16 unchanged sentences
Important factors that could cause such differences include, but are not limited to:
−Removed: history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty
−Removed: regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to
−Removed: continue as a going concern;
−Removed: need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult
−Removed: to obtain and could dilute out stockholders’ ownership interests;
−Removed: inability to secure and maintain regulatory approvals for the sale of our products;
−Removed: clinical trial results or lengthy product delays in key markets;
−Removed: ability to maintain compliance with the Nasdaq Capital Market listing standards;
−Removed: ability to generate revenues from our products and obtain and maintain regulatory approvals for our products;
−Removed: ability to adequately protect our intellectual property rights;
−Removed: dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards;
−Removed: risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology
−Removed: is an attractive alternative to other procedures and products;
−Removed: competition in our industry, with competitors having greater financial, technological, research and development, regulatory and clinical,
−Removed: manufacturing, marketing and sales, distribution and personnel resources than we do;
−Removed: of new competitors and products and potential technological obsolescence of our products;
−Removed: to carry out research, development and commercialization plans;
−Removed: of a key customer or supplier;
−Removed: problems with our research and products and potential product liability claims;
−Removed: malfunctions;
−Removed: increases for supplies and components;
−Removed: economic conditions;
−Removed: or inadequate reimbursement by governmental and other third-party payers for our products;
−Removed: federal, state and local government regulation in the United States, Europe, Israel and other foreign jurisdictions;
−Removed: fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical
−Removed: and communications challenges, burdens and costs of compliance with foreign laws and political and economic volatility in certain
−Removed: jurisdictions;
−Removed: escalation of hostilities in Israel, which could impair our ability to manufacture our products;
−Removed: or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated
−Removed: liquidity risk.
+Added: our history of recurring
+Added: losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy
+Added: of our liquidity to pursue our complete business objectives;
+Added: our need to raise additional
+Added: capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute
+Added: out stockholders’ ownership interests;
+Added: an inability to secure
+Added: and maintain regulatory approvals for the sale of our products;
+Added: negative clinical trial
+Added: results or lengthy product delays in key markets;
+Added: our ability to maintain
+Added: compliance with the Nasdaq Capital Market listing standards;
+Added: our ability to generate
+Added: revenues from our products and obtain and maintain regulatory approvals for our products;
+Added: our ability to adequately
+Added: protect our intellectual property rights;
+Added: our dependence on a single
+Added: manufacturing facility and our ability to comply with stringent manufacturing quality standards;
+Added: the risk that the data
+Added: collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive
+Added: alternative to other procedures and products;
+Added: intense competition in
+Added: our industry, with competitors having greater financial, technological, research and development, regulatory and clinical, manufacturing,
+Added: marketing and sales, distribution and personnel resources than we do;
+Added: entry of new competitors
+Added: and products and potential technological obsolescence of our products;
+Added: inability to carry out
+Added: research, development and commercialization plans;
+Added: loss of a key customer
+Added: technical problems with
+Added: our research and products and potential product liability claims;
+Added: product malfunctions;
+Added: price increases for supplies
+Added: and components;
+Added: adverse economic conditions;
+Added: insufficient or inadequate
+Added: reimbursement by governmental and other third-party payers for our products;
+Added: adverse federal, state
+Added: and local government regulation in the United States, Europe, Israel and other foreign jurisdictions;
+Added: the fact that we conduct
+Added: business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications
+Added: challenges, burdens and costs of compliance with foreign laws and political and economic volatility in certain jurisdictions;
+Added: the escalation of hostilities
+Added: in Israel, which could impair our ability to manufacture our products;
+Added: current or future unfavorable economic and market conditions
+Added: and adverse developments with respect to financial institutions and associated liquidity risk.
foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or
37 unchanged sentences
C-Guardians is a prospective, multicenter, single-arm, pivotal study to evaluate
−Removed: the safety and efficacy of the CGuard™ Carotid Sten System when used to treat symptomatic and asymptomatic carotid artery stenosis
+Added: the safety and efficacy of the CGuard™ Carotid Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis
in patients undergoing carotid artery stenting.
9 unchanged sentences
primary endpoint rate is < 11.6% and the p-value is less than 0.025.
