UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): September 3, 2020
InspireMD, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | | 001-35731 | | 26-2123838 |
(State or other jurisdiction of incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
4 Menorat Hamaor St. Tel Aviv, Israel | | 6744832 |
| (Address of principal executive offices) | | (Zip Code) |
(888) 776-6804
(Registrant’s telephone number, including area code)
N/A
(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:
| [ ] | 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 exchange on which registered |
| Common Stock, par value $0.0001 per share | | NSPR | | NYSE American |
| Warrants, exercisable for one share of Common Stock | | NSPR.WS | | NYSE American |
| Series B Warrants, exercisable for one share of Common Stock | | NSPR.WSB | | NYSE American |
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 8.01 Other Events.
On September 3, 2020, InspireMD, Inc. (the “Company”) issued a press release that included updated data regarding the results of a large, long-term PARADIGM-EXTEND study involving the Company’s CGuard™ Embolic Prevention System (EPS). The data was included in a presentation made as part of the European Society of Cardiology 2020 Carotid Update e-presentation at the European Society of Cardiology (ESC) Congress 2020. The study is an investigator-driven, on-going study performed with CGuard Carotid stent for primary and secondary stroke prevention in a large, consecutive all-comers population, with 5 years (60 months) follow-up.
The results tracked 480 patients who completed the 30-day follow-up. There were no peri-procedural major strokes or death among those 480 patients. The total death/stroke /myocardial incidence at 30 days was 1.04% (5/480) due to two minor strokes, one myocardial infarction and two stent-unrelated deaths. 354 of the 480 patients completed a 12-month follow-up, with only one patient experiencing in-stent restenosis, constituting only 0.28% (1/354) of those participating. At the 12-month follow-up, there were no other device-related adverse clinical events. For the 46 patients who completed the 60-month follow-up period, there was only one more case of in-stent restenosis and no additional cases of device-related stroke.
A copy of the press release including the updated data from the study is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| | InspireMD, Inc. |
| | | |
| Date: September 3, 2020 | By: | /s/ Craig Shore |
| | Name: | Craig Shore |
| | Title: | Chief Financial Officer |
