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Robotics company MMI gets FDA nod for early-feasibility REMIND trial to test brain lymphatic surgery
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Summary
MMI CEO Mark Tolan said the FDA granted an early feasibility study (REMIND) for a surgical procedure intended to restore brain lymphatic flow; initial U.S. enrollment will be ~15 patients at four centers and costs were estimated at about $75,000 per patient.
Mark Tolan, CEO of microsurgical robotics firm MMI, presented a company program that applies microsurgical robotics to restore lymphatic drainage in the brain as a potential adjunct for patients with mild or moderate Alzheimer's disease. Tolan said early clinical experience in Asia (a small series of six patients in South Korea) showed changes in MOCA scores that moved some patients from moderate to mild impairment, a result he described as "really remarkable," but he repeatedly cautioned that these early data do not demonstrate a cure.
MMI approached the U.S. Food and Drug Administration about U.S.-based trials and was granted an early feasibility study (EFS) called REMIND. Tolan said the trial's initial sites include Baptist Health (Florida), Stanford (Palo Alto), Jacobs Institute (Buffalo), and Yale (New Haven) and that the EFS will enroll about 15 patients to assess safety and feasibility before a potential pivotal trial.
Tolan described the trial as resource-intensive: "It costs around $75,000 per patient to enroll," he said, and added that MMI will seek funding partners and engage federal agencies (FDA, CMS, NIH) about pathways for coverage if trials show safety and benefit. He framed the approach as "clean the brain before you treat the brain," emphasizing the company aims to generate rigorous evidence through multicenter trials with trained physicians and multidisciplinary teams.
Why it matters: FDA clearance for an early-feasibility surgical trial marks advancement from preclinical and small international reports to U.S.-based evidence generation. The small size and exploratory design mean results will be preliminary, but the trial could determine whether a larger pivotal study is feasible.
What the transcript shows: Tolan presented the REMIND EFS approval, named participating centers, noted the small international dataset that motivated U.S. work, and identified trial costs and funding as near-term obstacles. He characterized the work as exploratory and positioned the company to work with regulators and payers if evidence supports benefit.
Next steps: MMI said IRBs are complete, physicians are trained, screening is underway, and enrollment will begin imminently; broader questions remain about funding, generalizability, and long-term outcomes.
