New Risk • 9h
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 42% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (42% average weekly change). Earnings have declined by 0.3% per year over the past 5 years. Shareholders have been substantially diluted in the past year (70% increase in shares outstanding). Revenue is less than US$1m (US$289k revenue). Minor Risk Market cap is less than US$100m (US$31.7m market cap). Ankündigung • Apr 15
Inspira Technologies OXY B.H.N. Ltd Appoints Yoav Rozanovich as Chief Business Officer Inspira Technologies OXY B.H.N. Ltd. announced the appointment of Mr. Yoav Rozanovich as Chief Business Officer (CBO) of Inspira Technologies. Mr. Rozanovich brings international experience across additive manufacturing, advanced electronics, and complex systems integration. From November 2021 to April 2026, Mr. Rozanovich served as VP of Global Customer Success at Nano Dimension, where he led global sales and customer operations for advanced electronics manufacturing platforms. Earlier in his career, he held senior roles in operations and systems integration at industry leaders including Stratasys Ltd. and Orbotech Ltd. As CBO, Mr. Rozanovich will lead Inspira Technologies’ commercial strategy with a clear focus on near-term revenue execution and long-term market expansion: Immediate Revenue Integration - Overseeing the transition of the active, revenue-generating AME operations, ensuring continuity of existing contracts and immediate contribution to cash flow. Acceleration of Existing Business - Driving forward the current AME sales pipeline while optimizing conversion of the existing global customer base. Expansion into Quantum Markets - Building a new revenue pipeline around Inspira Technologies’ quantum computing connectivity solutions, targeting a rapidly emerging multibillion-dollar market. Strategic Partnerships - Establishing alliances across the quantum computing and advanced electronics ecosystems to position Inspira Technologies within critical industry infrastructure layers. New Risk • Apr 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 0.3% per year over the past 5 years. Shareholders have been substantially diluted in the past year (70% increase in shares outstanding). Revenue is less than US$1m (US$289k revenue). Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$21.0m market cap). Ankündigung • Mar 31
Inspira Technologies Oxy B.H.N. Ltd. has withdrawn its Follow-on Equity Offering in the amount of $2.015985 million. Inspira Technologies Oxy B.H.N. Ltd. has withdrawn its Follow-on Equity Offering in the amount of $2.015985 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Transaction Features: At the Market Offering New Risk • Mar 29
New major risk - Revenue and earnings growth Earnings have declined by 0.3% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 0.3% per year over the past 5 years. Shareholders have been substantially diluted in the past year (69% increase in shares outstanding). Revenue is less than US$1m (US$289k revenue). Minor Risk Market cap is less than US$100m (US$17.0m market cap). Ankündigung • Feb 18
Inspira Technologies Oxy B.H.N. Ltd. has filed a Follow-on Equity Offering in the amount of $2.015985 million. Inspira Technologies Oxy B.H.N. Ltd. has filed a Follow-on Equity Offering in the amount of $2.015985 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Transaction Features: At the Market Offering Ankündigung • Feb 10
Inspira Technologies OXY B.H.N. Ltd. Secures Vendor Approval from $12 Billion Revenue HMO, Enabling Immediate ART100 Deployment Inspira™? Technologies OXY B.H.N. Ltd. announced a pivotal commercial advancement. The Company has received official approval from the Medical Equipment Committee of Clalit Health Services ("Clalit"), recognized as the second-largest integrated Health Maintenance Organization (HMO) globally. The approval enables the INSPIRA™? ART100 system for immediate procurement and operational use across Clalit's extensive medical ecosystem. Key Highlights: Commercial Activation: The approval transitions the ART100 from regulatory clearance to active commercial availability within a network serving approximately 4.9 million members. Tier-1 Network Scale: Clalit operates 14 major hospitals (including Rabin Medical Center and Soroka Medical Center, often ranked among Newsweek's "World's Best Smart Hospitals") and over 1,600 clinics. This approval effectively opens the door to one of the most sophisticated healthcare supply chains in the world. Validation of Clinical Value: The approval follows a rigorous technical and clinical review by the Professional Committee for Medical Equipment regarding Thoracic and Cardiac Surgery, signaling strong validation of the ART100's safety and efficacy profile to other global health systems. The Company views this approval as confirmation of the suitability of the INSPIRA ART100 for the organization's specific clinical needs in cardiopulmonary procedures. It enables all medical centres within the Clalit network to initiate procurement processes in accordance with the organization's supply chain protocols. Ankündigung • Feb 05
Inspira Technologies Oxy B.H.N. Ltd. has filed a Follow-on Equity Offering in the amount of $4.749722 million. Inspira Technologies Oxy B.H.N. Ltd. has filed a Follow-on Equity Offering in the amount of $4.749722 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 4,000,000
Price\Range: $0.7
Discount Per Security: $0.049
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 2,785,715
Price\Range: $0.6999
Discount Per Security: $0.048993
Transaction Features: Registered Direct Offering Ankündigung • Feb 04
Inspira Technologies OXY B.H.N. Ltd. Validates Next-Gen Standalone HYLA Blood Sensor with Clinical-Grade Accuracy, Targeting $48 Billion Heart-Lung Surgery Market Inspira Technologies OXY B.H.N. Ltd. announced the successful validation in the Company's advanced blood labs of its Next-Generation Standalone HYLA System. Designed to function independently of the Company's respiratory support devices, this new configuration allows Inspira Technologies to penetrate the broader approximately $50 billion heart-lung surgery market immediately upon clearance. In advanced bench testing, the system demonstrated 94.2% accuracy for the continuous optical measurement of Partial Pressure of Carbon Dioxide (pCO2), a performance level that aligns with clinical needs. The validation data confirms that the HYLA optical sensor tracks real-time patient status with high fidelity. This validation marks a strategic evolution for the HYLA platform. By decoupling the sensor from Inspira Technologies' life-support hardware, the Company is advancing a standalone system capable of integrating into any existing operating room or ICU workflow. This ' universal compatibility' strategy significantly expands Inspira Technologies's total addressable market and activates a high-margin, recurring revenue model based on the sale of disposable optical sensors and modular software upgrades. Inspira Technologies is advancing this standalone direction based on extensive industry engagement identifying extracorporeal procedures as an immediate commercial opportunity. The Company's approach supports recurring revenue through modular sensor and software upgrades and aligns with Inspira Technologies' long-term expansion into blood-based diagnostics, including its recently proposed potential acquisition of an advanced liquid biopsy business. Ankündigung • Jan 29
Inspira Technologies Oxy B.H.N. Ltd. Announces U.S. Food and Drug Administration-cleared INSPIRA ART100 System Inspira™ Technologies OXY B.H.N. Ltd. announced that its U.S. Food and Drug Administration (the “FDA”)-cleared INSPIRA™ ART100 system has completed its full clinical evaluation and advanced to a budgeted procurement execution process at a leading U.S. academic medical center, ranked among the top hospitals in the United States. The ART100 becomes Inspira's first system at this institution to complete a clinical evaluation and to transition from pilot use to standard clinical workflow, following the successful treatment of approximately 30 patients across multiple medical indications: life-saving procedures, surgeries and transplants. Based on consistent clinical performance and repeat utilization by medical staff, the ART100 systems have now been incorporated into that medical center’s routine workflow, with no remaining open clinical evaluation phase. Following completion of the clinical phase, the medical center has initiated an internal procurement process for the acquisition of multiple ART100 systems. The procurement is now subject to procedural budget release, with the clinical decision-making phase fully concluded. This marks the first instance at a major U.S. academic medical center where the ART100 has progressed from clinical evaluation to a formal, budgeted procurement pathway. Major Estimate Revision • Jan 09
Consensus revenue estimates fall by 73% The consensus outlook for revenues in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$1.79m to US$490.0k. Forecast losses increased from -US$0.42 to -US$0.44 per share. Medical Equipment industry in the US expected to see average net income growth of 17% next year. Consensus price target of US$5.00 unchanged from last update. Share price was steady at US$0.93 over the past week. Ankündigung • Nov 26
Inspira Technologies Oxy B.H.N. Ltd., Annual General Meeting, Dec 30, 2025 Inspira Technologies Oxy B.H.N. Ltd., Annual General Meeting, Dec 30, 2025. Location: 2 ha-tidhar street, raanana 4366504, Israel Ankündigung • Nov 16
Inspira Technologies OXY B.H.N. Ltd. Completes Clinical Study for HYLA Blood Sensor - Ahead of Regulatory Submission Inspira™? Technologies OXY B.H.N. Ltd. announced the completion of the clinical study for its HYLA, non-invasive blood sensor, toward regulatory submission and future commercialization. Based on the clinical trial results and ongoing lab tests, showing between 95% to 99% accuracy across measured parameters, Inspira is soon entering the final validation and verification stage ahead of planned regulatory submission. Inspira is leveraging its proprietary non-invasive platform and integrating advanced Machine Learning algorithms to further extend the HYLA sensor's capabilities beyond its core parameters. This development focuses on adding critical physiological parameters currently unavailable through existing non-invasive monitoring systems. The HYLA is a smart, non-in invasive blood sensor designed to deliver continuous, real-time blood data without the need for blood draws. Developed for use in operating rooms, ICUs, ECMO/CRRT/dialysis settings, and cardiac care units, HYLA provides clinicians with immediate access to critical physiological information. By enabling seamless, real-time monitoring, the system is engineered to enhance patient safety, improve workflow efficiency, and support more informed decision-making in demanding critical-care environments. Ankündigung • Nov 08
Inspira Technologies Nears Final Regulatory Clearance for the ART100 in the UAE, Accelerating Gulf Region Expansion Inspira Technologies OXY B.H.N. Ltd. announced that it has completed the regulatory submission of its FDA-cleared INSPIRA™? ART100 system ("ART100") to the United Arab Emirates Ministry of Health and Prevention ("MOHAP"). Final approval is expected within days, marking a decisive step toward commercial entry into the Gulf region. This regulatory milestone follows successful high-level government discussions in the UAE, during which Inspiraaid the groundwork for potential nationwide deployment and clinical integration of the ART100 system following the approval by the MOHAP. The achievement further advances Inspira's global commercialization roadmap. The UAE is recognized for its efficient and innovation-driven regulatory framework. Inspira believes that the ART100's anticipated authorization will reinforce its regional partnerships and unlock broad commercialization potential across the UAE region's enterprise healthcare networks. Ankündigung • Oct 22
