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Yahoo
5 days ago
- Business
- Yahoo
CORRECTION - Inspira Scales Up ART100 Production Capabilities Amid Advanced Negotiation with European Government Authority
RA'ANANA, Israel, June 05, 2025 (GLOBE NEWSWIRE) -- RA'ANANA, Israel, June 5, 2025 -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira," 'Inspira Technologies,' or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced preparations for scaled-up its production capabilities for its U.S. Food and Drug Administration (FDA)-cleared INSPIRA™ ART100 system (the 'ART100 system'), in response to expected demand from a European governmental authority with which the Company is currently in advanced-stage procurement negotiations. this ramp up strategic production aims to meet near-term delivery needs as Inspira expects these negotiations move toward finalization. The ART100 system, already implemented in clinical settings in the United States, is gaining traction as a reliable device for a critical care and emergency preparedness programs. 'We are preparing for commercial execution,' said Dagi Ben Noon, Chief Executive Officer of Inspira Technologies. 'Our dialogue with a European government body has advanced to a stage where operational readiness is essential. Expanding our production capacity will enable us to meet projected deployment needs quickly and efficiently.' This move follows Inspira's recent announcement of its global rollout strategy and reflects the Company's commitment to fast-track revenue generation from the ART100 system, while continuing its development of its next-generation platforms, the ART500 and the HYLA™ blood sensor. The Company believes the current momentum—combined with a growing global focus on scalable respiratory solutions—may accelerate the Company's emergence as a strategic public health supplier across both governmental and private sectors. About Inspira Technologies Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions. The Company's U.S. FDA -cleared INSPIRA ART100 system is approved for cardiopulmonary bypass in the U.S. and ECMO (Extracorporeal Membrane Oxygenation) procedures outside the U.S and serves as a technological foundation for the development of the INSPIRA ART500 — a next-generation system designed to deliver oxygenation while patients remain awake and spontaneously breathing. Inspira Technologies is also advancing HYLA™, a proprietary blood sensor platform offering continuous, non-invasive monitoring. With multiple cleared products, a growing IP portfolio, and strategic streamlining of its operations, Inspira Technologies is increasingly positioned as an attractive platform within the critical care and MedTech landscape. The Company's recent internal shifts may reflect broader alignment with long-term industry trends, including consolidation, cross-sector collaboration, and potential strategic partnerships. For more information, visit: Forward-Looking Statement Disclaimer This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses that it expects demand for its ART100 system from a European governmental authority, that it has ramped up its production in order to meet expected near term delivery needs, , the benefits and advantages of the ART100, that the ART100 system is gaining traction as a reliable device for a critical care and emergency preparedness programs, the potential outcome of its procurement negotiations with a European government authority, its belief that expanding its production capacity enables the Company to meet projected deployment needs quickly and efficiently, and its belief that current momentum may accelerate the Company's emergence as a strategic public health supplier across both governmental and private sectors. These forward-looking statements and their implications are based solely on the current expectations of the Company's management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (the "SEC"), which is available on the SEC's website at Company ContactInspira Technologies – Media RelationsEmail: info@ +972-9-9664485Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
5 days ago
- Business
- Yahoo
CORRECTION - Inspira Scales Up ART100 Production Capabilities Amid Advanced Negotiation with European Government Authority
