Document And Entity Information
Document And Entity Information | 12 Months Ended |
Dec. 31, 2022 shares | |
Document Information Line Items | |
Entity Registrant Name | ICECURE MEDICAL LTD. |
Trading Symbol | ICCM |
Document Type | 20-F |
Current Fiscal Year End Date | --12-31 |
Entity Common Stock, Shares Outstanding | 45,623,434 |
Amendment Flag | false |
Entity Central Index Key | 0001584371 |
Entity Current Reporting Status | Yes |
Entity Voluntary Filers | No |
Entity Filer Category | Non-accelerated Filer |
Entity Well-known Seasoned Issuer | No |
Document Period End Date | Dec. 31, 2022 |
Document Fiscal Year Focus | 2022 |
Document Fiscal Period Focus | FY |
Entity Emerging Growth Company | true |
Entity Shell Company | false |
Entity Ex Transition Period | false |
ICFR Auditor Attestation Flag | false |
Document Registration Statement | false |
Document Annual Report | true |
Document Transition Report | false |
Document Shell Company Report | false |
Entity File Number | 001-40753 |
Entity Incorporation, State or Country Code | L3 |
Entity Address, Address Line One | 7 Ha’Eshel St |
Entity Address, Address Line Two | PO Box 3163 |
Entity Address, City or Town | Caesarea |
Entity Address, Postal Zip Code | 3079504 |
Entity Address, Country | IL |
Contact Personnel Name | Eyal Shamir |
Title of 12(b) Security | Ordinary Shares, no par value |
Security Exchange Name | NASDAQ |
Entity Interactive Data Current | Yes |
Document Accounting Standard | U.S. GAAP |
Auditor Firm ID | 1197 |
Auditor Name | Brightman Almagor Zohar & Co. |
Auditor Location | Tel Aviv, Israel |
Business Contact | |
Document Information Line Items | |
Entity Address, Address Line One | 7 Ha’Eshel St |
Entity Address, Address Line Two | PO Box 3163 |
Entity Address, City or Town | Caesarea |
Entity Address, Postal Zip Code | 3079504 |
Entity Address, Country | IL |
Contact Personnel Name | Eyal Shamir |
City Area Code | +972 |
Local Phone Number | 4.6230333 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 23,659 | $ 25,621 |
Restricted deposit | 296 | |
Trade accounts receivable | 78 | 456 |
Inventory | 2,857 | 1,955 |
Prepaid expenses and other receivables | 1,240 | 2,290 |
Total current assets | 28,130 | 30,322 |
NON-CURRENT ASSETS | ||
Right of use assets | 668 | 913 |
Property and equipment, net | 1,356 | 713 |
Prepaid expenses and other long-term assets | 34 | 333 |
Total non-current assets | 2,058 | 1,959 |
TOTAL ASSETS | 30,188 | 32,281 |
CURRENT LIABILITIES | ||
Trade accounts payable | 714 | 881 |
Lease liabilities | 167 | 224 |
Other current liabilities | 3,455 | 2,915 |
Total current liabilities | 4,336 | 4,020 |
NON-CURRENT LIABILITIES | ||
Long term lease liabilities | 430 | 685 |
Other long-term liabilities | 618 | |
Total non-current liabilities | 430 | 1,303 |
Commitments and contingencies | ||
SHAREHOLDERS’ EQUITY | ||
Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued and outstanding: 45,623,434 shares and 35,780,335 shares as of December 31, 2022 and December 31, 2021, respectively | ||
Pre-funded warrants to ordinary shares, Issued and outstanding: zero Pre-funded warrants and 1,034,000 Pre-funded warrants as of December 31, 2022 and December 31, 2021, respectively | ||
Additional paid-in capital | 100,831 | 85,389 |
Accumulated deficit | (75,409) | (58,431) |
Total shareholders’ equity | 25,422 | 26,958 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 30,188 | $ 32,281 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Ordinary shares, shares authorized | 2,500,000,000 | 2,500,000,000 |
Ordinary shares, shares issued | 45,623,434 | 35,780,335 |
Ordinary shares, shares outstanding | 45,623,434 | 35,780,335 |
Pre-funded warrants to ordinary shares, issued | 0 | 1,034,000 |
Pre-funded warrants to ordinary shares, outstanding | 0 | 1,034,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | |||
Revenues | $ 3,085 | $ 4,138 | $ 3,868 |
Cost of revenues | 1,640 | 1,943 | 1,424 |
Gross profit | 1,445 | 2,195 | 2,444 |
Research and development expenses | 9,123 | 5,877 | 3,809 |
Sales and marketing expenses | 3,204 | 1,917 | 1,063 |
General and administrative expenses | 5,857 | 4,125 | 1,714 |
Operating loss | 16,739 | 9,724 | 4,142 |
Financial expenses (income), net | 239 | 171 | (412) |
Net loss and comprehensive loss | $ 16,978 | $ 9,895 | $ 3,730 |
Basic and diluted net loss per share (in Dollars per share) | $ 0.46 | $ 0.35 | $ 0.22 |
Weighted average number of shares outstanding used in computing basic and diluted net loss per share (in Shares) | 37,016,631 | 28,548,676 | 17,128,903 |
Consolidated Statements of Co_2
Consolidated Statements of Comprehensive Loss (Parentheticals) - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | |||
Basic and diluted net loss per share | $ 0.46 | $ 0.35 | $ 0.22 |
Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 37,016,631 | 28,548,676 | 17,128,903 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Shareholders’ Equity - USD ($) $ in Thousands | Ordinary shares | Treasury shares | Pre-funded warrants | Additional paid- in capital | Accumulated deficit | Total | |
Balance at Dec. 31, 2019 | $ 3,318 | $ (41) | $ 44,820 | $ (44,806) | $ 3,291 | ||
Balance (in Shares) at Dec. 31, 2019 | 15,029,470 | (5,434) | |||||
Issuance of ordinary shares, net | [1] | $ 1,203 | 4,644 | 5,847 | |||
Issuance of ordinary shares, net (in Shares) | [1] | 5,175,000 | |||||
Options exercised | $ 3 | 8 | 11 | ||||
Options exercised (in Shares) | 13,750 | ||||||
Share-based compensation related to options granted | 229 | 229 | |||||
Cancelation of par value | (4,524) | 4,524 | |||||
Loss for the year | (3,730) | (3,730) | |||||
Balance at Dec. 31, 2020 | $ (41) | 54,225 | (48,536) | 5,648 | |||
Balance (in Shares) at Dec. 31, 2020 | 20,218,220 | (5,434) | |||||
Issuance of ordinary shares, net | [2] | 14,586 | 14,586 | ||||
Issuance of ordinary shares, net (in Shares) | [2] | 11,485,697 | |||||
Issuance of ordinary shares public offering net | [3] | 12,400 | 12,400 | ||||
Issuance of ordinary shares public offering net (in Shares) | [3] | 3,892,152 | |||||
Issuance of pre- funded warrants | 3,566 | 3,566 | |||||
Issuance of pre- funded warrants (in Shares) | 1,034,000 | ||||||
Cancelation of treasury shares | $ 41 | (41) | |||||
Cancelation of treasury shares (in Shares) | (5,434) | 5,434 | |||||
Options exercised | 337 | 337 | |||||
Options exercised (in Shares) | 189,700 | ||||||
Share-based compensation related to options granted | 316 | 316 | |||||
Loss for the year | (9,895) | (9,895) | |||||
Balance at Dec. 31, 2021 | 85,389 | (58,431) | 26,958 | ||||
Balance (in Shares) at Dec. 31, 2021 | 35,780,335 | 1,034,000 | |||||
Issuance of ordinary shares, net | [4] | 6 | 6 | ||||
Issuance of ordinary shares, net (in Shares) | [4] | 21,000 | |||||
Issuance of ordinary shares public offering net | [5] | 13,569 | 13,569 | ||||
Issuance of ordinary shares public offering net (in Shares) | [5] | 8,787,880 | |||||
Pre- funded warrants exercised | 1 | 1 | |||||
Pre- funded warrants exercised (in Shares) | 1,034,000 | (1,034,000) | |||||
Options exercised | 1 | 1 | |||||
Options exercised (in Shares) | 219 | ||||||
Share-based compensation related to options granted | 1,865 | 1,865 | |||||
Loss for the year | (16,978) | (16,978) | |||||
Balance at Dec. 31, 2022 | $ 100,831 | $ (75,409) | $ 25,422 | ||||
Balance (in Shares) at Dec. 31, 2022 | 45,623,434 | ||||||
[1]Net of issuance cost of approximately $219[2]Net of issuance cost of approximately $414[3]Net of issuance cost of approximately $1,028[4]Net of issuance cost of approximately $6[5]Net of issuance cost of approximately $931 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | |||
Net loss | $ (16,978) | $ (9,895) | $ (3,730) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 248 | 127 | 63 |
Share-based compensation | 1,865 | 316 | 229 |
Exchange rate changes in cash and cash equivalents and deposit | 359 | 5 | (452) |
Changes in assets and liabilities: | |||
Decrease (increase) in trade accounts receivable | 378 | (362) | (77) |
Increase in inventory | (902) | (891) | (386) |
Decrease (increase) in prepaid expenses and other receivables | 1,050 | (2,030) | 121 |
Decrease in prepaid expenses and other long- term assets | 17 | ||
Decrease (increase) in right of use assets | 245 | (607) | (81) |
Increase (decrease) in trade accounts payable | (167) | 236 | 217 |
Increase (decrease) in lease liabilities | (312) | 577 | 92 |
Increase (decrease) in other current liabilities | 540 | 60 | (135) |
Increase (decrease) in other long-term liabilities | (618) | (141) | 432 |
Net cash used in operating activities | (14,292) | (12,605) | (3,690) |
Cash flows from investing activities: | |||
Realization of (Investment in) deposits | 4,621 | (4,432) | |
Investment of restricted deposits | (296) | (15) | |
Purchase of property and equipment | (891) | (533) | (223) |
Net cash provided by (used in) investing activities | (891) | 3,792 | (4,670) |
Cash flows from financing activities: | |||
Issuance of ordinary shares, net of issuance costs | 13,569 | 14,586 | 5,847 |
Issuance of restricted ordinary shares | 6 | ||
Issuance of ordinary shares and pre- funded warrants, net of issuance costs | 15,966 | ||
Exercise of pre- funded warrants | 1 | ||
Exercise of options to ordinary shares | 1 | 337 | 11 |
Net cash provided by financing activities | 13,577 | 30,889 | 5,858 |
Increase (decrease) in cash and cash equivalents | (1,606) | 22,076 | (2,502) |
Cash and cash equivalents beginning of the year | 25,621 | 3,502 | 5,789 |
Effect of foreign exchange rate on cash and cash equivalents | (356) | 43 | 215 |
Cash and cash equivalents end of the year | $ 23,659 | $ 25,621 | $ 3,502 |
General
General | 12 Months Ended |
Dec. 31, 2022 | |
General Abstract | |
GENERAL | NOTE 1 - GENERAL A. Description of the Company: IceCure Medical Ltd. (“IceCure Medical Ltd.”, the “Company”, “we” or “our”) is a medical device Company incorporated in Israel. The Company’s ordinary shares are listed on the NASDAQ and Tel Aviv Stock Exchange. Since its establishment, IceCure Medical Ltd., and its wholly-owned subsidiaries, IceCure Medical Inc. in the United States (the “US Subsidiary”), IceCure Medical HK Limited in Hong Kong (the “Hong Kong Subsidiary”) and IceCure (Shanghai) MedTech Co., Ltd. in China (the “Chinese Subsidiary”, and together with the Company, US Subsidiary and Hong Kong Subsidiary, the “Group”), have been engaged in the research, development and commercialization of minimally invasive medical devices for cryoablation (freezing) of tumors in the human body, using its propriety liquid nitrogen Cryoablation technology, as an alternative to surgical intervention to remove the tumor. The Company received regulatory approvals for marketing its products in the United States, Europe and other territories. The US Subsidiary was established on April 6, 2011 in the State of Delaware and is engaged in business development, marketing, clinical trial management and sale of the Company’s products in the United States. The Hong Kong Subsidiary was established on September 26, 2018 and commenced its activity in 2021. The Chinese Subsidiary was established on July 14, 2020 and is wholly owned by the Hong Kong Subsidiary. The Chinese Subsidiary in China commenced its operation on January 1, 2021 and is engaged in business development, obtaining regulatory approvals and marketing activities for the Company’s products. The Group’s activities are subject to significant risks and uncertainties, including failing to secure additional funding to commercialize its technology, obtaining regulatory approvals, developing its next generation systems and other risks. In addition, the Group is subject to risks from, among other things, competition associated with the industry in general, other risks associated with financing, liquidity requirements, rapidly changing customer requirements and limited operating history. B. Risk factors: Our ability to operate successfully is materially uncertain and our operations are subject to significant risks inherent in a developing business enterprise. Additional funding will be required to complete the Company’s research and development and clinical trials, to attain regulatory approvals, to continue our commercialization efforts and to achieve a level of sales adequate to support the Company’s cost structure. We will need to raise additional funds to meet our anticipated expenses so that we can execute our business plan. We expect to incur substantial and increasing net losses for the foreseeable future as we increase our spending to execute our development programs. The amount of financing required will depend on many factors including our research and development costs, our clinical trials, our commercialization efforts, and other working capital requirements. Our ability to access the capital markets, or to secure partnerships is mainly dependent on the progress of our research and development, our clinical trials, regulatory approval of our products and our success in commercialization of our products. C. Going Concern: As of December 31, 2022, the Company has accumulated losses which amounted to $75,409. In the year ended December 31, 2022, the Company generated losses which amounted to $16,978 and negative cash flows from operating activities of $14,292. To date, management expects the Company to continue to generate substantial operating losses and to continue to fund its operations primarily through utilization of its current financial resources, sales of its products, and through additional raises of capital. As of March 29, 2023, the Company’s cash, cash equivalents and short-term deposits were $20,216 thousand. Management expects that its cash, cash equivalents and short-term deposits as of the issuance date of the financial statements will be sufficient for at least 12 months of operations. