Nashua, NH, United States
Nashua, NH, United States

iCAD Inc. , headquartered in Nashua, New Hampshire, is a medical-device manufacturer. Having acquired another device-maker, Xoft, at the end of 2010, iCAD almost immediately faced a case of mistaken consequences in some Xoft test-study patients. Wikipedia.

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News Article | March 8, 2017
Site: globenewswire.com

NASHUA, N.H., March 08, 2017 (GLOBE NEWSWIRE) -- iCAD, Inc. (Nasdaq:ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today reported financial results for the three and twelve months ended December 31, 2016. “Our fourth quarter revenue grew 15% sequentially compared to the third quarter of 2016, reflecting improved performance in our cancer therapy business,” said Ken Ferry, Chief Executive Officer.  “This included a stronger quarter for IORT system and balloon applicator sales, as result of greater sales activity, and increased procedure volume in both the U.S. and international markets.  We also had our strongest quarter of the year adding new customers in our skin electronic brachytherapy business.  Our cancer detection team continues to make good progress with the development of software tools that enhance the workflow and interpretation of 3D tomosynthesis breast exams.  We expect these tools to be a major growth opportunity for the Company over time.  Currently, these products are available in certain international markets and are pending FDA clearance in the United States.” Mr. Ferry added, “We remain confident in the longer term outlook for our business.  In the fourth quarter we made additional key investments in support of our goal of obtaining a CPT 1 reimbursement code for skin electronic brachytherapy, added sales personnel to support future growth in the skin therapy and cancer detection software markets, and had a robust presence at the two most important medical meetings that we attend, ASTRO and RSNA.  Also, in January 2017, we strengthened our balance sheet with the sale of our MRI CAD business for $3.2 million.” Revenue:  Total revenue for the fourth quarter of 2016 decreased 9% to $6.9 million from $7.6 million in the fourth quarter of 2015, reflecting a 15% increase in product revenue and a 21% decrease in service revenue.  The decrease in the Company’s revenue in the fourth quarter of 2016 was primarily driven by the comparable decline of therapy service revenue associated with the treatment of non-melanoma skin cancer in the United States.  On a sequential quarter basis, total revenue for the fourth quarter of 2016 increased 15% from $6.0 million in the third quarter of 2016.  Service revenue for the fourth quarter of 2016 was approximately 57% of total revenues compared to approximately 65% of total revenues in the fourth quarter of 2015. Cancer detection revenue for the fourth quarter of 2016 decreased by 3%, which includes digital mammography, breast density, MRI and CT CAD platforms, as well as the associated service revenue.  Therapy revenue decreased by 17%, which includes Xoft® Axxent® Electronic Brachytherapy System® product sales, as well as the associated service revenue. Gross Profit:  Gross profit for the fourth quarter of 2016 decreased to $4.5 million, or 65% of revenue, from $5.3 million, or 70% of revenue, for the fourth quarter of 2015. Operating Expenses:  Total operating expenses for the fourth quarter of 2016 increased to $7.8 million from $7.6 million for the fourth quarter of 2015. The year-over-year increase reflects investments in strategic growth drivers, partially offset by the Company’s cost reduction initiatives which were implemented in 2015. GAAP Net Loss:  Net loss for the fourth quarter of 2016 was $(3.3) million, or $(0.20) per share, compared with net loss of $(2.4) million, or $(0.15) per share, for the fourth quarter of 2015. Non-GAAP Adjusted EBITDA:  Non-GAAP adjusted EBITDA, a non-GAAP financial measure as defined below, was a loss $(2.0) million for the fourth quarter of 2016, compared with non-GAAP adjusted EBITDA loss of $(1.1) million for the fourth quarter of 2015. Non-GAAP Adjusted Net Income/Loss: Non-GAAP adjusted net loss, as defined below, for the fourth quarter of 2016 was $(3.2) million, or $(0.20) per share, compared with a non-GAAP adjusted net loss of $(2.2) million, or $(0.14) per share, for the fourth quarter of 2015. Cash and Cash Equivalents:  As of December 31, 2016, the Company had cash and cash equivalents of $8.6 million, compared with $15.3 million as of December 31, 2015. The Company used $1.6 million of cash from operating activities in the fourth quarter of 2016. Revenue:  Total revenue for fiscal year 2016 decreased 37% to $26.3 million from $41.6 million for fiscal year 2015, reflecting a 26% decrease in product revenue and a 42% decrease in service revenue. The decrease in the Company’s revenue in fiscal year 2016 was primarily driven by declining revenues related to the treatment of non-melanoma skin cancer in the United States. The decrease was also driven by a reduction of approximately $2.1 million of MRI-CAD product sales due to the Company’s exclusive distribution partner exercising its right in August 2015 to a fully paid-up license to distribute the software. This provided the Company with a cash payment of $2.0 million during the third quarter of 2015 that is being amortized over the term of the contract through July 2017.  