Inspira Technologies Oxy Bhn Ltd Stock Price, News & Analysis

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.

Inspira Technologies (NASDAQ: IINN) CEO Dagi Ben Noon shared a comprehensive update on the company's progress in revolutionizing respiratory care. The company's flagship product, the INSPIRA ART500, aims to provide an alternative to mechanical ventilation for Acute Respiratory Failure patients.

Key developments include:

• The INSPIRA ART100 system received FDA clearance in 2024 for Cardiopulmonary Bypass blood circulation
• The HYLA Blood Sensor is targeting FDA submission in H2-2025
• A Single-Use Patient Kit is planned for 2025/2026 FDA submissions
• The INSPIRA ART500 FDA submission is projected within the next 18 months

The company is targeting the $19 billion global mechanical ventilation market and expects to receive a prepayment from its U.S. distributor for INSPIRA ART100 systems. The company is focusing its resources on accelerating the development of the INSPIRA ART500 system while exploring strategic distribution partnerships in Latam and Asia.

Inspira Technologies (Nasdaq: IINN) has received a notification from Nasdaq on March 10, 2025, indicating non-compliance with the minimum bid price requirement. The company's shares have traded below $1.00 for 30 consecutive business days, violating Nasdaq Listing Rule 5550(a)(2).

Inspira has been granted a 180-calendar day compliance period until September 8, 2025, to regain compliance by maintaining a closing bid price of at least $1.00 for 10 consecutive business days. If unsuccessful, the company may qualify for an additional 180-day period, provided it meets other Nasdaq Capital Market listing requirements.

The company's shares continue trading on Nasdaq during this period while management explores options to address the deficiency, including the possibility of a reverse share split.

Inspira Technologies (NASDAQ: IINN) reported its full year 2024 financial results and business updates. The company achieved significant milestones, including FDA 510(k) clearance for its INSPIRA™ ART100 system and its deployment to Westchester Memorial Center, NY. The HYLA™ blood sensor showed promising clinical results with 96% accuracy compared to traditional analyzers.

Financial highlights for 2024 include:

• Total operating expenses decreased to $11.27M from $12.13M in 2023
• R&D expenses reduced to $6.32M from $7.32M
• G&A expenses increased to $4.19M from $4.06M
• Net loss was $11.05M compared to $11.29M in 2023
• Cash position stood at $5.78M as of December 31, 2024

Key developments include a manufacturing partnership with Zriha Medical, positive results from infection prevention technology showing 95% bacterial reduction, and new INSPIRA ART100 system enhancements for improved efficiency.