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). A. Use of estimates: The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Management believes that the estimates, judgments and assumptions used are reasonable based upon information available at the time they are made. Actual results could differ from those estimates. B. Financial statements in U.S. dollars and functional currency: The functional currency of the Company and its subsidiaries is the U.S dollar (“USD” or “dollar” or “$”) since the dollar is the currency of the primary economic environment in which the Company has operated and expects to continue to operate in the foreseeable future. Most of the Company’s revenues are derived from sales outside of Israel, which are based primarily on dollar. In addition, the majority of the Company’s equity raising is denominated in dollars. Thus, the functional currency of the Company and certain subsidiaries is the dollar. Transactions and balances denominated in dollars are presented at their original amounts. Transactions and balances denominated in foreign currencies have been re-measured to dollars in accordance with the provisions of Accounting Standards Codification (“ASC”) 830-10, “Foreign Currency Translation”. All transaction gains and losses from re-measurement of monetary balance sheet items denominated in non-dollar currencies are reflected in the statements of comprehensive loss as financial income or expenses, as appropriate. C. Principles of consolidation: The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation. Profits from intercompany sales, not yet realized outside the Group, were also eliminated. D. Cash and cash equivalents: Cash equivalents are short-term highly liquid investments that are readily convertible into cash with original maturities of three months or less. E. Trade Accounts Receivable: Accounts receivable are recorded at the invoiced amount, are unsecured and do not bear interest. Accounts receivable are stated at their net realizable value, net of allowances. The allowance for doubtful accounts is based on the Company’s periodic assessment of the collectability of the accounts based on a combination of factors including the payment terms of each account, its age, the collection history of each customer, and the customer’s financial condition. No doubtful accounts expense was recorded for the years ended December 31, 2022, 2021 and 2020. F. Inventories: Inventories are valued using the lower of cost and net realizable value, and include raw materials, work in progress and finished goods. The cost of inventories is determined as follows: Cost of raw materials is determined on a standard cost basis utilizing the weighted average cost of historical purchases, which approximates actual cost. Cost of work in progress (“WIP”) and finished goods are based on the standard cost method and determined on the cost of raw materials and subcontracted work, and the applicable share of the cost of labor on the weighted average cost basis which approximates actual cost. The Company regularly evaluates the value of inventory based on a combination of factors including the following: historical usage rates, product end of life dates, technological obsolescence and product introductions. G. Property and equipment: Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets. The annual depreciation rates are as follows: % Consoles and equipment 15 - 20 Computers and software 33 Office furniture and equipment 7 - 15 Leasehold improvements Over the shorter of the related lease period or the useful lives of the asset The Company periodically performs impairment testing on its long-lived assets either annually or whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. H. Leases: We determine if an arrangement is a lease at inception. Operating lease assets are presented as operating lease right of use (“ROU”) assets, and corresponding operating lease liabilities are presented as lease liabilities within current liabilities (current portions), and as long-term lease liabilities within non - current liabilities (long-term portions), on our consolidated balance sheets. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the remaining lease payments over the lease term at commencement date. The rate implicit in our leases are not reasonably determinable and, we use our incremental borrowing rate. We calculate the incremental borrowing rate to reflect the interest rate that we would have to pay to borrow on a collateralized basis an amount equal to the lease payments in a similar economic environment over a similar term, and consider our historical borrowing activities and market data in this determination. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. Our lease terms may include options to extend the lease when it is reasonably certain that we will exercise that option. Lease expense is recognized on a straight-line basis over the lease term. Some of our leases contain variable lease payments, which are expensed as incurred unless those payments are based on an index or rate. Variable lease payments based on an index or rate are initially measured using the index or rate in effect at lease commencement and included in the measurement of the lease liability; thereafter, changes to lease payments due to rate or index updates are recorded as rent expense in the period incurred. Our lease agreements do not contain any material residual value guarantees or material restrictive covenants. In addition, we do not have any related party leases. I. Contingencies: The Company accounts for its contingent liabilities in accordance with ASC Topic 450, Contingencies (“ASC 450”). A provision is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter. J. Revenue recognition: Revenue is measured as the amount of consideration the Company expects to be entitled to, in exchange for transferring products or providing services to its customers and is recognized when or as performance obligations under the terms of contracts with the Company’s customers are satisfied. ASC 606 prescribes a five-step model for recognizing revenue from contracts with customers: (i) identify contract(s) with the customer; (ii) identify the separate performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the separate performance obligations in the contract; and (v) recognize revenue when (or as) each performance obligation is satisfied. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services. The Company then allocates the transaction price (the amount of consideration the Company expects to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognizes the associated revenue when (or as) each performance obligation is satisfied. Revenues from product sales are recognized upon the transfer of control, which is generally upon shipment or delivery. Provisions for discounts, rebates and sales incentives to customers, returns and other adjustments are provided for in the period the related sales are recorded. Sales incentives to customers are not material. Deferred revenue represents amounts received by the Company for which the related revenues have not been recognized because one or more of the revenue recognition criteria have not been met. The current portion of deferred revenue represents the amount to be recognized within one year from the balance sheet date based on the estimated performance period of the underlying performance obligation. The noncurrent portion of deferred revenue represents amounts to be recognized after one year through the end of the performance period of the performance obligation. As of December 31, 2022, and 2021, the Company’s deferred revenue balance is $646 and $1,502 (out of which $646 and $884 are presented as current), respectively. For further analysis of the Company’s main revenue contract, see Note 10 below. K. Share-based compensation: The Company applies ASC 718, “Share-Based Payment,” which requires the measurement and recognition of compensation expense for all share-based payment awards, including stock options, made to employees and directors under the Company’s stock plans based on estimated fair values. ASC 718-10 requires companies to estimate the fair value of share-based payment awards on the date of grant. The portion of the share value of the award that is ultimately expected to vest is recognized as share-based compensation expense over the requisite service periods in the Company’s consolidated statements of comprehensive loss. The Company estimates the fair value of stock options granted using a Black-Scholes option-pricing model. The Black-Scholes option-pricing model requires a number of assumptions, the most significant of which are the expected stock-price volatility and the expected option term (the time from the grant date until the options are exercised or expire). The Company’s calculations of the expected volatility were based upon actual historical stock-price movements over the period, which was equal to the expected option term. The expected option term was calculated for options granted to employees and directors in accordance with ASC 718-10-S99, using the “simplified” method, and grants to non-employees were based on the contractual term. Historically, the Company has not paid dividends, and has no foreseeable plans to do so. The risk-free interest rate is based on the yield from Israel Treasury zero-coupon bonds with an equivalent term. Changes in the determination of each of the inputs can affect the fair value of the options granted and the results of operations of the Company. L. Research and development costs: Research and development costs are charged to the consolidated statements of comprehensive loss as incurred. Grants for funding approved research and development projects are recognized at the time the Company is entitled to such grants, on the basis of the costs incurred and applied as a deduction from the research and development expenses. M. Severance pay: Under Israeli employment laws, all of the Company’s employees in Israel are included under Section 14 of the Severance Compensation Act, 1963 (“Section 14”). Pursuant to Section 14, these employees are entitled to monthly deposits at a rate of 8.33% of their monthly salary, made on their behalf by the Company. Payments in accordance with Section 14 exempt the Company from any future severance pay liabilities in respect of those employees. The aforementioned deposits are not recorded as an asset in the Company’s consolidated balance sheets. N. Income taxes: The Company accounts for income taxes utilizing the asset and liability method in accordance with ASC 740, “Income Taxes.” Current tax liabilities are recognized for the estimated taxes payable on tax returns for the current year. Deferred tax liabilities or assets are recognized for the estimated future tax effects attributable to temporary differences between the income-tax bases of assets and liabilities and their reported amounts in the consolidated financial statements and for tax loss carry forwards and are measured using the enacted tax rates and laws, that will be in effect when the differences are expected to reverse. Measurement of current and deferred tax liabilities and assets is based on provisions of enacted tax laws, and deferred tax assets are reduced, if necessary, by the amount of tax benefits, the realization of which is not considered more likely than not based on available evidence. As of December 31, 2022, the Company had a full valuation allowance against deferred tax assets. ASC 740-10 requires a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate settlement. The Company has not recorded any liability for uncertain tax positions for the year ended December 31, 2022. O. Fair value of financial instruments: The Company applies ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”), pursuant to which fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value: ● Level 1 – Quoted prices in active markets for identical assets or liabilities. ● Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and ● Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The carrying values of cash and cash equivalents, trade accounts receivable, prepaid expenses and other receivables, other long-term assets, trade accounts payable, other current liabilities and other long-term liabilities approximate their fair value due to the short-term maturity of these instruments. P. Concentrations of credit risk: Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, deposit and trade accounts receivables. The majority of the Company’s cash and cash equivalents and deposit are in USD in a major bank in Israel. The management believes that the financial institutions that hold the Company’s investments are corporations with high credit standing. Accordingly, management believes that low credit risk exists with respect to these financial investments. The trade accounts receivables of the Company are derived from sales to customers located primarily in the Americas, APAC, and Europe. The Company performs ongoing credit evaluations of its customers’ financial condition. Under certain circumstances, the Company may require advance payments. Q. Segment Reporting: The chief operating decision maker (the “CODM”) of the Company is the Chief Executive Officer. The CODM reviews financial information presented on a consolidated basis for purposes of allocating resources and evaluating financial performance. Accordingly, management has determined that the Company operates in one reportable segment. R. Basic and diluted net loss per share: Basic net loss per share is computed based on the weighted-average number of ordinary shares outstanding during each year. Diluted net loss per share is computed based on the weighted-average number of ordinary shares outstanding during each year, plus the dilutive potential of the ordinary shares considered outstanding during the year, in accordance with ASC 260 - S. Comprehensive loss: The purpose of reporting comprehensive income (loss) is to report a measure of all changes in equity of an entity that result from recognized transactions and other economic events of the period resulting from transactions from non-owner sources. T. Recently issued accounting pronouncements: From time to time, new accounting pronouncements are issued by FASB, or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. (1) In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which replaces the existing incurred loss impairment model with an expected credit loss model and requires a financial asset measured at amortized cost to be presented at the net amount expected to be collected. The guidance became effective for the Company beginning January 1, 2023, and interim periods therein. Early adoption is permitted. The Company is currently evaluating the effect that ASU 2016-13 will have on its consolidated financial statements. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
INVENTORY | NOTE 3 - INVENTORY Composition: As of As of December 31, December 31, 2022 2021 Raw materials 1,566 704 Work in progress 356 457 Finished goods 935 794 2,857 1,955 |
Prepaid Expenses and Other Rece
