Globus Medical Inc. entered into a definitive agreement to buy Nuvasive Inc. in an all-stock transaction that will combine two leaders in the musculoskeletal industry into one of the largest companies in the spinal surgery market. While there are many companies in the spine market, the acquisition may still set off an alarm among regulators concerned about consolidation in the field. Both boards unanimously approved the deal.
Orthogen AG received an investigational device exemption (IDE) from the U.S. FDA for its Orthogen technology device. This approval allows the company to start a pivotal trial on the device, used for treating patients with mild stage (II) to severe stage (IV) knee osteoarthritis. The trial will compare improvements in pain levels and function using standalone glucocorticoid injection, the current standard of care, against the Orthogen device.
Companion Spine SAS has acquired Backbone SAS, a company that develops implantable functional motion restoration devices for treating spinal disorders. The inclusion of Backbone's flagship medical device, Lisa – a lumbar implant for stiffness augmentation – completes the Companion Spine portfolio.
Zimmer Biomet Holdings Inc. (ZBH) agreed to acquire Embody Inc. for $155 million at closing with an additional $120 million in contingent milestone payments over the next three years. The deal includes Embody’s entire portfolio of collagen-based regenerative solutions for soft tissue injuries. The transaction is expected to close in February.
Curvebeam AI Ltd. won a U.S. FDA breakthrough device designation for Ossview, its investigational software that detects osteopenia or reduced bone mass in the already fragile bones of women 70 years of age and older. Osteopenia is difficult to diagnose using conventional bone mineral density (BMD) testing because small changes in density mask major changes in bone microstructure.
The annual North American Spine Society (NASS) Conference wraps up in Chicago on Oct. 15 and management discussions and analysts make it clear that the sector is not yet back to normal. While September showed an uptick in procedures, spinal surgery continues to lag the recovery seen elsewhere in orthopedics. As the challenges of the past two years recede, two players have posted notable gains in market share and revenue—Globus Medical Inc. and Alphatec Holdings Inc.—perhaps indicating a competitive advantage for smaller, more agile companies.
Limacorporate SpA reported U.S. FDA approval for Prima, its new shoulder platform focused on versatility and operating roam efficiency. “For the first time in our history, both the glenoid base plate and humeral stem are fully 3D-printed, leveraging our long legacy in additive manufacturing,” Massimo Calafiore, CEO of Limacorporate, told BioWorld.
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.
Stryker Corp. reported the launch of its Q Guidance system for spine applications. The system leverages new optical tracking options via a redesigned camera with the advanced algorithms of the newly released Spine Guidance software.