−Removed: July 23, 2021, we announced the initiation of enrollment and successful completion of the first cases of our C-Guardian trial of CGuard
−Removed: There are 315 patients who are expected to be enrolled in the trial and receive CGuard EPS in the treatment of carotid artery stenosis
−Removed: in symptomatic and asymptomatic patients undergoing carotid artery stenting.
−Removed: We are currently continuing with the enrolment phase at
−Removed: approximately 20 trial sites and expect it to be completed approximately at the end of the second quarter of 2023.
+Added: In June 2023, we completed enrollment of 315 patients across
+Added: 25 trial sites in the U.S.
+Added: and Europe in our IDE clinical trial,
Additionally,
21 unchanged sentences
were organized in the State of Delaware on February 29, 2008.
−Removed: Recent Developments
−Removed: Private Placement
May 12, 2023, we entered into a securities purchase agreement (the “Purchase Agreement”) pursuant to which we agreed to sell
2 unchanged sentences
common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants to purchase
−Removed: up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078 shares of
−Removed: common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the “Series
+Added: up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078 shares
+Added: of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the “Series
J Warrants”) and Series K warrants to purchase up to 12,914,086 shares of common stock (the “Series K Warrants” and
1 unchanged sentence
per Private Placement Share and associated Warrants and an offering price of $1.6326 per Pre-Funded Warrant and associated Warrants.
−Removed: Pre-Funded Warrants will be immediately exercisable at an exercise price of $0.0001 per share and will not expire until exercised in full.
−Removed: The Warrants will be immediately exercisable upon issuance at an exercise price of $1.3827 per share, subject to adjustment as set forth
−Removed: The Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) (A) in the case of the Series H
−Removed: Warrants, 20 trading days following the Company’s public release of primary and secondary end points related to one year follow
−Removed: up study results from the Company’s C-Guardians pivotal trial, (B) in the case of the Series I Warrants, 20 trading days following
−Removed: the Company’s announcement of receipt of Premarket Approval from the Food and Drug Administration (“FDA”) for the CGuard
−Removed: Prime Carotid Stent System (135 cm), (C) in the case of the Series J Warrants, 20 trading days following the Company’s announcement
−Removed: of receipt of FDA approval for the SwitchGuard and CGuard Prime 80 and (D) in the case on the Series K Warrants, 20 trading days following
−Removed: the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid Stent System in
−Removed: the United States begins.
−Removed: The Warrants may be exercised on a cashless basis if there is no effective registration statement registering
−Removed: the shares underlying the warrants.
+Added: Pre-Funded Warrants will be immediately exercisable at an exercise price of $0.0001 per share and will not expire until exercised in
+Added: The Warrants will be immediately exercisable upon issuance at an exercise price of $1.3827 per share, subject to adjustment as
+Added: set forth therein.
+Added: The Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) (A) in the case of the
+Added: Series H Warrants, 20 trading days following the Company’s public release of primary and secondary end points related to one year
+Added: follow up study results from the Company’s C-Guardians pivotal trial, (B) in the case of the Series I Warrants, 20 trading days
+Added: following the Company’s announcement of receipt of Premarket Approval from the Food and Drug Administration (“FDA”)
+Added: for the CGuard Prime Carotid Stent System (135 cm), (C) in the case of the Series J Warrants, 20 trading days following the Company’s
+Added: announcement of receipt of FDA approval for the SwitchGuard and CGuard Prime 80 and (D) in the case on the Series K Warrants, 20 trading
+Added: days following the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid
+Added: Stent System in the United States begins.
+Added: Warrants may be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the Warrants.
+Added: Under the terms of the Pre-Funded Warrants and Warrants, certain of the selling stockholders may not exercise the Pre-Funded Warrants
+Added: or Warrants to the extent such exercise would cause such selling stockholder, together with its affiliates and attribution parties, to
+Added: beneficially own a number of shares of common stock which would exceed 4.99% or 9.99% of our then outstanding common stock following
+Added: such exercise, excluding for purposes of such determination common stock issuable upon exercise of the Pre-Funded Warrants or Warrants
+Added: which have not been exercised.
+Added: The Warrants may be exercised into pre-funded warrants if the selling stockholder is unable to exercise
+Added: the Warrant due to the foregoing beneficial ownership limitation or at the selling shareholder’s election.
connection with the Purchase Agreement, we entered into a registration rights agreement (the “Registration Rights Agreement”).
