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Item 1. Business

2026-02-13 compared with 2025-02-10 · 170 added, 146 removed, 569 unchanged (36% of the section changed)

We are a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea ("OSA").

Our proprietary Inspire system is the first and only FDA, European Union ("EU") Regulation No.

Our proprietary Inspire system is the first FDA, European Union ("EU") Regulation No.

2017/745 ("MDR" or "EU Medical Devices Regulation"), and Japan Pharmaceuticals and Medical Devices Agency-approved neurostimulation technology of its kind that provides a safe and effective treatment for patients with moderate to severe OSA.

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Inspire therapy is indicated for patients with moderate to severe OSA who do not have significant central sleep apnea and do not have a complete concentric collapse of the airway at the soft palate level.

Physicians have treated more than 90,000 patients with Inspire therapy at over 1,575 medical centers across the United States ("U.S."), Europe, and Asia.

Physicians have treated more than 125,000 patients with Inspire therapy across the United States ("U.S."), Europe, and Asia.

Sleep apnea is a serious and chronic disease that negatively impacts a patient’s sleep, health, and quality of life.

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Left untreated, OSA increases the risk of high blood pressure, hypertension, heart failure, stroke, coronary artery disease, and other life-threatening diseases.

CPAP is the leading therapy for patients with moderate to severe OSA.

Continuous positive airway pressure ("CPAP") is the leading therapy for patients with moderate to severe OSA.

CPAP is delivered through a face or nasal mask that connects through a hose to a bedside air pump.

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Data shows that patients with CPAP intolerant OSA have a higher risk for mortality than patients with CPAP-tolerant OSA and higher healthcare utilization rates based on increased cardiovascular health risks.

Two recent findings published in 2022 from Medicare and the French national healthcare insurance databases have demonstrated, in large national cohorts, risks of CPAP intolerance.

Two findings published in 2022 from Medicare and the French national healthcare insurance databases have demonstrated, in large national cohorts, risks of CPAP intolerance.

Specifically, Medicare patients with CPAP intolerance had higher risks of new cardiovascular events than those who were adherent.

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In addition to the STAR trial, we have established a global real-world patient registry ("ADHERE") to collect data on safety, effectiveness, weekly usage, overall compliance, and satisfaction from patients who have been implanted with an Inspire system for one year after implant.

The target enrollment of 5,000 patients was achieved in 2024 and patient follow-up is ongoing.

The target enrollment of 5,000 patients was achieved in 2024 and patient follow-up was completed in 2025 with final results pending analysis.

For more details on ADHERE, please see the section titled "Clinical Results and Studies—ADHERE Patient Registry" below.

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We have secured positive coverage policies with many U.S.

commercial payors, including all large national commercial insurers, encompassing approximately 260 million covered lives in the U.S.

commercial payors, including all large national commercial insurers, encompassing over 300 million covered lives in the U.S.

We are in active discussions with regional commercial insurers to establish additional positive coverage policies, as well as modify existing positive coverage policies to support reimbursement of Inspire therapy.

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• First to market with an innovative, closed-loop, minimally invasive solution.

We have developed the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for patients with moderate to severe OSA who have been confirmed to fail or cannot tolerate PAP treatments, such as CPAP.

We have developed the first FDA-approved neurostimulation technology that provides a safe and effective treatment for patients with moderate to severe OSA who have been confirmed to fail or cannot tolerate PAP treatments, such as CPAP.

We received a PMA from the FDA in 2014 for our Inspire therapy.

Unlike CPAP, which is limited by low patient compliance primarily due to patient discomfort with the mask or device, our innovative, closed-loop, minimally invasive solution is designed to provide comfort and convenience, resulting in high compliance for patients with moderate to severe OSA.

We believe we have a significant first mover advantage and momentum over future competitors, as physicians have treated more than 90,000 patients with Inspire therapy.

We believe we have a significant first mover advantage and momentum over current and future competitors, as physicians have treated more than 125,000 patients with Inspire therapy.

• Significant body of strong clinical data.

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Our commitment to driving innovation has allowed us to achieve continuous, significant improvements of our Inspire therapy.

For example, in 2024, we received approval from the FDA for our next generation

Inspire system, which we expect to fully launch in the U.S.

For example, in 2024, we received approval from the FDA for our Inspire V

neurostimulator, which we began to market for sale in the U.S.

We have a comprehensive patent portfolio to protect our intellectual property and technology, with rights as of December 31, 2025 to 119 issued U.S.

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We also plan to continue building patient awareness through our direct-to-consumer marketing initiatives, which include paid online search, radio, social media, television, and online videos.

• Expand our sales and marketing organization to facilitate adoption of our Inspire therapy.

We plan to continue to expand our sales and marketing organization and seek to recruit and train exceptionally talented sales representatives in existing and new markets to help facilitate further adoption and broaden awareness of our Inspire therapy.

• Utilize our dedicated sales and marketing organization to facilitate further adoption of our Inspire therapy.

We plan to continue to utilize our talented sales representatives in existing and new markets to help facilitate further adoption and broaden awareness of our Inspire therapy.

Our success to date in developing new markets has been primarily due to our ability to identify new regions with high volume medical centers, educate ENT and sleep physicians, help generate steady patient demand, and provide sufficient support staff to our sales representatives.

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• Invest in research and development to drive innovation and expand indications.

Our foundational commitment to driving innovation and improving patient lives fuels our desire for continuous product

We intend to invest in existing and next generation technologies to further improve our products and clinical outcomes, optimize patient acceptance and comfort, and broaden the patient population that can benefit from our Inspire therapy.

Recent examples of our product innovation include the next generation of the Inspire system and our SleepSync™ programmer as discussed above.

We have launched a cloud-based patient management system called the SleepSync™ platform (formerly referred to as Inspire Cloud), which allows physicians to monitor patient compliance and more efficiently coordinate patient care, and the Inspire Sleep app for patients' smartphones.

A recent example of our efforts to expand our label indications for the Inspire system include obtaining FDA approval in 2023 to offer Inspire therapy to certain pediatric patients with Down syndrome.

Additionally in 2023, we received approval from the FDA on an expanded indication which includes an increase on the upper limit of the AHI to 100 events per hour from 65 and raises the BMI warning in the labeling to 40 from 32.

Our foundational commitment to driving innovation and improving patient lives fuels our desire for continuous product development.

We intend to invest in existing and next generation technologies to further improve our

products and clinical outcomes, optimize patient acceptance and comfort, and broaden the patient population that can benefit from our Inspire therapy.

Recent examples of our product innovation include the next generation of the Inspire system and our SleepSync™ programmer.

