Si-Bone this week released 2-year results from the SIFI trial of iFuse implant system designed for sacroiliac joint fusion procedures, touting improvements in quality of life and a 28% reduction in opioid use. Results from the trial were published in The International Journal of Spine Surgery, the San Jose, Calif.-based company said. The 172-patient multi center […]
SiBone
Si-Bone expands European footprint, adds 2 new execs
Si-Bone said today it is expanding its European presence by forming Si-Bone UK Ltd. and bolstering the executive team for its European, Middle East and Africa businesses. Si-Bone said it tapped Richard Moss as its new U.K. & Ireland GM, leading all operations of its newly formed SI-Bone U.K. division. The company also picked up […]
Si-Bone touts midwest Medicare reimbursement win
Si-Bone said today it won a positive local coverage determination from Kentucky and Ohio Medicare administrative contractor CGS Administrators for its minimally invasive surgical sacroiliac iFuse Implant joint. The reimbursement decision will take effect Feb. 1, 2016, San Jose, Calif.-based Si-Bone said. CGS is the 6th MAC to provide coverage for the joint fusion device. […]
Si-Bone wins FDA 510(k) for iFuse sacroiliac joint system
Si-Bone said today it won FDA 510(k) clearance for its minimally invasive iFuse implant system designed for fusion of the sacroiliac joint. The device is cleared for treating certain disorders of the sacroiliac joint, and its indication includes a statement that treatments with the device “improved pain, patient function and quality of life at 12-months […]
Si-Bone touts data from 3 study results
Si-Bone today released results from 3 studies of its iFuse minimally invasive sacroiliac joint fusion system, reporting positive results across all studies. Included in the new data are 1-year results from 2 clinical trials and a systemic review of 18 different studies of the MIS SI joint fusion system. “Collectively, these 3 recent publications significantly […]
Si-Bone raises $21m, appoints new CFO
Si-Bone said yesterday that the medical device company raised a $21 million funding round and hired Laura Francis as its new CFO.
Allergan CEO Pyott steps down from Edwards Lifesciences board | Personnel Moves
SI-Bone announces big plans for its newly raised $33 million | Medtech funding stories for the week of Apr. 28, 2014
SI-Bone has big plans for newly raised $33M
San Jose, Calif.-based SI-Bone has big plans for its newly raised $33 million, saying it’ll use the new funds to add additional resources and chase regulatory approvals overseas for its iFuse bone fixation system.
Financing came from new investors Orbimed and Novo A/S, as well as from existing funders Skyline Ventures and Montreux Equity Partners, SI-Bone reported.
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.
FDA clears Biomet’s hip implant | Regulatory roundup
Biomet Inc. received FDA 510(k) clearance for its new hip replacement device.
Warsaw, Ind.-based company said its Active Articulation E1 dual mobility hip system is an implant option for orthopedic surgeons performing hip replacement surgery.