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.
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.
Nano-x Imaging Ltd.’s (Nanox) subsidiary Nanox.AI has received the FDA’s 510(k) clearance for Healthost, an artificial intelligence (AI) software device providing qualitative and quantitative analysis of the spine from CT scans.
The NMPA approved two different surgical robots for marketing, a step forward in growth of a sector that remains underdeveloped in China. One of the robots approved for marketing by the NMPA is from Yuanhua Orthopedic Robotic Ltd. and the other is Suzhou Microport Orthobot Co. Ltd. Both robots are used for total knee arthroplasty (TKA), removing damaged cartilage and bones from the surface of the knee joint and replacing them with artificial implants.
The U.S. FDA’s safety and performance-based pathway (SPBP) is intended as a leaner, meaner alternative to the conventional 510(k) pathway that would sidestep some of the presumed problems with the concept of substantial equivalence. The agency recently added four device types to this program, including orthopedic fracture fixation plates.
Ossio Inc. has received FDA clearance for Ossiofiber suture anchors used to fix soft tissue to bone in the shoulder, foot and ankle. This is the most recent of clearances for the company’s intelligent bone regeneration technology which began in 2019 as a possible alternative to permanent fixation implants for the foot and ankle alone.
Software Machines and Adaptive Implants in Orthopedics (SMAIO) SA raised $10 million on the Paris Euronext Growth market. The offer price was set at $6.66 a share. “Thanks to this IPO, we will now be able to ramp commercial development of our I-Kontrol arthrodesis platform in Europe and secure a foothold in the United States,” Philippe Roussouly, CEO of SMAIO SA, told BioWorld.
Bioventus LLC continues to strengthen its portfolio through acquisitions and investments with a move to exercise its option to purchase Cartiheal Ltd. for $315 million up front and a potential payment of $135 million contingent on achievement of $100 million in trailing 12-month sales. The Cartiheal transaction follows the acquisition of Bioness Inc. and Misonix Inc. last year. Cartiheal developed the Agili-C implant, which received FDA breakthrough device designation in 2020 and premarket approval last week.
3Spine Inc. has raised $33 million in an oversubscribed series C private offering for a phase II clinical study to assess what it calls “the first total joint replacement” for the lower back. This brings total private investment in the Balancedback total joint replacement to $50.3 million, largely due, said 3Spine CEO Marc Peterman, to “tremendous clinical outcomes and a mountain of benchtop research.”
A thin film electrode platform technology developed by Neuroone Medical Technologies Corp. could be used to treat chronic back pain according to new tests. Eden Prairie, Minn.-based Neuroone said it concluded initial testing that demonstrate the electrode could provide chronic stimulation at typical stimulation parameters currently used to treat patients suffering with chronic back pain due to multiple failed back surgeries.
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