Service revenue for fiscal year 2016 was approximately 60% of total revenues compared to approximately 66% of total revenues for fiscal year 2015. Cancer detection revenue for fiscal year 2016 decreased by 11%, which includes digital mammography, breast density, MRI and CT CAD platforms, as well as the associated service revenue.  When adjusted for the $2.1 million reduction in MRI-CAD product revenue, cancer detection revenues were essentially flat compared to fiscal year 2015.  Therapy revenue for fiscal year 2016 decreased by 59%, which includes Xoft® Axxent® Electronic Brachytherapy System® product sales, as well as the associated service revenue. Gross Profit:  Gross profit for fiscal year 2016 decreased to $18.5 million, or 70% of revenue, from $29.4 million, or 71% of revenue, for fiscal year 2015.  Gross profit for fiscal year 2016 included a U.S. medical device excise tax refund of $0.5 million. Operating Expenses:  Total operating expenses for fiscal year 2016 decreased to $28.5 million from $59.4 million for fiscal year 2015, which included $27.4 million of goodwill and long-lived asset impairment. Operating expenses for fiscal year 2015 were $32.0 million excluding the impairment.  The year-over-year decline reflects the effect of the Company’s cost reduction initiatives implemented in 2015. GAAP Net Loss:  Net loss for fiscal year 2016 was $(10.1) million, or $(0.63) per share, compared with net loss of $(32.5) million, or $(2.07) per share, for fiscal year 2015. Non-GAAP Adjusted EBITDA:  Non-GAAP adjusted EBITDA, a non-GAAP financial measure as defined below, was a loss of $(5.3) million for fiscal year 2016, compared with non-GAAP adjusted EBITDA of $3.9 million, or 9% of revenue, for fiscal year 2015. Non-GAAP Adjusted Net Income/Loss:  Non-GAAP adjusted net loss, as defined below, for fiscal year 2016 was $(9.8) million, or $(0.63) per share, compared with a non-GAAP adjusted net loss of $(2.2) million, or $(0.14) per share, for fiscal year 2015. iCAD management will host a conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a company update.  The dial-in numbers are (855) 217-4501 for domestic callers and (716) 220-9431 for international callers.  The conference ID is 57732542.  A live webcast of the conference call will be available online at www.icadmed.com. A replay of the webcast will remain on the Company’s website until the Company releases its first quarter 2017 financial results.  In addition, a telephonic replay of the conference call will be available until March 15, 2017.  The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers.  The replay conference ID is 57732542. Use of Non-GAAP Financial Measures In its quarterly news releases, conference calls, slide presentations or webcasts, the Company may use or discuss non-GAAP financial measures as defined by SEC Regulation G.  The GAAP financial measures most directly comparable to each non-GAAP financial measure used or discussed, and a reconciliation of the differences between each non-GAAP financial measure and the comparable GAAP financial measure, are included in this press release after the condensed consolidated financial statements.  When analyzing the Company's operating performance, investors should not consider these non-GAAP measures as a substitute for the comparable financial measures prepared in accordance with GAAP.  The Company's quarterly news releases containing such non-GAAP reconciliations can be found on the Investors section of the Company's website at www.icadmed.com. iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes.  iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast, prostate and colorectal cancers.  iCAD’s Xoft® Axxent® Electronic Brachytherapy (eBx®) System® is a painless, non-invasive technology that delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue.  The Xoft System is FDA cleared and CE marked for use anywhere in the body, including treatment of non-melanoma skin cancer, early-stage breast cancer and gynecological cancers.  The comprehensive iCAD technology platforms include advanced hardware and software, as well as management services designed to support cancer detection and radiation therapy treatments.  For more information, visit www.icadmed.com or www.xoftinc.com. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.  Such factors include, but are not limited to the Company’s ability to defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission.  The words “believe”, “demonstrate”, “intend”, “expect”, “would”, “could”, “consider”, “project”, “estimate”, “will”, “continue”, “anticipate”, “likely”, “seek”, and similar expressions identify forward-looking statements.  Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made.  The Company is under no obligation to provide any updates to any information contained in this release.  For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, including the 10-K for the year ended December 31, 2015, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov. RECONCILIATION OF NON-GAAP FINANCIAL MEASURES TO COMPARABLE GAAP MEASURES (Unaudited, in thousands, except per share amounts) The following is a reconciliation of the non-GAAP financial measures used by the Company to describe the Company's financial results determined in accordance with United States generally accepted accounting principles (GAAP).  An explanation of these measures is also included below under the heading "Explanation of Non-GAAP Financial Measures." While management believes that these non-GAAP financial measures provide useful supplemental information to investors regarding the underlying performance of the Company's business operations, investors are reminded to consider these non-GAAP financial measures in addition to, and not as a substitute for, financial performance measures prepared in accordance with GAAP.  In addition, it should be noted that these non-GAAP financial measures may be different from non-GAAP financial measures used by other companies, and management may utilize other measures to illustrate performance in the future.  Non-GAAP financial measures have limitations in that they do not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. The Company reports its financial results in accordance with United States generally accepted accounting principles, or GAAP.  However, management believes that in order to properly understand the Company's short-term and long-term financial and operational trends, investors may wish to consider the impact of certain non-cash or non-recurring items, when used as a supplement to financial performance measures in accordance with GAAP.  These items result from facts and circumstances that vary in frequency and/or impact on continuing operations.  Management also uses results of operations before such items to evaluate the operating performance of the Company and compare it against past periods, make operating decisions, and serve as a basis for strategic planning.  These non-GAAP financial measures provide management with additional means to understand and evaluate the operating results and trends in the Company's ongoing business by eliminating certain non-cash expenses and other items that management believes might otherwise make comparisons of the Company's ongoing business with prior periods more difficult, obscure trends in ongoing operations or reduce management's ability to make useful forecasts.  Management believes that these non-GAAP financial measures provide additional means of evaluating period-over-period operating performance.  In addition, management understands that some investors and financial analysts find this information helpful in analyzing the Company's financial and operational performance and comparing this performance to its peers and competitors. Management defines "Non-GAAP Adjusted EBITDA" as the sum of GAAP net income (loss) before provision for taxes, acquisition-related expenses, total other (income) expense, stock-based compensation expense, depreciation and amortization, severance, gain on sale, loss on warrant, loss on extinguishment of debt, amortization of acquired intangibles, patent litigation and recall costs, contingent consideration, indemnification, asset and goodwill impairment charges.  Management considers this non-GAAP financial measure to be an important indicator of the Company's operational strength and performance of its business and a good measure of its historical operating trends, in particular the extent to which ongoing operations impact the Company's overall financial performance. Management defines "Non-GAAP Adjusted Net Income (loss)" as the sum of GAAP net income (loss) before provision for the gain on sale of asset, severance, transaction, patent litigation and recall costs, contingent consideration, indemnification, loss on extinguishment of debt and asset and goodwill impairment charges. Management considers this non-GAAP financial measure to be an important indicator of the Company's operational strength and performance of its business and a good measure of its historical operating trends, in particular the extent to which ongoing operations impact the Company's overall financial performance. Management excludes each of the items identified below from the applicable non-GAAP financial measure referenced above for the reasons set forth with respect to that excluded item: On occasion in the future, there may be other items, such as significant asset impairments, restructuring charges or significant gains or losses from contingencies that the Company may exclude if it believes that doing so is consistent with the goal of providing useful information to investors and management.


