Orthofix has a new CEO

LimaCorporate CEO Massimo Calafiore

Orthofix Medical (Nasdaq: OFIX) + announced today that it named Massimo Calafiore as its new president and CEO.

Lewisville, Texas-based Orthofix expects the appointment of Calafiore to go into effect in early 2024. He currently serves as CEO of LimaCorporate and will take over the corner office at Orthofix following the completion of Lima’s acquisition by Enovis. The company also expects him to join its board of directors.

Calafiore’s appointment comes following a major upheaval at Orthofix earlier this year. After the company opened the year with a massive merger with SeaSpine, in September, it terminated a trio of executives with cause. The company cut ties with CEO Keith Valentine, CFO John Bostjancic and chief legal officer Patrick Keran following an investigation.

An independent outside legal counsel conducted the investigation and Orthofix’s independent direc…

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Orthofix launches new fixation system, first cases performed

The Galaxy Fixation Gemini system. [Image courtesy of Orthofix]Orthofix Medical (Nasdaq: OFIX) + today announced the full U.S. commercial launch and initial successful cases of its Galaxy Fixation Gemini system.

Lewisville, Texas-based Orthofix’s latest Galaxy product offers stable external fixation. It comes in several sterile procedure kit configurations as a quick, off-the-shelf solution. The system treats fractures resulting from trauma in the lower and upper limbs.

Sterile kits eliminate the need for the sterilization of trays, which takes an average of 139 minutes, Orthofix says. In addition to the time consumption, sterilization adds cost to healthcare facilities and can cause operating room delays.

Galaxy Fixation Gemini is the only pin-to-bar system with specific clamps available in a sterile kit configuration, Orthofix says. It gives surgeons more efficient solutions in lower extremity trauma situat…

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Analysts downgrade Orthofix after the company terminates executives with cause

Orthofix (Nasdaq: OFIX) + today announced a slew of executive changes after terminating its CEO, CFO and chief legal officer with cause.

Shares of OFIX sank nearly 25% at $14.06 apiece in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell nearly 1%.

The Lewisville, Texas-based company’s board’s independent directors came to a unanimous decision to terminate the executives. Keith Valentine, John Bostjancic and Patrick Keran now depart those respective roles. The board also requested that Valentine resign from his position on the board. It plans to immediately begin a search for permanent successors.

Orthofix’s decision to terminate the executives followed an investigation conducted by independent outside legal counsel. Orthofix’s independent directors directed and oversaw the investigation. As a re…

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Orthofix launches new spine surgery navigation system

The 7D Flash navigation system. [Image courtesy of Orthofix]Orthofix Medical (Nasdaq: OFIX) + today announced the full U.S. commercial launch for its 7D Flash navigation system percutaneous module 2.0.

The company also confirmed the completion of the first cases in the U.S. with the module. It provides new planning features and increased functionality for the 7D Flash navigation system for minimally invasive spine surgery. The 7D system came from 7D Surgical, acquired by SeaSpine in 2021, after Orthofix and SeaSpine completed a merger this year.

7D Flash uses visible light to create a three-dimensional image for surgical navigation within seconds. This enables faster and more efficient spinal procedures, according to Orthofix. The company says it’s the only image guidance system that utilizes novel and proprietary camera-based technology coupled with machine-vision algorithms.

Orthofix said 7D Flash eliminate…

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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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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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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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The 10 largest orthopedic device companies in the world

Stryker, Johnson & Johnson’s DePuy Synthes and Zimmer Biomet top the list of largest orthopedic device companies. [Adobe Stock image]With elective procedure numbers rebounded after the darkest days of the COVID-19 pandemic, most of the world’s largest orthopedic device companies saw their revenues increase by double-digit percentages during their most recent fiscal years.

Here are the world’s 10 largest orthopedic device companies, ranked by ortho business revenue pulled from their most recent annual reports:

Largest orthopedic device companies Annual revenue (% change) Headquarters 1 Stryker $17.1 billion (+19.2%) Kalamazoo, Michigan 2 Johnson & Johnson – DePuy Synthes $8.6 billion (+10.6%) Locations: Raynham, Massachusetts.; West Chester, Pennsylvania; Warsaw, Indiana; Palm Beach Gardens, Florida 3 Zimmer Biomet (minus ZimVie spinoff) $6.8 billion (+11.6%) Warsaw, Indiana 4 Medtronic – Cranial & Spinal Technologies $4.5 billion (+3.9%) Locat…
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Orthofix announces first clinical use of its autograft substitute

Orthofix Medical today announced the limited market release and first implant of its Virtuos Lyograft autograft substitute.

Lewisville, Texas-based Orthofix designed Virtuos Lyograft as a shelf-stable and complete autograft substitute for spine and orthopedic procedures. It is prepared by MTF Biologics through a process that preserves all biologic components needed for bone healing within the graft.

“The Virtuos allograft is unique in the fact that it can be stored at room temperature and is ready to implant within two minutes of being hydrated,” said Dr. Tomas Ellis, a neurosurgeon at Baylor Scott and White Surgical Hospital in Fort Worth, Texas, who implanted the first patient. “This helps ensure we can always have an easy-to-use, moldable, complete bone graft on hand, and it streamlines the preparation and overall surgical procedure time.”

Virtuos Lyograft is an addition to the company’s line of biologics that includes the Trinity Elite, Trinity…

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