8 unchanged sentences
sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.
−Removed: CGuard EPS combines MicroNet and a self-expandable nitinol stent in a single device for use in carotid artery applications.
−Removed: EPS received CE mark approval in the European Union in March 2013 and was fully launched in Europe in September 2015.
−Removed: Subsequently, we
−Removed: launched CGuard EPS in Russia and certain countries in Latin America and Asia, including India.
−Removed: In September 2020, we launched CGuard
−Removed: EPS in Brazil after receiving regulatory approval in July 2020 and as discussed below, on February 3, 2021, we executed a distribution
−Removed: agreement with Chinese partners for the purpose of expanding our presence in China.
−Removed: Currently, we are seeking strategic partners for
−Removed: a potential launch of CGuard EPS in Japan.
−Removed: September 8, 2020, we received approval from the FDA of our IDE, thereby allowing us to proceed with a pivotal study of our CGuard™
−Removed: Carotid Stent System, C-Guardians, for prevention of stroke in patients in the United States.
−Removed: C-Guardians is a prospective, multicenter,
−Removed: single-arm, pivotal study to evaluate the safety and efficacy of the CGuard™ Carotid Stent System when used to treat symptomatic
−Removed: and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting.
−Removed: The trial was designed to enroll approximately
−Removed: 315 subjects in a maximum of 40 study sites located in the United States and Europe.
−Removed: Study sites in Europe may contribute a maximum of
−Removed: approximately 50% of the total enrollees.
−Removed: The primary endpoint of the study will be the composite of incidence of death (all-cause mortality),
−Removed: all stroke, and myocardial infarction (DSMI) through 30-days post-index procedure, based on the clinical events committee (CEC) adjudication
−Removed: and ipsilateral stroke from 31-365 day follow-up, based on Clinical Events Committee (CEC) adjudication.
+Added: CGuard™ carotid embolic prevention system (“CGuard EPS”) combines MicroNet and a self-expandable nitinol stent in a
+Added: single device for use in carotid artery applications.
+Added: Our CGuard EPS originally received CE mark approval in the European Union in March
+Added: 2013 and was fully launched in Europe in September 2015.
+Added: Subsequently, we launched CGuard EPS in Russia and certain countries in Latin
+Added: America and Asia, including India.
+Added: In September 2020, we launched CGuard EPS in Brazil after receiving regulatory approval in July 2020
+Added: and on February 3, 2021, we executed a distribution agreement with Chinese partners for the purpose of expanding our presence in China.
+Added: Currently, we are seeking strategic partners for a potential launch of CGuard EPS in Japan and other Asian countries.
+Added: Our CE mark for CGuard EPS under
+Added: the MDD expired on November 12, 2022, and we are in the final stages of technical documentation review by the Notified Body auditor to
+Added: meet the MDR requirements for recertification.
+Added: In the meantime, on February 14, 2023, we received a derogation per Article 97 paragraph
+Added: 1 of Regulation 2017/745 from the Agency for Medicines and Health Products (FAMHP) allowing us to continue marketing CGuard EPS in the
+Added: EU until August 15, 2023, subject to certain procedural requirements.
+Added: Subsequently, on March 20, 2023, Regulation (EU) 2023/607 was published
+Added: allowing us to continue marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027.
+Added: As a result of the foregoing,
+Added: we may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural requirements while our MDR CE
+Added: recertification is pending.
+Added: We continue to expedite the review process for recertification under the MDR.
+Added: September 8, 2020, we received approval from the U.S.
+Added: Food and Drug Administration (“FDA”) of our Investigation Device Exemption
+Added: (“IDE”), thereby allowing us to proceed with a pivotal study of our CGuard™ Carotid Stent System, C-Guardians, for
+Added: prevention of stroke in patients in the United States.
+Added: C-Guardians is a prospective, multicenter, single-arm, pivotal study to evaluate
+Added: the safety and efficacy of the CGuard™ Carotid Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis
+Added: in patients undergoing carotid artery stenting.
+Added: The trial was designed to enroll approximately 315 subjects in a maximum of 40 study
+Added: sites located in the United States and Europe.
