Inspira Clarifies Routine Nature of Registration Statement on Form F-3 Filing Performed Every Three Years
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Aug 07 2025
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Should l Buy IINN?
Source: Newsfilter
Company Announcement: Inspira Technologies has filed a new shelf registration statement with the U.S. SEC as part of its routine renewal process, replacing the previous statement set to expire on August 18, 2025.
Product Development: The company specializes in advanced respiratory support and blood monitoring solutions, including the INSPIRA™ ART100 system and the upcoming INSPIRA ART500, while also advancing its proprietary HYLA™ blood sensor platform.
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About IINN
Inspira Technologies Oxy B.H.N Ltd, formerly Insense Medical Ltd, incorporated on February 27, 2018, is a specialty medical device company based in Israel. The Company is engaged in the research, development, manufacture, and marketing of respiratory support technology that is intended to provide an alternative to invasive mechanical ventilation (MV). It provides patients with acute respiratory distress syndrome to maintain spontaneous breathing and avoid the various risks associated with the use of MV.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Inspira Technologies Secures Major Procurement Approval
- Stock Surge: Inspira Technologies OXY (IINN) shares surged over 28% in pre-market trading on Monday, reflecting strong market interest and heightened investor confidence in the company's new product.
- Procurement Approval: Israel's largest health services provider, Clalit Health Services, approved the procurement of Inspira's FDA-cleared ART100 platform, marking a significant milestone in the medical device sector for the company.
- Market Reach: The ART100 system will be rapidly deployed across Clalit’s healthcare network, which serves approximately 4.9 million members, indicating a swift expansion of the company's market share and enhanced brand presence.
- Clinical Validation: The approval of ART100 represents not only a successful regulatory clearance but also strong clinical validation for its application in cardiopulmonary bypass and ECMO procedures, signaling substantial future commercial growth potential.
See More
Inspira Technologies Secures Clalit Approval for ART100 System
- Commercial Activation: Inspira Technologies' INSPIRA™ ART100 system has received approval from Clalit Health Services, marking its transition to commercial availability within a network serving approximately 4.9 million members, which is expected to significantly enhance the company's competitiveness in the medical device market.
- Network Scale: Clalit operates 14 major hospitals and over 1,600 clinics, and this approval allows the ART100 to penetrate one of the most sophisticated healthcare supply chains globally, further solidifying Inspira's market position in high-end medical devices.
- Clinical Value Validation: Following a rigorous technical and clinical review, the ART100's safety and efficacy have been strongly validated, providing a powerful reference case for Inspira's promotion in other global health systems and enhancing its market credibility.
- Long-Term Revenue Foundation: CEO Dagi Ben-Noon stated that this approval lays the groundwork for potentially long-term, high-quality revenue, and is expected to accelerate the company's commercialization efforts in the U.S. and other global markets.
See More
Inspira Technologies Validates HYLA System for Heart-Lung Surgery Market
- Market Penetration Opportunity: Inspira Technologies has successfully validated its HYLA™ system, which is expected to rapidly enter the approximately $50 billion heart-lung surgery market, marking a strategic expansion for the company in the medical device sector.
- Technical Performance Breakthrough: The HYLA™ system demonstrated a 94.2% accuracy in pCO₂ measurement during advanced lab testing, aligning with clinical needs and enabling real-time patient monitoring, thereby reducing complications during heart-lung machine and ECMO procedures.
- Standalone System Advantage: By decoupling the sensor from life-support hardware, the HYLA™ system achieves universal compatibility with existing operating room or ICU workflows, significantly expanding the company's total addressable market and activating a high-margin recurring revenue model.
- Future Development Strategy: The company plans to submit a regulatory application to the FDA in 2026, with CEO Dagi Ben-Noon stating that offering HYLA as a standalone solution will accelerate market entry and meet the substantial global demand for perfusion systems.
See More
Inspira Technologies Achieves Major Milestone in U.S. Hospital
- Clinical Evaluation Completed: Inspira's INSPIRA™ ART100 system has completed its clinical evaluation at a leading U.S. academic medical center, successfully treating approximately 30 patients, marking its transition from pilot use to standard clinical workflow and significantly enhancing the company's recognition in the medical device market.
- Procurement Process Initiated: The medical center has initiated an internal procurement process for multiple ART100 systems, indicating that the technology's clinical value and reliability have been thoroughly validated, which is expected to drive broader adoption of ART100 across other healthcare institutions.