Inspira Technologies Oxy B.H.N. Ltd. Announces Board Changes Inspira Technologies Oxy B.H.N. Ltd. announced the appointment of Ms. Sivan Matza as a member of the board of directors of the Company . The Board appointed Ms. Matza to serve as an independent director of the Company until the next annual general meeting of the Company's shareholders. Ms. Matza will also serve as a member of the Board's compensation committee, audit committee and financial statement examination committee. Ms. Matza will succeed Ms. Limor Rosen, who is stepping down from the Board. Ms. Sivan Matza is a Director at a leading international investment management firm overseeing tens of billions of dollars in assets. Her extensive experience in global finance, regulation and accounting strengthens Inspira's governance framework as the Company accelerates its commercial expansion. Major Estimate Revision • Oct 08
Consensus revenue estimates increase by 19%, EPS downgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$1.50m to US$1.79m. EPS estimate fell from -US$0.37 to -US$0.42 per share. Medical Equipment industry in the US expected to see average net income growth of 16% next year. Consensus price target of US$5.00 unchanged from last update. Share price rose 5.9% to US$1.26 over the past week. New Risk • Oct 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$9.9m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$9.9m free cash flow). Shareholders have been substantially diluted in the past year (38% increase in shares outstanding). Revenue is less than US$1m (US$289k revenue). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$3.5m net loss next year). Share price has been volatile over the past 3 months (16% average weekly change). Market cap is less than US$100m (US$32.5m market cap). New Risk • Sep 26
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (38% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported December 2024 fiscal period end). Share price has been volatile over the past 3 months (16% average weekly change). Market cap is less than US$100m (US$32.8m market cap). Ankündigung • Sep 20
Inspira Technologies OXY B.H.N. Ltd. to Unveil HYLA Real-Time Blood Sensor at U.S. ELSO Inspira™? Technologies OXY B.H.N. Ltd. announced it will present its HYLA blood sensor ("HYLA") to the global medical community for the first time. The presentation will take place at the U.S. ELSO Annual Conference in Washington, D.C., between September 27-30, 2025. This official unveiling follows the Company's recent announcement of the HYLA sensor's performance data, which demonstrated 97.35% accuracy compared to standard blood gas analyzers. The ELSO conference, widely regarded as the largest and most influential global event for extracorporeal life support (ECLS), represents the ideal platform to showcase this new technology to thousands of the world's leading clinicians, researchers, and industry leaders. Alongside the HYLA presentation, Inspira's management is scheduled to conduct high-level meetings with decision-makers from leading global medical device companies and hospital networks. These meetings are aimed at advancing discussions around commercialization and strategic partnerships for the HYLA platform. Inspira will also be showcasing its FDA-cleared ART100 system at the conference, highlighting the Company's comprehensive platform of advanced life-support and monitoring solutions. Ankündigung • Sep 13
Inspira Technologies OXY B.H.N. Ltd. Announces Pivotal Results for HYLA Blood Sensor Inspira™? Technologies OXY B.H.N. Ltd. announced pivotal results for its HYLA blood sensor, achieving 97.35% accuracy in its latest performance testing phase that will support its upcoming U.S. Food and Drug Administration ("FDA") submission. These results represent a significant advancement from the initial data obtained in a clinical study, as announced on March 4, 2025. The clinical study from March, conducted at a medical center ranked among the world's leading hospitals, provided validation for HYLA's performance, while these latest test results confirm the device's readiness for the regulatory pathway in the U.S. and Europe. Key features of the HYLA Blood Sensor include: High Accuracy: Achieves 97.35% accuracy relative to standard blood gas analyzers. Continuous Monitoring: Provides second-by-second data, eliminating the need for intermittent blood draws. Non-invasive Technology: Utilizes optical measurement, operating without drawing blood from the patient. Major Estimate Revision • Sep 03
Consensus revenue estimates increase by 50% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$1.00m to US$1.50m. EPS estimate unchanged from -US$0.37 at last update. Medical Equipment industry in the US expected to see average net income growth of 16% next year. Consensus price target up from US$3.00 to US$5.00. Share price was steady at US$1.17 over the past week. Breakeven Date Change • Sep 02
Forecast to breakeven in 2026 The analyst covering Inspira Technologies Oxy B.H.N expects the company to break even for the first time. New forecast suggests the company will make a profit of US$4.35m in 2026. Average annual earnings growth of 87% is required to achieve expected profit on schedule. Ankündigung • Aug 22
Inspira Technologies OXY B.H.N. Ltd. Receives U.S. Patent Approval for the ART500 Core Technology Inspira™? Technologies OXY B.H.N. Ltd. has received U.S. Patent approval for low flow rates extracorporeal oxygenation system and methods of use. This patent represents the core technology of the ART500 device, a key asset in the Company's strategy to penetrate the $20 billion estimated market for advanced respiratory support. This innovation has 16 claims found to be novel. The patent provides further protection for the underlying core technology of Inspira's ART500 system, which is designed to provide extracorporeal oxygenation at low flow rates while maintaining patient safety and treatment efficiency. This capability targets a large, underserved patient population that requires respiratory support but may not be sick enough for traditional, high-flow ECMO systems, significantly expanding the potential market for Inspira's technology. This approval strengthens Inspira's intellectual property portfolio and reinforces the Company's technological leadership in the field of advanced extracorporeal life support. The newly received patent provides protection at least until the year 2043, covering key claims related to the ART500's functionality, design, and clinical applications. Inspira is pursuing additional patents in major jurisdictions worldwide to expand its intellectual property coverage. New Risk • Jul 07
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 19% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$5.4m net loss in 2 years). Market cap is less than US$100m (US$30.5m market cap). Ankündigung • Jun 12
Inspira’s ART100 in Use At Tier-1 U.S. Hospitals, Generating Strong Clinical Interest and Accelerating Sales Discussions Inspira™ Technologies OXY B.H.N. Ltd. announced that its FDA-cleared ART100 system adoption has begun to positively impact commercialization interest and efforts, representing a key milestone and significantly contributes to the Company's commercial validation. The ART100 system has been successfully integrated into real-world clinical workflows at leading tier-one U.S. hospitals over the past several months. Details of specific hospital deployments are subject to confidentiality, but reflect Tier-1 facilities in the U.S. This clinical use reflects growing confidence in the system’s potential to support patients in critical condition and positions Inspira at the forefront of a rapidly evolving market of life-saving technologies. The consistent use of the ART100 has prompted a wave of interest from additional U.S. and international healthcare institutions, as well as governmental authorities. The Company is currently engaged in commercial discussions with various stakeholders across multiple regions and is scaling up operational capabilities to support the anticipated adoption of the ART100. Ankündigung • Jun 06
Inspira Technologies Oxy B.H.N. Ltd. Scales Up ART100 Production Capabilities Amid Advanced Negotiation with European Government Authority Inspira Technologies Oxy B.H.N. Ltd. announced that it has scaled-up its production capabilities for its U.S. Food and Drug Administration (FDA)-cleared INSPIRA 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. 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. New Risk • Jun 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (48% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$15m net loss in 2 years). Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (US$15.3m market cap). Ankündigung • May 29
Inspira Technologies Initiates Global Commercial Rollout of FDA -Cleared ART100 System Inspira™? Technologies OXY B.H.N. Ltd. announced a strategic shift to accelerate the commercialization of its U.S. FDA (Food and Drug Administration)-cleared INSPIRA™? ART100 system (the "ART100"), while maintaining the development and regulatory pathways of its portfolio of products. The Company is currently engaged in active sales discussions in multiple locations. This development follows the initial clinical implementation of the ART100 system in medical centers in the U.S., where the device has been used to treat patients in real-world clinical settings. Several of these discussions are in advanced stages and involve structured procurement frameworks. Based on the current ongoing discussions, deliveries are expected to begin in the second half of 2025, subject to logistical and regulatory alignment, and the finalization of commercial and legal terms. By growing demand for alternatives to mechanical ventilation, Inspira continue to support its innovation pipeline, including the next-generation INSPIRA™?ART500 and the HYLA™? blood sensor, while prioritizing near-term revenue activities from ART100. The Company's expansion efforts come amid an increase in the global focus on scalable respiratory solutions, which may position the Company as a strategic platform for public health initiatives and cross-sector partnerships. Ankündigung • May 07
Inspira Technologies Oxy B.H.N. Ltd. Announces That the INSPIRA™? ART100 Has Been Approved by Israel's Largest Healthcare Provider for Use in Organ Transplant Patients Inspira™? Technologies OXY B.H.N. Ltd. announced that the INSPIRA™? ART100 has been approved by Israel's largest healthcare provider to undergo a clinical validation by leading physicians who intend to use the innovative life-support and diagnostic device during organ transplant procedures. As part of this advancement, Inspira will deploy the U.S. Food and Drug Administration ("FDA") approved INSPIRA ART100 system at one of Israel's renowned medical centers affiliated with the largest health care provider. A team of pioneering physicians at a renowned medical center has requested to validate the INSPIRAART100 system for application in highly complex organ transplant procedures. This deployment will allow leading Israeli transplant specialists to gain hands-on experience with Inspira's innovative technology, specifically exploring its potential to maintain organ viability through advanced blood oxygenation. The INSPIRA ART100 systems may serve a unique role by providing out of body blood oxygenation to keep the patient alive during the organ transplant procedure as well as for several hours in the recovery room. This validation process represents a new clinical application for the innovative INSPIRA ART100 System, offering the Company a unique opportunity to gather valuable insights from leading medical specialists as they evaluate the system's performance in demanding transplantation environments. The clinical data collected during these procedures will be strategically used to support the ongoing development program of Inspira's INSPIRA ART500 system designed to oxygenate a patient's blood and support vital organs during acute respiratory failure. The INSPIRAART100 System was granted FDA 510(k) clearance on May 2024, for cardiopulmonary bypass procedures and in July 2024 received the Israeli AMAR certification for cardiopulmonary bypass and extra-corporeal membrane oxygenation (ECMO) procedures. The system's proprietary hardware and software platform serves as the foundation for the Company's flagship INSPIRA ART500 System, which is currently under development and aims to revolutionize respiratory care by providing direct blood oxygenation without mechanical ventilation. Ankündigung • Apr 24