+Added: Study sites in Europe may contribute a maximum of approximately 50% of the total enrollees.
+Added: The primary endpoint of the study will be the composite of incidence of death (all-cause mortality), all stroke, and myocardial infarction
+Added: (DSMI) through 30-days post-index procedure, based on the clinical events committee (CEC) adjudication and ipsilateral stroke from 31-365
+Added: day follow-up, based on Clinical Events Committee (CEC) adjudication.
+Added: The composite index will be compared to a performance goal based
+Added: on the observed rate of the two components of the primary endpoint from previous pivotal stent trials which are considered industry standard.
+Added: The performance goal will be considered met if the upper bound of the two-sided 95% confidence interval calculated from the observed
+Added: primary endpoint rate is < 11.6% and the p-value is less than 0.025.
July 23, 2021, we announced the initiation of enrollment and successful completion of the first cases of our C-Guardian trial of CGuard
5 unchanged sentences
We are currently continuing with the enrollment phase.
+Added: In April 2022, we
+Added: completed our first European recruitment.
Additionally,
we intend to continue to invest in current and future potential product and manufacturing enhancements for CGuard EPS that are expected
−Removed: to reduce cost of goods and/or provide the best-in-class performing delivery system.
−Removed: In furtherance of our strategy that focuses on establishing
−Removed: CGuard EPS as a viable alternative to vascular surgery, we are exploring adding new delivery systems and accessory solutions for procedural
−Removed: protection to our portfolio.
+Added: to reduce cost of goods and/or provide the best-in-class performing delivery system, CGuard Prime.
+Added: In furtherance of our strategy that
+Added: focuses on establishing CGuard EPS as a viable alternative to vascular surgery, we are exploring adding new delivery systems and accessory
+Added: solutions for procedural protection to our portfolio such as SwitchGuard.
consider the current addressable market for our CGuard EPS to be individuals with diagnosed, symptomatic high-grade carotid artery stenosis
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total available market for CGuard EPS in 2022 will be approximately $5 billion.
−Removed: MGuard Prime EPS is marketed for use in patients with acute coronary syndromes, notably acute myocardial infarction (heart attack) and
−Removed: saphenous vein graft coronary interventions, or bypass surgery.
−Removed: MGuard Prime EPS combines MicroNet with a bare-metal cobalt-chromium
−Removed: MGuard Prime EPS received CE mark approval in the European Union in October 2010 for improving luminal diameter and providing
−Removed: embolic protection.
−Removed: However, as a result of a shift in industry preferences away from bare-metal stents in favor of drug-eluting, or
−Removed: drug-coated, stents, in 2014 we decided to curtail further development of this product in order to focus on the development of a drug-eluting
−Removed: stent product, MGuard DES™.
−Removed: Due to limited resources, however, our efforts have been limited to testing drug-eluting stents manufactured
−Removed: by potential partners for compatibility with MicroNet and seeking to incorporate MicroNet onto a drug-eluting stent manufactured by a
−Removed: potential partner.
−Removed: The FDA has clarified that the primary mode of action for drug-eluting cardiovascular stents, which are regulated
−Removed: as combination products, is that of the device component and has assigned the FDA Center for Devices and Radiological Health (CDRH) primary
−Removed: responsibility for premarket review and regulation, providing some clarity about what to expect regarding the regulatory framework related
−Removed: to the development of MGuard DES™.
−Removed: As a result of declining sales of the MGuard Prime EPS, which we believe is largely driven by
−Removed: the predominant industry preferences favoring drug-eluting stents rather than bare metal stents such as MGuard Prime EPS in STEMI patients,
−Removed: we intend to phase out future sales of our MGuard Prime EPS in 2022.
−Removed: also intend to develop a pipeline of other products and additional applications by leveraging our MicroNet technology to new applications
−Removed: to improve peripheral vascular and neurovascular procedures, such as the treatment of the superficial femoral artery disease, vascular
−Removed: disease below the knee and neurovascular stenting to seal aneurysms in the brain.
