Inspira Technologies Oxy B.H.N. Ltd. reports developments in Additively Manufactured Electronics, quantum connectivity and its medical technology portfolio. Company updates focus on AME system orders and deployments, QTREX-branded cryogenic interconnect work for superconducting quantum systems, customer activity with research, defense and technology organizations, and leadership or strategic-direction announcements.
The company's medical technology context includes respiratory support and blood monitoring platforms, including INSPIRA ART, INSPIRA ART100 and the HYLA Blood Sensor, while recent communications emphasize a dedicated medical business unit alongside the AME and quantum connectivity strategy.
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 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 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.
Inspira Technologies (NASDAQ: IINN) has delivered its INSPIRA™ ART100 systems to Glo-Med Networks for deployment at a leading U.S. hospital. The systems will be distributed to hospitals on the U.S. east coast, including a top-ranking cardiothoracic surgery division in New York.
The INSPIRA™ ART100, which received FDA 510(k) clearance for cardiopulmonary bypass procedures in May 2024, will be integrated with the HYLA™ blood monitoring technology. The HYLA™ is currently undergoing clinical evaluations at Sheba Hospital in preparation for FDA submission in 2025.
The company is developing breakthrough respiratory support technologies, including the INSPIRA ART, aimed at potentially replacing the $19 billion mechanical ventilation market. This technology is designed to stabilize decreasing oxygen levels without requiring ventilation, allowing patients to remain awake during treatment.
Inspira Technologies (Nasdaq: IINN) has appointed Tal Parnes as the new chairman of the board, effective February 1, 2025. Parnes, who has served as an independent director since July 2021, brings over 30 years of experience in technology, particularly in medical technology and pharmaceuticals. He succeeds Prof. Benad Goldwasser, who resigned for personal reasons.
Parnes' background includes co-founding and serving as CEO of Zuta-Core and HQL Pharmaceuticals , along with executive roles at several technology companies. The appointment aims to enhance Inspira's leadership and market position.
The company recently achieved significant milestones with its INSPIRA ART100 system receiving FDA 510(k) clearance for CBP procedures and Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures in June and July 2024.
Inspira Technologies (Nasdaq: IINN) announced on Jan. 17, 2025 a collaboration with Zriha Medical to establish a dedicated production line for a flow mechanism used in its extracorporeal oxygenation devices.
Zriha Medical brings >50 years of medical manufacturing experience, ISO 13485 certification, and clean-room assembly capabilities. The move is presented as a step to scale production and accelerate path to market for Inspira's respiratory support systems.
The company noted prior regulatory milestones: FDA 510(k) clearance in May and July 2024 for the INSPIRA ART100 for CBP procedures; several other devices remain in design and are not yet tested in humans or approved.
Inspira Technologies (Nasdaq: IINN) has partnered with Zriha Medical to establish a dedicated production line for a important flow mechanism component of its respiratory support system. Zriha Medical, with over 50 years of experience and ISO 13485 certification, will manufacture components for extracorporeal blood circulation during oxygenation.
The company's flagship product, the INSPIRA ART, aims to revolutionize the $19 billion mechanical ventilation market by providing an alternative to traditional ventilators. The system recently 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.