Core Viewpoint - Inspira Technologies has received a notice from Nasdaq indicating non-compliance with the minimum bid price requirement, as its ordinary shares have been trading below $1.00 for 30 consecutive business days [1][2]. Compliance Period and Requirements - The company has been granted a 180-calendar day compliance period until September 8, 2025, to regain compliance by ensuring the closing bid price meets or exceeds $1.00 for at least 10 consecutive business days [2]. - If compliance is not achieved by the deadline, the company may qualify for a second 180-calendar day compliance period, provided it meets other listing requirements and notifies Nasdaq of its intention to cure the deficiency [3]. Monitoring and Future Actions - The company plans to monitor the closing bid price of its ordinary shares and will consider options to regain compliance within the specified period [4]. - Despite the notice, the company's ordinary shares will continue to be listed and traded on the Nasdaq Capital Market during this compliance period [4]. Company Overview - Inspira Technologies is focused on developing innovative respiratory support and diagnostic technologies, with its flagship product, the INSPIRA ART system, designed to improve critical care by stabilizing oxygen levels without mechanical ventilation [6]. - The INSPIRA ART100 system has received regulatory approvals for use in cardiopulmonary bypass procedures in both the U.S. and Israel [6]. - The company is also developing the HYLA™ blood sensor technology for continuous, real-time blood monitoring without blood draws, along with other pipeline products that are currently in development [6].

Core Insights - Inspira Technologies experienced a transformative year in 2024, marked by significant technological advancements and regulatory milestones, including FDA clearance for the INSPIRA ART100 system [2][4] - The company aims to advance its flagship INSPIRA ART core technologies and plans to submit the HYLA blood monitoring sensor for FDA clearance in the second half of 2025 [2][5] Recent Business and Operational Highlights - The FDA-cleared INSPIRA ART100 system was deployed to Westchester Memorial Center, NY, for clinical evaluation [5] - A modular configuration for the VORTX blood oxygenation technology was unveiled, enhancing critical care practices [5] - The HYLA blood sensor achieved 96% accuracy in clinical studies, with plans for ongoing studies and FDA submission in 2025 [5] - A dedicated production line was established in partnership with Zriha Medical Ltd. to support the manufacturing of key components [5] - New support features for the INSPIRA ART100 system were introduced to improve efficiency for medical teams [5] - Positive initial results were reported from collaboration with Ennocure MedTech Ltd. for infection prevention technology [5] - Leadership was strengthened with the appointment of Mr. Tal Parnes as Chairman of the Board [5] Full Year 2024 Financial Highlights - Total operating expenses decreased to $11,267,000 in 2024 from $12,133,000 in 2023 [8] - R&D expenses decreased to $6,323,000 in 2024 from $7,320,000 in 2023, attributed to various factors including exchange rates and staffing changes [8] - G&A expenses increased to $4,185,000 in 2024 from $4,063,000 in 2023, primarily due to higher professional fees and compensation [8] - Net loss attributable to ordinary shareholders was $11,053,000 in 2024, compared to $11,286,000 in 2023 [8][10] - Cash position as of December 31, 2024, was $5,779,000, down from $7,361,000 in 2023, indicating financial stability for ongoing development [8] Balance Sheet Overview - Total assets decreased to $8,070,000 as of December 31, 2024, from $9,310,000 in 2023 [9] - Current assets included cash and cash equivalents of $5,111,000 and cash deposits of $668,000 [9] - Total liabilities increased slightly to $3,370,000 in current liabilities as of December 31, 2024, from $2,984,000 in 2023 [9]

