RTI Surgical (NSDQ:RTIX) said it’s launching a new line of spinal implants, the Streamline OCT system, for fusion procedures involving the occipto-cervico-thoracic spine.
Spine
Mainstay Medical readies European IPO
Mainstay Medical is preparing an initial public offering on the EuroNext stock exchange that could be worth up to $42 million, according to a regulatory filing.
Mainstay, which last month launched a new clinical trial of its ReActiv8 implantable neurostimulator for chronic lower back pain, said it plans to offer some 1.1 million shares at €20-€27 per share, or about $27.77 to $37.50 per share.
FzioMed turns to FDA’s Dispute Panel to contest Oxiplex denial
Once-scorned biomaterials maker FzioMed is getting another day with the FDA to discuss its Oxiplex spinal surgery gel, which was rejected by U.S. healthcare officials in 2008.
FzioMed will meet June 10, 2014, with the FDA’s Medical Device Dispute Resolution Panel to discuss the "approvability" of the Oxiplex gel, which has been on the European market since 2012 and is approved for sale in 70 countries. The product has already been used in more than 350,000 surgeries, FzioMed said.
Zimmer brings new ‘no profile’ Optio-C spine implant to the U.S.
Mazor Robotics moves into brain surgery
Mazor Robotics (NSDQ:MZOR) said it’s planning the début of a new brain module for its Renaissance robotic surgery system next week.
Spinal firm K2M aims for $100M IPO
Spinal surgery devices maker K2M Group Holdings hopes to raise as much as $100 million through its impending initial public offering, according to registration documents filed with the SEC.
SI-Bone wins coverage nod for iFuse sacroiliac fusion device
Si-Bone said a Medicare administrative contractor, Palmetto GBA, reversed its non-coverage policy on the medical device company’s iFuse spinal fusion device.
The decision opens coverage for the iFuse sacroiliac procedure to patients on a case-by-case basis in North Carolina, South Carolina, Virginia and West Virginia, according to a press release.
Chinese study compares Medtronic spine implants
NuVasive shares jump on Street-beating Q4 numbers
NuVasive Inc. (NSDQ:NUVA) shares gained nearly 8% today after the medical device company reported beating expectations with its 4th-quarter earnings as it swung to black ink.
Benvenue Medical closes $3.5M funding round
Spinal devices maker Benvenue Medical closed a $3.5 million funding round with the help of 9 unnamed investors, according a regulatory filing.
The Santa Clara, Calif.-based company raised the funds through sales of debt, rights and securities or rights to acquire securities. Benvenue provided few other details on the funding round.
Paradigm Spine lands $75 million in debt financing
Paradigm Spine said it inked a $75 million credit agreement with PDL BioPharma.
Paradigm Spine, which makes spinal implants, said it will take the 1st $50 million in at closing, with another $25 million in milestone-based payments on the table.