Orthofix beats The Street in Q3 results, raises full-year guidance

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

The Lewisville, Texas-based orthopedic company reported a net loss of $10.7 million, or -53¢ per share, on sales of $114 million for the three months ended Sept. 30 for a sales gain of 1.39% compared with Q3 2021.

Adjusted to exclude one-time items, earnings per share were 13¢, 1¢ ahead of The Street, where analysts were looking for sales of $113 million.

“New product innovation and commercial channel execution delivered a strong performance during the third quarter,” Orthofix President and CEO Jon Serbousek said in a news release. “Global Orthopedics, Biologics, and Bone Growth Therapies drove topline growth as solid portfolio-wide sales were bolstered by exciting market adoption trends from a number of recently launched products such as AccelStim Bone Healing Therapy and Virtuos Lyograft.”

“We are bullish about the future of Orthofix, ev…

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First patients implanted with Orthofix Legacy demineralized bone matrix

The Legacy DBM. [Image from Orthofix]Orthofix (Nasdaq:OFIX) announced today that it completed the full market release and first implants of its Legacy demineralized bone matrix (DBM).

Lewisville, Texas-based Orthofix designed the Legacy DBM as a putty for filling voids or gaps. It operates in boney defects or traumatic injuries of the spine, pelvis or extremities.

MTF Biologics processes the Legacy DBM, according to a news release. Its tailored processing methods preserve the inherent growth factors natural to the bone.

Dr. Alan Daniels, chief of spine surgery at University Orthopedics in Providence, Rhode Island, implanted the first patient.

“Bone healing is a dynamic process where multiple factors play an integral role in deciding which biologic best meets the individual needs of the patient to aid them on their road to recovery,” said Daniels. “Legacy DBM provides a cost-effective option, without compromising clinical experience or the handling ne…

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Orthofix, SeaSpine plan all-stock merger to create global spine and orthopedic company

Orthofix (Nasdaq:OFIX) and SeaSpine (Nasdaq:SPNE) today announced a definitive agreement to combine companies in an all-stock merger of equals.

Under the terms of the agreement, SeaSpine shareholders will receive 0.4163 shares of Orthofix common stock for each share of SeaSpine common stock owned. Once the transaction closes, Orthofix shareholders will own approximately 56.5% of the combined companies. SeaSpine shareholders will own approximately 43.5% of the combined company on a diluted basis, according to an SEC filing.

Both companies’ boards have unanimously approved the merger. They plan to close the transaction in the first quarter of 2023, naming the new combined company beforehand.

Shares in OFIX were down more than 21% to $14.49 apiece, and SPNE was up more than 5% to $5.90 apiece in premarket trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down more than 3%. Read more

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Orthofix lowers full-year revenue guidance on missed Q2 results

Orthofix (Nasdaq:OFIX) this week reported second-quarter results that missed the overall consensus on Wall Street.

The Lewisville, Texas-based orthopedic device maker reported profits of $2.5 million, or 12¢ per share, on sales of $118.1 million for the three months ended June 30, for a bottom-line gain of 2.9% on sales loss of 2.74%.

Adjusted to exclude one-time items, earnings per share were 8¢, 2¢ behind The Street, where analysts were looking for sales of $118.25 million.

“We’re pleased with our execution in the second quarter, which was led by double-digit growth in our global orthopedic business as well as early commercial traction of new spine products. In addition, we made significant progress on our innovation initiatives, highlighted by the successful launches of the AccelStim bone healing therapy and Virtuos Lyograft, as well as our recent partnerships with LimaCorporate and CGBio,” President and CEO Jon Serbousek said in a news release.…

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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 partners with LimaCorporate on hip dislocation solution

Orthofix’s Fitbone system. [Image from Orthofix]Orthofix Medical (Nasdaq:OFIX) announced today that it entered into a licensing partnership for the U.S. market with LimaCorporate.

The licensing partnership aims to provide a novel solution for patients with the challenging condition of chronic high dislocation of the hip. It will combine the limb-lengthening technology of Orthofix’s Fitbone intramedullary nail system with LimaCorporate’s proprietary, patient-specific, 3D-printed pelvic fixation device.

Lewisville, Texas-based Orthofix said in a news release that, once surgically implanted, the devices work together with the aim of allowing surgeons to distract the femur to an anatomically correct position, allowing for the correction of the leg-length discrepancy, reducing strain on the spine and allowing for a total hip replacement to follow.

The new solution currently does not have FDA clearance and is only available through an FDA compas…

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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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