0001493152-17-014711.txt : 20171218 0001493152-17-014711.hdr.sgml : 20171218 20171218133151 ACCESSION NUMBER: 0001493152-17-014711 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20171218 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20171218 DATE AS OF CHANGE: 20171218 FILER: COMPANY DATA: COMPANY CONFORMED NAME: InspireMD, Inc. CENTRAL INDEX KEY: 0001433607 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 262123838 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35731 FILM NUMBER: 171261000 BUSINESS ADDRESS: STREET 1: 4 MENORAT HAMAOR ST. CITY: TEL AVIV STATE: L3 ZIP: 6744832 BUSINESS PHONE: (888) 776-6804 MAIL ADDRESS: STREET 1: 4 MENORAT HAMAOR ST. CITY: TEL AVIV STATE: L3 ZIP: 6744832 FORMER COMPANY: FORMER CONFORMED NAME: Saguaro Resources, Inc. DATE OF NAME CHANGE: 20080428 8-K 1 form8-k.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): December 18, 2017

 

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)

 

Registrant’s telephone number, including area code: (888) 776-6804

 

 

 

(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))

 

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 December 18, 2017, InspireMD, Inc. announced that CGuardTM EPS was prominently featured in a live clinical case at ENDOGRAFT, the Endovascular Global Roman Arterial Featured Therapies conference, which was held from December 14th-16th, 2017 in Rome. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is hereby incorporated by reference herein.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number   Description
99.1   Press release dated December 18, 2017

 

 

 

 

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: December 18, 2017 By: /s/ Craig Shore
  Name: Craig Shore
  Title: Chief Financial Officer

 

 

 

 

 

EX-99.1 2 ex99-1.htm

 

 

InspireMD’s CGuard™ Embolic Prevention System Once Again Featured in a

Successful Live Clinical Case at Leading Industry Conference

 

Professor Pierfrancesco Veroux treated a patient
with carotid artery disease using CGuard™ EPS

 

Tel Aviv, Israel— December 18, 2017 - InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that CGuardTM EPS was once again prominently featured in a live clinical case at an industry conference. Professor Pierfrancesco Veroux, Head of Vascular Surgery and Transplant Center, Policlinico Vittorio Emanuele di Catania, performed the live procedure featuring the CGuard™ EPS at ENDOGRAFT. ENDOGRAFT is the Endovascular Global Roman Arterial Featured Therapies conference, which was held from December 14th-16th, 2017 in Rome. The case was transmitted real time to the entire congress on December 15, 2017. Professor Veroux is also a President of the conference.

 

The ENDOGRAFT conference is an international and multidisciplinary conference dedicated to the treatment of complex vascular diseases. The conference brings together endovascular specialists including vascular surgeons, interventional cardiologists, radiologists and neurologists from around the world.

 

Professor Veroux commented, “The CGuard™ EPS performed extremely well during the live procedure, and I believe this technology should become standard-of-care given the strong supporting clinical data which demonstrates the MicroNet™ technology’s ability to reduce the risk of post-procedural embolism and stroke.”

 

“We were honored to have Professor Veroux feature CGuard™ and the MicroNet™ technology in a live case transmission at the ENDOGRAFT conference,” said James Barry, PhD, Chief Executive Officer of InspireMD. “We continue to see that key opinion leaders across all clinical specialties not only want to use CGuard™ EPS to treat their patients suffering from carotid artery disease, but are also demonstrating its benefits to other physicians. We are especially gratified to have our technology featured so prominently at this leading industry conference by a surgeon of Professor Veroux’s caliber and reputation. While most of these conferences have a limited amount of live transmissions, CGuard™ is being chosen by these thought leaders once again.”

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

 

InspireMD intends to pursue applications of this MicroNet technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS.

 

 
 

 

Forward-looking Statements

 

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

 

InspireMD, Inc.

Craig Shore

Chief Financial Officer

Phone: 1-888-776-6804 FREE

Email: craigs@inspiremd.com

 

Crescendo Communications, LLC

David Waldman

Phone: (212) 671-1021

Email: NSPR@crescendo-ir.com

 

 
 

 

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