Inspira Technologies OXY B.H.N. Ltd Files 2024 Annual Report

TL;DR

<b>Inspira Technologies OXY B.H.N. Ltd has filed its annual report for fiscal year 2023, detailing its outstanding shares and trading information.</b>

AI Summary

Inspira Technologies OXY B.H.N. Ltd (IINNW) filed a Foreign Annual Report (20-F) with the SEC on March 25, 2024. Inspira Technologies OXY B.H.N. Ltd filed its annual report on Form 20-F for the fiscal year ended December 31, 2023. The company's ordinary shares trade on the Nasdaq Capital Market under the symbol IINN, and warrants under IINNW. As of December 31, 2023, there were 15,652,176 ordinary shares outstanding. The principal executive offices are located at 2 Ha-Tidhar St., Ra'anana, Israel. The filing is an annual report, not a registration statement or transition report.

Why It Matters

For investors and stakeholders tracking Inspira Technologies OXY B.H.N. Ltd, this filing contains several important signals. This filing provides stakeholders with an update on the company's financial and operational status as of year-end 2023. The 20-F filing is a standard requirement for foreign private issuers, ensuring transparency for investors in the US market.

Risk Assessment

Risk Level: low — Inspira Technologies OXY B.H.N. Ltd shows low risk based on this filing. The filing is a routine annual report and does not contain new financial performance data or significant operational updates that would indicate immediate risk.

Analyst Insight

Investors should review the full 20-F filing for detailed financial statements and management discussion and analysis for a comprehensive understanding of the company's performance and outlook.

Key Numbers

• 15,652,176 — Ordinary Shares Outstanding (As of December 31, 2023)
• 2023-12-31 — Fiscal Year End (Period covered by the report)
• 2024-03-25 — Filing Date (Date the report was submitted)

Key Players & Entities

• Inspira Technologies OXY B.H.N. Ltd (company) — Filer of the 20-F report
• Nasdaq Capital Market (company) — Exchange where securities are registered
• IINN (company) — Trading symbol for ordinary shares
• IINNW (company) — Trading symbol for warrants
• 2024-03-25 (date) — Filing date of the report
• 2023-12-31 (date) — Fiscal year end date

FAQ

Industry Context

Inspira Technologies OXY B.H.N. Ltd operates in the medical device sector, specifically focusing on surgical and medical instruments and apparatus.

Regulatory Implications

As a foreign private issuer incorporated in Israel, the company is subject to SEC regulations, including the requirement to file annual reports on Form 20-F.

What Investors Should Do

1. Review the full 20-F filing for detailed financial statements and management discussion.
2. Monitor future filings for updates on operational performance and strategic initiatives.
3. Analyze the company's market position within the surgical and medical instruments sector.

Key Dates

• 2024-03-25: Filing of 20-F Annual Report — Provides year-end financial and operational overview for 2023.
• 2023-12-31: Fiscal Year End — End date for the financial reporting period.

Year-Over-Year Comparison

This is the annual report for the fiscal year ended December 31, 2023, following previous filings as required by the SEC.

Filing Documents

• ea0202167-20f_inspira.htm (20-F) — 1904KB
• ea020216701ex2-1_inspira.htm (EX-2.1) — 51KB
• ea020216701ex4-6_inspira.htm (EX-4.6) — 16KB
• ea020216701ex12-1_inspira.htm (EX-12.1) — 9KB
• ea020216701ex12-2_inspira.htm (EX-12.2) — 9KB
• ea020216701ex13-1_inspira.htm (EX-13.1) — 3KB
• ea020216701ex13-2_inspira.htm (EX-13.2) — 3KB
• ea020216701ex15-1_inspira.htm (EX-15.1) — 3KB
• ea020216701ex97-1_inspira.htm (EX-97.1) — 40KB
• image_001.jpg (GRAPHIC) — 20KB
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• image_012.jpg (GRAPHIC) — 94KB
• image_013.jpg (GRAPHIC) — 101KB
• image_014.jpg (GRAPHIC) — 90KB
• image_015.jpg (GRAPHIC) — 93KB
• image_016.jpg (GRAPHIC) — 65KB
• image_017.jpg (GRAPHIC) — 63KB
• ex15-1_001.jpg (GRAPHIC) — 2KB
• 0001213900-24-025316.txt (&nbsp;) — 10981KB
• iinn-20231231.xsd (EX-101.SCH) — 79KB
• iinn-20231231_cal.xml (EX-101.CAL) — 46KB
• iinn-20231231_def.xml (EX-101.DEF) — 330KB
• iinn-20231231_lab.xml (EX-101.LAB) — 591KB
• iinn-20231231_pre.xml (EX-101.PRE) — 330KB
• ea0202167-20f_inspira_htm.xml (XML) — 911KB

Item 18

Item 17 Item 18 If this is an annual report, indicate by check mark whether the registrant is a shell company. Yes No TABLE OF CONTENTS Page INTRODUCTION iii CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS v SUMMARY

RISK FACTORS

RISK FACTORS vii PART I ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS 1 ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 1 ITEM 3. KEY INFORMATION 1 A. [Reserved] 1 B. Capitalization and Indebtedness. 1 C. Reasons for the Offer and Use of Proceeds 1 D. Risk Factors 1 ITEM 4. INFORMATION ON THE COMPANY 41 A. History and Development of the Company 41 B.