Inspira Technologies OXY B.H.N. Ltd. Achieves above 99% Gas Exchange Efficiency in VORTX™? Technology In-Vivo Animal Testing Inspira Technologies OXY B.H.N. Ltd. announced a major milestone achievement in the in-vivo testing of its next-generation VORTX technology. This breakthrough innovation is uniquely designed to oxygenate blood effectively without the trauma associated with conventional hollow fiber technologies. The in vivo testing achieved above 99% gas exchange target at a defined flow rate. The VORTX technology, slated for integration into Inspira's pipeline, including the INSPIRA ART500, aims to transform acute respiratory care, providing an advanced alternative for patients who might otherwise require invasive mechanical ventilation. The distinctive design of the VORTX is meant to ensure a zero-pressure difference during the oxygenation process, potentially reducing levels of harmful blood trauma, a prevalent limitation in traditional fiber-based oxygenators. This critical in-vivo experiment was conducted with an 80 kg swine at the renowned Institute of Animal Research, Israel's premier large-animal preclinical research facility, as part of an Israel Innovation Authority -funded initiative. The trial successfully confirmed prior lab-based findings, demonstrating proof-of-concept, scalability, and validating Inspira's continued progress toward its key development objectives. Inspira plans to further evaluate and refine the VORTX oxygen delivery technology, with additional results and development updates anticipated in the near future. Ankündigung • Apr 07
Inspira Technologies Oxy B.H.N. Ltd. Announces Successful Treatment of First Patient with Inspira Art100 At Westchester Medical Center Inspira Technologies OXY B.H.N. Ltd. 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. The installation, training program and professional services relating to the clinical use of the INSPIRA ART 100 was led by Glo-Med. Ankündigung • Mar 15
Inspira Technologies Oxy B.H.N. Ltd. has filed a Follow-on Equity Offering in the amount of $1.019 million. Inspira Technologies Oxy B.H.N. Ltd. has filed a Follow-on Equity Offering in the amount of $1.019 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Transaction Features: At the Market Offering Ankündigung • Mar 14
Inspira Technologies Receives Nasdaq Notification Regarding Minimum Bid Requirement Inspira Technologies OXY B.H.N. Ltd. ("Inspira" or the "Company") announced that on March 10, 2025, the Company received a written notice (the "Notice") from the Nasdaq Stock Market LLC indicating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2), as the Company's closing bid price for its ordinary shares, or Ordinary Shares, was below $1.00 per share for the last 30 consecutive business days. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has been granted a 180-calendar day compliance period, or until September 8, 2025, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Ordinary Shares must meet or exceed $1.00 per share for at least 10 consecutive business days during the 180-calendar day compliance period. If the Company is not in compliance by September 8, 2025, the Company may be afforded a second 180-calendar day compliance period. To qualify for this additional time, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the minimum bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, including by effectuating a revere share split, if necessary. If the Company does not regain compliance within the allotted compliance period(s), including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company's Ordinary Shares will be subject to delisting. The Company intends to monitor the closing bid price of its Ordinary Shares between now and September 8, 2025, and intends to consider available options to cure the deficiency and regain compliance with the minimum bid price requirement within the compliance period. The Company's Ordinary Shares will continue to be listed and trade on the Nasdaq Capital Market during this period, and are unaffected by the receipt of the written notice from Nasdaq. This announcement is made in compliance with Nasdaq Listing Rule 5810(b), which requires prompt disclosure of receipt of a deficiency notification. Ankündigung • Mar 04
Inspira Technologies Announces Positive Results from Clinical Study of HYLA Blood Sensor Inspira™ Technologies OXY B.H.N. Ltd. 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. 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. Ankündigung • Feb 12
Inspira Achieves Positive Results of Above 95% For Preventing Bloodstream Infections Inspira™ Technologies OXY B.H.N. Ltd. announced positive initial results from its previously reported collaboration with Ennocure MedTech Ltd. to develop a novel bio-electronic treatment for preventing bloodstream infections. In ex-vivo porcine skin model testing, the bio-electronic patch demonstrated a 95% reduction in bacterial presence within 4 hours, with continued effectiveness observed over a 24-hour period. The technology, which uses physical electric stimulation rather than chemical agents, showed promising results in preventing pathogen growth on treated surfaces. The bio-electronic technology is being designed to address several key challenges associated with traditional IV dressings, including: Prevention of bacterial growth through physical rather than chemical means; Potential for extended wear time, reducing frequency of dressing changes; Applicability to both skin surface and cannula areas; Real-time monitoring capabilities. Ankündigung • Feb 06
Inspira Technologies Strengthens Its Ai-Powered Blood Sensor with New Capabilities, Intends to Share Clinical Findings Soon Inspira Technologies has announced a significant advancement in its AI-driven medical platform with the integration of a next-generation oxygenation indicator into its HYLA blood sensor technology. This enhancement enables rapid detection of critical oxygen-related conditions without requiring intermittent blood draws, representing a potential breakthrough in continuous patient monitoring. The HYLA System: A New Paradigm in Blood Monitoring, powered by AI: The enhanced HYLA blood sensor system leverages sophisticated optical sensors and machine learning algorithms to provide real-time monitoring of vital blood parameters. This AI-powered technology is designed to detect and alert healthcare providers to changes in tissue oxygenation and early warning signs of respiratory complications, including hypoxia. The company has announced plans for 510(k) FDA submissions in the second half of 2025, marking a clear regulatory pathway for this innovative technology. Notably, the product is intended for dual use – both as a standalone product, as well as an addon to Inspira’s ART100 system, which is already in commercialization phases after reviewing FDA clearance. The ART100 is designed to revolutionize extracorporeal blood circulation by integrating cutting-edge technology with intuitive design to optimize patient care during crucial times. As such, this enhancement of the HYLA also strengthens Inspira’s offering also in what the companies says is a $19 billion mechanical ventilation market. Expansive Product line with FDA Cleared Products being Deployed: While HYLA advances through clinical evaluation, Inspira has already achieved significant business milestones with its INSPIRA ART100 system. Following FDA 510(k) clearance in May 2024 for Cardiopulmonary Bypass procedures and subsequent Israeli AMAR certification, the company secured its first U.S. purchase order through distribution partner Glo-Med Networks in June 2024. The ART100 system is now being prepared for deployment in U.S. hospitals, demonstrating Inspira's ability to navigate both regulatory requirements and its operational implementation. Inspira's technology ecosystem extends beyond blood monitoring to address critical challenges in respiratory care. The company's proprietary VORTX technology represents a novel approach to blood oxygenation, designed to minimize blood trauma compared to traditional fiber membrane technologies. This innovation supports their INSPIRA ART (Gen 2) system, which targets the $19 billion mechanical ventilation market by offering an alternative to conventional ventilation methods that often require medically induced coma and intubation. Ankündigung • Jan 27
Inspira Technologies OXY B.H.N. Ltd. Announces Addition of New Support Features to the INSPIRA ART100 Inspira Technologies OXY B.H.N. Ltd. has announced the addition of new support features to the INSPIRA™ ART100, a system cleared by the U.S. Food and Drug Administration. These enhancements are designed to assist medical team procedures to reduce staff overhead and improve efficiency, further solidifying Inspira’s position at the forefront of extracorporeal life support technology. The new features provide valuable resources for clinical teams using the system within its intent of use. For example, the system is designed to integrate a given hospital’s established procedures and safety practices and includes system-activated alarm troubleshooting uniquely designed to provide valuable direction when time is of the essence and user anxiety is running high. The system also provides a prominent screen with advanced software that displays information in an accessible and visible manner during complicated and challenging care situations – for example when the patient is isolated or in-transit. These new features are intended to further support staff using the INSPIRA ART100’s existing advanced and cutting-edge software already designed to navigate the staff through a step-by-step setup process, demonstrating another example of Inspira’s dedication through innovation to assist medical teams to manage complex medical procedures more effectively. The INSPIRA ART100 system utilizes a technique that adds oxygen to the blood and removes carbon dioxide, with the enriched blood being circulated back to the patient, taking over the functionality of the heart and/or lungs in critical care patients. The INSPIRA ART100 has a small footprint design, provides up to four hours of uptime in emergency scenarios, and can be used with various types of disposable equipment available on the market. Ankündigung • Jan 21
Inspira Technologies Oxy B.H.N. Ltd. Announces Appointment of Tal Parnes as the New Chairman of the Board, Effective February 1, 2025 Inspira Technologies OXY B.H.N. Ltd. announced the appointment of Tal Parnes as the new chairman of the board of directors, effective February 1, 2025. Mr. Parnes brings a wealth of experience and expertise to his new role at Inspira. With a distinguished career spanning over three decades in the technology sector, with a special focus in the medical technology and pharmaceutical industries, Mr. Parnes has consistently demonstrated exceptional leadership and strategic vision. As a serial entrepreneur, Parnes has demonstrated his ability to drive innovation and growth across various high-tech sectors, including medical technology, communications and defense. Mr. Parnes is familiar with the Company and its technology, having served as an independent director of the Company since July 2021. Mr. Parnes are a veteran executive in the medical technology industry. He co-founded and is the former chief executive and president at Zuta-Core Ltd. and HQL Pharmaceuticals Ltd. Mr. Parnes also served as chief operating officer at Silynx Communications Inc. as a vice president of operations at Wavion Inc. and Atrica Ltd. He also served as chief financial officer and director of business development of Printlife Ltd. The Company is eager to harness Mr. Parnes' insights and experience as the Company reaches new heights. The Company accepted Prof. Goldwasser's resignation from his position, which was due to personal reasons. New Risk • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 38% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (38% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Market cap is less than US$100m (US$19.1m market cap). Ankündigung • Jan 14