+Added: MGuard™ Prime™ embolic protection system (“MGuard Prime EPS”) was marketed for use in patients with acute coronary
+Added: syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions, or bypass surgery.
+Added: Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent.
+Added: MGuard Prime EPS received CE mark approval in the European
+Added: Union in October 2010 for improving luminal diameter and providing embolic protection.
+Added: Over the past years there has been a shift in
+Added: industry preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”)
+Added: As a result of declining sales of the MGuard Prime EPS, which we believe this is largely driven by the predominant industry
+Added: preferences favoring drug-eluting, or drug-coated, stents, during the second quarter of 2022 we ceased sales of our MGuard Prime EPS
+Added: following a phase out period.
+Added: also intend to develop a pipeline of other products and additional applications by leveraging our MicroNet technology to improve peripheral
+Added: procedures such as the treatment of the superficial femoral artery disease and vascular disease below the knee as well as neurovascular
+Added: procedures, such as the treatment of acute stroke.
none of our products may be sold or marketed in the United States, but we do derive revenues from the use of our products in the currently
56 unchanged sentences
leases with a lease term of 12 months or less.
−Removed: Our Israeli subsidiary has a lease agreement for a facility in Israel, which expires on
−Removed: December 31, 2022 with an option to extend the agreement for two additional years until December 31, 2024 under the terms stipulated
−Removed: in the agreement.
−Removed: The Option Period was taken in consideration when calculating the operating lease right of use assets and liabilities
−Removed: since we believe that we will stay in this facility until atleast the end of the Option Period.
−Removed: The Option period added approximately
−Removed: $780,000 to the leasing liability.
+Added: Our Israeli subsidiary had a lease agreement for a facility in Israel, which expired on
+Added: December 31, 2022, with an option to extend the agreement for two additional years until December 31, 2024.
+Added: On May 25, 2022 the Company
+Added: amended the agreement mentioned above and extended it until December 31, 2026 as well as leasing of additional space in the facility,
+Added: the additional space amendment was taken in consideration when calculating the operating lease right of use assets and liabilities.
+Added: amendment period added approximately $835,000 to the leasing liability.
contract with a customer exists only when:
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This sales increase
−Removed: was mainly due to the fact that in the twelve months ended December 31, 2021, procedures with the CGuard EPS, which are generally scheduled
−Removed: for non-emergency procedures began to return to normal levels as compared to the twelve months ended December 31, 2020, when procedures
−Removed: with CGuard EPS were postponed as hospitals shifted resources to patients affected by COVID-19 (beginning in February 2020).
−Removed: the increase in revenue is also partially attributable to an increase in sales of MGuard Prime EPS, from a Revenue net of settlement
−Removed: payment of ($279,000) during the twelve months ended December 31, 2020, to $186,000 during the twelve months ended December 31, 2021.
−Removed: Revenues during the twelve months ended December 31, 2020 were negatively impacted by a settlement of litigation with a former distributor
−Removed: in 2014 under which we agreed to pay them $580,000, as under U.S.
−Removed: generally accepted accounting principles, we were required to charge
−Removed: that amount against revenues.
−Removed: respect to regions, the increase in revenue was primarily attributable to an increase of $1,762,000 in revenue from sales made in Europe.
−Removed: This increase was predominately driven by an increase of $1,250,000 in sales volume of CGuard EPS due to the impact of COVID-19 as discussed
−Removed: in the paragraph above and a $512,000 increase of MGuard Prime EPS driven by the settlement payment in 2020 as discussed above.
−Removed: there was an increase of revenue of $115,000 in Asia, $106,000 in Latin American and $27,000 in other regions predominately driven by
−Removed: the impact of COVID-19 on CGuard EPS as discussed above and the decrease in MGuard EPS revenue as discussed above.
+Added: was mainly due to growth in existing and new markets and sales in the United States related to stents used in our C-Guardians FDA study
+Added: as enrolment accelerated.
+Added: respect to regions, the increase in revenue was primarily attributable to a $269,000 increase in Latin America, a $112,000 increase in
+Added: Asia, a $94,000 increase in Europe and a $50,000 increase in other geographies.
