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 ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) Inspira Technologies made significant progress in 2023, including FDA submissions, advanced technology development, and securing substantial distribution agreements, while exploring strategic partnerships [CEO Commentary & Strategic Highlights](index=1&type=section&id=CEO%20Commentary%20%26%20Strategic%20Highlights) Inspira Technologies' CEO highlighted significant progress in 2023, including FDA submissions for INSPIRA™ ART100 and planned submission for HYLA™ blood sensor. The company is advancing its INSPIRA™ ART Gen 2 and VORTX™ technologies, achieving high accuracy for HYLA™ and securing pre-conditional distribution agreements totaling up to $546 million, while also exploring strategic partnerships - Achieved significant progress in diversifying business development and reaching important milestones in 2023[2](index=2&type=chunk) - Submitted INSPIRA™ ART100 to the U.S. Food and Drug Administration (FDA) and plans to submit HYLA™ blood sensor for FDA clearance later in 2024[2](index=2&type=chunk) - Signed pre-conditional summary distribution agreements totaling up to **$546 million**, subject to product development and regulatory approvals[2](index=2&type=chunk) - Focused on working with potential strategic partners to leverage strengths of large corporations[2](index=2&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Inspira Technologies reported reduced operating expenses and net loss in 2023, despite a decrease in cash and a significant increase in financial liabilities [Full Year 2023 Financial Highlights](index=2&type=section&id=Full%20Year%202023%20Financial%20Highlights) Inspira Technologies reported a decrease in total operating expenses and a reduced net loss in 2023 compared to 2022, primarily due to a decline in share-based compensation and D&O insurance costs. Cash and cash equivalents decreased, while financial liabilities at fair value significantly increased Key Financial Metrics | Metric | 2023 (US$ thousands) | 2022 (US$ thousands) | Change (YoY) | | :-------------------------- | :------------------- | :------------------- | :----------- | | Total Operating Expenses | 12,133 | 14,893 | -18.53% | | Net Loss | 11,286 | 14,976 | -24.64% | Balance Sheet Highlights | Metric | Dec 31, 2023 (US$ thousands) | Dec 31, 2022 (US$ thousands) | Change (YoY) | | :-------------------------- | :--------------------------- | :--------------------------- | :----------- | | Cash and cash equivalents | 7,361 | 13,903 | -47.06% | | Financial liabilities at fair value | 1,470 | 26 | +5553.85% | Operating Expense Breakdown | Expense Category | 2023 (US$ thousands) | 2022 (US$ thousands) | Change (YoY) | | :-------------------------- | :------------------- | :------------------- | :----------- | | Research and development (R&D) | 7,320 | 8,183 | -10.55% | | General and administrative (G&A) | 4,063 | 5,375 | -24.41% | | Sales and marketing (S&M) | 746 | 1,328 | -43.82% | [Business Updates](index=3&type=section&id=Business%20Updates) Inspira Technologies achieved key milestones in late 2023, including high accuracy for its HYLA™ sensor, a grant for VORTX™, a new U.S. patent, FDA submission, and strategic agreements for clinical trials [Recent Business Developments](index=3&type=section&id=Recent%20Business%20Developments) Inspira Technologies achieved several key milestones in late 2023, including 95% accuracy for its HYLA™ blood sensor, a grant for VORTX™ technology from the Israeli Innovation Authority, and a new U.S. patent for the INSPIRA™ ART device. The company also submitted its INSPIRA ART 100 to the FDA and signed a strategic agreement for clinical trials, contributing to potential revenues of over $546 million from distribution agreements - HYLA™ blood sensor achieved **95% accuracy** compared to standard blood gas analyzers, enabling continuous and real-time blood monitoring[7](index=7&type=chunk) - Received a grant from the Israeli Innovation Authority (IIA) for the VORTX™ Disposable Blood Oxygenation Technology[8](index=8&type=chunk) - Granted an additional U.S. patent for the INSPIRA™ ART respiratory medical device, specifically for a novel automated self-priming module[9](index=9&type=chunk) - Submitted the INSPIRA ART 100 cardio-pulmonary bypass device to the U.S. FDA via the 510(k) pathway, with potential clearance expected in the **first half of 2024**[10](index=10&type=chunk) - Signed a strategic agreement with Innovimed SpA. z o.o for planned clinical trials of INSPIRA™ ART medical devices, contributing to over **$546 million** in potential revenues from distribution agreements across multiple regions[11](index=11&type=chunk) [Company Information](index=3&type=section&id=Company%20Information) Inspira Technologies is an innovative medical technology company developing Augmented Respiration Technology (INSPIRA ART) to rebalance patient oxygen saturation, with products currently in development and awaiting regulatory approval [About Inspira Technologies](index=3&type=section&id=About%20Inspira%20Technologies) Inspira Technologies is an innovative medical technology company focused on respiratory treatment. It has developed Augmented Respiration Technology (INSPIRA ART) to rebalance patient oxygen saturation, aiming to reduce the need for invasive mechanical ventilation. The company's products are currently in development and have not yet been tested in humans or approved by regulatory entities - Inspira Technologies is an innovative medical technology company in the respiratory treatment arena[12](index=12&type=chunk) - Developed Augmented Respiration Technology (INSPIRA ART) designed to rebalance patient oxygen saturation levels, potentially allowing patients to remain awake during treatment and reducing the need for invasive mechanical ventilation[12](index=12&type=chunk) - Company's products have not yet been tested or used in humans and have not been approved by any regulatory entity[12](index=12&type=chunk) [Legal & Disclosures](index=4&type=section&id=Legal%20%26%20Disclosures) This section outlines the forward-looking nature of statements in the press release, subject to risks and uncertainties, with no obligation for public updates [Forward-Looking Statements Disclaimer](index=4&type=section&id=Forward-Looking%20Statements%20Disclaimer) This press release contains forward-looking statements based on current management expectations, subject to factors and uncertainties that could cause actual results to differ materially. The company disclaims any obligation to publicly update these statements, advising readers to consult the 'Risk Factors' section in its annual report on Form 20-F for more detailed information - The press release contains express or implied forward-looking statements based on current management expectations[14](index=14&type=chunk) - These statements are subject to factors and uncertainties that could cause actual results to differ materially from those described[14](index=14&type=chunk) - The Company undertakes no obligation to publicly release any revisions to these forward-looking statements, and more detailed risks are in the annual report on Form 20-F[14](index=14&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The financial statements reveal a decrease in total assets and equity, a reduced comprehensive loss, and significant changes in liabilities and capital structure for 2023 [Statements of Balance Sheets](index=5&type=section&id=Statements%20of%20Balance%20Sheets) The balance sheet shows a decrease in total assets from $16,166 thousand in 2022 to $9,310 thousand in 2023, primarily driven by a reduction in cash and cash equivalents. Total liabilities increased, mainly due to a significant rise in financial liabilities at fair value, while total equity decreased substantially Assets | ASSETS (US dollars in thousands) | December 31, 2023 | December 31, 2022 | | :------------------------------- | :---------------- | :---------------- | | Cash and cash equivalents | 5,041 | 6,783 | | Cash deposits | 2,320 | 7,120 | | Other accounts receivable | 432 | 589 | | **Total current assets** | **7,793** | **14,492** | | Right of use assets, net | 1,011 | 1,263 | | Property, plant and equipment, net | 506 | 411 | | **Total non-current assets** | **1,517** | **1,674** | | **Total Assets** | **9,310** | **16,166** | Liabilities and Shareholders' Equity | LIABILITIES AND SHAREHOLDERS' EQUITY (US dollars in thousands) | December 31, 2023 | December 31, 2022 | | :------------------------------------------------------------- | :---------------- | :---------------- | | Trade accounts payables | 198 | 152 | | Other accounts payable | 1,026 | 1,216 | | Lease liabilities (current) | 290 | 268 | | Financial Liabilities at Fair Value | 1,470 | 26 | | **Total current liabilities** | **2,984** | **1,662** | | Lease liabilities (non-current) | 588 | 873 | | **Total non-current liabilities** | **588** | **873** | | Share capital and additional paid in capital | 61,259 | 57,866 | | Accumulated deficit | (55,521) | (44,235) | | **Total equity** | **5,738** | **13,631** | | **Total Liabilities and Shareholders' Equity** | **9,310** | **16,166** | [Statements of Comprehensive Loss](index=6&type=section&id=Statements%20of%20Comprehensive%20Loss) Inspira Technologies reported a decrease in total comprehensive loss for the year ended December 31, 2023, to $11,286 thousand from $14,976 thousand in 2022. This improvement