2023 Q2 Form 10-Q Financial Statement
#000149315223017317 Filed on May 15, 2023
Income Statement
Concept | 2023 Q2 | 2023 Q1 | 2022 Q1 |
---|---|---|---|
Revenue | $1.649M | $1.239M | $1.183M |
YoY Change | 7.71% | 4.73% | 17.59% |
Cost Of Revenue | $1.158M | $866.0K | $1.061M |
YoY Change | 5.27% | -18.38% | 17.89% |
Gross Profit | $491.0K | $373.0K | $122.0K |
YoY Change | 13.92% | 205.74% | 15.09% |
Gross Profit Margin | 29.78% | 30.1% | 10.31% |
Selling, General & Admin | $3.813M | $2.911M | $2.928M |
YoY Change | 24.77% | -0.58% | 13.44% |
% of Gross Profit | 776.58% | 780.43% | 2400.0% |
Research & Development | $1.993M | $1.843M | $1.680M |
YoY Change | -3.06% | 9.7% | 100.24% |
% of Gross Profit | 405.91% | 494.1% | 1377.05% |
Depreciation & Amortization | $58.00K | $55.00K | $41.00K |
YoY Change | 34.88% | 34.15% | -19.61% |
% of Gross Profit | 11.81% | 14.75% | 33.61% |
Operating Expenses | $5.806M | $4.754M | $4.608M |
YoY Change | 13.58% | 3.17% | 34.74% |
Operating Profit | -$5.315M | -$4.381M | -$4.486M |
YoY Change | 13.54% | -2.34% | 35.37% |
Interest Expense | |||
YoY Change | |||
% of Operating Profit | |||
Other Income/Expense, Net | $238.0K | $125.0K | $5.000K |
YoY Change | 428.89% | 2400.0% | -92.96% |
Pretax Income | -$5.077M | -$4.256M | -$4.481M |
YoY Change | 9.51% | -5.02% | 38.17% |
Income Tax | |||
% Of Pretax Income | |||
Net Earnings | -$5.077M | -$4.256M | -$4.481M |
YoY Change | 9.51% | -5.02% | 38.17% |
Net Earnings / Revenue | -307.88% | -343.5% | -378.78% |
Basic Earnings Per Share | -$0.24 | -$0.53 | -$0.57 |
Diluted Earnings Per Share | -$0.24 | -$0.53 | -$574.2K |
COMMON SHARES | |||
Basic Shares Outstanding | 8.356M shares | 8.327M shares | 7.804M shares |
Diluted Shares Outstanding | 21.07M shares | 8.093M shares |
Balance Sheet
Concept | 2023 Q2 | 2023 Q1 | 2022 Q1 |
---|---|---|---|
SHORT-TERM ASSETS | |||
Cash & Short-Term Investments | $46.99M | $12.89M | $29.85M |
YoY Change | 77.53% | -56.84% | -32.21% |
Cash & Equivalents | $11.55M | $4.228M | $7.798M |
Short-Term Investments | $35.45M | $8.657M | $22.05M |
Other Short-Term Assets | $56.00K | $394.0K | $291.0K |
YoY Change | -74.66% | 35.4% | 40.58% |
Inventory | $1.689M | $1.697M | $1.286M |
Prepaid Expenses | $56.00K | $394.0K | |
Receivables | $1.470M | $1.417M | $1.113M |
Other Receivables | $312.0K | $310.0K | $91.00K |
Total Short-Term Assets | $50.52M | $16.70M | $32.63M |
YoY Change | 71.25% | -48.81% | -29.44% |
LONG-TERM ASSETS | |||
Property, Plant & Equipment | $2.261M | $887.0K | $1.624M |
YoY Change | 223.0% | -45.38% | -2.29% |
Goodwill | |||
YoY Change | |||
Intangibles | |||
YoY Change | |||
Long-Term Investments | |||
YoY Change | |||
Other Assets | $857.0K | $859.0K | $915.0K |
YoY Change | 0.94% | -6.12% | 26.56% |
Total Long-Term Assets | $3.118M | $3.218M | $2.539M |
YoY Change | -4.53% | 26.74% | 6.46% |
TOTAL ASSETS | |||
Total Short-Term Assets | $50.52M | $16.70M | $32.63M |
Total Long-Term Assets | $3.118M | $3.218M | $2.539M |
Total Assets | $53.64M | $19.92M | $35.17M |
YoY Change | 63.7% | -43.36% | -27.68% |
SHORT-TERM LIABILITIES | |||
YoY Change | |||
Accounts Payable | $4.829M | $607.0K | $900.0K |
YoY Change | 328.48% | -32.56% | 124.44% |
Accrued Expenses | $742.0K | $933.0K | $2.696M |
YoY Change | -52.53% | -65.39% | 15.21% |
Deferred Revenue | |||
YoY Change | |||
Short-Term Debt | $0.00 | $0.00 | $0.00 |
YoY Change | |||
Long-Term Debt Due | |||
YoY Change | |||
Total Short-Term Liabilities | $4.829M | $4.383M | $3.691M |
YoY Change | 2.48% | 18.75% | 28.79% |
LONG-TERM LIABILITIES | |||
Long-Term Debt | $0.00 | $0.00 | $0.00 |
YoY Change | |||
Other Long-Term Liabilities | $1.996M | $2.112M | $1.776M |
YoY Change | -13.67% | 18.92% | -2.15% |
Total Long-Term Liabilities | $1.996M | $2.112M | $1.776M |
YoY Change | -13.67% | 18.92% | -2.15% |
TOTAL LIABILITIES | |||
Total Short-Term Liabilities | $4.829M | $4.383M | $3.691M |
Total Long-Term Liabilities | $1.996M | $2.112M | $1.776M |
Total Liabilities | $6.825M | $6.495M | $5.467M |
YoY Change | -2.83% | 18.8% | 16.79% |
SHAREHOLDERS EQUITY | |||
Retained Earnings | -$210.9M | -$205.8M | |
YoY Change | 9.73% | ||
Common Stock | $2.000K | $1.000K | |
YoY Change | 100.0% | ||
Preferred Stock | |||
YoY Change | |||
Treasury Stock (at cost) | |||
YoY Change | |||
Treasury Stock Shares | |||
Shareholders Equity | $46.81M | $13.43M | $29.70M |
