Latest news with #INSPIRA™ART100
Yahoo
3 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
3 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
3 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
15-04-2025
- Business
- Yahoo
Inspira Technologies Announces Successful Treatment of First Patient with INSPIRA ART100 at Westchester Medical Center
First Clinical Use of INSPIRA ART100 System Successfully Completes Full Treatment Cycle, Validating the Technology's Performance in a Real-World Clinical Environment and Garnering Overwhelmingly Positive Feedback RA'ANANA, Israel, April 07, 2025 (GLOBE NEWSWIRE) -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) ("Inspira" or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced the successful completion of the first human treatment using its U.S. Food and Drug Administration-cleared INSPIRA™ ART100 system in a critical life-support procedure. The procedure was successfully performed by expert physicians at Westchester Medical Center in New York State, marking the first real-world implementation of Inspira's innovative technology. During the life-support procedure, the INSPIRA ART100 effectively provided comprehensive heart and lung support by oxygenating and circulating the patient's blood. Following the procedure, the patient was safely transitioned off the system, demonstrating its effective support. Dr. David Spielvogel, MD, Section Chief of Cardiothoracic Surgery at Westchester Medical Center commented: "The INSPIRA ART100 system performed exceptionally well during this critical procedure. We were particularly impressed with the system's reliability and responsiveness throughout the procedure. I believe that the seamless transition during both the connection and disconnection phases demonstrated the technology's sophistication and clinical readiness. This successful first case represents a promising advancement in extracorporeal support technology that could benefit numerous patients requiring this level of care. We look forward to continuing and expanding our relationship with Inspira." Joe Hayon, President of Inspira, added: "This first successful patient use of INSPIRA ART100 is a pivotal milestone for Inspira, validating the real-world potential of the INSPIRA ART100. We believe that the positive outcome at Westchester Medical Center sets the stage for broader adoption across leading hospitals, with Glo-Med Networks Inc. ('Glo-Med'), our U.S. distributor. We remain committed to expanding clinical use and advancing critical care solutions for patients worldwide." The installation, training program and professional services relating to the clinical use of the INSPIRA ART100 was led by Inspira Technologies Inspira Technologies is developing innovative respiratory support and diagnostics technologies. The Company's flagship INSPIRA ART500 system also known as the INSPIRA ART 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 ART500, and HYLA blood sensor, are currently in development and have not yet received regulatory approval. For more information, please visit our corporate website at About Glo-Med Networks, Inc. Glo-Med, known for delivering unique healthcare solutions, collaborates with top medical device and biomedical companies worldwide to meet the growing demand for innovative medical devices and related products in domestic and international markets. Glo-Med maintains extensive access to next-generation medical products globally via long-term partnerships and relationships with medical providers and through its sister company focused on medical device servicing with a focus on hospital beds and medical mattresses, Med-Stat Consulting Services, Inc. (est. 2003). Along with the largest and most prominent healthcare organizations in New York and Florida as clients, Glo-Med has offices and partner companies in the U.S., Latin America, Europe, the Middle East, and Africa, providing extensive access to the global medical network. For more information, please visit the corporate website: 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 the INSPIRA ART100 represents a promising advancement in extracorporeal support technology that could benefit numerous patients, the prospective future collaboration between Westchester Medical Center and Inspira, the belief that the seamless transition during both the connection and disconnection phases of the patient treatment demonstrated the technology's sophistication and clinical readiness, the belief that the successful patient treatment with the INSPIRA ART100 represents a huge milestone for the Company and validates its technology's potential to transform critical care, the belief that the positive outcome at Westchester Medical Center sets the stage for broader adoption across leading hospitals, led by Glo-Med, and the belief that the successful deployment of its system in a leading cardiopulmonary facility demonstrates the readiness of its technology for real-world clinical applications. 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 ContactInspira Technologies – Media Relations Email: info@ Phone: +972-9-9664485 Capital Markets & Investor ContactArx | Capital Markets Advisors North American Equities Desk inspira@
Yahoo
19-03-2025
- Business
- Yahoo
Inspira Technologies' Innovative Life-Support System to be Showcased at AmSECT 63rd International Conference 2025 in San Diego
Leading perfusion professionals to experience Inspira's FDA-cleared cardiopulmonary bypass INSPIRA™ ART100 technology at premier industry event RA'ANANA, Israel, March 19, 2025 /PRNewswire/ -- 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 its U.S. Food and Drug Administration-cleared life-support system, the INSPIRA™ ART100, will be showcased at the American Society of Extracorporeal Technology (AmSECT) 63rd International Conference, taking place March 19-23, 2025, at the Loews Coronado Bay Resort in San Diego, California, by their distributor Glo-Med Networks Inc ("Glo-Med"). Conference attendees will have the opportunity to explore Inspira's cutting-edge cardiopulmonary bypass technology at Glo-Med's booth. The INSPIRA ART100 system, which received FDA 510(k) clearance in May 2024 for use in cardiopulmonary bypass procedures, represents an advancement in extracorporeal circulation technology. "The AmSECT International Conference brings together leading perfusion professionals, providing an ideal platform to showcase our INSPIRA ART100 system," said Dagi Ben-Noon, Chief Executive Officer of Inspira Technologies. "This event offers an excellent opportunity to further expose our innovative technology to the perfusion community. We look forward to connecting with industry experts and demonstrating how our solutions can support medical professionals." Visitors interested in scheduling a personal meeting are welcome to contact Mr. Levi Perryman at levi@ or visit Booth number 4. About AmSECT 63rd International Conference The American Society of ExtraCorporeal Technology (AmSECT) International Conference is the premier global event for perfusion professionals, focusing on advancements in extracorporeal circulation, patient care, and perfusion education. The event will feature the latest medical technologies, research, and discussions shaping the future of perfusion. About Inspira Technologies Inspira Technologies is developing innovative respiratory support and diagnostics technologies. The Company's flagship INSPIRA ART500 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 ART500 (Gen 2), INSPIRA Cardi-ART, and HYLA blood sensor, are currently in development and have not yet received regulatory approval. For more information, visit: Company ContactInspira Technologies – Media RelationsEmail: info@ +972-9-9664485 Capital Markets & Investor ContactArx | Capital Markets AdvisorsNorth American Equities Deskinspira@ View original content: SOURCE Inspira Technologies Sign in to access your portfolio
