Orthofix Archives - Medical Design Sourcing

Orthofix beats Street in Q4, analysts see positive signs for future

Orthofix Medical (Nasdaq: OFIX) + shares dipped slightly before hours on fourth-quarter results that topped the consensus forecast.

The Lewisville, Texas-based company posted losses of $22.2 million in the quarter. That equals 59¢ per share on sales of $200.4 million for the three months ended Dec. 31, 2023. The company’s bottom line dipped by more than $15 million further into the red on 64% sales growth.

Adjusted to exclude one-time items, earnings per share came in at 3¢. That landed 11¢ ahead of expectations on Wall Street. Sales also topped projections as analysts forecasted $195.3 million in revenue.

The company saw growth across segments, with Bone Growth Therapies sales ticking up 13.5%. The biggest change, though, came in Spinal Implants, Biologics and Enabling Technologies, which grew 152.4% year-over-year. Global Spine grew 78.8% and Global Orthopedics grew 7.2%.

“We are pleased to …

Orthofix announces new president of Bone Growth Therapies

Jason Shallenberger, Orthofix’s new president of Bone Growth Therapies [Image courtesy of Orthofix]Orthofix Medical (NASDAQ:OFIX) is promoting from within to fill a new business president position at the company.

The Lewisville, Texax–base spine and ortho tech company announced today that it moving its Bone Growth Therapies business out from under the leadership of its Spine business.

Jason Shallenberger, previously the VP of U.S. sales and marketing for the Bone Growth Therapies business, is now Orthofix’s president of Bone Growth Therapies.

“Jason has led sales and marketing for this successful franchise for a number of years,” Orthofix President and CEO Massimo Calafiore said in a news release. “Under his guidance, the sales team has produced quarter-after-quarter of double-digit growth in 2023. I am confident he will do an amazing job as President and continue to contribute greatly to the success of Orthofix.”

Shallenberger said he wa…

Orthofix partners with MRIguidance on orthopedic imaging

The 7D Flash navigation system, which will incorporate MRIguidance software. [Image courtesy of Orthofix]Orthofix Medical (Nasdaq: OFIX) + announced today that it entered into an agreement with MRIguidance to distribute its imaging software in the U.S.

The Lewisville, Texas-based company agreed to distribute the BoneMRI software in the U.S. It also announced the successful completion of the world’s first eight cases using BoneMRI with its 7D Flash navigation system.

BoneMRI creates a synthetic CT from an MRI imaging exam without the use of harmful radiation. This partnership aims to offer radiation-free preoperative imaging and spinal navigation using the Orthofix and MRIguidance technologies.

“Our team is passionate about optimizing clinical workflows and reducing radiation exposure to improve patient care and physician safety. In addition to removing the need for pre-operative radiation, this collaborative …

Orthofix has a new CFO as Massimo Caliafiore takes over as CEO

LimaCorporate CEO Massimo Calafiore

Orthofix Medical (Nasadaq: OFIX) + announced that it appointed a new CFO as its newly appointed CEO takes over the corner office.

The large orthopedic device maker appointed Julie Andrews as CFO as Massimo Calafiore assumes his position as CEO. Orthofix named Calafiore as its next CEO in November. However, the company had to wait until Enovis completed its acquisition of LimaCorporate for the appointment to go into effect. Calafiore served as Lima’s CEO until Enovis completed its acquisition last week.

Orthofix’s executive appointments come as part of a major shuffle at the top following the termination of three high-ranking executives. After the company began 2023 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 followi…

Orthofix has positive spine stimulation tech data

The SpinalStim system. [Image courtesy of Orthofix]Orthofix Medical (Nasadaq: OFIX) + today announced new data investigating pulsed electromagnetic field (PEMF) stimulation with lumbar spinal fusion.

Lewisville, Texas-based Orthofix evaluated PEMF stimulation as an adjunct to lumbar spinal fusion procedures in patients at risk for pseudoarthrosis. Patients treated with the SpinalStim bone growth device demonstrated a high rate of successful fusion. They also showed significant improvements in pain, function and quality of life, despite having risk factors for pseudoarthrosis.

SpinalStim, an FDA-approved bone growth stimulation therapy, offers an adjunct treatment for lumbar spinal fusion. It also functions as a nonsurgical treatment for spinal pseudoarthrosis. The device utilizes PEMF technology that provides 360 degrees of treatment coverage around the fusion site.

Orthofix says its system has an overall success r…

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…

Orthofix launches OsteoCove bioactive synthetic graft

[Image courtesy of Orthofix]Orthofix today announced it received FDA 510(k) clearance for its OsteoCove bioactive synthetic graft.

The graft is available in both a putty and strip configuration and Orthofix designed it to provide superior bone-forming capabilities with handling characteristics for a wide range of spine and orthopedic procedural applications.

“Using the same disciplined R&D approach we have historically taken with our internally processed demineralized bone matrix solutions, we created a product that challenges the performance expectations of typical synthetic bone graft substitutes,” said Orthofix Chief Scientific Officer Frank Vizesi. “OsteoCove is another prime example of leveraging our strengths in product development in combination with our vertically integrated manufacturing expertise.”

OsteoCove is made of biphasic ceramic granule that is comprised of β-tricalcium phosphate (ß-TCP) and hydroxyapatite (HA) combined with type-I bovi…

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…

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…

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…

The 10 largest orthopedic device companies in the world

The goal of Stryker’s Mako robotic-arm assisted surgery is to provide more predictable outcomes. [Image courtesy of Stryker]

Two of the world’s largest orthopedic device companies expect accelerated revenue growth this year.

Stryker and Zimmer Biomet both upped their 2023 guidance during recent earnings calls, a sign that orthopedic procedures are bouncing back from the COVID-19 pandemic.

GlobalData predicted earlier this year that the recovery will lift the ortho devices market to nearly $50 billion this year. The question is whether companies can continue the momentum. Stryker and ZB are betting on innovation, building arrays of products and services around their surgical robotics systems and surgical planning and digital health tools.

During Zimmer Biomet’s second-quarter earnings call, CEO Bryan Hanson noted that ZB has 40 planned product launches between this year and the end of 2025, the …

The 10 largest orthopedic device companies in the world

The goal of Stryker’s Mako robotic-arm assisted surgery is to provide more predictable outcomes. [Image courtesy of Stryker] Two of the world’s largest orthopedic device companies expect accelerated revenue growth this year.

Stryker (NYSE: SYK) + and Zimmer Biomet (NYSE: ZBH) + both upped their 2023 guidance during recent earnings calls, a sign that orthopedic procedures are bouncing back from the COVID-19 pandemic.

GlobalData predicted earlier this year that the recovery will lift the ortho devices market to nearly $50 billion this year. The question is whether companies can continue the momentum. Stryker and ZB are betting on innovation, building arrays of products and services around their surgical robotics systems and surgical planning and digital health tools.

During Zimmer Biomet’s second-quarter earnings call, CEO Bryan Hanson noted that ZB has 40 planned product …