RA'ANANA, Israel, June 05, 2025 (GLOBE NEWSWIRE) -- RA'ANANA, Israel, June 5, 2025 -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira," 'Inspira Technologies,' or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced preparations for scaled-up its production capabilities for its U.S. Food and Drug Administration (FDA)-cleared INSPIRA™ ART100 system (the 'ART100 system'), in response to expected demand from a European governmental authority with which the Company is currently in advanced-stage procurement negotiations. this ramp up strategic production aims to meet near-term delivery needs as Inspira expects these negotiations move toward finalization. The ART100 system, already implemented in clinical settings in the United States, is gaining traction as a reliable device for a critical care and emergency preparedness programs. 'We are preparing for commercial execution,' said Dagi Ben Noon, Chief Executive Officer of Inspira Technologies. 'Our dialogue with a European government body has advanced to a stage where operational readiness is essential. Expanding our production capacity will enable us to meet projected deployment needs quickly and efficiently.' This move follows Inspira's recent announcement of its global rollout strategy and reflects the Company's commitment to fast-track revenue generation from the ART100 system, while continuing its development of its next-generation platforms, the ART500 and the HYLA™ blood sensor. The Company believes the current momentum—combined with a growing global focus on scalable respiratory solutions—may accelerate the Company's emergence as a strategic public health supplier across both governmental and private sectors. About Inspira Technologies Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions. The Company's U.S. FDA -cleared INSPIRA ART100 system is approved for cardiopulmonary bypass in the U.S. and ECMO (Extracorporeal Membrane Oxygenation) procedures outside the U.S and serves as a technological foundation for the development of the INSPIRA ART500 — a next-generation system designed to deliver oxygenation while patients remain awake and spontaneously breathing. Inspira Technologies is also advancing HYLA™, a proprietary blood sensor platform offering continuous, non-invasive monitoring. With multiple cleared products, a growing IP portfolio, and strategic streamlining of its operations, Inspira Technologies is increasingly positioned as an attractive platform within the critical care and MedTech landscape. The Company's recent internal shifts may reflect broader alignment with long-term industry trends, including consolidation, cross-sector collaboration, and potential strategic partnerships. For more information, visit: Forward-Looking Statement Disclaimer This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses that it expects demand for its ART100 system from a European governmental authority, that it has ramped up its production in order to meet expected near term delivery needs, , the benefits and advantages of the ART100, that the ART100 system is gaining traction as a reliable device for a critical care and emergency preparedness programs, the potential outcome of its procurement negotiations with a European government authority, its belief that expanding its production capacity enables the Company to meet projected deployment needs quickly and efficiently, and its belief that current momentum may accelerate the Company's emergence as a strategic public health supplier across both governmental and private sectors. These forward-looking statements and their implications are based solely on the current expectations of the Company's management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (the "SEC"), which is available on the SEC's website at Company ContactInspira Technologies – Media RelationsEmail: info@ +972-9-9664485
Associated Press
5 days ago
- Business
- Associated Press
Inspira Scales Up ART100 Production Capabilities Amid Advanced Negotiation with European Government Authority
RA'ANANA, Israel, June 05, 2025 (GLOBE NEWSWIRE) -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ('Inspira,' 'Inspira Technologies,' or the 'Company'), a pioneer in innovative life-support and diagnostic technologies, today announced that it has scaled-up its production capabilities for its U.S. Food and Drug Administration (FDA)-cleared INSPIRA™ ART100 system (the 'ART100 system'), in response to expected demand from a European governmental authority with which the Company is currently in advanced-stage procurement negotiations. Inspira has ramped up strategic production in order to meet near-term delivery needs as Inspira expects these negotiations move toward finalization. The ART100 system, already implemented in clinical settings in the United States, is gaining traction as a reliable device for a critical care and emergency preparedness programs. 'We are preparing for commercial execution,' said Dagi Ben Noon, Chief Executive Officer of Inspira Technologies. 