We have a cloud-based patient management system called the SleepSync™ platform which allows physicians to monitor patient compliance and more efficiently coordinate patient care, and the Inspire Sleep app for patients' smartphones.

Examples of our efforts to expand our label indications for the Inspire system include obtaining FDA approval in 2023 to offer Inspire therapy to certain pediatric patients with Down syndrome.

• Further penetrate and expand into existing and new international markets.

We plan to continue to establish and strengthen our presence internationally.

Our goal is to further increase sales of our Inspire therapy in existing international markets in Europe, including Germany, France, and the Netherlands, and in the Asia Pacific region, including Japan, Singapore, and Hong Kong.

We also plan to expand our reach to markets in new regions, such as Thailand and South Korea.

We also plan to expand our reach to markets in new regions, such as South Korea.

We plan to strategically invest in new markets based on our assessment of market size and opportunity and prospects for compelling reimbursement coding and coverage.

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Overview of Inspire Therapy

Our proprietary Inspire system is the first and only FDA-approved closed-loop neurostimulation technology that provides a safe and effective treatment for patients with moderate to severe OSA.

Our proprietary Inspire system is the first FDA-approved closed-loop neurostimulation technology that provides a safe and effective treatment for patients with moderate to severe OSA.

Both our Inspire IV and Inspire V systems consists of a remote control and the following implantable components (except as otherwise noted):

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This electrical stimulation of the hypoglossal nerve causes a slight forward movement of the back of the tongue that helps maintain an open airway, thereby preventing obstructive events and enabling the patient to inhale freely.

To receive the Inspire system, patients undergo a short outpatient surgical procedure, typically lasting about 90 minutes, during which the neurostimulator, sensing lead, and stimulation lead are implanted.

To receive the Inspire system, patients undergo a short outpatient surgical procedure, typically lasting about 30 to 90 minutes, during which the neurostimulator and stimulation lead are implanted, and for the Inspire IV system, a pressure sending lead to monitor the breathing cycle.

The Inspire V system incorporates the respiratory sensor inside the neurostimulator so a sensing lead is not required.

The procedure is minimally invasive and performed with two small incisions.

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The effectiveness of Inspire therapy to relieve OSA is objectively measured during a sleep study or polysomnogram.

A sleep study records a patient’s breathing, airflow, and blood oxygen levels before and after

activating the device.

A sleep study records a patient’s breathing, airflow, and blood oxygen levels before and after activating the device.

Before activation, the patient experiences multiple periods of interrupted breathing, and oxygen levels repeatedly drop before the patient experiences a transient arousal that allows air intake.

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• Minimally invasive outpatient procedure.

The Inspire system’s implantable components are placed during an approximately 90-minute outpatient procedure.

The Inspire system’s implantable components are placed during an approximately 30 to 90-minute outpatient procedure.

The procedure is minimally invasive and performed with two small incisions.

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Additionally, we received a certificate of conformity for commercialization of our Inspire system in the EU in 2010 which allowed us to affix the European Conformity ("CE") mark on our device.

Japan's MLHW approved Inspire therapy to treat moderate to severe OSA in 2018 and was formally added to the Japan National Health Insurance Payment Listing in 2021.

Reimbursement in Singapore is handled through hospital innovation budgets or private health insurance sources .

Japan's MLHW approved Inspire therapy in 2018 and Inspire therapy was approved in Singapore and Thailand in 2025.

To commercialize our Inspire system, we focus on physician and patient awareness and adoption of our Inspire therapy.

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Our direct sales force utilizes strong direct-to-consumer marketing initiatives to create awareness of the benefits of our Inspire system.

We intend to make significant investments building our sales and marketing organization by increasing the number of U.S.

sales representatives and continuing our direct-to-consumer marketing efforts in existing and new markets throughout the U.S.

In Singapore and Hong Kong, our commercialization approach is through exclusive distribution partners, who are responsible for local sales and promotional activities focused on ENT physicians, sleep centers, and community awareness.

We intend to continue to make significant investments in our direct-to-consumer marketing efforts in existing and new markets throughout the U.S.

In Singapore, Hong Kong, and Thailand, our commercialization approach is through exclusive distribution partners, who are responsible for local sales and promotional activities focused on ENT physicians, sleep centers, and community awareness.

We work closely with the distributors to ensure a globally consistent approach and effective employee and customer training are in place.

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One incision is under the lower jaw, where the stimulation lead is attached around a distal branch of the hypoglossal nerve that is responsible for forward movement of the tongue.

A second incision in the upper right chest below the clavicle is used to implant the neurostimulator, which houses all the electronics and battery power for the device, and a pressure sensing lead to monitor the breathing cycle.

The functionality of the Inspire system is tested in the operating room to verify proper placement of the stimulation and pressure sensing leads.

The wires for the electrodes are tunneled under the skin and the incisions are closed.

A second incision in the upper right chest below the clavicle is used to implant the neurostimulator, which houses all the electronics and battery power for the device, and, for the Inspire IV system, a pressure sensing lead to monitor the breathing cycle.

The Inspire V system incorporates the respiratory sensor inside the neurostimulator so a sensing lead is not required.

The functionality of the Inspire system is tested in the operating room to verify proper placement of the lead or leads.

The Inspire system is powered by an internal battery that is designed to last approximately 11 years without needing to be recharged.

After this time, the neurostimulator is replaced during a simple outpatient procedure.

The implantation procedure is performed in an outpatient setting and surgery is completed in approximately 90 minutes.

The implantation procedure is performed in an outpatient setting and surgery is completed in approximately 30 to 90 minutes.

Patients may experience mild discomfort and swelling at the incision sites for a few days that is usually managed with over-the-counter pain medications.

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Patients are allowed to heal for a month before the Inspire system is activated through a wireless connection to the device in the clinician’s office.

The initial activation is performed by the clinician using a programming tablet that is able to turn the system on as well as change various parameters such as the strength, timing, and duration of the stimulation pulse, the stimulating electrode configuration, and the sensitivity of respiration detection.

The initial activation is performed by the clinician using the SleepSync™ programmer that is able to turn the system on as well as change various parameters such as the strength, timing, and duration of the stimulation pulse, the stimulating electrode configuration, and the sensitivity of respiration detection.

With the exception of pulse strength, the factory default settings are used in the majority of patients.

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Select Recent Clinical Results and Studies

Meta-analysis showed Inspire therapy has been effective over time

Do Hyun Kim and colleagues published a meta-analysis of hypoglossal nerve stimulation therapy effectiveness in 2024 in Otolaryngology–Head and Neck Surgery .

Meta-analysis is a statistical method to estimate effect size across data from high quality publications, i.e.

a “study of studies”, and can identify potential trends and consistency across a body of data.