+Added: This growth was mainly due to growth in existing and
+Added: In addition, there was a $151,000 increase in revenue from North America due to sales in the United States related to stents
+Added: used in our C-Guardians FDA study.
For the twelve months ended December 31, 2022, gross profit (revenue less cost of revenues) increased by 48.1%, or $363,000,
to $1,117,000, compared to a gross profit of $754,000 for the same period in 2021.
−Removed: This increase in gross profit resulted from the impact
−Removed: of the $580,000 settlement with our former distributor in 2014 which was recorded in the twelve months ended December 31, 2020 (as mentioned
−Removed: above), as well as a $419,000 increase in revenues, less the related material and labor costs (as mentioned above).
−Removed: This increase was
−Removed: partially offset by an increase in write-offs of $187,000, which were driven mainly by components supply issues, a $100,000 increase
−Removed: in new employees training costs and an increase of $41,000 in miscellaneous expenses.
−Removed: Gross margin (gross profits as a percentage of
−Removed: revenue) increased to 16.8% during the twelve months ended December 31, 2021 from 3.3% during the twelve months ended December 31, 2020,
−Removed: driven by the reasons mentioned above.
+Added: This increase in gross profit resulted from a $186,000
+Added: increase in revenues (as mentioned above) less the associated related material and labor costs and a decrease of $177,000 in miscellaneous
+Added: Gross margin (gross profits as a percentage of revenue) increased to 21.6% during the twelve months ended December 31, 2022
+Added: from 16.8% during the twelve months ended December 31, 2021, driven by the reasons mentioned above.
and Development Expenses .
2 unchanged sentences
This increase resulted primarily from an
−Removed: increase of $2,032,000 in expenses related to the commencement of the C-Guardians FDA study, $458,000 in development expenses related
−Removed: to CGuard EPS new delivery system and accessory solutions, $353,000 in compensation expenses and $82,000 in miscellaneous expenses.
+Added: increase of $2,431,000 in expenses related to the enrollment in the C-Guardians FDA study which commenced in the second half of 2021
+Added: and an increase of $221,000 in miscellaneous expenses.
and Marketing Expenses .
2 unchanged sentences
This increase resulted primarily from an increase in
−Removed: compensation expenses of $629,000 and other sales and marketing expenses of $175,000, both relating to increased activity associated
−Removed: with expansion of existing and new markets.
+Added: salary expenses of $297,000, an increase in tradeshows and travel expenses of $288,000 in light of resumed marketing activities following
+Added: the lifting of restrictions related to COVID-19, and an increase in share-based compensation expenses of $157,000 due to the expense
+Added: recognition of grants made during the fourth quarter of 2021.
and Administrative Expenses .
1 unchanged sentence
or $951,000, to $8,356,000, from $7,405,000 during the twelve months ended December 31, 2021.
−Removed: This increase resulted primarily from
−Removed: an increase in compensation expenses of $1,198,000, consisting of increases in share-based compensation-related expenses of $755,000
−Removed: following the expense recognition of grants made since August 31, 2020.
−Removed: In addition, compensation expenses increased due to an increase
−Removed: in salary expenses and related accruals of $443,000 primarily as a result of temporary salary reductions during the twelve months ended
−Removed: December 31, 2020 that were implemented in response to the COVID-19 effect on revenues, as well as additional headcount.
−Removed: we had an increase in directors’ and officers’ liability insurance expenses of $351,000 due to increased premiums caused
−Removed: by recent trends in the overall insurance industry, and an increase in shareholder related expenses of $170,000 mainly due to a special
−Removed: shareholders meeting and higher costs of our annual stockholder meeting in 2021 compared to our annual stockholder meeting in 2020.
−Removed: increases were partially offset by a decrease of $400,000 due to expenses for a settlement agreement with an underwriter of prior offerings
−Removed: which occurred in the three months ended March 31, 2020 and a decrease of $41,000 in miscellaneous expenses.
−Removed: For the twelve months ended December 31, 2021, financial expenses decreased by 1.9%, or $3,000, to $157,000, from $160,000
−Removed: during the twelve months ended December 31, 2020.
