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 11, 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 11, 2021, Microbot Medical Inc. issued a press release announcing that it has concluded 2020 with the achievement of several operating and developmental milestones, with plans to execute additional developmental, regulatory and clinical goals in 2021 as specified in the press release.
The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K is incorporated herein by reference. The information in this report (including Exhibit 99.1) 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 Exhibit 99.1).
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit Number |
Description | |
| 99.1 | Press Release |
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 11, 2021
Exhibit 99.1
Microbot Medical Demonstrates Significant Progress in 2020; Outlines Anticipated Milestones for 2021
Hingham, MA – January 11, 2021 – Microbot Medical Inc. (Nasdaq CM: MBOT) has concluded 2020 with the achievement of several operating and developmental milestones. The Company believes it is well positioned to leverage and capitalize upon this momentum through 2021, with plans to execute additional developmental, regulatory and clinical goals.
Key 2020 Operational and Product Achievements
| ● | Officially unveiled the LIBERTY™ Robotic System, the world’s first fully disposable surgical robotic system, which features a unique compact design with the capability to be operated remotely, reduce radiation exposure and physical strain to the physician. | |
| ● | Initiated animal feasibility studies using the LIBERTY™ Robotic System. To date, the LIBERTY Robotic system met the required end points with no intraoperative adverse events. The results support the Company’s objectives to allow physicians to remotely conduct catheter-based procedures from outside procedure rooms, avoiding radiation exposure, physical strain and the risk of cross contamination from infectious pathogens, such as COVID 19. | |
| ● | Held a pre-submission meeting with the U.S. Food and Drug Administration (FDA) to apply for an Early Feasibility Study (EFS) for the Self-Cleaning Shunt (SCS). | |
| ● | Expanded IP Portfolio with Global Patent Allowances resulting in a total of 40 patents granted and 23 patent applications pending approval. | |
| ● | Bolstered management team with Dr. Eyal Morag as Chief Medical Officer, to lead development and execution of clinical strategy for the Company’s technology platforms, including the Self-Cleaning Shunt (SCS) and LIBERTY Robotic System, as well as its future pipeline. Dr. Morag had been a member of the Company’s Scientific Advisory Board since November 2017. | |
| ● | Strengthened Board of Directors with the additions of Eileen Stockburger and Tal Wenderow. |
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Eileen Stockburger is an experienced executive and consultant with extensive expertise in strategizing, managing and closing sizable, complex worldwide mergers and acquisitions, licensing agreements and divestitures, as well as expertise in business development, strategic planning and finance. |
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Tal Wenderow is an expert medical device and robotics executive with a proven track record in small and mid-size companies. He co-founded Corindus Vascular Robotics, a robotic-assisted vascular interventions company, and contributed to the company’s success, leading to its $1.1 billion acquisition by Siemens Healthineers AG in October 2019. |
| ● | Enhanced thought leadership capabilities with the addition of new members to the Company’s Scientific Advisory Board (SAB). |
Anticipated 2021 Key Operational and Product Milestones
| ● | Conclude animal feasibility studies on the LIBERTY Robotic System. | |
| ● | Achieve design freeze for LIBERTY Robotic System by Q3 2021. | |
| ● | Initiate pivotal animal study for the LIBERTY Robotic system in the second half of 2021. | |
| ● | Finalize FDA pre-submission for the LIBERTY Robotic System by Q4 2021. | |
| ● | Conclude EFS pre-submission in regards to the SCS with the FDA by end of Q1 2021. | |
| ● | Continue to explore M&A opportunities that will enhance the Company’s assets and core capabilities. | |
| ● | Expand and protect the Company’s global IP portfolio in global jurisdictions, which creates significant barriers to entry. | |
| ● | Continue to recruit medical pioneers and thought leaders to the Company’s senior leadership, Board of Directors and SAB. |
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 LIBERTY 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 Contacts:
Michael Polyviou
EVC Group
mpolyviou@evcgroup.com
732-933-2754
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