MMI (Medical Microinstruments Inc.) 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.

The postmarket trial will further evaluate the Symani surgical system’s performance in free flap reconstruction and lymphatic repair procedures. It will enroll up to 455 patients in top U.S.  cancer centers.

“The PRECISE study is a milestone for the broader field of reconstructive microsurgery,” said Mark Toland, CEO of MMI. “It reflects MMI’s commitment to building the rigorous clinical evidence needed to expand patient access to advanced microsurgical care and validate the long-term value of robotic assistance in complex procedures.”

The study’s two cohorts—free tissue transfer and lymphatic repair—will be followed for 30 days and three months, respectively. Key clinical endpoints include anastomosis patency, ischemia time, limb volume reduction, freedom from device-related adverse events, and quality-of-life-outcomes.

MMI said this study is the beginning of a broader clinical initiative to strengthen evidence for robotic technology in microsurgical applications. Symani is currently the only commercially available surgical robot designed for microsurgery. Its wristed microinstruments, tremor-reducing and motion-scaling capabilities allow precision in anatomically delicate, open surgical procedures.

The Symani robot received U.S. Food and Drug Administration (FDA) de novo approval in April 2024.

“PRECISE fills a critical gap for the microsurgical community by providing real world clinical evidence on robotic microsurgical outcomes in patient populations where precision and long-term results matter the most,” said Dr. Bohdan Pomahac, National Principal Investigator and Division Chief of Plastic and Reconstructive Surgery at Yale Surgery and Smilow Cancer Hospital.