was driven by reductions across all operating expense categories (R&D, S&M, G&A) and favorable finance income Comprehensive Loss | (US dollars in thousands) | Year ended December 31, 2023 | Year ended December 31, 2022 | | :------------------------ | :--------------------------- | :--------------------------- | | Research and development expenses | 7,320 | 8,183 | | Sales and marketing expenses | 746 | 1,328 | | General and administrative expenses | 4,063 | 5,375 | | Other expenses (income) | 4 | 7 | | **Operating loss** | **12,133** | **14,893** | | Interest Income from deposits | (318) | (192) | | Finance expenses(income), net | (529) | 275 | | **Loss before tax** | **11,286** | **14,976** | | Taxes on income | - | - | | **Total comprehensive loss for the period** | **11,286** | **14,976** | [Statements of Changes in Shareholders' Equity](index=7&type=section&id=Statements%20of%20Changes%20in%20Shareholders'%20Equity) Shareholders' equity decreased from $13,631 thousand at the beginning of 2023 to $5,738 thousand by year-end. This was primarily due to the total comprehensive loss of $11,286 thousand, partially offset by capital raised through share issuances and share-based compensation Changes in Shareholders' Equity | (US dollars in thousands) | Number of shares | Share capital and additional paid in capital | Accumulated deficit | Total | | :------------------------ | :--------------- | :------------------------------------------- | :------------------ | :---- | | Balance on January 01, 2023 | 11,338,940 | 57,866 | (44,235) | 13,631 | | Issuance of shares and private warrants, net | 3,031,250 | 1,806 | - | 1,806 | | Issuance of Placement agent warrants | - | 131 | - | 131 | | Issuance of shares (pursuant to ATM facility) | 17,566 | 26 | - | 26 | | Exercise of share-based payments | 37,972 | 3 | - | 3 | | Restricted share unit ("RSU") vesting | 1,226,448 | - | - | - | | Share-based compensation | - | 1,427 | - | 1,427 | | Comprehensive and net loss | - | - | (11,286) | (11,286) | | Balance on December 31, 2023 | 15,652,176 | 61,259 | (55,521) | 5,738 |

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 ...

[Sales Agreement Overview](index=1&type=section&id=Sales%20Agreement%20Overview) This section outlines the agreement between the Company and the Agent for the issuance and sale of Ordinary Shares, detailing the registration and prospectus filings [Issuance and Sale of Shares](index=1&type=section&id=1.1%20Issuance%20and%20Sale%20of%20Shares) The Company may issue and sell Ordinary Shares through the Agent, subject to limitations like the Maximum Amount and authorized shares - The Company may issue and sell Ordinary Shares (Placement Shares) through or to the Agent[1](index=1&type=chunk) - Sales are subject to limitations, including the number or dollar amount permitted by the Registration Statement, authorized but unissued shares, Form F-3 limits, and filed Prospectus Supplement limits (collectively, the **"Maximum Amount"**)[1](index=1&type=chunk) - Compliance with these limitations is the sole responsibility of the Company; the Agent has no obligation in connection with such compliance[1](index=1&type=chunk) [Registration Statement and Prospectus](index=2&type=section&id=1.2%20Registration%20Statement%20and%20Prospectus) The Company filed a Form F-3 registration statement with the SEC, including a base prospectus and supplement for Placement Shares - The Company filed a registration statement on Form F-3 (File No. 333-266748) with the SEC, including a base prospectus, for the Placement Shares[2](index=2&type=chunk) - A specific prospectus supplement for the Placement Shares (the **"Prospectus Supplement"**) has been prepared and will be furnished to the Agent[2](index=2&type=chunk) - References to the Registration Statement or Prospectus include all documents incorporated or deemed incorporated by reference, and filings made via EDGAR[2](index=2&type=chunk) [Placement and Settlement Procedures](index=2&type=section&id=Placement%20and%20Settlement%20Procedures) This section details the process for initiating, selling, suspending, and settling Placement Shares [Placements](index=2&type=section&id=2.1%20Placements) The Company initiates Placement Share sales via a 'Placement Notice' to the Agent, specifying terms, with Agent compensation per Schedule 2 - The Company initiates sales by sending a **'Placement Notice'** to the Agent via email, specifying the number/dollar value of shares, sales period, daily limits, and minimum price[3](index=3&type=chunk) - The Placement Notice becomes effective unless the Agent declines, the shares are sold, the Company suspends/terminates it, or the Agreement is terminated[3](index=3&type=chunk) - Compensation for the Agent is calculated according to Schedule 2[3](index=3&type=chunk) [Sale of Placement Shares by Agent](index=3&type=section&id=2.2%20Sale%20of%20Placement%20Shares%20by%20Agent) The Agent will use commercially reasonable efforts to sell Placement Shares, providing daily confirmation of sales, compensation, and net proceeds - The Agent will use commercially reasonable efforts to sell Placement Shares according to the Placement Notice, consistent with normal trading practices and applicable laws[4](index=4&type=chunk) - The Agent will provide written confirmation to the Company by the opening of the next Trading Day, detailing shares sold, compensation, and Net Proceeds[4](index=4&type=chunk) - Sales may be conducted by any method permitted as an **"at the market offering"** under Rule 415 of the Securities Act[4](index=4&type=chunk) [Suspension of Sales](index=3&type=section&id=2.3%20Suspension%20of%20Sales) Either party may suspend Placement Share sales with notice, but obligations for prior sales remain, and no sales occur with material non-public information - Either the Company or the Agent may suspend sales of Placement Shares with written or telephone notice[5](index=5&type=chunk) - Suspension does not affect obligations for shares sold prior to notice receipt[5](index=5&type=chunk) - No sales will take place when the Company is in possession of material non-public information[6](index=6&type=chunk) [Sale and Delivery to the Agent; Settlement](index=4&type=section&id=2.4%20Sale%20and%20Delivery%20to%20the%20Agent%3B%20Settlement) Placement Share settlement occurs on the second trading day, with the Company transferring shares and indemnifying the Agent for delivery defaults - Settlement for sales of Placement Shares typically occurs on the second Trading Day following the sale date (**"Settlement Date"**)[9](index=9&type=chunk) - Net Proceeds to the Company equal the aggregate sales price minus the Agent's commission/discount and transaction fees[9](index=9&type=chunk) - The Company must electronically transfer Placement Shares to the Agent's account on the Settlement Date; failure to deliver incurs indemnification obligations for the Company[10](index=10&type=chunk) [Limitations on Offering Size](index=5&type=section&id=2.5%20Limitations%20on%20Offering%20Size) The Company cannot sell Placement Shares exceeding the Maximum Amount, Registration Statement limits, or board-authorized amounts, nor below a minimum price - The Company cannot offer or sell Placement Shares if the aggregate gross sales proceeds would exceed the lesser of (A) the **Maximum Amount**, (B) the amount available under the Registration Statement, or (C) the amount authorized by the Company's board[12](index=12&type=chunk) - Sales are prohibited at a price lower than the minimum price authorized by the Company's board of directors[12](index=12&type=chunk) [Company Representations and Warranties](index=5&type=section&id=Company%20Representations%20and%20Warranties) The Company provides assurances regarding its legal compliance, corporate status, financial health, and operational integrity [Securities Law Compliance](index=5&type=section&id=3.1%20Securities%20Law%20Compliance) The Company warrants compliance with securities laws, ensuring accuracy and effectiveness of its Registration Statement and Prospectus, and fair financial presentation [Registration Statement and Prospectus Accuracy](index=5&type=section&id=3.1.1%20Registration%20Statement%20and%20Prospectus%20Accuracy) The Company affirms its Registration Statement and Prospectus meet Form F-3, are effective, lack material misstatements, and face no SEC stop orders - The Registration Statement and Prospectus comply with Form F-3 and Rule 415 under the Securities Act[13](index=13&type=chunk) - No order from the Commission prevents or suspends the use of the Registration Statement, nor are proceedings threatened[13](index=13&type=chunk) - The Registration Statement and Prospectus do not and will not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements not misleading[15](index=15&type=chunk) [Conformity with Securities Act and Exchange Act](index=6&type=section&id=3.1.2%20Conformity%20with%20Securities%20Act%20and%20Exchange%20Act) The Company warrants its Registration Statement, Prospectus, and related documents materially conform to Securities Act and Exchange Act requirements - The Registration Statement, Prospectus, Issuer Free Writing Prospectus, and Incorporated Documents conform in all material respects with the Securities Act and Exchange Act[16](index=16&type=chunk) [Financial Information Accuracy](index=6&type=section&id=3.1.3%20Financial%20Information%20Accuracy) The Company represents its financial statements and non-GAAP disclosures