Conventus Orthopaedics gained FDA clearance for a device that helps repair shoulder fractures, and will pursue a "measured" U.S. market rollout in the weeks ahead, company officials said.
Minneapolis-based Conventus’ regulatory win comes 5 months after it raised a $24 million Series AA round last December. That money was slated, in part, to commercialize its FDA-cleared Conventus DRS device for distal fractures of the radius, and to propel research and development for its Proximal Humerus PH device for shoulders.
Conventus has the FDA’s regulatory O.K for the Conventus PH Cage. It’s made of nitinol, and expands inside the bone to prevent collapse of a shoulder fracture and establish an internal scaffold after the implant procedure. Previously, shoulder replacements or fixation devices to keep the shoulder immobile have been the norm.
The company said it worked with surgeons to create the device, which helps preserve tissue and blood supply at the fracture, stabilizing bone pieces and helping the patient move sooner through less invasive surgery.
Conventus CEO Paul Buckmen said in prepared remarks that the Conventus PH Cage will let surgeons "repair a wider variety of proximal humeral fractures through less invasive means."