Inspira Technologies Oxy Bhn Ltd Stock Price, News & Analysis

Inspira Technologies (NASDAQ: IINN) has announced a significant scale-up of production capabilities for its FDA-cleared INSPIRA ART100 system in response to advanced-stage procurement negotiations with a European governmental authority. The company is positioning itself to meet anticipated near-term delivery requirements as these negotiations progress toward finalization. The ART100 system, which has already been implemented in U.S. clinical settings, is being recognized as a reliable device for critical care and emergency preparedness programs. This production expansion aligns with Inspira's recently announced global rollout strategy and demonstrates the company's focus on accelerating revenue generation while continuing development of next-generation platforms including the ART500 and HYLA blood sensor.

Inspira Technologies (NASDAQ: IINN) is launching the global commercial rollout of its FDA-cleared INSPIRA™ ART100 system following successful clinical implementations in U.S. medical centers. The company is actively engaged in sales discussions with governmental health departments and private organizations, with deliveries expected to begin in H2 2025. The ART100, designed as an alternative to mechanical ventilation, has demonstrated real-world effectiveness in critical care settings. While focusing on ART100 commercialization, Inspira continues developing its innovation pipeline, including the next-generation INSPIRA™ ART500 and HYLA™ blood sensor. The strategic shift aims to capitalize on growing demand for respiratory solutions while prioritizing near-term revenue generation.

Inspira Technologies (NASDAQ: IINN), a respiratory support and diagnostic systems company, announced key executive changes. Co-Founder and President Joe Hayon is stepping down from his operational role but will remain as an active Board member. The company has decided not to appoint a successor to the President position, aiming to streamline its leadership structure. This transition is part of broader internal restructuring initiatives to enhance institutional readiness and strategic positioning. CEO Dagi Ben-Noon affirmed that the change won't impact ongoing operations or R&D timelines. The restructuring aligns with Inspira's focus on advancing its proprietary respiratory technologies portfolio and adapting to an evolving market landscape characterized by consolidation and cross-sector opportunities.

Inspira Technologies (NASDAQ: IINN) announced that its INSPIRA ART100 system has been approved by Israel's largest healthcare provider for clinical validation in organ transplant procedures. The FDA-approved system will be deployed at a renowned Israeli medical center, where transplant specialists will evaluate its potential for maintaining organ viability through blood oxygenation during transplants and post-operative recovery.

The ART100 system received FDA 510(k) clearance in May 2024 for cardiopulmonary bypass procedures and Israeli AMAR certification in July 2024 for both bypass and ECMO procedures. This technology serves as the foundation for Inspira's flagship INSPIRA ART500 system, currently under development, which aims to provide direct blood oxygenation without mechanical ventilation for respiratory care.

Inspira Technologies (Nasdaq: IINN) has announced a significant breakthrough in the in-vivo testing of its VORTX™ technology, achieving above 99% gas exchange efficiency at a defined flow rate. The testing was conducted on an 80 kg swine at Israel's Institute of Animal Research as part of an Israel Innovation Authority-funded initiative.

The VORTX technology, designed to oxygenate blood without the trauma associated with conventional hollow fiber technologies, will be integrated into Inspira's pipeline, including the INSPIRA ART500. The system's unique design maintains zero-pressure difference during oxygenation, potentially reducing harmful blood trauma commonly seen in traditional fiber-based oxygenators.

This successful in-vivo experiment validates previous lab-based findings, demonstrating proof-of-concept and scalability. The company plans to continue evaluating and refining the VORTX oxygen delivery technology, with additional results expected in the near future.

Inspira Technologies (NASDAQ: IINN) has achieved a significant milestone by generating its first revenues from the deployment of FDA-cleared INSPIRA ART100 systems at a premier U.S. academic medical center. The revenue, in the low hundreds of thousands of dollars, comes from U.S. distributor Glo-Med Networks for the recently installed systems.

Additional systems are planned for installation at a second leading academic medical center. The INSPIRA ART100, designed for cardiopulmonary bypass procedures, circulates and oxygenates blood outside the body during cardiac surgeries. This technology serves as the foundation for their flagship INSPIRA ART500 system under development, which aims to provide direct blood oxygenation for respiratory failure patients without mechanical ventilation, targeting the $19 billion mechanical ventilation market.

Inspira Technologies (Nasdaq: IINN) has announced the successful completion of the first human treatment using its FDA-cleared INSPIRA ART100 system at Westchester Medical Center in New York State. The life-support procedure demonstrated effective heart and lung support through blood oxygenation and circulation, with the patient safely transitioning off the system afterward.

Dr. David Spielvogel, Section Chief of Cardiothoracic Surgery at Westchester Medical Center, praised the system's reliability and responsiveness, highlighting the seamless transition during connection and disconnection phases. The procedure's success validates the technology's performance in a real-world clinical environment.

The installation, training, and professional services were managed by Glo-Med Networks Inc., Inspira's U.S. distributor, as they prepare for broader hospital adoption.

Inspira Technologies (NASDAQ: IINN) has successfully completed the installation and training program for its FDA-cleared INSPIRA ART100 system at a premier New York hospital. The system, designed for cardiopulmonary bypass procedures, is now ready for clinical use, marking a significant milestone in the company's deployment strategy.

The installation serves as a precursor to implementing core technologies of the flagship INSPIRA ART500 system, which aims to transform the $19 billion mechanical ventilation market. Inspira's goal is to replace a substantial portion of the estimated 100,000 ventilators in the U.S. with their innovative alternative.

This deployment follows the FDA 510(k) clearance for the INSPIRA ART100 system and aligns with the company's expansion strategy of collaborating with leading medical opinion leaders and institutions. The company expects to receive clinical feedback in the coming weeks.

Inspira Technologies (Nasdaq: IINN) announced the showcase of its FDA-cleared life-support system, the INSPIRA™ ART100, at the AmSECT 63rd International Conference in San Diego from March 19-23, 2025. The system, which received FDA 510(k) clearance in May 2024 for cardiopulmonary bypass procedures, will be displayed at distributor Glo-Med Networks' booth.

The conference, held at the Loews Coronado Bay Resort, provides a platform for leading perfusion professionals to experience Inspira's innovative extracorporeal circulation technology. The showcase represents an opportunity for the company to expand exposure of their technology within the perfusion community.