Welcome to our dedicated page for Orthofix Med news (Ticker: OFIX), a resource for investors and traders seeking the latest updates and insights on Orthofix Med stock.
Orthofix Medical Inc. (NASDAQ: OFIX) is a global medical technology company headquartered in Lewisville, Texas, with a focus on musculoskeletal care. The Orthofix news stream highlights developments across its spinal hardware, bone growth therapies, specialized orthopedic solutions, biologics and enabling technologies, including updates related to the 7D FLASH™ Navigation System.
Investors and healthcare professionals following Orthofix news can review regular earnings announcements, where the company reports net sales and segment performance for Bone Growth Therapies, Spinal Implants, Biologics and Enabling Technologies, Global Spine and Global Orthopedics. These releases often include commentary on trends in U.S. Spine Fixation, bone growth therapy performance, and the progress of its orthopedics business focused on limb reconstruction.
News coverage also features regulatory and product milestones, such as FDA 510(k) clearance and CE Mark for the TrueLok™ Elevate Transverse Bone Transport System and the global commercial launch of TrueLok Elevate. Orthofix uses these announcements to describe how TrueLok Elevate fits into its TrueLok family of multiplanar external fixators and supports limb preservation and diabetic wound-related treatment needs.
In addition, Orthofix issues releases about upcoming investor conference appearances and the timing of quarterly financial results and conference calls. For anyone tracking OFIX, this news page provides a centralized view of the company’s public communications on financial performance, product launches, regulatory clearances and investor events.
Orthofix Medical reported Q2 2022 net sales of $118.1 million, down 3% year-over-year, with GAAP EPS at $0.12. Global Orthopedics saw an 11% growth in net sales on a constant currency basis, driven by new products. The company announced a partnership with CGBio to commercialize Novosis™ rhBMP-2 in the U.S. and Canada. Despite operational challenges and a decrease in gross profit margin to 73.2%, the company projects full-year revenue of $455 to $465 million, indicating flat to 2% growth. Adjusted EPS is expected to range between $0.45 and $0.55.
Orthofix Medical Inc has announced a strategic partnership with CGBio, focusing on the clinical development and commercialization of Novosis, a novel bone graft technology. This partnership targets the U.S. and Canadian markets and involves Orthofix conducting clinical studies and seeking regulatory approvals. CGBio will receive upfront and milestone payments under this agreement. Orthofix aims to enhance its regenerative technology portfolio, offering surgeons new options to improve patient outcomes.
Orthofix Medical Inc. (NASDAQ:OFIX) will announce its second quarter 2022 financial results on August 5, 2022, before the market opens. The CEO, Jon Serbousek, and CFO, Doug Rice, will host a conference call at 8:30 a.m. ET to discuss the results. Interested participants can join the call by dialing (844) 200-6205 for U.S. and Canadian callers, or (929) 526-1599 for international calls, using access code 135199. A replay will be available for three weeks.
Orthofix Medical Inc (NASDAQ: OFIX) has announced the limited market release and first patient implant of the Virtuos™ Lyograft, a groundbreaking, shelf-stable autograft substitute designed for spine and orthopedic surgeries. Developed through a proprietary process by MTF Biologics, this allograft allows for quick hydration and use within two minutes, enhancing surgical efficiency. The product offers logistical and cost-saving benefits by eliminating the need for dry ice and freezer storage, aiming to reduce the carbon footprint while streamlining hospital operations.
Orthofix Medical Inc. (NASDAQ: OFIX) has partnered with LimaCorporate S.p.A. to introduce a licensing agreement in the U.S. for a groundbreaking solution targeting chronic high dislocation of the hip. This collaboration combines Orthofix's patented Fitbone™ intramedullary nail system with LimaCorporate's 3D-printed pelvic fixation device, aimed at correcting leg-length discrepancies. Notably, this solution currently lacks FDA clearance and is available only through a Compassionate Use Exemption. The partnership reflects a strategic move to meet unmet medical needs in the orthopedics market.
Orthofix Medical Inc. (NASDAQ:OFIX) announced five-year data from the M6-C artificial cervical disc IDE study, revealing significant benefits over anterior cervical discectomy and fusion (ACDF) in reducing neck disability and pain. Presented at the ISASS annual meeting on June 3, results show a mean Neck Disability Index improvement of 47.5 points for M6-C patients versus 33.4 for ACDF. The M6-C group also reported a low revision surgery rate of 3.1%, indicating strong clinical efficacy. The study aims to continue collecting data, supporting its safety and performance in spinal procedures.
Orthofix Medical Inc. (NASDAQ:OFIX) announced that CEO Jon Serbousek and CFO Doug Rice will present at the UBS Global Healthcare investor conference on May 23, 2022, at 2:45 p.m. ET. The event will be held at the Lotte New York Palace in New York City and will be available for live streaming and replay on the company’s website for up to one year. Orthofix specializes in spinal and orthopedic devices, aiming to enhance patient mobility through innovative solutions distributed in over 60 countries.
Orthofix Medical reported Q1 2022 net sales of $106.4 million, marking a 1% increase year-over-year. The rise was fueled by new product innovations, particularly in Biologics, Spinal Implants, and Orthopedics. Despite facing challenges like COVID-19 and global supply chain issues, the company received FDA approvals for AccelStim and TrueLok™ EVO. The net loss narrowed to $(4.5) million from $(5.8) million in the prior year. Adjusted EBITDA dropped to $7.1 million. For 2022, the company anticipates net sales between $475 million and $490 million, with expected growth in constant currency.
Orthofix Medical Inc. (NASDAQ:OFIX) has received FDA pre-market approval for its AccelStim™ bone healing therapy, a Class III device aimed at treating fresh fractures and nonunions. The AccelStim device employs Low-Intensity Pulsed Ultrasound (LIPUS) to promote natural bone healing. Commercial launch is expected in Q2 2023, targeting a $100 million market for LIPUS solutions. This advancement positions Orthofix as a leader in bone growth stimulation, offering both PEMF and LIPUS devices.
Orthofix Medical Inc (NASDAQ:OFIX) announces the renewal of its exclusive partnership with MTF Biologics, extending marketing rights to the Trinity™ allograft line through 2032. The agreement also includes the development of a new demineralized bone matrix (DBM) under the Legacy™ brand. This aims to enhance Orthofix's portfolio and offers expanded treatment options for patients. The Legacy DBM is expected to be available in Q3 2022. Both companies emphasize their commitment to innovative solutions in orthopedic and spine surgical applications.