5 unchanged sentences
We will be obligated to pay
−Removed: certain liquidated damages if we fail to file the Registration Statement when required, fails to cause the Registration Statement to be
−Removed: declared effective by the SEC when required, of if we fail to maintain the effectiveness of the Registration Statement.
−Removed: gross proceeds to us in respect of the Private Placement Offering are expected to be approximately $42.2 million, before deducting fees
−Removed: payable to the placement agent and other offering expenses.
−Removed: If the Warrants are exercised in cash in full this would result in an additional
−Removed: $71.4 million of proceeds.
−Removed: agreed to pay LifeSci Capital LLC, a placement fee equal to 5.6% of the aggregate gross proceeds from the closing of the Private Placement
−Removed: Offering and a non-accountable expense allowance of $25,000.
−Removed: In addition, we have agreed to pay Piper Sandler & Co.
−Removed: a financial advisory
−Removed: fee of $1.5 million and AGP/Alliance Global Partners a financial advisory fee of $250,000.
−Removed: Private Placement Offering is expected to close on or about May 15, 2023, subject to satisfaction of customary closing conditions.
+Added: certain liquidated damages if we fail to file the Registration Statement when required, fails to cause the Registration Statement to
+Added: be declared effective by the SEC when required, of if we fail to maintain the effectiveness of the Registration Statement.
+Added: The Registration
+Added: Statement was subsequently filed on May 23, 2023 and declared effective on June 1, 2023.
+Added: We paid LifeSci Capital LLC, a placement fee
+Added: equal to 5.6% of the aggregate gross proceeds from the closing of the Private Placement Offering, or approximately $2.4 million, and
+Added: legal expenses of $41,600.
+Added: In addition, we paid Piper Sandler & Co.
+Added: a financial advisory fee of $1.5 million, AGP/Alliance Global
+Added: Partners a financial advisory fee of $250,000 and lead investor counsel expenses of $125,000.
Accounting Policies
5 unchanged sentences
Statements included in the Annual Report on Form 10-K for the year ended December 31, 2022.
−Removed: There have not been any material changes
−Removed: to such critical accounting policies since December 31, 2022.
+Added: Other than the following new accounting policies,
+Added: there have not been any material changes to such critical accounting policies since December 31, 2022.
+Added: and Cash Equivalents
+Added: consider all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents.
+Added: As of June 30, 2023, cash and cash equivalents consisted of cash, short-term deposits (up to three months from the date of deposit) and
+Added: money market funds.
+Added: As of December 31, 2022, this balance consisted solely of cash.
+Added: securities consist of debt securities.
+Added: we elected the fair value option to measure and recognize its investments in debt securities in
+Added: accordance with ASC 825, Financial Instruments as we manage our portfolio and evaluates the performance on a fair value basis.
+Added: in fair value, realized gains and losses on sales of marketable securities, are reflected in the statements of operation as finance expense
+Added: (income), net.
currency of the primary economic environment in which our operations are conducted is the U.S.
10 unchanged sentences
of Operations
−Removed: months ended March 31, 2023, compared to the three months ended March 31, 2022
−Removed: For the three months ended March 31, 2023, revenue increased by $56,000, or 4.7%, to $1,239,000, from $1,183,000 during the three months
−Removed: ended March 31, 2022.
+Added: months ended June 30, 2023, compared to the three months ended June 30, 2022
+Added: For the three months ended June 30, 2023, revenue increased by $118,000, or 7.7%, to $1,649,000, from $1,531,000 during the three months
+Added: ended June 30, 2022.
This increase was predominantly driven by a 9.6% increase in sales of CGuard EPS from $1,505,000 during the three
−Removed: months ended March 31, 2022, to $1,239,000 during the three months ended March 31, 2023.
−Removed: During the second half of the quarter, our CE
−Removed: mark was reinstated under the MDD directive allowing us to resume sales and shipments to the EU countries and we spent the remainder
−Removed: of the quarter shipping product in order to reduce the backlog of orders that accumulated over the past few months.
−Removed: We believe the quarter
−Removed: over quarter increase in revenue is not representative of the real market demand for CGuard EPS, due to our inability to ship product
−Removed: for the first half of the quarter.
−Removed: We continue to expedite the review process for recertification under the MDR.
−Removed: respect to geographical regions, the increase in revenue was primarily attributable to a $177,000 increase in Europe, for reasons mentioned
−Removed: in the paragraph above, and a $13,000 increase from the Middle East.