in the Registration Statement and Prospectus are accurate and IFRS-compliant - Financial statements present fairly the Company's financial position, results of operations, and cash flows, prepared in compliance with Securities Act and Exchange Act, and in conformity with **IFRS**[17](index=17&type=chunk) - Other financial and statistical data are accurately and fairly presented, consistent with financial statements[17](index=17&type=chunk) - Disclosures regarding **"non-GAAP financial measures"** comply with Regulation G and Item 10 of Regulation S-K[17](index=17&type=chunk) [EDGAR Filing Conformity](index=7&type=section&id=3.1.4%20EDGAR%20Filing%20Conformity) The Company warrants the Prospectus delivered to the Agent will be identical to the EDGAR-filed version, as permitted by Regulation S-T - The Prospectus delivered to the Agent will be identical to the EDGAR-filed version, except as permitted by Regulation S-T[19](index=19&type=chunk) [F-3 Eligibility and Non-Affiliate Shares](index=10&type=section&id=3.1.5%20F-3%20Eligibility%20and%20Non-Affiliate%20Shares) The Company confirms Form F-3 eligibility, provides non-affiliate share market value, and states it has not been a shell company for 12 months - The Company meets the requirements for Form F-3 under the Securities Act, including General Instruction I.B.5[36](index=36&type=chunk) Non-Affiliate Shares Market Value (February 8, 2023) | Metric | Value (USD) | | :----- | :---------- | | Aggregate Market Value of Non-Affiliate Shares | $5,481,334 | - The Company is not and has not been a shell company for at least 12 calendar months[36](index=36&type=chunk) [Status Under the Securities Act](index=16&type=section&id=3.1.6%20Status%20Under%20the%20Securities%20Act) The Company represents it was not and is not an ineligible issuer under Rule 405 of the Securities Act for the Placement Shares offering - The Company was not and is not an ineligible issuer as defined in Rule 405 under the Securities Act[63](index=63&type=chunk) [No Misstatement or Omission in Issuer Free Writing Prospectus](index=16&type=section&id=3.1.7%20No%20Misstatement%20or%20Omission%20in%20Issuer%20Free%20Writing%20Prospectus) The Company warrants each Issuer Free Writing Prospectus does not conflict with the Registration Statement or Prospectus, unless based on Agent-furnished information - Each Issuer Free Writing Prospectus does not and will not conflict with information in the Registration Statement or Prospectus[64](index=64&type=chunk) [Corporate Status and Operations](index=7&type=section&id=3.2%20Corporate%20Status%20and%20Operations) The Company provides comprehensive representations on its corporate status, financial health, legal compliance, intellectual property, and operational integrity [Organization and Qualification](index=7&type=section&id=3.2.1%20Organization%20and%20Qualification) The Company is duly organized and in good standing under Israeli law, possessing all necessary licenses and corporate authority for its operations - The Company is duly organized, validly existing, and in good standing under Israeli law[20](index=20&type=chunk) - It is duly licensed or qualified in all other necessary jurisdictions, with all corporate power and authority, unless failure would not result in a Material Adverse Effect[20](index=20&type=chunk) [Subsidiaries](index=7&type=section&id=3.2.2%20Subsidiaries) The Company owns or controls only listed subsidiaries, holding all equity interests free of encumbrances, validly issued, fully paid, and non-assessable - The Company owns or controls only subsidiaries listed in its most recent Form 20-F[21](index=21&type=chunk) - All equity interests in subsidiaries are directly or indirectly owned, free of liens, validly issued, fully paid, non-assessable, and free of preemptive rights[21](index=21&type=chunk) [No Violation or Default](index=7&type=section&id=3.2.3%20No%20Violation%20or%20Default) The Company warrants no violation of organizational documents, material agreements, or laws, unless such would not result in a Material Adverse Effect - The Company is not in violation of its charter or by-laws[22](index=22&type=chunk) - No default exists under any material agreement or instrument, nor is the Company in violation of any law, statute, judgment, order, rule, or regulation, unless such violation would not have a Material Adverse Effect[22](index=22&type=chunk) [No Material Adverse Effect](index=7&type=section&id=3.2.4%20No%20Material%20Adverse%20Effect) No Material Adverse Effect, material transactions, or undisclosed changes in capital stock or indebtedness have occurred since the Registration Statement dates - No Material Adverse Effect has occurred since the dates of information in the Registration Statement and Prospectus[23](index=23&type=chunk) - No material transactions, obligations, or liabilities have been incurred, nor material changes in capital stock or long-term indebtedness, except in the ordinary course of business or as disclosed[23](index=23&type=chunk) [Capitalization](index=8&type=section&id=3.2.5%20Capitalization) The Company's capital stock is validly issued, fully paid, non-assessable, and free of preemptive rights, with authorized capitalization as disclosed - Issued and outstanding capital stock is validly issued, fully paid, non-assessable, and free of preemptive rights (except as disclosed)[25](index=25&type=chunk) - Authorized capitalization conforms to the description in the Registration Statement and Prospectus[25](index=25&type=chunk) - No outstanding options, rights, warrants, or commitments to issue capital stock exist beyond those disclosed[25](index=25&type=chunk) [Authorization; Enforceability](index=8&type=section&id=3.2.6%20Authorization%3B%20Enforceability) The Company affirms its legal authority to enter and perform this duly authorized Agreement, making it a valid and binding obligation - The Company has full legal right, power, and authority to enter into and perform this Agreement[26](index=26&type=chunk) - This Agreement is a duly authorized, executed, and binding agreement of the Company, enforceable in accordance with its terms, subject to bankruptcy laws and equitable principles[26](index=26&type=chunk) [Authorization of Placement Shares](index=8&type=section&id=3.2.7%20Authorization%20of%20Placement%20Shares) Placement Shares, upon issuance, will be duly authorized, validly issued, fully paid, non-assessable, free of encumbrances, and Exchange Act registered - Placement Shares, when issued and delivered, will be duly authorized, validly issued, fully paid, and non-assessable[27](index=27&type=chunk) - They will be free and clear of any pledge, lien, encumbrance, or other claim, including preemptive rights[27](index=27&type=chunk) - Placement Shares will be registered pursuant to Section 12 of the Exchange Act and conform to the Prospectus description[27](index=27&type=chunk) [No Consents Required](index=8&type=section&id=3.2.8%20No%20Consents%20Required) No governmental or regulatory consents are required for this Agreement or Placement Share issuance, except for minor regulatory filings or those without Material Adverse Effect - No governmental or regulatory consents are required for the Agreement's execution or Placement Share issuance/sale, except for state securities laws, FINRA, or Exchange rules, or those whose absence would not have a Material Adverse Effect[28](index=28&type=chunk) [No Preferential Rights](index=9&type=section&id=3.2.9%20No%20Preferential%20Rights) The Company represents no person holds rights to compel share issuance, preemptive rights, or underwriter/advisor roles for its securities - No person has contractual rights to cause the Company to issue or sell Ordinary Shares or other securities[30](index=30&type=chunk) - No person has preemptive rights, resale rights, rights of first refusal, or other similar rights to purchase Company securities[30](index=30&type=chunk) - No person has the right to act as an underwriter or financial advisor for Ordinary Share sales or to require registration of securities under the Securities Act[30](index=30&type=chunk) [Independent Public Accountant](index=9&type=section&id=3.2.10%20Independent%20Public%20Accountant) BDO Ziv haft, the Company's independent accountant, is compliant with Securities Act, PCAOB, and Sarbanes-Oxley independence requirements - BDO Ziv haft is the Company's independent registered public accounting firm[31](index=31&type=chunk) - The Accountant is independent within the meaning of the Securities Act and PCAOB, and not in violation of Sarbanes-Oxley auditor independence requirements[31](index=31&type=chunk) [Enforceability of Agreements](index=9&type=section&id=3.2.11%20Enforceability%20of%20Agreements) The Company warrants all material Prospectus agreements are legal, valid, and enforceable, subject to standard limitations and no Material Adverse Effect - All material agreements referenced in the Prospectus are legal, valid, and binding obligations of the Company, enforceable in accordance with their terms[32](index=32&type=chunk) - Enforceability is subject to bankruptcy laws, equitable principles, and limitations on indemnification provisions by securities laws, provided any unenforceability would not have a Material Adverse Effect[32](index=32&type=chunk) [No Litigation](index=9&type=section&id=3.2.12%20No%20Litigation) No pending or threatened litigation exists that would cause a Material Adverse Effect or hinder Agreement performance, with