, or misappropriate proprietary or confidential information, which could impair our competitive position.
As of December 31, 2025, we had 25 pending patent applications and 96 issued patents relating to the design and construction of our respiratory devices.
10 unchanged sentences
patents 9,283,346, 10,004,869 and 10,869,986 are directed towards the Inogen at Home stationary oxygen concentrator.
−Removed: This category of patents expires in 2031 or later and may serve to deter competitors from reverse engineering or copying our design elements.
+Added: This category of patents generally expires in 2031 or later (without taking into account any patent term adjustments or terminal disclaimers) and may serve to deter competitors from copying our design elements.
The second category of patents and patent applications within our portfolio pertains to operating features and design techniques.
2 unchanged sentences
and 9,283,346 are directed towards design features of the Inogen One G3, Inogen One G4, and Inogen at Home products.
−Removed: This category of patents expires in 2031 or later (without taking into account any patent term adjustments).
+Added: This category of patents generally expires in 2031 or later (without taking into account any patent term adjustments or terminal disclaimers).
These features and designs are developed to facilitate the design, manufacturing, and usefulness of our products.
3 unchanged sentences
patent 9,907,926, which is directed to an oxygen concentrator for mechanical ventilation.
−Removed: This category of patents expires in 2023 or later (without taking into account any patent term adjustments).
+Added: This category of patents generally expires in 2023 or later (without taking into account any patent term adjustments or terminal disclaimers).
Patents and patent applications in this category and others may facilitate the design and development of future respiratory products that can serve patients in need of supplemental oxygen and or mechanical ventilation therapies.
1 unchanged sentence
These patents and patent applications provide coverage for the aspects of the Simeox device and potential improvements and adaptions that may be implemented into the device or similar devices in the future.
−Removed: We own a number of United States registered trademarks that we use in our business.
−Removed: In addition, many of our trademarks are also registered for use in certain foreign countries where we have determined it is commercially advantageous to do so.
−Removed: We utilize our trademarks to represent the quality and goodwill of our products and company and monitor for any unauthorized use of our trademarks, taking action where we deem appropriate and necessary.
+Added: We own a number of registered trademarks in the United States and have also registered certain trademarks in selected foreign jurisdictions where we have determined such protection to be commercially advantageous.
+Added: Our trademarks are used to signify the quality, reliability, and goodwill associated with our products and brand.
+Added: We monitor for unauthorized use of our trademarks and take enforcement action where we deem appropriate and necessary.
Human capital
−Removed: At Inogen, we believe our employees are critical to our success and our ability to focus on product quality, continuous improvement, and outstanding customer satisfaction.
+Added: At Inogen, we believe our employees are critical to our success and our ability to deliver high quality products, drive continuous improvement, and achieve high levels of customer satisfaction.
The unique demands of our industry, together with the challenges of running an enterprise focused on the development, manufacture and commercialization of innovative products, require talent that is highly educated and/or has significant industry experience.
Additionally, for certain key functions, we require specific expertise to oversee and conduct research and development activities and complex manufacturing requirements for our products.
−Removed: We seek the best people we can find and support them to be productive and engaged.
+Added: We seek to attract, develop, and retain highly qualified employees and to foster an environment that supports productivity and engagement.
We strive to ensure our measures of safety, remuneration and employee engagement are competitive with those of leading companies in our industry.
−Removed: As of December 31, 2024, we had 766 full and part-time employees worldwide, consisting of 356 employees in sales, marketing, clinical and client services, 187 employees in operations, manufacturing, quality assurance, manufacturing engineering, and repair, 185 employees in general administration and 38 employees in research and development.
+Added: As of December 31, 2025, we had 753 full and part-time employees worldwide, consisting of 333 employees in sales, marketing, clinical, and client services;
+Added: 178 employees in operations, manufacturing, quality assurance, manufacturing engineering, and repair;
+Added: 200 employees in general administration;
+Added: and 42 employees in research and development.
None of our employees are represented by a collective bargaining agreement and we believe that our employee relations are good.
32 unchanged sentences
Environmental matters
−Removed: Our research and development and manufacturing processes involve the controlled use of hazardous materials, including flammables, toxics, and corrosives.
−Removed: Our research and manufacturing operations produce hazardous chemical waste products.
−Removed: We seek to comply with applicable laws regarding the handling and disposal of such materials.
−Removed: Given the small volume of such materials used or generated at our facilities, we do not expect our compliance efforts to have a material effect on our capital expenditures, earnings, and competitive position.
−Removed: However, we cannot eliminate the risk of accidental contamination or discharge and any resultant injury from these materials.
−Removed: We do not currently maintain separate environmental liability coverage and any such contamination or discharge could result in significant cost to us in penalties, damages, and suspension of our operations.
+Added: Our research and development and manufacturing activities involve the controlled use of hazardous materials, including flammable, toxic, and corrosive substances, and generate hazardous chemical waste.
+Added: We seek to comply with applicable environmental, health, and safety laws and regulations governing the handling, storage, and disposal of these materials.
+Added: Based on the limited quantities used or generated at our facilities, we do not currently expect compliance with such requirements to have a material effect on our capital expenditures, earnings, or competitive position.