Inspira Technologies Unveils Modular Configuration for Revolutionary VORTX™ Blood Oxygenation Delivery Technology Inspira Technologies OXY B.H.N. Ltd. announced the development of a modular configuration for its groundbreaking VORTX blood oxygenation delivery technology. Company believe that this innovative approach represents a significant advancement in the field of extracorporeal oxygenation and has the potential to transform critical care practices worldwide. The unique modular configuration of the VORTX blood oxygenation delivery system is expected to extend the INSPIRA ART's range of blood oxygen enrichment and carbon dioxide removal, potentially expanding the versatility of the INSPIRA ART. The flagship INSPIRA ART system targets to revolutionize the $19 Billion Mechanical ventilation market, and is being designed to elevate and stabilize declining oxygen saturation levels in patients while they are awake, and without a ventilator. Inspira's VORTX system represents a potential paradigm shift in blood oxygenation technology. Unlike traditional fiber-based oxygenators, the VORTX is designed to maintain a more natural blood flow, potentially reducing harmful effects on blood components. This novel approach has garnered significant attention, with the technology now protected by 32 novel patent claims. As Inspira continues to develop and refine the modular VORTX blood oxygenation delivery technology, the Company remains committed to advancing respiratory care and improving patient outcomes. The modular configuration is expected to enhance the versatility and applicability of the VORTX technology across various medical scenarios. Ankündigung • Jan 08
Inspira Technologies Oxy B.H.N. Ltd. announced that it has received $82.95686 million in funding On January 7, 2025, Inspira Technologies Oxy B.H.N. Ltd. closed the transaction. The transaction included participation from 12 investors. New Risk • Dec 24
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 22% per year over the past 5 years. Shareholders have been substantially diluted in the past year (54% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$16.5m market cap). Board Change • Dec 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Stephane Ledot was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Ankündigung • Nov 26
Inspira Technologies Oxy B.H.N. Ltd., Annual General Meeting, Dec 30, 2024 Inspira Technologies Oxy B.H.N. Ltd., Annual General Meeting, Dec 30, 2024. Location: 2 ha-tidhar street, raanana 4366504, Israel New Risk • Oct 11
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 22% per year over the past 5 years. Shareholders have been substantially diluted in the past year (54% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Market cap is less than US$100m (US$25.1m market cap). Ankündigung • Oct 09
Inspira Technologies Oxy B.H.N. Ltd. Announces Development of New Disposable Kit with Built-In Performance Monitoring Mechanism Inspira Technologies OXY B.H.N. Ltd. announced the development of a new disposable kit for the perfusion market. This strategic move is central to Inspira's business strategy of generating recurring revenues for products to be deployed in conjunction with the INSPIRA ART100 and that are also intended to be compatible with other life support machines, thus potentially tapping into the $1 billion perfusion systems market. The innovative disposable kit is being developed as a single-use product designed to identify and alert users on changes in the performance of the disposable during operation and treatment. The unique design and features of the disposable are expected to provide a smart, compatible, and adjustable experience for medical teams. This is intended to enhance product safety and improve patient protection. The disposable kit will be the subject of a planned application for U.S. Food and Drug Administration (FDA) clearance for marketing. Once cleared for marketing, the disposable is expected to be offered to hospitals that use the INSPIRA ART 100 system. The INSPIRA ART100 system received FDA 510(k) clearance in May 2024 for Cardiopulmonary Bypass (CPB) procedures and in July 2024 received Israeli medical device and accessory certification for extra-corporeal membrane oxygenation and cardiopulmonary bypass procedures. The first manufactured devices are expected to be deployed in the U.S. by the end of 2024. Ankündigung • Sep 13
Inspira Secures Second U.S. Patent Approval for Orbiting Blood Oxygenation Delivery System Inspira Technologies OXY B.H.N. Ltd. has secured an additional U.S. Patent approval for the VORTX™ orbiting blood oxygenation delivery system, a core technology of the revolutionary INSPIRA™ ART device, bringing the combined total of claims deemed novel relating to the core technology of the INSPIRA™ ART device, to 32. The VORTX™ system aims to oxygenate blood without fiber membranes, potentially transforming the medical field as this technology is expected to reduce both blood damage and costs. Today's fiber technologies for blood oxygenation significantly harm the patient's blood cells, since existing fiber oxygenators force blood to flow through multiple fiber layers, causing harmful turbulence, friction, and shear forces. Due to the fiber fabric's high resistance to blood flow, it creates pressure differences that can severely damage blood components, potentially causing hemolysis, white blood cell damage, inflammatory and immune system activation, and blood clotting. Recent Insider Transactions Derivative • Aug 28
Independent Chairman of the Board notifies of intention to sell stock Benad Goldwasser intends to sell 44k shares in the next 90 days after lodging an Intent To Sell Form on the 26th of August. If the sale is conducted around the recent share price of US$1.18, it would amount to US$52k. Since March 2024, Benad has owned 129.32k shares directly. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Ankündigung • Aug 22
Inspira Technologies OXY B.H.N. Ltd. Announces FDA Listing and Market Readiness of New Product Inspira Technologies OXY B.H.N. Ltd. announced the U.S. Food and Drug Administration listing of its medical cart (INSPIRA™ CART) which has been custom designed for use with the INSPIRA™ ART100 system. With this dynamic combination of cutting-edge technology and operational efficiency, Inspira aims to streamline healthcare delivery in a variety of clinical scenarios, transforming the INSPIRA™® ART100 system into a mobile workstation supporting medical personnel in administering medical care quickly. The INSPIRA™ Cart is intended for use by medical professionals in operating rooms in the United States during Cardiopulmonary Bypass procedures. Classified as a Class I Medical Device and 510(K) Exempt under the FDA code for cardiopulmonary bypass accessory equipment, this device's regulatory status underscores its compliance with safety and efficacy standards, facilitating its entry into the U.S. market. Ankündigung • Aug 01
Inspira Technologies OXY B.H.N. Introduces the INSPIRA Cardi-ART, Aiming to Provide Oxygen to the Brain During Cardiac Arrest Inspira Technologies OXY B.H.N. Ltd. introduced the INSPIRA Cardi-ART, a portable modular device, currently in development, to provide oxygen to the brain during cardiac arrest. The device is expected to expand the next-generation INSPIRA ART platform to a wider range of applications with a combined potential market of approximately $58.8 billion ($19 billion global mechanical ventilation market and $39.8 billion global cardiac arrest market). The INSPIRA Cardi-ART is being designed to support vital organ oxygenation during cardiac arrest to treat patients both in and outside of hospitals. The Company plans the regulatory submission of the Device to the U.S. Food and Drug Administration for as early as 2026, pending the final regulatory pathway. The INSPIRA Cardi-ART portable modular unit is being designed for fast emergency response during CPR (cardio pulmonary resuscitations) in and outside of hospitals, allowing for rapid cannulation and the delivery of oxygenated blood throughout the body to reduce damage to the heart and brain during cardiac arrest. The Device is being designed to monitor key vital parameters using the HYLA blood sensor technology. The INSPIRA Cardi-ART is being designed to provide quick hemodynamic support in the case of cardiac failure as it drains blood, exchanges gases, and then returns the blood to the arterial system to maintain systemic perfusion. The technique has been used in other procedures that have been recommended in medical guidelines as set out by the American Heart Association (AHA). New Risk • Jul 24
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 56% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 22% per year over the past 5 years. Shareholders have been substantially diluted in the past year (56% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$20.2m market cap). Ankündigung • Jul 11
Inspira Technologies OXY B.H.N. Ltd. Receives Israeli Regulatory Approval for the INSPIRA ART100 System Inspira Technologies OXY B.H.N. Ltd. announced the receipt of the Israeli Ministry of Health's medical devices and accessories ("AMAR") approval for the INSPIRA ART100, an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system. This is a pivotal milestone in Inspira's strategy to conduct business development activities to bring its innovative products and technologies to the market. The Company believes that receiving Israeli regulatory approval marks an important step towards growing local support and adoption for the INSPIRA™? ART100 and demonstrates Inspira's capabilities in obtaining regulatory approvals for its products. The INSPIRA™ ART (Gen 2), also known as the INSPIRA™ ART500, will include the Company's Adaptive Blood Oxygenation technology and is being designed to continuously measure the patient's blood parameters in real-time, delivering needed oxygen volume straight into the blood. By elevating patient oxygen saturation levels in minutes, this technology potentially allows patients to remain awake during treatment and therefore may enable patients to be treated in and beyond intensive care units, reducing the need for mechanical ventilation systems that require intubation and medically induced coma. The Company's INSPIRA™ ART100 system received FDA 510(k) clearance for Cardiopulmonary Bypass procedures and AMAR certification for Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures. The Company's other products, including the INSPIRA™ ART (Gen 2) and HYLA™ blood sensor, have not yet been tested or used in humans and have not been approved by any regulatory entity. Ankündigung • Jun 19
Inspira™ Introduces Advanced Life Support Solutions to Key International Leaders at the Annual iECOs Conference in Israel Inspira™ Technologies OXY B.H.N. Ltd. announced that the Company will present at the annual iECOs Conference in Herzliya, Israel on June 18th, 2024. The Company will present the INSPIRA™ ART100 System, recently 510(k) U.S. Food and Drug Administration-cleared, and which is pending approval from AMAR, the medical device division of the Israeli Ministry of Health. In addition, the Inspira Technologies research and development team will be available at its booth at the conference to answer questions about its technologies and products currently in development. Ankündigung • May 03
Inspira™ Announces Start of Production of the Inspira™ Art100 Inspira™ Technologies OXY B.H.N. Ltd. announced the start of production of the INSPIRA ART100 medical device. The INSPIRA ART100 device is being contract manufactured by a leading technology company that provides high-technology electronic assembly solutions for the medical, aero-space and aviation, communications and defense industries. The manufacturer has commenced with the production and assembly of the first batch of INSPIRA ART100 devices, which will be used for deployment in several initial sites, subject to U.S. Food and Drug Administration (FDA) regulatory clearance. Price Target Changed • Apr 18
Price target increased by 44% to US$13.00 Up from US$9.00, the current price target is provided by 1 analyst. New target price is 618% above last closing price of US$1.81. Stock is up 53% over the past year. The company posted a net loss per share of US$0.93 last year. Ankündigung • Apr 11
