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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): August 22, 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 August 22, 2024, Microbot Medical Inc. (the “Company”) issued a press release announcing that it has entered into a Phase 2 collaboration agreement with Corewell HealthTM that will continue their collaboration to advance remote telesurgery for endovascular procedures.

 

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 entered into a Phase 2 collaboration agreement with Corewell HealthTM that will continue their collaboration to advance remote telesurgery for endovascular procedures. During Phase 2, the Company and Corewell HealthTM will work together to develop the capabilities to perform simulated cardiovascular interventional procedures with the LIBERTY® Endovascular Robotic System across two sites within the Corewell Health system which are five miles apart.

 

Forward Looking Statements

 

This Item 8.01 of this Current Report on Form 8-K may contain “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: August 22, 2024

 

 

 

 

Exhibit 99.1

 

 

Microbot Medical Signs Phase 2 Collaboration Agreement with Corewell Health to Advance Remote Telesurgery Using the LIBERTY® Endovascular Robotic System

 

The agreement follows the successful completion of Phase 1 which evaluated the viability of LIBERTY as a remote telesurgery platform

 

The objective of Phase 2 is to develop and demonstrate new telesurgery capabilities by performing simulated interventional procedures between two facilities within the Corewell Health system

 

BRAINTREE, Mass., August 22, 2024 — Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic System, announces that it entered into a Phase 2 collaboration agreement with Corewell HealthTM that will continue their collaboration to advance remote telesurgery for endovascular procedures. The Company had previously announced positive results from the first phase, which demonstrated LIBERTY’s technical capabilities and outlined potential future applications in a range of endovascular interventions, including the feasibility of LIBERTY to support the remote telesurgery project.

 

During Phase 2, the Company and Corewell Health will work together to develop the capabilities to perform simulated cardiovascular interventional procedures with LIBERTY across two sites within the Corewell Health system which are 5 miles apart.

 

The project is led by Ryan Madder, M.D., Section Chief of Interventional Cardiology and Director of the Cardiac Cath Lab at Corewell Health in West Michigan. Following the completion of Phase 1, Dr. Madder and colleagues published a manuscript in the Journal of the American College of Cardiology: Cardiovascular Interventions, highlighting the Technical Success of Coronary Guidewire and Stent Delivery Using a Novel Miniaturized Robotic System in a Pre-Clinical Study.

 

“Incorporating telesurgery capabilities is an important part of our long-term strategy for LIBERTY,” said Harel Gadot, CEO, President and Chairman of Microbot Medical. “We believe that physicians in the U.S. and around the globe want to increase access to care for patients in remote locations, and we are excited to continue our collaboration with Corewell Health and Dr. Madder on this next phase of development.”

 

Dr. Madder’s manuscript is available at: https://doi.org/10.1016/j.jscai.2024.102148

 

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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