Medical Microinstruments (MMI) said the U.S. Food and Drug Administration has approved a supplement to its Investigational Device Exemption, letting the Italian surgical robotics company expand enrollment in REMIND — the first US early feasibility study using robotic microsurgery to restore lymphatic drainage in the deep cervical lymph nodes of patients with confirmed Alzheimer's-related lymphatic abnormalities.
What the FDA cleared
The supplement was granted after the agency reviewed 30-day safety data from the first cohort of up to five patients treated with MMI's Symani Surgical System, the company said in a July 30 announcement from Jacksonville, Florida. The approval opens the door to full enrollment of 15 patients across the early feasibility study. "Patient safety is paramount, and we're pleased with this important step forward by the FDA," said Adnan Siddiqui, professor of neurosurgery at SUNY Buffalo, CEO of The Jacobs Institute and national principal investigator on REMIND.
Why Symani matters for a brain-disease trial
REMIND stands for Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease. The trial is exploring whether re-establishing lymphatic outflow from the brain via the deep cervical lymph nodes can influence Alzheimer's progression — a procedure that requires anastomosing vessels smaller than a millimeter across. Symani pairs the world's smallest wristed micro-instruments with tremor filtering and motion scaling, and is the only surgical robot cleared for that class of open, soft-tissue microsurgery. It is FDA-authorized in the US and CE-marked in Europe, where it is also approved for peripheral nerve reconstruction.
Building the clinical case
REMIND is one of several MMI studies aimed at building evidence for what the company calls "microrobotic surgical intervention" in new indications. "This milestone reflects continued momentum for REMIND as we explore the potential of microrobotic surgical intervention to reshape the treatment of Alzheimer's disease," said MMI CEO Mark Toland. The company said data generated through REMIND is expected to inform future research, including a potential larger pivotal trial. The Symani platform remains investigational for this use in the US.
The clearance lands in an increasingly busy month for surgical robotics that also saw FDA De Novo authorization for J&J's OTTAVA, Momentis' Anovo multiport clearance, and Endorobotics' incisionless ROBOPERA.
Reporting based on coverage from GlobeNewswire (Medical Microinstruments, Inc.) and MMI's REMIND study disclosures.