Microbot Medical submits surgical robot for FDA IDE

The Liberty surgical robot system. [Image courtesy of Microbot Medical]Microbot Medical (Nasdaq:MBOT) announced today that it filed an FDA investigational device exemption (IDE) application for its surgical robot.

Braintree, Massachusetts-based Microbot designed the Liberty surgical robot for potential use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on physicians.

Microbot believes Liberty’s remote operation could potentially make it the first system to democratize endovascular interventional procedures.

Approval of the IDE application would enable a pivotal human clinical trial for Liberty in the U.S.

The company recently expanded its U.S. operations ahead of the now-filed IDE submission to prepare for its next steps. It also has momentum from its positive good laboratory practices (GLP) pre-clinical study.…

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Microbot Medical settles investors’ lawsuit for more than $2M

Microbot Medical (Nasdaq: MBOT), the developer of the Liberty endovascular robotic surgical system, announced today that it has settled a years-old lawsuit involving a securities purchase agreement.

Empery Asset Master, Empery Tax Efficient, Empery Tax Efficient II,  and Hudson Bay Master Fund sued Microbot Medical in 2020 in the New York state court in New York County (Manhattan) over a June 2017 securities purchase agreement.

According to Microbot Medical’s telling, the suit claimed that the company had breached multiple representations and warranties — and sought the return of the plaintiffs’ $6.75 million in financing.

Under the settlement announced today, Microbot Medical will pay the investors $2.154 million, according to a Form 8-K filed with the SEC. The amount includes $1.1 million in cash from the company’s insurance carrier, with the rest covered by over 1 million shares of restricted company common stock.

According to…

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Microbot Medical expands U.S. operations to prep for first in-human clinical study

The Liberty endovascular robotic surgical system [Image courtesy of Microbot Medical]Microbot Medical, the developer of the Liberty endovascular robotic surgical system, is building on the momentum from the positive results of its good laboratory practices (GLP) pre-clinical study. The company is adding a clinical research associate to support its pending investigational device exemption, or IDE, submission to commence its first-in-human clinical trial.

The clinical research associate (CRA) will join the Braintree Massachuesetts–based company‘s established clinical team in the U.S. The team is led by Dr. Juan Diaz-Cartelle, chief medical officer of Microbot Medical.

“Following the successful completion of our pivotal GLP pre-clinical trial, and as we are in the final stage of submitting our IDE, having an in-house CRA is a key piece for establishing the right infrastructure for clinical trial execution” said Diaz-Cartelle in a release.

Microbot Medical aims to…
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Microbot Medical meets objectives in preclinical surgical robot study, seeks FDA IDE

The Liberty surgical robot system. [Image from Microbot Medical]Microbot Medical (Nasdaq:MBOT) today announced the successful completion of its GLP pivotal preclinical surgical robot study.

Braintree, Massachusetts-based Microbot completed the study using a porcine model. It operated under the guidelines of FDA-required levels of planning, controlling, monitoring and reporting.

Microbot said earlier this month that the study used its Liberty endovascular surgical robotic system to perform 96 robotic navigations. It evaluated target vessels with surrounding tissue microscopically after they were subjected to procedures using a number of commercially available intravascular catheterization devices. Microbot hopes data can support FDA investigational device exemption (IDE), leading to human clinical studies.

Liberty offers capabilities in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and …

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Microbot Medical, Corewell collab on telerobotics for endovascular surgical robot

Microbot Medical (Nasdaq:MBOT) announced today that it entered into a collaboration with Corewell Health to enable telerobotic capabilities.

The collaboration, separated into multiple phases, seeks to enable telerobotics between remote centers. It aims to do so utilizing the Liberty endovascular robotic surgical system. The Braintree, Massachusetts-based company has plans to submit Liberty for FDA IDE approval in the meantime, too.

It designed Liberty for use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on physicians. Microbot Medical believes Liberty’s remote operation could potentially make it the first system to democratize endovascular interventional procedures.

Microbot’s agreement with Corewell includes the right to mutually evaluate the Liberty system for remote procedures. The companies tabbed Dr. R…

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Microbot Medical is a step closer to an FDA IDE submission

Microbot Medical today announced the successful completion of its pivotal pre-clinical study of its Liberty endovascular robotic surgical system.

The study, performed under good laboratory practice (GLP) and essential for the company’s investigational device exemption (IDE) submission, took place under rigorous FDA guidelines. The study involved pigs.

In this study, three interventional radiologists performed 96 robotic navigations using Liberty. They used the system to control various commercially available intravascular catheterization devices. They then microscopically examined and evaluated the target vessels and surrounding tissue.

Microbot Medical officials think Liberty’s remote operation could enable it to democratize endovascular interventional procedures.

“I am very pleased with the positive outcomes of the histopathology report and the completion of the GLP study,” said Juan Diaz Cartelle, chief medical officer of Braintree,…

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Microbot Medical inks deal to expand surgical robot manufacturing capabilities

The Liberty surgical robot system. [Image from Microbot Medical]Microbot Medical (Nasdaq:MBOT) announcd today that it signed a manufacturing agreement with B.Y. Medimor for its surgical robot.

Braintree, Massachusetts-based Microbot develops the Liberty single-use endovascular robotic surgical system. It designed Liberty for use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on physicians.

Microbot believes Liberty’s remote operation could potentially make it the first system to democratize endovascular interventional procedures.

The agreement with Medimor governs the manufacturing of Liberty for its first-in-human clinical trial. It also covers the initial Liberty systems expected to hit the market following the completion of regulatory requirements. Medimor provides new product introduction (NPI) solutions and…

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Microbot Medical completes pre-clinical study of endovascular surgical robot

The Liberty surgical robot system. [Image from Microbot Medical]Microbot Medical (Nasdaq:MBOT) announced today that it successfully completed an extended pre-clinical study of its surgical robot system.

Hingham, Massachusetts-based Microbot develops the Liberty single-use endovascular robotic surgical system. It designed Liberty for use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on physicians.

Key opinion leaders (KOLs) at a New York-based research lab conducted the pre-clinical study. A team of leading interventional radiologists used the system to perform dozens of catheterizations. That includes using the system’s remote operating capabilities on pre-determined vascular targets. Microbot Medical reported a 100% success rate in reaching the intended target with no observable on-site complications.

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