Inspira™ Preparing Production in Response to Spread of Respiratory Virus in China
Inspira Technologies (Nasdaq: IINN) announced preparations for potential production ramp-up of its INSPIRA™ ART100 device in response to the human metapneumovirus (hMPV) outbreak in China. The company is engaging with leading providers in affected regions and securing raw materials to meet possible demand increases.
The INSPIRA ART100 device, which received FDA 510(k) clearance and Israeli AMAR certification in June and July 2024 for CBP procedures, offers an alternative to traditional mechanical ventilators. The technology aims to stabilize decreasing oxygen saturation levels without requiring ventilation, while patients remain awake during treatment.
The company's innovative system targets the $19 billion mechanical ventilation market, addressing the needs of 20 million ICU patients with acute respiratory failure annually. The device includes a HYLA™ blood sensor for real-time continuous monitoring without requiring blood samples.
Inspira Technologies (Nasdaq: IINN) ha annunciato la preparazione per un potenziale aumento della produzione del suo dispositivo INSPIRA™ ART100 in risposta all'epidemia di metapneumovirus umano (hMPV) in Cina. L'azienda sta collaborando con fornitori leader nelle regioni colpite e sta assicurando materie prime per soddisfare i possibili aumenti della domanda.
Il dispositivo INSPIRA ART100, che ha ricevuto il nulla osta 510(k) della FDA e la certificazione AMAR israeliana a giugno e luglio 2024 per le procedure CBP, offre un'alternativa ai ventilatori meccanici tradizionali. La tecnologia punta a stabilizzare i livelli di saturazione di ossigeno in diminuzione senza richiedere ventilazione, mentre i pazienti rimangono svegli durante il trattamento.
Il sistema innovativo dell'azienda mira al mercato della ventilazione meccanica da 19 miliardi di dollari, affrontando le esigenze di 20 milioni di pazienti in terapia intensiva con insufficienza respiratoria acuta ogni anno. Il dispositivo include un sensore di sangue HYLA™ per il monitoraggio continuo in tempo reale senza richiedere campioni di sangue.
Inspira Technologies (Nasdaq: IINN) anunció preparativos para un posible aumento en la producción de su dispositivo INSPIRA™ ART100 en respuesta al brote de metapneumovirus humano (hMPV) en China. La empresa está colaborando con proveedores líderes en las regiones afectadas y asegurando materias primas para satisfacer posibles aumentos en la demanda.
El dispositivo INSPIRA ART100, que recibió la autorización 510(k) de la FDA y la certificación AMAR israelí en junio y julio de 2024 para procedimientos de CBP, ofrece una alternativa a los ventiladores mecánicos tradicionales. La tecnología tiene como objetivo estabilizar los niveles de saturación de oxígeno en disminución sin requerir ventilación, mientras los pacientes permanecen despiertos durante el tratamiento.
El sistema innovador de la empresa se dirige al mercado de ventilación mecánica de 19 mil millones de dólares, abordando las necesidades de 20 millones de pacientes en UCI con insuficiencia respiratoria aguda cada año. El dispositivo incluye un sensor de sangre HYLA™ para monitoreo continuo en tiempo real sin requerir muestras de sangre.
Inspira Technologies (Nasdaq: IINN)는 중국의 인간 메타폐렴 바이러스(hMPV) 유행에 대응하기 위해 INSPIRA™ ART100 장치의 잠재적 생산 증가 준비를 발표했습니다. 회사는 피해 지역의 주요 공급업체들과 협력하고 있으며, 가능한 수요 증가에 대비하기 위해 원자재를 확보하고 있습니다.
INSPIRA ART100 장치는 2024년 6월과 7월에 CBP 절차에 대한 FDA 510(k) 승인 및 이스라엘 AMAR 인증을 받았으며, 전통적인 기계 환기 장치에 대한 대안을 제공합니다. 이 기술은 환기가 필요 없이 산소 포화도 감소를 안정화하는 것을 목표로 하며, 환자는 치료 중 깨어 있습니다.
회사의 혁신적인 시스템은 190억 달러 규모의 기계 환기 시장을 목표로 하며, 매년 급성 호흡 부전으로 인한 2000만 명의 중환자실 환자의 요구를 충족합니다. 이 장치는 혈액 샘플이 필요 없는 실시간 연속 모니터링을 위한 HYLA™ 혈액 센서를 포함하고 있습니다.
Inspira Technologies (Nasdaq: IINN) a annoncé des préparations pour une éventuelle augmentation de la production de son dispositif INSPIRA™ ART100 en réponse à l'épidémie de métapneumovirus humain (hMPV) en Chine. L'entreprise collabore avec des fournisseurs leaders dans les régions touchées et s'assure d'avoir les matières premières nécessaires pour faire face à une possible augmentation de la demande.
Le dispositif INSPIRA ART100, qui a reçu le certificat 510(k) de la FDA et la certification AMAR israélienne en juin et juillet 2024 pour les procédures CBP, offre une alternative aux ventilateurs mécaniques traditionnels. La technologie vise à stabiliser les niveaux de saturation en oxygène décroissants sans nécessiter de ventilation, tandis que les patients restent éveillés pendant le traitement.
