Articles from Microbot Medical Inc.

Operations Leader to Enhance Operational Efficiencies by Managing Production Scale-up and Cost Reduction Activities to Support Commercialization

Mr. Wilson has a Track Record of Leading Product Launches and Achieving Revenue Growth in the Endovascular Devices Market

BRAINTREE, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 3,788,550 shares of the Company’s common stock at a purchase price of $2.27 per share of common stock. In addition, in a concurrent private placement, the Company issued unregistered short-term series H preferred investment options. The short-term series H preferred investment options to purchase up to 7,577,100 shares of common stock have an exercise price of $2.10 per share and are immediately exercisable following issuance for a period of two years thereafter.

HINGHAM, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has entered into definitive agreements for the purchase and sale of 3,788,550 shares of the Company’s common stock at a purchase price of $2.27 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered short-term series H preferred investment options. The short-term series H preferred investment options to purchase up to 7,577,100 shares of common stock have an exercise price of $2.10 per share and are immediately exercisable following issuance for a period of two years thereafter. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about January 9, 2025, subject to the satisfaction of customary closing conditions.

HINGHAM, Mass., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 4,000,001 shares of the Company’s common stock at a purchase price of $1.75 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company issued unregistered short-term series G preferred investment options. The short-term series G preferred investment options to purchase up to 8,000,002 shares of common stock have an exercise price of $1.75 per share and are immediately exercisable following issuance for a period of two years thereafter.

HINGHAM, Mass., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has entered into definitive agreements for the purchase and sale of 4,000,002 shares of the Company’s common stock at a purchase price of $1.75 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered short-term series G preferred investment options. The short-term series G preferred investment options to purchase up to 8,000,004 shares of common stock have an exercise price of $1.75 per share and are immediately exercisable following issuance for a period of two years thereafter. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about January 7, 2025, subject to the satisfaction of customary closing conditions.

Company Shifts Focus to Preparing for Commercial Launch as it Enters 2025

Livestream Interview Can be Viewed Today at 10:50am ET at Benzinga All Access Live

FDA 510(k) Submission Follows the Successful Completion of the Pivotal Human Clinical Trial

U.S. Food and Drug Administration (FDA) Submission Expected by end of 2024

Confirms the Company on Track for FDA 510(k) Submission by end of 2024

Completion of enrollment expected in Q4 with FDA submission for commercialization anticipated by the end of 2024

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

The ISO 13485 certification is a validation of the Company’s robust quality system

The evaluation phase will explore the potential of integrating robotics, procedure planning and navigation into a single autonomous system

As the third and final clinical site, Memorial Sloan Kettering Cancer Center joins Brigham Women’s Hospital and Baptist Hospital of Miami as sites for the pivotal human clinical trial

Baptist Hospital of Miami is the second site to perform clinical procedures as part of the Company’s Pivotal Human Clinical Trial.

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

Following the Company’s recent FDA approval to commence its pivotal human clinical trial, Baptist Hospital of Miami is the second clinical site to enroll in the trial

Following FDA Approval to Commence the Clinical Trial, an Official Site Initiation Has Taken Place as Preparation for Patient Enrollment Advances

The Site Initiation Visit for the BWH clinical staff is complete and a shipment of LIBERTY investigational units was delivered

HINGHAM, Mass., June 04, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has closed its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 1,566,669 shares of the Company’s common stock at a purchase price of $1.50 per share of common stock . In addition, in a concurrent private placement, the Company has issued unregistered series F preferred investment options. The series F preferred investment options to purchase up to 3,133,338 shares of common stock have an exercise price of $1.50 per share and are immediately exercisable following issuance for a period of two years thereafter.

HINGHAM, Mass., June 03, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has entered into definitive agreements for the purchase and sale of 1,566,669 shares of the Company’s common stock at a purchase price of $1.50 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered series F preferred investment options. The series F preferred investment options to purchase up to 3,133,338 shares of common stock have an exercise price of $1.50 per share and are immediately exercisable following issuance for a period of two years thereafter. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about June 4, 2024, subject to the satisfaction of customary closing conditions.

