Inspira™ to Publish HYLA™ Clinical Results in Fourth Quarter 2024
Inspira Technologies (Nasdaq: IINN) has announced plans to report clinical results for its HYLA™ blood sensor in Q4 2024. The clip-on sensor aims to alert physicians of changes in a patient's condition without intermittent blood samples, targeting a potential $2.5 billion Point of Care testing and Arterial Blood Gas analyzer market. Inspira is expanding its blood testing facilities to accelerate HYLA™ development, with a 510(k) submission to the FDA planned for early 2025.
The company's broader strategy involves transforming respiratory and life-support sectors, addressing an estimated $59 billion annual market opportunity. Inspira plans to deploy its FDA-cleared INSPIRA™ ART100 system in top U.S. and Israeli hospitals. The company is also developing additional products, including the INSPIRA™ ART (Gen 2) and INSPIRA™ Cardi-ART, focusing on innovative oxygenation and blood monitoring technologies.
Inspira Technologies (Nasdaq: IINN) ha annunciato piani per riportare i risultati clinici del suo sensore ematico HYLA™ nel quarto trimestre del 2024. Il sensore clip-on ha l’obiettivo di allertare i medici riguardo ai cambiamenti nelle condizioni di un paziente senza necessità di prelievi ematici intermittenti, mirando a un potenziale mercato da 2,5 miliardi di dollari per i test in loco e gli analizzatori di gas arteriosi nel sangue. Inspira sta ampliando le sue strutture di analisi del sangue per accelerare lo sviluppo di HYLA™, con una presentazione 510(k) all'FDA programmata per inizio 2025.
La strategia più ampia della compagnia prevede la trasformazione dei settori respiratorio e di supporto vitale, affrontando un'opportunità di mercato annuale stimata di 59 miliardi di dollari. Inspira prevede di implementare il suo sistema INSPIRA™ ART100, approvato dall'FDA, nei principali ospedali statunitensi e israeliani. L'azienda sta anche sviluppando prodotti aggiuntivi, tra cui l'INSPIRA™ ART (Gen 2) e l'INSPIRA™ Cardi-ART, concentrandosi su tecnologie innovative per l'ossigenazione e il monitoraggio del sangue.
Inspira Technologies (Nasdaq: IINN) ha anunciado planes para informar los resultados clínicos de su sensor de sangre HYLA™ en el cuarto trimestre de 2024. El sensor tipo clip tiene como objetivo alertar a los médicos sobre cambios en la condición de un paciente sin necesidad de muestras de sangre intermitentes, apuntando a un mercado potencial de 2.5 mil millones de dólares para pruebas en el lugar y analizadores de gases arteriales en sangre. Inspira está ampliando sus instalaciones de análisis de sangre para acelerar el desarrollo de HYLA™, con una presentación 510(k) a la FDA planificada para principios de 2025.
La estrategia más amplia de la compañía implica transformar los sectores respiratorios y de soporte vital, abordando una oportunidad de mercado anual estimada en 59 mil millones de dólares. Inspira planea implementar su sistema INSPIRA™ ART100, aprobado por la FDA, en los principales hospitales de EE. UU. e Israel. La empresa también está desarrollando productos adicionales, incluyendo el INSPIRA™ ART (Gen 2) y el INSPIRA™ Cardi-ART, enfocándose en tecnologías innovadoras para la oxigenación y el monitoreo de la sangre.
Inspira Technologies (Nasdaq: IINN)는 2024년 4분기에 HYLA™ 혈액 센서의 임상 결과를 보고할 계획을 발표했습니다. 이 클립형 센서는 환자의 상태에 변화가 있을 때 의사에게 경고를 주는 것을 목표로 하며, 간헐적인 혈액 샘플 없이 진행됩니다. 이는 25억 달러 규모의 현장 검사 및 동맥혈가스 분석기 시장을 타겟으로 하고 있습니다. Inspira는 HYLA™ 개발을 가속화하기 위해 혈액 검사 시설을 확장하고 있으며, 2025년 초에 FDA에 510(k) 제출을 계획하고 있습니다.
