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): January 14, 2021

 

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.)

 

25 Recreation Park Drive, Unit 108

Hingham, Massachusetts 02043

(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 January 14, 2021, Microbot Medical Inc. (the “Company”) issued a press release announcing that the continued progression of its LIBERTYTM Robotic System was further demonstrated as the Company announced the successful completion of an additional feasibility animal study using the world’s first fully disposable surgical robotic system. The animal feasibility studies to date, support the Company’s assertion that LIBERTY will potentially allow physicians to safely and easily conduct catheter-based peripheral and neurovascular procedures remotely, avoiding radiation exposure, physical strain and the risk of cross contamination.

 

The Company is also furnishing presentation materials as Exhibit 99.2 to this Current Report on Form 8-K, which may also be accessed via the ‘Investors’ section, under ‘Presentations + Resources’ of the Registrant’s website at www.microbotmedical.com. The Company is not undertaking to update this presentation.

 

The press release furnished as Exhibit 99.1 and the presentation furnished as Exhibit 99.2 to this Current Report on Form 8-K are incorporated herein by reference. The information in this report (including Exhibits 99.1 and 99.2) is being furnished pursuant to Item 7.01 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 herein (including Exhibits 99.1 and 99.2).

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
Number
  Description
     
99.1   Press Release
99.2   Presentation

 

 

 

 

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: January 14, 2021

 

 

 

 

Exhibit 99.1

 

 

Microbot Medical Announces Positive Results of Additional Animal Feasibility Study with LIBERTYTM Robotic System

 

Results Validate Findings of Initial Study; End Points Achieved with No Intraoperative Adverse Events

 

Management Presenting at Needham Growth Conference Today at 2:00pm ET

 

HINGHAM, Mass., January 14, 2021 – The continued progression of Microbot Medical Inc.’s (Nasdaq: MBOT) LIBERTYTM Robotic System was further demonstrated as the Company announced the successful completion of an additional feasibility animal study using the world’s first fully disposable surgical robotic system. The study end points included navigating to a clot, crossing the clot, deploying a stent retriever, and manually retrieving an arterial clot in a live pig. All the end points were met with no intraoperative adverse events. The animal feasibility studies to date, support the Company’s assertion that LIBERTY will potentially allow physicians to safely and easily conduct catheter-based peripheral and neurovascular procedures remotely, avoiding radiation exposure, physical strain and the risk of cross contamination.

 

“As we continue to evaluate LIBERTY in the hands of leading clinicians, the system is performing to our expectations and achieving the desired clinical and usability outcomes,” commented Harel Gadot, Chief Executive Officer, President, and Chairman. “Additional studies are planned throughout the coming year to allow us to achieve our regulatory goals.”

 

The procedure was performed by Dr. Gal Yaniv, a recently added member of the Company’s Scientific Advisory Board (SAB), who also serves as Director of Endovascular Neurosurgery at Sheba Tel HaShomer City of Health and Chief Medical Officer of Aidoc Medical, a full body imaging AI software firm. Dr. Yaniv conducted the procedure and the results demonstrated robust navigation capabilities and intuitive usability.

 

Mr. Gadot will be presenting an overview of the Company later today at 2:00pm ET. The live and archived replays of the presentation may be accessed via the ‘Investors’ section, under ‘Presentation + Resources’ of the Company’s website at www.microbotmedical.com.

 

About Microbot Medical

 

Microbot Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, focused primarily on both natural and artificial lumens within the human body. Microbot’s current proprietary technological platforms provide the foundation for the development of a Multi Generation Pipeline Portfolio (MGPP).

 

Microbot Medical was founded in 2010 by Harel Gadot, Prof. Moshe Shoham, and Yossi Bornstein with the goals of improving clinical outcomes for patients and increasing accessibility through the use of micro-robotic technologies. Further information about Microbot Medical is available at http://www.microbotmedical.com.

 

 

 

 

Safe Harbor

 

Statements pertaining to the registered direct offering, timing, the amount and anticipated use of proceeds and statements pertaining 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 and the satisfaction of customary closing conditions, risks inherent in the development and/or commercialization of potential products, including LIBERTYTM and SCS, the outcome of its studies to evaluate LIBERTY, SCS and other existing and future technologies, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, 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:

 

Michael Polyviou

EVC Group

mpolyviou@evcgroup.com

732-933-2754

 

 

 

 

Exhibit 99.2