Core Viewpoint - Inspira Technologies is positioning itself to enter the multi-billion dollar liquid biopsy diagnostics market through a proposed acquisition and a strategic equity investment of $15 million, while ensuring protections for existing shareholders [1][2]. Equity Investment - The proposed transaction includes a $15 million equity investment at a premium to the current market capitalization, based on a pre-money valuation of $180 million, reflecting the strategic investor's assessment of the liquid biopsy technology's potential [3]. - The identity of the strategic investor will be disclosed after shareholder approval and execution of definitive agreements, with $12 million of the investment proceeds allocated to fund existing technologies [4]. Strategic Acquisition - The acquisition involves an advanced liquid biopsy diagnostics business, allowing Inspira to enter the growing liquid biopsy market with a proprietary platform designed for cancer characterization [5]. - The platform has shown high concordance with traditional tissue biopsy in clinical studies, indicating its potential to provide valuable diagnostic insights [5][6]. - The initial clinical focus of the platform is on breast cancer, with a projected global liquid biopsy market size of approximately $58 billion over the next decade [6]. Regulatory Pathway - Following the acquisition, the company plans to pursue FDA clearance for the liquid biopsy platform through the 510(k) regulatory pathway, leveraging existing regulatory precedents [7]. - An existing reimbursement code is already in place for the intended clinical use, facilitating a clear path to reimbursement upon regulatory clearance [8]. Shareholder Protection Framework - The transaction includes a shareholder protection framework to preserve the economic upside of existing technologies for current shareholders while allowing participation in the growth potential of the liquid biopsy platform [9]. - Existing shareholders are expected to receive contingent value rights, ensuring that future realizations of value from respiratory technology assets are allocated exclusively to them [9]. Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products and a growing IP portfolio [10].

Core Viewpoint - Inspira Technologies has announced a proposed two-part transaction involving the acquisition of a liquid biopsy diagnostics business and a concurrent $15 million strategic equity investment, aimed at expanding into the high-growth diagnostics market [1][2]. Equity Investment - The transaction includes a $15 million equity investment at a premium to the current market capitalization, based on a pre-money valuation of $180 million, reflecting the strategic investor's assessment of the liquid biopsy technology's value [3]. - The identity of the strategic investor will be disclosed after shareholder approval and execution of definitive agreements, with $12 million of the investment proceeds allocated to fund existing respiratory and blood monitoring technologies [4]. Strategic Acquisition - The acquisition involves an advanced liquid biopsy diagnostics business through an all-share transaction, allowing entry into the growing liquid biopsy market with a proprietary platform designed for cancer characterization [5]. - The platform has shown high concordance with traditional tissue biopsy in clinical validation studies, indicating its potential to provide meaningful diagnostic insights [5][6]. - The initial clinical focus of the platform is on breast cancer, with applicability across other oncology indications, and the global liquid biopsy market is projected to reach approximately $58 billion in the next decade [6]. Regulatory Pathway - Following the acquisition, the company plans to pursue FDA clearance for the liquid biopsy platform through the 510(k) regulatory pathway, leveraging existing reimbursement codes for intended clinical use [7]. Shareholder Protection Framework - The transaction includes a shareholder protection framework to preserve the economic upside of existing respiratory and blood-monitoring platforms for current shareholders while allowing participation in the growth potential of the liquid biopsy platform [9].

Core Viewpoint - Inspira Technologies has reaffirmed binding purchase orders totaling $49.5 million, with payment activities set to commence in the 2026 fiscal cycle, aligning with regulatory and deployment milestones [1][2]. Group 1: Purchase Orders and Execution - The company confirmed that the purchase orders remain valid and the distributor plans to advance these orders during 2026 [2]. - The payment framework for the binding purchase orders is structured to align with the company's revenue recognition framework, starting in the 2026 fiscal cycle [2][4]. - The updated schedule reflects necessary regulatory sequencing and technical implementation requirements, which are standard for large-scale healthcare deployments [3]. Group 2: Coordination and Risk Management - Inspira is actively coordinating with distribution partners, regulators, and funding organizations to advance execution milestones and finalize delivery schedules [4]. - This alignment aims to reduce execution risk, enhance operational visibility, and support a phased rollout across target markets [4]. - The company expects to provide updates regarding upcoming execution and deployment milestones [4]. Group 3: Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA™ ART100 system [5]. - The company is developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake [5]. - Inspira is also advancing the HYLA™ blood sensor platform, which offers continuous, non-invasive monitoring, positioning the company as an attractive player in the MedTech landscape [5].

