8-K
AtriCure, Inc. (ATRC)
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): April 13, 2020
AtriCure, Inc.
(Exact name of registrant as specified in charter)
| Delaware<br><br>(State or other jurisdiction of incorporation) | 000-51470<br><br>(Commission File Number) | 34-1940305<br><br>(IRS Employer Identification No.) |
|---|
7555 Innovation Way, Mason OH 45040
(Address of Principal Executive Offices, and Zip Code)
(513) 755-4100
(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)) | |
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| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| --- | --- | --- |
| Common Stock, $.001 par value | ATRC | NASDAQ |
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 7.01 Regulation FD
On April 13, 2020 AtriCure issued a press release announcing that its CONVERGE IDE trial results have been accepted for presentation in the late-breaking abstract sessions at the Heart Rhythm Society (HRS) Scientific Sessions. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and also is incorporated by reference into this Item 7.01.
The information contained in Item 7.01 and in the accompanying Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing or other document under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), regardless of any general incorporation language in any such filing or document, except as shall be expressly set forth by specific reference in any such filing or document.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| No. | Description |
|---|---|
| 99.1 | Press Release dated April 13, 2020 announcing CONVERGE IDE Trial Results Accepted for HRS |
| 104 | Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document. |
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 hereunto duly authorized.
| ATRICURE, INC. | |||
|---|---|---|---|
| Dated: | April 13, 2020 | By: | /s/ M. Andrew Wade |
| M. Andrew Wade | |||
| Chief Financial Officer |
Exhibit 991
| <br> Exhibit 99.1 |
|---|
For immediate release
April 13, 2020
AtriCure Announces CONVERGE IDE Trial Results Accepted for Late-Breaking Clinical Trial Sessions at Annual Heart Rhythm Society (HRS) Meeting
MASON, Ohio — April 13, 2020 — AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, today announced that results from the CONVERGE IDE trial, have been accepted for presentation in the late-breaking abstract sessions at the Heart Rhythm Society (HRS) Scientific Sessions. The abstract will be presented as a webinar on Heart Rhythm 365, the society’s digital information platform. Specific details on the exact timing of the presentation will follow in a separate announcement.
“I want to thank the HRS for accepting the abstract for presentation during the virtual programming as part of the annual meeting,” said Dr. David B. DeLurgio, Director of Electrophysiology at the Emory Heart and Vascular Center at Emory St. Joseph’s Hospital, and National Principal Investigator for the CONVERGE trial. “I’m grateful for the opportunity to present on this very important trial.”
About CONVERGE IDE Trial
The CONVERGE IDE trial is a landmark prospective, randomized trial comparing the Convergent approach to endocardial catheter ablation for patients with persistent or long-standing persistent Afib. The Convergent approach is a multi-disciplinary therapy in which a closed chest epicardial ablation is performed by a surgeon, and then complemented by an endocardial catheter ablation performed by an electrophysiologist. Patients were enrolled at 25 sites across the United States, along with two sites in the United Kingdom.
The CONVERGE study’s primary efficacy endpoint is for enrolled patients to be free from Afib, atrial tachycardia, and atrial flutter, absent class I and III AADs except for a previously failed or intolerant class I or III anti-arrhythmic drugs, with no increase in dosage following the three month blanking period through the 12 months post procedure follow-up visit. The company has submitted final documentation to the Food and Drug Administration and is seeking a pre-market approval (PMA).
About AtriCure
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first and only medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
Forward-Looking Statements
This press release contains “forward-looking statements”– that is, statements related to future events that by their nature address matters that are uncertain. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, visit http://www.atricure.com/fls as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. We do not undertake to update our forward-looking statements. This document also includes forward-looking projected financial information that is based on current estimates and forecasts. Actual results could differ materially.
CONTACTS:
Andy Wade
AtriCure, Inc.
Chief Financial Officer
(513) 755-4564
awade@atricure.com
Lynn Pieper Lewis
Gilmartin Group
Investor Relations
(415) 937-5402
lynn@gilmartinir.com