Prepaid Expenses and Other Receivables | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expenses and Other Receivables [Abstract] | |
PREPAID EXPENSES AND OTHER RECEIVABLES | NOTE 4 - PREPAID EXPENSES AND OTHER RECEIVABLES Composition: As of As of December 31, December 31, 2022 2021 Tax authorities 124 128 Insurances 527 1,700 Prepaid expenses 80 95 Advances to payables 345 180 Other 164 187 1,240 2,290 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
LEASES | NOTE 5 - LEASES On January 1, 2020, the Company expanded its leases from 494 square meters to approximately 581 square meters at its location in Caesarea, Israel, and extended its operating lease agreement for another 12 months until July 14, 2022, with additional option to extend until July 14, 2025. On August 10, 2021, the Company expanded its leases from 581 square meters to approximately 813 square meters at its location in Caesarea, Israel, and extended its operating lease agreement for another 12 months until July 31, 2023, with additional option to extend until July 31, 2026. To secure the lease payments, the Company provided a bank guarantee of $20. In addition, the Company leases vehicles under various operating lease agreements. As of December 31, 2022, and 2021, total ROU assets totaled to approximately $668 and $913 and the lease liabilities for operating leases totaled to approximately $597 and $909, respectively. Supplemental cash flow information related to operating leases was as follows: Year ended Year ended Year ended Cash payments for operating leases 242 247 185 The maturities of operating leases liabilities and the reconciliation of undiscounted cash flows of operating lease to operating lease liabilities as of December 31, 2022 was as follows: 2023 214 2024 196 2025 182 2026 105 2027 - Undiscounted cash flows of operating leases 697 Less: amount representing interest (100 ) Operating lease liabilities 597 The weighted average lease term and weighted average discount rate as of December 31, 2022, was as follows: Operating leases weighted average remaining lease term (in years) 2.26 Operating leases weighted average discount rate 7.99 % |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | NOTE 6 - PROPERTY AND EQUIPMENT, NET Composition: As of As of December 31, December 31, 2022 2021 Cost Consoles and equipment 1,524 567 Computers and software 404 211 Office furniture and equipment 127 100 Leasehold improvements 207 133 2,262 1,011 Less - accumulated depreciation Consoles and equipment 443 119 Computers and software 323 114 Office furniture and equipment 48 37 Leasehold improvements 92 28 906 298 Property and Equipment, Net 1,356 713 Depreciation and amortization expenses for the years ended December 31, 2022, 2021 and 2020 were $248,$127 and $63 respectively. |
Other Current Liabilities
Other Current Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Other Liabilities and Financial Instruments Subject to Mandatory Redemption [Abstract] | |
OTHER CURRENT LIABILITIES | NOTE 7 - OTHER CURRENT LIABILITIES Composition: As of As of December 31, December 31, 2022 2021 Deferred revenues 646 884 Provision for royalties to IIA 47 62 Payroll and social benefits 1,580 991 Vacation and recuperation provision 554 410 Accrued expenses and others 628 568 3,455 2,915 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 8 - COMMITMENTS AND CONTINGENCIES A. Israeli Innovation Authority (the “IIA”): The Company undertook to pay royalties to the IIA in respect of grants it received from the IIA for the years 2006 through 2014 for participation in research and development costs. According to the terms of the grants, the IIA was entitled to receive royalties at the rate of 3.5% of the revenue, up to the amount of the grants received, including accumulated interest. As of the second half of 2017, new provisions to the grant agreements have entered into force, which stipulate that small companies (up to an annual turnover of $70,000) will pay royalties at the rate of 3%. The liability to the IIA shown in Note 8 is calculated based on the Company’s revenue from products developed with grants from the IIA. As of December 31, 2022, based on the second median of 2022 revenue, the Company recorded a liability for royalties in an amount of $47. As of December 31, 2022, the Company has no open application for grants to the IIA. Total grants received by the Company, including accumulated interest, amount to approximately $2,575 ($2,076 net of royalties paid). The grants are linked to the exchange rate of the dollar and bears interest of LIBOR per annum. B. Liens: The Company pledged a deposit in the amount of NIS 70 (approximately $20) to secure a bank guarantee issued in connection with a lease agreement. In addition, the Company pledged a deposit in the amount of $15 to secure a bank guarantee issued in connection with a credit card issued. The deposits are presented in the consolidated balance sheets as a non-current asset under “Prepaid expenses and other long-term assets”. The Company pledged a deposit in the amount of $296 to secure a bank guarantee issued in favor of a customer agreement. The deposits are presented in the consolidated balance sheets as a non-current asset under “Prepaid expenses and other long-term assets”. C. Class Action: (1) On July 5, 2021, the Company was informed that a motion (the “motion”) to certify a claim as a Class Action was filed against it and the members of the Board of Directors, the controlling shareholder and the investors who took part in the private placement that was approved by the general meeting on March 7, 2021 (the “investors”). The Motion to Certify was filed with the Tel Aviv District court by a shareholder of the Company, (the “Plaintiff”). In the motion, the plaintiff claims, inter alia, that the Company made a private placement of securities to the controlling shareholder and the investors at a significant discount on the share price at that time, which did not reflect the material information that was allegedly in the Company’s possession and which was also brought to the attention of the investors. The motion also alleged defects in the manner of approving the private placement at the meeting of the Company’s shareholders. The plaintiff estimated the amount of his individual claim at a sum of approximately NIS 30,000 (USD 9,191), the amount of the class action, insofar as it will be qualified as such, at a sum of approximately NIS 163,459 (USD 50,079) for the class damages that the plaintiff claims had their shares diluted unlawfully, and at a sum of approximately NIS 234,349 (USD 71,798), for damage that was supposedly caused to the shareholders due to a sale at less than the allegedly full market price. On October 2, 2022, the Company and the other respondents filed their response to the motion (the “Company’s Response”). In the Company’s Response, the Company and its directors denied the arguments asserted in the motion and stated that the motion cannot be maintained as a motion for class certification because the events that actually occurred (as opposed to the theories that were made up by the Plaintiff) do not establish grounds for such a motion. The Company’s Response further asserted that the motion was filed in bad faith. Moreover, the Company and its Directors stated that they acted in good faith, taking into account the interests of the Company, and observed its obligations set out by law – both with respect to the private placement transaction that the Company made with the investors, and in all information that was presented to the public during the argued period that was lawfully published and reported in compliance with its duty of disclosure. The Company’s Response was supported by two expert opinions, including: (1) an expert opinion regarding FDA issues (the “FDA Expert Opinion”) and (2) an expert opinion (regarding economic issues), as well as by affidavits from the CEO of the Company and a member of the Board of Directors, the Company’s Vice President, Regulatory, Quality Assurance and Clinical Applications, and a regulatory consultant of the Company. On December 15, 2022, the Plaintiff asked the court to order the Company to disclose any Company materials provided by the Company to the FDA expert in connection with his preparation of the FDA Expert Opinion (“Motion to Disclose”). On January 24, 2023, the Company filed a response in which it refuted and objected to the Motion to Disclose. The court ordered the parties to reach an understanding regarding the procedure of the disclosure of said materials. After a review of the motion and its responses, the Company believes that the motion is without merit and that the factual description and the data underlying the motion are incorrect and/or imprecise. (2) On July 29, 2021, the Company was informed that a motion to certify a claim as a Class Action was filed against it claiming that the Company’s reports filed on the Tel Aviv Stock Exchange (the “TASE”) electronic filing site, the MAYA, and on the ISA electronic filing site, the MAGNA, were not in compliance with applicable accessibility guidelines, and, therefore, the Company prevents or reduces the access of people with disabilities to such reports. The claim is in the amount of NIS 5,000 (USD 1,541). As far as the Company is aware, this motion was filed against many companies that trade on the TASE. (the ‘motion’). Since the plaintiff filed many duplicative motions against numerous respondents (the ‘motions’), the respondents (following a court decision dated March 6, 2022) filed a joint response on July 20, 2022, on the common issues of motions raised. Following a hearing that took place on February 16, 2023, the plaintiff filed, on March 2, 2023, a notice to the court agreeing to a dismissal of the motion with prejudice and without costs. On March 5, 2023, the court dismissed the motions with prejudice and without costs. |
Shareholders_ Equity
Shareholders’ Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
SHAREHOLDERS’ EQUITY | NOTE 9 - SHAREHOLDERS’ EQUITY A. Ordinary shares: (1) The ordinary shares confer upon the holders the right to receive notice to participate and vote in general meetings of shareholders of the Company, the right to receive dividends, if declared, and the right to participate in the distribution of the surplus assets of the Company in an event of liquidation. (2) Public and private placements: On August 5, 2020, the Company raised $6,067 (gross) through a public offering of 5,175,000 ordinary shares at $1.168 per share. After deducting closing costs and fees, the Company received proceeds of approximately $5,847. On January 27, 2021, the Company entered, subject to the approval of the general meeting of shareholders, into a series of share purchase agreement with its controlling shareholder, Epoch Partner Investments Limited, for a total of $7,500, Alpha Capital Anstalt, for a total of $4,000, Clover Wolf Capital Limited Partnership for a total of $3,100 and Clover Alpha L.P for a total of $400. According to the agreements, the investors will invest in two tranches a total of $15,000, and in return the Company will issue to the investors a total of 11,485,697 ordinary shares at a share price of $1.304, reflecting a 20% discount on the average closing price of the Company’s share in the seven trading days preceding the date of the transaction’s approval by the Board. The first tranche of $9,000 (60% of the total investment) was received following the approval of the Company’s shareholders at a general meeting of the shareholders, on March 7, 2021 (“the first Closing Date”), and the Company issued 6,891,418 shares. The second tranche of $6,000 was due following the approval of the listing of the Company’s securities on Nasdaq (the “Second Closing Milestone” and such date, “the Second Closing Date”). In May 2021, the Company and the investors agreed to execute the second tranche prior to the achievement of the Second Closing Milestone, and the second tranche of $6,000 was received on May 9, 2021. Accordingly, the Company issued to the investors 4,594,279 shares. On December 13, 2021, the Company raised $16,994 (gross) through a public offering of 3,892,152 ordinary shares inclusive of 578,325 shares offered pursuant to the underwriters’ over-allotment option, at a price to the public of $3.45 per share, gross, and to certain investors in lieu of ordinary shares, pre-funded warrants to purchase up to an aggregate of 1,034,000 ordinary shares at a price of $3.449 per pre-funded warrant. The exercise price for each such pre-funded warrant to ordinary share is $0.001. After deducting closing costs underwriting discounts and fees, the Company received proceeds of approximately $15,966. The pre-funded warrants were classified as a component of permanent equity because they met the permanent equity criteria classification. The pre-funded warrants are freestanding financial instruments that are legally detachable and separately exercisable from the ordinary shares with which they were issued, are immediately exercisable and grant the holders the right to receive a fixed number of ordinary shares upon exercise. The pre-funded warrants do not embody an obligation for the Company to repurchase its shares and do not provide any guarantee of value or return. On June 3, 2022, 1,034,000 pre-funded warrants issued as part of our public offering that closed on December 8, 2021, were exercised into 1,034,000 ordinary shares at an exercise price of $0.001 per share. On July 18, 2022, the Company issued 21,000 restricted ordinary shares to a consultant of the Company. The shares shall be restricted from any offer, sale, contract for sale, encumbrance, grant of any options for the sale of or otherwise disposed of for a period of 12 months from July 1, 2022. On December 23, 2022, the Company raised $14,500 (gross) through a public offering of 8,787,880 ordinary shares, at a price to the public of $1.65 per share, gross, in lieu of ordinary shares. After deducting closing costs underwriting discounts and fees, the Company received proceeds of approximately $13,569. (3) On September 13, 2020, the Company’s general meeting of shareholders approved an increase of the Company’s authorized share capital to 2,500,000,000 shares and canceled the shares par value. (4) On August 8, 2021, the Company completed a reverse stock split of its ordinary shares. As a result of the reverse stock split, the following changes occurred (i) every eight shares were combined into one share; (ii) the number of shares underlying each option