Product Development and Commercialization - The company is highly dependent on the successful development, marketing, and sale of its respiratory support products, which are critical to its business model [63]. - The company anticipates significant challenges in commercializing its products, including potential financial resource limitations and manufacturing capabilities [63][64]. - The success of the company's products relies on market acceptance and the ability to compete effectively against existing solutions in the respiratory support market [65]. - The company faces risks related to regulatory approvals, which are crucial for the commercialization of its products [69]. - The company plans to expand its commercial operations in the U.S., Israel, and Europe, which is vital for revenue growth [75]. - The company has limited manufacturing history and anticipates incurring significant losses until it can successfully commercialize its products globally [81]. - The company may need to curtail or discontinue product development efforts if funding is not obtained in a timely manner [141]. - The company submitted a 510(k) application for the INSPIRA ART100 system in September 2023 and received class II regulatory clearance in May 2024 [151]. - Any modifications to the INSPIRA ART100 system that have not been previously cleared may require a new 510(k) premarket notification or PMA approval, which could delay product introductions [151]. Financial Condition and Capital Requirements - The company has incurred accumulated losses of approximately $67 million as of December 31, 2024, raising substantial doubt about its ability to continue as a going concern [127]. - The company has not generated significant revenues from its activities and has incurred substantial operating losses since its inception [127]. - Significant capital expenditures may be required for expected growth, potentially diverting financial resources from other projects [88]. - The company expects to continue generating substantial operating losses and will primarily fund operations through current financial resources and additional capital raises [127]. - The company will need to raise substantial additional funding to support operations and product commercialization, which may not be available on acceptable terms [137]. - As of December 31, 2024, the company had cash and cash equivalents of approximately $5.8 million, with a working capital of approximately $5.0 million, expected to fund operations for only the next six months [137]. - Future acquisitions or strategic partnerships may increase capital requirements and expose the company to various risks, including dilution of shareholders and additional debt [114]. Competition and Market Risks - The company faces intense competition from established players in the medical device industry, which may limit its market entry and sales [92]. - Competitors have greater brand recognition, financial resources, and regulatory capabilities, posing a risk to the company's market share [93]. - The company may struggle to maintain adequate reimbursement rates from third-party payors, negatively impacting revenue [97]. - Recent declines in reimbursement rates from certain third parties could continue, affecting the company's financial condition [98]. - Future healthcare reforms may lead to more rigorous coverage criteria and downward pressure on reimbursement rates for approved products [191]. Regulatory and Compliance Challenges - The company faces risks related to regulatory approvals, which are crucial for the commercialization of its products [69]. - The company is subject to extensive government regulation and oversight, with potential consequences for non-compliance that could adversely affect operations [145]. - Regulatory approvals are critical for the company’s products, with the 510(k) clearance process typically taking three to twelve months, while the PMA process can take one to three years or longer [148]. - The company must ensure that third-party manufacturers comply with applicable regulations to avoid delays in product delivery and potential enforcement actions [163]. - The company is subject to ongoing regulatory requirements governing the manufacture, marketing, and sale of devices, which could impact its operations and financial condition [158]. - Changes in regulations or policies could impose additional costs or lengthen review times for future products, affecting the company's operations [185]. Operational Risks - The company is vulnerable to supply chain issues due to reliance on third-party manufacturers and suppliers for its product components [77][78]. - The company may face challenges in maintaining high-quality service from third-party providers, which could impact its product utility and reputation [83]. - The company has a small workforce of 38 full-time employees, and the loss of key personnel could adversely affect its business operations [86]. - The company may face difficulties in recruiting additional employees and consultants, which could disrupt operations [87]. - The company has implemented business continuity and disaster recovery plans, but remains vulnerable to cybersecurity incidents and data breaches [116]. Intellectual Property and Litigation Risks - The ability to protect patent rights is crucial for competitive positioning, and failure to secure patents may allow competitors to replicate products [205]. - The company may face significant litigation expenses and resource diversion due to potential claims of intellectual property infringement, which could adversely affect its business [216]. - Changes in patent laws or their interpretation could increase uncertainties and costs related to patent applications and enforcement, impacting the company's financial condition [217]. - The company may not be able to protect its intellectual property rights globally, leading to potential competition from products developed in jurisdictions without patent protection [223]. - The company may experience substantial costs and distractions from defending against claims challenging the inventorship of its intellectual property [222]. Market and Economic Conditions - Changes in economic conditions could adversely affect customer expenditures and the company's liquidity [104]. - The company is subject to potential product liability claims and recalls, which could harm its reputation and financial results [102]. - The trading price of the company's Ordinary Shares and Warrants has been highly volatile since the IPO in July 2021, influenced by broader market conditions and industry factors [228]. - The company may experience future dilution from additional equity offerings, which could affect existing shareholders [244]. Geopolitical Risks - The company’s principal operations are located in Israel, making it susceptible to political, economic, and military instability in the region [249]. - As of March 3, 2025, the ongoing multi-front conflict in the region may adversely affect the company's operations and financial condition [250]. - Four employees have been called up for military service due to the current conflict, which may disrupt operations [252]. - The company may face increased risks from boycotts, divestment, and sanctions, which could impact its financial condition and business expansion [253]. - Changes to Israel's judicial system may negatively impact the business environment, affecting foreign investment and the company's ability to raise funds [254].