회사의 광범위한 전략은 호흡기 및 생명 유지 부문을 혁신하여 연간 약 590억 달러의 시장 기회를 다루는 것입니다. Inspira는 FDA 승인을 받은 INSPIRA™ ART100 시스템을 미국과 이스라엘의 주요 병원에 배포할 계획입니다. 회사는 또한 혁신적인 산소 공급 및 혈액 모니터링 기술에 중점을 두고 INSPIRA™ ART(Gen 2)와 INSPIRA™ Cardi-ART를 포함한 추가 제품을 개발하고 있습니다.
Inspira Technologies (Nasdaq: IINN) a annoncé des projets de rapport sur les résultats cliniques de son capteur sanguin HYLA™ au quatrième trimestre 2024. Ce capteur clip-on vise à alerter les médecins des changements de l'état d'un patient sans échantillons sanguins intermittents, ciblant un marché potentiel de 2,5 milliards de dollars pour les tests au point de soin et les analyseurs de gaz artériel dans le sang. Inspira élargit ses installations de test sanguin pour accélérer le développement de HYLA™, avec une soumission 510(k) prévue à la FDA pour début 2025.
La stratégie plus large de l'entreprise consiste à transformer les secteurs respiratoires et de soutien vital, en visant une opportunité de marché annuelle estimée à 59 milliards de dollars. Inspira prévoit de déployer son système INSPIRA™ ART100, approuvé par la FDA, dans les meilleurs hôpitaux des États-Unis et d'Israël. L'entreprise développe également des produits supplémentaires, notamment l'INSPIRA™ ART (Gen 2) et l'INSPIRA™ Cardi-ART, en se concentrant sur des technologies innovantes d'oxygénation et de surveillance du sang.
Inspira Technologies (Nasdaq: IINN) hat Pläne angekündigt, im 4. Quartal 2024 klinische Ergebnisse seines HYLA™ Blut Sensors zu berichten. Der Clip-on-Sensor zielt darauf ab, Ärzte über Veränderungen im Zustand eines Patienten zu informieren, ohne dass punktuelle Blutproben erforderlich sind, und spricht einen potenziellen Markt für Point-of-Care-Tests und arterielle Blutgasanalyse von 2,5 Milliarden Dollar an. Inspira erweitert seine Blutuntersuchungseinrichtungen, um die Entwicklung von HYLA™ zu beschleunigen, mit einer 510(k)-Einreichung bei der FDA, die für Anfang 2025 geplant ist.
Die breitere Strategie des Unternehmens umfasst die Transformation der Atem- und Lebensunterstützungssektoren, um eine geschätzte jährliche Marktchance von 59 Milliarden Dollar zu nutzen. Inspira plant, sein von der FDA genehmigtes INSPIRA™ ART100-System in führenden US-amerikanischen und israelischen Krankenhäusern einzusetzen. Das Unternehmen entwickelt außerdem weitere Produkte, darunter den INSPIRA™ ART (Gen 2) und den INSPIRA™ Cardi-ART, mit einem Fokus auf innovative Technologien für Sauerstoffversorgung und Blutüberwachung.
- Targeting a potential $2.5 billion market with the HYLA™ blood sensor
- Planned 510(k) submission to FDA for HYLA™ in early 2025
- Addressing an estimated $59 billion annual market opportunity in respiratory and life-support sectors
- FDA clearance already obtained for INSPIRA™ ART100 system
- Clinical results for HYLA™ blood sensor not available until Q4 2024
- Additional products still in development and not yet tested on humans or approved by regulatory agencies
The planned publication of HYLA™ clinical results marks a significant milestone for Inspira Technologies. This innovative blood sensor could revolutionize patient monitoring in critical care settings. The technology's ability to provide real-time, continuous monitoring without blood draws could enhance patient care and streamline clinical workflows.
