Orthofix Archives - Medical Design Sourcing

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 …

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…

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…

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…

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…

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…