MMI (Medical Microinstruments Inc.) has gained U.S. Food and Drug Administration (FDA) approval of an investigational device exemption (IDE) study using a novel microsurgical intervention for Alzheimer’s disease.

The REMIND (Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease) feasibility study will collect data from the Symani surgical system and microsurgical techniques to reestablish lymphatic drainage pathways in the deep cervical lymph nodes (dCLNs) of patients with Alzheimer’s and confirmed lymphatic obstruction.

The study’s primary endpoint is device-related serious adverse events through 30 days post-procedure. Other endpoints include adverse events, biomarker and imaging changes, and cognitive assessments six months after the procedure.

The possible therapeutic pathway enabled by robotics could improve clearance of harmful proteins like amyloid beta and tau, and serve as a treatment for Alzheimer’s disease.

Operating on the dLCNs need precision at a supermicrosurgical scale because these lymphatic vessels can be 0.2 mm in diameter, about the thickness of two sheets of paper. The first-ever surgical approach involves establishing precise connection of lymphatic vessels or nodes in the neck to neighboring veins using Symani’s robotic precision. This would allow for draining of neurotoxins from the brain and could support reduced variability in outcomes, the company said.

“This FDA approval is more than a milestone for our company—it’s a signal of what’s possible in science when we bring together the right experts, technology, and research,” said Mark Toland, CEO of MMI. “We’re at the threshold of a new era in microsurgery; one where robotic precision could play a central role in unlocking novel treatment pathways for devastating diseases like Alzheimer’s. With REMIND, we’re just beginning to explore the extraordinary potential of robotic lymphatic intervention in redefining a critical standard of care.”

The company is teaming up with a group of leading U.S. and European research institutions to begin enrollment in this study in the near future. This and future studies will generate essential data to strengthen evidence for expanded robotic microsurgical applications, the company said.

“The REMIND study offers the potential to open an entirely new chapter in the treatment of neurodegenerative disease,” added Kate Rumrill, chief scientific officer of MMI. “Bringing robotic precision to more surgeons stands to change patient lives and medicine. Initiating such critical research may help pave the way for further studies to explore the promise of lymphatic microsurgery in improving the lives of more than 7 million Americans impacted by Alzheimer’s and bringing renewed hope to the caregivers who support them every day.”

Last month, the company announced the first patient was enrolled in its PRECISE clinical study—the largest prospective, multicenter clinical trial of its kind in the U.S. focused on robotic-assisted microsurgery using the Symani system.