all disclosures in the Prospectus - No pending or threatened legal, governmental, or regulatory actions, suits, or proceedings exist that would reasonably be expected to have a Material Adverse Effect or affect the Company's ability to perform this Agreement[33](index=33&type=chunk) - All required litigation disclosures are included in the Prospectus, and all required exhibits are filed with the Registration Statement[33](index=33&type=chunk) [Licenses and Permits](index=10&type=section&id=3.2.13%20Licenses%20and%20Permits) The Company possesses all necessary business licenses and permits, with no notice of revocation, unless such issues would not cause a Material Adverse Effect - The Company possesses all necessary federal, state, local, or foreign governmental licenses, permits, and authorizations for its business[35](index=35&type=chunk) - No written notice of revocation or modification of any Permit has been received, nor is there reason to believe renewal will not occur in the ordinary course, unless such failure would not have a Material Adverse Effect[35](index=35&type=chunk) [No Material Defaults](index=10&type=section&id=3.2.14%20No%20Material%20Defaults) The Company has not defaulted on material indebtedness or leases, nor reported such defaults since its last Form 20-F, that would cause a Material Adverse Effect - The Company has not defaulted on any installment on indebtedness for borrowed money or on any rental on one or more long-term leases, which defaults would reasonably be expected to have a Material Adverse Effect[36](index=36&type=chunk) - No report filed under Section 13(a) or 15(d) of the Exchange Act since the last Form 20-F indicates such defaults[36](index=36&type=chunk) [Certain Market Activities](index=11&type=section&id=3.2.15%20Certain%20Market%20Activities) Neither the Company nor its affiliates have taken actions to stabilize or manipulate its securities' price for Placement Share sales - Neither the Company nor its directors, officers, or controlling persons have taken action to stabilize or manipulate the price of Company securities to facilitate Placement Share sales[38](index=38&type=chunk) [Broker/Dealer Relationships](index=11&type=section&id=3.2.16%20Broker%2FDealer%20Relationships) Neither the Company nor its related entities are required to register as a broker/dealer or are associated with a FINRA member - Neither the Company nor any related entities are required to register as a **"broker"** or **"dealer"** under the Exchange Act[39](index=39&type=chunk) - Neither the Company nor any related entities control or are a **"person associated with a member"** of FINRA[39](index=39&type=chunk) [No Reliance on Agent](index=11&type=section&id=3.2.17%20No%20Reliance%20on%20Agent) The Company has not relied on the Agent or its counsel for legal, tax, or accounting advice regarding Placement Share offering - The Company has not relied on the Agent or its legal counsel for legal, tax, or accounting advice regarding the Placement Shares offering[40](index=40&type=chunk) [Taxes](index=11&type=section&id=3.2.18%20Taxes) The Company has filed all tax returns and paid due taxes, with no known material tax deficiencies that would cause a Material Adverse Effect - The Company has filed all required federal, state, local, and foreign tax returns and paid all taxes shown thereon[41](index=41&type=chunk) - No tax deficiency has been determined adversely to the Company that would reasonably be expected to have a Material Adverse Effect[41](index=41&type=chunk) [Title to Real and Personal Property](index=11&type=section&id=3.2.19%20Title%20to%20Real%20and%20Personal%20Property) The Company holds good title to all material property, free of liens, and valid leases, without material business interference or Material Adverse Effect - The Company has good and valid title in fee simple to all material real property and good and valid title to all personal property, free and clear of all liens, encumbrances, and claims[42](index=42&type=chunk) - Leased real property is held under valid, existing, and enforceable leases[42](index=42&type=chunk) [Intellectual Property](index=11&type=section&id=3.2.20%20Intellectual%20Property) The Company owns or has rights to all necessary IP, with no material infringement claims or challenges to its IP rights - The Company owns or possesses adequate enforceable rights to use all Intellectual Property necessary for its business, unless failure would not have a Material Adverse Effect[43](index=43&type=chunk) - No written notice of infringement claims has been received that would result in a Material Adverse Effect[43](index=43&type=chunk) - No pending or threatened judicial proceedings challenge the Company's IP rights or validity[43](index=43&type=chunk) [Environmental Laws](index=12&type=section&id=3.2.21%20Environmental%20Laws) The Company complies with Environmental Laws, holds required permits, and has no material hazardous substance liability notices - The Company complies with all applicable Environmental Laws[45](index=45&type=chunk) - It possesses all required environmental permits, licenses, and approvals[45](index=45&type=chunk) - No notice of actual or potential liability for hazardous substance remediation has been received, unless such failure or liability would not have a Material Adverse Effect[45](index=45&type=chunk) [Disclosure Controls](index=12&type=section&id=3.2.22%20Disclosure%20Controls) The Company maintains effective internal and disclosure controls for reliable financial reporting, with no material weaknesses or significant changes reported - The Company maintains systems of internal controls designed for reasonable assurance of transaction execution, financial statement preparation, asset accountability, and access control[46](index=46&type=chunk) - No material weaknesses in internal control over financial reporting are known (other than as set forth in the Prospectus)[46](index=46&type=chunk) - Disclosure controls and procedures are established and designed to ensure material information is known to certifying officers, and are effective[46](index=46&type=chunk) [Sarbanes-Oxley Compliance](index=13&type=section&id=3.2.23%20Sarbanes-Oxley%20Compliance) The Company and its officers comply with Sarbanes-Oxley Act provisions, with principal officers having made all required certifications - The Company and its directors/officers comply with applicable Sarbanes-Oxley Act provisions[48](index=48&type=chunk) - Principal executive and financial officers have made all certifications required by Sections 302 and 906 of Sarbanes-Oxley Act for past 12 months' reports[48](index=48&type=chunk) [Finder's Fees](index=13&type=section&id=3.2.24%20Finder%27s%20Fees) The Company has not incurred liability for finder's fees or brokerage commissions, except those with the Agent under this Agreement - The Company has not incurred liability for finder's fees, brokerage commissions, or similar payments, except as may exist with the Agent under this Agreement[49](index=49&type=chunk) [Labor Disputes](index=13&type=section&id=3.2.25%20Labor%20Disputes) No labor disturbance or dispute exists or is threatened that would reasonably cause a Material Adverse Effect - No labor disturbance or dispute exists or is threatened that would reasonably be likely to have a Material Adverse Effect[49](index=49&type=chunk) [Investment Company Act Status](index=13&type=section&id=3.2.26%20Investment%20Company%20Act%20Status) The Company is not and will not become an 'investment company' or controlled by one, as defined in the Investment Company Act of 1940 - The Company is not and will not become an **"investment company"** or an entity **"controlled"** by an **"investment company"** as defined in the Investment Company Act of 1940[49](index=49&type=chunk) [Money Laundering Laws Compliance](index=13&type=section&id=3.2.27%20Money%20Laundering%20Laws%20Compliance) The Company's operations comply with Money Laundering Laws, with no pending actions that would cause a Material Adverse Effect - The Company's operations comply with applicable Money Laundering Laws, except as would not have a Material Adverse Effect[50](index=50&type=chunk) - No action, suit, or proceeding involving the Company with respect to Money Laundering Laws is pending or threatened[50](index=50&type=chunk) [Off-Balance Sheet Arrangements](index=13&type=section&id=3.2.28%20Off-Balance%20Sheet%20Arrangements) No undisclosed Off-Balance Sheet Transactions exist that could materially affect the Company's liquidity or capital resources - No undisclosed Off-Balance Sheet Transactions exist that could materially affect the Company's liquidity or capital resources, as required to be described in the Prospectus[51](index=51&type=chunk) [Underwriter Agreements](index=14&type=section&id=3.2.29%20Underwriter%20Agreements) The Company is not party to any other 'at the market' or continuous equity transaction agreement, except for this Agreement - The Company is not a party to any other **"at the market"** or continuous equity transaction agreement with an agent or underwriter, other than this Agreement[53](index=53&type=chunk) [ERISA Compliance](index=14&type=section&id=3.2.30%20ERISA%20Compliance) The Company's employee benefit plans comply with ERISA and the Internal Revenue Code, with no material prohibited transactions or underfunded plans - Each material employee benefit plan complies with its terms and requirements of ERISA and the Internal