- Technology Validation: The ART100 system is the first to progress from clinical evaluation to a budgeted procurement pathway at a major U.S. academic medical center, reflecting Inspira's competitiveness and market potential in the medical device sector, thereby strengthening its commercial positioning.
- Future Development Outlook: Inspira CEO Dagi Ben-Noon stated that this milestone will facilitate the broader adoption of the ART100 platform across leading healthcare institutions, further solidifying the company's market position in life support and MedTech.
See More
Biotech Surge Post-Market: Inspira, MediciNova, and DiaMedica Therapeutics Among Top Performers
Biotech Stocks Performance: Several small-cap biotech and healthcare companies saw notable gains in after-hours trading, driven by recent corporate updates and clinical milestones.
Inspira Technologies Update: Inspira Technologies Oxy B.H.N. Ltd. rose 5.88% following a recent agreement for a registered direct offering and a Standby Equity Purchase Agreement, despite no new news on the day.
MediciNova's Clinical Trial Success: MediciNova, Inc. advanced 4.83% after successfully completing patient enrollment in its Phase 2 OXTOX study, which evaluates MN-166 for preventing chemotherapy-induced peripheral neuropathy.
DiaMedica's FDA Meeting: DiaMedica Therapeutics Inc. gained 2.89% after a productive pre-IND meeting with the FDA regarding its study of DM199 in preeclampsia, with an additional non-clinical study requested.
See More
Inspira Secures Japanese Patent for Convertible Dual Lumen Cannula, Enhancing Market Position
- Patent Grant: Inspira Technologies has been awarded Patent No. 7777598 by the Japan Patent Office, covering its Convertible Dual Lumen Cannula device and method of use, securing exclusive commercial rights in Japan, one of the world's most advanced medical device markets, until 2041, thereby strengthening its competitive position in the global healthcare market.
- Technological Innovation: This patented technology allows a single-lumen cannula to convert into a dual-lumen cannula after insertion, reducing the need for additional incisions, which is expected to lower infection risks and procedural complications while significantly decreasing hospital costs and enhancing patient safety.
- Market Potential: Inspira's convertible cannula is positioned for standalone commercialization as a high-value disposable product, in addition to its integration into the INSPIRA™ ART System, which enhances the company's competitive edge in respiratory support platforms and drives future revenue growth.
- Strategic Positioning: By securing patent protection in both the U.S. and Japan, Inspira has solidified the foundation for its respiratory support platforms and future disposable revenue streams, demonstrating the company's commitment to high-standard regulatory markets and aligning with long-term industry trends of consolidation and cross-sector collaboration.
See More
Inspira Technologies Secures Major Procurement Approval
- Stock Surge: Inspira Technologies OXY (IINN) shares surged over 28% in pre-market trading on Monday, reflecting strong market interest and heightened investor confidence in the company's new product.
- Procurement Approval: Israel's largest health services provider, Clalit Health Services, approved the procurement of Inspira's FDA-cleared ART100 platform, marking a significant milestone in the medical device sector for the company.
- Market Reach: The ART100 system will be rapidly deployed across Clalit’s healthcare network, which serves approximately 4.9 million members, indicating a swift expansion of the company's market share and enhanced brand presence.
- Clinical Validation: The approval of ART100 represents not only a successful regulatory clearance but also strong clinical validation for its application in cardiopulmonary bypass and ECMO procedures, signaling substantial future commercial growth potential.
See More
Inspira Technologies Secures Clalit Approval for ART100 System
- Commercial Activation: Inspira Technologies' INSPIRA™ ART100 system has received approval from Clalit Health Services, marking its transition to commercial availability within a network serving approximately 4.9 million members, which is expected to significantly enhance the company's competitiveness in the medical device market.
- Network Scale: Clalit operates 14 major hospitals and over 1,600 clinics, and this approval allows the ART100 to penetrate one of the most sophisticated healthcare supply chains globally, further solidifying Inspira's market position in high-end medical devices.
- Clinical Value Validation: Following a rigorous technical and clinical review, the ART100's safety and efficacy have been strongly validated, providing a powerful reference case for Inspira's promotion in other global health systems and enhancing its market credibility.