YoY Change | |||
Total Liabilities & Shareholders Equity | $53.64M | $19.92M | $35.17M |
YoY Change | 63.7% | -43.36% | -27.68% |
Cashflow Statement
Concept | 2023 Q2 | 2023 Q1 | 2022 Q1 |
---|---|---|---|
OPERATING ACTIVITIES | |||
Net Income | -$5.077M | -$4.256M | -$4.481M |
YoY Change | 9.51% | -5.02% | 38.17% |
Depreciation, Depletion And Amortization | $58.00K | $55.00K | $41.00K |
YoY Change | 34.88% | 34.15% | -19.61% |
Cash From Operating Activities | -$3.325M | -$4.831M | -$4.152M |
YoY Change | 7.57% | 16.35% | 14.03% |
INVESTING ACTIVITIES | |||
Capital Expenditures | $45.00K | $25.00K | -$37.00K |
YoY Change | -139.13% | -167.57% | 42.31% |
Acquisitions | |||
YoY Change | |||
Other Investing Activities | -$26.85M | $4.474M | -$10.00K |
YoY Change | -1467.6% | -44840.0% | -600.0% |
Cash From Investing Activities | -$26.89M | $4.449M | -$47.00K |
YoY Change | -1555.14% | -9565.96% | 95.83% |
FINANCING ACTIVITIES | |||
Cash Dividend Paid | |||
YoY Change | |||
Common Stock Issuance & Retirement, Net | |||
YoY Change | |||
Debt Paid & Issued, Net | |||
YoY Change | |||
Cash From Financing Activities | 37.53M | ||
YoY Change | -101543.24% | ||
NET CHANGE | |||
Cash From Operating Activities | -3.325M | -$4.831M | -4.152M |
Cash From Investing Activities | -26.89M | $4.449M | -47.00K |
Cash From Financing Activities | 37.53M | ||
Net Change In Cash | 7.318M | -$404.0K | $0.00 |
YoY Change | -671.72% | -100.0% | |
FREE CASH FLOW | |||
Cash From Operating Activities | -$3.325M | -$4.831M | -$4.152M |
Capital Expenditures | $45.00K | $25.00K | -$37.00K |
Free Cash Flow | -$3.370M | -$4.856M | -$4.115M |
YoY Change | 13.24% | 18.01% | 13.83% |
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13426000 | usd |
CY2023Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-4256000 | usd |
CY2022Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-4481000 | usd |
CY2023Q1 | us-gaap |
Depreciation
Depreciation
|
55000 | usd |
CY2022Q1 | us-gaap |
Depreciation
Depreciation
|
41000 | usd |
CY2023Q1 | us-gaap |
Defined Benefit Plan Settlements Benefit Obligation
DefinedBenefitPlanSettlementsBenefitObligation
|
36000 | usd |
CY2022Q1 | us-gaap |
Defined Benefit Plan Settlements Benefit Obligation
DefinedBenefitPlanSettlementsBenefitObligation
|
46000 | usd |
CY2023Q1 | us-gaap |
Other Noncash Income Expense
OtherNoncashIncomeExpense
|
-22000 | usd |
CY2022Q1 | us-gaap |
Other Noncash Income Expense
OtherNoncashIncomeExpense
|
-7000 | usd |
CY2023Q1 | NSPR |
Change In Right Of Use Asset And Leasing Liability
ChangeInRightOfUseAssetAndLeasingLiability
|
34000 | usd |
CY2022Q1 | NSPR |
Change In Right Of Use Asset And Leasing Liability
ChangeInRightOfUseAssetAndLeasingLiability
|
25000 | usd |
CY2023Q1 | us-gaap |
Share Based Compensation
ShareBasedCompensation
|
289000 | usd |
CY2022Q1 | us-gaap |
Share Based Compensation
ShareBasedCompensation
|
653000 | usd |
CY2023Q1 | NSPR |
Loss Gains On Amounts Funded In Respect Of Employee Rights Upon Retirement Net
LossGainsOnAmountsFundedInRespectOfEmployeeRightsUponRetirementNet
|
23000 | usd |
CY2022Q1 | NSPR |
Loss Gains On Amounts Funded In Respect Of Employee Rights Upon Retirement Net
LossGainsOnAmountsFundedInRespectOfEmployeeRightsUponRetirementNet
|
18000 | usd |
CY2023Q1 | NSPR |
Interest Income From Shortterm Bank Deposits
InterestIncomeFromShorttermBankDeposits
|
-14000 | usd |
CY2022Q1 | NSPR |
Interest Income From Shortterm Bank Deposits
InterestIncomeFromShorttermBankDeposits
|
17000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Prepaid Expense
IncreaseDecreaseInPrepaidExpense
|
-261000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Prepaid Expense
IncreaseDecreaseInPrepaidExpense
|
-231000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Accounts Receivable
IncreaseDecreaseInAccountsReceivable
|
383000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Accounts Receivable
IncreaseDecreaseInAccountsReceivable
|
-111000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Other Receivables
IncreaseDecreaseInOtherReceivables
|
97000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Other Receivables
IncreaseDecreaseInOtherReceivables
|
-74000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
76000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
143000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Accounts Payable Trade