Revenue Code[54](index=54&type=chunk) - No prohibited transaction has occurred that would result in a material liability to the Company[54](index=54&type=chunk) - For funded plans, the fair market value of assets exceeds the present value of all accrued benefits[54](index=54&type=chunk) [Forward Looking Statements](index=14&type=section&id=3.2.31%20Forward%20Looking%20Statements) All forward-looking statements in the Registration Statement and Prospectus were made with a reasonable basis, in good faith, and comply with safe harbor provisions - No forward-looking statement in the Registration Statement and Prospectus was made without a reasonable basis or disclosed other than in good faith[55](index=55&type=chunk) - Forward-looking statements are within the safe harbor of the Securities Act and Exchange Act, reflect the Company's best estimate, and comply with Item 10 of Regulation S-K[55](index=55&type=chunk) [Agent Purchases](index=14&type=section&id=3.2.32%20Agent%20Purchases) The Company acknowledges the Agent may purchase/sell Ordinary Shares for its own account, excluding during active Placement Notices (except riskless principal sales) - The Agent may purchase and sell Ordinary Shares for its own account, to the extent permitted by securities laws[56](index=56&type=chunk) - Such purchases/sales are not permitted while a Placement Notice is in effect (except for riskless principal sales)[56](index=56&type=chunk) - The Company does not authorize or consent to such purchases or sales by the Agent[56](index=56&type=chunk) [Margin Rules](index=15&type=section&id=3.2.33%20Margin%20Rules) The issuance, sale, and delivery of Placement Shares and use of proceeds will not violate Federal Reserve Regulations T, U, or X - The issuance, sale, and delivery of Placement Shares and the application of proceeds will not violate Regulations T, U, or X of the Federal Reserve System[58](index=58&type=chunk) [Insurance](index=15&type=section&id=3.2.34%20Insurance) The Company maintains adequate insurance coverage for its business, consistent with industry customary practices - The Company carries or is covered by insurance in adequate amounts and covering risks customary for similar businesses[59](index=59&type=chunk) [No Improper Practices](index=15&type=section&id=3.2.35%20No%20Improper%20Practices) The Company warrants no improper practices, including unlawful contributions, undisclosed related-party dealings, or payments to influence business, and complies with anti-corruption laws - Neither the Company nor its executive officers have made unlawful political contributions or undisclosed payments to officials[60](index=60&type=chunk) - No undisclosed direct/indirect relationships exist between the Company/affiliates and its directors, officers, or stockholders as required by securities laws or FINRA rules[60](index=60&type=chunk) - The Company has not offered shares to unlawfully influence customers, suppliers, or trade journalists, and complies with anti-corruption laws like the Foreign Corrupt Practices Act[60](index=60&type=chunk) [Compliance with Applicable Laws (Product-related)](index=15&type=section&id=3.2.36%20Compliance%20with%20Applicable%20Laws%20%28Product-related%29) The Company materially complies with product-related laws, holds necessary Authorizations, and has no material non-compliance notices from regulatory authorities - The Company is in material compliance with all Applicable Laws related to its products[61](index=61&type=chunk) - It possesses all material Authorizations (licenses, certificates, approvals) which are valid and in full force[61](index=61&type=chunk) - No notice of material non-compliance, claims, or actions from the FDA or other authorities has been received, unless such issues would not result in a Material Adverse Effect[61](index=61&type=chunk) [Clinical Studies](index=16&type=section&id=3.2.37%20Clinical%20Studies) All clinical trials comply with laws and protocols, results are accurately described, and no termination notices have been received - All clinical trials were and are conducted in material compliance with Applicable Laws and experimental protocols[62](index=62&type=chunk) - Descriptions of clinical trial results in the Registration Statement and Prospectus are accurate in all material respects[62](index=62&type=chunk) - No written notices from the FDA or other agencies requiring termination or suspension of clinical trials have been received[62](index=62&type=chunk) [OFAC Compliance](index=16&type=section&id=3.2.38%20OFAC%20Compliance) Neither the Company nor its associated persons are subject to sanctions, and proceeds will not finance sanctioned activities or entities - Neither the Company nor its directors, officers, agents, employees, affiliates, or representatives are subject to U.S. or international sanctions (OFAC, UNSC, EU, HMT)[66](index=66&type=chunk) - The Company will not use offering proceeds to finance activities of sanctioned persons or entities[66](index=66&type=chunk) - The Company has not knowingly engaged in, is not now knowingly engaged in, and will not engage in dealings with sanctioned persons or territories for the past 5 years (except as detailed in the Prospectus)[66](index=66&type=chunk) [Stock Transfer Taxes](index=17&type=section&id=3.2.39%20Stock%20Transfer%20Taxes) All stock transfer taxes related to Placement Share sales will be fully paid or provided for by the Company on each Settlement Date - All stock transfer or other taxes (excluding income taxes) related to Placement Share sales will be fully paid or provided for by the Company on each Settlement Date[68](index=68&type=chunk) [Cybersecurity](index=17&type=section&id=3.2.40%20Cybersecurity) The Company's IT Systems are adequate and secure, with no material breaches or non-compliance with privacy and security laws - The Company's IT Systems are adequate, operate as required, and are free of material bugs, errors, or malware[69](index=69&type=chunk) - Commercially reasonable physical, technical, and administrative controls are maintained to protect confidential and personal data[69](index=69&type=chunk) - No material breaches, violations, or unauthorized uses of IT Systems or data have occurred, and the Company is in material compliance with privacy and security laws[69](index=69&type=chunk) [Compliance with Data Privacy Laws](index=17&type=section&id=3.2.41%20Compliance%20with%20Data%20Privacy%20Laws) The Company materially complies with data privacy laws like HIPAA, CCPA, and GDPR, with no notices of violations or liabilities - The Company is in material compliance with all applicable state and federal data privacy and security laws, including HIPAA, CCPA, and GDPR[70](index=70&type=chunk) - Policies and procedures relating to data privacy and security are in place and complied with[70](index=70&type=chunk) - No notice of actual or potential liability or violation under Privacy Laws has been received[70](index=70&type=chunk) [Emerging Growth Company Status](index=18&type=section&id=3.2.42%20Emerging%20Growth%20Company%20Status) The Company has been and remains an 'emerging growth company' under Section 2(a) of the Securities Act since its initial registration filing - The Company has been and is an **"emerging growth company"** as defined in Section 2(a) of the Securities Act since its first registration statement filing[72](index=72&type=chunk) [PFIC Status](index=18&type=section&id=3.2.43%20PFIC%20Status) The Company does not expect to be classified as a PFIC for fiscal years 2022 or 2023, based on income, assets, and proceeds estimates - The Company does not believe it was a **PFIC** for the fiscal year ended December 31, 2022[73](index=73&type=chunk) - The Company does not expect to be classified as a PFIC for the fiscal year ending December 31, 2023, based on certain estimates and intended use of proceeds[73](index=73&type=chunk) [CFC Status](index=18&type=section&id=3.2.44%20CFC%20Status) The Company was not a CFC for 2022 and does not expect to be for 2023, based on shareholder expectations - The Company was not a **CFC** for the taxable year ended December 31, 2022[74](index=74&type=chunk) - The Company does not expect to be classified as a CFC for the taxable year ending December 31, 2023, based on shareholder expectations[74](index=74&type=chunk) [Validity of Choice of Law](index=18&type=section&id=3.2.45%20Validity%20of%20Choice%20of%20Law) The Company confirms New York law as governing this Agreement is valid under Israeli law and submits to New York court jurisdiction - The choice of New York law as the governing law is valid under Israeli law and should be honored by Israeli courts[75](index=75&type=chunk) - The Company has irrevocably submitted to the personal jurisdiction of New York courts and waived any objection to venue[75](index=75&type=chunk) [Officer's Certificate](index=18&type=section&id=3.3%20Officer%27s%20Certificate) Any certificate signed by a Company officer and delivered to the Agent is deemed a representation and warranty by the Company - Any certificate signed by a Company officer and delivered to the Agent or its counsel is deemed a representation and warranty by the Company[76](index=76&type=chunk) [Company Covenants](index=19&type=section&id=Company%20Covenants) The Company commits to regulatory filings, financial reporting, market activities, and ongoing compliance [Registration and Prospectus Maintenance](index=19&type=section&id=4.1%20Registration%20and%20Prospectus%20Maintenance) The