Si-Bone wins FDA clearance for expanded iFuse-TORQ implant indication

[Image from Si-Bone]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 options for the iFuse-TORQ represent a market opportunity totaling approximately $300 million.

“Many elderly patients with sacral fragility fractures require long periods of immobility while their fracture heals, often leading to complications associated with bedrest,” Dr. Michael Gardner, Chief of Orthopedic Trauma at Stanford University Hospital, said in the release. “A paradigm shift is required. The strength and osseointegrative features of iFuse-TORQ make it the most attractive implant on the market to re…

Read more
  • 0

Si-Bone wins FDA clearance for pelvic fixation, fusion tech

[Image from Si-Bone]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 for the Granite implant, as well as a Centers for Medicare and Medicaid Services (CMS) proposal for a new technology add-on payment (NTAP). CMS also issued new technology “Section X” ICD-10 unique procedure coding for hospitals to report NTAP eligible cases that use Granite as an internal fixation device with tulip connector for either open or percutaneous sacroiliac joint fusion and sacropelvic fixation.

Duke University Spine Division Chief Dr. Christopher Shaffrey said in the release that Granite offers a device &#…

Read more
  • 0

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 with Q4 2020.

Earnings per share were 5¢ behind The Street, where analysts were looking for sales of $24.81 million.

“I am pleased with the team’s execution in 2021, as we extended our market leadership, grew our commercial infrastructure, expanded exclusive payor coverage, and ended the year with a record active surgeon base,” CEO Laura Francis said in a news release. “As we look beyond the near-term impact from the recent resurgence of COVID-19 on elective procedures and hospital infrastructure, we see strong underlying momentum in our business. In 2022 we will continue to le…

Read more
  • 0

Laura Francis to move up to CEO spot at Si-Bone

Laura Francis, soon-to-be CEO of 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 executive chair.

“Laura has been an exemplary leader and operator for Si-Bone since joining the Company in 2015. She is an exceptional executive who is passionate about our mission. She is highly respected by investors and our team as well as our board of directors. She is committed to our principles and values and knows how to lead and execute our strategy to invest in future growth,” Dunn said in a news release out today.

Francis said it’s a period of unique opportunity for Si-Bone — which is also promoting its CCO Tony Recupero to the position of president, commercial operations, in charge of worldw…

Read more
  • 0