Inspira™? and Ennocure In Vitro Study Results Show 100% Prevention of Bacterial Growth Causes Bloodstream Infections Inspira™ Technologies OXY B.H.N. Ltd. together with Ennocure MedTech Ltd. announced results from their collaborative development of a proprietary bio-electronic treatment to prevent associated bloodstream infections in patients in intensive care units. Once developed, Inspira plans to integrate the bio-electronic novel physical stimulation technology, into the INSPIRA™ ART patient treatment. The results of the in vitro study showed a 75% reduction in bacterial growth 4 hours after the application of the treatment and a 100% reduction within 24 hours. The in vitro study was carried out at the Hebrew University of Jerusalem and involved testing bioelectric patches in an in vitro environment. As part of the in vitro study, bacteria were cultured and spread on agar in petri dishes. The bioelectric patch was then applied to the agar plate and activated for a pre-specified duration. Following the procedure, the agar plates were transferred to an incubation chamber for 24 hours and thereafter examined. This technology is based on the use of electrical pulses that inhibit bacterial proliferation. This technology may prevent bacteria from multiplying and spreading by physical means, a solution that does not require antiseptic and disinfectant agents. This technology may have certain advantages, including as a potential effective mitigation solution to certain side effects in current standard care solutions that use antiseptic agents and materials, such as allergies. These standard care solutions may also encounter bacterial resistance and limited efficacy. The next major research and development milestone in the company's collaboration with Ennocure involves conducting tests on an ex vivo model to evaluate the efficacy of the treatment in anticipation of the first prospective first-in-human trials. Ankündigung • Apr 03
Inspira™ Technologies Oxy B.H.N. Ltd. Announces Program to Pioneer the Applicable Use of the INSPIRA™ ART100 Device for an Artificial Womb Inspira™ Technologies OXY B.H.N. Ltd. announced the commencement of a program to explore the applicable use of the INSPIRA™ ART100 Device for an artificial womb for neonates in need of vital respiratory support. Inspira aims to explore how this potential additional application of the INSPIRA ART100 device to provide neonates with vital respiratory support could replace the currently used mechanical ventilators. The high pressure and complications associated with mechanical ventilation can cause harsh and long-term negative effects on neonates who require respiratory life support during the early and critical stages of their neonatal development. The potential additional application targets prematurely born neonates with underdeveloped respiratory systems and neonates with life-threatening disorders such as meconium aspiration syndrome, the disorder that results in neonates experiencing difficulty in breathing as a result of meconium in the lungs, and congenital diaphragmatic hernia, where the muscle that bisects the chest from the abdomen fails to close. New Risk • Apr 02
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 52% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$7.4m net loss in 2 years). Market cap is less than US$100m (US$32.8m market cap). New Risk • Mar 26
New major risk - Revenue and earnings growth Earnings have declined by 24% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 24% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$7.4m net loss in 2 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (US$24.9m market cap). Ankündigung • Mar 20
Inspira Technologies OXY B.H.N. Ltd. Announces AMAR Regulatory Submission of the INSPIRA™ ART100, to Enter the Southeast Asia and South American Markets Inspira™ Technologies OXY B.H.N. Ltd. announced the AMAR submission for approval of the INSPIRA™ ART100, marking a significant milestone in Inspira's venture into new markets. AMAR - the Israeli Ministry of Health's medical device regulation unit, is the authority responsible for controlling medical device licenses and approvals including the issuance of certificates of free sale which are necessary for marketing regulatory approvals in the Southeast Asia and South American markets, potentially propelling the Company towards targeting exceptional growth opportunities. The INSPIRA™ ART (Gen 2) utilizes adaptive blood oxygenation technology to continuously measure the patient's blood parameters in real-time to deliver needed oxygen volume straight into the blood. The unique technology is designed to allow for the targeted control of oxygenation levels, thereby adapting to the individual needs of each patient. This method is expected to significantly reduce complications associated with traditional ventilation methods, shorten hospital stays and potentially save lives. The INSPIRA™ ART (Gen 2) device is the culmination of extensive research and development efforts by the team at Inspira. It is designed to offer an alternative to traditional mechanical ventilation, providing patients with a less invasive, more comfortable, and potentially more effective treatment option. The device is intended to integrate cutting-edge technologies to enhance oxygenation, reduce the need for intubation, and improve overall patient outcomes. Ankündigung • Mar 12
Inspira Releases New Data Demonstrating Superiority of its Core Technology, Across Key Endpoints of HMSS Indicator Inspira Technologies OXY B.H.N. Ltd. announced that the Company's U.S. patent backed technology, the orbiting blood oxygenation technology (VORTX™) has broken through a significant technological barrier, meeting 100% of regulatory guideline requirements for blood oxygenation and carbon dioxide removal, at various blood flow rates with the pressure gradient on the blood across the device remaining at zero level. Pressure gradient is associated with high mechanical shear stress (HMSS), which plays a dominant role in damaging blood components such as red blood cells, immune cells, thrombocytes and more. These primary results for the key endpoints of a new blood oxygenation technology without the need for fiber membranes and with zero levels of pressure gradient mark a huge milestone for the Company and for the INSPIRA™ ART (Gen 2) device. The advanced experiments demonstrated the primary performance of the VORTX™ by collecting data on oxygenation, carbon dioxide removal, and pressures across the device during blood use. The unique design of the VORTX™ system suggests that scaling up may result in negligible to zero pressure, even at higher flow rates. This stands in stark contrast to membrane-based devices, which typically experience significant pressure drops, leading to potential damage to the patient's blood. Inspira™ Technologies is an innovative medical technology company in the respiratory treatment arena. The Company has developed a breakthrough Augmented Respiration Technology (INSPIRA™ ART), designed to rebalance patient oxygen saturation levels. This technology potentially allows patients to remain awake during treatment while reducing the need for highly invasive, risky, and costly mechanical ventilation systems that require intubation and medically induced coma. The Company's products have not yet been tested or used in humans and has not been approved by any regulatory entity. Ankündigung • Feb 22
Inspira Technologies OXY B.H.N. Ltd. Introduces High-End Platform for Bio-Mimicking Blood parameters for Development and Testing of Core Technologies Inspira Technologies OXY B.H.N. Ltd. has unveiled an exclusive in-house capability designed to simulate both the arterial and venous blood parameters of patients with specific medical conditions without the need of in vivo animal testing. This platform has played, and will continue to play, a vital role in advancing the development of HYLA Blood Sensor and VORTX Orbiting blood oxygenation delivery system, which are the core technologies of the Inspira ART500. Using unique methods and equipment, team of scientists has the ability to simulate human blood conditions based on a predefined medical profile. The proprietary setting allows the management of blood parameters continuously and in real-time for a range of blood flow rates in order to simulate a patient's oxygen-deficient and carbon dioxide-rich blood after it has flowed through body organs and tissues. The company believe that these break-through capabilities may enable to further expand research within a shorter timeframe and with a better use of resources, thereby reducing time and costs. The increased access to data is an important contributing factor towards efforts to accelerate the development, testing and release of new technologies and products as well as for more advanced verification and validation prior to regulatory submissions. This platform allows Inspira Technologies to control the blood parameters over a wide range, allowing it to test the efficacy and accuracy of its technologies in key scenarios, such as simulating the blood parameters of patients who may suffer from acute medical conditions. The Company's high-end lab capabilities include the means for monitoring oxygen and carbon dioxide levels and detecting hemolysis and other key parameters and elements under extreme conditions. Ankündigung • Feb 14
Inspiratm Technologies OXY B.H.N. Ltd. Receives First Ever U.S. Patent Approval for an Orbiting Blood Oxygenation Delivery System Inspiratm Technologies OXY B.H.N. Ltd. has received the first ever U.S. Patent approval for an orbiting blood oxygenation delivery system, a core technology of the revolutionary INSPIRAtm ART500 device. This innovation has 16 claims found to be novel. The orbiting blood oxygenation delivery system (VORTX™?) is designed to oxygenate blood without fiber membranes, and the company believe it is expected to revolutionize the medical landscape. The current fiber technologies used for blood oxygenation cause substantial damage to the patient's blood cells. Unlike the natural laminar blood flow in blood vessels inside the body, in existing fiber oxygenators, the blood is "forced" to flow in a harmful turbulent flow through many layers of fibers while experiencing friction and shear forces within the fiber walls. Since the fiber fabric is a significant resistor to blood flow, high-pressure differences are formed and cause significant damage to the various blood components, including, high hemolysis (breakdown of red cells), damage to white blood cells, activation of the inflammatory system in the body, activation of the immune system, and blood clotting. The INSPIRA ART500 is a breakthrough device, designed to empower breathing in patients that are awake, by continuously measuring the patient's blood parameters in real-time, and delivering needed oxygen volume straight into the blood. As the INSPIRAART500 is to be equipped with the HYLA blood sensor, it is being designed to continuously scan the patient's blood, potentially allowing for real-time detection of changes in patient condition and providing physicians with decision-supportive data. New Risk • Feb 01
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$8.7m net loss in 2 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (US$12.8m market cap). Ankündigung • Jan 09
Inspira Technologies Oxy B.H.N. Ltd. Announces Plans to Launch and Target Single-Use Disposable Blood Oxygenation Kit for A New Disposable Perfusion Market Opportunity Inspira Technologies OXY B.H.N Ltd. announced its plan to launch a single-use disposable blood oxygenation kit (the "Kit"), currently in development, for its INSPIRA ART medical device series. The Kit is also intended to be compatible with various other life support machines, tapping into the disposable perfusion systems market. The Kit, anticipated to be submitted for US Food & Drug Administration (FDA) authorization in 2025, is a single-use product designed for efficient blood oxygenation and carbon dioxide removal. The Kit represents a strategic move to enhance hospital budget spending by potentially reducing costs. The Company is focusing on making the Kit compatible with other medical devices such as certain types of cardio-pulmonary bypass machines. Ankündigung • Dec 29
Inspira Technologies Oxy B.H.N. Ltd. has completed a Follow-on Equity Offering in the amount of $3.88 million. Inspira Technologies Oxy B.H.N. Ltd. has completed a Follow-on Equity Offering in the amount of $3.88 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,375,000
