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): October 12, 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>File<br>Number) | (IRS<br>Employer<br><br>Identification No.) |
| **4Menorat Hamaor St.**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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> 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<br> Stock, par value $0.0001 per share | NSPR | The<br> 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. ☐
Item7.01 Regulation FD Disclosure.
On October 12, 2023, InspireMD, Inc. (the “Company”) issued a press release titled “InspireMD Supports CMS’ Final National Coverage Determination (NCD) Expanding Coverage of Carotid Stenting (CAS) to Include Both Asymptomatic and Standard Risk Patients”. 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.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description |
|---|---|
| 99.1 | Press release, dated October 12, 2023 (furnished herewith pursuant to Item 7.01) |
| 104 | Cover<br> 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:<br> October 12, 2023 | By: | /s/ Craig Shore |
| Name: | Craig<br> Shore | |
| Title: | Chief<br> Financial Officer |
Exhibit99.1
InspireMDSupports CMS’ Final National Coverage Determination (NCD) Expanding Coverage
of Carotid Stenting (CAS) to Include Both Asymptomaticand Standard Risk Patients
Providesadditional treatment options for patients and treating physicians; likely expands CAS addressable market
Potentiallyaccelerates conversion of carotid interventions from surgery (carotid endarterectomy) to minimally invasive CAS and TCAR procedures
InspireMDadvancing both CAS and TCAR stent delivery platforms along U.S. and E.U. regulatory pathways leveraging proven CGuard EPS stent system
TelAviv, Israel, and Miami, Florida — October 12, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced its support for the Centers for Medicare and Medicaid Services (CMS) final National Coverage Determination (NCD) which expands coverage of carotid artery stenting (CAS) and transcarotid artery revascularization (TCAR) to include both asymptomatic and standard risk patients.
Marvin Slosman, Chief Executive Officer of InspireMD, stated, “We support CMS’s final decision on the expansion of coverage of CAS to include both symptomatic and asymptomatic carotid artery disease patients considered to be either standard or high risk for surgery. This decision offers a new treatment alternative to patients and their treating physicians and, we believe, will accelerate the ongoing shift toward an endovascular ‘stent first’ approach and away from more invasive surgery, the current standard of care.
“Importantly, at InspireMD, we continue to advance our mission, focusing on the importance of the implant first in both our CAS and TCAR programs, which are advancing through regulatory pathways in the U.S. and E.U. These programs both feature our next-generation CGuard EPS stent that has demonstrated unmatched clinical outcomes across nine clinical trials that have enrolled more than 1,850 patients, as well as over 40,000 real-world procedures performed to date. The CGuard EPS stent remains the cornerstone of our business, and this decision by CMS will broaden access to what we regard as this best-in-class technology, with anticipated FDA approval.”
In June 2023, InspireMD announced completion of enrollment in the C-GUARDIANS investigational device exemption (IDE) clinical trial of its CGuard™ EPS stent system. Thirty-day safety results from the trial will be presented as a Late Breaking Clinical Trial at the VIVA (Vascular InterVentional Advances) conference on November 1, 2023, in Las Vegas. The company anticipates filing for Premarket Approval (PMA) in the second half of 2024 when one-year follow up has been completed.
InspireMD will provide further updates on this and other recent developments during its regularly scheduled third quarter 2023 conference call in November.
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