News Article | May 2, 2017
Site: globenewswire.com

NASHUA, N.H., May 02, 2017 (GLOBE NEWSWIRE) -- iCAD, Inc. (Nasdaq:ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today reported financial results for the three-months ended March 31, 2017. “In the first-quarter of 2017, we achieved strong revenue growth compared to the prior year period.  The growth reflects increased product sales in both our detection and therapy businesses in the U.S. and international markets,” said Ken Ferry, Chief Executive Officer.  “Sales of PowerLook Tomo Detection and Mammo Detection Systems were particularly strong in the U.S. and international markets, significantly contributing to the year-over-year product sales growth.  Moreover, with the Premarket Approval (PMA) of our PowerLook Tomo Detection by the FDA on March 24, 2017, we were pleased to generate initial sales of this latest innovation within days of the announcement in the U.S.  We believe this underscores the underlying need for advanced interpretive software workflow tools to assist radiologists with the reading of 3D Tomo exams.  In our U.S. reader study using PowerLook Tomo Detection, 20 radiologists read 240 Tomo exams with an average reduction in reading time of greater than 29% without compromise in detection accuracy.” “As we look at additional growth drivers throughout 2017, we are making good progress adding customers in our skin brachytherapy business and procedure volume continues to grow nicely.  We expect this business to become a more significant revenue catalyst over the course of the year,” added Mr. Ferry. Revenue:  Total revenue for the first quarter of 2017 increased 12.5% to $6.8 million from $6.0 million in the first quarter of 2016, reflecting a 54% increase in product revenue and a 9% decrease in service revenue as compared to the same period last year.  Service revenue for the first quarter of 2017 was approximately 54% of total revenues compared to approximately 66% of total revenues in the first quarter of 2016. Cancer detection revenue for the first quarter of 2017, which included revenue from digital mammography, breast density, and CT CAD platforms, as well as the associated service revenue, increased by 14% over the same period in 2016.  These revenues include just a few selling days in the U.S. at the end of the first quarter of 2017 for the new PowerLook Tomo Detection software.  Therapy revenue increased by 9%, which included Xoft® Axxent® Electronic Brachytherapy System® product sales as well as the associated service revenue. Gross Profit:  Gross profit for the first quarter of 2017 increased to $4.7 million, or 69% of revenue, compared with $4.2 million, or 69% of revenue, for the first quarter of 2016. Operating Expenses:  Total operating expenses for the first quarter of 2017 decreased to $5.1 million from $6.7 million for the first quarter of 2016.  The year-over-year decrease reflects the gain on sale of the Company’s MRI assets which was partially offset by an increase in non-cash stock compensation expense as well as investments in strategic growth initiatives, including Marketing, Sales, and Product Development. GAAP Net Loss:  Net loss for the first quarter of 2017 was $(0.5) million, or $(0.03) per share, compared with net loss of $(2.5) million, or $(0.16) per share, for the first quarter of 2016.  The GAAP Net Loss in Q1 2017 includes a gain on sale of the Company’s MRI assets of $2.5 million, which was considered a non-core asset.  The sale was completed in January 2017 for $3.2 million. Non-GAAP Adjusted EBITDA:  Non-GAAP adjusted EBITDA, a non-GAAP financial measure as defined below, was a loss of $(1.5) million for the first quarter of 2017, consistent with non-GAAP adjusted EBITDA loss of $(1.5) million for the first quarter of 2016.  Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA results for the three-month periods ended March 31, 2017 and 2016, respectively. Non-GAAP Adjusted Net Income/Loss: Non-GAAP adjusted net loss, as defined below, for the first quarter of 2017 was $(2.9) million, or $(0.18) per share, compared with a non-GAAP adjusted net loss of $(2.7) million, or $(0.17) per share, for the first quarter of 2016.  Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss results for the three-month periods ended March 31, 2017 and 2016, respectively. Cash and Cash Equivalents:  As of March 31, 2017, the Company had cash and cash equivalents of $9.5 million, compared with $8.6 million as of December 31, 2016.  This cash position primarily reflects an increase in cash from the sale of the MRI assets, which was partially offset by the use of cash from operations during the first quarter of 2017. iCAD management will host a conference and live webcast call today at 4:30 p.m. Eastern Time to discuss the first quarter financial results and provide a company update.  The dial-in numbers are 800-263-8506 for domestic callers and 719-457-2083 for international callers.  The conference ID is 6543529.  A live webcast of the conference call will be available online at www.icadmed.com. A replay of the webcast will remain on the Company’s website until the Company releases its second quarter 2017 financial results.  In addition, a telephonic replay of the conference call will be available until May 16, 2017.  The replay dial-in numbers are 844-512-2921 for domestic callers and 412-317-6671 for international callers.  The replay conference ID is 6543529. Use of Non-GAAP Financial Measures In its quarterly news releases, conference calls, slide presentations or webcasts, the Company may use or discuss non-GAAP financial measures as defined by SEC Regulation G.  The GAAP financial measures most directly comparable to each non-GAAP financial measure used or discussed, and a reconciliation of the differences between each non-GAAP financial measure and the comparable GAAP financial measure, are included in this press release after the condensed consolidated financial statements.  When analyzing the Company's operating performance, investors should not consider these non-GAAP measures as a substitute for the comparable financial measures prepared in accordance with GAAP.  