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Microbot Medical (MBOT) Files IDE to Start Human Clinical Study

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Microbot Medical Inc. (MBOT - Free Report) recently announced that it has filed an Investigation Device Exemption (IDE) application with the FDA.

The FDA's clearance of the IDE application would enable the business to start its pivotal human clinical study in the United States. The IDE application is the result of several preclinical activities completed to offer preliminary safety and effectiveness evidence.

Price Performance

For the past six months, MBOT’s shares have declined 45.2% against the industry’s growth of 2.0%. The S&P 500 increased 9.3% in the same time frame.

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The filing of the IDE is an important development for the company as it is another step toward achieving FDA clearance for the MBOT’s LIBERTY Endovascular Robotic Surgical System.

The company would be able to begin its pivotal human clinical research in the United States if the FDA approved the IDE application. In December 2023, the company announced the successful completion of its GLP pivotal pre-clinical study, done under the guidelines of FDA-required levels of planning, controlling, monitoring, and reporting, using a porcine model.

The company recently announced that it has added a U.S.-based Clinical Research Associate to support its planned IDE submission to start its first in-person clinical study in response to the recent positive results of its crucial GLP Pre-Clinical Study.

MBOT also entered into a collaboration agreement with Corewell Health to enable telerobotics between remote centers by utilizing the LIBERTY Endovascular Robotic Surgical System. This collaboration will likely help the company to support LIBERTY’s launch activities.

Industry Prospects

Per a report by Mordor Intelligence, the global surgical robots market size is estimated to be $7.7 billion in 2024 and is expected to grow at 9.07% to reach $11.8 billion by 2029.

The market is being driven by the escalating need for automation in the healthcare industry, the prevalence of chronic illnesses, the growing elderly population, the complexity of surgical procedures, and the expanding desire for non-invasive operations with more accuracy and adaptability.

Zacks Rank & Stocks to Consider

MBOT carries a Zacks Rank #3 (Hold) at present.

Some better-ranked stocks to consider in the broader medical space are Universal Health Services (UHS - Free Report) , Integer Holdings Corporation (ITGR - Free Report) and Elevance Health, Inc (ELV - Free Report) .

Universal Health Services, carrying a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 4.4% for 2024. UHS’s earnings surpassed estimates in all the trailing four quarters, delivering an average surprise of 5.47%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

UHS’s shares have gained 1.9% in the past six months against the industry’s 5% decline.

Integer Holdings, presently carrying a Zacks Rank of 2, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 11.9%.

Integer Holdings’ shares have rallied 43.5% in the past year against the industry’s 3.7% decline.

Elevance Health, carrying a Zacks Rank of 2, reported fourth-quarter 2023 adjusted EPS of $5.62, beating the Zacks Consensus Estimate by 1.3%. Revenues of $42.45 billion outpaced the consensus mark by 1.5%.

Elevance Health has a long-term estimated growth rate of 12%. ELV’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 3.1%.

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