IncreaseDecreaseInAccountsPayableTrade
|
-52000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Accounts Payable Trade
IncreaseDecreaseInAccountsPayableTrade
|
7000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Other Accounts Payable
IncreaseDecreaseInOtherAccountsPayable
|
-633000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Other Accounts Payable
IncreaseDecreaseInOtherAccountsPayable
|
-656000 | usd |
CY2023Q1 | us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-4831000 | usd |
CY2022Q1 | us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-4134000 | usd |
CY2023Q1 | us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
25000 | usd |
CY2022Q1 | us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
37000 | usd |
CY2023Q1 | us-gaap |
Payments To Acquire Investments
PaymentsToAcquireInvestments
|
2500000 | usd |
CY2022Q1 | us-gaap |
Payments To Acquire Investments
PaymentsToAcquireInvestments
|
6000000 | usd |
CY2023Q1 | us-gaap |
Proceeds From Sale Maturity And Collections Of Investments
ProceedsFromSaleMaturityAndCollectionsOfInvestments
|
7000000 | usd |
CY2022Q1 | us-gaap |
Proceeds From Sale Maturity And Collections Of Investments
ProceedsFromSaleMaturityAndCollectionsOfInvestments
|
6000000 | usd |
CY2023Q1 | NSPR |
Amounts Withdrawn In Respect Of Employee Rights Upon Retirement Net
AmountsWithdrawnInRespectOfEmployeeRightsUponRetirementNet
|
26000 | usd |
CY2022Q1 | NSPR |
Amounts Withdrawn In Respect Of Employee Rights Upon Retirement Net
AmountsWithdrawnInRespectOfEmployeeRightsUponRetirementNet
|
28000 | usd |
CY2023Q1 | us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
4449000 | usd |
CY2022Q1 | us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
-65000 | usd |
CY2023Q1 | us-gaap |
Effect Of Exchange Rate On Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
EffectOfExchangeRateOnCashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
-22000 | usd |
CY2022Q1 | us-gaap |
Effect Of Exchange Rate On Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
EffectOfExchangeRateOnCashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
-7000 | usd |
CY2023Q1 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
|
-404000 | usd |
CY2022Q1 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
|
-4206000 | usd |
CY2022Q4 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
4632000 | usd |
CY2021Q4 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
12004000 | usd |
CY2023Q1 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
4228000 | usd |
CY2022Q1 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
7798000 | usd |
CY2023Q1 | us-gaap |
Nature Of Operations
NatureOfOperations
|
<p id="xdx_801_eus-gaap--NatureOfOperations_zboRiqJQ4Eg3" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 1 - <span id="xdx_821_zqmIFncsj8fa">DESCRIPTION OF BUSINESS</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>a.</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>General</b></span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">InspireMD, Inc., a Delaware corporation (the “Company”), together with its subsidiaries, is a medical device company focusing on the development and commercialization of its proprietary MicroNet™ stent platform technology for the treatment of complex vascular and coronary disease. MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures. </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company’s carotid product (CGuard™ EPS) combines MicroNet and a self-expandable nitinol stent in a single device to treat carotid artery disease.</span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company’s MGuard™ Prime™ embolic protection system (“MGuard Prime EPS”) was marketed for use in patients with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions, or bypass surgery. MGuard Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent. MGuard Prime EPS received CE mark approval in the European Union in October 2010 for improving luminal diameter and providing embolic protection. Over the past years, there has been a shift in industry preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”) patients. As a result of declining sales of the MGuard Prime EPS, which the Company believes is largely driven by the predominant industry preferences favoring drug-eluting, or drug-coated, stents, during the second quarter of 2022, the Company ceased sales of the Company’s MGuard Prime EPS following a phase out period.