Core Insights - Inspira Technologies announced positive results from its clinical study of the AI-powered HYLA blood sensor, achieving 96% accuracy for a key parameter compared to traditional blood test analyzers [2][3] - The HYLA technology aims to provide continuous, real-time blood monitoring without the need for blood draws, targeting multiple multi-billion-dollar market segments [1][5] - The company plans to submit for FDA approval in the second half of 2025, with the goal of deploying the technology in U.S. hospitals for data collection and post-market validation [4][6] Clinical Study Details - The clinical study involved 6 patients undergoing open-heart surgery, where the HYLA sensor was attached to monitor blood flow during the procedure [2][3] - The HYLA sensor demonstrated 92.3% accuracy in identifying oxygen deficiencies, showcasing its potential for early detection and personalized care [2][3] - Data from the clinical study will be used to enhance the AI algorithms and improve the accuracy of the monitoring system [2][3] Market Potential - The HYLA blood sensor targets the blood gas analyzer market, projected to reach $5.7 billion by 2030, and could strengthen Inspira's position in the $19 billion mechanical ventilation market [5] - The technology is designed for versatility across various clinical settings, including intensive care units and operating rooms, with applications in critical care monitoring and emergency medicine [5][6] Company Overview - Inspira Technologies focuses on developing innovative respiratory support and diagnostic technologies, with its flagship INSPIRA ART system aimed at revolutionizing critical care [6][7] - The company has received regulatory approvals for its INSPIRA ART100 system for cardiopulmonary bypass procedures in the U.S. and Israel [7]

Core Viewpoint - Inspira Technologies announced positive initial results from its collaboration with Ennocure MedTech to develop a novel bio-electronic treatment aimed at preventing bloodstream infections in critical patients [1][3] Group 1: Technology and Testing Results - The bio-electronic patch demonstrated a 95% reduction in bacterial presence within 4 hours during ex-vivo porcine skin model testing, with continued effectiveness observed over a 24-hour period [2] - The technology utilizes physical electric stimulation instead of chemical agents, showing promising results in preventing pathogen growth on treated surfaces [2][8] - Testing followed standardized protocols, including the AATCC TM100 standard for antimicrobial performance, showing consistent bacterial reduction under active patches compared to controls [3] Group 2: Market Potential and Company Overview - There are an estimated 250,000 bloodstream infections related to intravenous lines occurring worldwide each year, indicating a significant market opportunity for the new technology in critical care settings [3] - Inspira Technologies is focused on innovative medical technology in life support and respiratory treatment, with its INSPIRA™ ART system targeting the $19 billion mechanical ventilation market [5] - The company has developed the HYLA™ blood sensor technology for continuous, real-time blood monitoring, targeting the $2.5 billion blood gas analyzer market [5]

