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EX-99.1 - InspireMD, Inc.ex99-1.htm

 

 

 

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): June 25, 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. [  ]

 

 

 

 
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Item 8.01 Other Events.

 

On June 25, 2020, InspireMD, Inc. (the “Company”) issued a press release announcing that the results from an investigator-initiated SIBERIA randomized clinical trial of the Company’s CGuard™ Embolic Prevention System (EPS) are being featured as a late-breaking presentation in an EuroPCR e-Course, which is being held June 25-27, 2020.

 

The trial, which evaluated 30-day silent brain infarcts associated with the use of the Acculink™ conventional open-cell nitinol stent vs the CGuard™ Micronet™-covered stent, displayed that CGuard™ had a statistically significant (greater than three-fold) reduction in the procedure-generated mean cerebral lesion volume relative to Acculink™. At 30 days, there were zero new cerebral lessons in the CGuard™ arm, compared to six in the Acculink™ arm, also statistically significant.

 

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number   Description
99.1   Press release dated June 25, 2020

 

 
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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: June 25, 2020 By: /s/ Craig Shore
  Name: Craig Shore
  Title: Chief Financial Officer