Price\Range: $1.28
Discount Per Security: $0.0896
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,656,250
Transaction Features: Registered Direct Offering Ankündigung • Dec 28
Inspira Technologies Oxy B.H.N. Ltd. has filed a Follow-on Equity Offering in the amount of $3.88 million. Inspira Technologies Oxy B.H.N. Ltd. has filed a Follow-on Equity Offering in the amount of $3.88 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,375,000
Price\Range: $1.28
Discount Per Security: $0.0896
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,656,250
Transaction Features: Registered Direct Offering Ankündigung • Dec 26
Inspira Technologies OXY BHN Ltd. Announces 95% Accuracy Results for HYLA™? Blood Sensor, Planning FDA Submission for Clearance in 2024 Inspira Technologies OXY BHN Ltd. announced a significant advancement in its sensor technology by its team of experts. This breakthrough, in achieving 95% accuracy compared to standard blood gas analyzers, brings continuous and real-time blood monitoring capabilities compared to traditional blood gas analyzers systems used in hospitals that typically require intermittent blood draws. This advancement signals Inspira's potential entry into the disposables market. The development of the first HYLA variant, key to this advancement, marks a significant step towards its submission under a 510(k) pathway with the U.S. Food & Drug Administration ("FDA"), which is expected in the second half of 2024. This sensor technology is designed to be integrated with the Company's INSPIRA ART100 and was submitted to the FDA in September 2023, with clearance anticipated in the first half of 2024. The HYLA Blood Sensor line (the " Blood Sensor") is set to transform intensive care unit (ICU) operations, offering continuous, real-time blood data collection and analysis. This enhances patient care with critical insights and alerts, with the aim to improve medical procedures and device efficiency. Key features of the Blood Sensor include: High Accuracy: Achieves 95% accuracy relative to standard blood gas analyzers; Non-invasive: Eliminates the need for blood draws; Durability: Built to handle ICU and operating room environments; Versatility: Compatible with various medical procedures, including: the cardio pulmonary bypass, extracorporeal membrane oxygenation, continuous renal replacement therapy, and dialysis; and Modular Design: Engineered to complement existing medical devices, targeting the two-million annual open-heart surgery patients globally. In developing the HYLA Blood Sensor line, Inspira utilizes in-house lab testing as well as hospital collaborations for the purpose of clinical research and development. This approach has enabled to define the Blood Sensor's disposable materials and methods, with HYLA's planned razor blade business model. While primarily designed for INSPIRA ART devices, plans are underway also to offer a variant of the Blood Sensor as a standalone device. Ankündigung • Dec 12
Inspira Technologies Oxy B.H.N. Ltd. Announces Appointment of Dan Gorfil to its Medical Advisory Board Inspira Technologies OXY B.H.N. Ltd. announced the appointment of Dr. Dan Gorfil to its medical advisory board. Dr. Gorfil is a distinguished specialist in cardiac surgery and intensive care medicine. Dr. Gorfil is both the head of the Cardiothoracic Surgery Intensive Care Unit and the Extracorporeal Membrane Oxygenation program at the Department of Cardiothoracic Surgery at Rabin Medical Center, Israel. Dr. Gorfil’s expertise is expected to significantly contribute to the deployment of the INSPIRA™ ART100. U.S. Food and Drug Administration (FDA) approval is expected in the first half of 2024. Ankündigung • Nov 23
Inspira Technologies Oxy B.H.N. Ltd., Annual General Meeting, Dec 27, 2023 Inspira Technologies Oxy B.H.N. Ltd., Annual General Meeting, Dec 27, 2023, at 16:00 Israel Standard Time. Location: 2 Ha-Tidhar Street Ra’anana Israel Agenda: To re-appoint Ziv Haft, Certified Public Accountants (Israel), a member of BDO Global, an independent registered public accounting firm, as the Company's independent auditor of the Company until the next annual general meeting of shareholders, and to authorize the Company's board of directors to determine the compensation of Ziv Haft until the next annual general meeting; to re-elect Mr. Dagi Ben-Noon, Mr. Joe Hayon, Prof. Benad Goldwasser, Mr. Tal Parnes, Mr. Lior Amit and Mrs. Limor Rozen as members of the Board of Directors until the next annual general meeting of shareholders; and To present and discuss the Company's financial statements and annual report for the year ended December 31, 2022. Ankündigung • Nov 07
Inspira Technologies Oxy B.H.N. Ltd. Announces Israeli Innovation Authority Grant for New VORTX Disposable Blood Oxygenation Technology Inspira Technologies OXY B.H.N. Ltd. announced the recent approval of a grant from the Israeli Innovation Authority (IIA) for the VORTX™? Disposable Blood Oxygenation Technology. At the core of the Company's technology lies the VORTX Disposable Blood Oxygenator, specifically being designed for compatibility with the INSPIRA ART Device line of products. Distinguishing itself from conventional hollow fiber membrane-based oxygenators in the market, the VORTX is being engineered to oxygenate blood and remove carbon dioxide, mitigating common fiber-membrane complications, such as device failure, coagulation and hemolysis. This grant underscores the IIA's endorsement of the Company and its new cutting edge solutions. The IIA has committed to supporting the VORTX development project by granting funds equal to 40% of the first-year IIA approved budget of $1 million. Ankündigung • Oct 26
Inspira Technologies OXY BHN Ltd. Announces the Grant of an Additional Patent by the U.S. Patent and Trademark Office for its Respiratory Medical Device, the INSPIRAART500 Inspira Technologies OXY BHN Ltd. announced the grant of an additional patent by the U.S. Patent and Trademark Office for its respiratory medical device, the INSPIRAART500. The newly granted patent relates to a novel automated self-priming module designed for the INSPIRA ART500 device. This unique innovative operating module further expands the INSPIRA ART 500 advancement to potentially ensure patient safety with a proprietary built-in self-automated priming module aimed to ensure an emboli-free connection to the patient'sascular system, thereby potentially reducing risks of the formation of clots that reduces blood flow. The patent consists of nine distinct claims, all deemed novel with inventive merit and practical applicability. In addition to the United States, the Company has initiated patent applications in Europe and several countries in other regions. In a market that serves approximately 20 million patients every year who are treated by mechanical ventilation systems and may suffer from the associated risks and medical complications, the INSPIRA ART50 potentially brings hope for change by aiming to reduce the need for mechanical ventilation systems that are associated with a sliding 50% mortality rate, may heighten the risk of coma, and may cause bacterial infections and associated mechanical ventilation lung injuries. Ankündigung • Sep 29
Inspira Technologies Unveils the Inspira™ Art Line of Medical Devices At the World's Largest Extracorporeal Life Support Conference Inspira Technologies OXY B.H.N. Ltd. announced the unveiling of its INSPIRA ART line at the Extracorporeal Life Support Organization (ELSO) Conference in Seattle, WA. The INSPIRA ART medical device line includes the INSPIRA ART100 a cardio-pulmonary bypass (CPB) device designed for patients undergoing CPB procedures as well as the INSPIRA ART500 device that represents a significant breakthrough in healthcare, potentially offering highly effective treatment for the 20 million patients that face severe breathing problems each year. The INSPIRAART500 is being designed to provide acute respiratory support with the intention to become a new procedure for patients who may require legacy mechanical ventilation. INSPIRA ART100 is estimated to receive U.S. Food and Drug Administration (FDA) clearance in the first half of 2024. Inspira is currently working on plans to make INSPIRA ART100 available in the United States. The Company has recently entered into a collaboration with Perfusion Solution Inc., a leading U.S. based company that provides a platform of advanced medical devices, training and staffing to leading U.S. hospitals. The ELSO conference is a global gathering of experts in healthcare, research, and industry players. ELSO is dedicated to improving a special type of life support called extracorporeal life support, which involves using external devices to support patients with severe breathing and/or heart problems. ECMO clinicians, research scientists, and members of regulatory and public health institutions are eligible for membership in ELSO. There are currently over 20,000 users and center members from over 50 countries. Memberships allow physicians, nurses, perfusionists, respiratory therapists, researchers, and other healthcare professionals to become more directly involved in the world's largest ECMO community. Ankündigung • Sep 14
Inspira™? Announces 510(k) FDA Submission of INSPIRA™? ART100 Towards Commercialization Inspira Technologies OXY BHN Ltd. announced it had submitted its INSPIRA ART 100, a cardio-pulmonary bypass device, to the U.S. Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. The Company's vision is to transform external breathing assistance for over 20 million patients each year that require ventilation and oxygenation via external mechanical ventilation machinery. Legacy systems for breathing assistance are causing multiple complications leading to physical damage, infection and possible death. Inspira aims to revolutionize the medical ventilation and oxygenation market by delivering next-generation superior treatment, that will reduce the reliance on mechanical ventilation. INSPIRA ART 100 was submitted to the FDA post the completion of a comprehensive usability study in Boston, Massachusetts, with an expected approval timeline of approximately six months, which is targeted for the first half of 2024. Ankündigung • May 31
Inspira Technologies Appoints Dr. Nir as Chief Medical Officer Inspira Technologies OXY B.H.N. Ltd. has announced the appointment of Dr. Adi Rizansky Nir, PhD to the position of Chief Medical Officer ("CMO"). Dr. Nir brings a wealth of expertise and a distinguished track record in the field of medicine and healthcare administration to the Company. As CMO, Dr. Nir will play a critical role in overseeing and guiding Inspira's medical operations and strategic initiatives. Dr. Nir holds a PhD in Health Economics, an MSc. in Molecular Biology, and an MBA from the Hebrew University of Jerusalem. Dr. Nir has made significant contributions to clinical research and advancements in multiple therapeutic areas. Dr. Nir has extensive experience in clinical strategy implementation and in the scientific and commercial evaluation of R&D assets. Dr. Nir specializes in health economics, market evaluation, and the financial valuation of pharmaceutical assets, medical devices, and digital health products. She also has vast experience in managing strategic planning, negotiations, in-and-out-licensing, and comprehensive due diligence processes, of which she has conducted many. Dr. Nir joined the company in 2021 and has significantly contributed to the Company's clinical strategy and product development activities. Ankündigung • May 17
Inspira Technologies Oxy B.H.N. Ltd. to Reveal the New ALICE Device at the World's Largest Extracorporeal Life Support Conference Inspira Technologies OXY B.H.N. Ltd. has announced it will reveal the new ALICE device at the Extracorporeal Life Support Organization (ELSO) conference, the 34th Annual ELSO Conference in Seattle, Washington, which will be held between the 28th of September and the 1st of October 2023. The ALICE is an extracorporeal blood circulation medical device allowing for cardiac and pulmonary support. During the extracorporeal treatment, the ALICE device is designed to provide continuous enrichment of the blood with oxygen and carbon dioxide removal. The device is designed with an innovative user interface and unique features aimed to facilitate and enhance user experience. Prior to the ELSO conference, Inspira is planning to submit the ALICE medical device to the U.S. Food and Drug Administration under the 510(k) pathway. Ankündigung • May 12
