With FDA 510(k) clearance of its Kinguide robotic-assisted surgical system, Point Robotics Medtech Inc became the first robotics company in Taiwan to gain U.S. clearance for an orthopedic surgical robot.
Zavation Medical Products LLC received FDA 510(k) clearance for its Varisync cervical intervertebral body fusion device. Varisync’s plate and spacer components can be used together or paired separately with other components in the company’s cervical spine portfolio. The clearance follows the release Aug. 10 of in vitro and in vivo results of Zavation’s Labyrinth porous interbody device.
Moximed Inc. has received $40 million in series C financing to pursue regulatory approval for its implantable shock absorber (ISA) for knee osteoarthritis (OA). Fremont, Calif.-based Moximed secured backing from investors including Advent Life Sciences, New Enterprise Associates, Future Fund, Vertex Healthcare and Runway Growth Capital to advance the Misha knee system. The company is touting the technology as the world’s first implantable shock absorber for OA.
Enovis Corp. reported that it has completed its acquisition of Insight Medical Systems Inc., the developer of a wearable surgical navigation system to enhance surgeon performance during orthopedic procedures. Financial terms of the deal were not disclosed.
Pediatric orthopedics company Orthopediatrics Corp. has signed a $33 million deal to buy competitor Pega Medical Inc. As part of the deal, Orthopediatrics will acquire Pega’s Fassier-Duval telescopic intramedullary system. The implant is designed to treat bone deformities in children with osteogenesis imperfecta. Orthopediatrics will pay a $31 million upfront cash payment plus $2 million in stock – which includes certain restrictions for three years.
The U.S. FDA has granted de novo approval for Bonesupport AB’s Cerament G, an antibiotic-eluting bone graft designed to osteomyelitis. The company plans to launch in the U.S. in late September or early October.
Orthoson Ltd. closed a £8.9 million (US$11.1 million) oversubscribed series A, which will be devoted to completing preparations for its ultrasound/hydrogel combination treatment for repairing degenerated spinal discs to start phase I clinical trials.
Orthofix Medical Inc. continues to expand its bone growth product line with a new premarket approval from the FDA for its Accelstim bone healing therapy device. Indicated for certain fresh fractures and fractures that have not healed, the device uses low-intensity pulsed ultrasound to stimulate the natural healing process. The company plans to take a phased approach to the launch, which will begin within weeks.
The rehabilitation robot market will soon have a new entrant as Able Human Motion SL prepares to launch a next-generation robotic exoskeleton. The Universitat Politècnica de Catalunya spin-off is on a mission to shake up the exoskeleton technology market with a low-cost, lightweight model that can be accessed by anyone with mobility impairments.
With an oversubscribed $30 million series B in hand, Carlsmed Inc. is in a good posture to take the next steps in its plan to make its personalized spinal implants central to ending frequent revisions in spine surgery. The company’s Aprevo devices, which are 3D printed for each patient, received FDA breakthrough device designation and 510(k) clearance in late 2020.