Company commits to maintaining the effectiveness and accuracy of its Registration Statement and Prospectus, including timely amendments and notifications [Registration Statement Amendments](index=19&type=section&id=4.1.1%20Registration%20Statement%20Amendments) The Company will promptly notify the Agent of Registration Statement amendments or SEC requests, and will not file Placement Share amendments without Agent's review - The Company will promptly notify the Agent of any amendments/supplements to the Registration Statement/Prospectus or SEC requests for information[78](index=78&type=chunk) - The Company will prepare and file necessary amendments/supplements upon the Agent's reasonable request[78](index=78&type=chunk) - The Company will not file amendments/supplements relating to Placement Shares without submitting a copy to the Agent within a reasonable period and receiving no objection[78](index=78&type=chunk) [Notice of Commission Stop Orders](index=19&type=section&id=4.1.2%20Notice%20of%20Commission%20Stop%20Orders) The Company will promptly notify the Agent of SEC stop orders or related proceedings, and use efforts to prevent or withdraw such orders - The Company will promptly advise the Agent of any SEC stop order, suspension of Placement Shares qualification, or related proceedings[79](index=79&type=chunk) - The Company will use commercially reasonable efforts to prevent or withdraw any stop order[79](index=79&type=chunk) - The Company will promptly advise the Agent of any SEC requests for amendments or additional information[79](index=79&type=chunk) [Delivery of Prospectus; Subsequent Changes](index=20&type=section&id=4.1.3%20Delivery%20of%20Prospectus%3B%20Subsequent%20Changes) The Company will comply with Securities Act requirements, file reports, and amend the Prospectus if misleading, notifying the Agent to suspend sales - The Company will comply with Securities Act requirements and file all required reports with the Commission[81](index=81&type=chunk) - If the Prospectus becomes misleading or non-compliant, the Company will promptly notify the Agent to suspend sales and will amend or supplement the filings[81](index=81&type=chunk) [Delivery of Registration Statement and Prospectus](index=20&type=section&id=4.1.4%20Delivery%20of%20Registration%20Statement%20and%20Prospectus) The Company will furnish the Agent with copies of the Registration Statement, Prospectus, and all amendments during the Prospectus Delivery Period - The Company will furnish the Agent and its counsel with copies of the Registration Statement, Prospectus, and all amendments/supplements during the Prospectus Delivery Period[83](index=83&type=chunk) - Copies will be provided in reasonably requested quantities, unless available on EDGAR[83](index=83&type=chunk) [Operational and Financial Covenants](index=20&type=section&id=4.2%20Operational%20and%20Financial%20Covenants) The Company covenants on Placement Share listing, financial reporting, use of proceeds, sales notifications, due diligence, and ongoing legal/accounting certifications [Listing of Placement Shares](index=20&type=section&id=4.2.1%20Listing%20of%20Placement%20Shares) The Company will use commercially reasonable efforts to list Placement Shares on the Exchange and qualify them for sale in designated jurisdictions - The Company will use commercially reasonable efforts to cause Placement Shares to be listed on the Exchange[82](index=82&type=chunk) - The Company will qualify Placement Shares for sale under securities laws of Agent-designated jurisdictions, without being required to qualify as a foreign corporation or dealer[82](index=82&type=chunk) [Earnings Statement](index=20&type=section&id=4.2.2%20Earnings%20Statement) The Company will provide a 12-month earnings statement to security holders within 15 months of the fiscal quarter end, complying with Securities Act rules - The Company will make an earnings statement covering a 12-month period available to security holders within **15 months** after the current fiscal quarter end[84](index=84&type=chunk) - The earnings statement must satisfy Section 11(a) and Rule 158 of the Securities Act[84](index=84&type=chunk) [Use of Proceeds](index=20&type=section&id=4.2.3%20Use%20of%20Proceeds) The Company covenants to use Net Proceeds from Placement Share sales as described in the Prospectus's 'Use of Proceeds' section - The Company will use the Net Proceeds as described in the **"Use of Proceeds"** section of the Prospectus[84](index=84&type=chunk) [Notice of Other Sales](index=21&type=section&id=4.2.4%20Notice%20of%20Other%20Sales) The Company will not sell other Ordinary Shares or convertible securities without Agent consent during an active Placement Notice, with specific exceptions - The Company will not offer or sell other Ordinary Shares or convertible securities without the Agent's prior written consent during an active Placement Notice period and for **two trading days** thereafter[85](index=85&type=chunk) - This restriction also applies to other **"at the market"** or continuous equity transactions before the Agreement terminates[85](index=85&type=chunk) - Exceptions include shares issued under employee plans, upon conversion of existing securities, or in negotiated strategic transactions not primarily for capital raising[85](index=85&type=chunk) [Change of Circumstances](index=21&type=section&id=4.2.5%20Change%20of%20Circumstances) The Company will promptly advise the Agent of any material changes affecting required documents during an active Placement Notice - The Company will promptly advise the Agent of any information or fact that would materially alter any required opinion, certificate, letter, or document during an active Placement Notice[86](index=86&type=chunk) [Due Diligence Cooperation](index=21&type=section&id=4.2.6%20Due%20Diligence%20Cooperation) The Company will cooperate with the Agent's due diligence, providing information, documents, and access to senior officers - The Company will cooperate with the Agent's reasonable due diligence review[87](index=87&type=chunk) - Cooperation includes providing information, documents, and making senior corporate officers available[87](index=87&type=chunk) [Required Filings Relating to Placement of Placement Shares](index=21&type=section&id=4.2.7%20Required%20Filings%20Relating%20to%20Placement%20of%20Placement%20Shares) The Company will file prospectus supplements detailing Placement Share sales, Net Proceeds, and Agent compensation, and deliver copies to exchanges - The Company will file a prospectus supplement with the Commission under Rule 424(b) on required dates[88](index=88&type=chunk) - The supplement will detail Placement Shares sold, Net Proceeds, and Agent compensation[88](index=88&type=chunk) - Copies of the prospectus supplement will be delivered to relevant exchanges[88](index=88&type=chunk) [Representation Dates; Certificate](index=21&type=section&id=4.2.8%20Representation%20Dates%3B%20Certificate) The Company must provide a 'Representation Date Certificate' on the Agreement date and after certain filings, with waiver conditions for new Placement Notices - The Company must furnish a **'Representation Date Certificate'** (Exhibit 7(l)) on the Agreement date and within **five trading days** of certain filings (e.g., Prospectus amendments, annual reports, semi-annual financials)[89](index=89&type=chunk)[91](index=91&type=chunk) - A waiver for the certificate requirement applies if no Placement Notice is pending, but it is lifted if a new Placement Notice is delivered or for annual report filings[91](index=91&type=chunk) [Legal Opinion](index=22&type=section&id=4.2.9%20Legal%20Opinion) The Company must provide legal opinions from U.S. and Israeli counsel on the Agreement date, and negative assurance letters after certain filings - On the Agreement date, the Company must furnish written opinions and negative assurance letters from U.S. Company Counsel and Israeli Company Counsel[92](index=92&type=chunk) - Within **five Trading Days** of each non-waived Representation Date, a negative assurance letter from U.S. Company Counsel is required, or a Reliance Letter for subsequent periodic filings[92](index=92&type=chunk) [Comfort Letter](index=23&type=section&id=4.2.10%20Comfort%20Letter) The Company's independent accountants must furnish Comfort Letters to the Agent on the Agreement date and after certain filings, confirming independence and financial findings - On the Agreement date and within **five Trading Days** of each non-waived Representation Date, the Company's independent accountants must furnish Comfort Letters to the Agent[94](index=94&type=chunk) - Comfort Letters must confirm accountant independence, state findings on financial information, and update previous information[94](index=94&type=chunk) - If requested by the Agent, a Comfort Letter must be furnished within **ten Trading Days** of any material transaction or event, including financial restatement[94](index=94&type=chunk) [Market Activities](index=23&type=section&id=4.2.11%20Market%20Activities) The Company covenants not to engage in market stabilization or manipulation of its securities, nor to sell or purchase shares outside of the Agent - The Company will not engage in market stabilization or manipulation of its securities[95](index=95&type=chunk) - The Company will not sell, bid for, or purchase Ordinary Shares, or pay for soliciting purchases, other than through the Agent[95](index=95&type=chunk) [Investment