were proportionately decreased on an 8-for-1 basis, and the exercise price of each such outstanding share option were proportionately increased on a 8-for-1 basis. Accordingly, all option numbers, share numbers, share prices, exercise prices and losses per share were adjusted within these consolidated financial statements, on a retroactive basis, to reflect this 8-for-1 reverse stock split. B. Shares and options for employees: (1) The fair value of options granted was estimated using the Black-Scholes option pricing model, and based on the following assumptions: For the year ended For the year ended For the year ended 2022 2021 2020 Exercise price $1.78 - $3.61 $1.69 - $8.75 $1.56 - $1.77 Expected volatility 91.0% - 91.6% 89.8% - 96.1% 88.77% - 90.84% Risk-free interest 0.92% - 2.43% 0.67% - 1.02% 0.4% - 0.46% Expected life of up to (years) 5.56 – 6.25 6.22 6.2 (2) The following table summarizes the changes in options granted to employees, officers and members of the Company’s Board of Directors (“the Board”) for the years ended December 31, 2022, 2021 and 2020.: Number of Weighted Weighted (in years) Balance as of January 1, 2020 1,272,615 $ 1.52 Granted 370,351 $ 1.60 Expired (35,788 ) $ 1.60 Forfeited 137,667 ) $ 1.68 Exercised (13,750 ) $ 0.88 Balance as of December 31, 2020 1,455,761 $ 1.68 7.69 Granted 108,929 $ 2.02 Expired (13,875 ) $ 2.94 Forfeited (24,635 ) $ 1.85 Exercised (189,700 ) $ 2.06 Balance as of December 31, 2021 1,336,480 $ 1.64 7.03 Granted 1,806,316 $ 3.3 Expired (3,380 ) $ 3.43 Forfeited (63,262 ) $ 2.04 Exercised (219 ) $ 1.64 Balance as of December 31, 2022 3,075,935 $ 2.55 7.8 Exercisable at the end of year 1,059,573 $ 1.48 5.7 As of December 31, 2022, a total of 583,281 outstanding and exercisable options are “in the money” with aggregate intrinsic value of $316. The weighted average fair value of options granted during the year ended December 31, 2022, was $1.82 per share. (3) Options granted during 2022, 2021 and 2020: (a) On June 4, 2020, the Company granted 142,594 options to purchase an aggregate of 142,594 ordinary shares to 27 employees of the Company at an exercise price of $1.68 per share. The options will vest in four equal installments over a period of four years from the date of grant. The options are exercisable for 10 years from the date of grant. (b) On August 30, 2020, the Company granted 170,258 options to purchase an aggregate of 170,258 ordinary shares to six officers of the Company, as follows: 27,333 options for the Company’s CEO, and 142,925 options for five officers of the Company, at an exercise price of $1.52 per share. The CEO’s options will vest in 16 equal quarterly installments over a period of four years from the date of grant. The officer’s options will vest as follows: a quarter after one year and the rest will vest in 12 equal quarterly installments over a period of three years from August 30, 2021. The options are exercisable for 10 years from the date of grant. (c) On October 28, 2020, the Company granted 57,500 options to purchase an aggregate of 57,500 ordinary shares to 2 officers of the Company, as follows: 32,500 options for the Company’s CEO, and 25,000 options for the Chairman of the Board of Directors, at an exercise price of $1.60 per share. The options will vest as follows: a quarter after one year and the rest will vest in 12 equal quarterly installments over a period of three years from October 28, 2021. The options are exercisable for 10 years from the date of grant. (d) In January 2021, the Company granted 100,000 options to purchase an aggregate of 100,000 ordinary shares to a member of the Company’s Board of directors, at an exercise price of $1.60 per share. The options will vest as follows: a. 25,000 options - a quarter after one year and the rest will vest in 12 equal quarterly installments over a period of three years from December 13, 2020. b. 75,000 options- based on target achievement: i. 37,500 options will vest and become exercisable, on the date of receipt by the company of two regulatory approvals in China from the NMPA (National Medical Products Administration) for the marketing and sale of ProSense product and for the sale of probes of the company, and no later than December 31, 2022. On December 31, 2022, the 37,500 options were forfeited since the two regulatory approvals were not received. ii. 37,500 options will vest and become exercisable, with the sale of Consoles and Probes as determined in the options agreement in one calendar year in China, and no later than the end of 2024. The options are exercisable for 10 years from the date of grant. (e) On April 28, 2021, the Company granted 8,929 options to purchase an aggregate of 8,929 ordinary shares to five officers of the Company, as follows: 4,319 options for the Company’s CEO, and 4,610 options for four officers, at an exercise price of $5.76 per share. The options will vest as follows: a quarter after one year and the rest will vest in 12 equal quarterly installments over a period of three years from April 28, 2022. The options are exercisable for 10 years from the date of grant. (f) On January 12, 2022, the Company granted 1,720,660 options to purchase an aggregate of 1,720,660 ordinary shares to 59 optionees of the Company, as follows: 333,992 options to the Company’s CEO, the Chairman of the Board and a member of the board, 443,674 options to five officers of the Company and 942,994 options to 51 employees of the Company, at an exercise price of $3.61 per share. The options granted to the CEO, chairman of the board, board member and the officers will vest as follows: a quarter after one year and the rest will vest in 12 equal quarterly installments over a period of three years from January 12, 2022. The options granted to the 51 employees will vest in four equal installments over a period of four years from the date of grant. The options are exercisable for 10 years from the date of grant. On March 23, 2022, the Company granted 30,434 options to purchase an aggregate of 30,434 ordinary shares to five officers of the Company, as follows: 13,720 options for the Company’s CEO, and 16,714 options for four officers, at an exercise price of $2.73 per share. The options will vest as follows: a quarter after one year and the rest will vest in 12 equal quarterly installments over a period of three years from March 23, 2022. The options are exercisable for 10 years from the date of grant. (g) On July 4, 2022, the Company granted to a consultant of the company 55,222 options to purchase an aggregate of 55,222 ordinary shares, at an exercise price of $1.78 per share. The options will vest as follows: 8 equal quarterly installments over a period of two years from October 4, 2022. The options are exercisable for 10 years from the date of grant. (4) The total share-based compensation the Company recognized for share-based payments is as follows: Year ended Year ended Year ended 2022 2021 2020 Cost of revenues 137 15 16 Sales and marketing 208 15 26 Research and development 785 109 67 General and administrative 735 177 120 1,865 316 229 As of December 31, 2022, the total unrecognized share-based compensation cost, related to non-vested share options grant arrangements under the plan was $1,783. This cost is expected to be recognized over the remaining vesting period of 3.2 years, until the end of March 31, 2026. |
Revenues
Revenues | 12 Months Ended |
Dec. 31, 2022 | |
Revenues [Abstract] | |
REVENUES | NOTE 10 - REVENUES The Company’s revenues are derived primarily from the sale of consoles and disposables. Revenues from warranty and services are not material and therefore are included in revenue from consoles in the following table. Composition: Year ended Year ended Year ended December 31, 2022 2021 2020 Consoles 1,002 1,560 1,817 Disposables 1,336 1,208 1,006 Exclusive distribution agreement 747 1,370 1,045 3,085 4,138 3,868 For maintenance agreements that provide service beyond the Company’s standard warranty and other service agreements, revenue is recognized over the contract term. A time-based measure of progress appropriately reflects the transfer of services to the customer. Payment terms between the Company and its customers vary by the type of customer and the territory of sale. The term between invoicing and the payment due date is not significant. Exclusive distribution agreement in China On June 12 2022, the Chinese Subsidiary signed an exclusive sale and distribution agreement for the Consoles and disposables with Shanghai Medtronic Zhikang Medical Devices Co. Ltd. (“Shanghai Medtronic Zhikang”) and Turing for an initial term of 36 months, with a minimum purchase target of $3.5 million within this term. Pursuant to the Distribution Agreement, the Chinese Subsidiary will sell the Products to Turing, which will import the Products from Israel to mainland China, and resell them to Shanghai Medtronic Zhikang. Shanghai Medtronic Zhikang will be responsible for, among other matters: (i) marketing and promoting the Products within mainland China; and (ii) holding professional medical education events for the Products within mainland China. Turing will be responsible for warehousing, logistics, warranty services, training, and other support and after sale services. Under the terms of the Distribution Agreement, if Shanghai Medtronic Zhikang meets the accumulated three-year Minimum Purchase Target, it will then have the right to extend the term of the Distribution Agreement for three consecutive years subject to an agreement on a new Minimum Purchase Target. The Distribution Agreement may be terminated in certain circumstances, including in the event of default, material breach or insolvency. Furthermore, under the Distribution Agreement’s terms, the Chinese Subsidiary will be responsible for obtaining and maintaining any and all regulatory approvals in mainland China required for marketing, promotion, distribution, sale and use of the Products, issued by mainland China’s NMPA, its local branches or any other government authorities. The Chinese Subsidiary has already obtained Regulatory approvals for the consoles and is required to obtain Regulatory Approvals for the disposable Cryoprobes for commercial procedures within nine months of the Effective Date of the Distribution Agreement. If the Chinese Subsidiary fails to obtain the Regulatory Approvals for the Cryoprobes by such time, Shanghai Medtronic Zhikang has the right to terminate the Distribution Agreement. Exclusive distribution agreement in Japan On August 30, 2019, the Company entered into an exclusive distribution agreement with Terumo Corporation (“Terumo”), in which Terumo will be appointed as an exclusive distributor of the Company’s products in Japan and in Singapore. According to the agreement, Terumo will take full responsibility for registration, importing, marketing, selling, promoting, and distributing the Company’s products for cryoablation of breast cancer in Japan and Singapore. The agreement is for a period of five years from the date of the receipt of regulatory approvals for the sale of the Company’s products in Japan, which will be extended automatically for an additional period of five years each, unless either party notifies the other party of its intention to terminate the agreement at least one year prior to the end of the period of the agreement (either the initial five year period or any of the renewal periods). The agreement can be canceled in certain circumstances. Pursuant to the agreement, Terumo will be responsible and will bear the costs of performing the activities that are required, including clinical research, insofar as they may be required, for the purpose of receiving the regulatory approvals in Japan. As of December 31, 2022, the Company is unable to assess what will be required for the purpose of receiving such regulatory approvals. The Company assesses that, the timeframe for obtaining the regulatory approval in Japan is approximately between three to four years from the time of signing the agreement. The Company assessed the following promises in the contract in order to identify all relevant performance obligations: ● Sale of products (consoles and disposables); ● Providing technical regulatory and clinical materials and information for obtaining the regulatory approval; ● Assistance and support in submitting and obtaining the reimbursement approval from the Japanese Ministry of Health for the medical procedures; ● Stand ready obligation to keep providing the consoles and disposables throughout the contract term; and ● Providing exclusivity rights to Terumo. The Company assessed all of the aforementioned promises and identified 3 performance obligations as follows: (1) Selling products; (2) Providing technical regulatory and clinical materials and information and support services in obtaining the regulatory approval; and (3) Assistance and support in submitting and obtaining the reimbursement approval from the Japanese Ministry of Health for the medical procedures. The stand ready obligation and the exclusive rights were not recognized as separate performance obligations. The overall fixed consideration is as follows: (1) $1,000 were paid to the Company for an exclusive distribution right and sharing of information for the purpose of a submission of a regulatory approval request to the Japanese regulatory authorities; and (2) $3,000 were paid to the Company as an advance payment, of which $1,500 were paid in 2019 and the remaining balance was paid in 2020. In addition, milestones have been set, for which, if met, the Company will receive the following amounts (that were identified by the Company as variable consideration): (1) $250 will be paid to the Company upon the submission of an application for regulatory approval for the products in Japan; (2) $250 will be paid to the Company upon the receipt of regulatory approval in Japan (considered as variable consideration); and (3) $500 will be paid to the Company upon the receipt of approval for medical reimbursement for the procedure in Japan (considered as variable consideration). The Company evaluated whether the aforementioned milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal will not occur, the associated milestone value is included in the transaction price. The receipt of the regulatory approval and the receipt of approval for medical reimbursement milestone payments are not within the control of the Company or Terumo, and hence are not considered probable of being achieved until those approvals are received. However, the submission of the application for the regulatory approval milestone payment is considered probable of being achieved and thus the Company included this milestone payment in the allocation of the transaction price. A total amount of $4,250 was allocated to the identified performance obligations as follows: Consoles and disposables – $866 were allocated based on sale price of these products to similar customers in similar contracts Submission of an application for regulatory approval – $250 were allocated based on a standalone selling price of the submission fee. Assistance in obtaining the regulatory approval – $3,134 were allocated based on the residual approach since the Company has not yet established a price for this service and has not sold it on a standalone basis The Company recognizes revenues from sales of consoles and disposables when the control is transferred to Terumo and recognizes revenue from assistance in obtaining the regulatory approval over the estimated period as evaluated by the Company. As of December 31, 2022, the Company has received $4,000 of the total consideration, of which $3,727 was recognized as revenue. |
