Inspira Technologies Oxy Bhn Ltd Stock Price, News & Analysis

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.

Inspira Technologies (NASDAQ: IINN) has achieved breakthrough clinical results for its AI-powered HYLA blood sensor, demonstrating 96% accuracy in key parameters compared to traditional blood analyzers and 92.3% accuracy in detecting oxygen deficiencies.

The clinical study, conducted at Sheba Hospital, validated the sensor's capabilities across 6 patients undergoing open-heart surgery. The HYLA sensor operates as a clip-on device that monitors blood parameters in real-time during cardiopulmonary bypass procedures.

This development strengthens Inspira's position in both the $5.7 billion blood gas analyzer market and the $19 billion mechanical ventilation market. The company's INSPIRA ART100 system, which received FDA 510(k) clearance in May 2024, is being deployed in U.S. hospitals through Glo-Med Networks.

Additionally, Inspira reported positive results from its collaboration with Ennocure MedTech , showing a 95% reduction in bacterial presence within 4 hours in preventing bloodstream infections.

Inspira Technologies (Nasdaq: IINN) has announced positive results from the clinical study of its AI-powered HYLA blood sensor, achieving 96% accuracy compared to traditional blood test analyzers. The study, conducted at Sheba Hospital with 6 patients undergoing open-heart surgery, demonstrated the device's ability to monitor blood continuously without requiring blood draws.

The HYLA sensor, which clips onto blood circuit tubing, successfully monitored blood flow during bypass procedures at two different points. Additionally, the device showed 92.3% accuracy in identifying oxygen deficiencies through a new indicator. The clinical study data is being used to enhance the system's AI-powered learning capabilities.

The company plans to expand the study for additional patient data collection and aims to submit for FDA clearance in H2 2025. Following FDA approval, Inspira intends to deploy this technology as part of their INSPIRA ART system in U.S. hospitals for data collection and post-market validation.

Inspira Technologies (Nasdaq: IINN) announced positive initial results from its collaboration with Ennocure MedTech to develop a novel bio-electronic treatment for preventing bloodstream infections. The ex-vivo testing on porcine skin model demonstrated a 95% reduction in bacterial presence within 4 hours, maintaining effectiveness over 24 hours.

The innovative technology uses physical electric stimulation instead of chemical agents to prevent pathogen growth. This development addresses an estimated 250,000 annual bloodstream infections related to intravenous lines worldwide. The bio-electronic technology aims to overcome traditional IV dressing challenges through bacterial growth prevention, extended wear time, applicability to both skin surface and cannula areas, and real-time monitoring capabilities.

Testing followed adjusted standardized protocols, including the AATCC TM100 standard for antimicrobial performance, showing consistent bacterial reduction under active patches versus controls.

Inspira Technologies (NASDAQ: IINN) has enhanced its AI-driven medical platform by integrating a next-generation oxygenation indicator into its HYLA blood sensor technology. This advancement enables rapid detection of oxygen-related conditions without requiring blood draws, targeting the $2.5 billion Arterial Blood Gas analyzer market.

The HYLA system, currently under clinical evaluation at Sheba Medical Center, uses optical sensors and machine learning for real-time blood parameter monitoring. The company plans 510(k) FDA submissions in the second half of 2025. The technology complements their FDA-cleared INSPIRA ART100 system, which received its first U.S. purchase order through Glo-Med Networks in June 2024.

This development comes amid strong medtech M&A activity, with Q3 2024 seeing 275 deals worth $34 billion, a 35% increase year-over-year. The company is targeting both the blood gas analysis market and the $19 billion mechanical ventilation market, addressing the needs of approximately 20 million patients requiring mechanical ventilation globally.

Inspira Technologies (NASDAQ: IINN) has announced the integration of a next-generation oxygenation indicator into its AI-powered HYLA blood sensor technology. This enhancement enables continuous monitoring of tissue oxygenation and early hypoxia detection without requiring intermittent blood draws.

The technology is currently undergoing clinical validation at Sheba Medical Center, with preliminary results expected soon. The non-invasive system uses optical sensors and machine-learning algorithms for continuous blood parameter monitoring, targeting the $2.5 billion point-of-care testing and arterial blood gas analyzer market. FDA submission is planned for the second half of 2025.

When combined with the FDA-cleared INSPIRA ART100 system, HYLA aims to provide comprehensive patient care through continuous, non-invasive monitoring while maintaining consciousness during treatment.

Inspira Technologies (Nasdaq: IINN) has announced new support features for its FDA-cleared INSPIRA™ ART100 system, enhancing medical team procedures and efficiency in extracorporeal life support technology. The updates include integration with hospital procedures, system-activated alarm troubleshooting, and advanced software display features for complex care situations.

The ART100 system adds oxygen to blood and removes carbon dioxide, functioning as a heart-lung support for critical care patients. Key features include a compact design, four-hour emergency uptime, and compatibility with various disposable equipment. The system received FDA 510(k) clearance for CBP procedures and Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures in May and July 2024.