Inspira™ Technologies Unveils Modular Configuration for Revolutionary VORTX™ Blood Oxygenation Delivery Technology
Inspira Technologies has unveiled a modular configuration for its VORTX blood oxygenation delivery technology, targeting the $19 billion mechanical ventilation market. The VORTX system, protected by 32 novel patent claims, is designed to maintain more natural blood flow compared to traditional fiber-based oxygenators.
The company's flagship INSPIRA ART system aims to stabilize declining oxygen saturation levels in awake patients without requiring a ventilator, potentially benefiting approximately 20 million ICU patients with respiratory failure annually. In mid-2024, the INSPIRA ART100 system received both FDA 510(k) clearance for CBP procedures and Israeli AMAR certification for Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.
The modular VORTX configuration is expected to extend the INSPIRA ART's capabilities in blood oxygen enrichment and carbon dioxide removal, enhancing its versatility across various medical scenarios.
Inspira Technologies ha svelato una configurazione modulare per la sua tecnologia di somministrazione dell'ossigenazione del sangue VORTX, rivolta al mercato della ventilazione meccanica del valore di 19 miliardi di dollari. Il sistema VORTX, protetto da 32 rivendicazioni di brevetto innovative, è progettato per mantenere un flusso sanguigno più naturale rispetto ai tradizionali ossigenatori a base di fibra.
Il sistema di punta dell'azienda, INSPIRA ART, mira a stabilizzare i livelli di saturazione dell'ossigeno in calo nei pazienti svegli senza richiedere un ventilatore, portando potenzialmente benefici a circa 20 milioni di pazienti in terapia intensiva affetti da insufficienza respiratoria ogni anno. A metà del 2024, il sistema INSPIRA ART100 ha ricevuto sia l'approvazione FDA 510(k) per le procedure CBP che la certificazione AMAR israeliana per le procedure di ossigenazione extracorporea a membrana e bypass cardiopolmonare.
La configurazione modulare VORTX si prevede che estenda le capacità dell'INSPIRA ART nell'arricchimento dell'ossigeno nel sangue e nella rimozione dell'anidride carbonica, migliorando la sua versatilità in vari scenari medici.
Inspira Technologies ha presentado una configuración modular para su tecnología de entrega de oxigenación sanguínea VORTX, que está dirigida al mercado de ventilación mecánica de 19 mil millones de dólares. El sistema VORTX, protegido por 32 reclamaciones de patentes nuevas, está diseñado para mantener un flujo sanguíneo más natural en comparación con los oxigenadores basados en fibra tradicionales.
El sistema insignia de la empresa, INSPIRA ART, tiene como objetivo estabilizar los niveles en declive de saturación de oxígeno en pacientes despiertos sin necesidad de un ventilador, beneficiando potencialmente a aproximadamente 20 millones de pacientes en UCI con insuficiencia respiratoria cada año. A mediados de 2024, el sistema INSPIRA ART100 recibió la autorización 510(k) de la FDA para procedimientos de CBP y la certificación AMAR israelí para procedimientos de oxigenación extracorpórea y bypass cardiopulmonar.
Se espera que la configuración modular VORTX amplíe las capacidades del INSPIRA ART en el enriquecimiento de oxígeno en sangre y la eliminación de dióxido de carbono, mejorando su versatilidad en varios escenarios médicos.
Inspira Technologies는 190억 달러 규모의 기계 환기 시장을 겨냥하여 VORTX 혈액 산소화 전달 기술을 위한 모듈형 구성을 공개했습니다. 32개의 새로운 특허 청구로 보호되는 VORTX 시스템은 기존의 섬유 기반 산소 공급장치에 비해 보다 자연스러운 혈액 흐름을 유지하도록 설계되었습니다.
회사의 주력 제품인 INSPIRA ART 시스템은 환자가 깨어 있는 상태에서 인공호흡기 없이 산소 포화도 저하를 안정시키는 것을 목표로 하며, 매년 약 2000만 명의 호흡 부전 ICU 환자에게 혜택을 줄 수 있습니다. 2024년 중반, INSPIRA ART100 시스템은 CBP 절차를 위한 FDA 510(k) 승인을 받고 이스라엘 AMAR 인증을 받아 외부막 산소화 및 심폐우회 절차를 수행했습니다.
모듈형 VORTX 구성은 INSPIRA ART의 혈액 산소 농축 및 이산화탄소 제거 능력을 확장하여 다양한 의료 시나리오에서의 활용성을 높일 것으로 예상됩니다.
Inspira Technologies a dévoilé une configuration modulaire pour sa technologie de délivrance d'oxygénation sanguine VORTX, visant le marché de la ventilation mécanique d'une valeur de 19 milliards de dollars. Le système VORTX, protégé par 32 revendications de brevet novatrices, est conçu pour maintenir un flux sanguin plus naturel par rapport aux oxygenateurs à base de fibres traditionnels.
