Orthofix beats The Street in Q2, upping full-year guidance

Orthofix Medical (NASDAQ:OFIX) +  posted second-quarter results this evening that beat the consensus forecast on Wall Street.

It also raised its revenue and adjusted EBITDA guidance for the rest of the year, reflecting positive developments in Bone Growth Therapies and other sectors. It’s been more than eight months since Orthofix’s merger with SeaSpine.

The Lewisville, Texas–based orthopedic device manufacturer reported a net loss of $39.4 million, or $1.07 per share, on sales of $187.0 million for the three months ended June 30, 2023. Sales were up 58% on a reported basis and 7% on a pro forma constant currency basis over the prior year.

Adjusted to exclude one-time items, earnings per share were 2¢. The result was 49¢ ahead of The Street, where the consensus had Orthofix losing 47¢ per share on sales of $185.63 million.

“I am very pleased with Orthofix’s performance this quarter, deliv…

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May 2023 edition: Endolumik’s big step for safety, ortho hot topics, SaMD development lessons



Endolumik’s illuminated device takes a big step for safety

The top orthopedic device news out of AAOS 2023

SaMD development lessons from Cordio’s voice AI heart failure app

Orthopedic device tech advances

High in the Wind River mountains of present-day Wyoming, the inhabitants of a remote alpine village — perhaps the oldest in North America — may have used fresh rawhide soaked in water as a splint to immobilize fractured bones thousands of years ago.

Before them, the ancient Egyptians used tree bark and linens, and native tribes of South Australia used thick clay.

They would all no doubt be amazed by the modern practice of orthopedics on display at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting — after they recovered from the shock of the scintillating sights of Las Vegas.

In this edition of Medical Design & Outsourcing, Executive E…

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May 2023 edition: Endolumik’s big step for safety, ortho hot topics, SaMD development lessons



Endolumik’s illuminated device takes a big step for safety

The top orthopedic device news out of AAOS 2023

SaMD development lessons from Cordio’s voice AI heart failure app

Orthopedic device tech advances

High in the Wind River mountains of present-day Wyoming, the inhabitants of a remote alpine village — perhaps the oldest in North America — may have used fresh rawhide soaked in water as a splint to immobilize fractured bones thousands of years ago.

Before them, the ancient Egyptians used tree bark and linens, and native tribes of South Australia used thick clay.

They would all no doubt be amazed by the modern practice of orthopedics on display at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting — after they recovered from the shock of the scintillating sights of Las Vegas.

In this edition of Medical Design & Outsourcing, Executive E…

Read more
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Orthofix launches two access retractor systems for spine procedures

[Image courtesy of Orthofix]Orthofix Medical (Nasdaq:OFIX) + today announced it launched two access retractor system to help surgeons during minimally invasive spine procedures.

The company commercially launched the Lattus lateral access system and the Fathom pedicle-based retractor system to expand its offering of access solutions.

Orthofix designed Lattus for ease of use and versatility. The blade retraction strength and “down-and-out” splay feature give access to challenging anatomy. Used in combination with a full suite of instrumentation that uses the company’s innovative WaveForm L and Regatta NanoMetalene interbody devices, the Lattus retractor system can optimize the lateral procedure, according to the company.

“The Lattus Lateral Access System addresses five important areas of lateral spine surgery: access to the spine, preparation or removal of the disc, interbody placement, plate fixati…

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The top orthopedic device news out of AAOS 2023

Stryker’s next-gen Mako total robotic knee surgery system and more AI integration for Zimmer Biomet’s ZBEdge surgical platform topped the news at this year’s AAOS 2023.

The American Academy of Orthopaedic Surgeons 2023 annual meeting drew top medical and medtech talent to Las Vegas from March 7–11.

Here is a roundup of major news coming out of the show:

Stryker launches Mako Total Knee 2.0 surgical robotics platform The goal of Stryker’s Mako robotic-arm assisted surgery is to provide more predictable outcomes. [Image courtesy of Stryker]Stryker unveiled Mako Total Knee 2.0 at AAOS 2023. Informed by more than 500,000 procedures, Stryker said it designed the next-gen version of the robotic knee surgery system to provide an elevated user experience with customizable workflows and other key features. New features include a digital tensioner for assessing knee stability intraoperatively during total knee arthroplasty — without the need f…
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Orthofix hits 5,000 mark for Fitbone implantations

The Fitbone limb lengthening system. [Image courtesy of Orthofix]Orthofix Medical (Nasdaq:OFIX) announced today that it surpassed 5,000 device implants for its Fitbone TAA intramedullary limb-lengthening system.

Lewisville, Texas-based Orthofix said the system features more than 20 years of clinical history. Over that time, the device demonstrated safety and effectiveness in limb lengthening and deformity correction in adults and children.

Orthofix acquired the Fitbone intramedullary lengthening nail from Wittenstein SE in March 2020. The fully implantable system corrects leg length and deformity discrepancies through a minimally invasive implantation procedure.

Fitbone features a motorized intramedullary nail, a subcutaneously placed receiver and an external control set. This enables the patient to manage the distraction phase at home. Once the patient completes their treatment, they have the nail and receiver removed.