−Removed: This increase was offset by a $87,000 decrease in Latin America
−Removed: and $52,000 decrease in revenue from other regions such as Australia and Asia due to the timing of shipments to our distributers.
−Removed: For the three months ended March 31, 2023, gross profit (revenue less cost of revenues) increased by $251,000, or 205.6%,
−Removed: to $373,000, from $122,000 during the three months ended March 31, 2022.
−Removed: This increase in gross profit resulted from a decrease in write-offs
−Removed: of $184,000 and a $71,000 increase in revenues (as mentioned above), less the associated related material and labor.
−Removed: Gross margin (gross
−Removed: profits as a percentage of revenue) increased to 30.1% during the three months ended March 31, 2023 from 10.3% during the three months
−Removed: ended March 31, 2022, driven by the factors mentioned above.
+Added: months ended June 30, 2022, to $1,649,000 during the three months ended June 30, 2023.
+Added: This sales increase was mainly due to growth in
+Added: existing markets.
+Added: respect to geographical regions, the increase in revenue was primarily attributable to a $63,000 increase in Asia, a $53,000 increase
+Added: in Latin America and a $13,000 increase in other geographies, for reasons mentioned in the paragraph above.
+Added: increase was offset by a $11,000 decrease in Europe.
+Added: For the three months ended June 30, 2023, gross profit (revenue less cost of revenues) increased by $60,000, or 14.0%, to
+Added: $491,000, from $431,000 during the three months ended June 30, 2022.
+Added: This increase in gross profit resulted from a $90,000 increase in
+Added: revenues (as mentioned above), less the associated related material and labor offset by $30,000 in miscellaneous expenses.
+Added: Gross margin (gross profits as a percentage of revenue) increased to 29.8% during the three months ended June 30, 2023, from 28.1% during
+Added: the three months ended June 30, 2022, driven by the factors mentioned above.
and Development Expenses .
−Removed: For the three months ended March 31, 2023, research and development expenses increased by $163,000, or
−Removed: 9.7%, to $1,843,000, from $1,680,000 during the three months ended March 31, 2022.
−Removed: This increase resulted primarily from an increase
−Removed: of $170,000 in expenses related to the CGuard Prime regulatory and approval process and an increase of $88,000 in miscellaneous expenses
−Removed: offset, in part, by a decrease of $95,000 in expenses related to the C-Guardians FDA study.
+Added: For the three months ended June 30, 2023, research and development expenses decreased by $63,000, or 3.1%,
+Added: to $1,993,000, from $2,056,000 during the three months ended June 30, 2022.
+Added: This decrease resulted primarily from a decrease of $261,000
+Added: in expenses related to the C-Guardians FDA study, offset, in part, by an increase of $132,000 in compensation expenses, and an increase
+Added: of $66,000 in miscellaneous expenses.
and Marketing Expenses .
−Removed: For the three months ended March 31, 2023, selling and marketing expenses increased by $42,000, or 5.6%,
−Removed: to $788,000, from $746,000 during the three months ended March 31, 2022.
−Removed: This increase resulted primarily from an increase in compensation
−Removed: expenses of $49,000 offset, in part, by a decrease of $7,000 in miscellaneous expenses.
+Added: For the three months ended June 30, 2023, selling and marketing expenses decreased by $94,000, or 9.5%, to
+Added: $892,000, from $986,000 during the three months ended June 30, 2022.
+Added: This decrease resulted primarily from a decrease in compensation
+Added: expenses of $104,000 offset, in part, by an increase of $10,000 in miscellaneous expenses.
and Administrative Expenses .
−Removed: For the three months ended March 31, 2023, general and administrative expenses decreased by $59,000,
−Removed: or 2.7%, to $2,123,000, from $2,182,000 during the three months ended March 31, 2022.
−Removed: This decrease resulted primarily from a decrease
−Removed: in share-based compensation-related expenses of $310,000 as no new grants were made from the fourth quarter of 2021 through March 31,
−Removed: 2023 offset, in part, by an increase in regulatory expenses of $171,000 related to MDR registration process and an increase of $80,000
−Removed: in miscellaneous expenses.
−Removed: For the three months ended March 31, 2023, financial income increased by $120,000, to $125,000, from $5,000 during the three
−Removed: months ended March 31, 2022.
+Added: For the three months ended June 30, 2023, general and administrative expenses increased by $851,000,
+Added: or 41.1%, to $2,921,000, from $2,070,000 during the three months ended June 30, 2022.