The trial will be conducted in the U.S. and its results will complement the preclinical data on the LIBERTY® Endovascular Robotic Surgical System, which together are expected to support a future 510(k) submission

The next step of the collaboration will explore potential future applications of the LIBERTY system, including its potential capabilities for remote endovascular procedures

All Regulatory, Clinical, Operational and Pre-Commercial Activities Continue to Stay on Track Despite the On-going Situation in Israel

The Investigational Device Exemption (IDE) application follows the completion of multiple activities necessary to file this application

All of the cash payable to the plaintiffs in the settlement will be covered by Microbot’s insurance carrier and will not impact company's cash position

Following the recent positive results of its pivotal GLP pre-clinical study, the Company added a CRA to facilitate the company's first in human clinical study

BRAINTREE, Mass., Dec. 29, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced the entry into a definitive agreement for the immediate exercise of certain outstanding preferred investment options to purchase up to an aggregate of 1,685,682 shares of common stock, having exercise prices ranging from $2.075 to $3.19 per share, issued by Microbot in October 2022 and June 2023, at a reduced exercise price of $1.62 per share. The shares of common stock issuable upon exercise of the preferred investment options are registered pursuant to an effective resale registration statement on Form S-1 (File No. 333-273207). The closing of the offering is expected to occur on or about January 3, 2024, subject to satisfaction of customary closing conditions.

The results of the study will support the Company’s IDE submission to the FDA to commence its human clinical study

The first phase in the collaboration will evaluate the current state of the LIBERTY® Robotic Surgical System in connection with remote enabled Endovascular treatments

The final histopathology and lab report supplements previous positive Company findings.

The former Senior Medical Director for the Peripheral Interventions Division at Boston Scientific Corporation joins the Company as it transitions to the clinical and regulatory phase.

The V&V process is an additional key milestone toward regulatory submission and is required to continue the regulatory process with the FDA

BRAINTREE, Mass., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Robotic Surgical System, the first single-use endovascular robotic system, today announced it had been granted a registered trademark from the US Patent and Trademark Office. The trademark “One & Done®” was given to the feature of the LIBERTY Robotic Surgical System which is being developed to integrate guidewires, microcatheters and other instruments required for complete endovascular procedures using the device.

Follow up visual examination three days after the procedures using the LIBERTY Robotic Surgical System, confirms 100% success rate in reaching the targets with no adverse events

The Company’s designated Notified Body confirmed dates for conducting audits for ISO 13485 certification to ensure Microbot complies with the QMS requirements of the EU MDR

BRAINTREE, Mass., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Robotic Surgical System, today announces that the United States District Court for the Southern District of New York, approved Microbot’s motion for summary judgment and dismissed with prejudice the previously announced Section 10(b) counterclaim brought by defendant as against Microbot in the action titled Microbot Medical Inc., Plaintiff v. Joseph Mona, Defendant.

BRAINTREE, Mass., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Robotic Surgical System, today announces the successful initial outcomes of using the LIBERTY Robotic Surgical System in its pivotal pre-clinical study.

The engagement is an additional step in the Company's path towards marketing clearance with the FDA

The presentation follows successful extensive uses of the Company’s endovascular robotic system in pre-clinical studies

The Agreement with a leading full turnkey manufacturer further strengthens the Company's progression towards expected first in human clinical trials followed by regulatory approval and commercialization

Professor Francois H. Cornelis is a world renown neuro interventional radiologist who specializes in minimally invasive image-guided therapies

Engagement includes audit plans for ISO 13485 certification, to pave the way for obtaining CE Mark for clearance of sales in the European Union

Believes that the reduction in radiation exposure the LIBERTY® system could empower more women to pursue careers in Interventional Radiology

The study was conducted over two days by a team of global key opinion leaders and with participation of executives from the medical industry

HINGHAM, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it closed its previously announced registered direct offering for the purchase and sale of 624,618 shares of the Company’s common stock at a purchase price of $3.25 per share of common stock priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company issued unregistered series D preferred investment options. The series D preferred investment options to purchase up to 312,309 shares of common stock have an exercise price of $3.19 per share and are immediately exercisable for a period of five and one-half years following issuance.

HINGHAM, Mass., June 27, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has entered into definitive agreements for the purchase and sale of 624,618 shares of the Company’s common stock at a purchase price of $3.25 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered series D preferred investment options. The series D preferred investment options to purchase up to 312,309 shares of common stock have an exercise price of $3.19 per share and are immediately exercisable for a period of five and one-half years following issuance. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about June 28, 2023, subject to the satisfaction of customary closing conditions.

Received Grant of Protection for a Design Patent in Japan Covering its Innovative LIBERTY® Robotic Drive

Company Believes the Continuous Accumulation of Peer-Reviewed Data will Accelerate the Adoption of its Novel Interventional Endovascular System Once Commercialized

HINGHAM, Mass., June 06, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has closed its previously announced registered direct offering for the purchase and sale of 701,756 shares of the Company’s common stock at a purchase price of $2.1375 per share of common stock priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company issued unregistered series C preferred investment options. The series C preferred investment options to purchase up to 350,878 shares of common stock have an exercise price of $2.075 per share and are immediately exercisable for a period of five and one-half years following issuance.