Core Viewpoint - Inspira Technologies has developed an innovative AI-powered blood sensor technology, HYLA, which enables continuous monitoring of tissue oxygenation and early detection of hypoxia, with preliminary clinical results expected soon [1][3]. Group 1: Technology and Innovation - The integration of a next-generation oxygenation indicator into the HYLA blood sensor represents a significant enhancement in critical care monitoring, allowing for real-time and continuous monitoring of oxygenation therapy [2][4]. - The HYLA technology positions itself as a potential game-changer in the $2.5 billion point-of-care testing and arterial blood gas analyzer market [2]. - The non-invasive technology utilizes advanced optical sensors and machine-learning algorithms for continuous monitoring of blood parameters and oxygen levels [3]. Group 2: Clinical Validation and Regulatory Path - Clinical validation of the enhanced HYLA blood sensor is currently underway at Sheba Medical Center, which is recognized as one of the world's top smart hospitals [3]. - The company anticipates submitting for FDA regulatory clearance in the second half of 2025 [3]. Group 3: Market Potential and Applications - Inspira Technologies has developed the Augmented Respiration Technology (INSPIRA ART), which aims to revolutionize the $19 billion mechanical ventilation market by stabilizing oxygen saturation levels without the use of a ventilator [5]. - The INSPIRA ART, combined with the HYLA blood sensor, aims to provide a comprehensive approach to patient care by enabling continuous, non-invasive monitoring while patients remain conscious during treatment [4][5].

Core Insights - Inspira Technologies OXY B.H.N. Ltd. has introduced new support features to its INSPIRA™ ART100 system, enhancing efficiency and reducing staff overhead in medical procedures [1][4] - The INSPIRA ART100 system is designed to integrate with hospital procedures and includes advanced software for real-time monitoring and troubleshooting during critical care situations [2][3] Company Overview - Inspira Technologies is focused on innovative medical technology, particularly in life support and respiratory treatment, with the INSPIRA ART100 system positioned to potentially replace the $19 billion mechanical ventilation market [5] - The company aims to assist medical professionals in treating patients effectively, with the INSPIRA ART100 capable of enriching blood with oxygen and removing carbon dioxide, thus supporting critical care patients [4][5] Product Features - The INSPIRA ART100 system features a small footprint design, up to four hours of uptime in emergencies, and compatibility with various disposable equipment [4] - New features include system-activated alarm troubleshooting and a prominent screen for displaying critical information during complex care situations [2][3] Regulatory Status - The INSPIRA ART100 system has received FDA 510(k) clearance for use in Cardiopulmonary Bypass procedures and Israeli AMAR certification for Extra-Corporeal Membrane Oxygenation [6]

Core Viewpoint - Inspira Technologies has successfully delivered its INSPIRA™ ART100 systems to Glo-Med Networks Inc. for deployment in a leading U.S. hospital, marking a significant step in introducing its innovative respiratory support technology to the market [1][2]. Company Overview - Inspira Technologies is focused on revolutionizing life support and respiratory treatment with its Augmented Respiration Technology (INSPIRA™ ART), which aims to potentially replace the $19 billion mechanical ventilation market [4]. - The company targets the 20 million intensive care unit patients with acute respiratory failure annually, offering a non-ventilator solution that stabilizes oxygen saturation levels quickly while allowing patients to remain awake during treatment [4]. Product Development and Regulatory Approvals - The INSPIRA™ ART100 system has received FDA 510(k) clearance for use in cardiopulmonary bypass (CBP) procedures and has also obtained Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and CBP procedures [5]. - The INSPIRA™ ART100 is designed in collaboration with leading U.S. clinicians and is set to integrate with the HYLA™ continuous blood monitoring technology, which is currently undergoing clinical evaluations [3]. Market Strategy - The initial deployment of the INSPIRA™ ART100 systems will target hospitals on the U.S. east coast, specifically a top-ranked New York hospital's cardiothoracic surgery division, to facilitate collaboration and brand introduction [2]. - The company aims to leverage these deployments to familiarize physicians and perfusionists with its technologies and brand [2].