+Added: This increase resulted primarily from an increase
+Added: in compensation expenses of $457,000, mainly due to an increase of approximately $257,000 of share-based compensation-related expenses
+Added: due to the expense recognition of grants made during the second quarter of 2023 and an increase in salary expenses and related accruals
+Added: of $208,000 mainly due to hiring of a General Manager of North America and VP of Global Marketing, an increase of legal expenses
+Added: of $219,000 and an increase of $175,000 in miscellaneous expenses.
+Added: For the three months ended June 30, 2023, financial income increased by $193,000, to $238,000, from $45,000 during the three
+Added: months ended June 30, 2022.
The increase in financial income primarily resulted from a $211,000
−Removed: increase in interest income from short-term bank deposits .
−Removed: For the three months ended March 31, 2023, there was no change in our tax expenses as compared to the three months ended
−Removed: March 31, 2022.
−Removed: Our net loss decreased by $225,000, or 5.0%, to $4,256,000, for the three months ended March 31, 2023, from $4,481,000 during
−Removed: the three months ended March 31, 2022.
−Removed: The decrease in net loss resulted primarily from an increase of $251,000 in gross profit and an
−Removed: increase of $120,000 in financial income partially offset by an increase of $146,000 in operating expenses.
+Added: increase in interest income from investment in marketable securities, money market funds and short-term bank deposits .
+Added: For the three months ended June 30, 2023, there was no change in our tax expenses as compared to the three months ended
+Added: June 30, 2022.
+Added: Our net loss increased by $441,000, or 9.5%, to $5,077,000, for the three months ended June 30, 2023, from $4,636,000 during
+Added: the three months ended June 30, 2022.
+Added: The increase in net loss resulted primarily from an increase of $694,000 in operating expenses
+Added: partially offset by an increase of $193,000 in financial income and an increase of $60,000 in gross profit.
+Added: months ended June 30, 2023, compared to the six months ended June 30, 2022
+Added: For the six months ended June 30, 2023, revenue increased by $174,000, or 6.4%, to $2,888,000, from $2,714,000 during the six months
+Added: ended June 30, 2022.
+Added: This increase was predominantly driven by a 8.3% increase in sales volume of CGuard EPS from $2,666,000 during the
+Added: six months ended June 30, 2022, to $2,888,000 during the six months ended June 30, 2023.
+Added: This sales increase was mainly due to growth
+Added: in existing markets.
+Added: respect to geographical regions, the increase in revenue was primarily attributable to a $167,000 increase in Europe, a $38,000 increase
+Added: in Asia and a $3,000 increase in other geographies.
+Added: This increase in sales of was partially offset by a $34,000 decrease in Latin
+Added: This growth was mainly due to reason mentioned in the paragraph above.
+Added: For the six months ended June 30, 2023, gross profit (revenue less cost of revenues) increased by 56.2%, or $311,000, to
+Added: $864,000, compared to a $553,000 for the same period in 2022.
+Added: This increase in gross profit resulted from a decrease in write-offs of
+Added: $181,000 and a $161,000 increase in revenues (as mentioned above) less the associated related material and labor costs.
+Added: This increase
+Added: was partially offset by an increase of $31,000 in miscellaneous expenses.
+Added: Gross margin (gross profits as a percentage of revenue) increased
+Added: to 29.9% during the six months ended June 30, 2023, from 20.4% during the six months ended June 30, 2022, driven by the reasons mentioned
+Added: and Development Expenses .
+Added: Research and Development Expenses .
+Added: For the six months ended June 30, 2023, research and
+Added: development expenses increased by 2.7%, or $100,000, to $3,836,000, from $3,736,000 during the six months ended June 30, 2022.
+Added: increase resulted primarily from an increase of $158,000 in expenses related to the CGuard Prime regulatory and approval process,
+Added: increase in compensation expenses of $169,000 and an increase of $129,000 in miscellaneous expenses offset, in part, by a decrease
+Added: of $356,000 in expenses related to the C-Guardians FDA study.
+Added: and Marketing Expenses .
+Added: For the six months ended June 30, 2023, selling and marketing expenses decreased by 3.0%, or $52,000, to
+Added: $1,680,000, from $1,732,000 during the six months ended June 30, 2022.