They identified 44 studies (total of 8,670 patients) of sufficient quality for inclusion.

For 12 month follow up, they found that 82% of patients evaluated in this publication had an AHI<15 and a success rate of 80%, where success was defined as the patient’s residual AHI is no greater than half of the baseline AHI, and is also no greater than 20.

A similar trend was reported for three year follow up at which 74% of patients had an AHI<15 and a success rate of 73%.

The authors concluded that hypoglossal nerve stimulation is an effective treatment for obstructive sleep apnea that can significantly improve clinical outcomes over long-term

(three year) follow up.

We note that this meta-analysis included publications using other devices, but most of the data was from Inspire therapy patients.

Meta-analysis showed Inspire therapy is an effective alternative to other airway surgeries

Kim and colleagues published another meta-analysis in the Journal of Sleep Research in 2024 of papers that compared hypoglossal nerve stimulation outcomes to outcomes either from no treatment or from other airway surgeries (e.g., uvulopalatopharyngoplasty).

They identified ten papers (nine of which included only Inspire therapy patients) that met inclusion criteria for a total of 2,209 patients in the analysis.

Among their findings:

compared to airway surgeries and to PAP therapy, hypoglossal nerve stimulation therapy had higher rate of patients achieving AHI<15.

Analysis also showed that the hypoglossal nerve stimulation therapy success rate was higher than the success rate from all other evaluated airway surgeries.

Success was defined as residual AHI no greater than 20 and no greater than half of the baseline AHI.

The results of this meta-analysis suggest that hypoglossal nerve stimulation has shown results comparable to those evaluating PAP, and potentially superior to other airway surgeries, in reducing AHI, and that all therapies have demonstrated similar effectiveness in reducing daytime sleepiness.

The authors conclude that hypoglossal nerve stimulation could be an effective treatment for moderate to severe obstructive sleep apnea patients who are intolerant of PAP.

Post market surveillance data support the safety of Inspire therapy

Inspire partnered with implanting surgeons and sleep physicians to publish an analysis of Inspire’s post-market surveillance data in 2024 in the Journal of Clinical Sleep Medicine .

Medical device manufacturers are mandated by government regulations to collect and monitor adverse events such as surgical revisions or device explants.

Precise estimates of revision and explant rates were calculated by combining the post-market surveillance data with corresponding sales volume.

Of 20,881 Inspire therapy devices implanted at least one year prior to the analysis, 151 devices (0.7%) were explanted and 322 devices (1.5%) required a surgical revision procedure within a year of the implant.

A subset of 5,820 of these devices were implanted three years prior to the analysis, of which 156 devices (2.7%) were explanted, and 207 devices (3.6%) required a revision procedure between one and three years after implant.

Meta-analysis showed many patients with body mass index greater than 32 kg/m 2 benefit from Inspire therapy

Coleton Evans and colleagues published a meta-analysis and systematic review of studies that reported on adult patients who received Inspire therapy for OSA, and that also included analysis on patients above and below BMI of 32 kg/m 2 (a common cutoff for insurance approval).

They identified seven studies encompassing 1,572 patients to include in their systematic review, of which four studies (1,017 patients) were included in the meta-analysis.

The pooled odds ratio for treatment success for BMI ≥ 32 kg/m 2 vs BMI < 32 kg/m 2 was 0.87 (95% confidence interval 0.68 - 1.11).

This suggests no statistically significant difference in surgical success between the BMI groups, and that many patients with BMI ≥ 32 kg/m 2 achieved clinically meaningful objective and subjective improvements with Inspire therapy.

Inspire therapy has been shown to effectively treat supine and non-supine obstructive sleep apnea

Lidice Hernandez and colleagues published a retrospective observational study of 27 patients who had sufficient positional data which showed reductions in both supine and non-supine AHI.

The authors concluded that their findings support the clinical utility of Inspire therapy in both positional dependent and non-positional dependent OSA.

Long term follow-up of Inspire therapy in adolescents with Down syndrome

Danielle Larrow and colleagues published long term follow up data for 33 patients with Down syndrome and OSA.

These patients, implanted as adolescents, were part of the 42 patient cohort whose outcomes (published in 2022) supported Inspire’s expanded indications for teenagers with Down syndrome.

Follow up time averaged four years with a standard deviation of 1.9 years, at which point 29/33 (88%) demonstrated a 50% reduction in AHI, with an average decrease of 60% across all 33 patients.

These data show that adolescents with Down syndrome showed durable improvement in objective measures of their OSA.

Inspire has the potential to improve neurocognitive and psychosocial outcomes

Arman Saeedi and colleagues published Patient Reported Outcome Measurement Information System ("PROMIS") survey results from a cohort of 42 patients (all aged over 50 years) who had Inspire implanted to treat their OSA.

PROMIS surveys are validated and psychometrically sound measures of life domains developed by the U.S.

Department of Health and Human Services.

This cohort showed a reduction from an average AHI of 31 to an average of 14 while using Inspire therapy for an average of seven hours per night.

Their PROMIS scores showed significant post-treatment improvements in sleep impairment, cognitive function, depression, anxiety, anger, and loneliness.

Sales and Marketing

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patients, physicians, and sleep centers.

We sell our Inspire system through a direct sales force that primarily targets ENT physicians and sleep centers in the U.S., Europe, and Japan, and through distributors in Singapore and Hong Kong.

We sell our Inspire system through a direct sales force that primarily targets ENT physicians and sleep centers in the U.S., Europe, and Japan, and through distributors in Singapore, Hong Kong, and Thailand.

The implant procedure for our Inspire therapy is typically performed by an ENT physician or in some cases by a neurosurgeon.

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In addition, because OSA is sometimes diagnosed during other procedures, we have developed programs to help educate general practitioners and specialists in other fields, such as cardiovascular surgeons, electrophysiologists, and dentists, regarding our Inspire therapy.

We have 335 sales territories in the U.S.

and 25 outside of the U.S.

We continue to make significant investments in our sales and marketing organization by increasing the number of sales support personnel.

In 2025, we began optimizing our sales model through targeted territory consolidation and increased field clinical representatives ("FCRs"), consistent with our strategy of a ratio of 1:1 territory manager to FCR.

This enables territory managers to focus on therapy awareness, surgeon recruiting and training, and driving the adoption of Inspire therapy, while FCRs provide technical and clinical expertise as well as educational and field support.

As of December 31, 2025, we had 295 U.S.

sales territories and 275 U.S.

FCRs, as compared with 335 U.S.

sales territories and 230 U.S.

FCRs as of December 31, 2024.