'Our dialogue with a European government body has advanced to a stage where operational readiness is essential. Expanding our production capacity will enable us to meet projected deployment needs quickly and efficiently.' This move follows Inspira's recent announcement of its global rollout strategy and reflects the Company's commitment to fast-track revenue generation from the ART100 system, while continuing its development of its next-generation platforms, the ART500 and the HYLA™ blood sensor. The Company believes the current momentum—combined with a growing global focus on scalable respiratory solutions—may accelerate the Company's emergence as a strategic public health supplier across both governmental and private sectors. About Inspira Technologies Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions. The Company's U.S. FDA -cleared INSPIRA ART100 system is approved for cardiopulmonary bypass in the U.S. and ECMO (Extracorporeal Membrane Oxygenation) procedures outside the U.S and serves as a regulatory foundation for the development of the INSPIRA ART500 — a next-generation system designed to deliver oxygenation while patients remain awake and spontaneously breathing. Inspira Technologies is also advancing HYLA™, a proprietary blood sensor platform offering continuous, non-invasive monitoring. With multiple cleared products, a growing IP portfolio, and strategic streamlining of its operations, Inspira Technologies is increasingly positioned as an attractive platform within the critical care and MedTech landscape. The Company's recent internal shifts may reflect broader alignment with long-term industry trends, including consolidation, cross-sector collaboration, and potential strategic partnerships. For more information, visit: Forward-Looking Statement Disclaimer This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses that it expects demand for its ART100 system from a European governmental authority, that it has ramped up its production in order to meet expected near term delivery needs, , the benefits and advantages of the ART100, that the ART100 system is gaining traction as a reliable device for a critical care and emergency preparedness programs, the potential outcome of its procurement negotiations with a European government authority, its belief that expanding its production capacity enables the Company to meet projected deployment needs quickly and efficiently, and its belief that current momentum may accelerate the Company's emergence as a strategic public health supplier across both governmental and private sectors. These forward-looking statements and their implications are based solely on the current expectations of the Company's management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading 'Risk Factors' in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (the 'SEC'), which is available on the SEC's website at . Company Contact Inspira Technologies – Media Relations Email: [email protected] Phone: +972-9-9664485
Yahoo
11-03-2025
- Business
- Yahoo
Inspira Technologies Reports Full Year 2024 Financial Results and Provides Business Updates
Significant progress in HYLA blood sensor and INSPIRA ART core technologies RA'ANANA, Israel, March 11, 2025 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira" or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced its financial results for the full year ended December 31, 2024, and provided a corporate update. Dagi Ben-Noon, Chief Executive Officer of Inspira, commented: "2024 was a transformative year for Inspira, marked by significant technological advancements and a major regulatory milestone. We successfully obtained 510(k) clearance from the Food and Drug Administration ("FDA") for our INSPIRA™ ART100 system and began its preparation for deployment in leading hospitals in the United States. In 2025, our focus is on the rapid advancement of our flagship INSPIRA™ ART core technologies, with the HYLA™ blood monitoring sensor expected to lead the way towards our planned FDA submission for clearance in the second half of the year. We've already deployed the FDA-cleared INSPIRA ART100 system to Westchester Memorial Center, NY, for its evaluation by their team of medical experts using the device in clinical procedures pursuant to the collaboration with the hospital." Recent Business and Operational Highlights FDA-Cleared System Deployment: In January 2025, Inspira delivered its FDA-cleared INSPIRA ART100 systems to Glo-Med Networks Inc. for distribution to hospitals across the east coast of the U.S., including, as reported, a cardiothoracic surgery division at a leading New York hospital ranked among the top 15 percent of cardiothoracic programs in the U.S. The deployment includes collaborative support from both parties to ensure seamless integration of this unique technology into clinical use. VORTX™ Technology Advancement: In January 2025, the Company unveiled a modular configuration for its VORTX blood oxygenation technology, representing a significant advancement in extracorporeal oxygenation with the potential to transform critical care practices by reducing harmful effects on blood components. HYLA™ Blood Sensor Clinical Results: In March 2025, Inspira announced positive results from the clinical study of its AI-powered HYLA™ blood sensor, which achieved 96% accuracy for a key parameter compared to traditional blood test analyzers. Additionally, a new indicator for identifying oxygen deficiencies demonstrated 92.3% accuracy. The clinical study, conducted at Sheba Medical Center, involved six patients undergoing open-heart surgery with the clip-on HYLA blood sensor monitoring blood parameters in