Cost of Revenues
Cost of Revenues | 12 Months Ended |
Dec. 31, 2022 | |
Cost of Revenues [Member] | |
COST OF REVENUES | NOTE 11 - COST OF REVENUES Composition: Year ended Year ended Year ended 2022 2021 2020 Payroll and related benefits (including share-based compensation) 896 796 655 Raw materials subcontractors and auxiliary materials 298 828 461 Shipping 48 50 39 Royalties to the IIA 93 123 116 Depreciation 111 33 7 Others 194 113 146 1,640 1,943 1,424 |
Research and Development Expens
Research and Development Expenses | 12 Months Ended |
Dec. 31, 2022 | |
Research and Development [Abstract] | |
RESEARCH AND DEVELOPMENT EXPENSES | NOTE 12 - RESEARCH AND DEVELOPMENT EXPENSES Composition: Year ended Year ended Year ended 2022 2021 2020 Payroll and related benefits (including share-based compensation) 5,969 3,748 2,273 Raw materials subcontracted work and consulting 1,742 1,440 1,058 Clinical trials 495 200 159 Others 917 489 319 9,123 5,877 3,809 |
Sales and Marketing Expenses
Sales and Marketing Expenses | 12 Months Ended |
Dec. 31, 2022 | |
Sales And Marketing Expenses Abstract | |
SALES AND MARKETING EXPENSES | NOTE 13 - SALES AND MARKETING EXPENSES Composition: Year ended Year ended Year ended 2022 2021 2020 Payroll and related benefits (including share-based compensation) 1,599 1,036 576 Consulting and professional services 431 215 157 Travel 274 126 29 Advertising and promotion expenses 74 60 36 Sales commissions 13 60 57 Conferences 301 93 33 Others 512 327 175 3,204 1,917 1,063 |
General and Administrative Expe
General and Administrative Expenses | 12 Months Ended |
Dec. 31, 2022 | |
General And Administrative Expenses [Abstract] | |
GENERAL AND ADMINISTRATIVE EXPENSES | NOTE 14 - GENERAL AND ADMINISTRATIVE EXPENSES Composition: Year ended Year ended Year ended 2022 2021 2020 Payroll and related benefits (including share-based compensation) 2,262 1,403 965 Professional services 3,369 2,440 611 Others 226 282 138 5,857 4,125 1,714 |
Taxes on Income
Taxes on Income | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
TAXES ON INCOME | NOTE 15 - TAXES ON INCOME A. General: The Company is assessed for tax purposes on an unconsolidated basis. Each of the Company’s subsidiaries is subject to the tax rules prevailing in its country of incorporation. B. Corporate Taxation: The Company is subject to Israeli corporate tax rate of 23% for the years ended December 31, 2022, 2021 and 2020. The US subsidiary is subject to U.S. federal tax rate of 21% for the years ended December 31, 2022, 2021 and 2020. The China subsidiary is subject to China tax rate of 2.5% up to taxable income of one million RMB, 5% on taxable income between one million RMB to three million RMB and 20% on taxable income higher than three million RMB, for the year ended December 31, 2022. C. Net loss carryforward: As of December 31, 2022, the Company has an accumulated tax loss carryforward of approximately $74,710 in Israel, which may be carried forward and offset against taxable income in the future for an indefinite period. D. Tax assessments The Company received final tax assessments in Israel through the year ended December 31, 2017. E. Deferred income taxes: Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets are as follows: As of As of 2022 2021 Net loss carryforward 17,183 14,113 Other reserves and allowance 127 94 Total deferred tax assets 17,310 14,207 Valuation allowance (17,310 ) (14,207 ) Net deferred tax asset - - As of December 31, 2022, the Company has provided valuation allowances of $17,310 in respect of deferred tax assets resulting from tax loss carryforward and other temporary differences. Management currently believes that because the Company has a history of losses, it is more likely than not that the deferred tax regarding the loss carryforward and other temporary differences will not be realized in the foreseeable future. F. Effective tax expense (benefit): The components of loss before tax and a reconciliation of the Company’s tax expense to the Company’s theoretical statutory tax benefit is as follows: Year ended Year ended Year ended 2022 2021 2020 Loss (profit) before taxes: Local 16,952 10,081 3,735 Foreign 1 26 (186 ) (5 ) Net loss, as reported in the consolidated statements of comprehensive loss 16,978 9,895 3,730 Israeli statutory income tax rate 23 % 23 % 23 % Theoretical tax benefit 3,905 2,276 858 Losses and other items for which a valuation allowance was provided or benefit from loss carryforwards (3,905 ) (2,161 ) (858 ) Other - (115 ) - Income tax expense - - - 1 Foreign is amount related to the US & China Subsidiaries |
Geographic and Significant Cust
Geographic and Significant Customer Information | 12 Months Ended |
Dec. 31, 2022 | |
Geographic and Significant Customer Information [Abstract] | |
GEOGRAPHIC AND SIGNIFICANT CUSTOMER INFORMATION | NOTE 16 - GEOGRAPHIC AND SIGNIFICANT CUSTOMER INFORMATION The Company has identified one reportable and operating segment that designs, develops, manufactures and markets Cryoablation medical devices. The results of operations provided to and analyzed by the CODM are at the consolidated level and accordingly, key resources and assessments of performance are performed at the consolidated level. We continue to evaluate our internal reporting structure and the potential impact of any changes on our segment reporting. The following table sets forth reporting revenue information by geographic region: Year ended Year ended Year ended 2022 2021 2020 Japan 1,130 1,380 2,097 Israel 30 108 7 United States 604 471 276 Thailand 30 964 528 Other 2 1,291 1,215 960 3,085 4,138 3,868 The following table sets forth reporting property and equipment information by geographic region: As of As of 2022 2021 Israel 929 622 United States 427 91 1,356 713 The following table is a summary of customer concentrations as a percentage of revenue: Year ended Year ended Year ended 2022 2021 2020 Customer A 25 % 30 % 47 % Customer B - * 14 % Customer C * 23 % - Customer D 20 % 11 % * * Lower than 10% 2 No country represented is greater than 10% of our revenue as of the years presented, other than the countries presented above. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 17 - SUBSEQUENT EVENTS The following are the significant events that took place subsequent to December 31, 2022: (a) On February 19, 2023, the Company granted 1,080,992 options to purchase an aggregate of 1,066,528 ordinary shares to 75 optionees of the Company, as follows: 172,321 options to the Company’s CEO, the Chairman of the Board and a member of the board, 252,371 options to six officers of the Company and 656,300 options to 67 employees of the Company, at an exercise price of NIS 4.68 (approximately $1.37) per share. The options granted to the CEO, chairman of the board, board member and the officers will vest as follows: a quarter after one year and the rest will vest in 12 equal quarterly installments over a period of three years from February 19, 2023. The options granted to the 67 employees will vest in four equal installments over a period of four years from the date of grant. The options are exercisable for 10 years from the date of grant. (h) On February 19, 2023, the Company granted to a consultant of the company 41,412 options to purchase an aggregate of 41,412 ordinary shares, at an exercise price of NIS 4.68 (approximately $1.37) per share. The options will vest as follows: 6 equal quarterly installments from February 19, 2023. The options are exercisable for 10 years from the date of grant. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Use of estimates | A. Use of estimates: The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Management believes that the estimates, judgments and assumptions used are reasonable based upon information available at the time they are made. Actual results could differ from those estimates. |
Financial statements in U.S. dollars and functional currency | B. Financial statements in U.S. dollars and functional currency: The functional currency of the Company and its subsidiaries is the U.S dollar (“USD” or “dollar” or “$”) since the dollar is the currency of the primary economic environment in which the Company has operated and expects to continue to operate in the foreseeable future. Most of the Company’s revenues are derived from sales outside of Israel, which are based primarily on dollar. In addition, the majority of the Company’s equity raising is denominated in dollars. Thus, the functional currency of the Company and certain subsidiaries is the dollar. Transactions and balances denominated in dollars are presented at their original amounts. Transactions and balances denominated in foreign currencies have been re-measured to dollars in accordance with the provisions of Accounting Standards Codification (“ASC”) 830-10, “Foreign Currency Translation”. All transaction gains and losses from re-measurement of monetary balance sheet items denominated in non-dollar currencies are reflected in the statements of comprehensive loss as financial income or expenses, as appropriate. |
Principles of consolidation | C. Principles of consolidation: The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation. Profits from intercompany sales, not yet realized outside the Group, were also eliminated. |
Cash and cash equivalents | D. Cash and cash equivalents: Cash equivalents are short-term highly liquid investments that are readily convertible into cash with original maturities of three months or less. |
Trade Accounts Receivable | E. Trade Accounts Receivable: Accounts receivable are recorded at the invoiced amount, are unsecured and do not bear interest. Accounts receivable are stated at their net realizable value, net of allowances. The allowance for doubtful accounts is based on the Company’s periodic assessment of the collectability of the accounts based on a combination of factors including the payment terms of each account, its age, the collection history of each customer, and the customer’s financial condition. No doubtful accounts expense was recorded for the years ended December 31, 2022, 2021 and 2020. |
Inventories | F. Inventories: Inventories are valued using the lower of cost and net realizable value, and include raw materials, work in progress and finished goods. The cost of inventories is determined as follows: Cost of raw materials is determined on a standard cost basis utilizing the weighted average cost of historical purchases, which approximates actual cost. Cost of work in progress (“WIP”) and finished goods are based on the standard cost method and determined on the cost of raw materials and subcontracted work, and the applicable share of the cost of labor on the weighted average cost basis which approximates actual cost. The Company regularly evaluates the value of inventory based on a combination of factors including the following: historical usage rates, product end of life dates, technological obsolescence and product introductions. |
Property and equipment | G. Property and equipment: Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets. The annual depreciation rates are as follows: % Consoles and equipment 15 - 20 Computers and software 33 Office furniture and equipment 7 - 15 Leasehold improvements Over the shorter of the related lease period or the useful lives of the asset The Company periodically performs impairment testing on its long-lived assets either annually or whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. |
Leases | H. Leases: We determine if an arrangement is a lease at inception. Operating lease assets are presented as operating lease right of use (“ROU”) assets, and corresponding operating lease liabilities are presented as lease liabilities within current liabilities (current portions), and as long-term lease liabilities within non - current liabilities (long-term portions), on our consolidated balance sheets. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the remaining lease payments over the lease term at commencement date. The rate implicit in our leases are not reasonably determinable and, we use our incremental borrowing rate. We calculate the incremental borrowing rate to reflect the interest rate that we would have to pay to borrow on a collateralized basis an amount equal to the lease payments in a similar economic environment over a similar term, and consider our historical borrowing activities and market data in this determination. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. Our lease terms may include options to extend the lease when it is reasonably certain that we will exercise that option. Lease expense is recognized on a straight-line basis over the lease term. Some of our leases contain variable lease payments, which are expensed as incurred unless those payments are based on an index or rate. Variable lease payments based on an index or rate are initially measured using the index or rate in effect at lease commencement and included in the measurement of the lease liability; thereafter, changes to lease payments due to rate or index updates are recorded as rent expense in the period incurred. Our lease agreements do not contain any material residual value guarantees or material restrictive covenants. In addition, we do not have any related party leases. |