Outside of the U.S., we had 21 and 25 sales territories at December 31, 2025 and 2024, respectively.

We seek to recruit sales representatives with strong sales backgrounds, direct experience developing markets with new technologies, and core knowledge of medical device coding, reimbursement, and the prior authorization process.

In certain Asian markets, we rely on our distribution partners for local sales and promotional activities.

We believe that direct patient education is essential to our ability to become a mainstay therapy which is why we intentionally invest in a robust direct-to-consumer marketing program.

We reach patients through national TV (both linear and streaming), Facebook, Google, and other high-performing digital channels.

Our goal is to ensure that all eligible OSA patients are aware of the therapy, can learn more on our website, and get connected with a doctor in their area to see if the therapy is right for them.

We believe that our direct-to-consumer program continues to be highly effective in driving patient engagement and conversion.

We also have the Inspire Sleep app for patients' smartphones.

This app is an educational tool for patients and also interfaces with our SleepSync TM platform to allow physicians to collect clinical data from patients directly.

We continue to enhance the functionality of this app as part of our overall digital platform development.

Direct patient education remains a core growth strategy for us.

Our marketing investments focus on efficiently reaching qualified patients across high‑impact channels and the InspireSleep.com website, where they can better understand OSA, learn about Inspire therapy as a proven option for OSA treatment, and get connected with trained providers in their area.

Through our tested direct-to-patient messaging, we aim to bring advanced medical

topics to an approachable level for patient consumers, We leverage more than a decade of real‑world outcomes and patient stories to demonstrate therapy effectiveness and benefits that can only be achieved by a therapy that has been shown to be used consistently by patients night after night, accelerating patient interest and activation.

These efforts continue to support strong awareness, engagement, and conversion.

We continue to refine our communication to health care professionals to reinforce Inspire’s value proposition and support ongoing clinical adoption.

The Inspire app remains an important tool for patient education and provider insight through its integration with SleepSync™.

Going forward, we expect to further optimize our targeting, strengthen our brand platform across all audiences, and maintain a consistent level of marketing investment.

We operate a call center, known as the Inspire Advisor Care Program, which assists patients in connecting with a qualified healthcare provider based on their specific needs.

The program also uses a digital scheduling capability that streamlines and simplifies patient access to care.

We plan to continue enhancing and expanding this scheduling capability throughout 2026.

Commercial Activities Outside of the U.S.

Our general practice is to limit commercial investments in countries until such time as there is a determined reimbursement pathway.

We have 25 sales territories in Europe and Japan, and we sell our products through distributors in Singapore and Hong Kong.

We have 21 sales territories in Europe and Japan, and we sell our products through distributors in Singapore, Hong Kong, and Thailand.

We provide consistent training in geographies outside of the U.S.

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and have established a support team in Europe and Japan for patient outreach and education, implant support, and device programming.

In Singapore and Hong Kong, we assist our distribution partners with patient outreach and education initiatives.

In areas in which we use distributors, we assist our distribution partners with patient outreach and education initiatives, as well as with remote implant support and post-implant titration.

We expect to continue to scale our commercial activities in Europe as we continue to develop country-wide reimbursement in additional markets.

We also have regulatory approval in Thailand and are currently pursuing regulatory approval in Korea.

We are currently pursuing regulatory approval in Korea.

Third-Party Reimbursement

Our market access team is responsible for all of our reimbursement processes and initiatives.

Our team of professionals are focused on all key aspects of reimbursement, which include coding, payment, coverage, and prior authorization.

Our team of professionals are focused on all key aspects of reimbursement, which include prior authorization, coding, coverage, and payment.

Coding and Payment

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These customers in turn bill various third-party payors, such as commercial payors and Medicare, for the cost required to treat each patient.

These costs and the related reimbursements for aspects of the Inspire IV and Inspire V therapies can vary and are not the same across commercial payors and government payors.

In addition, there are currently, and can be in the future, different codes, modifiers (where applicable), and processes (such as prior authorization) used for our Inspire therapy given the variety of payors.

Our customers and providers also have many different models that may result in coding and reimbursement decisions having more or less impact on our revenues and results of operations (for example, fee-for-service and value-based care models).

Third-party payors require physicians and hospitals to identify the service for which they are seeking reimbursement by using Current Procedural Terminology (“CPT") codes, which are created and maintained by the American Medical Association.

The procedures performed to implant, revise, or explant our Inspire IV device are described for billing purposes using Category I CPT codes (64582, 64583, and 64584, respectively) to identify hypoglossal nerve stimulator services.

A Category I code (42975) is used for DISE, which may be a necessary procedure to determine which patients are appropriate for Inspire therapy.

Physician reimbursement under Medicare is based on a defined fee schedule, the Medicare Physician Fee Schedule, through which payment amounts are determined by the relative values of the professional service rendered.

Medicare provides reimbursement to our hospital and ASC customers under the outpatient prospective payment system and ASC prospective payment system, respectively, which provide bundled amounts generally intended to reimburse the hospital or ASC for all facility costs related to procedures performed in the outpatient setting.

Medicare provides reimbursement to our hospital and ASC customers under the outpatient prospective payment system and ASC prospective payment system, respectively, which provide bundled amounts generally intended to reimburse the hospital or ASC for device and facility costs related to procedures performed in the outpatient setting.

Reimbursement rates from commercial payors vary depending on the procedure performed, the commercial payor, contract terms, and other factors.

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We have been successful in helping our customers and patients pursue prior authorization approvals from most commercial payors for the Inspire device and procedure.

Historically, commercial payors, including Medicare Advantage plans, cover approximately 65% to 70% of Inspire implants in the U.S.

Historically, commercial payors cover approximately 45% to 50% of Inspire implants in the U.S.

Medicare Advantage, which is also managed by the private commercial health care plans, covers approximately 15% to 20% of Inspire implants.

We estimate that the majority of patients who meet the FDA-approved indication for Inspire therapy are covered by commercial insurance companies and we have secured coverage policies with all major national commercial payors.

All seven MACs provide coverage of Inspire therapy when certain coverage criteria are met.

In terms of government program coverage, all seven MACs provide coverage of Inspire therapy when certain coverage criteria are met.

Fee-for-service Medicare beneficiaries have historically accounted for approximately 25% to 30% of all Inspire system implantations in the U.S.

In addition, we have a contract with the U.S.

government that covers implantations of our Inspire system performed in Veterans Affairs and military hospitals, which account for approximately 5% of all Inspire system implantations historically in the U.S.

government that covers implantations of our Inspire system performed in Veterans Affairs and military hospitals, which account for approximately 5% to 10% of all Inspire system implantations historically in the U.S.