HINGHAM, Mass., June 02, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has entered into definitive agreements for the purchase and sale of 701,756 shares of the Company’s common stock at a purchase price of $2.1375 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered series C preferred investment options. The series C preferred investment options to purchase up to 350,878 shares of common stock have an exercise price of $2.075 per share and are immediately exercisable for a period of five and one-half years following issuance. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about June 6, 2023, subject to the satisfaction of customary closing conditions.

HINGHAM, Mass., June 02, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Robotic Surgical System, the first single-use endovascular robotic surgical system, announced it has received a grant from the Israel Innovation Authority ("IIA”) in the amount of NIS 1.62 million, which based on a recent exchange rate to the U.S. dollar, would be approximately $440,000, to further support the development of the Company’s manufacturing process of its flagship robotic surgical system, the LIBERTY®.

The data collected from the usage and experience of the medical professionals in the formative study will be used to support the Company's anticipated milestones

This Significant Achievement Represents Major Progression Toward Regulatory and Commercialization Paths

HINGHAM, Mass., May 24, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has closed its previously announced registered direct offering for the purchase and sale of 1,209,500 shares of the Company’s common stock (or common stock equivalents) at a purchase price of $2.20 per share of common stock priced at-the-market under Nasdaq rules.

HINGHAM, Mass., May 23, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has entered into definitive agreements for the purchase and sale of 1,209,500 shares of the Company’s common stock (or common stock equivalents) at a purchase price of $2.20 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about May 25, 2023, subject to the satisfaction of customary closing conditions.

HINGHAM, Mass., May 23, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has closed its previously announced registered direct offering for the purchase and sale of 655,569 shares of the Company’s common stock at a purchase price of $2.20 per share of common stock priced at-the-market under Nasdaq rules.

HINGHAM, Mass., May 22, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has entered into definitive agreements for the purchase and sale of 655,569 shares of the Company’s common stock at a purchase price of $2.20 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about May 24, 2023, subject to the satisfaction of customary closing conditions.

A team of six leading European interventional radiologists used the LIBERTY® Surgical Robotic System and performed a total of 48 catheterizations

Company will enable focus on its LIBERTY technology through the introduction of the Core Business Focus Program coupled with cost restructuring to support it

Distinguished publisher and lecturer, Interventional Radiologist Prof. Francisco Cesar Carnevale Expected to Perform the World’s First Clinical Cases at the Prestigious Institute of Radiology at the University of Sao Paulo Medical School Hospital

Data supports next regulatory steps for the LIBERTY Robotic System

95% success rate of reaching pre-determined vascular target with no intraoperative complications presented during pre-clinical studies

Widely Published Interventional Radiologist Has Earned Well-Regarded Reputation Working with Prestigious Medical Centers in the U.S. and Europe

Internationally Recognized Academic Leader Awarded the National Institute for Health Research (NIHR) Research Rising Star Award, and Cardiovascular and Interventional Radiology (CVIR) Editors Medal

Internationally Recognized and Awarded Interventional Radiologist Enhances Depth of Expertise as the LIBERTY® Robotic System Races Towards Regularity and Commercialization Objectives

HINGHAM, Mass., March 09, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Robotic System, the first single-use endovascular robotic system, today announced that an abstract was accepted for a podium presentation at the Israeli Conference on Robotics (ICR) annual meeting, being held March 28th in Herzliya, Israel.

Engagement with Interventional Radiologists Reaches Highest Level Yet as Company Continues to Progress Through Regulatory and Clinical Phases; Company Seeking to Create Interest and Anticipation for When the System is Commercialized

Continues to Raise Awareness of the LIBERTY® Robotic System Ahead of Commercialization Plans

Increases Key Opinion Leaders to 13 Throughout the Americas, Israel, and Europe to Support the Company’s Next Regulatory and Commercialization Paths for the LIBERTY® Robotic System

Allows Endovascular Procedure to be Performed from the Cath-Lab Control Room, Potentially Minimizing Radiation Exposure and Reducing Physical Strain for the Healthcare Providers

Dr. Giora Weisz, a Practicing Interventional Cardiologist and Clinical Researcher who was One of the Early Users of Robotic-Enhanced Coronary Interventions, as well as Navigation and Positioning Technologies, Will be the Guest Speaker.

Panel of Proven Medical Device Entrepreneurs and Surgical Robotics Pioneers Will Share Their Personal Experiences of Taking Innovative New Technologies from Development to Commercialization