- Long-Term Revenue Foundation: CEO Dagi Ben-Noon stated that this approval lays the groundwork for potentially long-term, high-quality revenue, and is expected to accelerate the company's commercialization efforts in the U.S. and other global markets.
See More
Inspira Technologies Validates HYLA System for Heart-Lung Surgery Market
- Market Penetration Opportunity: Inspira Technologies has successfully validated its HYLA™ system, which is expected to rapidly enter the approximately $50 billion heart-lung surgery market, marking a strategic expansion for the company in the medical device sector.
- Technical Performance Breakthrough: The HYLA™ system demonstrated a 94.2% accuracy in pCO₂ measurement during advanced lab testing, aligning with clinical needs and enabling real-time patient monitoring, thereby reducing complications during heart-lung machine and ECMO procedures.
- Standalone System Advantage: By decoupling the sensor from life-support hardware, the HYLA™ system achieves universal compatibility with existing operating room or ICU workflows, significantly expanding the company's total addressable market and activating a high-margin recurring revenue model.
- Future Development Strategy: The company plans to submit a regulatory application to the FDA in 2026, with CEO Dagi Ben-Noon stating that offering HYLA as a standalone solution will accelerate market entry and meet the substantial global demand for perfusion systems.
See More
Inspira Technologies Achieves Major Milestone in U.S. Hospital
- Clinical Evaluation Completed: Inspira's INSPIRA™ ART100 system has completed its clinical evaluation at a leading U.S. academic medical center, successfully treating approximately 30 patients, marking its transition from pilot use to standard clinical workflow and significantly enhancing the company's recognition in the medical device market.
- Procurement Process Initiated: The medical center has initiated an internal procurement process for multiple ART100 systems, indicating that the technology's clinical value and reliability have been thoroughly validated, which is expected to drive broader adoption of ART100 across other healthcare institutions.
- Technology Validation: The ART100 system is the first to progress from clinical evaluation to a budgeted procurement pathway at a major U.S. academic medical center, reflecting Inspira's competitiveness and market potential in the medical device sector, thereby strengthening its commercial positioning.
- Future Development Outlook: Inspira CEO Dagi Ben-Noon stated that this milestone will facilitate the broader adoption of the ART100 platform across leading healthcare institutions, further solidifying the company's market position in life support and MedTech.
See More
Biotech Surge Post-Market: Inspira, MediciNova, and DiaMedica Therapeutics Among Top Performers
Biotech Stocks Performance: Several small-cap biotech and healthcare companies saw notable gains in after-hours trading, driven by recent corporate updates and clinical milestones.
Inspira Technologies Update: Inspira Technologies Oxy B.H.N. Ltd. rose 5.88% following a recent agreement for a registered direct offering and a Standby Equity Purchase Agreement, despite no new news on the day.
MediciNova's Clinical Trial Success: MediciNova, Inc. advanced 4.83% after successfully completing patient enrollment in its Phase 2 OXTOX study, which evaluates MN-166 for preventing chemotherapy-induced peripheral neuropathy.
DiaMedica's FDA Meeting: DiaMedica Therapeutics Inc. gained 2.89% after a productive pre-IND meeting with the FDA regarding its study of DM199 in preeclampsia, with an additional non-clinical study requested.
See More
Inspira Secures Japanese Patent for Convertible Dual Lumen Cannula, Enhancing Market Position
- Patent Grant: Inspira Technologies has been awarded Patent No. 7777598 by the Japan Patent Office, covering its Convertible Dual Lumen Cannula device and method of use, securing exclusive commercial rights in Japan, one of the world's most advanced medical device markets, until 2041, thereby strengthening its competitive position in the global healthcare market.
- Technological Innovation: This patented technology allows a single-lumen cannula to convert into a dual-lumen cannula after insertion, reducing the need for additional incisions, which is expected to lower infection risks and procedural complications while significantly decreasing hospital costs and enhancing patient safety.
- Market Potential: Inspira's convertible cannula is positioned for standalone commercialization as a high-value disposable product, in addition to its integration into the INSPIRA™ ART System, which enhances the company's competitive edge in respiratory support platforms and drives future revenue growth.
- Strategic Positioning: By securing patent protection in both the U.S. and Japan, Inspira has solidified the foundation for its respiratory support platforms and future disposable revenue streams, demonstrating the company's commitment to high-standard regulatory markets and aligning with long-term industry trends of consolidation and cross-sector collaboration.
See More