</span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company markets its products through distributors in international markets, mainly in Europe.</span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>b.</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Liquidity</b></span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company has an accumulated deficit as of March 31, 2023, as well as a history of net losses and negative operating cash flows in recent years. The Company expects to continue incurring losses and negative cash flows from operations until its product, CGuard™ EPS, reaches commercial profitability. As a result of these expected losses and negative cash flows from operations, along with the Company’s current cash position, the Company has sufficient resources to fund operations until the end of September 2023. Therefore, there is substantial doubt about the Company’s ability to continue as a going concern. These financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Management’s plans include the continued commercialization of the Company’s product and raising capital through the sale of additional equity securities, debt or capital inflows from strategic partnerships. There are no assurances however, that the Company will be successful in obtaining the level of financing needed for its operations. If the Company is unsuccessful in commercializing its products and raising capital, it may need to reduce activities, curtail or cease operations.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"/> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On May 12, 2023, the Company entered into a securities purchase agreement for the issuance and sale of Company securities in a private placement. <span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Aggregate gross proceeds to the Company in respect of the private placement is expected to be approximately $<span id="xdx_90E_eus-gaap--ProceedsFromIssuanceOfPrivatePlacement_pn5n6_c20230511__20230512__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember_zaQThNHS6KN7" title="Private placement">42.2</span> million, before deducting fees payable to the placement agent and other offering expenses payable by the Company and before exercising any warrants. The offering is expected to close on or about May 15, 2023, subject to the satisfaction of customary closing conditions. </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>c.</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Failure to satisfy regulatory requirements of the new European Medical Device Regulation could prevent the Company from marketing CGuard EPS in countries requiring the CE Mark.</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For the European Union nations, medical devices must obtain a CE mark before they may be placed on the market. In order to obtain and maintain the CE mark, the Company must Company with EU law on medical devices, which, until May 26, 2021 was governed by the MDD, by presenting comprehensive technical files for the Company’s products demonstrating safety and efficacy of the product to be placed on the market and passing initial and annual quality management system audit as per ISO 13485 standard by a European Notified Body. The company has obtained ISO 13485 quality system certification and CGuard EPS that the Company currently distribute into the European Union, displays the required CE mark. In order to maintain certification, the Company is required to pass an annual surveillance audit conducted by Notified Body auditors. The European Union replaced the MDD with the new MDR regulations. The MDR entered into force after a transitional period of three years and a one year extension of that transition period due to the COVID-19 pandemic on May 26, 2021 and which changes several aspects of the regulatory framework in the European Union. Manufacturers had the duration of the transition period to update their technical documentation and processes to meet the new requirements in order to obtain a CE Mark. In the Company’s specific case, the Company’s CE mark for CGuard EPS under the MDD expired on November 12, 2022, and the Company is in the final stages of technical documentation review by the Notified Body auditor to meet the MDR requirements for recertification. In the meantime, on February 14, 2023, the Company received a derogation per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines and Health Products (FAMHP) allowing the Company to continue marketing CGuard EPS in the EU until August 15, 2023, subject to certain procedural requirements. Subsequently, on March 20, 2023 Regulation (EU) 2023/607 was published allowing the Company to continue marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027. As a result of the foregoing, the Company may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural requirements while the Company’s MDR CE recertification is pending.