Core Viewpoint - Inspira Technologies OXY B.H.N. Ltd. has appointed Mr. Tal Parnes as the new chairman of the board of directors, effective February 1, 2025, aiming to enhance the company's leadership and strategic vision in the medical technology sector [1][4]. Company Leadership - Mr. Tal Parnes brings over three decades of experience in the technology sector, particularly in medical technology and pharmaceuticals, and has served as an independent director of the company since July 2021 [1][2]. - His previous roles include co-founding and serving as CEO of Zuta-Core Ltd. and HQL Pharmaceuticals Ltd., as well as holding executive positions at Silynx Communications Inc., Wavion Inc., Atrica Ltd., and Printlife Ltd. [3]. Strategic Impact - Mr. Parnes' leadership is expected to refine the company's strategic vision and bolster its competitive advantage in the market, positioning the company for sustainable success [4]. - The company expresses gratitude to Prof. Benad Goldwasser for his contributions as chairman since 2021, highlighting his support during the company's Nasdaq listing [5]. Product Innovation - Inspira Technologies is focused on life-support technology, having developed the Augmented Respiration Technology (INSPIRA™ ART), which aims to revolutionize the $19 billion mechanical ventilation market [6]. - The INSPIRA ART provides an alternative for patients with acute respiratory failure, stabilizing oxygen saturation levels without the need for a ventilator, allowing patients to remain awake during treatment [6]. Regulatory Approvals - The INSPIRA™ ART100 system has received FDA 510(k) clearance for use in cardiopulmonary bypass procedures and has also obtained Israeli AMAR certification for similar applications [7]. Future Developments - The company is in the process of designing and developing additional products, including the INSPIRA™ ART500, INSPIRA™ Cardi-ART, VORTX™ Oxygen Delivery System, and HYLA™ blood sensor, which are not yet tested or approved for human use [8].

Company Collaboration and Production - Inspira Technologies is establishing a dedicated production line for a crucial component of its respiratory support system in collaboration with Zriha Medical Ltd, a leading international manufacturer specializing in medical device production [1] - The collaboration involves the manufacture of a flow mechanism integrated into Inspira's products for use in extracorporeal circulation of blood during oxygenation [1] - Zriha Medical's capabilities in precision assembly and clean room environments are well-suited for this collaboration, potentially enabling Inspira to scale up production and accelerate market entry [2] - Zriha Medical brings over 50 years of experience in advanced plastic and silicone injection, metal processing technologies, and ISO 13485-certified clean room facilities [2] Inspira Technologies' Products and Market - Inspira Technologies is an innovative medical technology company focused on life support and respiratory treatment, with a breakthrough Augmented Respiration Technology (INSPIRA™ ART) targeting the $19 billion mechanical ventilation market [3] - The INSPIRA ART offers a potential alternative to mechanical ventilators by stabilizing oxygen saturation levels in minutes without requiring patients to be sedated, with 20 million ICU patients suffering from acute respiratory failure annually [3] - The INSPIRA ART is equipped with a clip-on HYLA™ blood sensor, a real-time continuous blood monitoring technology designed to alert physicians of changes in patient conditions without intermittent blood sampling [3] - The INSPIRA™ ART100 system has obtained FDA 510(k) clearance for use in CBP procedures and Israeli AMAR certification for ECMO and Cardiopulmonary Bypass procedures [4] Product Development and Regulatory Status - Inspira's other products, including the INSPIRA™ ART500 (Gen 2), INSPIRA™ Cardi-ART portable modular device, VORTX™ Oxygen Delivery System, and HYLA™ blood sensor, are currently in the design and development phase and have not yet been tested in humans or approved by regulatory entities [5]