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Microbot Signs Manufacturing Agreement with B.Y. Medimor

Article-Microbot Signs Manufacturing Agreement with B.Y. Medimor

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The agreement covers the manufacturing for Microbot’s first in-human clinical trial and its initial production run following regulatory requirement completion.

Microbot Medical recently announced it has signed a manufacturing agreement with B.Y. Medimor to advance the commercialization of its Liberty Robotic Surgical System.

Liberty is a single use endovascular surgical robotic system designed to streamline endovascular procedures by eliminating the need for large, cumbersome, and expensive capital equipment and reducing radiation exposure and physician strain. According to Microbot, only <1% of endovascular procedures are currently done robotically. However, >75% of interventionalists said they plan for robotics to become a part of their practice in the next three to five years.

The company said they are on a mission to break down barriers and increase access to robotics for endovascular procedures. To do this, they have implemented no upfront capital expenses when obtaining the device. Additionally, they highlighted the pro’s of using the robot for endovascular procedures, include reduced exposure to radiation, elimination of user physical strain, increases in procedure efficiency, a small footprint because there isn’t a dedicated infrastructure required, utilization in multiple sites of service, and its use off-the-shelf instruments.

The agreement with Medimor covers the manufacturing of the device for Microbot’s first in-human clinical trial and its initial run that is expected to be marketed following regulatory requirement completion. Medimor, a contact manufacturer, provides new product introduction solutions and full turnkey manufacturing for medical devices, including integration, parts cleaning, clean room assembly, and testing.

“We continue our transition from a research and development stage to a clinical and commercial stage in the field of endovascular robotics," said Simon Sharon, Microbot’s CTO and general manager. “We believe that the manufacturing agreement supports our efforts to deliver a state-of-the-art advanced robotic system and facilitates our next steps."

The news of the agreement comes after a late-July announcement stating that Microbot has taken its first steps towards being able to put Liberty on the European Union’s market by engaging with a notified body who will audit the Hingham, MA-based company. The audit will verify Microbot’s compliance of its quality management system and “the quality of the Liberty robotic surgical system’s development with widely acceptable standards in the medical device industry,” MD+DI previously reported. “The company said it is also preparing to obtain EU Medical Device Regulation certification to sell the Liberty system throughout the [EU].”

At the time of the announcement, Harel Gadot, Microbot’s CEO, said, “Following the success of multiple pre-clinical studies conducted with the participation of leading European-based interventional radiologists, Microbot is now expanding to seek a wider range of potential users in key growth markets. We believe the Liberty Robotic Surgical System has the potential to revolutionize the way catheterization is being done today, by providing a single-use system designed to provide a high degree of stability, as demonstrated in our pre-clinical studies.”

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