</span></p></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="width: 0.5in"> </td> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>d.</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Risks Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe</b></span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td> </td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td> </td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In February 2022, Russia launched a military invasion into Ukraine. The Company derived approximately 12.1% of total sales in Russia and Belarus in 2022 while during the three months ended March 31, 2023 and March 31,2022, The Company’s sales to Russia and Belarus were 7.9% and 1.5% respectively. The escalation of geopolitical instability in Russia and Ukraine as well as currency fluctuations in the Russian Ruble could negatively impact the Company’s operations, sales, and future growth prospects in that region.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As a result of the crisis in Ukraine, the United States and the EU have implemented sanctions against certain Russian individuals and entities and have made it more difficult for the Company to collect on outstanding accounts receivable from customers in this region. The Company’s global operations expose the Company to risks that could adversely affect the Company’s business, financial condition, results of operations, cash flows or the market price of the Company’s securities, including the potential for increased tensions between the United States and Russia resulting from the current situation involving Russia and Ukraine, tariffs, economic sanctions and import-export restrictions imposed by either nation, and retaliatory actions by the other nation, as well as the potential negative impact on the Company’s business and sales in Russia, and Belarus. Current geopolitical instability in Russia and Ukraine and related sanctions by the U.S. government against certain companies and individuals may hinder the Company’s ability to conduct business with potential or existing customers and vendors in these countries.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The U.S. government has imposed sanctions through several executive orders restricting U.S. companies from conducting business with specified Russian individuals and companies. While the Company believes that the executive orders currently do not preclude the Company from conducting business with the Company’s current customers or vendors in Russia, and Belarus, the sanctions imposed by the U.S. government may be expanded in the future to restrict the Company from engaging with them. If the Company is unable to conduct business with new or existing customers or vendors or pursue business opportunities in Russia, or Belarus, the Company’s business, including revenue, profitability and cash flows, and operations could be adversely affected. The Company cannot provide assurance that current sanctions or potential future changes in sanctions will not have a material impact on the Company’s operations in Russia, and Belarus or on the Company’s financial results.</span></p></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> | |
CY2023Q1 | us-gaap |
Basis Of Accounting
BasisOfAccounting
|
<p id="xdx_808_eus-gaap--BasisOfAccounting_z2OTnFICU8t5" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 2 - <span id="xdx_829_zBapmg9ZwAr2">BASIS OF PRESENTATION</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify; text-indent: -12pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The accompanying unaudited consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of the Company, the financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of its financial position as of March 31, 2023 and its results of operations, changes in equity and cash flows for the three months ended March 31, 2023 and 2022. These consolidated financial statements and notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2022, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2023. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of results that could be expected for the entire fiscal year.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> | |