real-time. The Company plans to advance with the ongoing clinical study and expects FDA submission for the first HYLA configuration in the second half of 2025. Manufacturing Partnership: In January 2025, the Company established a dedicated production line for a crucial flow mechanism component to be integrated into Inspira's products for use in the extracorporeal circulation of blood during the oxygenation process. The collaboration with Zriha Medical Ltd., a leading international manufacturer specializing in medical device production, enables to support scaling of production for its innovative respiratory support system and candidate technologies. INSPIRA ART100 System Enhancements: In January 2025, Inspira introduced new support features for the INSPIRA ART100 system designed to assist medical teams, reduce staff overhead, and improve efficiency through customizable protocols and advanced alarm troubleshooting capabilities. Infection Prevention Technology: In February 2025, Inspira reported positive initial results from its collaboration with Ennocure MedTech Ltd., with ex-vivo testing showing a 95% reduction in bacterial presence within 4 hours using a novel bio-electronic patch technology designed to prevent bloodstream infections. Leadership Strengthening: In January 2025, the Company appointed Mr. Tal Parnes as the new Chairman of the Board, bringing over three decades of experience in the medical technology and pharmaceutical sectors to enhance the Company's strategic vision and market positioning. In January 2025, the Company accepted Prof. Goldwasser's resignation from his position, which was due to personal reasons. Increasing Operational Efficiency: In 2024, Inspira implemented strategic cost management while maintaining focused research and development (R&D) investments and achieving significant technological advancements. The Company strategically managed R&D expenses by optimizing personnel resources, and securing government grants, all without compromising progress toward critical product milestones. Full Year 2024 Financial Highlights Operating Expenses: Total operating expenses decreased to US$11,267,000 in the year ended December 31, 2024, from US$12,133,000 in the same period in 2023. R&D Investments: R&D expenses decreased to US$6,323,000 for the year ended December 31, 2024, from US$7,320,000 in the same period in 2023. The decrease was primarily attributable to the reflection of the exchange rate on salary and related expenses, changes in the Company's staffing and development project's needs, and an Israel Innovation Authority grant deducted from the R&D expenses. G&A Expenses: General and administrative (G&A) expenses increased to US$4,185,000 for the year ended December 31, 2024, from US$4,063,000 in the same period in 2023. The increase was primarily attributable to an increase in professional fees, salary and related expenses and share-based compensation. Sales and Marketing: Sales and marketing (S&M) expenses increased to US$754,000 for the year ended December 31, 2024, from US$746,000 in the same period in 2023. The increase is attributable to an increase in salary and related expenses and share-based compensation that is offset by decrease in professional fees paid for projects related to digital marketing and media materials. Net Loss: Net loss attributable to ordinary shareholders was US$11,053,000 in 2024, compared with US$11,286,000 in 2023. Cash Position: As of December 31, 2024, the Company had cash, cash equivalents and deposits of US$5,779,000 compared to US$7,361,000 as of December 31, 2023, providing financial stability to support ongoing product development and upcoming regulatory submissions. Financial Liabilities: As of December 31, 2024, financial liabilities at fair value totaled US$1,575,000 compared to US$1,470,000. The financial liabilities represent the fair value of the Company's equity liabilities. About Inspira Technologies Inspira Technologies is developing innovative respiratory support and diagnostics technologies. The Company's flagship INSPIRA ART system aims to revolutionize critical care by enabling patients to remain awake during treatment while stabilizing oxygen levels without mechanical ventilation. The FDA-cleared INSPIRA ART100 system has received regulatory approvals for Cardiopulmonary Bypass procedures in the U.S. and for Cardiopulmonary Bypass procedures and Extra Corporeal Membrane Oxygenation in Israel. The Company's HYLA blood sensor technology is designed to provide continuous, real-time blood monitoring without the need for blood draws. The Company's pipeline products, including the INSPIRA ART (Gen 2), INSPIRA Cardi-ART, and HYLA blood sensor, are currently in development and have not yet received regulatory approval. For more information, visit: Forward-Looking Statement Disclaimer This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses the potential benefits of its products, the expected timing of its FDA submissions, the expected