MMI Gets FDA OK to Expand Trial of Surgical Robot in Alzheimer’s

MMI (Medical Microinstruments Inc.) announced that the U.S. Food and Drug Administration (FDA) FDA approved an Investigational Device Exemption (IDE) supplement for the REMIND study following its review of 30-day safety data from the initial patients.

The approval expands enrollment from an initial cohort of up to five patients to the full 15-patient early feasibility study, which is evaluating robotic-assisted microsurgery for neurodegenerative diseases, including Alzheimer’s disease. The REMIND study is a global, prospective early feasibility study evaluating the safety and feasibility of the Symani surgical system and microsurgical techniques to restore lymphatic drainage in the deep cervical lymph nodes of patients with Alzheimer’s disease and confirmed lymphatic abnormalities.

As enrollment continues, REMIND data may inform future research, including a potential pivotal trial. The study is part of MMI’s broader effort to generate clinical evidence for expanding robotic microsurgery into emerging applications.

Earlier this year, the company launched its Robotic Suture in the U.S. It’s the first suture purpose-built for the Symani surgical system and is suitable for cases where delicate suturing is required.

Comments from MMI exec and clinician

Mark Toland, CEO: “This milestone reflects continued momentum for REMIND as we explore the potential of microrobotic surgical intervention to reshape the treatment of Alzheimer’s disease for the millions of people and their families impacted by this debilitating disease.”

Adnan Siddiqui, MD, Ph.D., Professor of Neurosurgery at the State University of New York at Buffalo, CEO of The Jacobs Institute, and National PI of the REMIND study: “Patient safety is paramount, and we’re pleased with this important step forward by the FDA, which allows us to continue expanding enrollment in this first-of-its-kind study.”