Orthofix announces 5-year positive data for its M6-C artificial cervical disc

Cutaway image of the M6-C artificial cervical disc that shows its nucleus-annulus design that mimics a native disc’s natural structure. [Image courtesy of Orthofix Medical]Orthofix Medical (Nasdaq:OFIX) today announced positive five-year data from the single-level IDE study of its M6-C artificial cervical disc.

Lewisville, Texas–based Orthofix will hold a presentation of the data on June 3 at the International Society for the Advancement of Spine Surgery annual meeting in Nassau, Bahamas.

It’s been more than three years since FDA approved the M6-C for the treatment of cervical disc degeneration. Since 2006, Orthifix has had more than 60,000 of its M6-C discs implanted in over 20 countries.

“We are pleased to see that at five years postoperative, participants in the study who received the M6-C artificial cervical disc continue to show significant benefits in Neck Disability Index (NDI) scores and neck and shoulder/arm pain Visual Analog Scale (VA…

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Orthofix beats The Street in Q1, reaffirms 2022 guidance

Orthofix (Nasdaq:OFIX) recorded first-quarter financial results that came in ahead of the consensus forecast on Wall Street.

The Lewisville, Texas-based orthopedic implant company posted losses of $4.5 million, or 22¢ per share, on sales of $106.4 million for the three months ended March 31, 2022, for a slight bottom-line gain closer to breakeven on sales growth of 0.8%.

Adjusted to exclude one-time items, earnings per share were 17¢, 8¢ ahead of Wall Street, where analysts were looking for sales of $104.4 million.

“We’re very pleased with our financial and operational performance in the first quarter given the COVID-19 and labor headwinds, ongoing global supply chain disruptions, and macro financial impacts stemming from political instability in Europe,” Orthofix President and CEO Jon Serbousek said in a news release. “The strategic investments we have made over the last two years, including a focus on new product innovation and the de…

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Orthofix wins FDA PMA for bone growth stimulation device

[Image from Orthofix]Orthofix (Nasdaq:OFIX) announced today that it received FDA premarket approval (PMA) for its AccelStim bone healing therapy device.

Lewisville, Texas-based Orthofix designed the AccelStim device to provide a safe and effective nonsurgical treatment for indicated fresh fractures and for fractures that have not healed (nonunions).

According to a news release, the device generates a low-intensity pulsed ultrasound (LIPUS) signal to stimulate the bone’s natural healing process to promote fracture healing. The device, worn externally in the region of the fracture for about 20 minutes daily (treatment length varies on an individual basis), was designed to be lightweight, adjustable and portable with a rechargeable battery that allows freedom of movement during treatment. The system also includes a treatment calendar to engage patients in their recovery.

LIPUS technology stimulates bone healing at the molecular, cellular and tissue level…

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Orthofix names Kimberley Elting as orthopedics business president

Orthofix (NSDQ:OFIX) today announced it appointed Kimberley Elting to president of the global orthopedics business, effective immediately.

Elting, who most recently was the company’s chief legal and development officer, will succeed Paul Gonsalves who is pursuing other opportunities.

“With more than 25 years in the medical device space, a track record of success at Orthofix, and a demonstrated passion for our Orthopedics business, Kim will bring strong leadership and meaningful perspective to this business,” CEO Jon Serbousek said in a news release. “We have made significant investments to build the Orthopedics Business unit and we feel confident that she is the right person to lead this team to continue to drive growth in this sector of our business.”

Prior to the leadership transition, Elting held numerous leadership roles in Orthofix, including regulatory and quality, corporate communications, business development and legal. She will transition …

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FDA clears Orthofix TrueLok Evo Ring fixation system

Orthofix today announced that it received FDA 510(k) clearance for its TrueLok Evo Ring Fixation system.

The Lewisville, Texas-based orthopedics company designed the device for complex limb reconstruction and deformity correction procedures. It is a circular fixator that has radiolucent rings and struts for clear radiographic visualization, which allows physicians to better assess bone anatomy during and after surgery.

“We are constantly evolving our solutions to meet surgeons’ and patients’ needs,” said Paul Gonsalves, president of global orthopedics at Orthofix. “Orthofix ring fixation systems are the preferred solutions to thousands of surgeons worldwide and have been used to treat more than 80,000 patients to date. Today we are proud to launch the TrueLok Evo system as part of our portfolio of solutions to help healthcare professionals restore patient anatomy, mobility and quality of life.”

TrueLok is an advanced external fixation system that is made…

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Orthofix beats The Street in Q4 results

Orthofix (NSDQ:OFIX) this week posted fourth-quarter results that beat the overall consensus on Wall Street.

The Lewisville, Texas-based orthopedic device maker reported losses of -$32.8 million, or -$1.65 per share, on sales of $125.1 million, for the three months ended Dec. 31, 2021, for a sales growth of 6.33% compared with Q4 2020.

Adjusted to exclude one-time items, earnings per share were 27¢, 14¢ ahead of The Street, where analysts were looking for sales of $124.87 million.