The Company's quarterly news releases containing such non-GAAP reconciliations can be found on the Investors section of the Company's website at www.icadmed.com. About iCAD, Inc. iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast and colorectal cancers. iCAD's Xoft® Axxent® Electronic Brachytherapy (eBx®) System® is a painless, non-invasive technology that delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue.  The Xoft System is FDA-cleared and CE marked for use anywhere in the body, including treatment of non-melanoma skin cancer, early-stage breast cancer and gynecological cancers.  The comprehensive iCAD technology platforms include advanced hardware and software as well as management services designed to support cancer detection and radiation therapy treatments.  For more information, visit or www.icadmed.com or www.xoftinc.com. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.  Such factors include, but are not limited to the Company’s ability to defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission.  The words “believe”, “demonstrate”, “intend”, “expect”, “would”, “could”, “consider”, “project”, “estimate”, “will”, “continue”, “anticipate”, “likely”, “seek”, and similar expressions identify forward-looking statements.  Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made.  The Company is under no obligation to provide any updates to any information contained in this release.  For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, including the 10-K for the year ended December 31, 2016, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov. RECONCILIATION OF NON-GAAP FINANCIAL MEASURES TO COMPARABLE GAAP MEASURES (Unaudited, in thousands, except per share amounts) The following is a reconciliation of the non-GAAP financial measures used by the Company to describe the Company's financial results determined in accordance with United States generally accepted accounting principles (GAAP).  An explanation of these measures is also included below under the heading "Explanation of Non-GAAP Financial Measures." While management believes that these non-GAAP financial measures provide useful supplemental information to investors regarding the underlying performance of the Company's business operations, investors are reminded to consider these non-GAAP financial measures in addition to, and not as a substitute for, financial performance measures prepared in accordance with GAAP.  In addition, it should be noted that these non-GAAP financial measures may be different from non-GAAP financial measures used by other companies, and management may utilize other measures to illustrate performance in the future.  Non-GAAP financial measures have limitations in that they do not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. The Company reports its financial results in accordance with United States generally accepted accounting principles, or GAAP.  However, management believes that in order to properly understand the Company's short-term and long-term financial and operational trends, investors may wish to consider the impact of certain non-cash or non-recurring items, when used as a supplement to financial performance measures in accordance with GAAP.  These items result from facts and circumstances that vary in frequency and/or impact on continuing operations.  Management also uses results of operations before such items to evaluate the operating performance of the Company and compare it against past periods, make operating decisions, and serve as a basis for strategic planning.  These non-GAAP financial measures provide management with additional means to understand and evaluate the operating results and trends in the Company's ongoing business by eliminating certain non-cash expenses and other items that management believes might otherwise make comparisons of the Company's ongoing business with prior periods more difficult, obscure trends in ongoing operations or reduce management's ability to make useful forecasts.  Management believes that these non-GAAP financial measures provide additional means of evaluating period-over-period operating performance.  In addition, management understands that some investors and financial analysts find this information helpful in analyzing the Company's financial and operational performance and comparing this performance to its peers and competitors. Management defines "Non-GAAP Adjusted EBITDA" as the sum of GAAP Net Loss before provisions for interest expense, other income, stock-based compensation expense, depreciation and amortization, tax expense, loss on disposal of assets, gain on sale of assets, gain from acquisition settlement, and  acquisition related expenses.  Management considers this non-GAAP financial measure to be an important indicator of the Company's operational strength and performance of its business and a good measure of its historical operating trends, in particular the extent to which ongoing operations impact the Company's overall financial performance. Management defines "Non-GAAP Adjusted Net Loss" as the sum of GAAP Net Loss before provisions for the loss on disposal of assets, gain on sale of assets, gain from acquisition settlement, and acquisition related expenses.  Management considers this non-GAAP financial measure to be an important indicator of the Company's operational strength and performance of its business and a good measure of its historical operating trends, in particular the extent to which ongoing operations impact the Company's overall financial performance. Management excludes each of the items identified below from the applicable non-GAAP financial measure referenced above for the reasons set forth with respect to that excluded item: On occasion in the future, there may be other items, such as significant asset impairments, restructuring charges or significant gains or losses from contingencies that the Company may exclude if it believes that doing so is consistent with the goal of providing useful information to investors and management.


