Microbot Robotic Surgical System FDA-Approved to Begin Human Trials

Microbot Medical, a surgical robotics company, has announced the FDA approval to start its human clinical trials for the Liberty Endovascular Robotic Surgical System.

The Liberty system was designed, according to the company, for single use procedures to reduce exposure to radiation and eliminate user physical strain when operating seated away from radiation source. The system has a small footprint, having no required dedicated infrastructure, can be used in multiple sites, and is designed to utilize off-the-shelf instruments.

For the human trial — which is part of Microbot’s investigational device exemption (IDE) application that it submitted in February— the company said it has signed a clinical trial service agreement with a “leading academic medical center” in the US and is also in talks with other leading medical centers for potential participation.

Recently expanding its US operations ahead of the IDE submission to prepare for next steps, Microbot is continuing the momentum it gained from a previous positive good laboratory practices pre-clinical study.

“The recent authorization by the FDA to commence our pivotal clinical study, following submission of the results of our extensive pre-clinical studies and tests, reinforces our confidence in our innovative technology,” said Harel Gadot, CEO, president and chairman of Microbot, in a statement. “It is also a testament to our commitment to meet meaningful milestones as we continue our path towards potential regulatory clearance and subsequent commercialization in the US and other regions across the globe.”

Data collected in the human trial is expected to be used to support a future 510(k) submission.

While capitalizing on Liberty’s positive wave, the company settled a years-old lawsuit in January with Empery Asset Master, Empery Tax Efficient, Empery Tax Efficient II, and Hudson Bay Master Fund over a June 2017 securities purchase agreement. The suit claimed that Microbot had breached multiple representations and warranties and sought the return of its $6.75 million in financing.

Under the settlement, Microbot will pay investors $2.154 million, according to the SEC. Additionally, the amount will include $1.1 million in cash from the company’s insurance carrier, with the rest covered by over a million shares of restricted company common stock.