+Added: Nevertheless, we cannot eliminate the risk of accidental contamination, release, or exposure, or any resulting injury or environmental harm.
+Added: We do not maintain separate environmental liability insurance coverage, and any such incident could result in significant costs, including remediation expenses, penalties, damages, or suspension of operations, which could adversely affect our business, financial condition, and results of operations.
Climate Change
20 unchanged sentences
See Note 2 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional information related to our U.S.
+Added: and international revenue.
We believe our sales may be impacted by seasonal factors.
4 unchanged sentences
We were incorporated in Delaware in November 2001.
−Removed: Our principal executive offices are located at 859 Ward Drive, Suite 200, Goleta, California 93111.
+Added: Our principal executive offices are located at 500 Cummings Center, Suite 2800, Beverly, Massachusetts 01915.
Our telephone number is (805) 562-0500.
4 unchanged sentences
The address of the site is www.sec.gov .
−Removed: We webcast our earnings calls and certain events we participate in or host with members of the investment community on our investor relations page of our website.
+Added: We webcast our earnings calls and certain events we participate in or host with members of the investment community on our investor relations page on our website.
In addition, we use our website http://investor.inogen.com as a means of disclosing information about our company, our products, our planned financial and other announcements, our attendance at upcoming investor conferences, and other matters.
12 unchanged sentences
Executive Vice President, Chief Commercial Officer
+Added: Jennifer Yi Boyer
+Added: Executive Vice President, Enterprise Enablement & Chief Human Resources Officer
+Added: Vice President, Chief Accounting Officer
Smith has served as our President, Chief Executive Officer, and as a director since November 2023.
8 unchanged sentences
Most recently, Mr.
−Removed: Bourque served as Chief Financial Officer and Treasurer of Chase Corporation from February 2021 to February 2024.
−Removed: He also served as Chief Financial Officer of Keystone Dental from April 2019 to September 2020, as Senior Vice President, Chief Financial Officer and Treasurer of Analogic Corporation, and as Vice President of Finance for Axcelis Technologies.
+Added: Bourque served as Chief Financial Officer and Treasurer of Chase Corporation, a manufacturer of industrial coatings and tapes for high-reliability applications, from February 2021 to February 2024.
+Added: He also served as Chief Financial Officer of Keystone Dental Inc.
+Added: from April 2019 to September 2020.
+Added: Prior to that, Mr.
+Added: Bourque served as Chief Financial Officer from 2017 to 2018 and in other senior finance leadership positions from 2014 to 2017 of Analogic Corporation, a corporation specialized in healthcare technology and aviation security industries, and as Vice President of Finance for Axcelis Technologies.
Bourque received a B.S.
7 unchanged sentences
Smith worked for multinational law firms in New York, Silicon Valley, and London.
−Removed: Smith earned his B.S.
−Removed: in Mechanical Engineering from Rensselaer Polytechnic Institute and his J.D.
−Removed: from Albany Law School.
−Removed: Gregoire Ramade has served as our Chief Commercial Officer since January 2024 and served as our Senior Vice President of International Sales from November 2023 to January 2024.
+Added: Smith holds a B.S.
+Added: in Mechanical Engineering from Rensselaer Polytechnic Institute, a J.D.
+Added: from Albany Law School, and an MBA from UMass Amherst's Isenberg School of Management.
+Added: Gr é goire Ramade has served as our Chief Commercial Officer since January 2024 and served as our Senior Vice President of International Sales from November 2023 to January 2024.
Prior to joining the Company, Mr.
4 unchanged sentences
in International Business with a minor in Economics from the American University of Paris and an MBA in International Business and Marketing from the Ecole Nationale des Ponts et Chausses School of International Management.
+Added: Jennifer Yi Boyer has served as Executive Vice President, Enterprise Enablement and Chief Human Resources Officer of the Company since May 2025.
+Added: Yi Boyer joined Inogen in February 2022 as Chief Human Resources Officer and has risen internally to her current role.
+Added: Prior to joining Inogen, Ms.
+Added: Yi Boyer served as Chief People Officer and Senior Vice President of Diversity, Equity and Inclusion at Fiscal Note from January 2021 to February 2022.
+Added: She also held the positions of Chief Talent Officer at ACT from August 2011 to October 2020, Vice President Talent Strategies at Diversey, Inc., Vice President of Talent Development at CIT Group, and prior to that in various other human resources and quality management roles across various industries.
+Added: Yi Boyer holds a B.S.
+Added: in Hotel Administration from Cornell University and a Masters in Strategic Communication and Leadership from Seton Hall University.
+Added: She also completed an executive leadership certificate at the JFK School of Government at Harvard University.
+Added: Mary Wright has served as Vice President, Chief Accounting Officer since May 2025.
+Added: Wright joined Inogen in May 2015 and has risen internally to her current role, previously serving as Vice President, Corporate Controller, Accounting from October 2024 and Vice President, Technical Accounting & Financial Reporting from July 2022.
+Added: Prior to joining Inogen, Ms.
+Added: Wright served in various roles of increasing seniority at Deloitte & Touche LLP.
+Added: Wright received a B.A.
+Added: in Accounting and International Business from Ohio University and is a member of the American Institute of Certified Public Accountants (AICPA).
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.