Contingencies | I. Contingencies: The Company accounts for its contingent liabilities in accordance with ASC Topic 450, Contingencies (“ASC 450”). A provision is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter. |
Revenue recognition | J. Revenue recognition: Revenue is measured as the amount of consideration the Company expects to be entitled to, in exchange for transferring products or providing services to its customers and is recognized when or as performance obligations under the terms of contracts with the Company’s customers are satisfied. ASC 606 prescribes a five-step model for recognizing revenue from contracts with customers: (i) identify contract(s) with the customer; (ii) identify the separate performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the separate performance obligations in the contract; and (v) recognize revenue when (or as) each performance obligation is satisfied. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services. The Company then allocates the transaction price (the amount of consideration the Company expects to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognizes the associated revenue when (or as) each performance obligation is satisfied. Revenues from product sales are recognized upon the transfer of control, which is generally upon shipment or delivery. Provisions for discounts, rebates and sales incentives to customers, returns and other adjustments are provided for in the period the related sales are recorded. Sales incentives to customers are not material. Deferred revenue represents amounts received by the Company for which the related revenues have not been recognized because one or more of the revenue recognition criteria have not been met. The current portion of deferred revenue represents the amount to be recognized within one year from the balance sheet date based on the estimated performance period of the underlying performance obligation. The noncurrent portion of deferred revenue represents amounts to be recognized after one year through the end of the performance period of the performance obligation. As of December 31, 2022, and 2021, the Company’s deferred revenue balance is $646 and $1,502 (out of which $646 and $884 are presented as current), respectively. For further analysis of the Company’s main revenue contract, see Note 10 below. |
Share-based compensation | K. Share-based compensation: The Company applies ASC 718, “Share-Based Payment,” which requires the measurement and recognition of compensation expense for all share-based payment awards, including stock options, made to employees and directors under the Company’s stock plans based on estimated fair values. ASC 718-10 requires companies to estimate the fair value of share-based payment awards on the date of grant. The portion of the share value of the award that is ultimately expected to vest is recognized as share-based compensation expense over the requisite service periods in the Company’s consolidated statements of comprehensive loss. The Company estimates the fair value of stock options granted using a Black-Scholes option-pricing model. The Black-Scholes option-pricing model requires a number of assumptions, the most significant of which are the expected stock-price volatility and the expected option term (the time from the grant date until the options are exercised or expire). The Company’s calculations of the expected volatility were based upon actual historical stock-price movements over the period, which was equal to the expected option term. The expected option term was calculated for options granted to employees and directors in accordance with ASC 718-10-S99, using the “simplified” method, and grants to non-employees were based on the contractual term. Historically, the Company has not paid dividends, and has no foreseeable plans to do so. The risk-free interest rate is based on the yield from Israel Treasury zero-coupon bonds with an equivalent term. Changes in the determination of each of the inputs can affect the fair value of the options granted and the results of operations of the Company. |
Research and development costs | L. Research and development costs: Research and development costs are charged to the consolidated statements of comprehensive loss as incurred. Grants for funding approved research and development projects are recognized at the time the Company is entitled to such grants, on the basis of the costs incurred and applied as a deduction from the research and development expenses. |
Severance pay | M. Severance pay: Under Israeli employment laws, all of the Company’s employees in Israel are included under Section 14 of the Severance Compensation Act, 1963 (“Section 14”). Pursuant to Section 14, these employees are entitled to monthly deposits at a rate of 8.33% of their monthly salary, made on their behalf by the Company. Payments in accordance with Section 14 exempt the Company from any future severance pay liabilities in respect of those employees. The aforementioned deposits are not recorded as an asset in the Company’s consolidated balance sheets. |
Income taxes | N. Income taxes: The Company accounts for income taxes utilizing the asset and liability method in accordance with ASC 740, “Income Taxes.” Current tax liabilities are recognized for the estimated taxes payable on tax returns for the current year. Deferred tax liabilities or assets are recognized for the estimated future tax effects attributable to temporary differences between the income-tax bases of assets and liabilities and their reported amounts in the consolidated financial statements and for tax loss carry forwards and are measured using the enacted tax rates and laws, that will be in effect when the differences are expected to reverse. Measurement of current and deferred tax liabilities and assets is based on provisions of enacted tax laws, and deferred tax assets are reduced, if necessary, by the amount of tax benefits, the realization of which is not considered more likely than not based on available evidence. As of December 31, 2022, the Company had a full valuation allowance against deferred tax assets. ASC 740-10 requires a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate settlement. The Company has not recorded any liability for uncertain tax positions for the year ended December 31, 2022. |
Fair value of financial instruments | O. Fair value of financial instruments: The Company applies ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”), pursuant to which fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value: ● Level 1 – Quoted prices in active markets for identical assets or liabilities. ● Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and ● Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The carrying values of cash and cash equivalents, trade accounts receivable, prepaid expenses and other receivables, other long-term assets, trade accounts payable, other current liabilities and other long-term liabilities approximate their fair value due to the short-term maturity of these instruments. |
Concentrations of credit risk | P. Concentrations of credit risk: Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, deposit and trade accounts receivables. The majority of the Company’s cash and cash equivalents and deposit are in USD in a major bank in Israel. The management believes that the financial institutions that hold the Company’s investments are corporations with high credit standing. Accordingly, management believes that low credit risk exists with respect to these financial investments. The trade accounts receivables of the Company are derived from sales to customers located primarily in the Americas, APAC, and Europe. The Company performs ongoing credit evaluations of its customers’ financial condition. Under certain circumstances, the Company may require advance payments. |
Segment Reporting | Q. Segment Reporting: The chief operating decision maker (the “CODM”) of the Company is the Chief Executive Officer. The CODM reviews financial information presented on a consolidated basis for purposes of allocating resources and evaluating financial performance. Accordingly, management has determined that the Company operates in one reportable segment. |
Basic and diluted net loss per share | R. Basic and diluted net loss per share: Basic net loss per share is computed based on the weighted-average number of ordinary shares outstanding during each year. Diluted net loss per share is computed based on the weighted-average number of ordinary shares outstanding during each year, plus the dilutive potential of the ordinary shares considered outstanding during the year, in accordance with ASC 260 - |
Comprehensive loss | S. Comprehensive loss: The purpose of reporting comprehensive income (loss) is to report a measure of all changes in equity of an entity that result from recognized transactions and other economic events of the period resulting from transactions from non-owner sources. |
Recently issued accounting pronouncements | T. Recently issued accounting pronouncements: From time to time, new accounting pronouncements are issued by FASB, or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. (1) In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which replaces the existing incurred loss impairment model with an expected credit loss model and requires a financial asset measured at amortized cost to be presented at the net amount expected to be collected. The guidance became effective for the Company beginning January 1, 2023, and interim periods therein. Early adoption is permitted. The Company is currently evaluating the effect that ASU 2016-13 will have on its consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of annual depreciation rates | % Consoles and equipment 15 - 20 Computers and software 33 Office furniture and equipment 7 - 15 Leasehold improvements Over the shorter of the related lease period or the useful lives of the asset |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | As of As of December 31, December 31, 2022 2021 Raw materials 1,566 704 Work in progress 356 457 Finished goods 935 794 2,857 1,955 |
Prepaid Expenses and Other Re_2
Prepaid Expenses and Other Receivables (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expenses and Other Receivables [Abstract] | |
Schedule of prepaid expenses and other receivables | As of As of December 31, December 31, 2022 2021 Tax authorities 124 128 Insurances 527 1,700 Prepaid expenses 80 95 Advances to payables 345 180 Other 164 187 1,240 2,290 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Schedule of supplemental cash flow | Year ended Year ended Year ended Cash payments for operating leases 242 247 185 |
Schedule of operating leases liabilities and the reconciliation of undiscounted cash flows | 2023 214 2024 196 2025 182 2026 105 2027 - Undiscounted cash flows of operating leases 697 Less: amount representing interest (100 ) Operating lease liabilities 597 |
Schedule of weighted average lease term and weighted average discount rate | Operating leases weighted average remaining lease term (in years) 2.26 Operating leases weighted average discount rate 7.99 % |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of composition property and equipment | As of As of December 31, December 31, 2022 2021 Cost Consoles and equipment 1,524 567 Computers and software 404 211 Office furniture and equipment 127 100 Leasehold improvements 207 133 2,262 1,011 Less - accumulated depreciation Consoles and equipment 443 119 Computers and software 323 114 Office furniture and equipment 48 37 Leasehold improvements 92 28 906 298 Property and Equipment, Net 1,356 713 |
Other Current Liabilities (Tabl
Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Other Liabilities and Financial Instruments Subject to Mandatory Redemption [Abstract] | |
Schedule of other current liabilities | As of As of December 31, December 31, 2022 2021 Deferred revenues 646 884 Provision for royalties to IIA 47 62 Payroll and social benefits 1,580 991 Vacation and recuperation provision 554 410 Accrued expenses and others 628 568 3,455 2,915 |
Shareholders_ Equity (Tables)
Shareholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Schedule of fair value of options granted was estimated using the Black-Scholes option pricing model | For the year ended For the year ended For the year ended 2022 2021 2020 Exercise price $1.78 - $3.61 $1.69 - $8.75 $1.56 - $1.77 Expected volatility 91.0% - 91.6% 89.8% - 96.1% 88.77% - 90.84% Risk-free interest 0.92% - 2.43% 0.67% - 1.02% 0.4% - 0.46% Expected life of up to (years) 5.56 – 6.25 6.22 6.2 |
Schedule of option activity | Number of Weighted Weighted (in years) Balance as of January 1, 2020 1,272,615 $ 1.52 Granted 370,351 $ 1.60 Expired (35,788 ) $ 1.60 Forfeited 137,667 ) $ 1.68 Exercised (13,750 ) $ 0.88 Balance as of December 31, 2020 1,455,761 $ 1.68 7.69 Granted 108,929 $ 2.02 Expired (13,875 ) $ 2.94 Forfeited (24,635 ) $ 1.85 Exercised (189,700 ) $ 2.06 Balance as of December 31, 2021 1,336,480 $ 1.64 7.03 Granted 1,806,316 $ 3.3 Expired (3,380 ) $ 3.43 Forfeited (63,262 ) $ 2.04 Exercised (219 ) $ 1.64 Balance as of December 31, 2022 3,075,935 $ 2.55 7.8 Exercisable at the end of year 1,059,573 $ 1.48 5.7 |
Schedule of share-based compensation the company recognized for share-based payments | Year ended Year ended Year ended 2022 2021 2020 Cost of revenues 137 15 16 Sales and marketing 208 15 26 Research and development 785 109 67 General and administrative 735 177 120 1,865 316 229 |
Revenues (Tables)
Revenues (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Revenues [Abstract] | |
Schedule of revenues from warranty and services are not material | Year ended Year ended Year ended December 31, 2022 2021 2020 Consoles 1,002 1,560 1,817 Disposables 1,336 1,208 1,006 Exclusive distribution agreement 747 1,370 1,045 3,085 4,138 3,868 |
Cost of Revenues (Tables)
Cost of Revenues (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Cost of Revenues [Member] | |
Schedule of cost of revenues | Year ended Year ended Year ended 2022 2021 2020 Payroll and related benefits (including share-based compensation) 896 796 655 Raw materials subcontractors and auxiliary materials 298 828 461 Shipping 48 50 39 Royalties to the IIA 93 123 116 Depreciation 111 33 7 Others 194 113 146 1,640 1,943 1,424 |
Research and Development Expe_2
Research and Development Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Research and Development [Abstract] | |