News Article | April 24, 2017
Site: globenewswire.com

NASHUA, N.H., April 24, 2017 (GLOBE NEWSWIRE) -- iCAD, Inc. (Nasdaq:ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that it will release financial results for the three months ended March 31, 2017 after the close of the market, and host a conference call at 4:30pm Eastern Time, on Tuesday, May 2, 2017. In addition, a replay of the call will remain on the Company’s website (www.icadmed.com) until the Company releases its second quarter 2017 financial results.  About iCAD, Inc. iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast, prostate and colorectal cancers. iCAD's Xoft® Axxent® Electronic Brachytherapy (eBx®) System® is a painless, non-invasive technology that delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue. The Xoft System is FDA-cleared and CE marked for use anywhere in the body, including treatment of non-melanoma skin cancer, early-stage breast cancer and gynecological cancers. The comprehensive iCAD technology platforms include advanced hardware and software as well as management services designed to support cancer detection and radiation therapy treatments. For more information, visit or www.icadmed.com or www.xoftinc.com. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.  Such factors include, but are not limited to the Company’s ability to defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission.  The words “believe”, “demonstrate”, “intend”, “expect”, “would”, “could”, “consider”, “project”, “estimate”, “will”, “continue”, “anticipate”, “likely”, “seek”, and similar expressions identify forward-looking statements.  Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made.  The Company is under no obligation to provide any updates to any information contained in this release.  For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, including the 10-K for the year ended December 31, 2016, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.


News Article | April 24, 2017
Site: globenewswire.com

NASHUA, N.H., April 24, 2017 (GLOBE NEWSWIRE) -- iCAD, Inc. (Nasdaq:ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that it will release financial results for the three months ended March 31, 2017 after the close of the market, and host a conference call at 4:30pm Eastern Time, on Tuesday, May 2, 2017. In addition, a replay of the call will remain on the Company’s website (www.icadmed.com) until the Company releases its second quarter 2017 financial results.  About iCAD, Inc. iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast, prostate and colorectal cancers. iCAD's Xoft® Axxent® Electronic Brachytherapy (eBx®) System® is a painless, non-invasive technology that delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue. The Xoft System is FDA-cleared and CE marked for use anywhere in the body, including treatment of non-melanoma skin cancer, early-stage breast cancer and gynecological cancers. The comprehensive iCAD technology platforms include advanced hardware and software as well as management services designed to support cancer detection and radiation therapy treatments. For more information, visit or www.icadmed.com or www.xoftinc.com. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.  Such factors include, but are not limited to the Company’s ability to defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission.  The words “believe”, “demonstrate”, “intend”, “expect”, “would”, “could”, “consider”, “project”, “estimate”, “will”, “continue”, “anticipate”, “likely”, “seek”, and similar expressions identify forward-looking statements.  Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made.  The Company is under no obligation to provide any updates to any information contained in this release.  For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, including the 10-K for the year ended December 31, 2016, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.