Inspira™ Technologies OXY B.H.N. Ltd. Develops the VORTX™ Blood Oxygenator, a Unique Technology for Saturating Blood With Oxygen and Removing Carbon Dioxide Inspira™ Technologies OXY B.H.N. Ltd. announced the development of the VORTX™ Blood Oxygenator, an Augmented Respiration Technology based on a new breakthrough technological approach, being designed with the intent to imitate the function of the lung, by efficiently saturating the blood with oxygen and removing carbon dioxide. The VORTX™ Blood Oxygenator, which is under development, has the potential to revolutionize the perfusionists systems market, currently valued at $1.16 billion in 20231, targeting approx. 2 million extracorporeal procedures performed annually including open-heart surgeries and extracorporeal membrane oxygenation ("ECMO") treatment2. The Company anticipates that this market segment may grow substantially with the additional market opportunity represented by the new treatment category potentially created by its flagship INSPIRA™ ART. The VORTX™ Blood Oxygenator is being designed to improve hemodynamic performance and reduce oxygenator failure. The current blood oxygenator market3 is based upon hollow fiber membrane technology, associated with medical complications including device failure, coagulation (clotting) and hemolysis (damage or destruction of red blood cells), which induces risks and impacts patient outcomes. The VORTX™ Blood Oxygenator is being developed as an independent stand-alone disposable unit that will also be compatible with its flagship INSPIRA™ ART system and ALICE™ device. Upon completion of development and testing of the VORTX™ Blood Oxygenator, the unit is expected is to be submitted to the U.S. Food and Drug Administration (FDA) for regulatory review and approval. Ankündigung • Feb 14
Inspira(TM) Technologies Receives Approval from Sheba Medical Center to Conduct Clinical Study of the HYLA(TM) Blood Sensor Inspira™ Technologies OXY B.H.N. Ltd. announced that it has received approval by the Ethics Committee at Sheba Medical Center in Israel to conduct a clinical study of its HYLA blood sensor in patients undergoing open-heart surgery. The study is planned to commence in the first quarter of 2023. The HYLA blood sensor is a non-invasive optical blood sensor being developed using machine learning based algorithms to measure blood parameters, intended to provide continuous measurements in real-time during extracorporeal procedures. The HYLA blood sensor is being designed as a stand-alone or integrated device. Continuous and real-time measurements of key blood parameters will potentially provide alerts to physicians of sudden changes in a patient's condition, enabling prompt medical intervention, as well as alerts relating to sudden changes in extracorporeal blood oxygenation circuit performance (i.e., blood clotting, gas supply failure, system dysfunction and blood recirculation). Early medical intervention may improve patient outcomes, reduce complications, and reduce associated costs. The purpose of the clinical study is to assess the correlation of blood parameters measured by the HYLA blood sensor versus a standard blood gas analyzer results. As a prospective data collection clinical study, it is designed to integrate clinical research into the product development cycle. The INSPIRA ART introduces a new mode of acute respiratory care by supporting a patient's spontaneous breathing while they are awake and alert, potentially reducing the need for invasive mechanical ventilation. The ALICE is an extracorporeal blood circulation device designed to provide cardiac and pulmonary support. The HYLA blood sensor, as part of the INSPIRA ART system or ALICE Device, will allow for patient blood oxygenation while displaying continuous key blood measurements in real-time. This may empower medical teams' patient monitoring capabilities. Ankündigung • Jan 24
Inspira Technologies Receives Patent by U.S. Patent Office for the INSPIRA ART System's Convertible Dual Lumen Cannula Device and Method of Use Inspira Technologies OXY B.H.N. Ltd. announced that the novel convertible dual lumen cannula device and method of use, being developed for the INSPIRA™ ART System, has been granted a patent by the U.S. Patent and Trademark Office (USPTO). The patent approval includes 20 claims that were found to be novel, with inventive step and industrial applicability. Based on the U.S. patent grant, the Company plans to file for similar patents in additional countries. The Company expects to integrate the convertible dual lumen cannula with additional Inspira products in the future. In addition, the Company may consider the future commercialization of the convertible dual lumen cannula separately as a disposable product. A dual lumen cannula is a medical disposable device often used for the simultaneous venous drainage and reinfusion of blood during processes such as, but not limited to, extracorporeal membrane oxygenation (ECMO) in Intensive Care Units (ICUs). The dual lumen cannula is a single tube with two separate inner channels or "lumens" and requires only a single incision point. Inspira Technologies' convertible dual lumen cannula device uniquely intravascularly converts a single-lumen cannula into a dual lumen cannula after initial insertion, thus allowing for the same incision point to potentially have multiple uses. The convertible dual lumen cannula is designed to allow for switching from a single lumen to a dual lumen cannula, and vice versa, without the need for new incisions required when changing or adding additional cannulas. The Inspira Technologies convertible dual lumen is designed to potentially allow for fast action and reduced risk, complications and additional infection points. The newly patented convertible dual lumen cannula is expected to be a core component of the INSPIRA™ ART system, a potential new mode of acute respiratory care under development, designed to reduce the need for invasive mechanical ventilation allowing the patient to remain awake and maintain spontaneous breathing. The dual lumen cannula device is planned to be utilized during INSPIRA ART treatment with awake patients, potentially facilitating a safer and more comfortable cannulation procedure. For example, by inserting the INSPIRA ART convertible dual lumen in the jugular vein located in the neck, the company believes that this will potentially contribute to patient benefits and enhance the INSPIRA ART system's usability and comprehensive medical value to both patients and medical staff. Ankündigung • Dec 21
Inspira Technologies Oxy B.H.N. Ltd. Begins Manufacturing of the ALICE™ CPB Device, ahead of planned 2023 FDA submission Inspira Technologies OXY B.H.N. Ltd. Announced that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the "ALICE device") to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. If FDA clearance is obtained, the ALICE device production line will be extended for Low-Rate Initial Production (LWRIP), which is an important operational stage in developing infrastructure to support serial manufacturing, quality control and shipping. Additional units are expected to be assembled for the targeted future first deployments of the ALICE devices in the U.S. and Israel. The ALICE device is being contract manufactured by an end-to-end solution provider that offers New Product Introduction (NPI) services to mass production capabilities for leading medical electronic device companies. This includes full turn-key manufacturing, full system integration, including PCB (Printed Circuit Board) manufacturing, assembly services, testing and packaging in facilities that meet Good Manufacturing Practices (GMP) compliance. The ALICE device is intended to provide potential advantages in medical device design, including a large touchscreen and novel colorful graphical presentation, that increases the visibility and functionality of data displayed to the medical staff. The ALICE device is being designed to be both lightweight and highly durable and is designed to be equipped with long battery life. The ALICE device is intended to be indicated for use in clinical settings requiring CPB support. Inspira plans for the ALICE to be the first device to Integrate the HYLA™ Blood Sensor designed to be non-invasive, perform continuous measurements and alert physicians at real time of sudden changes in a patient's specific key blood indicators. Inspira Technologies' goal is to set a new standard in various aspects of patient care, targeting intensive care units (ICUs), general medical units, operating theaters, emergency medical services and small urban and rural hospitals, with the focus of increasing accessibility to medical care for millions of patients worldwide. As part of strategy to reach these goals, and in parallel to pursuing regulatory approvals, Company are actively working to establish collaborations with strategic partners and globally ranked health centers to provide endorsement and clinical adoption for regional deployments of respiratory support, CPB, and blood measuring products and technologies. Board Change • Nov 16
Less than half of directors are independent There are 8 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 8 new directors. 4 experienced directors. No highly experienced directors. 2 independent directors (4 non-independent directors). Co-Founder, CEO & Director Dagi Ben-Noon is the most experienced director on the board, commencing their role in 2020. Independent Director Limor Rozen was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Ankündigung • Nov 11
Inspira Technologies Oxy B.H.N. Ltd. Receives Patent by the Israeli Patent Office for Key Safety Component for the INSPIRATM ART System Inspira Technologies OXY B.H.N. Ltd. (the Company or Inspira Technologies) announced that the Israeli Patent Office (ILPO) granted a patent for a key safety component of the INSPIRATM ART system. The component is to be located on the patient's neck and is designed to secure a neck cannula from moving or dislodging. Cannula movement can occur during a change of a patient's posture in bed, during physiotherapy treatment, while an awake patient is taken by the medical staff out of bed for a short walk and/or during transportation within and between hospitals. The ILPO is a certified International Searching and Examining Authority (ISA), appointed by the World Intellectual Property Organization (WIPO), and a party to the PCT-PPH Program, an international initiative amongst 30+ national patent offices to promote work-sharing and enable accelerated patent applicant processing. The Company plans to file for patent coverage in additional countries. Enhances Usability and Medical Value of INSPIRA ART System The newly patented technology shall be a key component of the INSPIRA ART system, a potential new mode of acute respiratory care under development, designed to minimize the need for invasive mechanical ventilation allowing the patient to remain awake and maintain spontaneous breathing The component will be utilized during INSPIRA ART treatment with awake patients, potentially allowing them to be mobile with reduced risk of cannula movement and subsequent bleeding. The Company believes that such improvement in patient safety and mobilization increases patient benefit and enhances the INSPIRA ART system's usability and comprehensive medical value to both patient and medical staff, which may accelerate market adoption. Recent Insider Transactions Derivative • Oct 21
Chairman of the Board notifies of intention to sell stock Benad Goldwasser intends to sell 35k shares in the next 90 days after lodging an Intent To Sell Form on the 17th of October. If the sale is conducted around the recent share price of US$1.46, it would amount to US$51k. Since March 2022, Benad has owned 82.30k shares directly. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Ankündigung • Sep 10