Schedule of research and development expenses | Year ended Year ended Year ended 2022 2021 2020 Payroll and related benefits (including share-based compensation) 5,969 3,748 2,273 Raw materials subcontracted work and consulting 1,742 1,440 1,058 Clinical trials 495 200 159 Others 917 489 319 9,123 5,877 3,809 |
Sales and Marketing Expenses (T
Sales and Marketing Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Sales And Marketing Expenses Abstract | |
Schedule of sales and marketing expenses | Year ended Year ended Year ended 2022 2021 2020 Payroll and related benefits (including share-based compensation) 1,599 1,036 576 Consulting and professional services 431 215 157 Travel 274 126 29 Advertising and promotion expenses 74 60 36 Sales commissions 13 60 57 Conferences 301 93 33 Others 512 327 175 3,204 1,917 1,063 |
General and Administrative Ex_2
General and Administrative Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
General And Administrative Expenses [Abstract] | |
Schedule of general and administrative expenses | Year ended Year ended Year ended 2022 2021 2020 Payroll and related benefits (including share-based compensation) 2,262 1,403 965 Professional services 3,369 2,440 611 Others 226 282 138 5,857 4,125 1,714 |
Taxes on Income (Tables)
Taxes on Income (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of deferred tax assets | As of As of 2022 2021 Net loss carryforward 17,183 14,113 Other reserves and allowance 127 94 Total deferred tax assets 17,310 14,207 Valuation allowance (17,310 ) (14,207 ) Net deferred tax asset - - |
Schedule of tax expense to the company’s theoretical statutory tax benefit | Year ended Year ended Year ended 2022 2021 2020 Loss (profit) before taxes: Local 16,952 10,081 3,735 Foreign 1 26 (186 ) (5 ) Net loss, as reported in the consolidated statements of comprehensive loss 16,978 9,895 3,730 Israeli statutory income tax rate 23 % 23 % 23 % Theoretical tax benefit 3,905 2,276 858 Losses and other items for which a valuation allowance was provided or benefit from loss carryforwards (3,905 ) (2,161 ) (858 ) Other - (115 ) - Income tax expense - - - 1 Foreign is amount related to the US & China Subsidiaries |
Geographic and Significant Cu_2
Geographic and Significant Customer Information (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Geographic and Significant Customer Information [Abstract] | |
Schedule of sets forth reporting revenue information | Year ended Year ended Year ended 2022 2021 2020 Japan 1,130 1,380 2,097 Israel 30 108 7 United States 604 471 276 Thailand 30 964 528 Other 2 1,291 1,215 960 3,085 4,138 3,868 2 No country represented is greater than 10% of our revenue as of the years presented, other than the countries presented above. |
Schedule of sets forth reporting property and equipment information | As of As of 2022 2021 Israel 929 622 United States 427 91 1,356 713 |
Schedule of customer concentrations as a percentage of revenue | Year ended Year ended Year ended 2022 2021 2020 Customer A 25 % 30 % 47 % Customer B - * 14 % Customer C * 23 % - Customer D 20 % 11 % * * Lower than 10% 2 No country represented is greater than 10% of our revenue as of the years presented, other than the countries presented above. |
General (Details)
General (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 29, 2023 | |
General (Details) [Line Items] | ||||
Accumulated losses | $ (75,409) | $ (58,431) | ||
Generated losses | (16,978) | (9,895) | $ (3,730) | |
Operating activities | $ (14,292) | $ (12,605) | $ (3,690) | |
Subsequent Event [Member] | ||||
General (Details) [Line Items] | ||||
Cash, cash equivalents and short term deposits | $ 20,216 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Accounting Policies [Abstract] | ||
Deferred revenue | $ 646 | $ 1,502 |
Deferred revenue present of current | $ 646 | $ 884 |
Deposits rate | 8.33% | |
Tax benefit largest amount | 50% |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of annual depreciation rates | 12 Months Ended |
Dec. 31, 2022 | |
Consoles and equipment [Member] | Minimum [Member] | |
Summary of Significant Accounting Policies (Details) - Schedule of annual depreciation rates [Line Items] | |
Annual depreciation rate | 15% |
Consoles and equipment [Member] | Maximum [Member] | |
Summary of Significant Accounting Policies (Details) - Schedule of annual depreciation rates [Line Items] | |
Annual depreciation rate | 20% |
Computers and software [Member] | |
Summary of Significant Accounting Policies (Details) - Schedule of annual depreciation rates [Line Items] | |
Annual depreciation rate | 33% |
Office furniture and equipment [Member] | Minimum [Member] | |
Summary of Significant Accounting Policies (Details) - Schedule of annual depreciation rates [Line Items] | |
Annual depreciation rate | 7% |
Office furniture and equipment [Member] | Maximum [Member] | |
Summary of Significant Accounting Policies (Details) - Schedule of annual depreciation rates [Line Items] | |
Annual depreciation rate | 15% |
Leasehold improvements [Member] | |
Summary of Significant Accounting Policies (Details) - Schedule of annual depreciation rates [Line Items] | |
Annual depreciation rate description | Over the shorter of the related lease period or the useful lives of the asset |
Inventory (Details) - Schedule
Inventory (Details) - Schedule of inventory - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Inventory Abstract | ||
Raw materials | $ 1,566 | $ 704 |
Work in progress | 356 | 457 |
Finished goods | 935 | 794 |
Total | $ 2,857 | $ 1,955 |
Prepaid Expenses and Other Re_3
Prepaid Expenses and Other Receivables (Details) - Schedule of prepaid expenses and other receivables - Prepaid and Other Receivable [Member] - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expenses and Other Receivables (Details) - Schedule of prepaid expenses and other receivables [Line Items] | ||
Tax authorities | $ 124 | $ 128 |
Insurances | 527 | 1,700 |
Prepaid expenses | 80 | 95 |
Advances to payables | 345 | 180 |
Other | 164 | 187 |
Total | $ 1,240 | $ 2,290 |
Leases (Details)
Leases (Details) - USD ($) | 12 Months Ended | |||
Aug. 10, 2021 | Jan. 01, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | |
Leases [Abstract] | ||||
Leases description | the Company expanded its leases from 581 square meters to approximately 813 square meters at its location in Caesarea, Israel, and extended its operating lease agreement for another 12 months until July 31, 2023, with additional option to extend until July 31, 2026. | the Company expanded its leases from 494 square meters to approximately 581 square meters at its location in Caesarea, Israel, and extended its operating lease agreement for another 12 months until July 14, 2022, with additional option to extend until July 14, 2025. | ||
Bank guarantee | $ 20 | |||
Operating lease, right-of-use asset | 668,000 | $ 913,000 | ||
Operating leases totaled | $ 597,000 | $ 909,000 |
Leases (Details) - Schedule of
Leases (Details) - Schedule of supplemental cash flow - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Supplemental Cash Flow [Abstract] | |||
Cash payments for operating leases | $ 242 | $ 247 | $ 185 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of operating leases liabilities and the reconciliation of undiscounted cash flows $ in Thousands | Dec. 31, 2022 USD ($) |
Schedule of Operating Leases Liabilities and the Reconciliation of Undiscounted Cash Flows [Abstract] | |
2023 | $ 214 |
2024 | 196 |
2025 | 182 |
2026 | 105 |
2027 | |
Undiscounted cash flows of operating leases | 697 |
Less: amount representing interest | (100) |
Operating lease liabilities | $ 597 |
Leases (Details) - Schedule o_3
Leases (Details) - Schedule of weighted average lease term and weighted average discount rate | Dec. 31, 2022 |
Schedule of Weighted Average Lease Term and Weighted Average Discount Rate [Abstract] | |
Operating leases weighted average remaining lease term (in years) | 2 years 3 months 3 days |
Operating leases weighted average discount rate | 7.99% |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation and amortization expenses | $ 248 | $ 127 | $ 63 |
Property and Equipment, Net (_2
Property and Equipment, Net (Details) - Schedule of composition property and equipment - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Cost | ||
Total cost | $ 2,262 | $ 1,011 |
Less - accumulated depreciation | ||
Less - accumulated depreciation, Total | 906 | 298 |
Property and Equipment, Net | 1,356 | 713 |
Consoles and equipment [Member] | ||
Cost | ||
Total cost | 1,524 | 567 |
Less - accumulated depreciation | ||
Less - accumulated depreciation, Total | 443 | 119 |
Computers and software [Member] | ||
Cost | ||
Total cost | 404 | 211 |
Less - accumulated depreciation | ||
Less - accumulated depreciation, Total | 323 | 114 |
Office furniture and equipment [Member] | ||
Cost | ||
Total cost | 127 | 100 |
Less - accumulated depreciation | ||
Less - accumulated depreciation, Total | 48 | 37 |
Leasehold improvements [Member] | ||
Cost | ||
Total cost | 207 | 133 |
Less - accumulated depreciation | ||
Less - accumulated depreciation, Total | $ 92 | $ 28 |
Other Current Liabilities (Deta
Other Current Liabilities (Details) - Schedule of other current liabilities - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Other Current Liabilities Abstract | ||
Deferred revenues | $ 646 | $ 884 |
Provision for royalties to IIA | 47 | 62 |
Payroll and social benefits | 1,580 | 991 |
Vacation and recuperation provision | 554 | 410 |
Accrued expenses and others | 628 | 568 |
Total | $ 3,455 | $ 2,915 |
Commitments and Contingencies (
Commitments and Contingencies (Details) ₪ in Thousands, $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2022 USD ($) | Dec. 31, 2022 ILS (₪) | Dec. 31, 2022 ILS (₪) | Jul. 29, 2021 USD ($) | Jul. 29, 2021 ILS (₪) | |
Commitments and Contingencies (Details) [Line Items] | |||||
Royalties paid | $ 2,076 | ||||
Deposit amount | 20 | ₪ 70 | |||
Plaintiff (in New Shekels) | ₪ | ₪ 30,000 | ||||
Claim | 9,191 | ||||
Class action (in New Shekels) | ₪ | 163,459 | ||||
Class damages | 50,079 | ||||
Plaintiff claims (in New Shekels) | ₪ | ₪ 234,349 | ||||
Allegedly | 71,798 | ||||
Claim amount | $ 1,541 | ₪ 5,000 | |||
Customer Agreement [Member] | |||||
Commitments and Contingencies (Details) [Line Items] | |||||
Deposit amount | 296 | ||||
Bank Guarantee [Member] | |||||
Commitments and Contingencies (Details) [Line Items] | |||||
Deposit amount | $ 15 | ||||
Israeli Innovation Authority [Member] | |||||
Commitments and Contingencies (Details) [Line Items] | |||||
Revenue rate, percentage | 3.50% | 3.50% | |||
Annual turnover | $ 70,000 | ||||
Royalties at the rate | 3% | 3% | |||
Liability for royalties | $ 47 | ||||
Accumulated interest | $ 2,575 |
Shareholders_ Equity (Details)
Shareholders’ Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||||||||||||||
Jul. 04, 2022 | Jun. 03, 2022 | May 09, 2022 | Jan. 12, 2022 | Dec. 13, 2021 | Dec. 08, 2021 | Sep. 13, 2020 | Aug. 05, 2020 | Aug. 01, 2020 | Jun. 04, 2020 | Dec. 23, 2022 | Jul. 18, 2022 | Mar. 23, 2022 | Apr. 28, 2021 | Jan. 27, 2021 | Oct. 28, 2020 | Aug. 30, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 07, 2021 | |
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Gross amount (in Dollars) | $ 16,994 | $ 6,067 | ||||||||||||||||||
Ordinary shares issued | 3,892,152 | |||||||||||||||||||
Gross proceeds (in Dollars) | $ 15,966 | |||||||||||||||||||
Total investments (in Dollars) | $ 9,000 | |||||||||||||||||||
Discount on the average percentage | 20% | |||||||||||||||||||
Total Investment percentage | 60% | |||||||||||||||||||
Number of shares issue | 6,891,418 | |||||||||||||||||||
Second tranche (in Dollars) | $ 6,000 | $ 6,000 | ||||||||||||||||||
Company shares to issued investors | 4,594,279 | |||||||||||||||||||
Pre-funded warrants issued | 1,034,000 | 1,034,000 | ||||||||||||||||||
Exercise price (in Dollars per share) | $ 0.001 | |||||||||||||||||||
Restricted ordinary shares | 21,000 | |||||||||||||||||||
Gross amount (in Dollars) | $ 14,500 | |||||||||||||||||||
Ordinary shares | 8,787,880 | |||||||||||||||||||
Per share (in Dollars per share) | $ 1.65 | |||||||||||||||||||
Received proceeds (in Dollars) | $ 13,569 | |||||||||||||||||||
Authorized share capital | 2,500,000,000 | |||||||||||||||||||
Reverse stock split | Accordingly, all option numbers, share numbers, share prices, exercise prices and losses per share were adjusted within these consolidated financial statements, on a retroactive basis, to reflect this 8-for-1 reverse stock split. | |||||||||||||||||||
Outstanding and exercisable options | 583,281 | |||||||||||||||||||
Aggregate intrinsic value (in Dollars) | $ 316 | |||||||||||||||||||
Fair value granted options per share (in Dollars per share) | $ 1.82 | |||||||||||||||||||
Options to purchase | 55,222 | 1,720,660 | 142,594 | 30,434 | 8,929 | 57,500 | 170,258 | |||||||||||||
Aggregate of ordinary shares | 55,222 | 1,720,660 | 142,594 | 30,434 | 8,929 | 57,500 | 170,258 | |||||||||||||
Exercise price per share (in Dollars per share) | $ 1.78 | $ 3.61 | $ 1.68 | $ 2.73 | $ 5.76 | $ 1.6 | $ 1.52 | |||||||||||||
Shares of options | 333,992 | 13,720 | 4,319 | 32,500 | 27,333 | |||||||||||||||
Exercisable date of grant | 10 years | 10 years | 10 years | 10 years | 10 years | 10 years | ||||||||||||||
Unrecognized share-based compensation cost (in Dollars) | $ 1,783 | |||||||||||||||||||
Vesting period | 3 years 2 months 12 days | |||||||||||||||||||
Common Stock [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Investors shares | 11,485,697 | |||||||||||||||||||
Shares price (in Dollars per share) | $ 3.449 | $ 1,304 | ||||||||||||||||||
Number of shares issue | 1,034,000 | |||||||||||||||||||
Warrant [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Shares price (in Dollars per share) | $ 0.001 | |||||||||||||||||||
IPO [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Ordinary shares issued | 5,175,000 | |||||||||||||||||||
Ordinary shares price per share (in Dollars per share) | $ 1,168 | |||||||||||||||||||
Gross proceeds (in Dollars) | $ 5,847 | |||||||||||||||||||
Over-Allotment Option [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Shares price (in Dollars per share) | $ 3.45 | |||||||||||||||||||
Number of shares issue | 578,325 | |||||||||||||||||||
Capital Support Agreement [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Total investments (in Dollars) | $ 15,000 | |||||||||||||||||||
