- Galen Robotics, a startup founded in 2016 to commercialize the work of a lab at Johns Hopkins University, said its surgical robot has received the Food and Drug Administration’s de novo authorization for ear, nose and throat procedures.
- The company also said it is opening a bridge round to its series B financing. It plans to use the funds to secure materials and expand manufacturing capabilities to support its growth plans.
- Beyond ENT procedures, Galen’s platform is being developed to fill “unserved needs” in the surgical device market to assist surgeons in specialties including neurosurgery, otolaryngology, tissue reconstruction, intrauterine brain and spine surgery, according to the company.
Galen is among a burst of new companies eyeing niches in the growing robot-assisted surgery market, which remains dominated by Intuitive Surgical and is a key focus for deep-pocketed challengers such as Medtronic and Johnson & Johnson.
In recent weeks, smaller hopefuls including CMR Surgical, Virtual Incision and Moon Surgical have announced fundraising rounds to support their development efforts, while others, such as Levita and Insight Medbotics, have secured FDA clearances or disclosed other milestones in their progress.
The Galen robot is designed to work with standard surgical instruments to improve stability and ergonomics in a number of minimally invasive procedures, according to the company, which is aiming to add more indications for the platform.
The Baltimore-based company said it continues to work closely with Johns Hopkins as well as other university research organizations to explore future applications based on the platform.
“This bridge round marks the advent of an exciting phase in our journey,” Galen CEO Bruce Lichorowic said in a statement. “The additional funding will play a pivotal role in boosting our operating capabilities and manufacturing domain.”