0001193805-21-000456.txt : 20210405 0001193805-21-000456.hdr.sgml : 20210405 20210405165353 ACCESSION NUMBER: 0001193805-21-000456 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20210330 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210405 DATE AS OF CHANGE: 20210405 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ICAD INC CENTRAL INDEX KEY: 0000749660 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 020377419 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09341 FILM NUMBER: 21806166 BUSINESS ADDRESS: STREET 1: 98 SPIT BROOK ROAD, SUITE 100 CITY: NASHUA STATE: NH ZIP: 03062 BUSINESS PHONE: 603-882-5200 MAIL ADDRESS: STREET 1: 98 SPIT BROOK ROAD, SUITE 100 CITY: NASHUA STATE: NH ZIP: 03062 FORMER COMPANY: FORMER CONFORMED NAME: HOWTEK INC DATE OF NAME CHANGE: 19920703 8-K 1 e620450_8k-icad.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT PURSUANT

TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): March 30, 2021

iCAD, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware

(State or Other Jurisdiction of Incorporation)


001-09341		02-0377419
(Commission File Number)		(IRS Employer Identification No.)

98 Spit Brook Road, Suite 100, Nashua, New Hampshire		03062
(Address of Principal Executive Offices)		(Zip Code)

(603) 882-5200

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐		Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

symbol(s)

Name of each exchange

on which registered

Common Stock, $0.01 par value

ICAD

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02.

Results of Operations and Financial Condition.

On April 5, 2021, iCAD, Inc. (the “Company”) issued a press release announcing its estimated revenues for the quarter ended March 31, 2021. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On March 30, 2021, R. Scott Areglado, the Chief Financial Officer of the Company, who is the Company’s Principal Financial and Accounting Officer, resigned from his position with the Company, effective May 4, 2021. Mr. Areglado indicated to the Company that he did not resign as a result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.

Item 9.01.

Financial Statements and Exhibits.

Exhibit 99.1 is being furnished pursuant to Item 2.02, is not to be considered filed under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be incorporated by reference into any of the Company’s previous or future filings under the Securities Act of 1933, as amended, or the Exchange Act.

(d) Exhibits

Exhibit No.		Exhibit Description

99.1		Press Release dated April 5, 2021

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	iCAD, INC. (Registrant)

	By:		/s/ Michael Klein
			Michael Klein Chief Executive Officer

Date: April 5, 2021

EX-99.1 2 e620450_99-1.htm

iCAD Announces Estimated Q1 Revenues and Upcoming CFO Transition

Company expects preliminary estimated revenues to exceed $8.1 million

Successor CFO search underway

NASHUA, N.H. – April 5, 2021 - iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, reported select preliminary, unaudited financial results for the first quarter of 2021. Based on preliminary, unaudited financial information, the Company expects total revenue for the first quarter of 2021 to exceed $8.1 million. Unaudited cash and cash equivalents as of March 31, 2021 were approximately $46.9 million, which includes proceeds of the public offering closed in March 2021 that generated gross proceeds of approximately $25.0 million.

“For the first quarter of 2021, anticipated final revenue numbers represent significant growth, compared to the first quarter of 2020,” according to Michael Klein, iCAD’s Chairman and CEO. “Our strong results were driven by growth in both AI Detection revenue, due to continued market penetration for ProFound AI® and ProFound AI® Risk, and Xoft® Therapy revenues.”

iCAD also today announced that its Chief Financial Officer (CFO), R. Scott Areglado, will be leaving the Company in early May to accept a position with another company. An interim CFO will be appointed shortly to serve until such time as a permanent successor to Mr. Areglado is in place. The search and selection process for a successor to Mr. Areglado is already underway.

“Scott has been a valued member of the iCAD team for 10 years, having served as CFO for the last two years. During his tenure as CFO, Scott played an instrumental role in helping accelerate revenue growth and strengthening our competitive position. We wish Scott well in his future endeavors,” Mr. Klein continued. “Both our current VP of Finance and Controller will assume expanded responsibilities during this period of transition.”

“It has been exciting to be a part of the successful growth of iCAD and the expansion of our products and markets," said Mr. Areglado. "I am proud to have worked with such a talented team with a track record of delivering on strategic and financial objectives.”

iCAD’s consolidated financial statements for the three months ended March 31, 2020 are not yet available. The preliminary estimated financial information included in this press release for the three months ended March 31, 2021 is based solely on management’s estimates reflecting currently available preliminary information, and remains subject to iCAD’s consideration of subsequent events, particularly as it relates to material estimates and assumptions used in preparing our consolidated financial statements for the three months ended March 31, 2021. iCAD’s final consolidated financial results as of and for the three months ended March 31, 2021 may materially differ from estimates and the interim balances set forth in this release. Furthermore, the information presented herein does not present all information necessary for an understanding of the Company’s first quarter of 2021.

About iCAD, Inc.

Headquartered in Nashua, NH, iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions.

ProFound AI™ is a high-performing workflow solution for 2D and 3D mammography, or digital breast tomosynthesis (DBT), featuring the latest in deep-learning artificial intelligence. In 2018, ProFound AI for DBT became the first artificial intelligence (AI) software for DBT to be FDA-cleared; it was also CE marked and Health Canada licensed that same year. It offers clinically proven time-savings benefits to radiologists, including a reduction of reading time by 52.7 percent, thereby halving the amount of time it takes radiologists to read 3D mammography datasets. Additionally, ProFound AI for DBT improved radiologist sensitivity by 8 percent and reduced unnecessary patient recall rates by 7.2 percent.

The Xoft System is FDA-cleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body. It uses a proprietary miniaturized x-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site, while minimizing risk of damage to healthy tissue in nearby areas of the body.

For more information, visit www.icadmed.com and www.xoftinc.com.

Forward-Looking Statements

Certain statements contained in this release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the future prospects for the Company’s technology platforms and products, and statements about the preliminary revenue results of the Company for the three months ended March 31, 2021, which preliminary results are based solely on management’s estimates reflecting currently available information. 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 consideration of subsequent events (particularly those related to material estimates and assumptions used in preparing the Company’s consolidated financial statements), the Company’s ability to achieve its business and strategic objectives, IORT’s ability to alleviate the burden to our health system and minimize a patient’s potential exposure to Covid-19, IORT’s benefits for patients which exceed the benefits of traditional therapy or acceptance of IORT by patients or clinicians, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, the Company’s need to engage in or defend legal actions to protect its 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,” “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, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

Contacts:

Media inquiries:

Jessica Burns, iCAD

+1-201-423-4492

jburns@icadmed.com

Investor Relations:

Jeremy Feffer, LifeSci Advisors

+1-212-915-2568

jeremy@lifesciadvisors.com

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Cover	Mar. 30, 2021
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 30, 2021
Entity File Number	001-09341
Entity Registrant Name	ICAD INC
Entity Central Index Key	0000749660
Entity Tax Identification Number	02-0377419
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	98 Spit Brook Road
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Nashua
Entity Address, State or Province	NH
Entity Address, Postal Zip Code	03062
City Area Code	(603)
Local Phone Number	882-5200
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.01 par value
Trading Symbol	ICAD
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
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