Prior Authorization Approval Process

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We believe our prior authorization team is highly effective in working with patients and physicians to support prior authorizations for our Inspire system, including assisting with the appeals process in the event of a denial.

Our customers have received thousands of prior authorization approvals from all of the largest commercial payors in the U.S., for example Elevance (formerly Anthem), Cigna, Blue Cross Blue Shield, and United Healthcare.

Our customers have received thousands of prior authorization approvals from all of the largest commercial payors in the U.S.

We believe we will continue to benefit from this efficient prior authorization process.

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in 2017, and in Europe in 2018.

Our next generation of the Inspire neurostimulator, Inspire V, was approved by the FDA in 2024, and our updated SleepSync™ programmer was approved by the FDA in 2023.

Our Bluetooth®-enabled patient remote control was approved by the FDA in 2021 and the initial commercial launch occurred in 2022.

Our latest generation of the Inspire neurostimulator, Inspire V, was approved by the FDA in 2024, and our updated SleepSync™ programmer was approved by the FDA in 2023.

Our Bluetooth®-enabled patient remote control was approved by the FDA in 2021.

We have launched a cloud-based patient management system called the SleepSync™ platform, which allows physicians to monitor patient compliance and more efficiently coordinate patient care.

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Enrollment of 600 patients in the study was completed in early 2024.

The results of this study suggest that approximately 10% of patients with OSA have complete concentric collapse ("CCC").

In general, the patients with CCC were younger, had a higher BMI, a larger neck circumference, and a higher baseline AHI.

Patients with CCC were also more likely to be male as compared to the non-CCC patients.

A CART model, combining BMI and neck circumference, was the most accurate prediction of non-CCC, indicating that patients with a BMI of less than 28 or BMI of less than 32 with a neck circumference of less than 17.7 inches were unlikely to have CCC.

We believe these results suggest that these patients may not need to undergo DISE screening for CCC.

Our industry is subject to rapid change from the introduction of new products, technologies, pharmaceuticals, and various activities of industry participants.

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In the U.S., Inspire therapy is only indicated for patients who have been confirmed to fail or cannot tolerate PAP treatments, such as CPAP.

Within the treatment market for patients with moderate to severe OSA, we compete with providers of CPAP or other types of PAP devices, which include ResMed Inc., Philips BV, Fisher & Paykel Healthcare Corporation Limited, and various regional and new-entrant manufacturers.

While we are second-line to PAP therapies, there remains some competition with PAP therapies as sleep physicians often remain committed to prescribing PAP despite poor patient adherence to therapy.

Our specific PAP-related competitors include ResMed Inc., Philips BV, Fisher & Paykel Healthcare Corporation Limited, and various regional and new-entrant manufacturers.

Currently, we have only one direct neurostimulation competitor in the US for the treatment of OSA, Nyxoah SA and its subsidiary Nyxoah, Inc.

Nyxoah provides an open-loop, bilateral stimulation system that does not include a respiratory sensor.

Indications for this device differ partially from those for Inspire.

In 2025, LivaNova PLC ("LivaNova") also submitted an application to the FDA to market a hypoglossal nerve stimulation device in the U.S.

Additionally, we compete with various other second-line therapies to treat OSA, including invasive surgical treatment options such as uvulopalatopharyngoplasty ("UPPP"), maxillomandibular advancement ("MMA"), robotic tongue reduction surgery, and, to a lesser extent, oral appliances, which are primarily used in the treatment of mild to moderate OSA.

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Outside of the U.S., in addition to the Inspire therapy, other second-line therapy alternatives that compete with CPAP and PAP include therapies marketed by Nyxoah and LivaNova.

Nyxoah markets an open-loop bilateral hypoglossal nerve stimulation device in certain countries and is seeking FDA approval in the U.S.

LivaNova, which markets a neurostimulation device, is currently undergoing a randomized control trial in the U.S.

Nyxoah markets their open-loop bilateral hypoglossal nerve stimulation device, described above in certain countries, and LivaNova also markets an open-loop neurostimulation device outside the U.S.

Additionally, a drug candidate produced by Apnimed is undergoing a Phase 3 clinical trial to assess the viability of its pharmaceutical to treat OSA.

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Some of the issued foreign patents and pending foreign patent applications preserve an opportunity to pursue patent rights in multiple countries.

There is no active patent litigation involving any of our patents and we have not received any notices of patent infringement.

We are currently a party to multiple adversarial proceedings with Nyxoah regarding our patent portfolio.

For additional information, see Note 11, Commitments and Contingencies to the consolidated financial statements included elsewhere in this Form 10-K.

As of December 31, 2025, we had 178 pending and registered trademark filings worldwide, some of which may apply to multiple countries.

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Our pending patent applications may not result in issued patents, and we cannot ensure that any current or subsequently issued patents will adequately protect our products or provide us with any competitive advantage.

While there is no active litigation involving any of our patents or other intellectual property rights and we have not received any notices of patent infringement, we may be required to enforce or defend our intellectual property rights against third parties in the future.

See Part I, "Item 1A.

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Our suppliers manufacture the components they produce for us and test our components and devices to our specifications.

We intend to maintain sufficient levels of inventory to enable us to continue our operations while we obtain another supplier in the event that one or more of our single-source suppliers were to encounter a delay in supply or end supply.

We have experienced and continue to experience supply disruptions that began during the COVID-19 pandemic, but to date we have managed to avoid major delays in implant procedures due to those issues.

We intend to maintain sufficient levels of inventory to enable us to continue our operations while we obtain another

supplier in the event that one or more of our single-source suppliers were to encounter a delay in supply or end supply.

We have experienced supply disruptions that began during the COVID-19 pandemic, but to date we have managed to avoid major delays in implant procedures due to those issues.

During the third quarter of 2023 and into the first half of 2024, we experienced an inventory supply issue related to our polyurethane-based stimulation leads, one component of the Inspire system currently used only in the European market, as a result of delays in the EU MDR certification process.

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See Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview” for additional information.

Our products are shipped directly to our U.S.

customers and to our distributors on a purchase order basis, primarily by a third-party vendor with facilities in California and North Carolina, although we do ship some products from our facility in Minnesota.

Warehousing and shipping operations for our European customers are handled by a third-party vendor with a facility located in the Netherlands, and warehousing and shipping operations for our Japanese customers are handled by a third-party with a facility in Japan.

Customers do not have the right to return a non-defective product, nor do we place product on consignment.

Our sales representatives do not maintain trunk stock.

Government Regulation

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These regulatory requirements subject our products and our business to numerous risks that are specifically discussed within Part I, Item 1A, “Risk Factors” within this Annual Report on Form 10-K.