Core Insights - Inspira Technologies has reaffirmed binding purchase orders totaling $49.5 million, with payment activities expected to commence in the 2026 fiscal cycle, aligning with regulatory and deployment milestones [1][2]. Group 1: Purchase Orders and Revenue Recognition - The company confirmed that the purchase orders remain valid and that the distributor plans to advance these orders toward execution in 2026 [2]. - The payment framework for the binding purchase orders is structured to align with the company's revenue recognition framework, which is set to begin in the 2026 fiscal cycle [2][4]. Group 2: Execution and Coordination - The updated schedule for execution reflects necessary regulatory sequencing, technical implementation requirements, and coordination with institutional capital allocations for deliveries [3]. - Inspira is actively coordinating with distribution partners, regulators, and funding organizations to advance execution milestones and finalize delivery schedules, aiming to reduce execution risk and enhance operational visibility [4]. Group 3: Company Overview - Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA™ ART100 system [5]. - The company is developing the INSPIRA ART500 system for oxygenation while patients remain awake and is advancing the HYLA™ blood sensor platform for continuous, non-invasive monitoring [5].

As filed with the Securities and Exchange Commission on December 22, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Form F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 INSPIRA TECHNOLOGIES OXY B.H.N.LTD. (Exact name of registrant as specified in its charter) State of Israel 3841 Not Applicable (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Nu ...

Core Insights - Several small-cap biotech and healthcare companies experienced notable gains in after-hours trading, driven by recent corporate updates and clinical milestones Company Updates - Inspira Technologies Oxy B.H.N. Ltd. (IINN) rose 5.88% to $1.08 following a recent definitive agreement for a registered direct offering of its ordinary shares and a Standby Equity Purchase Agreement with YA II PN, Ltd. [2] - Galectin Therapeutics Inc. (GALT) increased by 1.79% to close at $6.27, despite no new corporate developments reported [3] - MediciNova, Inc. (MNOV) advanced 4.83% to $1.52 after successfully completing patient enrollment in its Phase 2 OXTOX study, evaluating MN-166 for chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients [4] - Marker Therapeutics, Inc. (MRKR) gained 5.56% to $1.33 without any new company-specific announcements [5] - Sharps Technology, Inc. (STSS) climbed nearly 4% to $2.09, also without fresh updates [6] - DiaMedica Therapeutics Inc. (DMAC) rose 2.89% to $8.55 after a productive pre-IND meeting with the FDA regarding its planned study of DM199 in preeclampsia [6] - Corbus Pharmaceuticals Holdings, Inc. (CRBP) edged higher by 1.36% to $8.21, following the completion of its Phase 1a study of CRB-913 and initiation of the Phase 1b CANYON-1 trial [7] - ProMIS Neurosciences, Inc. (PMN) added 0.83% to $8.49, recovering slightly after a decline earlier in the day, with the completion of enrollment of 144 patients in its PRECISE-AD Phase 1b clinical trial for Alzheimer's disease [8]

Core Viewpoint - Inspira Technologies has announced a registered direct offering of ordinary shares and a Standby Equity Purchase Agreement (SEPA) to enhance its financial flexibility and support its strategic initiatives [1][4][7]. Group 1: Registered Direct Offering - The company will issue and sell 1,565,217 ordinary shares at a price of $1.15 per share, generating gross proceeds of approximately $1.8 million [2][9]. - The offering is expected to close on or about December 16, 2025, pending customary closing conditions [2]. Group 2: Standby Equity Purchase Agreement (SEPA) - The SEPA allows the company to sell up to $25 million of its ordinary shares over a 36-month period at its discretion, without any minimum purchase requirements [4][9]. - The company is not obligated to utilize this facility, providing it with opportunistic capital raising options as needed [4][9]. Group 3: Use of Proceeds - The net proceeds from the registered direct offering and any future proceeds from the SEPA will be used for working capital and general corporate purposes, specifically to support the company's strategic roadmap and planned operations [6][9]. Group 4: Company Overview - Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products and a growing intellectual property portfolio [8][10].