Patent
iCAD and Konica Minolta | Date: 2017-02-15

Lung segmentation and bone suppression techniques are helpful pre-processing steps prior to radiographic analyses of the human thorax, as may occur during cancer screenings and other medical examinations. Autonomous lung segmentation may remove spurious boundary pixels from a radiographic image, as well as identify and refine lung boundaries. Thereafter, autonomous bone suppression may identify clavicle, posterior rib, and anterior rib bones using various image processing techniques, including warping and edge detection. The identified clavicle, posterior rib, and anterior rib bones may then be supressed from the radiographic image to yield a segmented, bone suppressed radiographic image.


Patent
iCAD and Konica Minolta | Date: 2015-04-01

Lung segmentation and bone suppression techniques are helpful pre-processing steps prior to radiographic analyses of the human thorax, as may occur during cancer screenings and other medical examinations. Autonomous lung segmentation may remove spurious boundary pixels from a radiographic image, as well as identify and refine lung boundaries. Thereafter, autonomous bone suppression may identify clavicle, posterior rib, and anterior rib bones using various image processing techniques, including warping and edge detection. The identified clavicle, posterior rib, and anterior rib bones may then be suppressed from the radiographic image to yield a segmented, bone suppressed radiographic image.


A system and a method are disclosed that forms a novel, synthetic, two-dimensional image of an anatomical region such as a breast. Two-dimensional regions of interest (ROIs) such as masses are extracted from three-dimensional medical image data, such as digital tomosynthesis reconstructed volumes. Using image processing technologies, the ROIs are then blended with two-dimensional image information of the anatomical region to form the synthetic, two-dimensional image. This arrangement and resulting image desirably improves the workflow of a physician reading medical image data, as the synthetic, two-dimensional image provides detail previously only seen by interrogating the three-dimensional medical image data.


A system and a method are disclosed that forms a novel, synthetic, two-dimensional image of an anatomical region such as a breast. Two-dimensional regions of interest (ROIs) such as masses are extracted from three-dimensional medical image data, such as digital tomosynthesis reconstructed volumes. Using image processing technologies, the ROIs are then blended with two-dimensional image information of the anatomical region to form the synthetic, two-dimensional image. This arrangement and resulting image desirably improves the workflow of a physician reading medical image data, as the synthetic, two-dimensional image provides detail previously only seen by interrogating the three-dimensional medical image data.


Disclosed are methods, and associated systems comprising processors, input devices and output devices, of detecting regions of interest in a tomographic breast image. The methods may comprise: acquiring tomographic breast image data; deriving a plurality of synthetic sub-volumes from the tomographic breast image data; wherein each subvolume is defined by parallel planar top and bottom surfaces; wherein planar top and bottom surfaces of successive subvolumes are parallel to each other; and wherein a top planar surface of a sub-volume is offset from a top planar surface of a prior sub-volume, such that successive sub-volumes overlap; for each sub-volume, deriving a two-dimensional image; for each two-dimensional image, identifying regions of interest therein; deriving at least one region of interest of potential clinical interest from a plurality of identified regions of interest; and outputting information associated with at least one derived region of interest of potential clinical interest.


Disclosed are methods, and associated systems comprising processors, input devices and output devices, of detecting regions of interest in a tomographic breast image. The methods may comprise: acquiring tomographic breast image data; deriving a plurality of synthetic sub-volumes from the tomographic breast image data; wherein each subvolume is defined by parallel planar top and bottom surfaces; wherein planar top and bottom surfaces of successive subvolumes are parallel to each other; and wherein a top planar surface of a sub-volume is offset from a top planar surface of a prior sub-volume, such that successive sub-volumes overlap; for each sub-volume, deriving a two-dimensional image; for each two-dimensional image, identifying regions of interest therein; deriving at least one region of interest of potential clinical interest from a plurality of identified regions of interest; and outputting information associated with at least one derived region of interest of potential clinical interest.

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