+Added: This decrease resulted primarily from a decrease of approximately
+Added: $64,000 of share-based compensation-related expenses, offset, in part, by an increase of $12,000 in miscellaneous expenses.
+Added: and Administrative Expenses .
+Added: For the six months ended June 30, 2023, general and administrative expenses increased by 18.6%, or $792,000,
+Added: to $5,044,000, from $4,252,000 during the six months ended June 30, 2022.
+Added: This increase resulted primarily from an increase in salary
+Added: expenses of $276,000, an increase in legal expenses of $261,000, an increase in regulatory expenses of $193,000 related to MDR registration
+Added: process and an increase of $62,000 in miscellaneous expenses.
+Added: For the six months ended June 30, 2023, financial income increased by $313,000, to $363,000 of financial income, from $50,000
+Added: of financial income during the six months ended June 30, 2022.
+Added: The increase in financial income primarily resulted from a $299,000 increase
+Added: in interest income from investment in marketable securities, money market funds and short-term
+Added: bank deposits .
+Added: For the six months ended June 30, 2023, there was no change in our tax expenses as compared to the six months ended June
+Added: Our net loss increased by $216,000, or 2.4%, to $9,333,000, for the six months ended June 30, 2023, from $9,117,000 during
+Added: the six months ended June 30, 2022.
+Added: The increase in net loss resulted primarily from an increase of $840,000 in operating expenses, offset
+Added: by an increase of $313,000 in financial income and increase of $311,000 in gross profit.
and Capital Resources
−Removed: had an accumulated deficit as of March 31, 2023 of $206 million, as well as a net loss of $4,256,000 and negative operating cash flows.
−Removed: We expect to continue incurring losses and negative cash flows from operations until our product, CGuard EPS, reaches commercial profitability.
−Removed: As a result of these expected losses and negative cash flows from operations, along with our current cash position, we believe we have
−Removed: sufficient resources to fund operations until the end of September 2023.
−Removed: Therefore, there is substantial doubt about our ability to continue
−Removed: as a going concern.
+Added: of June 30, 2023, we have the ability to fund our planned operations for at least the next 12 months from issuance date of the financial
+Added: However, we expect to continue incurring losses and negative cash flows from operations until our products (primarily CGuard™
+Added: EPS) reach commercial profitability.
+Added: Therefore, in order to fund our operations until such time that we can generate substantial revenues,
+Added: we may need to raise additional funds.
plans include continued commercialization of our products and raising capital through sale of additional equity securities, debt or capital
4 unchanged sentences
curtail or cease operations.
−Removed: On May 12, 2023, we entered into
−Removed: a securities purchase agreement for the issuance and sale of our securities in a private placement.
−Removed: Aggregate gross proceeds to us in
−Removed: respect of the private placement is expected to be approximately $42.2 million, before deducting fees payable to the placement agent and
−Removed: other offering expenses payable us and before exercising any warrants.
−Removed: The offering is expected to close on or about May 15, 2023, subject
−Removed: to the satisfaction of customary closing conditions.
−Removed: months ended March 31, 2023 compared to the three months ended March 31, 2022
−Removed: At March 31, 2023, we had cash and cash equivalents of $4,228,000 and short-term bank deposits of $8,657,000 as compared to $4,632,000
−Removed: and short-term bank deposits of $13,171,000 as of December 31, 2022.
−Removed: We have historically met our cash needs through a combination of
−Removed: issuing new shares, borrowing activities and product sales.
−Removed: Our cash requirements are generally for research and development, marketing
−Removed: and sales activities, finance and administrative costs, capital expenditures and general working capital.
−Removed: the three months ended March 31, 2023, net cash used in our operating activities increased by $697,000, or 16.9%, to $4,831,000, from
+Added: May 2023, we closed a Private Placement Offering that resulted in aggregate gross proceeds of approximately $42.2 million, before deducting
+Added: fees payable to the placement agent and other offering expenses payable by the Company.
+Added: If the Warrants from the Private Placement Offering
+Added: are exercised in cash in full this would result in an additional $71.4 million of gross proceeds.
+Added: months ended June 30, 2023 compared to the six months ended June 30, 2022
+Added: At June 30, 2023, we had cash and cash equivalents of $11,545,000 short-term bank deposits of $6,631,000 and marketable securities of
+Added: $28,817,000 as compared to cash and cash equivalents of $4,632,000 and short-term bank deposits of $13,171,000 as of December 31, 2022.