Le système phare de l'entreprise, le système INSPIRA ART, vise à stabiliser les niveaux de saturation en oxygène en baisse chez les patients conscients sans nécessiter de ventilateur, pouvant potentiellement bénéficier à environ 20 millions de patients en unité de soin intensif souffrant d'insuffisance respiratoire chaque année. À la mi-2024, le système INSPIRA ART100 a reçu à la fois l'approbation FDA 510(k) pour les procédures CBP et la certification AMAR israélienne pour les procédures d'oxygénation extracorporelle et de pontage cardiopulmonaire.
La configuration modulaire VORTX devrait étendre les capacités de l'INSPIRA ART en matière d'enrichissement en oxygène dans le sang et d'élimination du dioxyde de carbone, améliorant ainsi sa polyvalence dans divers scénarios médicaux.
Inspira Technologies hat eine modulare Konfiguration für seine VORTX-Blutoxygenierungs-Technologie vorgestellt, die auf den Markt für mechanische Beatmung im Wert von 19 Milliarden Dollar abzielt. Das VORTX-System, das durch 32 neuartige Patentansprüche geschützt ist, wurde entwickelt, um einen natürlicheren Blutfluss im Vergleich zu herkömmlichen fasergestützten Oxygenatoren aufrechtzuerhalten.
Das Flaggschiff des Unternehmens, das INSPIRA ART-System, zielt darauf ab, abnehmende Sauerstoffsättigungswerte bei wachen Patienten zu stabilisieren, ohne einen Beatmungsgerätes zu benötigen, was potenziell etwa 20 Millionen Patienten auf der Intensivstation mit Atemversagen jährlich zugutekommen könnte. Mitte 2024 erhielt das INSPIRA ART100-System sowohl die FDA 510(k)-Zulassung für CBP-Verfahren als auch die israelische AMAR-Zertifizierung für extrakorporale Membranoxygenierung und herzchirurgische Bypassverfahren.
Die modulare VORTX-Konfiguration wird voraussichtlich die Fähigkeiten des INSPIRA ART im Bereich der Blutoxygenierung und der CO2-Entfernung erweitern und ihre Vielseitigkeit in verschiedenen medizinischen Szenarien erhöhen.
- FDA 510(k) clearance obtained for INSPIRA ART100 system
- Israeli AMAR certification received for multiple procedures
- 32 novel patent claims protecting VORTX technology
- Targeting large $19 billion mechanical ventilation market
- Core products including INSPIRA ART500, Cardi-ART, VORTX, and HYLA not yet tested in humans
- No regulatory approvals for main product line
- Products still in development phase
Insights
The modular VORTX configuration represents a notable technical advancement in extracorporeal oxygenation technology. The system's design philosophy of maintaining natural blood flow patterns could potentially reduce hemolysis and platelet activation compared to traditional fiber-based oxygenators. The 32 patent claims provide robust IP protection, though market success will ultimately depend on clinical validation.
The recent FDA 510(k) clearance for the INSPIRA ART100 system specifically for CPB procedures, combined with Israeli AMAR certification, establishes initial regulatory pathway momentum. However, the broader INSPIRA ART500 platform still requires extensive clinical testing and regulatory approvals before commercialization. The
The HYLA blood sensor integration could provide valuable continuous monitoring capabilities, potentially reducing the need for repeated blood draws and enabling faster clinical interventions. However, the technology remains in development phase without human testing or regulatory approval.
This development targets a critical market opportunity with 20 million ICU patients annually suffering from respiratory failure. The modular approach could enhance market adoption by offering flexibility in clinical applications and potentially reducing implementation barriers. Key competitive advantages include the unique awake-patient treatment capability and continuous blood monitoring features.
The regulatory clearances for the ART100 system represent initial market validation, though revenue impact remains uncertain given the approved use cases. The broader product portfolio's development status suggests a multi-year commercialization timeline before significant market penetration. The
The technology has the potential to provide life-saving support for the approximately 20 million ICU patients with respiratory failure annually
RA'ANANA,
The unique modular configuration of the VORTX blood oxygenation delivery system is expected to extend the INSPIRA ART's range of blood oxygen enrichment and carbon dioxide removal, potentially expanding the versatility of the INSPIRA ART. The flagship INSPIRA ART system targets to revolutionize the
Inspira's VORTX system represents a potential paradigm shift in blood oxygenation technology. Unlike traditional fiber-based oxygenators, the VORTX is designed to maintain a more natural blood flow, potentially reducing harmful effects on blood components. This novel approach has garnered significant attention, with the technology now protected by 32 novel patent claims.
As Inspira continues to develop and refine the modular VORTX blood oxygenation delivery technology, the Company remains committed to advancing respiratory care and improving patient outcomes. The modular configuration is expected to enhance the versatility and applicability of the VORTX technology across various medical scenarios.
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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SOURCE Inspira Technologies
FAQ
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