However, it's important to note that the results are not expected until Q4 2024, with FDA submission planned for early 2025. This extended timeline suggests a long road to market and potential investors should consider this when evaluating the company's near-term prospects. The
Inspira's focus on the
The company's diverse product pipeline, including the INSPIRA™ Cardi-ART and INSPIRA™ ART500, suggests a robust long-term strategy. Yet, these products are still in development and their market success remains uncertain. Inspira's financial health and burn rate should be closely monitored, as R&D costs for multiple products could impact profitability in the short term.
The clip-on HYLA™ blood sensor, designed to alert physicians of immediate signs of changes in a patient's clinical condition without the need for intermittent actual blood samples, targets a potential
RA'ANANA,
Dagi Ben-Noon, CEO of Inspira Technologies, said, "We believe that both the medical community and the industry are highly interested in the HYLA™ blood sensor. That is why we anticipate that these clinical results will be a key milestone aligned with our long-term growth plans."
Future Plans
Given the importance of HYLA™ blood monitoring technology, the Company is expanding its unique blood testing facilities. This effort seeks to accelerate and advance the development of HYLA™. The clinical study results for the first HYLA™ configuration are expected in the fourth quarter of 2024, with the Company aiming for a 510(k) submission to the
In developing the HYLA™ Blood Sensor line, Inspira utilizes in-house lab testing as well as hospital collaborations for the purpose of clinical research and development. This approach has enabled to define the Blood Sensor's materials and methods. While primarily designed for INSPIRA™ ART devices, plans are underway also to offer a variant of the Blood Sensor as a standalone device.
Inspira™ business overview
Inspira strives to transform the respiratory and life-support sectors by creating innovative oxygenation and blood monitoring technologies. Together, these advancements address an estimated
Inspira aims to deploy the FDA-cleared INSPIRA™ ART100 system in top hospitals in the
Inspira is steadily expanding and leading the development of the INSPIRA™ ART pipeline, which encompasses:
The HYLA™ blood sensor is a clip-on device designed for continuous, real-time monitoring of blood parameters.
The INSPIRA™ Cardi-ART is a portable device based on the INSPIRA™ ART (Gen 2), designed to oxygenate the brain for patients experiencing cardiac arrest.
INSPIRA™ ART (Gen 2), commonly referred to as the INSPIRA™ ART500, will feature the Company's Adaptive Blood Oxygenation technology along with the HYLA™ blood sensor. This is being developed to continuously monitor the patient's blood parameters in real-time, providing the necessary volume of oxygen directly into the bloodstream. By quickly boosting patient oxygen saturation levels within minutes, this technology could allow patients to stay awake during treatment. Consequently, it may enable treatments beyond intensive care units, potentially decreasing the dependence on mechanical ventilation systems that necessitate intubation and medically induced coma.
The Company's INSPIRA™ ART100 system has obtained FDA 510(k) clearance for use in Cardiopulmonary Bypass procedures, along with the Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.
The Company is in the process of designing and developing additional products, such as the INSPIRA™ ART (Gen 2), the INSPIRA™ Cardi-ART portable modular device, and the HYLA™ blood sensor. These items have not yet been tested on humans or received approval from any regulatory agencies. Any stated timeline for the clinical results is subject to the success the Company has with the recruitment of patients, data collection, and the time it takes to perform such date analysis.
For more information, please visit our corporate website: https://inspira-technologies.com
Forward-Looking Statement Disclaimer
This press release contains express or implied forward-looking statements pursuant to
Contact:
Inspira Technologies – Media Relations
Email: info@inspirao2.com
Phone: +972-9-9664485
Copyright © 2018-2024 Inspira Technologies OXY B.H.N. LTD., All rights reserved.
Logo: https://mma.prnewswire.com/media/1668495/Inspira_Technologies_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/inspira-to-publish-hyla-clinical-results-in-fourth-quarter-2024-302232887.html
SOURCE Inspira Technologies
FAQ
When will Inspira Technologies (IINN) publish clinical results for the HYLA™ blood sensor?
What is the target market size for Inspira's HYLA™ blood sensor?
When does Inspira (IINN) plan to submit a 510(k) application to the FDA for the HYLA™ blood sensor?
What is the estimated annual market opportunity that Inspira Technologies (IINN) is addressing?