Our products and our operations are subject to extensive regulation by the FDA and other federal and state authorities in the U.S., as well as comparable authorities in the European Economic Area ("EEA"), Japan, and in Thailand and Australia (where our products are approved for sale but where we have not yet commercialized

Our products and our operations are subject to extensive regulation by the FDA and other federal and state authorities in the U.S., as well as comparable authorities in the European Economic Area ("EEA"), Japan, and in Thailand, South Korea and Australia (where our products are approved for sale but where we have not yet commercialized them).

In the U.S., our products are subject to regulation as medical devices under the Federal Food, Drug, and Cosmetic Act ("FDCA") as implemented and enforced by the FDA.

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We expect additional state, federal, and foreign healthcare reform measures to be adopted in the future, which may adversely affect our business.

For additional information, see Part I, Item 1A, “Risk Factors - Healthcare policy changes, including recently enacted legislation reforming the U.S.

healthcare system, could harm our business, financial condition and results of operations.”

For additional information, see Part I, Item 1A, “Risk Factors - Current and future healthcare reform legislation or regulation may increase the difficulty and cost for us to commercialize our products and could harm our business, financial condition and results of operations.”

FDA Premarket Clearance and Approval Requirements

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Under the FDCA, medical devices are classified 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 manufacturer and regulatory control needed to ensure its safety and effectiveness.

Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the FCA's Quality System Regulation ("QSR"), facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials.

includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the FDA's Quality Management System Regulation ("QMSR"), facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials.

Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.

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The PMA must also contain a full description of the device and its components, a full description of the methods, facilities and controls used for manufacturing, and proposed labeling.

If the FDA accepts a submitted PMA application for substantive review, it has 180 days under the FDCA to complete its review, although in practice, the FDA’s review

often takes significantly longer.

In addition, the FDA will generally conduct a preapproval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing facility or facilities to ensure compliance with the QSR.

If the FDA accepts a submitted PMA application for substantive review, it has 180 days under the FDCA to complete its review, although in practice, the FDA’s review often takes significantly longer.

The FDA will approve the device for commercial distribution if it determines that the data and information in the PMA constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s).

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During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, study monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping, and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for them.

Additionally, after a study begins, the sponsor, the FDA or the IRB

could suspend or terminate a clinical study at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits.

Additionally, after a study begins, the sponsor, the FDA or the IRB could suspend or terminate a clinical study at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits.

Expedited Development and Review Programs

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• establishment registration and device listing with the FDA;

• QSR requirements, which currently require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the design and manufacturing process;

• QMSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the design and manufacturing process;

• labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced, provide adequate directions for use, and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling;

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• post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect public health or to provide additional safety and effectiveness data for the device.

Our manufacturing processes are required to comply with the applicable portions of the QSR, which currently cover the methods and the facilities, controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished devices intended for human use.

The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files.

Our manufacturing processes are required to comply with the applicable portions of the QMSR, which currently cover the methods and the facilities, controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished devices intended for human use.

The QMSR also requires, among other things, maintenance of a medical device master file and complaint files.

As a manufacturer, our facilities, records, and manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA.

Our failure to maintain compliance with the QSR or other applicable regulatory requirements could result in the shut-down of, or restrictions on, our manufacturing operations and the recall or seizure of our products.

Our failure to maintain compliance with the QMSR or other applicable regulatory requirements could result in the shut-down of, or restrictions on, our manufacturing operations and the recall or seizure of our products.

The discovery of previously unknown problems with any of our products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.

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The validity of our certificates, initially granted under the AIMDD, has been extended by virtue of the amendment to the EU Medical Devices Regulation, specifically Regulation (EU) 2023/607 as regards the transitional provisions for certain medical devices.

Surveillance of the initial AIMDD certificate has been

transferred from our original notified body BSI, to our current notified body DEKRA.

Surveillance of the initial AIMDD certificate has been transferred from our original notified body BSI, to our current notified body DEKRA.

This makes it possible for us to sell off inventory that is CE marked and labeled under the AIMDD.

The Inspire system is also now CE marked under the EU Medical Devices Regulation.

Unlike the EU Medical Devices Directive, the EU Medical Devices Regulation is directly applicable in EU member states without the need for member states to implement into national law.

Unlike the EU Medical Devices Directive and Active Implantable Medical Device Directive, the EU Medical Devices Regulation is directly applicable in EU member states without the need for member states to implement into national law.

In the EU, there is currently no premarket government review of medical devices.

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A notified body would typically audit and examine a product’s technical dossiers and the manufacturer’s quality system.

If satisfied that the relevant product conforms to the relevant general safety and performance requirements, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity.

If satisfied that the relevant product conforms to the relevant general safety and performance requirements, the notified body issues a certificate of conformity, which

the manufacturer uses as a basis for its own declaration of conformity.

The manufacturer may then apply the CE mark to the device, which allows the device to be placed on the market throughout the EU.

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Manufacturers are also notably responsible for entering the necessary data on Eudamed, which includes the UDI database, and for keeping it up to date.

Certain obligations for registration in Eudamed are expected to become applicable in Q1 2026 (as Eudamed is not yet fully functional).

Until Eudamed is fully functional, the corresponding provisions of the EU Medical Devices Directive and the AIMDD continue to apply for the purpose of meeting the obligations laid down in the provisions regarding exchange of information, including, and in particular, information regarding registration of devices and economic operators.

The obligations for registration in EUDAMED will become applicable on May 28, 2026 (for the first four modules related to (i) economic operators, (ii) UDI/devices registrations, (iii) NB/Certificates, and (iv) market surveillance).

Until the effective date, respectively until Eudamed is fully functional with regard to other modules, the corresponding provisions of the EU Medical Devices Directive and the AIMDD, respectively national provisions, continue to apply for the purpose of meeting the obligations laid down in the provisions regarding exchange of information, including, and in particular, information regarding registration of devices and economic operators.

All manufacturers placing medical devices into the market in the EU must comply with the EU medical device vigilance system.

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Since January 1, 2021, the Medicines and Healthcare Products Regulatory Agency (“MHRA”) has become the sovereign regulatory authority responsible for Great Britain (i.e.

England, Wales and Scotland) medical device market according to the requirements provided in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) that sought to give effect to EU Medical Devices Directive and AIMDD whereas Northern Ireland continues to be governed by EU rules according to the Northern Ireland Protocol.

Following the end of the United Kingdom's ("UK" withdrawal from the EU ("Brexit") transitional period on January 1, 2021, new regulations require all medical devices to be registered with the MHRA before being placed on the Great Britain market.

