Company: INGN
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029993
Chunk: 2

Company: Inogen Inc
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 2
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 or cylinders for mobile use, which we refer to as the delivery model. The tanks and cylinders must be delivered regularly and contain a finite amount of oxygen, which requires patients to plan activities outside of their homes around delivery schedules and a finite oxygen supply. Additionally, patients must attach long, cumbersome tubing to their stationary concentrators to enable mobility within their homes. 

We believe the following factors have hindered the market acceptance of POCs: 

•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;

•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;

•due to the nature of the capped reimbursement structure, patients' lack of ability to use their insurance benefits to switch from oxygen tanks or liquid deliveries to POCs; and

•constrained manufacturing costs of conventional POCs, driven by home medical equipment provider preference for products that have lower upfront equipment cost. 

Bronchiectasis

We expanded our addressable market opportunity into the bronchiectasis 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. 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. The device is used to treat a condition in the lungs known as bronchiectasis, where the lung’s bronchi become damaged and widened. Bronchiectasis is often present in cystic fibrosis and COPD patients. Simeox is used in pulmonary rehabilitation centers, as well as by patients at home. 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.

We believe that Inogen can potentially access a large growing bronchiectasis market opportunity in the U.S. following receipt of 510(k) clearance for the Simeox 200 device in December 2024. We intend to commercialize Simeox through the purchase of the product initially, followed