Inogen Receives FDA 510(k) Clearance for SIMEOX 200 Airway Clearance Device
Inogen (NASDAQ: INGN) has received FDA 510(k) clearance for its SIMEOX 200 Airway Clearance Device, expanding its respiratory product portfolio in the U.S. market. The device, which is an upgraded version of the original Simeox, uses high-frequency oscillatory vibrations and intermittent negative pressure during exhalation to enhance bronchial drainage in patients with chronic lung diseases such as Bronchiectasis, COPD, Cystic Fibrosis, and Primary Ciliary Dyskinesia.
The device is designed for patients capable of independently generating cough and can be used both in healthcare facilities and at home. Inogen plans a launch of SIMEOX 200 in targeted sites in 2025.
Inogen (NASDAQ: INGN) ha ricevuto l'approvazione FDA 510(k) per il suo SIMEOX 200 Dispositivo per la Pulizia delle Vie Aeree, ampliando il suo portafoglio di prodotti respiratori nel mercato statunitense. Il dispositivo, che è una versione aggiornata del Simeox originale, utilizza vibrazioni oscillanti ad alta frequenza e pressione negativa intermittente durante l'espirazione per migliorare il drenaggio bronchiale nei pazienti con malattie polmonari croniche come Bronchiectasia, BPCO, Fibrosi Cistica e Dischinesia Ciliare Primaria.
Il dispositivo è progettato per pazienti in grado di generare autonomamente la tosse e può essere utilizzato sia nelle strutture sanitarie che a casa. Inogen prevede il lancio del SIMEOX 200 in luoghi selezionati nel 2025.
Inogen (NASDAQ: INGN) ha recibido la aprobación 510(k) de la FDA para su Dispositivo de Limpieza de Vías Respiratorias SIMEOX 200, ampliando su cartera de productos respiratorios en el mercado estadounidense. El dispositivo, que es una versión mejorada del Simeox original, utiliza vibraciones de oscilación de alta frecuencia y presión negativa intermitente durante la exhalación para mejorar el drenaje bronquial en pacientes con enfermedades pulmonares crónicas como Bronquiectasia, EPOC, Fibrosis Quística y Discinesia Ciliar Primaria.
El dispositivo está diseñado para pacientes capaces de generar tos de manera independiente y se puede utilizar tanto en instalaciones de atención médica como en casa. Inogen planea lanzar el SIMEOX 200 en lugares seleccionados en 2025.
이노겐 (NASDAQ: INGN)은 미국 시장에서 호흡기 제품 포트폴리오를 확장하는 SIMEOX 200 기도 청소 장치에 대한 FDA 510(k) 승인을 받았습니다. 이 장치는 원래의 시메옥 버전을 업그레이드한 것으로, 고주파 진동과 호기 중의 간헐적인 음압을 이용하여 기관지 확장증, COPD, 낭포성 섬유증, 원발성 섬모 운동 이상증과 같은 만성 폐 질환 환자들의 기관지 배수를 향상합니다.
이 장치는 독립적으로 기침을 발생시킬 수 있는 환자를 위해 설계되었으며, 의료 시설과 자택 모두에서 사용할 수 있습니다. 이노겐은 2025년에 SIMEOX 200을 특정 장소에서 출시할 계획입니다.
Inogen (NASDAQ: INGN) a obtenu l'approbation 510(k) de la FDA pour son Dispositif de Nettoyage des Voies Respiratoires SIMEOX 200, élargissant ainsi son portefeuille de produits respiratoires sur le marché américain. Ce dispositif, qui est une version améliorée de l'original Simeox, utilise des vibrations oscillatoires à haute fréquence et une pression négative intermittente pendant l'expiration pour améliorer le drainage bronchique chez les patients atteints de maladies pulmonaires chroniques telles que Bronchiectasie, BPCO, Fibrose Kystique et Dyskinésie Ciliaire Primaire.
Le dispositif est conçu pour les patients capables de générer de manière autonome une toux et peut être utilisé à la fois dans les établissements de santé et à domicile. Inogen prévoit de lancer le SIMEOX 200 dans des sites ciblés en 2025.
Inogen (NASDAQ: INGN) hat von der FDA die 510(k)-Zulassung für sein SIMEOX 200 Atemwegsreinigungsgerät erhalten, wodurch das Produktportfolio im Bereich der Atemtherapie auf dem US-Markt erweitert wird. Das Gerät, das eine verbesserte Version des ursprünglichen Simeox ist, nutzt hochfrequente oszillierende Vibrationen und intermittierenden Unterdruck während der Exhalation, um die bronchiale Drainage bei Patienten mit chronischen Lungenerkrankungen wie Bronchiektasie, COPD, Mukoviszidose und primärer ziliärer Dyskinesie zu verbessern.
