Medical Microinstruments (MMI) has announced completion of the first robotic-assisted procedure in REMIND—the company’s US investigational device exemption (IDE) study evaluating microsurgical intervention for neurodegenerative disease. Performed by a multidisciplinary team at Baptist Health (Jacksonville, USA), the case—which involved a patient with moderate Alzheimer’s disease with confirmed abnormalities in their deep cervical lymph node (dCLN) region—represents the study’s inaugural procedure and first enrolment.
This “first-of-its-kind” trial has been approved by the US Food and Drug Administration (FDA), and is evaluating the safety and feasibility of using MMI’s Symani surgical system to perform microsurgical techniques in the region of the neck, as stated in a company press release.
The multicentre study is set to enrol 15 patients who will be followed through 12 months post-procedure. As enrolment continues, data generated through REMIND are expected to inform future research, including the potential for a larger pivotal trial.
“I’m honoured to join this effort in exploring how robotic lymphovenous bypass at the super-microsurgical level can be applied in a new clinical context,” said Michael DeFazio (Florida Plastic Surgery Group, Jacksonville, USA), who performed the procedure alongside REMIND site principal investigator Ricardo Hanel (Baptist Health, Jacksonville, USA). “Precision is paramount in such technically demanding procedures, and this robotic technology enables us to perform techniques with the control needed to explore this potential new and exciting application of lymphatic reconstruction.”
“The intersection of neuroscience and lymphatic biology is one of the most compelling frontiers in medicine today,” Hanel added. “By participating in this study, we’re accelerating beyond traditional research to explore how a surgical approach can open the door to exciting therapeutic pathways in neurodegenerative disease. This opens an exciting window of hope for all those patients and families living with this terrible condition.”
The procedure performed using Symani intends to explore whether restoring lymphatic drainage pathways in the dCLNs may support improved clearance of harmful neurotoxins that researchers believe contribute to the progression of Alzheimer’s disease.
MMI says Symani is the only commercially available robotic platform designed specifically for high-precision microsurgical and super-microsurgical procedures. The company goes on to detail that this novel approach brings together a dedicated team of specialists with areas of expertise spanning reconstructive microsurgery, neurology, neuroradiology, and neurosurgery, reflecting the uniquely collaborative effort required to explore new, emerging treatment pathways for complex neurodegenerative diseases.
“With Alzheimer’s disease impacting over 580,000 patients and families across Florida, we believe it’s our responsibility to advance potential new approaches that drive progress and expand access to treatments for those who need it most,” commented Matthew Zuino, president and chief executive officer (CEO) of Baptist Health. “We are proud to be bringing the next generation of treatments to the region while contributing to the development of innovative therapies globally.”
Michael Mayo—Baptist Health’s former president and CEO—also played a key role in bringing this technology and research to the health system.
“This is a historic first and important step in advancing a potential breakthrough intervention for neurodegenerative disease,” said MMI CEO Mark Toland. “By evaluating novel microsurgical robotic techniques, we’re building on a decade of global research that moves science closer to what could become a life-changing treatment option for the tens of millions of Alzheimer’s patients and caregivers globally.”
REMIND is one of several studies MMI is conducting with the aim of building the clinical evidence needed to support the advancement of robotic microsurgery into additional and emerging applications, the release adds.