England, Wales and Scotland) medical device market according to the requirements provided in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended)("UK Medical Devices Regulations") that sought to give effect to EU Medical Devices Directive and AIMDD whereas Northern Ireland broadly continues to be governed by EU rules according to the Northern Ireland Protocol.

Following the end of the United Kingdom's ("UK" withdrawal from the EU ("Brexit") transitional period on January 1, 2021, all medical devices are required to be registered with the MHRA before being placed on the Great Britain market.

The MHRA only registers devices where the manufacturer or their UK responsible person has a registered place of business in the UK.

Beginning January 1, 2022, manufacturers based outside the UK need to appoint a UK responsible person that has a registered place of business in the UK to register devices with the MHRA.

On June 26, 2022, the MHRA published its response to a 10-week consultation on the post-Brexit regulatory framework for medical devices and diagnostics.

MHRA seeks to amend the UK Medical Devices Regulations 2002 (which are based on EU legislation, primarily the EU Medical Devices Directive and the EU In Vitro Diagnostic Medical Devices Directive 98/79/EC), in particular to create new access pathways to support innovation, create an innovative framework for regulating software and artificial intelligence as medical devices, reform IVD regulation, and foster sustainability through the reuse and remanufacture of medical devices.

Regulations implementing the new regime were originally scheduled to come into force in July 2023, but the MHRA confirmed that the core elements of the new framework are now expected to be in place in 2025.

In addition, on November 14, 2024, the MHRA launched a new consultation on proposals to update the regulatory framework for medical devices in Great Britain.

The MHRA consultation was opened until January 5, 2025, and it is expected that secondary legislation implementing the proposals would be introduced in 2025.

Since January 1, 2022, manufacturers based outside the UK need to appoint a UK responsible person that has a registered place of business in the UK to register devices with the MHRA.

On June 16, 2025, an amendment to the UK Medical Devices Regulations came into force intended to clarify and strengthen the post-market surveillance requirements for medical devices in Great Britain.

This amendment aims to facilitate greater traceability of incidents and trends enabling the MHRA to act swiftly when needed to address safety issues and support the entire health system in better protecting patients.

Under the UK Medical Devices Regulations, in order to be lawfully placed on the Great Britain market, class I (non-sterile, non-measuring or non-re-useable) medical devices need to be “UKCA” self-certified, and other medical devices need to be “UKCA”

certified by a UK approved body.

However, certain medical devices in compliance with:

(1) the EU Medical Devices Directive can continue to be placed on the Great Britain market until the sooner of certificate expiration or June 30, 2028;

or (2) the EU Medical Devices Regulation can continue to be placed on the Great Britain market until June 30, 2030.

The MHRA has confirmed that it intends to launch a consultation regarding the indefinite recognition of such medical devices in Great Britain which is expected this year.

In addition, the trade deal between the UK and the EU generally provides for cooperation and exchange of information between the parties in the areas of product safety and compliance, including market surveillance, enforcement activities and measures, standardization-related activities, exchanges of officials, and coordinated product recalls.

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Such assessment may be conducted by an EU notified body, in which case a CE mark is required before placing the device on the market in the EU or Northern Ireland.

Alternatively, if a UK notified body conducts such assessment, a “UKNI” mark is applied, and the device may only be placed on the market in Northern Ireland and not the EU.

Alternatively, if a UK notified body conducts such assessment, a “UKNI” mark and a CE mark are applied, and the device may only be placed on the market in Northern Ireland and not the EU.

Similarly, we are subject to regulations and product registration requirements in many foreign countries in which we may sell our products, including in the areas of:

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The majority of states also have anti-kickback laws which establish similar prohibitions and in some cases may apply more broadly to items or services covered by any third-party payor, including commercial insurers and self-pay patients.

knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government.

The federal civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment or approval to the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government.

A claim includes “any request or demand” for money or property presented to the U.S.

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Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

More generally, expansion in the government’s role in the U.S.

healthcare industry has led to (and may in the future lead to) additional regulation and oversight that impacts us.

A recent example is the Wasteful and Inappropriate Service Reduction Model (“WISeR”) by CMS which tests the use of enhanced technology such as AI and machine learning to assess coverage determinations for a select set of items and services, including implantation of electric nerve stimulators, that CMS has determined (1) may pose concerns related to patient safety if delivered inappropriately, (2) have existing publicly available coverage criteria, or (3) may involve prior reports of fraud, waste, and abuse.

WISeR will run for six performance years from January 1, 2026 to December 31, 2031 in six states:

New Jersey, Ohio, Oklahoma, Texas, Arizona and Washington.

So far, the impact on our overall sales volumes from WISeR cannot be quantified, but it has caused some confusion among customers in the six states that are part of the program.

Many foreign countries have similar laws relating to healthcare fraud and abuse.

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In the U.S., the federal Physician Payments Sunshine Act imposes annual reporting requirements on certain drug, biologics, medical supplies and device manufacturers for which payment is available under Medicare, Medicaid or CHIP for payments and other transfers of value provided by them, directly or indirectly, to physicians, as defined by statute, certain other non-physician practitioners such as physician assistants and nurse practitioners, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

Manufacturers must submit reports by the 90th day of each calendar year.

Also, many U.S.

states have similar fraud and abuse statutes or regulations that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs.

In the EU, there has also been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU

member states have adopted national "Sunshine Acts" which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the United States, on medical device manufacturers.

In the EU, there has also been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU member states have adopted national "Sunshine Acts" which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the United States, on medical device manufacturers.

Certain foreign countries and U.S.

states also mandate implementation of commercial compliance programs, impose restrictions on device manufacturer marketing practices and require tracking and reporting of gifts, compensation, and other remuneration to healthcare professionals and entities.

Violation of any of the federal and state healthcare laws described above or any other governmental regulations that apply to device manufacturers may result in significant penalties, including the imposition of significant civil, criminal and administrative penalties, damages, disgorgement, monetary fines, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and/or oversight if the entity becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and curtailment of operations.

reputational harm, diminished profits and future earnings, additional reporting requirements and/or oversight if the entity becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and curtailment of operations.

In addition, responding to investigations of alleged violations of healthcare laws can be time-and resource-consuming and can divert management’s attention from the business.

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As of December 31, 2025, we had 1,333 employees, of which 1,243 are in the U.S., 83 are in Europe and 7 are in Japan.

We increased the number of employees by 23% during 2024 to support the rapid growth of our business.

As of December 31, 2024, 49% of our workforce identified as female, and 16% identified as a member of minority racial group.

We increased the number of employees by 7% during 2025 to support the growth of our business.

December 31, 2025, 52% of our U.S.

workforce identified as female, and 15% identified as a member of minority racial group.

