Si-Bone today announced the first patient procedures with its FDA breakthrough device, the iFuse Torq TNT implant system. Santa Clara, California-based Si-Bone designed TNT to address the anatomic and biomechanical challenges of pelvic fragility fractures. It particularly helps in patients with poor bone quality, offering a significant advancement over traditional cannulated screws. TNT received FDA […]
Si-Bone
Si-Bone wins FDA clearance, breakthrough nod for pelvic fixation implant
Si-Bone this week announced it received FDA 510(k) clearance and FDA breakthrough device designation for its iFuse Torq TNT Implant System. The Santa Clara, California-based orthopedic company designed the TNT implant for pelvic fragility fracture fixation and sacroilliac joint fusion. TNT (through and through) is designed to meet the specific anatomical and bone mineral density […]
Si-Bone launches iFuse Bedrock Granite Implant system
Si-Bone this week announced it launched its new iFuse Bedrock Granite Implant System and completed the first surgical procedures using the device. Santa Clara, California-based Si-Bone designed the iFuse Bedrock Granite implant for sacroiliac fusion and spinopelvic fixation as a foundational element for multi-segment spinal fusion. The system’s launch follows its January FDA 510(k) clearance, […]
Si-Bone grows sales 45% in Q1, raises full-year guidance
Si-Bone this week posted first-quarter results that beat the overall consensus on Wall Street. The Santa Clara, California-based orthopedic company reported profit losses of $11.1 million, or 32¢ per share, on sales of $32.7 million for the three months ended March 31, for a bottom-line gain of 36.1% on sales growth of 45.76% compared with […]
Si-Bone expects 26% sales growth in Q4 results
Si-Bone (Nasdaq:SIBN) this week announced preliminary fourth-quarter results that exceeded expectations on Wall Street. The Santa Clara, California-based orthopedic device company expects worldwide revenue to be in the range of $31.7-$31.9 million for Q4 2022. The sales represent a 26% growth year-over-year. For the full year 2022, Si-Bone anticipates reporting worldwide revenue in the range […]
Si-Bone wins expanded FDA clearance for iFuse Bedrock Granite implant
Si-Bone (Nasdaq:SIBN) announced today that it received additional FDA clearance for its iFuse Bedrock Granite implant. New indications for the implant include its use with a range of commercially available pedicle screw systems. Santa Clara, California-based Si-Bone received FDA 510(k) clearance for iFuse Bedrock Granite for spinal procedures in May. It designed the implant to […]
Si-Bone wins FDA clearance for expanded iFuse-TORQ implant indication
Si-Bone announced today that the FDA granted clearance for its iFuse-TORQ implant for pelvic fracture fixation. The regulatory nod expands Si-Bone’s iFuse-TORQ’s indication for acute, non-acute and non-traumatic pelvic fractures, including pelvic fragility fractures (fractures related to low-energy traumatic events) and pelvic insufficiency fractures. Santa Clara, California-based Si-Bone said in a news release that the […]
Si-Bone wins FDA clearance for pelvic fixation, fusion tech
Si-Bone announced today that it received FDA 510(k) clearance for its iFuse Bedrock Granite implant system for spinal procedures. Santa Clara, California-based Si-Bone designed the iFuse “Granite” implant to provide sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion. According to a news release, FDA clearance follows earlier breakthrough device designation […]
Si-Bone posts mixed bag Q4 results
Si-Bone (NSDQ:SIBN) this week posted fourth-quarter results that beat revenue consensus on Wall Street but miss earnings estimates. The Santa Clara, California-based musculoskeletal treatment device company reported losses of -$14.5 million, or -43¢ per share, on sales of $25.2 million for the three months ended Dec. 31, 2021 for a sales growth of 13.94% compared […]
Laura Francis to move up to CEO spot at Si-Bone
Si-Bone (NSDQ:SIBN) will promote its present CFO and COO Laura Francis into the corner office of the company, which makes the iFuse implant for treating lower back pain. Francis will become CEO once the company finds a new CFO or May 1 — whatever comes first. Present CEO Jeff Dunn will stay with the company as […]
Si-Bone tops estimates with Q4 prelims | Wall Street Beat
Si-Bone (NSDQ:SIBN) said today that it expects to record fourth-quarter sales of $15.4 million to $15.6 million, up 12 – 13% from the same period last year. The company pegged its full-year sales for 2018 between $55.2 million and $55.4 million, up 15% from 2017. Analysts on Wall Street are expecting Si-Bone to post Q4 sales […]