Core Viewpoint - Inspira Technologies has announced a definitive agreement for a registered direct offering of ordinary shares, aiming to raise approximately $1.8 million to support its strategic initiatives and operations [1][2][6]. Group 1: Registered Direct Offering - The company will issue and sell 1,565,217 ordinary shares at a price of $1.15 per share, resulting in gross proceeds of about $1.8 million [2]. - The offering is expected to close on or about December 16, 2025, pending customary closing conditions [2]. Group 2: Standby Equity Purchase Agreement (SEPA) - Inspira has entered into a SEPA with YA, allowing the company to sell up to $25 million of its ordinary shares over a 36-month period at its discretion [4]. - There are no minimum purchase requirements under the SEPA, and the company is not obligated to draw on this facility [4][9]. Group 3: Use of Proceeds - The net proceeds from the registered direct offering and any future proceeds from the SEPA will be used for working capital and general corporate purposes, specifically to support the company's strategic roadmap and planned operations [6]. Group 4: Company Overview - Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions, with products like the INSPIRA™ ART100 system and the upcoming INSPIRA ART500 [8]. - The company is positioned as an attractive platform within the life-support and MedTech landscape, supported by a growing IP portfolio and multiple cleared products [8].

Core Viewpoint - Inspira Technologies has secured a significant patent for its Convertible Dual Lumen Cannula device in Japan, enhancing its market position in the medical device sector and supporting future commercialization efforts [1][2]. Group 1: Patent and Market Position - The Japan Patent Office granted Patent No. 7777598, providing Inspira exclusive commercial rights for the Dual Lumen Cannula technology in Japan until 2041 [2]. - This patent complements an existing U.S. Patent granted in 2023, creating a protective barrier across two major healthcare markets [2]. - The patented technology allows a single-lumen cannula to convert into a dual-lumen cannula intravascularly, which may reduce infection risks and procedural complications compared to traditional solutions [3]. Group 2: Product and Strategic Implications - The Convertible Dual Lumen Cannula is designed to be a high-value disposable product, potentially enhancing patient safety and procedural efficiency while being more affordable than traditional dual-lumen cannulas [4]. - The company is positioned to benefit from both its respiratory support platforms and future disposable revenue streams due to the proprietary protection in the U.S. and Japan [4]. - Inspira Technologies is advancing its product offerings, including the INSPIRA™ ART100 system for cardiopulmonary bypass and the next-generation INSPIRA ART500 system, which aims to deliver oxygenation while patients remain awake [5].

Core Insights - Inspira Technologies has been granted Patent No. 7777598 by the Japan Patent Office for its Convertible Dual Lumen Cannula device, securing exclusive rights in Japan until 2041, complementing its existing U.S. patent [1][2] - The patented technology allows a single-lumen cannula to convert into a dual-lumen cannula intravascularly after insertion, potentially reducing infection risks and procedural complications compared to traditional solutions [3][4] - The company aims to commercialize the cannula as a high-value disposable product, enhancing patient safety and procedural efficiency while addressing the high manufacturing costs of traditional dual lumen cannulas [4] Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with its INSPIRA™ ART100 system approved for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S. [5] - The company is developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake, and advancing the HYLA™ blood sensor platform for continuous, non-invasive monitoring [5] - With a growing IP portfolio and strategic operational streamlining, Inspira Technologies is positioned as an attractive player in the life-support and MedTech landscape, aligning with industry trends such as consolidation and potential strategic partnerships [5]