K2M (NSDQ:KTWO) said yesterday it won CE Mark approval in the European Union for its Rhine cervical disc system designed to treat degenerative disc disease. The Leesburg, Va.-based company said the newly cleared device features a 1-piece compressible polymer core, dome-shaped, plasma-coated endplates and a central-split keel, formed through proprietary molding technology to minimize wear between […]
Spine
Centinel Spine wins FDA 510(k) for Altos cervical spine implant
Centinel Spine said today it won FDA 510(k) clearance for its Altos posterior cervical thoracic stabilization system with indications for use in lateral masses of the cervical spine or pedicles of the cervical-thoracic spine. The West Chester, Penn.-based company said the 1st surgical implantation of the system was performed earlier this month at Las Vegas’ Western […]
Globus, Johnson & Johnson’s Synthes bury the hatchet
Globus Medical (NYSE:GMED) said yesterday that it agreed to settle a quartet of patent infringement lawsuits with Johnson & Johnson (NYSE:JNJ) subsidiary Synthes. The lawsuits involve 5 patents covering spinal implant technology. Specific terms of the settlement were not announced, “but were to the parties’ mutual satisfaction,” Globus said. All of the lawsuits were brought in the U.S. District […]
Supremes remand Medtronic lawsuit against NuVasive to lower court
The U.S. Supreme Court today remanded a Medtronic (NYSE:MDT) lawsuit against longtime spinal implant rival NuVasive Inc. (NSDQ:NUVA) to a lower appeals court, after deciding last year that a defendant’s belief regarding patent validity is not a defense to an induced infringement claim. Last July Medtronic asked the U.S. Supreme Court to review the U.S. Court of Appeals for the […]
VertiFlex drums up $27m for spinal implants
VertiFlex reported raised nearly $27 million in an equity and options offering this month, according to a regulatory filing. San Clemente, Calif.-based VertiFlex, which won pre-market approval from the FDA for its Superion interspinous spacer last May for treating moderate lumbar spinal stenosis, said the round consisted of $10.5 million in new cash, a $16.2 million debt […]
SpineGuard lands $8m debt round
SpineGuard (EPA:ALSGD) said it landed a debt financing round worth some $8.4 million (€7.7 million) for its disposable spine surgery devices. Paris- and San Francisco-based SpineGuard said the round included a $1.6 million (€1.5 million) “innovation loan” from Bpifrance and $6.8 million (€6.2 million) in a 4-tranche bond offering with IPF Partners. SpineGuard said it […]
Benvenue Medical closes $60 million round for spine devices
Benvenue Medical said it put a bow around a $60 million funding round for its Luna and Kiva treatments for degenerative disc disease and vertebral compression fractures. The round consists of $23 million in equity and another $37 million in debt, Benvenue said, with DeNovo Ventures, Domain Associates, Esquilime Partners, InterWest Partners, Technology Partners and Versant Ventures participating […]
NuVasive in $410m deal to acquire Ellipse Technologies
NuVasive Inc. (NSDQ:NUVA) and Ellipse Technologies said yesterday that they inked a deal worth up to $410 million for NuVasive to acquire Ellipse and its adjustable orthopedic implants. Aliso Viejo, Calif.-based Ellipse, which registered a $75 million initial public offering last October, has a pair of orthopedic surgery devices already on the market: The Magec-Eos spinal bracing and […]
InVivo Therapeutics wins FDA approval for pivotal trial of spinal scaffold
InVivo Therapeutics (NSDQ:NVIV) said today that it won FDA approval to shift a pilot trial of its spinal scaffold to a pivotal probable benefit study. Cambridge, Mass.-based InVivo said it expects the FDA to OK its Inspire study, designed to enroll 20 patients with spinal cord injuries, after it submits 6-month data during the 2nd quarter […]
Hospitals to pony up $28m for false kyphoplasty claims
The U.S. Justice Dept. said today that a group of 32 hospitals agreed to pony up a collective $28 million to settle charges that they billed Medicare at the inpatient rate for outpatient kyphoplasty procedures. In kyphoplasty, a treatment for vertebral compression fractures from osteoporosis, surgeons create a void within the vertebra and fill it […]
FDA clears Life Spine’s Gruve cervical plate implant
Life Spine said yesterday it won FDA 510(k) clearance for its Gruve anterior cervical plate system. The Gruve plate allows for extreme bone screw angulation, large graft windows and a locking mechanism that provides tactile and visual confirmation of locking upon installation, Huntley, Ill.-based Life Spine said. “Our comprehensive cervical portfolio reinforces Life Spine’s commitment to […]