MBOT Microbot Medical Inc

 

 

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): July 8, 2024

 

MICROBOT MEDICAL INC.

(Exact name of registrant as specified in its charter)

 

Delaware		000-19871		94-3078125
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

288 Grove Street, Suite 388

Braintree, MA 02184

(Address of Principal Executive Offices) (Zip Code)

 

Registrant’s telephone number, including area code: (781) 875-3605

 

 

(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 each exchange on which registered
Common Stock, $0.01 par value		MBOT		NASDAQ Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

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 July 8, 2024, Microbot Medical Inc. (the “Company”) issued a press release announcing the completion of the first procedure in a patient utilizing its LIBERTY^® Endovascular Robotic Surgical System, at Brigham and Women’s Hospital.

 

The press release, which is furnished as Exhibit 99.1 to this Current Report on Form 8-K, is incorporated herein by reference. The information in this Item 7.01 and Exhibit 99.1 is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. This report will not be deemed an admission as to the materiality of any information in this Item 7.01 or Exhibit 99.1.

 

Item 8.01 Other Events.

 

The Company completed the first procedure in a patient utilizing its LIBERTY^® Endovascular Robotic Surgical System. The procedure took place at Brigham and Women’s Hospital as part of the Company’s pivotal human clinical trial. The trial is part of the Investigational Device Exemption for LIBERTY^®, and the Company expects its results will support the future submission to the FDA and subsequent commercialization.

 

Forward Looking Statements

 

This Item 8.01 of this Current Report on Form 8-K contains “forward-looking statements.” Such statements which are not purely historical (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “intends,” “would,” “could” and “estimates”) are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future, including but not limited to, regulatory milestones.

 

Actual results could differ from those projected in any forward-looking statements due to numerous factors. These forward-looking statements are made as of the date of this Form 8-K, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Although the Company believes that the beliefs, plans, expectations and intentions contained in this Form 8-K are reasonable, there can be no assurance that such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in the Company’s reports and statements filed from time-to-time with the Securities and Exchange Commission.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number		Description
99.1		Press Release
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 thereunto duly authorized.

 

	MICROBOT MEDICAL INC.
	By:	/s/ Harel Gadot
	Name:	Harel Gadot
	Title:	Chief Executive Officer, President and Chairman

 

Date: July 8, 2024

 

 

Exhibit 99.1

 

 

Microbot Medical Enrolled the First Patient in its

Pivotal Human Clinical Trial

 

The first clinical case was performed at Brigham and Women’s Hospital

 

The clinical trial is expected to support the future submission to the FDA for the commercialization of the LIBERTY^® Endovascular Robotic Surgical System

 

BRAINTREE, Mass., July 8, 2024 — Microbot Medical Inc. (Nasdaq: MBOT) today announced the completion of the first procedure in a patient utilizing its LIBERTY^® Endovascular Robotic Surgical System. The procedure took place at Brigham and Women’s Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, as part of the Company’s pivotal human clinical trial.

 

The clinical trial at BWH is led by Dr. Dmitry Rabkin, MD, PhD, Assistant Chief, Division of Angiography & Interventional Radiology, who also performed this first human case. The trial is part of the Investigational Device Exemption (“IDE”) for LIBERTY^®, and the Company expects its results will support the future submission to the FDA and subsequent commercialization.

 

“Enrolling the first patient in our pivotal human clinical trial is a significant milestone for the Company, and an important step on our journey to bring LIBERTY^® to U.S. physicians,” commented Juan Diaz-Cartelle, MD, Chief Medical Officer of Microbot Medical. “We are very pleased with the rapid pace of site activation, and I’m looking forward to enrolling additional patients in the near future.”

 

About Microbot Medical

 

Microbot Medical Inc. (NASDAQ: MBOT) is a clinical- stage medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body.

 

The Investigational LIBERTY^® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY^® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures.

 

Further information about Microbot Medical is available at

http://www.microbotmedical.com.

 

Safe Harbor

 

Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of the LIBERTY^® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY^® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law.

 

Investor Contact:

 

Michal Efraty

 

IR@microbotmedical.com

 

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Cover	Jul. 08, 2024
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Jul. 08, 2024
Entity File Number	000-19871
Entity Registrant Name	MICROBOT MEDICAL INC.
Entity Central Index Key	0000883975
Entity Tax Identification Number	94-3078125
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	288 Grove Street
Entity Address, Address Line Two	Suite 388
Entity Address, City or Town	Braintree
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02184
City Area Code	(781)
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Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.01 par value
Trading Symbol	MBOT
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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