“Despite the headwinds our industry faced throughout the year, we delivered double-digit revenue growth while continuing to advance initiatives that will fuel the future of the business,” president and CEO Jon Serbousek said in a news release. “We closed the year with strong fourth-quarter performance, driven by year-over-year growth in global spinal implants as well as growth in orthopedics, primarily as a result of the continued strength of key products such as the M6-C™ arti…

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Intersect ENT CEO joins Orthofix board

Orthofix (NSDQ:OFIX) announced today that Intersect ENT (NSDQ:XENT) executive Thomas A. West has joined its board of directors.

Lewisville, Texas-based Orthofix named West to its board and appointed him to its Compensation and Talent Development Committee.

West currently serves as President, CEO & Director of Intersect ENT, which develops drug-delivery devices for ear, nose and throat procedures. He has navigated the company through its recently announced $1.1 billion acquisition by Medtronic.

Before Intersect ENT, West was Division President of Diagnosis Solutions at Hologic. Before that, he had a 23-year stint at Johnson & Johnson in various domestic and international roles. West’s most recent position was Worldwide VP of Strategy & Business Development a Diabetes Solutions Companies.

“Tom joins the Orthofix Board of Directors with more than 30 years of global experience in the medical device industry,” Orthofix Chair of the Bo…

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Orthofix ticks up on Street-beating Q2 results

Orthofix (NSDQ:OFIX) posted second-quarter results today that beat the overall consensus on Wall Street.

The Lewisville, Texas-based company reported profits of $2.4 million, or 12¢ per share, on sales of $121.4 million, for the three months ended June 30 for a sales growth of 65.99% compared with Q2 2020.

Adjusted to exclude one-time items, earnings per share were 32¢, 21¢ ahead of The Street, where analysts were looking for sales of $108.2 million.

“We are proud of our second-quarter performance, in which we delivered accelerated topline growth sequentially and over pre-COVID levels,” president and CEO Jon Serbousek said in a news release. “We continue to see the positive impacts of our strategic initiatives, including increased product adoption driven through our expanded pool of strategic distribution partners, as well as ongoing strength from new products, in particular our M6-C artificial cervical disc and the Fitbone lengthening nail.”

“Int…

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Orthofix launches Fiberfuse Strip bone graft

Orthofix (NSDQ:OFIX) today announced that it has launched its FiberFuse Strip bone graft in the U.S.

Lewisville, Texas-based Orthofix designed the FiberFuse Strip to be a preformed bone-graft strip for posterior cervical, posterior lumbar and degenerative spinal procedures.

Get the full story on our sister site, Medical Design & Outsourcing.

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Orthofix launches Fiberfuse Strip bone graft

Orthofix (NSDQ:OFIX) today announced that it has launched its FiberFuse Strip bone graft in the U.S.

Lewisville, Texas-based Orthofix designed the FiberFuse Strip to be a preformed bone-graft strip for posterior cervical, posterior lumbar and degenerative spinal procedures.

FiberFuse Strip is 100% bone and has a unique mixture of mineralized cancellous and demineralized cortical bone with no carrier added. It creates a natural scaffold to allow for revascularization, cellular ingrowth and new bone formation.

“We are pleased to introduce this next-generation formulation in the FiberFuse allograft line,” Orthofix global spine president Kevin Kenny said in a news release. “The FiberFuse Strip delivers a high-quality advanced bone-graft option in a convenient, easy-to-use strip preparation. This technology advancement was developed as part of our strategy to provide procedurally-focused solutions for spine surgeons and their patients.”

MTF Biologics i…

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Orthofix announces U.S. launch, first patient implant of 3D-printed spacer system

Orthofix (NSDQ:OFIX) announced today that it launched and implanted the first 3D-printed Forza Ti PLIF spacer system in the U.S.

Lewisville, Texas-based Orthofix’s 3D-printed Forza Ti posterior lumbar interbody fusion (PLIF) spacer system uses the company’s Nanovate technology to comprise a titanium lumbar interbody device that allows the bone to grow into and through the spacer, according to a news release.

Orthofix touts features of the Forza Ti system that include a large open graft window for packing bone-grafting material, a bulleted nose to assist with distraction and 3D-printed porous titanium with macro, micro and nanoscale surface features.

Additionally, the system includes a nanoscale surface proven to increase proliferation and alkaline phosphatase activity in human stem cells in vitro, as well as a functional gradient porous structure with 80% porosity at the midline of the implant to allow for increased fluoroscopic visualization…

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Orthofix launches Oscar Pro arthroplasty system

Orthofix (NSDQ:OFIX) today said it fully launched its Oscar Pro ultrasonic arthroplasty revision system in the U.S. and Europe.

The ultrasonic surgical system is designed to aid in the removal of cement during complex joint revision surgeries.

Oscar Pro’s new design includes an enhanced user interface to enable a more efficient surgical experience and new data collection capabilities. The system uses ultrasonic vibrations to soften cement holding implants in place. It also has a tool that allows surgeons to remove the softened cement using specially designed probes.

“The Oscar Pro system is a fourth-generation product from the OSCAR line that has been the gold standard in assisting with complex joint revision surgeries since 1990,” Orthofix president of global orthopedics Paul Gonsalves said in a news release. “The technology is well accepted and has been used successfully for decades in removing cement total joint arthroplasties and aiding c…

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