MMI's Symani microsurgery robot secures de novo clearance from FDA

Hot on the heels of a $110 million fundraising round earlier this year, Medical Microinstruments has now received a groundbreaking green light from the FDA for its robotic surgery system.

The company’s Symani system claimed a de novo clearance from the agency for its fully wristed instruments designed to shrink down, replicate and smooth out the movements of a surgeon’s hands so they can help stitch together the body’s smallest vessels and most intricate tissues.

MMI described Symani as the only commercially available platform in the U.S. for reconstructive microsurgery—where some cases can involve blood and lymph vessels less than one millimeter in diameter. The emerging field can be employed during a range of open procedures, such as after a breast cancer-related mastectomy or lymphatic system repairs, for example.

“With the authorization from the FDA, our technology will expand its reach to pioneering hospitals in the U.S.,” MMI CEO Mark Toland said in a statement. “It will help those hospitals grow their open surgical programs, expand the number of physicians who can perform these highly complicated procedures, and increase patient access to the most advanced techniques for surgeries in complex disease states, such as lymphedema.”

“Our system will continue to provoke surgeons to challenge their definitions of ‘treatable’ and ‘untreatable’ and empower them to solve cases that have historically been too difficult to treat,” Toland added.

Symani has previously been approved for use in parts of the Asia-Pacific region and Europe with nearly 1,000 cases completed in the EU, according to the company, which said it plans to “immediately” begin the system’s launch in the U.S.

“By making open surgery less invasive and more precise, we can treat more conditions and offer robotic-assisted surgical options to patients that simply do not exist today,” said MMI’s co-chief medical officer, L. Scott Levin, M.D. “Within the next five years, this expanded portfolio of addressable open surgical procedures is expected to exceed the number of eligible laparoscopic, or minimally invasive, procedures that leverage robotic assistance.”

MMI previously estimated that the market of Symani’s eligible microsurgical procedures would increase from 3 million annually to 22 million by 2028, pending device development and future regulatory go-aheads.

In late February, the company racked up nine figures in a series C round led by Fidelity Management with additional backing from previous investors Deerfield Management, Wellington Partners, BioStar Capital, RA Capital Management, Andera Partners, Fountain Healthcare Partners, Panakès Partners and Sambatech.