Business Combination [Member] | CEO [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Options exercise description | the Company granted 100,000 options to purchase an aggregate of 100,000 ordinary shares to a member of the Company’s Board of directors, at an exercise price of $1.60 per share. The options will vest as follows: a.25,000 options - a quarter after one year and the rest will vest in 12 equal quarterly installments over a period of three years from December 13, 2020. b.75,000 options- based on target achievement: i.37,500 options will vest and become exercisable, on the date of receipt by the company of two regulatory approvals in China from the NMPA (National Medical Products Administration) for the marketing and sale of ProSense product and for the sale of probes of the company, and no later than December 31, 2022. On December 31, 2022, the 37,500 options were forfeited since the two regulatory approvals were not received. ii.37,500 options will vest and become exercisable, with the sale of Consoles and Probes as determined in the options agreement in one calendar year in China, and no later than the end of 2024. The options are exercisable for 10 years from the date of grant. | |||||||||||||||||||
Board of Directors Chairman [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Shares of options | 443,674 | 25,000 | ||||||||||||||||||
CEO [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Shares of options | 4,610 | |||||||||||||||||||
Epoch Partner Investments Limited [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Total working capital (in Dollars) | 7,500 | |||||||||||||||||||
Alpha Capital Anstalt [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Total working capital (in Dollars) | 4,000 | |||||||||||||||||||
Clover Wolf Capital Limited [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Total working capital (in Dollars) | 3,100 | |||||||||||||||||||
Clover Alpha L.P [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Total working capital (in Dollars) | $ 400 | |||||||||||||||||||
Five Officers [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Shares of options | 942,994 | 142,925 | ||||||||||||||||||
Four Officers [Member] | ||||||||||||||||||||
Shareholders’ Equity (Details) [Line Items] | ||||||||||||||||||||
Shares of options | 16,714 |
Shareholders_ Equity (Details)
Shareholders’ Equity (Details) - Schedule of fair value of options granted was estimated using the Black-Scholes option pricing model - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Shareholders’ Equity (Details) - Schedule of fair value of options granted was estimated using the Black-Scholes option pricing model [Line Items] | |||
Expected life of up to (years) | 6 years 2 months 19 days | 6 years 2 months 12 days | |
Minimum [Member] | |||
Shareholders’ Equity (Details) - Schedule of fair value of options granted was estimated using the Black-Scholes option pricing model [Line Items] | |||
Exercise price (in Dollars per share) | $ 1.78 | $ 1.69 | $ 1.56 |
Expected volatility | 91% | 89.80% | 88.77% |
Risk-free interest | 0.92% | 0.67% | 0.40% |
Expected life of up to (years) | 5 years 6 months 21 days | ||
Maximum [Member] | |||
Shareholders’ Equity (Details) - Schedule of fair value of options granted was estimated using the Black-Scholes option pricing model [Line Items] | |||
Exercise price (in Dollars per share) | $ 3.61 | $ 8.75 | $ 1.77 |
Expected volatility | 91.60% | 96.10% | 90.84% |
Risk-free interest | 2.43% | 1.02% | 0.46% |
Expected life of up to (years) | 6 years 3 months |
Shareholders_ Equity (Details_2
Shareholders’ Equity (Details) - Schedule of option activity - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Option Activity [Abstract] | |||
Number of Share Options, Balance | 1,336,480 | 1,455,761 | 1,272,615 |
Weighted Average Exercise Price Per Share, Balance | $ 1.64 | $ 1.68 | $ 1.52 |
Number of Share Options, Balance | 3,075,935 | 1,336,480 | 1,455,761 |
Weighted Average Exercise Price Per Share, Balance | $ 2.55 | $ 1.64 | $ 1.68 |
Weighted Average Remaining Contractual Term (in years), Balance | 7 years 9 months 18 days | 7 years 10 days | 7 years 8 months 8 days |
Number of Share Options, Granted | 1,806,316 | 108,929 | 370,351 |
Weighted Average Exercise Price Per Share, Granted | $ 3.3 | $ 2.02 | $ 1.6 |
Number of Share Options, Expired | (3,380) | (13,875) | (35,788) |
Weighted Average Exercise Price Per Share, Expired | $ 3.43 | $ 2.94 | $ 1.6 |
Number of Share Options, Forfeited | (63,262) | (24,635) | 137,667 |
Weighted Average Exercise Price Per Share, Forfeited | $ 2.04 | $ 1.85 | $ 1.68 |
Number of Share Options, Exercised | (219) | (189,700) | (13,750) |
Weighted Average Exercise Price Per Share, Exercised | $ 1.64 | $ 2.06 | $ 0.88 |
Number of Share Options, Exercisable at the end of year | 1,059,573 | ||
Weighted Average Exercise Price Per Share, Exercisable at the end of year | $ 1.48 | ||
Weighted Average Remaining Contractual Term (in years), Exercisable at the end of year | 5 years 8 months 12 days |
Shareholders_ Equity (Details_3
Shareholders’ Equity (Details) - Schedule of share-based compensation the company recognized for share-based payments - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Share Based Compensation the Company Recognized for Share Based Payments [Abstract] | |||
Cost of revenues | $ 137 | $ 15 | $ 16 |
Sales and marketing | 208 | 15 | 26 |
Research and development | 785 | 109 | 67 |
General and administrative | 735 | 177 | 120 |
Share based compensation | $ 1,865 | $ 316 | $ 229 |
Revenues (Details)
Revenues (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Jun. 12, 2022 | Dec. 31, 2022 | Dec. 31, 2019 | |
Revenues (Details) [Line Items] | |||
Initial term | 36 months | ||
Purchase target | $ 3,500 | ||
Paid advance payment | $ 3,000 | $ 1,500 | |
Total amount | 4,250 | ||
Consoles and disposables | 866 | ||
Regulatory approval | 250 | ||
Assistance in obtaining the regulatory approval | 3,134 | ||
Company received | 4,000 | ||
Total consideration | 3,727 | ||
Japan [Member] | |||
Revenues (Details) [Line Items] | |||
Paid to application for regulatory approval | 250 | ||
Paid to receipt regulatory approval | 250 | ||
Paid to medical reimbursement | 500 | ||
Japanese Regulatory Authorities [Member] | |||
Revenues (Details) [Line Items] | |||
Paid to company exclusive distribution rights | $ 1,000 |
Revenues (Details) - Schedule o
Revenues (Details) - Schedule of revenues from warranty and services are not material - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Revenues from Warranty and Services are not Material [Abstarct] | |||
Consoles | $ 1,002 | $ 1,560 | $ 1,817 |
Disposables | 1,336 | 1,208 | 1,006 |
Exclusive distribution agreement | 747 | 1,370 | 1,045 |
Total | $ 3,085 | $ 4,138 | $ 3,868 |
Cost of Revenues (Details) - Sc
Cost of Revenues (Details) - Schedule of cost of revenues - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Cost Revenues [Abstract] | |||
Payroll and related benefits (including share-based compensation) | $ 896 | $ 796 | $ 655 |
Raw materials subcontractors and auxiliary materials | 298 | 828 | 461 |
Shipping | 48 | 50 | 39 |
Royalties to the IIA | 93 | 123 | 116 |
Depreciation | 111 | 33 | 7 |
Others | 194 | 113 | 146 |
Total | $ 1,640 | $ 1,943 | $ 1,424 |
Research and Development Expe_3
Research and Development Expenses (Details) - Schedule of research and development expenses - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Research and Development Expenses [Abstract] | |||
Payroll and related benefits (including share-based compensation) | $ 5,969 | $ 3,748 | $ 2,273 |
Raw materials subcontracted work and consulting | 1,742 | 1,440 | 1,058 |
Clinical trials | 495 | 200 | 159 |
Others | 917 | 489 | 319 |
Total | $ 9,123 | $ 5,877 | $ 3,809 |
Sales and Marketing Expenses (D
Sales and Marketing Expenses (Details) - Schedule of sales and marketing expenses - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Sales and Marketing Expenses [Abstract] | |||
Payroll and related benefits (including share-based compensation) | $ 1,599 | $ 1,036 | $ 576 |
Consulting and professional services | 431 | 215 | 157 |
Travel | 274 | 126 | 29 |
Advertising and promotion expenses | 74 | 60 | 36 |
Sales commissions | 13 | 60 | 57 |
Conferences | 301 | 93 | 33 |
Others | 512 | 327 | 175 |
Total | $ 3,204 | $ 1,917 | $ 1,063 |
General and Administrative Ex_3
General and Administrative Expenses (Details) - Schedule of general and administrative expenses - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of General and Administrative Expenses [Abstract] | |||
Payroll and related benefits (including share-based compensation) | $ 2,262 | $ 1,403 | $ 965 |
Professional services | 3,369 | 2,440 | 611 |
Others | 226 | 282 | 138 |
Total | $ 5,857 | $ 4,125 | $ 1,714 |
Taxes on Income (Details)
Taxes on Income (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Taxes on Income (Details) [Line Items] | |||
Income Taxes description | The China subsidiary is subject to China tax rate of 2.5% up to taxable income of one million RMB, 5% on taxable income between one million RMB to three million RMB and 20% on taxable income higher than three million RMB, for the year ended December 31, 2022. | ||
Accumulated tax loss (in Dollars) | $ 74,710 | ||
Deferred tax assets (in Dollars) | $ 17,310 | ||
Israeli [Member] | |||
Taxes on Income (Details) [Line Items] | |||
Income tax rate | 23% | 23% | 23% |
U.S. [Member] | |||
Taxes on Income (Details) [Line Items] | |||
Income tax rate | 21% | 21% | 21% |
Taxes on Income (Details) - Sch
Taxes on Income (Details) - Schedule of deferred tax assets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule of Deferred Tax Assets [Abstract] | ||
Net loss carryforward | $ 17,183 | $ 14,113 |
Other reserves and allowance | 127 | 94 |
Total deferred tax assets | 17,310 | 14,207 |
Valuation allowance | (17,310) | (14,207) |
Net deferred tax asset |
Taxes on Income (Details) - S_2
Taxes on Income (Details) - Schedule of tax expense to the company’s theoretical statutory tax benefit - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | ||
Schedule of Effective Income Tax Rate Reconciliation [Abstract] | ||||
Local | $ 16,952 | $ 10,081 | $ 3,735 | |
Foreign | [1] | 26 | (186) | (5) |
Net loss, as reported in the consolidated statements of comprehensive loss | $ 16,978 | $ 9,895 | $ 3,730 | |
Israeli statutory income tax rate | 23% | 23% | 23% | |
Theoretical tax benefit | $ 3,905 | $ 2,276 | $ 858 | |
Losses and other items for which a valuation allowance was provided or benefit from loss carryforwards | (3,905) | (2,161) | (858) | |
Other | (115) | |||
Income tax expense | ||||
[1]Foreign is amount related to the US & China Subsidiaries |
Geographic and Significant Cu_3
Geographic and Significant Customer Information (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Geographic and Significant Customer Information [Abstract] | |
Total revenue percentage | 10% |
Geographic and Significant Cu_4
Geographic and Significant Customer Information (Details) - Schedule of sets forth reporting revenue information - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Total | $ 3,085 | $ 4,138 | $ 3,868 | |
Japan [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Total | 1,130 | 1,380 | 2,097 | |
Israel [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Total | 30 | 108 | 7 | |
United States [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Total | 604 | 471 | 276 | |
Thailand [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Total | 30 | 964 | 528 | |
Other Countries [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Total | [1] | $ 1,291 | $ 1,215 | $ 960 |
[1]No country represented is greater than 10% of our revenue as of the years presented, other than the countries presented above. |
Geographic and Significant Cu_5
Geographic and Significant Customer Information (Details) - Schedule of sets forth reporting property and equipment information - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Geographic and Significant Customer Information (Details) - Schedule of sets forth reporting property and equipment information [Line Items] | ||
Total | $ 1,356 | $ 713 |
Israel [Member] | ||
Geographic and Significant Customer Information (Details) - Schedule of sets forth reporting property and equipment information [Line Items] | ||
Total | 929 | 622 |
United States [Member] | ||
Geographic and Significant Customer Information (Details) - Schedule of sets forth reporting property and equipment information [Line Items] | ||
Total | $ 427 | $ 91 |
Geographic and Significant Cu_6
Geographic and Significant Customer Information (Details) - Schedule of customer concentrations as a percentage of revenue | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |||
Customer A [Member] | ||||||
Concentration Risk [Line Items] | ||||||
Percentage of customer concentrations | 25% | 30% | 47% | |||
Customer B [Member] | ||||||
Concentration Risk [Line Items] | ||||||
Percentage of customer concentrations | [1] | 14% | ||||
Customer C [Member] | ||||||
Concentration Risk [Line Items] | ||||||
Percentage of customer concentrations | [1] | 23% | ||||
Customer D [Member] | ||||||
Concentration Risk [Line Items] | ||||||
Percentage of customer concentrations | 20% | 11% | [1] | |||
[1]Lower than 10% |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] | 1 Months Ended | ||
Feb. 01, 2023 | Feb. 19, 2023 $ / shares shares | Feb. 19, 2023 ₪ / shares shares | |
Subsequent Events (Details) [Line Items] | |||
Options to purchase | 1,080,992 | 1,080,992 | |
Aggregate of ordinary shares | 1,066,528 | 1,066,528 | |
Shares of options | 172,321 | 172,321 | |
Exercise price per share | (per share) | $ 1.37 | ₪ 4.68 | |
Exercisable date of grant | 10 years | ||
Subsequent event description | Company granted to a consultant of the company 41,412 options to purchase an aggregate of 41,412 ordinary shares, at an exercise price of NIS 4.68 (approximately $1.37) per share. The options will vest as follows: 6 equal quarterly installments from February 19, 2023. The options are exercisable for 10 years from the date of grant. | Company granted to a consultant of the company 41,412 options to purchase an aggregate of 41,412 ordinary shares, at an exercise price of NIS 4.68 (approximately $1.37) per share. The options will vest as follows: 6 equal quarterly installments from February 19, 2023. The options are exercisable for 10 years from the date of grant. | |
Six Officers [Member] | |||
Subsequent Events (Details) [Line Items] | |||
Shares of options | 656,300 | 656,300 | |
Board of Directors Chairman [Member] | |||
Subsequent Events (Details) [Line Items] | |||
Shares of options | 252,371 | 252,371 |