Business

Business Overview 42 C. Organizational Structure 74 D. Property, Plants and Equipment 74 ITEM 4A. UNRESOLVED STAFF COMMENTS 74 ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 74 A. Operating Results 74 B. Liquidity and Capital Resources 80 C. Research and development, patents and licenses, etc. 81 D. Trend information 81 E. Critical Accounting Estimates 81 ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES. 82 A. Directors and Senior Management. 82 B. Compensation. 86 C. Board Practices 87 D. Employees 99 E. Share 100 F Disclosure of a registrant's action to recover erroneously awarded compensation 101 ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 101 A. Major Shareholders 101 B. Related Party Transactions 102 C. Interests of Experts and Counsel 103 ITEM 8. FINANCIAL INFORMATION 103 A. and Other Financial Information 103 B. Significant Changes 105 ITEM 9. THE OFFER AND LISTING 105 A. Offer and Listing Details 105 B. Plan of Distribution 105 C. Markets 105 D. Selling Shareholders 105 E.

Dilution

Dilution 105 F. Expenses of the Issue 105 ITEM 10. ADDITIONAL INFORMATION 105 A. Share Capital 105 B. Memorandum and Articles of Association 105 C. Material Contracts 106 D. Exchange Controls 106 E. Taxation 106 F. Dividends and Paying Agents 113 G. by Experts 113 H. Documents on Display 114 I. Subsidiary Information 114 J. Annual Report to Security Holders 114 i ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 114 ITEM 12.

DESCRIPTION OF SECURITIES

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 115 A. Debt Securities 115 B. Warrants and rights 115 C. Other Securities 115 PART II ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES 116 ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS 116 ITEM 15.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 116 ITEM 16. [RESERVED] 117 ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT 117 ITEM 16B. CODE OF ETHICS 117 ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES 117 ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES 118 ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS 118 ITEM 16F. CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT 118 ITEM 16G. CORPORATE GOVERNANCE 118 ITEM 16H. MINE SAFETY DISCLOSURE 121 ITEM 16I DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 121 ITEM 16J INSIDER TRADING POLICIES 121 ITEM 16K CYBERSECURITY 121 PART III ITEM 17.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 122 ITEM 18.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 122 ITEM 19. EXHIBITS 122

SIGNATURES

SIGNATURES 123 ii Inspira Technologies Oxy B.H.N. Ltd. INTRODUCTION We are a specialty medical device company engaged in the research, development, manufacturing, and marketing of proprietary life support technology with a vision to supersede traditional mechanical ventilators, or Mechanical Ventilation, which is the standard of care today for the treatment of acute respiratory failure. Although it may be sometimes lifesaving, Mechanical Ventilation is associated with increased risks, costs of care, extended lengths of stay, frequent incidence of infections, ventilator dependence and mortality. Using our state-of-the-art life support technology, our goal is to set a new standard of care and to provide patients with acute respiratory failure an opportunity to maintain spontaneous breathing and avoid the need for intubation, coma and various risks associated with the use of Mechanical Ventilation. As part of our strategy to reach this goal, and in parallel to pursuing regulatory approvals, we are actively working to establish collaborations with strategic partners, globally ranked hospitals, medical device companies and distributors both for endorsement and early clinical adoption. We plan to target intensive care units, or ICUs, general medical units, operating theaters, and small urban and rural hospitals, with the goal of making our solutions more accessible to millions of patients worldwide. We expect for these activities to support our strategy plan to reach market penetration and adoption of our life support technology. We are developing the following products: The INSPIRA TM ART (Gen 2) The INSPIRA ART device (Augmented Respiratory Technology) (also known as the INSPIRA ART500, ART system or ART), described herein as the INSPIRA ART, INSPIRA ART (Gen2), INSPIRA ART device or INSPIRA ART system, our flagship product, is a life support technology targeting to utilize direct blood oxygenation to boost patient saturation levels within minutes while the

Forward-looking statements

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among other things: Our planned level of revenues and capital expenditures; Our available cash our ability to obtain additional funding; Our ability to market and sell our products; Our expectation regarding the sufficiency of our existing cash and cash equivalents to fund our current operations; Our ability to advance the development of our products and future potential product candidates; Our ability to commercialize our products and future potential product candidates and future sales of our products or any other future potential product candidates; Our assessment of the potential of our products and future potential product candidates to treat certain indications; Our planned level of capital expenditures and liquidity; Our plans to continue to invest in research and development to develop technology for new products; Our ability to maintain our relationships with suppliers, manufacturers, distributors, and other partners; Anticipated actions of the FDA, scope of those trials and the prospects for regulatory approval or clearance of, or other regulatory action with respect to our products or services; The regulatory environment and changes in the health policies and regimes in the countries in which we intend to operate, including the impact of any changes i

IDENTITY OF DIRECTORS, SENIOR MANAGEMENT

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS Not applicable.

OFFER

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE Not applicable.

KEY INFORMATION

ITEM 3. KEY INFORMATION A. [Reserved] B. Capitalization and Indebtedness. Not applicable. C. Reasons for the Offer and Use of Proceeds. Not applicable. D. Risk Factors You should carefully consider the risks and uncertainties described below, together with all of the other information in this annual report on Form 20-F. If any of these risks actually occurs, our business and financial condition could suffer, and the price of our securities could decline. Risks Related to Our Business and Industry We are highly dependent on the successful development, marketing and sale of our products and on receiving the required regulatory approvals. Our products, focused on the treatment of respiratory failure, is the basis of our business. As a result, the success of our business plan is highly dependent on our ability to develop, manufacture and commercialize our products, and our failure to do so could cause our business to fail. Successful commercialization of medical devices is a complex and uncertain process, dependent on the efforts of management, manufacturers, local operators, integrators, medical professionals, third-party payors, as well as general economic conditions, among other factors. Any factor that adversely impacts the development and commercialization of our products, will have a negative impact on our business, financial condition, results of operations and prospects. We have limited experience in commercializing our products and we may face several challenges with respect to our commercialization efforts, including, among others, that: we may not have adequate financial or other resources to complete the development of our products; we may not be able to manufacture our products

View Full Filing

View this 20-F filing on SEC EDGAR