8-K
InspireMD, Inc. (NSPR)
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): June 26, 2023
InspireMD,Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
| 001-35731 | 26-2123838 |
|---|---|
| (Commission<br><br> <br>File<br> Number) | (IRS<br> Employer<br><br> <br>Identification<br> No.) |
| 4 Menorat Hamaor St.<br><br> <br>Tel Aviv, Israel | 6744832 |
| --- | --- |
| (Address<br> of Principal Executive Offices) | (Zip<br> 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<br> pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant<br> to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications<br> pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications<br> 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<br> $0.0001 per share | NSPR | The Nasdaq Capital Market<br> 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. ☐
Item7.01 Regulation FD Disclosure.
On June 26, 2023, InspireMD, Inc. (the “Company”) issued a press release titled “InspireMD Announces Completion of Enrollment in C-Guardians U.S. Investigational Device Exemption (IDE) Clinical Trial”. 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.
Item8.01 Other Events.
On June 26, 2023, the Company announced that it completed enrollment of its ongoing C-Guardians U.S. Investigational Device Exemption (IDE) clinical trial, designed to support potential U.S. marketing approval of the CGuard Prime EPS stent system.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description |
|---|---|
| 99.1 | Press release, dated June 26, 2023 (furnished herewith pursuant to Item 7.01) |
| 104 | Cover Page Interactive Data File (embedded within the<br> 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: June 26, 2023 | By: | /s/ Craig Shore |
| Name: | Craig Shore | |
| Title: | Chief Financial Officer |
Exhibit99.1
InspireMDAnnounces Completion of Enrollment in C-Guardians U.S. Investigational Device Exemption (IDE) Clinical Trial
Trialdesigned to support potential U.S. marketing approval of the CGuard™ Prime EPS stent system
Studyalso included first-in-human cases treated with CGuard Prime CAS stent delivery platform
Companyanticipates study results and Premarket Approval (PMA) submission in H2 2024, potential U.S. approval in H1 2025
TelAviv, Israel — June 26, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it completed enrollment of its ongoing C-Guardians U.S. Investigational Device Exemption (IDE) clinical trial, designed to support potential U.S. marketing approval of the CGuard Prime EPS stent system.
Marvin Slosman, chief executive officer of InspireMD, stated, “The completion of enrollment in our IDE trial is a significant milestone and brings us one step closer to potential U.S. approval of the CGuard Prime EPS stent system. Notably, the trial was fully enrolled in less than two years, including first-in-human cases treated with our next generation CGuard Prime CAS delivery platform. We believe the rapid enrollment reflects the comfort and support of the CGuard stent system by our investigators as we work to be the only company developing comprehensive next generation delivery and neuro protection platforms that achieve best implant performance and patient outcomes though both transfemoral (CAS) and trans carotid (TCAR) solutions. Completing enrollment of the C-Guardians trial, advancing our PMA submission and obtaining FDA approval would allow us to launch CGuard Prime EPS commercially in the U.S. and catalyze market adoption. We look forward to building on our global expansion and fulfilling our mission to deliver best patient therapy for carotid disease and stroke prevention.”
The C-Guardians clinical trial is evaluating the safety and efficacy of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis. The study, which commenced enrollment in July 2021, enrolled 315 patients across 25 trial sites in the U.S. and Europe.
The trial includes 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, and 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.
The company anticipates results from the study in H2 2024.
AboutInspireMD, 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-lookingStatements
Thispress release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statementsregarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Suchstatements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,”“anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,”“hopes,” “potential”, “scheduled” or similar words. Forward-looking statements are not guaranteesof future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many ofwhich are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materiallyfrom those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks anduncertainties associated with our history of recurring losses and negative cash flows from operating activities, significant future commitmentsand the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regardingour ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future andsuch capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptanceof our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial resultsor lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generaterevenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectualproperty; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standardsand to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficientto 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 technologicalobsolescence 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 suppliesand components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts tosuccessfully 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 conductbusiness in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communicationschallenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalationof hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic andmarket conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed informationabout the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’sfilings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its QuarterlyReports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site athttp://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of newinformation, future events or otherwise.
InvestorContacts:
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