Inogen, Inc. INGN recently announced the FDA 510(k) clearance for the SIMEOX 200 Airway Clearance Device. The clearance is likely to expand INGN’s ability to market the device and meet the various needs of patients with chronic respiratory diseases in the United States.

By leveraging its well-established network of healthcare providers, B2B partners, and direct-to-patient team, Inogen aims to deliver this next-generation airway clearance device to patients within the next year, with plans to significantly expand its reach over time.

Likely Trend of INGN Stock Following the News

Following the announcement, shares of the company moved 6.2% north to $9.11 on Monday. In the past year, INGN’s shares have gained 65.9% compared with the industry’s growth of 5.3%. The S&P 500 has gained 26.4% in the same time frame.

The FDA clearance of the SIMEOX 200 positions Inogen to tap into the large U.S. market for chronic respiratory care, potentially driving significant revenue growth. By offering an innovative, efficient alternative to traditional therapies, the device is likely to attract strong adoption from patients and healthcare providers, boosting sales. Coupled with a strategic limited launch and leveraging its existing distribution networks, this development enhances investor confidence, signaling growth opportunities that could positively impact INGN stock price.

Meanwhile, INGN currently has a market capitalization of $204.4 million. The Zacks Consensus Estimate for fiscal 2024 revenues is pegged at $329.5 million, indicating 4.4% growth from the reported fiscal 2023.

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More on the INGN’s SIMEOX 200 Airway Clearance Device

The SIMEOX 200 Airway Clearance Device by Inogen is an advanced respiratory therapy tool designed to enhance bronchial drainage for patients with chronic respiratory conditions. The device employs high-frequency oscillatory vibrations and intermittent negative pressure during exhalation to mobilize bronchial secretions effectively. It is intended for individuals with chronic obstructive pulmonary disease (COPD), Cystic Fibrosis, Bronchiectasis, and Primary Ciliary Dyskinesia, who can independently generate a cough.

The device is positioned as a superior alternative to traditional airway clearance methods, offering efficient mucus clearance even in low lung volumes. Patients can use it in healthcare settings and at home, making it a versatile and convenient solution.

Inogen plans a targeted launch of the SIMEOX 200 in 2025, leveraging its robust network of healthcare providers, business partners and direct-to-patient outreach. This next-generation device addresses common challenges with conventional therapies, such as time consumption and inconsistent results, offering patients a more reliable and effective experience. By introducing this innovation, Inogen aims to expand its market reach while improving the quality of life for individuals managing chronic respiratory diseases.

The FDA clearance provides Inogen with the regulatory approval needed to market the SIMEOX 200 in the United States, ensuring confidence in its safety and efficacy among healthcare providers and patients. The clearance also allows Inogen to differentiate the device as an innovative solution for chronic respiratory care, positioning it as a preferred choice in a competitive market and paving the way for widespread adoption.

Favorable Industry Prospects for INGN

Per a report by Grand View Research, the global respiratory disease testing market was valued at $6.18 billion in 2022 and is anticipated to witness a CAGR of 2.8% from 2023 to 2030. The constant rising incidence of respiratory diseases due to escalating air pollution levels is the prime factor driving the market's growth. The increasing rate of pollutants in the air and the release of hazardous gases causing lung diseases, including COPD and other respiratory diseases around the world, is driving the growth.

Recent Development for INGN

In October, INGN announced that it had commenced the U.S. market release of the Inogen Rove 4 Portable Oxygen Concentrator. The Rove 4 utilizes Inogen’s patented pulse-dose Intelligent Delivery Technology. This technology provides unparalleled triggering sensitivity to quickly detect a breath and deliver oxygen within the first 250 milliseconds of the inspiration, where oxygen has the most effect on lung gas exchange.

INGN’s Zacks Rank & Other Stocks to Consider

INGN carries a Zacks Rank #2 (Buy) at present.

Some other top-ranked stocks in the broader medical space are Masimo MASI, Accuray ARAY and Abbott Laboratories ABT.

Masimo, sporting a Zacks Rank #2 at present, has an estimated growth rate of 11.8% for 2025. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

MASI’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 17.10%. Its shares have risen 31.7% against the industry’s 1% decline in the past six months.

Accuray, carrying a Zacks Rank #2 at present, has an estimated growth rate of 1200% for 2025. Its earnings missed estimates in three of the trailing four quarters and met in one, delivering an average negative surprise of 141.97%.

ARAY’s shares have gained 8.8% against the industry’s 1% decline in the past six months.

Abbott, carrying a Zacks Rank of 2 at present, has an estimated earnings growth rate of 10% for 2025. It delivered a trailing four-quarter average earnings surprise of 1.64%.

ABT’s shares have risen 8.5% in the past six months compared with the industry’s 7.2% growth.

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