K2M (NSDQ:KTWO) said yesterday it launched its Everest minimally invasive XTower instrumentation designed to work with its Everest MI XT spinal system. The XTower addition allows surgeons to use the Everest MI XT system to treat complex defomities to achieve 3-dimensional spinal balance, the Leesburg, Va.-based company said. “The addition of the Everest MI XTower to the […]
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7 medtech stories we missed this week: Aug. 18, 2017
From Nemaura’s new Oceania distribution deal to Sanuwave’s promissory note expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Nemaura inks Oceania distribution deal for SugarBeat patch Nemaura announced in an Aug. 15 press release that it has signed a non-binding distribution deal with Device Technologies for […]
K2M slides on Q2 sales miss
Shares in K2M (NSDQ:KTWO) fell today after the medical device maker met loss per share expectations but missed sales consensus on Wall Street with its 2nd quarter earnings results. The Leesburg, Va.-based company posted losses of $9.1 million, or 21¢ per share, on sales of $65.7 million for the 3 months ended June 30, seeing losses […]
7 medtech stories we missed this week: July 21, 2017
From Second Sight’s South Korean market entry to Sanuwave’s Indonesian distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Second Sight enters South Korea market Second Sight announced in a July 5 press release that it has entered the market in South Korea with the implantation […]
K2M win FDA 510(k), CE Mark for Nile proximal fixation device
K2M (NSDQ:KTWO) said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its Nile proximal fixation spinal system designed for proximal construct augmentation. The Nile system is designed to address complex spinal deformities and consists of bands and connectors to be used in conjunction with spinal rod constructs to attach to […]
K2M wins FDA nod for Capri 3D-printed corpectomy cage
K2M (NSDQ:KTWO) said today it won FDA 510(k) clearance for its Capri small 3D static corpectomy cage system, touing it as the 1st-to-market 3D-printed, FDA-cleared device of its kind. The newly cleared device is designed for stabilizing the thoracolumbar spine during vertebral body resections as a result of trauma or tumors, the Leesburg, Va.-based company said. […]
K2M inks Down Under distro deal with LifeHealthcare
K2M (NSDQ:KTWO) said today it inked a 5-year supply and distribution agreement with LifeHealthcare Group for Australia and New Zealand. The deal will position LifeHealthcare Group to distribute its spinal technologies in the 2 regions, the Leesburg, Va.-based company said. The companies held a previous partnership deal originally inked in 2010. “I am very pleased to […]
K2M shares drop on Q4, FY2016 earnings release
Shares in K2M (NSDQ:KTWO) have fallen in after-hours trading today after the medical device maker missed earnings per share expectations on Wall Street with its 4th quarter and fiscal year 2016 earnings report. The Leesburg, Va.-based company posted losses of $12.5 million, or 30¢ per share, on sales of $61.8 million for the 3 months ended Dec. […]
FDA clears components for K2M’s Mesa spine implant
K2M (NSDQ:KTWO) said today it won FDA 510(k) clearance for screw and connector components used as part of the company’s Mesa spinal system. The newly cleared components from the Leesburg, Va.-based company are designed to be used as part of a growing rod construct designed to accomodate growth in pediatric patients 10 years and younger. “We are […]
K2M wins CE Mark for Rhine cervical disc
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 […]
Avedro CEO Muller is out | Personnel Moves
Avedro said CEO David Muller stepped down shortly after it closed a $32 million equity round last month, replaced on an interim basis by COO Brian Roberts, the former CFO at Insulet (NSDQ:PODD). Waltham-based Avedro said Muller left to “pursue other opportunities.” “On behalf of the board and all the Avedro employees, I want to thank […]