−Removed: For the twelve months ended December 31, 2021, tax increased by $41,000 compared to the twelve months ended December 31,
+Added: This increase resulted primarily from an
+Added: increase in share-based compensation-related expenses of $372,000, mainly due to the expense recognition of grants made during the fourth
+Added: quarter of 2021, an increase in regulatory expenses of $214,000 related to the implementation of the new European Medical Device Regulation,
+Added: an increase in patent related expenses of $155,000, an increase in travel expenses of $139,000 in light of resumed activities following
+Added: governments lifting restrictions related to COVID-19, an increase in directors’ and officers’ liability insurance expenses
+Added: of $107,000, due to increased premiums caused by recent trends in the overall insurance industry and an increase of $154,000 in miscellaneous
+Added: expenses offset, in part, by a decrease in shareholder related expenses of $190,000 mainly due to a special shareholders meeting (which
+Added: occurred in 2021, but not in 2022) and also due to higher costs of our annual stockholder meeting in 2021 compared to our annual stockholder
+Added: meeting in 2022.
+Added: Income (Expenses) .
+Added: For the twelve months ended December 31, 2022, financial income increased by $407,000, to $250,000 of financial
+Added: income, from $157,000 of financial expense during the twelve months ended December 31, 2021.
+Added: The increase in financial income primarily
+Added: resulted from a $229,000 increase in interest income from short-term bank deposits and an increase of $181,000 in financial income related
+Added: to changes in exchange rates.
+Added: For the twelve months ended December 31, 2022, tax decreased by $17,000 compared to the twelve months ended December 31,
Our expenses for income taxes reflect primarily the tax liability due to potential tax exposure.
2 unchanged sentences
The increase in net loss resulted primarily from an increase of $4,360,000 in operating
−Removed: expenses partially offset by an increase of $671,000 in gross profit.
+Added: expenses partially offset by an increase of $407,000 in financial income and an increase of $363,000 in gross profit.
and Capital Resources
−Removed: of the date of issuance of the consolidated financial statements, we have the ability to fund our planned operations for at least the
−Removed: next 12 months.
−Removed: However, we expect to continue incurring losses and negative cash flows from operations until our products (primarily
−Removed: CGuard™ EPS) reach commercial profitability.
−Removed: Therefore, in order to fund our operations until such time that we can generate substantial
−Removed: revenues, we may need to raise additional funds.
−Removed: June 5, 2020, we closed an underwritten public offering of (i) 509,053 Units, with each Unit being comprised of one share of our common
−Removed: stock, par value $0.0001 per share, and one Series F warrant to purchase one share of common stock, and (ii) 972,427 Pre-Funded Units,
−Removed: with each Pre-Funded Unit being comprised of one Pre-Funded Warrant to purchase one share of common stock and one Series F Warrant.
−Removed: connection with this public offering, the underwriter exercised the option practically in full, for 222,220 shares of common stock and
−Removed: 222,220 Series F Warrants.
−Removed: The offering price to the public was $6.75 per Unit and $6.735 per Pre-Funded Unit.
−Removed: Our net proceeds from
−Removed: the offering and the exercise of the underwriter’s over-allotment option were approximately $10.7 million, after deducting underwriting
−Removed: discounts and commissions and payment of other estimated expenses associated with the offering, but excluding the proceeds, if any, from
−Removed: the exercise of Series F Warrants and the Pre-Funded Warrants sold in the offering.
+Added: had an accumulated deficit as of December 31, 2022 of $201 million, as well as a net loss of $18,491,000 and negative operating cash
+Added: We expect to continue incurring losses and negative cash flows from operations until our product, CGuard EPS, reach commercial
+Added: profitability.
+Added: As a result of these expected losses and negative cash flows from operations, along with our current cash position, we
+Added: believe we have sufficient resources to fund operations until the end of September 2023.
+Added: Therefore, there is substantial doubt about
+Added: our ability to continue as a going concern.
July 28, 2020, we entered into a Sales Agreement with A.G.P.
2 unchanged sentences
the Sales Agreement will be issued and sold pursuant to the Company’s Registration Statement on Form S-3 (File No.
