The De Novo authorization is endorsed by clinical data from procedures employing the Hominis system on a range of patients in Belgium and Israel with Drs. Jan Baekelandt and Lior Lowenstein, respectively.
FREMONT, CA: Memic, a medical device firm dedicated to transforming robot-assisted surgery with its proprietary technology, announced that the U.S. Food and Drug Administration (FDA) has given De Novo marketing authorization of its Hominis robot-assisted surgical platform for use in a single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures along with benign hysterectomy. The De Novo authorization is endorsed by clinical data from procedures employing the Hominis system on a range of patients in Belgium and Israel with Drs. Jan Baekelandt and Lior Lowenstein, respectively.
"This FDA authorization represents a significant advance in the world of robot-assisted surgery and fulfills an unmet need in the world of robotic gynecological surgery," said Professor Jan Baekelandt, MD, Ph.D., a gynecologist at Imelda Hospital in Bonheiden, Belgium, who performed the first hysterectomy using the Hominis system in November 2018. "Research shows vaginal hysterectomy provides optimal clinical benefits to patients including reduced pain, recovery time and rates of infection but in most countries the incidence of vaginal hysterectomy is decreasing. In addition, transvaginal approaches result in no visible scars, which is very important to the gynecological patient. Hominis is the only robot specifically developed for transvaginal surgery and is therefore small and flexible enough to perform surgery through a small incision."
The Hominis (Latin for "humanoid") surgical robotic platform is the first and only FDA-approved surgical robotic platform with miniature humanoid-shaped robotic arms with human-level mobility, multi-planar stability, and 360 degrees of articulation. The biomimetic devices, including shoulder, elbow, and wrist joints, are designed to imitate a surgeon's arms' movements and capabilities. Many instruments can be introduced to the body from a single portal, and the 360-degree articulation provides for better access and working angles as well as obstacle avoidance. In addition to these capabilities, the device can be sold at a reduced cost than other robotic surgery devices presently on the market, eventually enabling more medical institutions, such as hospitals and ambulatory surgical centers, to access and incorporate surgical robotics.
"We are pleased to receive FDA De Novo authorization of our Hominis system, which offers a small, cost-effective and less invasive option over current robotic instruments limited to straight shaft and single wrist designs and controlled with large, complex and expensive equipment," said Dvir Cohen, CEO, Memic. "This authorization is also just the beginning; it opens the door for our novel system to expand to additional indications that, until now, have been off-limits to robot-assisted surgery."
The Hominis platform will be used for general surgery and transluminal indications, and the organization is focusing on AI-enabled functionality to serve all of its surgical indications.
"We believe the Hominis surgical system represents the most significant advancement in robotic soft tissue surgery in the last 20 years and will deliver great benefit to patients and their healthcare providers," added Maurice R. Ferr, MD, chairman of the board at Memic and Founder, MAKO Surgical.