results and impact of its clinical studies, the deployment of its product, and its belief that its reduced total expenses, its strategic investments in R&D and its cash position provide it with a solid foundation to support its ongoing product development initiatives and upcoming regulatory submissions in 2025. These forward-looking statements and their implications are based solely on the current expectations of the Company's management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (the "SEC"), which is available on the SEC's website at STATEMENTS OF BALANCE SHEETS(US dollars in thousands)December 31,December 31,20242023 ASSETSCurrent Assets:Cash and cash equivalents 5,1115,041 Cash deposits 6682,320 Other accounts receivable 587432 Inventory 444- Total current assets 6,8107,793 Non-Current Assets:Right of use assets, net 7611,011 Property, plant and equipment, net 499506 Total non-current assets 1,2601,517 Total Assets 8,0709,310December 31,December 31,20242023 LIABILITIES AND SHAREHOLDERS' EQUITYCurrent Liabilities:Trade accounts payables 154198 Other accounts payable 1,3641,026 Lease liabilities 277290 Financial Liabilities at Fair Value 1,5751,470 Total current liabilities 3,3702,984 Non-Current Liabilities:Lease liabilities 378588 Total non- current liabilities 378588 Shareholders' Equity:Share capital and additional paid in capital 70,89661,259 Accumulated deficit (66,574)(55,521) Total equity 4,3225,738 Total Liabilities and Shareholders' Equity 8,0709,310 STATEMENTS OF COMPREHENSIVE LOSS(US dollars in thousands)Year endedDecember 31, 2024Year endedDecember 31, 2023 Research and development expenses 6,3237,320 General and administrative expenses 4,1854,063 Sales and marketing expenses 754746 Other expenses (income) 54 Operating loss 11,26712,133 Interest Income from deposits (172)(318) Finance expenses(income), net (42)(529) Loss before tax 11,05311,286 Taxes on income -- Total comprehensive loss for the period 11,05311,286 STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY(US dollars in thousands) For the year Ended December 31, 2024: Number of shares Share capital and additional paid in capital Accumulated deficit TotalBalance on January 01, 2024 15,652,17661,259 (55,521)5,738Changes during the period:Issuance of ordinary shares, private warrants and Pre-funded warrants, net 6,231,1697,679 -7,679Exercise of options 19,0482 -2Exercise of June 2024 Pre-funded warrants into ordinary shares 1,709,7602 -2Restricted share unit ("RSU") vesting 594,943- --Issuance of ordinary Shares- advisor fees 45,00062 -62Share-based compensation -1,892 -1,892Comprehensive and net loss -- (11,053)(11,053)Balance on December 31, 2024 24,252,09670,896 (66,574)4,322For More Financial Information: For a comprehensive understanding of the Company's financial reports and related management's discussion and analysis for applicable periods, please review the company's annual report on Form 20-F for the fiscal year ended December 31, 2024, available on the company's EDGAR profile at Company Contact Inspira Technologies – Media RelationsEmail: info@ +972-9-9664485 Capital Markets & Investor Contact Arx | Capital Markets AdvisorsNorth American Equities Deskinspira@ Logo: View original content: SOURCE Inspira Technologies Sign in to access your portfolio
Yahoo
11-03-2025
- Business
- Yahoo
Inspira Technologies Announces Positive Results from Clinical Study of HYLA Blood Sensor, Achieving 96% Accuracy
Inspira's AI-powered continuous blood monitoring technology demonstrated a high degree of accuracy in a key parameter, targeting multiple multi-billion-dollar market segments; Company plans to advance with ongoing clinical study following this success; FDA submission planned for H2 2025 RA'ANANA, Israel, March 4, 2025 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) ("Inspira" or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced positive results from the clinical study of its AI-powered HYLA™ blood sensor. Inspira believes that these breakthrough results strengthen the Company's progress in developing its innovative real-time blood monitoring capabilities, as a means of enabling early diagnosis and personalized care without the need for intermittent blood draws. The Company is proud to report that the HYLA successfully achieved 96% accuracy in its clinical study results for a key parameter, as compared to traditional blood test analyzers. In addition, the Clinical study was utilized for testing new parameters including a new indicator for identifying oxygen deficiencies, demonstrating 92.3% accuracy. Data collected in clinical studies is analyzed to further enhance the algorithms and accuracy of the system's AI-powered learning capabilities. This accurate and real-time continuous measurement capability may help prevent blood oxygen deficiency during surgical procedures without the need for blood draws. The clinical study involved 6 patients undergoing open-heart surgery with the clip-on HYLA blood sensor attached at