Inspira Technologies Oxy B.H.N. Ltd., Annual General Meeting, Oct 18, 2022 Inspira Technologies Oxy B.H.N. Ltd., Annual General Meeting, Oct 18, 2022, at 16:00 Israel Standard Time. Location: 2 Ha-Tidhar Street Ra'anana Israel Agenda: To re-appoint Ziv Haft, Certified Public Accountants (Israel), a member of BDO firm, an independent registered public accounting firm, as the company’s independent auditor firm of the company until the next annual general meeting of the shareholders, and to authorize the company’s Board of Directors to determine their compensation until the next annual general meeting; to re-elect Mr. Dagi Ben-Noon, Mr. Joe Hayon, Prof. Benad Goldwasser, Mr. Tal Parnes, Mr. Lior Amit and Mrs. Limor Rozen as members of the Board of Directors until the next annual general meeting of shareholders; to change the company name and to amend the company’s Articles of Association accordingly; to approve an amendment to the terms of compensation of Mr. Tal Parnes, a member of the Board of Directors for a limited period of time; and a discussion regarding the company’s financial statements and annual report for the year ended December 31, 2021. Ankündigung • Sep 08
Inspira™ Technologies Performed HYLA™ Blood Sensor In-Vivo Study, in Preparation of Planned Human Studies Inspira™ Technologies OXY B.H.N. Ltd. announced the completion of an animal study that was conducted at Lahav C.R.O (contract research organization) by leading intensive care unit, or ICU, and respiratory specialists, who are members of Inspira's Scientific Advisory Board. The completion of the animal study is an additional important step toward initiating human studies using the HYLA™ blood sensor. During an animal study, the HYLA™ blood sensor performed measurements of blood parameters with results being compared to numerous blood samples taken and analyzed using a routine blood gas analyzer, which is considered the standard of care used by hospitals today. The HYLA™ blood sensor is a non-invasive device, designed to provide continuous real-time measurements, overcoming the disadvantages of standard blood gas analysis machines that require blood to be drawn and cannot provide a continuous display of data indicating the patient's condition in real-time. These important characteristics of the HYLATM blood sensor may be vital in providing immediate alerts of sudden changes in a patient's condition and may reduce risks, complications, and costs. The animal study was performed following prior successful ex-vivo data obtained with the HYLA™ blood sensor in the Company's laboratory. The lab results, accompanied by the encouraging animal study data, are important steps toward human studies. Ankündigung • Aug 12
Inspira Technologies Oxy B.H.N. Ltd. Announces Changes in Management The board of directors of Inspira Technologies Oxy B.H.N. Ltd. resolved to appoint Ms. Yafit Tehila as Chief Financial Officer, Principle Financial and Accounting Officer, or CFO, effective August 10, 2022, and shall replace Mr. Joe Hayon. Mr. Hayon will retain his position as President and Director of the Registrant. Prior to becoming CFO of the Registrant, Ms. Tehila served as its Vice President of Finance and Legal since February 2021. Ms. Tehila served as Director of Finance at Nano Dimension Ltd. from November 2020 through February 2021 and Financial Controller from February 2016 through November 2020. Ankündigung • Jul 12
Inspira™ Technologies Reveals Next Generation Liby™ ECMO Inspira™ Technologies OXY B.H.N. Ltd. introduced the "Liby™" System, an advanced form of life support better known by the medical industry as extracorporeal membrane oxygenation (ECMO), used to treat patients with life-threatening heart and lung failure. The Liby™ System is intended to target the $531million global ECMO market. The Inspira Technologies Liby™ system currently under development, is expected to be submitted to the U.S. Food and Drug Administration (FDA) for approval, during the first half of 2023. The Inspira Technologies Liby™ system is designed to be a new generation ECMO system, with potential advantages that may improve usability and patient care. The Liby™ system is also expected to be the first system designed for integration with the Company's recently revealed non-invasive HYLA™ blood sensor technology. The addition of the HYLA to patients treated with the Liby™ system, would potentially allow for the real-time and continuous monitoring of patient condition to alert physicians of immediate signs of changes in a patient's clinical condition The Liby™ system includes several Inspira Technologies developed features and capabilities as well as a new approach to medical device designs, including a large touchscreen and novel colorful graphical representation that increases the visibility, scope and functionality of data displayed to the medical staff. With its small footprint and lightweight characteristics, the Liby™ system is being designed with a rapid style aerospace-grade aluminum structure to be both lightweight and highly durable, and will be equipped with long battery life, a contributing factor to making the Liby™ system suitable for patient mobility within hospitals and for transportation of patients to hospitals in ambulances. Product Launch: The Liby™ system is expected to be submitted to the FDA for approval during the first half of 2023. Subject to FDA approval, the Liby™ system's expected regulatory pathway is intended to be designated as a Class II 510 (K), meaning it may not require human trials. Ankündigung • Jul 07
Inspira Technologies Develops A Non-Invasive Blood Sensor Inspira Technologies OXY B.H.N. Ltd. revealed the development of the HYLA™ blood sensor. Without the need to take actual blood samples from patients, Inspira's non-invasive optical blood sensor is being designed to perform real-time and continuous blood monitoring to alert physicians of immediate signs of changes in a patient's clinical condition. The HYLA blood sensor is targeting the potential $2.5 billion Point of Care testing, ABG (Arterial Blood Gas) analyzer market. The non-invasive HYLA blood sensor is being developed by a team of cyber-warfare specialists who formerly served in the Israeli Defense Forces' elite cyber-attack special forces. The HYLA blood sensor is being designed as a new platform based on key technologies being developed for Inspira's ART™ system, designed to reduce the need for invasive mechanical ventilation. Like the ART system, the HYLA blood sensor is designed to minimize the need for invasive medical procedures with the intention of reducing risks, complications and costs. The HYLA™ non-invasive blood sensor is attached to the outer walls of a tube that has blood flowing through it. The HYLA blood sensor may have broad application potential, benefiting patients undergoing procedures including intensive care unit (ICU) monitoring (approximately 40% of patients have a standard arterial line), Invasive Mechanical Ventilation, Extracorporeal Membrane Oxygenation (ECMO), Dialysis and Cardiopulmonary bypass. Targeted patient populations can potentially include those suffering from acute respiratory failure, cardiac failure, pneumonia, acute kidney injury (AKI), as well as patients undergoing open-heart surgery. Currently, in order to identify changes in a patient's medical condition, frequent invasive blood tests are needed. As a non-invasive real-time blood sensor, the HYLA is expected to reduce the need for frequent invasive blood tests. The HYLA blood sensor is expected to continuously measure several key indicators such as the levels of partial oxygen and carbon dioxide pressures, known to be precise indicators of health disorders and patient deterioration. Recent Insider Transactions Derivative • Jun 26
Chairman of the Board notifies of intention to sell stock Benad Goldwasser intends to sell 165k shares in the next 90 days after lodging an Intent To Sell Form on the 22nd of June. If the sale is conducted around the recent share price of US$1.38, it would amount to US$227k. Benad now holds 82.30k shares directly in their own name. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Board Change • Apr 27
Less than half of directors are independent There are 8 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 8 new directors. 4 experienced directors. No highly experienced directors. 2 independent directors (4 non-independent directors). Co-Founder, CEO & Director Dagi Ben-Noon is the most experienced director on the board, commencing their role in 2020. Independent Director Limor Rozen was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Ankündigung • Feb 04
Inspira Technologies Appoints Daniella Yeheskely-Hayon as the New Chief Technology Officer Inspira Technologies OXY B.H.N. Ltd. announced that Daniella Yeheskely-Hayon PhD, an expert in development of artificial lung, has been appointed as its Chief Technology Officer (CTO). The position of CTO to which Yeheskely-Hayon was appointed, is a key position within the Company. As part of her role, Yeheskely-Hayon takes charge of the research and development (R&D) department relating to its oxygenators and sensors research including its In-vitro and In-vivo studies. Yeheskely-Hayon has comprehensive project management experience in biomedical engineering as well as in key roles within medical device companies. Over the past six years, Yeheskely-Hayon has served as the director of research and development and Chief of Operations at O2Cure Ltd. Ankündigung • Jan 30
Inspira Technologies Oxy B.H.N. Ltd. Lists a Component of its ART and ECLS Systems on the U.S. Food and Drug Administration Class I 510(K) Exempt List Inspira Technologies Oxy B.H.N. Ltd. announced that has listed a component of its ART and ECLS systems on the U.S. Food and Drug Administration Class I 510(k) exempt list. The component is intended to reduce the potential complications associated with jugular vein cannula movement, occurring during a change of a patient's posture in bed and/or during transportation. The component can also be potentially utilized in the treatment of thousands of patients being treated each year by Extracorporeal Membrane Oxygenation (ECMO). This component is expected to allow the medical staff a safer mobilization for the awake cannulated patients within and between hospitals and medical centers. Ankündigung • Dec 09
Inspira Technologies Oxy B.H.N. Ltd. Files A Pct Patent Application for Its Flagship Art Device and Proprietary Method of Use to Minimize the Need for Mechanical Ventilation Inspira Technologies Oxy B.H.N. Ltd. announced it has filed a Patent Cooperation Treaty (PCT) patent application for its novel ART device and its proprietary methods of use to minimize the need for invasive mechanical ventilation which requires intubation and induced coma. Inspira Technologies designed the ART, a novel low-flow early extracorporeal blood oxygenation system intended to offer acute respiratory patients, who continue to deteriorate following non-invasive ventilation treatment, a new alternative to invasive mechanical ventilation. Today, despite that, at the non-invasive ventilation treatment stage, these patients are still breathing spontaneously, the only alternative treatment available to them after non-invasive ventilation has failed is invasive mechanical ventilation. The ART is designed to enrich approximately 1-1.5 liters of blood in a minute to rebalance oxygen saturation levels in minutes. The ART device utilizes a hemo-protective flow approach intended to increase blood oxygenation levels and remove CO2 to potentially prevent invasive mechanical ventilation and minimize the risks and complications associated with this type of treatment. The ART device, a novel extracorporeal oxygenation system, is being developed for treatment of patients in order to maintain spontaneous breathing. This initiates a circulation rate of 30 ml/Kg per minute that is significantly lower than the circulation rate used in extracorporeal membrane oxygenation (ECMO) that ranges between 60-80 ml/kg/min for veno-venous ECMO and 50-60 ml/kg/min for veno-arterial ECMO¹. Ankündigung • Jul 15
Inspira Technologies Oxy B.H.N. Ltd. has completed an IPO in the amount of $16.029091 million. Inspira Technologies Oxy B.H.N. Ltd. has completed an IPO in the amount of $16.029091 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 2,909,091
Price\Range: $5.51
Discount Per Security: $0.4408
Security Name: Pre-Funded Units
Security Type: Equity/Derivative Unit
Securities Offered: 2,909,091