Company Act Compliance](index=23&type=section&id=4.2.12%20Investment%20Company%20Act%20Compliance) The Company will conduct its affairs to avoid becoming an 'investment company' prior to the Agreement's termination - The Company will conduct its affairs to ensure it does not become an **"investment company"** prior to the Agreement's termination[96](index=96&type=chunk) [No Offer to Sell](index=23&type=section&id=4.2.13%20No%20Offer%20to%20Sell) Neither party will make unapproved written offers to sell or solicit Placement Shares, except for mutually approved Issuer Free Writing Prospectuses - Neither the Agent nor the Company (excluding the Agent in its capacity as agent) will make or refer to any written communication constituting an offer to sell or solicitation to buy Placement Shares[97](index=97&type=chunk) - An exception is made for Issuer Free Writing Prospectuses approved in advance by both the Company and the Agent[97](index=97&type=chunk) [Sarbanes-Oxley Act Compliance](index=24&type=section&id=4.2.14%20Sarbanes-Oxley%20Act%20Compliance) The Company covenants to maintain accurate books, internal accounting controls, and Sarbanes-Oxley compliant disclosure controls for financial reporting - The Company will maintain accurate books and records and internal accounting controls for reliable financial reporting in accordance with IFRS[99](index=99&type=chunk) - The Company will use commercially reasonable efforts to maintain controls and procedures required by Sections 302 and 906 of the Sarbanes-Oxley Act[99](index=99&type=chunk) - These controls are designed to ensure timely and accurate disclosure of information in Exchange Act reports to management[99](index=99&type=chunk) [Emerging Growth Company Status Notification](index=24&type=section&id=4.2.15%20Emerging%20Growth%20Company%20Status%20Notification) The Company will promptly notify the Agents if its Emerging Growth Company status changes during the Agreement term - The Company will promptly notify the Agents if it ceases to be an Emerging Growth Company during the Agreement term[100](index=100&type=chunk) [Expenses and Conditions to Agent's Obligations](index=24&type=section&id=Expenses%20and%20Conditions%20to%20Agent%27s%20Obligations) This section details the allocation of expenses and the conditions that must be met for the Agent to be obligated to sell shares [Payment of Expenses](index=24&type=section&id=5.1%20Payment%20of%20Expenses) The Company is responsible for all Agreement-related expenses, including filing, legal, accounting, and Agent's reasonable out-of-pocket costs up to specified limits - The Company will pay all expenses related to the Agreement, including preparation, filing, and printing of the Registration Statement and Prospectus[101](index=101&type=chunk) - This includes fees for Company counsel, accountants, transfer agent, FINRA review, and Exchange listing[101](index=101&type=chunk) - The Company will cover the Agent's reasonable out-of-pocket expenses, including counsel fees up to **$40,000** and quarterly disbursements up to **$5,000**[101](index=101&type=chunk) [Conditions to Agent's Obligations](index=25&type=section&id=5.2%20Conditions%20to%20Agent%27s%20Obligations) The Agent's obligations are contingent on the Company's accurate representations, performance, satisfactory due diligence, and fulfillment of various conditions [Registration Statement Effective](index=25&type=section&id=5.2.1%20Registration%20Statement%20Effective) The Agent's obligations are conditioned on the Registration Statement being effective and available for all Placement Share sales - The Registration Statement must be effective and available for the sale of all Placement Shares[103](index=103&type=chunk) [No Material Notices](index=25&type=section&id=5.2.2%20No%20Material%20Notices) The Agent's obligations are conditioned on the absence of SEC requests for amendments, stop orders, or misleading statements in the Registration Statement or Prospectus - No SEC requests for additional information requiring post-effective amendments or supplements to the Registration Statement/Prospectus[104](index=104&type=chunk) - No SEC stop orders suspending effectiveness of the Registration Statement or proceedings for that purpose[104](index=104&type=chunk) - No event has occurred that makes any material statement in the Registration Statement or Prospectus untrue or misleading[104](index=104&type=chunk) [No Misstatement or Material Omission](index=25&type=section&id=5.2.3%20No%20Misstatement%20or%20Material%20Omission) The Agent's obligations are conditioned on no advice to the Company regarding material misstatements or omissions in the Registration Statement or Prospectus - The Agent must not have advised the Company that the Registration Statement or Prospectus contains a material untrue statement or omission[105](index=105&type=chunk) [Material Changes](index=25&type=section&id=5.2.4%20Material%20Changes) The Agent's obligations are subject to no material adverse changes in capital stock, Material Adverse Effect, or securities rating downgrades making the offering inadvisable - No material adverse change in the Company's authorized capital stock or a Material Adverse Effect[106](index=106&type=chunk) - No downgrading or public surveillance/review of the Company's securities rating by any rating organization that makes the offering impracticable or inadvisable[106](index=106&type=chunk) [Legal Opinion](index=26&type=section&id=5.2.5%20Legal%20Opinion) The Agent's obligations are conditioned on receiving timely legal opinions and negative assurance letters from U.S. and Israeli Company Counsel - The Agent must receive the legal opinions and negative assurance letters from U.S. Company Counsel and Israeli Company Counsel as required by Section 7(m) by their due dates[108](index=108&type=chunk) [Comfort Letter](index=26&type=section&id=5.2.6%20Comfort%20Letter) The Agent's obligations are conditioned on receiving the Comfort Letter from the Company's independent accountants by its due date - The Agent must receive the Comfort Letter from the Company's independent accountants as required by Section 7(n) by its due date[109](index=109&type=chunk) [Representation Certificate](index=26&type=section&id=5.2.7%20Representation%20Certificate) The Agent's obligations are conditioned on receiving the Representation Date Certificate from the Company by its specified due date - The Agent must receive the Representation Date Certificate from the Company as required by Section 7(l) by its due date[109](index=109&type=chunk) [Secretary's Certificate](index=26&type=section&id=5.2.8%20Secretary%27s%20Certificate) On the Agreement date, the Agent must receive a satisfactory certificate signed by the Company's corporate Secretary - On the Agreement date, the Agent must receive a certificate signed by the Company's corporate Secretary, satisfactory to the Agent and its counsel[110](index=110&type=chunk) [No Suspension of Trading](index=26&type=section&id=5.2.9%20No%20Suspension%20of%20Trading) The Agent's obligations are conditioned on Ordinary Share trading not being suspended or delisted from the Exchange - Trading in the Ordinary Shares must not have been suspended or delisted from the Exchange[110](index=110&type=chunk) [Other Materials](index=26&type=section&id=5.2.10%20Other%20Materials) On each Representation Date, the Company must furnish the Agent with other reasonably requested, Agreement-compliant information and documents - On each date a Representation Date Certificate is required, the Company must furnish the Agent with other reasonably requested information, certificates, and documents[111](index=111&type=chunk) [Securities Act Filings Made](index=26&type=section&id=5.2.11%20Securities%20Act%20Filings%20Made) All Rule 424 filings required before any Placement Notice must have been made within the prescribed time period - All Rule 424 filings required prior to any Placement Notice must have been made within the applicable time period[112](index=112&type=chunk) [Approval for Listing](index=27&type=section&id=5.2.12%20Approval%20for%20Listing) Placement Shares must be approved for Exchange listing or a listing application filed prior to any Placement Notice - Placement Shares must be approved for listing on the Exchange (subject to notice of issuance) or a listing application filed at or prior to any Placement Notice[114](index=114&type=chunk) [No Termination Event](index=27&type=section&id=5.2.13%20No%20Termination%20Event) The Agent's obligations are conditioned on no event occurring that would permit Agreement termination under Section 12(a) - No event must have occurred that would permit the Agent to terminate this Agreement under Section 12(a)[114](index=114&type=chunk) [Indemnification and Contribution](index=27&type=section&id=Indemnification%20and%20Contribution) This section outlines the indemnification obligations between the Company and Agent, and provisions for contribution if indemnification is unavailable [Company Indemnification](index=27&type=section&id=6.1%20Company%20Indemnification) The Company indemnifies the Agent and its affiliates against losses from material misstatements or omissions in offering documents, except for Agent-furnished information - The Company indemnifies the Agent and its associated parties against losses arising from untrue statements or omissions of material fact in the Registration Statement, Prospectus, or Issuer Free Writing