−Removed: filed with the SEC on February 21, 2018 and the prospectus supplement thereto filed with the SEC on July 28, 2020, by methods deemed
−Removed: to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended,
−Removed: or if specified by us, by any other method permitted by law.
−Removed: On January 11, 2021, we increased the aggregate amount of our shares of
−Removed: common stock that may be sold under the Sales Agreement from $9,300,000 to $10,382,954, and, as a result, utilized and sold the maximum
−Removed: amount allowable under the ATM Facility, which resulted in an aggregate amount of $10,381,958.
+Added: filed with the Securities and Exchange Commission (“SEC”) on February 21, 2018 and the prospectus supplement thereto filed
+Added: with the SEC on July 28, 2020, by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated
+Added: under the Securities Act of 1933, as amended, or if specified by us, by any other method permitted by law.
+Added: On January 11, 2021, we increased
+Added: the aggregate amount of our shares of common stock that may be sold under the Sales Agreement from $9,300,000 to $10,382,954, and, as
+Added: a result, utilized and sold the maximum amount allowable under the ATM Facility, which resulted in an aggregate amount of $10,381,958.
February 8, 2021, we closed an underwritten public offering of 1,935,484 units, with each such unit being comprised of one share of our
23 unchanged sentences
of cash and cash equivalents and $22,036,000 Short-term bank deposits as of December 31, 2021.
−Removed: We have historically met our cash needs through
−Removed: a combination of issuing new shares, borrowing activities and product sales.
−Removed: Our cash requirements are generally for research and development,
−Removed: marketing and sales activities, finance and administrative cost, capital expenditures and general working capital.
+Added: We have historically met our cash needs
+Added: through a combination of issuing new shares, borrowing activities and product sales.
+Added: Our cash requirements are generally for research
+Added: and development, marketing and sales activities, finance and administrative cost, capital expenditures and general working capital.
the twelve months ended December 31, 2022, net cash used in our operating activities increased by $2,332,000 to $15,542,000, from $13,210,000
2 unchanged sentences
in payments for third party related expenses and for professional services (primarily due to payments related to our ongoing FDA trial,
−Removed: payments related to ongoing projects and production related payments), an increase of $1,658,000 in salary and bonus payments from $6,098,000
−Removed: in the twelve months ended December 31, 2020 to $7,756,000 during the same period in 2021 offset, in part, by an increase of $268,000
−Removed: in payments received from customers to $3,715,000 during the twelve months ended December 31, 2021, from $3,447,000 during the same period
−Removed: used by our investing activities was $22,457,000 during the twelve months ended December 31, 2021 compared to $187,000 during the twelve
−Removed: months ended December 31, 2020.
−Removed: The primary reasons for the increase in cash used by our investing activities was investment in short-term
−Removed: deposits of $24,000,000 an increase of $278,000 in net payments made for purchase of property, plant and equipment to $344,000 during
−Removed: the twelve months ended December 31, 2021, from $66,000 during the same period in 2020, offset, in part, by the withdrawal of $2,000,000
−Removed: of short-term deposits and a decrease of $8,000 in cash deposited to employee funds, to $113,000 during the twelve months ended December
−Removed: 31, 2021, from $121,000 during the same period in 2020.
−Removed: provided by financing activities for the twelve months December 31, 2021 was $35,034,000, compared to $16,395,000 during the same period
−Removed: The principal sources of the cash provided by financing activities during the twelve months ended December 31, 2021 were our
−Removed: February 2021 public offering of common stock and warrants, exercise of Series F and Series G warrants, proceeds from an At-the-market
−Removed: offering as well as proceeds from the issuance of shares to Chinese distributor that resulted in approximately $35,034,000 of aggregate
−Removed: net proceeds.
−Removed: The principal sources of the cash provided by financing activities during the twelve months ended December 31, 2020 were
−Removed: our June 2020 public offering of common stock, pre-funded warrants and warrants, the subsequent exercise of the pre-funded warrants sold
−Removed: in the offering, as well as exercise of warrants F and Unit Purchase Options, that resulted in approximately $12,169,000 of aggregate
−Removed: net proceeds, and funds received from our ATM Facility that resulted in approximately $ 4,126,000 of aggregate net proceeds.
