Ossdsign AB will abandon its 3D-printed cranial reconstructive implant business to focus on U.S. sales of its Ossdsign Catalyst, an off-the-shelf nanosynthetic bone graft that offers gross margins of 90% or better. The new strategy sharply reduces the capital required before the company projects achieving a cash-flow positive position.
Beijing Tinavi Medical Technologies Co. Ltd.’s surgical robot received approval from China’s National Medical Products Administration (NMPA) for total knee replacement, expanding its product portfolio to cover spine, trauma and joints in orthopedic surgery. The new product, named Tirobot Recon, provides support for surgeons in total knee arthroplasty.
Alphatec Holdings Inc. (ATEC) acquired the robotic-enabled minimally invasive (REMI) system from Fusion Robotics LLC, a division of Integrity Implants Inc. (dba Accelus Inc.), for $55 million in cash. The deal brings a sophisticated navigation system for spine procedures into the Alphatec fold, something management previously identified as a target for expansion. Alphatec focuses on spinal surgery solutions. REMI integrates navigation and robotics into a range of spinal procedures and allows use of either a 3D imaging scan or 2D fluoroscopic images to precisely guide instruments and implants to the desired location during surgery.
Orthofix Medical Inc. and Seaspine Holdings Corp. signed a definitive agreement to combine in an all-stock merger of (near) equals. Following the close, Orthofix shareholders will own approximately 56.5% of the company and Seaspine shareholders will own approximately 43.5%. The new company’s name will be announced prior to the transaction’s anticipated first quarter of 2023 closing.
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.
Just three months after raising $10 million from its IPO on the Paris Euronext Growth market, SMAIO SA (Software Machines and Adaptive Implants in Orthopedics) obtained U.S. FDA 510(k) clearance for its Balance Analyzer 3D surgery planning software and for its patient-specific union rods. This spinal realignment planning software uses medical imaging of the patient’s spine in an upright static position.
More than 1.6 million spinal procedures are performed in the U.S. each year and between 10% and 30% of them fail to achieve their objective, indicating that the field has abundant room for improvement. Both equipment manufacturers and the FDA hope to improve spinal surgery success rates as seen in two clearances granted on May 31.
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.
For patients with complex fractures, bone lost to cancer or trauma and those undergoing spine surgeries, the fear of incomplete or distorted bone growth remains an acute and well-founded concern.
PARIS – Companion Spine SAS has raised $55 million to help develop its noninvasive diagnostic and interventional implant solutions for the treatment of degenerative disc disease and lumbar spinal stenosis. This series A round was led by Viscogliosi Brothers LLC, a New York-based investment company specializing in financing disruptive technology in spine treatment.