CY2023Q1 | us-gaap |
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
|
2773675 | shares |
CY2022Q1 | us-gaap |
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
|
2903634 | shares |
CY2023Q1 | us-gaap |
Class Of Warrant Or Right Number Of Securities Called By Warrants Or Rights
ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights
|
1793504000 | shares |
CY2023Q1 | us-gaap |
Capital Units Authorized
CapitalUnitsAuthorized
|
155000000 | shares |
CY2023Q1 | NSPR |
Capital Stock Par Or Stated Value Per Share
CapitalStockParOrStatedValuePerShare
|
0.0001 | |
CY2023Q1 | us-gaap |
Common Stock Shares Authorized
CommonStockSharesAuthorized
|
150000000 | shares |
CY2023Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Description
ShareBasedCompensationArrangementByShareBasedPaymentAwardDescription
|
45,000 options are subject to a three-year vesting period (of which 20,000 options are vesting in the first year, 15,000 options are vesting in the second year and 10,000 options are vesting in the third year) and 5,000 options with performance conditions related to marketing activities. | |
CY2023Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
|
0 | pure |
CY2023Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMinimum
|
1.2458 | pure |
CY2023Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMaximum
|
1.2561 | pure |
CY2023Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMinimum
|
0.0365 | pure |
CY2023Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMaximum
|
0.0368 | pure |
CY2023Q1 | us-gaap |
Inventory Finished Goods
InventoryFinishedGoods
|
138000 | usd |
CY2022Q4 | us-gaap |
Inventory Finished Goods
InventoryFinishedGoods
|
179000 | usd |
CY2023Q1 | us-gaap |
Inventory Work In Process
InventoryWorkInProcess
|
690000 | usd |
CY2022Q4 | us-gaap |
Inventory Work In Process
InventoryWorkInProcess
|
510000 | usd |
CY2023Q1 | us-gaap |
Inventory Raw Materials And Supplies
InventoryRawMaterialsAndSupplies
|
869000 | usd |
CY2022Q4 | us-gaap |
Inventory Raw Materials And Supplies
InventoryRawMaterialsAndSupplies
|
932000 | usd |
CY2023Q1 | us-gaap |
Inventory Net
InventoryNet
|
1697000 | usd |
CY2022Q4 | us-gaap |
Inventory Net
InventoryNet
|
1621000 | usd |
CY2023Q1 | us-gaap |
Accrued Salaries Current
AccruedSalariesCurrent
|
970000 | usd |
CY2022Q4 | us-gaap |
Accrued Salaries Current
AccruedSalariesCurrent
|
1853000 | usd |
CY2023Q1 | us-gaap |
Accrued Vacation Current
AccruedVacationCurrent
|
240000 | usd |
CY2022Q4 | us-gaap |
Accrued Vacation Current
AccruedVacationCurrent
|
197000 | usd |
CY2023Q1 | us-gaap |
Accrued Liabilities Current
AccruedLiabilitiesCurrent
|
933000 | usd |
CY2022Q4 | us-gaap |
Accrued Liabilities Current
AccruedLiabilitiesCurrent
|
554000 | usd |
CY2023Q1 | NSPR |
Clinical Trial Accrual Current
ClinicalTrialAccrualCurrent
|
1046000 | usd |
CY2022Q4 | NSPR |
Clinical Trial Accrual Current
ClinicalTrialAccrualCurrent
|
1258000 | usd |
CY2023Q1 | NSPR |
Accrued Operating Lease Liabilities Current
AccruedOperatingLeaseLiabilitiesCurrent
|
417000 | usd |
CY2022Q4 | NSPR |
Accrued Operating Lease Liabilities Current
AccruedOperatingLeaseLiabilitiesCurrent
|
419000 | usd |
CY2023Q1 | us-gaap |
Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
|
170000 | usd |
CY2022Q4 | us-gaap |
Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
|
130000 | usd |
CY2023Q1 | us-gaap |
Accounts Payable Other Current
AccountsPayableOtherCurrent
|
3776000 | usd |
CY2022Q4 | us-gaap |
Accounts Payable Other Current
AccountsPayableOtherCurrent
|
4411000 | usd |
CY2023Q1 | us-gaap |
Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
|
1239000 | usd |
CY2022Q1 | us-gaap |
Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
|
1183000 | usd |
CY2023Q1 | us-gaap |
Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
|
1239000 | usd |
CY2022Q1 | us-gaap |
Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
|
1183000 | usd |