+Added: and production related payments), an increase of $802,000 in salary and bonus payments from $7,756,000 in the twelve months ended December
+Added: 31, 2021 to $8,558,000 during the same period in 2022 offset, in part, by an increase of $1,618,000 in payments received from customers
+Added: to $5,333,000 during the twelve months ended December 31, 2022, from $3,715,000 during the same period in 2021.
+Added: provided by our investing activities was $8,441,000 during the twelve months ended December 31, 2022, compared to cash used of $22,457,000
+Added: during the twelve months ended December 31, 2021.
+Added: The primary reasons for the increase in cash provided by our investing activities was
+Added: withdrawal of short-term deposits, net of investments of $9,000,000 during the twelve months ended December 31,2022 , compared to investment
+Added: in short-term deposits, net of withdrawals of $22,000,000 during the twelve months ended December 31,2021, and due to a decrease in employee
+Added: funds to $86,000 during the twelve months ended December 31, 2022, compared to employee funds of $113,000 during the same period in 2021,
+Added: offset, in part, by an increase of $129,000 in net payments made for purchase of property, plant and equipment to $473,000 during the
+Added: twelve months ended December 31, 2022, from $344,000 during the same period in 2021.
+Added: Used by financing activities for the twelve months December 31, 2022, was $140,000, compared to cash provided of $35,034,000 during the
+Added: same period in 2021.
+Added: The principal sources of the cash used by financing activities during the twelve months ended December 31, 2022
+Added: were due to issuance costs associated with a shelf registration statement on Form S-3 filed with the SEC on June 3, 2022.
+Added: The principal
+Added: sources of the cash provided by financing activities during the twelve months ended December 31, 2021 were our February 2021 public offering
+Added: of common stock and warrants, exercise of Series F and Series G warrants, proceeds from an At-the-market offering as well as proceeds
+Added: from the issuance of shares to Chinese distributor that resulted in approximately $35,034,000 of aggregate net proceeds.
of December 31, 2022, our current assets exceeded our current liabilities by a multiple of 4.2.
−Removed: Current assets increased by $21,755,000
+Added: Current assets decreased by $15,768,000
during the period and current liabilities increased by $723,000 during the period.
−Removed: As a result, our working capital increased by $21,113,000
+Added: As a result, our working capital decreased by $16,491,000
to $16,256,000 as of December 31, 2022.
17 unchanged sentences
companies, including Smaller Reporting Companies (“SRCs”), additional time to implement major FASB standards, including ASU
−Removed: Larger public companies will have an effective date for fiscal years beginning after December 15, 2019, including interim periods
−Removed: within those fiscal years.
−Removed: All other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier
−Removed: of fiscal periods beginning after December 15, 2022.
−Removed: Under the current SEC definitions, we meet the definition of an SRC as of the ASU
−Removed: 2019-10 issuance date and is adopting the deferral period for ASU 2016-13.
−Removed: The guidance requires a modified retrospective transition
−Removed: approach through a cumulative-effect adjustment to retained earnings as of the beginning of the period of adoption.
−Removed: We are currently
−Removed: evaluating the impact of the adoption of ASU 2016-13 on its consolidated financial statements, but does not believe the adoption of this
−Removed: standard will have a material impact on its consolidated financial statements.
+Added: Larger public companies had an effective date of December 15, 2019, including interim periods within those fiscal years.
+Added: other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier of fiscal periods beginning
+Added: after December 15, 2022.
+Added: Under the current SEC definitions, we meet the definition of an SRC and are adopting the deferral period for
+Added: The guidance requires a modified retrospective transition approach through a cumulative-effect adjustment to retained earnings
+Added: as of the beginning of the period of adoption.
+Added: We do not believe the adoption of this standard will have a material impact on our consolidated
+Added: financial statements.
November 2021, the FASB issued ASU 2021-10 “Government Assistance (Topic 832)”, which requires annual disclosures that increase
15 unchanged sentences
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.