Das Gerät ist für Patienten konzipiert, die in der Lage sind, selbstständig zu husten, und kann sowohl in Gesundheitseinrichtungen als auch zu Hause verwendet werden. Inogen plant die Einführung des SIMEOX 200 in ausgewählten Standorten im Jahr 2025.
- FDA 510(k) clearance received for SIMEOX 200 device
- Product expansion into U.S. market with next-generation technology
- Leveraging existing healthcare provider and B2B partner network for distribution
- launch planned for 2025 indicates delayed revenue impact
- Initial restricted deployment to targeted sites may limit initial market penetration
Insights
The FDA 510(k) clearance for SIMEOX 200 represents a strategic expansion into the airway clearance device market. This device employs advanced technology combining high-frequency oscillatory vibrations with intermittent negative pressure - a sophisticated approach compared to traditional airway clearance methods. The key differentiator lies in its effectiveness in low lung volumes, addressing a critical gap in current treatment options.
The target market is substantial, encompassing patients with Bronchiectasis, COPD, Cystic Fibrosis and Primary Ciliary Dyskinesia. In the U.S. alone, COPD affects approximately 15.7 million people, while Bronchiectasis impacts about 340,000-522,000 patients. The home-use capability significantly expands the potential market reach and aligns with the growing trend toward home healthcare solutions.
The planned launch in 2025 suggests a cautious, controlled rollout strategy to gather real-world data and refine market approach. Leveraging existing healthcare provider networks and B2B partnerships should accelerate market penetration, though revenue impact may take 12-18 months to materialize meaningfully.
The respiratory care device market is projected to reach
For investors, this represents a calculated move into a complementary market segment with strong growth potential. The device's dual-use capability (healthcare centers and home use) opens multiple revenue streams. Current market penetration of advanced airway clearance devices is relatively low, suggesting significant growth potential, particularly in the home care segment where Inogen already has established distribution channels.
SIMEOX 200 is the next-generation of the original Simeox (currently available in select international markets). It is intended to promote and improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough. SIMEOX 200 is predominantly aimed to help patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as Bronchiectasis, COPD (Chronic Obstructive Pulmonary Diseases), Cystic Fibrosis or Primary Ciliary Dyskinesia.
“We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy for patients in the U.S.,” said Kevin Smith, President and Chief Executive Officer. “By tapping into our well-established network of healthcare providers, B2B partners, and our Direct-to-Patient team, we aim to bring this next-generation airway clearance device to patients within the next year and significantly expand our reach over time.”
Traditional airway clearance therapies can be time consuming and constraining with mixed results. SIMEOX 200 provides an innovative alternative, delivering efficient bronchial drainage, specifically in low lung volumes, that can be administered in healthcare centers and institutions, as well as at home.
Inogen plans to pursue a limited launch of SIMEOX 200 in targeted sites in 2025.
About Inogen
Inogen, Inc. (Nasdaq: INGN) is a leading global medical technology company offering innovative respiratory products for use in the homecare setting. Inogen supports patient respiratory care by developing, manufacturing, and marketing innovative best-in-class respiratory therapy devices used to deliver care to patients suffering from chronic respiratory conditions. Inogen partners with patients, prescribers, home medical equipment providers, and distributors to make its respiratory therapy products widely available, allowing patients the chance to manage the impact of their disease.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this communication that are not historical facts, including, but not limited to, statements regarding Inogen’s future business plans, market opportunities, financial outlook, growth strategies, and anticipated operational results, are forward-looking statements. Words such as “aims,” “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from currently anticipated results, including but not limited to, risks and uncertainties relating to market acceptance of its products; competition; its sales, marketing and distribution capabilities; its planned sales, marketing, and research and development activities; interruptions or delays in the supply of components or materials for, or manufacturing of, its products; seasonal variations; unanticipated increases in costs or expenses; risks associated with international operations; and the possibility that Inogen will not realize anticipated revenue from recent or future technology acquisitions or that expenses and costs related thereto will exceed Inogen’s expectations. For a detailed discussion of these and other risks that could impact Inogen’s operations and financial performance, please refer to the “Risk Factors” section of its Annual Report on Form 10-K for the period ended December 31, 2023, its Quarterly Report on Form 10-Q for the calendar quarter ended March 31, 2024 and in its other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Inogen disclaims any obligation to update these forward-looking statements except as may be required by law.
For more information, please visit www.inogen.com.
Inogen has used, and intends to continue to use, its Investor Relations website, http://investor.inogen.com/, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241230561271/en/
Source: Inogen, Inc.
FAQ
When will Inogen (INGN) launch the SIMEOX 200 device in the US market?
What conditions can be treated with Inogen's SIMEOX 200 device?
How does the SIMEOX 200 airway clearance device work?
Where can the SIMEOX 200 device be used?
What regulatory approval has INGN received for SIMEOX 200?
