0001493152-24-011233.txt : 20240326 0001493152-24-011233.hdr.sgml : 20240326 20240326075646 ACCESSION NUMBER: 0001493152-24-011233 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240326 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240326 DATE AS OF CHANGE: 20240326 FILER: COMPANY DATA: COMPANY CONFORMED NAME: InspireMD, Inc. CENTRAL INDEX KEY: 0001433607 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] ORGANIZATION NAME: 08 Industrial Applications and Services 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: 24780951 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 from8-k.htm
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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 26, 2024

 

InspireMD, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

(State or Other Jurisdiction of Incorporation)

 

001-35731   26-2123838

(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)

 

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 each exchange on which registered
Common Stock, par value $0.0001 per share   NSPR   The Nasdaq Capital Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in 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 Disclosure.

 

On March 26, 2024, InspireMD, Inc. (the “Company”) issued a press release titled “InspireMD Announces Abstract of One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at LINC 2024”. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K that is furnished pursuant to this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number   Description
99.1   Press release, dated March 26, 2024 (furnished herewith pursuant to Item 7.01)
104   Cover Page Interactive Data File (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.

 

  INSPIREMD, INC.
     
Date: March 26, 2024 By: /s/ Craig Shore
  Name: Craig Shore
  Title: Chief Financial Officer

 

   

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

 

InspireMD Announces Abstract of One-Year Follow-Up Results from the

C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at LINC 2024

 

Tel Aviv, Israel, and Miami, Florida — March 26, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that an abstract of the one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Prime Carotid Stent System for the treatment of carotid artery stenosis has been accepted for presentation at the Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany.

 

Presentation details:

 

Title: One-Year Follow-Up Results from the C-GUARDIANS Pivotal Trial of the CGuard™ Carotid Stent System
   
Presenter: Chris Metzger, M.D., System Vascular Chief at Ohio Health, and lead investigator of the C-Guardians trial
   
Date/time: To be announced

 

Marvin Slosman, chief executive officer of InspireMD, stated, “At last year’s VIVA and VEITH conferences in November, Dr. Metzger, principal investigator for the C-GUARDIANS trial, presented positive 30-day follow-up data from the trial which demonstrated a DSMI1 rate of just 0.95% in the Intent-To-Treat (ITT) analysis population, and 0.63% in the per-protocol (PP) analysis population. We are very excited to announce today that an abstract of the 12-month outcomes data from this important trial has been accepted for presentation at the upcoming LINC 2024 conference, which is among the most influential and widely attended meetings focused on vascular intervention. We are optimistic that the results will show a similar level of neuroprotection, which may support a Premarket Approval Application (PMA) later this year and allow us to prepare for a commercial launch of CGuard Prime in the U.S. in the first half of 2025, if approved.”

 

About C-GUARDIANS

 

The C-GUARDIANS clinical trial evaluated the safety and efficacy of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe.

 

The trial included both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the composite of the following: incidence of the following major adverse events: death (all- cause mortality), all stroke, or myocardial infarction (DSMI) through 30-days post-index procedure, based on the Clinical Events Committee (CEC) adjudication or ipsilateral stroke from 31-365-day follow-up, based on CEC adjudication. The performance goal will be considered to have been met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is <11.6% and the p-value is <0.025.

 

 

1 Death (all-cause mortality), stroke, or myocardial infarction

 

   
 

 

 

 

About LINC

 

LINC, the Leipzig Interventional Course, is strongly committed to contribute to a systematic scientific evaluation and interdisciplinary discussion of new methods in the field of vascular medicine, allowing conclusions for daily interventional practice. LINC is an interdisciplinary live course, designed to provide a global platform, permitting the discussion of the “vascular patients” by integrating colleagues of different specialties from around the world who are performing endovascular interventions.

 

For more information, please visit: https://www.leipzig-interventional-course.com/

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.

 

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

 

Forward-looking Statements

 

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Examples of such statements include, but are not limited to, statements relating to the C-Guardians U.S. IDE clinical trial, including one-year results from such trial and that such results will be available to be presented at LINC 2024, as well as the timing and outcome of any subsequent results, PMA or potential launch. 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 our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; 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; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. 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:

 

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

 

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

 

   

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Cover
Mar. 26, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Mar. 26, 2024
Entity File Number 001-35731
Entity Registrant Name InspireMD, Inc.
Entity Central Index Key 0001433607
Entity Tax Identification Number 26-2123838
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 4 Menorat Hamaor St.
Entity Address, City or Town Tel Aviv
Entity Address, Country IL
Entity Address, Postal Zip Code 6744832
City Area Code (888)
Local Phone Number 776-6804
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.0001 per share
Trading Symbol NSPR
Security Exchange Name NASDAQ
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