+Added: We have historically met our cash needs through a combination of issuing new shares, borrowing activities and product sales.
+Added: requirements are generally for research and development, marketing and sales activities, finance and administrative costs, capital expenditures
+Added: and general working capital.
+Added: the six months ended June 30, 2023, net cash used in our operating activities increased by $913,000, or 12.6%, to $8,156,000, from $7,243,000
during the same period in 2022.
−Removed: The primary reason for the increase in cash used in our operating activities was an increase
−Removed: of $449,000 in compensation costs paid during the three months ended March 31, 2023 from $2,679,000 in the three months ended March 31,
−Removed: 2022 to $3,128,000 during the same period in 2023 and a decrease of $366,000 in payments received from customers, to $925,000 during
−Removed: the three months ended March 31, 2023 from $1,291,000 during the same period in 2022 ,offset in part by a decrease of $118,000 in payments
−Removed: for third party related expenses and for professional services
−Removed: provided in our investing activities was $4,449,000 during the three months ended March 31, 2023, compared to cash used of $65,000 during
−Removed: the three months ended March 31, 2022.
−Removed: The primary reasons for the increase in cash provided by our investing activities is a withdrawal
−Removed: of short-term deposits, net of investments of $4,500,000 of short-term deposits, offset by a decrease of $12,000 in payments made for
−Removed: purchase of property, plant and equipment to $25,000 during the three months ended March 31, 2023.
−Removed: was no cash provided by financing activities for the three months ended March 31, 2023 and for the three months ended March 31, 2022.
−Removed: of March 31, 2023, our current assets exceeded our current liabilities by a multiple of 3.8.
−Removed: Current assets decreased by $4,623,000 during
−Removed: the period and current liabilities decreased by $687,000 during the period.
−Removed: As a result, our working capital decreased by $3,936,000
−Removed: to $12,320,000 as of March 31, 2023.
+Added: The primary reason for the increase in cash used in our operating activities was an increase of $687,000
+Added: in compensation costs paid during the six months ended June 30, 2023 from $4,625,000 in the six months ended June 30, 2022 to $5,312,000
+Added: during the same period in 2023 and a decrease of $235,000 in payments received from customers, to $2,472,000 during the six months ended
+Added: June 30, 2023 from $2,707,000 during the same period in 2022, offset in part by a decrease of $9,000 in payments for third party related
+Added: expenses and for professional services.
+Added: used in our investing activities was $22,442,000 during the six months ended June 30, 2023, compared to cash provided of $1,801,000 during
+Added: the six months ended June 30, 2022.
+Added: The primary reasons for the increase in cash used by our investing activities is an investment in
+Added: marketable securities of $28,838,000, offset by an increase in withdrawal from short-term bank deposits, net of investment in short-term
+Added: deposits, of $4,500,00, and a decrease of $82,000 in payments made for purchase of property, plant and equipment to $70,000 during the
+Added: three months ended June 30, 2023.
+Added: provided by financing activities for the six months June 30, 2023, was $37,534,000.
+Added: The principal source of the cash provided by financing
+Added: activities during the six months ended June 30, 2023 were the proceeds from the Private Placement Offering in May 2023 that resulted
+Added: in approximately $37,534,000 of aggregate net proceeds.
+Added: Cash used by financing activities for the six months ended June 30, 2022 was
+Added: $37,000 and the cash used by financing activities during the six months ended June 30, 2022 were due to issuance cost associated with
+Added: a shelf registration statement on Form S-3 filed with the SEC on June 3, 2022.
+Added: of June 30, 2023, our current assets exceeded our current liabilities by a multiple of 10.5.
+Added: Current assets increased by $29,194,000
+Added: during the period and current liabilities decreased by $241,000 during the period.
+Added: As a result, our working capital increased by $29,435,000
+Added: to $45,691,000 as of June 30, 2023.
Balance Sheet Arrangements
11 unchanged sentences
Obligations and Commitments
−Removed: the three months ended March 31, 2023, there were no material changes to our contractual obligations and commitments.
+Added: the three months ended June 30, 2023, there were no material changes to our contractual obligations and commitments.
+Added: Adopted and Issued Accounting Pronouncements
+Added: Note 3 to our condensed financial statements in Part I, Item 1 of this Quarterly Report on Form 10-Q for new accounting pronouncements
Quantitative and Qualitative Disclosures About Market Risk.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.