two different points on the blood circuit tubing, allowing monitoring of the patients' blood as it flowed through the system during the bypass procedure. The HYLA monitored blood circulating from the patient to the heart-lung machine as well as from the machine back to the patient. The HYLA device's accuracy was determined by comparing results of routine blood samples withdrawn from patients and analyzed by traditional blood analyzers against the HYLA device readings. "We consider these exceptional results that mark a pivotal milestone in our mission to transform critical care monitoring," said Dagi Ben-Noon, CEO of Inspira Technologies. "We believe that achieving 96% accuracy as reflected in our clinical results in real-time blood monitoring without the need for blood draws represents a significant technological breakthrough. We plan to introduce the HYLA blood monitoring device for wide adoption across various medical procedures, targeting healthcare providers with early detection diagnostics to support patient treatment." The clinical study is conducted at Sheba Hospital, ranked among the world's top 8 hospitals by Newsweek, by the hospital's medical team and authorized members of the Company. With this clinical study being utilized to focus on accuracy testing against current hospital blood lab testing methods, the Company plans to advance the study to collect additional patient data to further expand the system's AI-powered learning capabilities, towards early detection diagnostics software development. The Company anticipates that these new results will support the advancement towards its expected Food and Drug Administration (FDA) submission of the first HYLA configuration in the second half of 2025. Once FDA clearance is obtained, the Company plans to deploy this core technology of the INSPIRA ART in U.S. hospitals for data collection and post-market validation. About the HYLA Blood Sensor The HYLA blood sensor is designed to monitor blood parameters continuously using non-invasive, AI-powered technology. Unlike traditional blood monitoring methods that require intermittent blood draws, the HYLA system aims to provide real-time data, enabling earlier detection of changes in patient condition and more timely medical interventions. As a standalone technology, the HYLA targets the blood gas analyzer market, projected to reach $5.7 billion by 2030, while also strengthening Inspira's position in the $19 billion mechanical ventilation market when and if integrated with the Company's respiratory support systems. The HYLA technology is being developed for versatility across multiple clinical settings, from intensive care units to operating rooms, with potential applications in cardiopulmonary bypass procedures, critical care monitoring, and emergency medicine. About Inspira Technologies Inspira Technologies is developing innovative respiratory support and diagnostics technologies. The Company's flagship INSPIRA ART system aims to revolutionize critical care by enabling patients to remain awake during treatment while stabilizing oxygen levels without mechanical ventilation. The FDA-cleared INSPIRA ART100 system has received regulatory approvals for Cardiopulmonary Bypass procedures in both the U.S. and for Cardiopulmonary Bypass procedures and Extra Corporeal Membrane Oxygenation in Israel. The Company's HYLA™ blood sensor technology is designed to provide continuous, real-time blood monitoring without the need for blood draws. The Company's pipeline products, including the INSPIRA ART (Gen 2), INSPIRA Cardi-ART, and HYLA blood sensor, are currently in development and have not yet received regulatory approval. For more information, visit: Forward-Looking Statement Disclaimer This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses the potential benefits of its products and the potential market size that it is targeting, the results of the clinical study, its belief that the results strengthen its progress in developing its innovative real-time blood monitoring capabilities and represents a significant technological breakthrough, that it plans to introduce the HYLA blood monitoring device at a cost point that could enable wide adoption across various medical procedures, the expected timing of its FDA submission of the first HYLA configuration and that it plans to deploy this core technology of the INSPIRA ART in U.S. hospitals for data collection and post market validation following receipt of FDA approval.. These forward-looking statements and their implications are based solely on the current expectations of the Company's management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (the "SEC"), which is available on the SEC's website at Company Contact Inspira Technologies – Media RelationsEmail: info@ +972-9-9664485 Capital Markets & Investor Contact Arx | Capital Markets AdvisorsNorth American Equities Deskinspira@ Logo - View original content: SOURCE Inspira Technologies Sign in to access your portfolio