None of our employees are currently subject to a collective bargaining agreement or represented by a trade or labor union.

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Code of Business Conduct and Ethics

Inspire is committed to conducting business in accordance with the highest ethical standards and applicable laws.

Inspire is committed to conducting business in accordance with high ethical standards and applicable laws.

We maintain, and all of our employees are expected to adhere to, our Code of Business Conduct and Ethics (the “Code of Conduct”), which serves as the foundation of our company’s culture.

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We believe strongly in providing employees with the opportunity to participate as owners of the company.

All of our full-time employees are eligible to receive stock awards, which may include stock options, restricted stock units, or performance stock units.

Many of our full-time employees are eligible to receive stock awards, which may include stock options, restricted stock units, or performance stock units.

employees are also eligible to elect to participate in our employee stock purchase program.

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Standard U.S.

employee benefits available to all full-time employees include medical, dental, and vision insurance, identity protection, disability insurance, life and AD&D insurance, and paid holidays.

Beginning in 2022, we also incorporated a 401(k)-employer match for all U.S.-based employees.

employee benefits available to all full-time employees include medical, dental, and vision insurance, identity protection, disability insurance, life and AD&D insurance, 401(k) employer match, and paid holidays.

Additionally, we recognize that Inspire employees have diverse needs for time off from work and maintain a flexible time off (“FTO”) policy, which provides all full-time employees the opportunity to take time off as needed without the need to accrue a specific amount of paid time off each year.

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Talent Acquisition

With our aggressive growth objectives, it is imperative that we continue to hire exceptional talent and invest in the growth and development of our existing employees.

To facilitate our continued evolution and growth, it is imperative that we hire exceptional talent and invest in the growth and development of our existing employees.

We develop and set an annual hiring plan to understand and plan for the organization’s talent recruitment and pipeline needs.

Inspire’s growth has required several strategies to attract talent and meet our growth plans, including a strong internal referral network.

We also work with search partners, who meet with our talent acquisition team on a quarterly basis to review and provide up-to-date public information to ensure potential candidates fully understand the potential Inspire can offer.

In addition to sourcing candidates, we also work with search partners as needed.

We encourage internal job movement opportunities for employees to support development.

We follow a defined and consistent interview process for open positions, whether internal or external.

In order to support our talent attraction efforts, we partner externally with organizations, universities, and colleges to assist with identifying talented pipelines.

Internally we continue to build and train hiring leaders on a structured interview process to attract talent.

Internally we continue to build and train hiring managers on a structured interview process to assess talent.

Talent Management

We review our pay practices twice per year for all employees and address any identified gaps.

We are establishing training and development programs focused on decency, dignity and respect in the workplace.

We seek to foster a culture where learning is continuous.

We seek to foster a culture where learning is continuous and curiosity and innovation are encouraged.

We believe in our people and their ability to accept new responsibilities and challenges, and to grow with us to contribute to our success.

Growth is fostered through professional development and learning programs, as well as practical experience leading projects or teams.

New employees joining Inspire are provided with a comprehensive learning path consisting of three key components.

New employees joining Inspire are provided with a comprehensive learning path consisting of two key components.

First, they gain an understanding of our organization, including our products, the customers and patients we serve, and the regulatory requirements to which we are accountable.

Next, training is conducted at the department level to build job role proficiency.

Finally, managers can opt to pair their new employee with a peer level new-hire success mentor to further foster engagement and confidence among new team members.

Next, training is conducted at the department level to build job role proficiency, and peer mentors may be assigned to help with acceleration of learning and onboarding.

On an ongoing basis, employees have the opportunity to engage in professional development to enhance their Inspire-specific knowledge and skills and their business acumen.

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Additionally, one-on-one coaching is available for our leaders through external partners.

On an annual basis, our leadership team participates in a talent review and succession planning exercise to identify organizational needs, development opportunities, and potential future leaders.

This enables us to identify the resources and skill sets needed to meet our growth objectives.

On an annual basis, our leadership team participates in a talent review and succession planning exercise to identify organizational needs, individual development opportunities, and potential future leaders.

This enables us to identify the resources and skill sets needed to meet our growth objectives while encouraging meaningful career and development conversations between leaders and direct reports.

We also review pay twice per year for all employees and address any identified gaps.

Inclusion and Belonging

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All new employees participate in training focused on appropriate, respectful, and inclusive workplace behavior.

We have created a training initiative for all employees which encourages awareness of unconscious bias and microaggressions.

The goals of the training are to encourage broad and diverse viewpoints to achieve the best outcomes for our patients, customers, and employees, and to build awareness of how our own behaviors impact our colleagues.

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In 2023, we launched InspireGives, Inspire’s community outreach program aimed at serving the communities in which we live and operate through financial donations and volunteerism.

Our contributions seek to provide crucial assistance to charitable organizations striving to treat critical illnesses, combat poverty and homelessness, ease hardship for people affected by disasters, eliminate barriers to equal opportunity, and support underserved communities to address inequities in health outcomes.

Our contributions seek to provide crucial assistance to charitable organizations striving to treat critical illnesses, combat poverty and homelessness, ease hardship for people affected by disasters, eliminate barriers to equal opportunity, promote healthy sleep, and support underserved communities to address inequities in health outcomes.

Our employees are passionate about improving the lives of others, so we provide channels for our team members to identify opportunities to engage with charitable organizations and events in our communities.

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To that end, we have implemented a corporate sustainability program and set sustainability objectives.

We published our third Sustainability Report in May 2024, which is available on our website, and expect to continue reporting on our progress to our various stakeholders annually.

We published our fourth Sustainability Report in 2025,

which is available on our website, and expect to continue reporting on our progress to our various stakeholders annually.

Available Information

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We also make these filings available, free of charge, under the Investor Relations section of our website at www.inspiresleep.com as soon as reasonably practicable after we electronically file such material with, or furnish such material to, the SEC.

Our Corporate Governance Guidelines, Code of Business Conduct and Ethics, ESG Report, and the charters for the committees of our Board of Directors are also available free of charge at https://investors.inspiresleep.com.

Information on our website, including our Corporate Governance Guidelines, Code of Business Conduct and Ethics, ESG Report, and committee charters, is not part of this or any other report we file with, or furnish to, the SEC.

Our Corporate Governance Guidelines, Code of Business Conduct and Ethics, Sustainability Report, and the charters for the committees of our Board of Directors are also available free of charge at https://investors.inspiresleep.com.

Information on our website, including our Corporate Governance Guidelines, Code of Business Conduct and Ethics, Sustainability Report, and committee charters, is not part of this or any other report we file with, or furnish to, the SEC.

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.

What changed 10-K

Item 1. Business