Le système innovant de l'entreprise cible le marché de la ventilation mécanique de 19 milliards de dollars, répondant aux besoins de 20 millions de patients en soins intensifs souffrant d'insuffisance respiratoire aiguë chaque année. Le dispositif comprend un capteur sanguin HYLA™ pour une surveillance continue en temps réel sans nécessiter d'échantillons de sang.
Inspira Technologies (Nasdaq: IINN) hat Vorbereitungen für eine mögliche Produktionssteigerung seines INSPIRA™ ART100 Geräts angekündigt, um auf den Ausbruch des menschlichen Metapneumovirus (hMPV) in China zu reagieren. Das Unternehmen arbeitet mit führenden Anbietern in den betroffenen Regionen zusammen und sichert Rohstoffe, um mögliche Nachfragesteigerungen zu decken.
Das INSPIRA ART100 Gerät, das im Juni und Juli 2024 die FDA 510(k) Zulassung und die israelische AMAR-Zertifizierung für CBP-Verfahren erhalten hat, bietet eine Alternative zu traditionellen mechanischen Beatmungsgeräten. Die Technologie zielt darauf ab, fallende Sauerstoffsättigungswerte zu stabilisieren, ohne eine Beatmung zu erfordern, während die Patienten während der Behandlung wach bleiben.
Das innovative System des Unternehmens richtet sich an den Markt für mechanische Beatmung im Wert von 19 Milliarden US-Dollar und geht auf die Bedürfnisse von jährlich 20 Millionen Intensivpatienten mit akuter Ateminsuffizienz ein. Das Gerät enthält einen HYLA™ Blutsensor zur kontinuierlichen Echtzeitüberwachung ohne die Notwendigkeit von Blutproben.
- FDA 510(k) clearance obtained for INSPIRA ART100 in June 2024
- Israeli AMAR certification received in July 2024
- Company targeting $19B mechanical ventilation market
- Production capacity ready to scale for potential market demand
- Core products including INSPIRA ART500, Cardi-ART, VORTX, and HYLA not yet tested in humans
- Key technologies still pending regulatory approvals
Insights
The strategic preparation for production ramp-up of the INSPIRA™ ART100 device represents a calculated response to China's hMPV outbreak. The device's FDA 510(k) clearance and Israeli AMAR certification obtained in mid-2024 position Inspira favorably to capitalize on potential demand. However, several critical factors warrant consideration:
The $19 billion mechanical ventilation market opportunity seems promising, but Inspira's
Supply chain readiness and discussions with regional providers demonstrate proactive management, but the company's ability to scale production significantly remains untested. The HYLA™ blood sensor integration adds value through continuous monitoring capabilities, though this component is still in development.
The timing of this announcement aligns with heightened global health concerns, but several market dynamics require examination:
- The company's positioning in the respiratory care market comes during increased attention to respiratory viruses, potentially elevating investor interest
- While the strategic timing is noteworthy, the actual revenue impact remains speculative without concrete orders or partnerships
- The company's small market capitalization suggests production capacity, which could constrain ability to meet sudden demand surges
For context, this preparedness announcement, while positive for market positioning, represents more of a strategic communication than a material business development. Investors should note that the company's core products beyond the ART100 remain in development phases, indicating a need for substantial capital to bring their full product pipeline to market.
RA'ANANA,
Inspira is already in discussions with leading providers in affected regions to evaluate demand for advance respiratory solutions and deployment of the INSPIRA™ ART100 device, ensuring rapid response capabilities in case of increased demand.
As global health authorities monitor the hMPV outbreak, Inspira™ believes that it is well-positioned to meet potential increased demand for advanced respiratory support systems. Inspira is working closely with suppliers to secure necessary raw materials and components to meet potential demand spikes. The Company is following the hMPV situation globally and working to adjust production plans as needed.
"While hMPV is not a new virus, and experts indicate the current outbreak is part of normal seasonal patterns, Inspira believes in being prepared," said Dagi Ben-Noon, CEO of Inspira. "Our increased production capacity will help ensure healthcare providers have access to vital respiratory care equipment should the need arise."
Inspira emphasizes that its preparedness measures are precautionary and align with the Company's commitment to global health readiness. The Company will work closely with health authorities in affected regions and adjust its plans based on the evolving situation.
Inspira™ Technologies OXY B.H.N. Ltd.
Inspira Technologies is an innovative medical technology company in the life support and respiratory treatment arena. The Company has developed a breakthrough Augmented Respiration Technology (INSPIRA™ ART), a groundbreaking device poised to revolutionize the
In June and July 2024, respectively, the Company's INSPIRA™ ART100 system has obtained FDA 510(k) clearance for use in CBP procedures, along with the Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.
The Company's other products and technologies, including the INSPIRA ART also known as the INSPIRA™ ART500 or Gen 2, the INSPIRA™ Cardi-ART portable modular device, VORTX™ Oxygen Delivery System, and HYLA™ blood sensor, are currently being designed and developed, and have not yet been tested or used in humans nor approved by any regulatory entity.
For more information, please visit our corporate website at https://inspira-technologies.com
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