Prospectus[115](index=115&type=chunk) - This includes settlement amounts (with Agent's consent) and reasonable expenses incurred in investigation or defense[115](index=115&type=chunk) - The indemnity does not apply to statements or omissions made in reliance on information furnished by the Agent[115](index=115&type=chunk) [Agent Indemnification](index=28&type=section&id=6.2%20Agent%20Indemnification) The Agent indemnifies the Company and its affiliates against losses from material misstatements or omissions, limited to Agent-furnished information - The Agent indemnifies the Company and its associated parties against losses arising from untrue statements or omissions of material fact in the Registration Statement or Prospectus[117](index=117&type=chunk) - This indemnity is limited to information specifically furnished in writing by the Agent for use in those documents[117](index=117&type=chunk) [Procedure for Indemnification](index=28&type=section&id=6.3%20Procedure%20for%20Indemnification) This section details indemnification procedures, including notice, defense assumption, counsel retention under specific conditions, and required consent for settlements - A party seeking indemnification must promptly notify the indemnifying party of any action[118](index=118&type=chunk) - The indemnifying party can assume defense with satisfactory counsel[118](index=118&type=chunk) - The indemnified party may retain its own counsel at the indemnifying party's expense if there's a conflict of interest or the indemnifying party fails to assume defense[118](index=118&type=chunk) - Settlements require the written consent of the indemnifying party, and no settlement can be made without the indemnified party's consent unless it includes an unconditional release and no admission of fault[118](index=118&type=chunk) [Contribution](index=29&type=section&id=6.4%20Contribution) If indemnification is unavailable, the Company and Agent will contribute to losses based on relative benefits or fault, with the Agent's contribution capped at commissions - If indemnification is unavailable, the Company and Agent will contribute to losses based on relative benefits received from Placement Share sales[120](index=120&type=chunk) - If relative benefits allocation is not permitted, contribution will be based on relative fault, considering information supplied, intent, knowledge, and opportunity to correct[120](index=120&type=chunk) - The Agent's contribution is capped at the commissions received under this Agreement[120](index=120&type=chunk) [General Provisions](index=30&type=section&id=General%20Provisions) This section covers miscellaneous legal and operational aspects of the agreement, including Agent's covenants, termination, notices, and governing law [Additional Covenants](index=30&type=section&id=7.1%20Additional%20Covenants) The Agent covenants on broker-dealer registration and legal compliance, while indemnity, contribution, and Company representations survive Agreement termination - The Agent represents it is duly registered as a broker-dealer under FINRA, the Exchange Act, and applicable state laws, and will maintain this registration[122](index=122&type=chunk) - The Agent will comply with all applicable laws and regulations in connection with the transactions[122](index=122&type=chunk) - Indemnity and contribution agreements, and Company representations/warranties, survive delivery, payment, and termination of the Agreement[123](index=123&type=chunk) [Termination of Agreement](index=30&type=section&id=7.2%20Termination%20of%20Agreement) The Agreement may be terminated by either party with notice, by the Agent due to adverse events, or automatically upon full share sale, with certain provisions surviving - The Agent may terminate the Agreement due to a Material Adverse Effect, material adverse changes in financial markets, trading suspensions, or banking moratoriums[124](index=124&type=chunk) - Both the Company and the Agent have the right to terminate the Agreement at their sole discretion with **five days' written notice**[125](index=125&type=chunk)[127](index=127&type=chunk) - The Agreement automatically terminates upon the issuance and sale of all Placement Shares[128](index=128&type=chunk) - Provisions regarding expenses, indemnification, survival of representations, governing law, and waiver of jury trial survive termination[124](index=124&type=chunk)[125](index=125&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) [Notices](index=31&type=section&id=7.3%20Notices) This section specifies written notice requirements, contact details for both parties, and defines when electronic and physical notices are deemed given - All notices must be in writing and delivered to specified addresses for the Agent (Roth Capital Partners, LLC) and the Company (Inspira Technologies Oxy B.H.N. Ltd.)[132](index=132&type=chunk) - Notices are deemed given when delivered personally, by verifiable facsimile/email (with original to follow), or on the next Business Day after timely delivery to an overnight courier[133](index=133&type=chunk) - Electronic communications are deemed written notice if sent to the specified email address and receipt is verified[134](index=134&type=chunk) [Successors and Assigns](index=32&type=section&id=7.4%20Successors%20and%20Assigns) The Agreement binds both parties and their successors/assigns, with assignment requiring consent, except for Agent assignments to affiliates - The Agreement benefits and binds the Company, the Agent, and their respective successors and permitted assigns[135](index=135&type=chunk) - Neither party may assign rights or obligations without prior written consent, except the Agent may assign to an affiliate without consent[135](index=135&type=chunk) [Adjustments for Stock Splits](index=32&type=section&id=7.5%20Adjustments%20for%20Stock%20Splits) All share-related numbers in this Agreement will be adjusted for stock splits, stock dividends, or similar events affecting Placement Shares - All share-related numbers in the Agreement will be adjusted for any stock split, stock dividend, or similar event affecting Placement Shares[136](index=136&type=chunk) [Entire Agreement; Amendment; Severability](index=33&type=section&id=7.6%20Entire%20Agreement%3B%20Amendment%3B%20Severability) This Agreement constitutes the entire understanding, amendable only in writing, with invalid provisions construed to reflect original intent - This Agreement constitutes the entire agreement, superseding all prior understandings[138](index=138&type=chunk) - Amendments require a written instrument executed by both the Company and the Agent[138](index=138&type=chunk) - If any provision is held invalid, illegal, or unenforceable, it will be given full effect to the extent valid, and remaining provisions will be construed to reflect the parties' intent[138](index=138&type=chunk) [Governing Law and Time; Waiver of Jury Trial](index=33&type=section&id=7.7%20Governing%20Law%20and%20Time%3B%20Waiver%20of%20Jury%20Trial) This Agreement is governed by New York law, with specified times referring to New York City, and the Company waives its right to a jury trial - The Agreement is governed by and construed in accordance with the laws of the State of New York[139](index=139&type=chunk) - Specified times refer to New York City time[139](index=139&type=chunk) - The Company irrevocably waives its right to a jury trial in any legal proceeding related to this Agreement[139](index=139&type=chunk) [Consent to Jurisdiction](index=33&type=section&id=7.8%20Consent%20to%20Jurisdiction) Each party submits to New York court jurisdiction for disputes, waiving inconvenient forum claims and consenting to service by mail - Each party irrevocably submits to the non-exclusive jurisdiction of New York State and Federal courts in Manhattan for disputes[140](index=140&type=chunk) - Each party irrevocably waives claims of inconvenient forum or improper venue[140](index=140&type=chunk) - Each party irrevocably waives personal service of process and consents to service by certified or registered mail[140](index=140&type=chunk) [Appointment of Agent for Service](index=34&type=section&id=7.9%20Appointment%20of%20Agent%20for%20Service) The Company irrevocably appoints Puglisi & Associates as its agent for service of process, waiving other jurisdictional objections - The Company irrevocably appoints Puglisi & Associates as its agent for service of process[142](index=142&type=chunk) - The Company waives other objections to personal jurisdiction and agrees to maintain the agent's appointment[142](index=142&type=chunk) [Use of Information](index=34&type=section&id=7.10%20Use%20of%20Information) The Agent is prohibited from using information gained from this Agreement to advise on unapproved transactions - The Agent may not use information gained from this Agreement or due diligence to advise parties on transactions not expressly approved by the Company[143](index=143&type=chunk) [Counterparts; Effect of Headings](index=34&type=section&id=7.11%20Counterparts%3B%20Effect%20of%20Headings) The Agreement may be executed in multiple counterparts, with headings for convenience only, and facsimile delivery is permitted - The Agreement may be executed in multiple counterparts, each deemed an original, forming one instrument[144](index=144&type=chunk) - Delivery of an executed Agreement can be made by facsimile transmission[144](index=144&type=chunk) - Section and Ex

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].