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Medtech Big 100: These companies just missed the list

Each year, it takes more and more revenue to make our Medtech Big 100 ranking of the world’s largest medical device companies.

This year’s No. 100 — Artivion (formerly CryoLife) — secured the final spot in our ranking with revenue of $313.8 million.

Last year, $236.2 million was enough to get Cardiovascular Systems (now part of Abbott) onto the Medtech Big 100 company ranking at No. 100.

Companies on the bubble in recent years have made their way onto the Medtech Big 100. For example, Inspire Medical Systems missed the list by a single spot last year, but made No. 94 in our new ranking.

With that in mind, here are the companies that would have ranked Nos. 101 to 105 on this year’s list. Watch out for them in future versions of the Medtech Big 100.

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Si-Bone grows sales 45% in Q1, raises full-year guidance

Si-Bone (Nasdaq:SIBN) + 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 Q1 2022.

Earnings per share were 9¢ ahead of The Street, where analysts were looking for sales of $29.22 million.

“I am thrilled with our stellar start to 2023, as record procedure demand in the quarter allowed us to deliver approximately 50% U.S. revenue growth and achieve significant operating leverage,” CEO Laura Francis said in a news release. “The continued trend of accelerating revenue growth over the last several quarters is a testament to the perseverance and grit of our dedicated team members and the strong reception for our expanded portfolio of solut…

Si-Bone expects 26% sales growth in Q4 results

Si-Bone (Nasdaq:SIBN) this week announced preliminary fourth-quarter results that exceed the 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 in Q4, representing a 26% growth year-over-year. For the full year, Si-Bone anticipates worldwide revenue in the range of $106.1-$106.3 million for an 18% growth compared to FY 2021, according to a news release.

The Q4 revenues are expected to top the consensus on Wall Street, where analysts are looking for sales of $30.31 million.

Si-Bone develops technology for the surgical treatment of musculoskeletal disorders of the sacropelvic anatomy. Its iFuse implant system for minimally invasive surgery of the SI joint has been used in more than 75,000 procedures, according to the company.

Shares in SIBN were down slightly to $15.81 apiece in mid-morning trading today. MassDevice‘s MedTech 100 Index — which i…

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 of $106.1-$106.3 million, according to a news release. That’s 18% higher compared to FY 2021,

The Q4 revenues would top the consensus on Wall Street, where analysts are looking for sales of $30.31 million.

Si-Bone develops technology for the surgical treatment of musculoskeletal disorders of the sacropelvic anatomy. The company says health providers have used its iFuse implant system in more than 75,000 procedures. The iFuse system is for minimally invasive surgery of the SI joint.

Shares in SIBN were down slightly to $15.81 apiece in mid-morning …

Si-Bone wins expanded FDA clearance for iFuse Bedrock Granite implant

The iFuse Bedrock Granite implant. [Image courtesy of Si-Bone]Si-Bone (Nasdaq:SIBN) announced today that it received additional FDA clearance for its iFuse Bedrock Granite implant.

New indications for the implant include 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 provide sacroiliac (SI) fusion and sacropelvic fixation for segmental spinal fusion.

Its uses include immobilizing and fusing the sacroiliac joint. It also serves as foundational support at the base of a spine fusion construct.

The FDA’s initial clearance covered use with a single manufacturer’s pedicle screw system. Expanded indications include use with a range of rods used in multilevel spine fusion surgeries. According to a news release, this allows surgeons to use preferred techniques an implant systems w…

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…

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 &#…

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…

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…