RA'ANANA, Israel, May 30, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira") a breakthrough medical technology company, announced today that Company President, Director, and co-founder, Mr. Joe Hayon, will discuss the Company's business targets, distribution agreements and next steps in a conference call to be held at 9:00am Eastern Time on Thursday, June 20, 2024. This follows the significant milestone of receiving FDA clearance for the INSPIRA™ AR ...

With a prominent screen, 360-degree LED flow presentation and large digit display, the patient's information is easily viewed from a distance, making the INSPIRA ART100 ideal in both standard and challenging care situations, such as isolation or in-transit scenarios. Potential Application of INSPIRA ART100 Inspira Technologies OXY B.H.N. Ltd. (IINN) recently received the FDA 510(k) clearance for its INSPIRA ART100 — a Cardiopulmonary Bypass System. This approval is a significant milestone for the company, h ...

RA'ANANA, Israel, May 28, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company", "Inspira", or "Inspira Technologies"), a breakthrough medical technology company, today announced that it has received notification of 510(k) class II clearance from the U.S. Food and Drug Administration (FDA) for its INSPIRA™ ART100, a Cardiopulmonary Bypass System. Dagi Ben Noon, CEO of Inspira, said "This is a proud moment for all of us at Inspira Technologies. We would like ...

RA'ANANA, Israel, May 2, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, 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 ...

RA'ANANA, Israel, April 25, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, announced that it has received the Canadian Standards Association (CSA) Certification of Compliance to U.S. standards for the INSPIRA ART100 device. This is a positive recognition of our product's quality and safety standards. We believe, subject to U.S. Food and Drug Administration (FDA) regulatory clearance, that this ...

RA'ANANA, Israel, April 16, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, is proud to announce the signing of a collaboration term sheet (the "Term Sheet") with the Beilinson Hospital in Israel for the evaluation of its proprietary INSPIRA ART100 device (the "Device") in organ transplant procedures. This Term Sheet marks a significant advancement and opportunity for the Company in its technol ...

RA'ANANA, Israel, April 10, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, together with Ennocure MedTech Ltd. ("Ennocure"), 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 tec ...

Exhibit 99.1 Inspira™ Technologies Reports Full Year 2023 Financial Results FDA Submission for approval of INSPIRA™ ART100 95% Accuracy Results for HYLA™ Blood Sensor Compared to Standard Blood Gas Analyzers Granted U.S. Patent for INSPIRA™ ART Medical Device Ra'anana, Israel, March 25, 2024 – Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company, today announced its financial results for the year ended December 31, 20 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission ...

Financial Performance - The company has incurred net losses of approximately $10.3 million and $16.9 million for the years ended December 31, 2022, and 2021, respectively, with an accumulated deficit of approximately $39 million as of December 31, 2022[51]. - The company has not generated any revenue from product sales and may never be profitable, as it has no products approved for marketing in any jurisdiction[55]. - As of December 31, 2022, the company's cash and cash equivalents were approximately $13.9 million, with a working capital of approximately $12.4 million, expected to fund operations for the next 12 months[60]. - The company expects to incur significant and increasing operating losses for the foreseeable future until it can successfully commercialize its products[52]. Research and Development - The company anticipates significant increases in research and development expenses as it plans expanded studies and seeks marketing approvals for its products[52]. - The company has focused on developing its INSPIRA ART system, HYLA Blood Sensor, and ALICE device, but has limited operating history and experience in the medical device industry[50]. - The company is focused on developing respiratory support technology and its success relies on market acceptance and regulatory approvals for its products[69]. Market and Competition - Future revenue generation will depend on successful commercialization of products, which includes establishing sales, marketing, and distribution infrastructure[55]. - The company faces numerous risks related to product development, including regulatory approvals, market acceptance, and competition from existing solutions[65]. - The company may encounter significant competition from various companies with greater financial and marketing resources, impacting its market position[77]. - The company competes with major players in the ICU and acute respiratory care market, such as Boston Scientific and Medtronic, which have greater resources and market share[98][99]. - Intense competition in the medical device sector may result in price reductions, longer selling cycles, and lower product margins, impacting revenue potential[101]. Regulatory and Compliance Risks - The company is subject to extensive government regulation, and non-compliance could result in significant penalties and operational restrictions[131]. - The FDA regulates the company's product candidates as medical devices, requiring extensive compliance with safety and effectiveness standards[130]. - The company must comply with ongoing regulatory requirements post-marketing, including submitting periodic reports to the FDA as a condition of 510(k) clearance[144]. - Regulatory compliance with data protection laws, such as the California Consumer Privacy Act (CCPA), could lead to increased costs and potential liabilities[122]. - The company is required to manufacture products in accordance with federal, state, and foreign regulations, with potential consequences for non-compliance including recalls[150]. Funding and Financial Stability - The company may need to raise substantial additional funding, which may not be available on acceptable terms, potentially requiring curtailment of product development efforts[60]. - Significant revenue is expected to be derived from strategic relationships with distributors such as Innovimed and Glo-Med; failure to maintain these relationships could lead to a material decrease in revenues[70]. - The company may face difficulties in recruiting additional employees necessary for its growth, which could disrupt operations[93]. Legal and Litigation Risks - The company faces potential litigation risks that could harm its reputation and financial results[105]. - Product liability claims and recalls could lead to significant costs and management distractions, impacting business operations[106]. - The company may face significant litigation expenses and resource diversion due to potential claims of intellectual property infringement from third parties[202]. Economic and Market Conditions - The COVID-19 pandemic has caused disruptions that may adversely affect the company's business and results of operations, with ongoing uncertainties regarding its impact[67]. - Economic conditions, including the COVID-19 pandemic and geopolitical tensions, may adversely affect customer spending and overall business performance[107][111]. Intellectual Property - The company faces challenges in protecting intellectual property, which is critical for maintaining competitive advantage in the market[192]. - The company’s ability to commercialize products may be adversely affected by existing patents held by third parties, necessitating costly licenses or litigation[197]. - Changes in patent laws or their interpretation could increase uncertainties and costs related to the prosecution and enforcement of patent applications[203]. Employee and Management Risks - As of March 28, 2023, the company had 38 full-time employees, and the loss of key personnel could adversely affect its business operations[92]. - The company may face challenges in managing growth activities, potentially leading to increased expenses and reduced revenue generation capabilities[94]. International Operations - International expansion poses various risks, including regulatory, operational, and financial challenges that could adversely affect future operations[95][96]. - The company must obtain international regulatory registrations and approvals to market its products outside the United States, which can be expensive and time-consuming[166]. Shareholder and Market Dynamics - The trading price of the company's Ordinary Shares and Warrants has been volatile since the initial public offering in July 2021, influenced by broader market conditions and specific industry factors[212]. - The company has never paid cash dividends and does not anticipate doing so in the foreseeable future[218].