Orthofix offers Fitbone in the…

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Medtech jobs: The world’s largest medical device companies are hiring

Medical device companies are trying to fill thousand of medtech jobs. [Photo by ijeab – stock.adobe.com]

The world’s largest medical device companies are still hiring for medtech jobs despite layoffs in tech and other industries.

Medtech developers — and medtech jobs — are resilient, with the industry’s COVID-19 pandemic performance only bolstering its recession-proof reputation.

That’s not to say there haven’t been job cuts in medtech, led by thousands of layoffs at Philips as it struggles with a massive recall of deadly respiratory devices. But most medical device manufacturers are still hiring, and in some cases they can’t attract enough candidates to fill every vacancy in a tight labor market.

Stryker, for example, grew to approximately 51,000 employees as of the end of 2022, increasing its headcount by nearly 11 percent last year. Boston Scientific reported nearl…

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Could 2023 be a boom year for orthopedic devices?

The goal of Stryker’s Mako robotic-arm assisted surgery is to provide more predictable outcomes. [Image courtesy of Stryker]The orthopedic devices market is expected to reach nearly $50 billion this year as procedures bounce back from COVID-19, according to GlobalData.

GlobalData predicts the orthopedic surgical robotics space will be even hotter this year, growing 25.6% year-over-year to $984 million.

“Boosted by artificial intelligence (AI) and machine learning, new generations of orthopedic robots are expected to further improve clinical outcomes. Unlike the general surgery robotics market — which is dominated by only one company, Intuitive Surgical — all major orthopedic manufacturers are competing in the orthopedic robotics market,” Tina Deng, principal medical devices analyst at GlobalData, said in a news release posted Feb. 1.

In addition, Global Data noted that the pandemic has accelerated the shift of procedures to outpatient or ambulat…

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Orthofix launches Mariner deformity pedicle screw system

The Mariner system. [Image courtesy of Orthofix]Orthofix Medical (Nasdaq:OFIX) announced that it initiated the full commercial launch of its Mariner deformity pedicle screw.

Lewisville, Texas-based Orthofix also announced the first patient cases with Mariner. It marks the first product launched since the merger between Orthifix and SeaSpine earlier this month. SeaSpine developed the Mariner screw system.

In a news release, Orthofix said the foundational Mariner system addresses complex adult deformity spine cases. The full commercial launch adds reduction and correction instrumentation, as well as specialized implant technologies. It also features robust osteotomy tools to deliver efficient and powerful surgical intervention.

“The Mariner deformity system represents an innovative collaboration between surgical minds and a cutting-edge product development team,” said Dennis Cirino, SeaSpine SVP, global spinal systems. “Combined with our market-leading biolog…

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Orthofix, SeaSpine complete merger

Orthofix and SeaSpine today completed its previously announced merger of equals to create a global spine and orthopedics company.

Under the terms of the agreement, Orthofix will merge with SeaSpine and SeaSpine will continue as the surviving company and a wholly-owned subsidiary of Orthofix. SeaSpine shares also ceased trading on the Nasdaq global market this morning.

Holders of SeaSpine common stock will receive 0.4163 shares of Orthofix common stock for each share of SeaSpine common stock owned. The combined companies will continue to trade on the Nasdaq under the symbol OFIX.

The two companies plan to rename the merged company at a later date, but it will be Orthofix Medical until then. The combined company will market spine and orthopedics with a complementary portfolio of biologics, spinal hardware solutions, market-leading bone growth therapies, specialized orthopedic solutions and a surgical navigation system.

“The completion of this merger…

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Data backs Orthofix cellular bone allograft for lumbar fusion

The Trinity Elite celluar bone allograft. [Image courtesy of Orthofix]Orthofix (Nasdaq:OFIX) today announced positive results from a clinical study evaluating its Trinity Elite cellular bone allograft (CBA).

The prospective, multicenter study evaluates the Orthofix Trinity Elite in lumbar spinal fusion procedures. It demonstrated fusion rates of 98.6%, measured by bridging bone at 12 months follow-up.

Investigators published the study results in Neurology International.

“The 12-month data show that patients treated with the Trinity Elite allograft achieved a high rate of successful fusion and significant improvements in ODI and VAS scores,” said Dr. Joshua Wind, neurosurgeon at Sibley Memorial Hospital and lead author of the journal article. “Additionally, these high fusion rates were observed in subjects reporting single and multiple risk factors for pseudoarthrosis. The findings from this study provide further evidence for the use of cellular bone allogra…

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Orthofix, SeaSpine announce CFO post-merger

SeaSpine CFO John Bostjancic [Image courtesy of SeaSpine]SeaSpine CFO John Bostjancic will continue as the top financial officer of the to-be-named orthopedic device giant created through a merger with Orthofix.

When the two companies announced their plans to merge last month, they said that Bostjancic’s present boss, SeaSpine CEO Keith Valentine, would be CEO.

“John has been a key leader of SeaSpine dating back to the successful spin-out of the organization in 2015. I am confident his background and experience in the medical device industry, coupled with his cultural influence, will benefit the newly combined company as we continue to grow,” Valentine said in today’s news release.

“I believe John is well positioned to help lead us through the successful integration of the two companies, ensuring accountability across all levels of the organization, as we focus on the key initiatives that will drive growth, scalability and shareholder value.” Read more

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