Orthofix Announces Publication of Data Demonstrating the Clinical Benefits of Trinity Elite Cellular Bone Allograft in Lumbar Fusion Procedures

LEWISVILLE, TEXAS, December 22, 2022 –(BUSINESS WIRE)– Orthofix Medical Inc. (NASDAQ:OFIX), a worldwide medical gadget firm with a spine and orthopedics focus, at present introduced outcomes from a potential, multicenter medical research evaluating the protection and efficacy of the Trinity Elite^™ mobile bone allograft (CBA) in lumbar spinal fusion procedures. Revealed in Neurology Worldwide, sufferers handled with the Trinity Elite CBA demonstrated fusion charges of 98.6 p.c, measured by bridging bone at 12 months follow-up.

“The 12-month knowledge present that sufferers handled with the Trinity Elite allograft achieved a excessive price of profitable fusion and vital enhancements in ODI and VAS scores,” stated Dr. Joshua Wind, neurosurgeon at Sibley Memorial Hospital and lead writer of the journal article. “Moreover, these excessive fusion charges had been noticed in topics reporting single and a number of threat elements for pseudoarthrosis. The findings from this research present additional proof for using mobile bone allografts as efficient bone graft substitutes in lumbar spinal fusion.”

On this potential, multicenter, open-label medical research, the Trinity Elite allograft was evaluated in topics present process posterolateral fusion (1-4 ranges) or interbody fusion (1-2 ranges) with CBA. Topic threat elements included smoking, diabetes, weight problems, and osteoporosis. A complete of 274 topics had been enrolled within the research, with out there knowledge from 201 topics who accomplished the 12-month follow-up. Radiographic fusion standing was assessed by an unbiased evaluation of dynamic radiographs and CT scans. Scientific final result measures included the Oswestry Incapacity Index (ODI) and visible analogue scale (VAS) for again and leg ache. At 12 months, 98.6 p.c fusion was assessed by the presence of bridging bone on thin-cut CT scans.

“We’re happy to proceed to put money into medical analysis and supply physicians the data they should make the perfect choices for his or her sufferers,” stated Orthofix President of International Backbone Kevin Kenny. “The outcomes of this publication help Trinity Elite as a secure and efficacious different to autograft for sufferers present process lumbar fusion procedures and show the compelling advantages of this mobile bone allograft. Trinity Elite is a key instance of our dedication to ship evidence-based, quality-driven options that may enhance sufferers’ lives.”

Trinity Elite is a cryopreserved CBA from allograft donor bone that facilitates bone formation by offering an osteoconductive scaffold, inherent osteoinductive development elements and osteogenic cells. Trinity Elite eliminates the necessity for harvesting autograft from sufferers, which reduces working time and expense in addition to discomfort and potential problems. Processed by MTF Biologics, a nonprofit group devoted to offering high quality tissue, Trinity Elite is a moldable bone graft materials that permits physicians to simply management the position of tissue throughout procedures.

About Orthofix

Orthofix Medical Inc. is a worldwide medical gadget firm with a spine and orthopedics focus. The Firm’s mission is to ship modern, quality-driven options whereas partnering with well being care professionals to enhance affected person mobility. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedics merchandise are distributed in additional than 60 nations by way of the Firm’s gross sales representatives and distributors. For extra info, please go to www.Orthofix.com.

About MTF Biologics

MTF Biologics is a worldwide nonprofit group that saves and heals lives by honoring donated items, serving sufferers and advancing science. They supply unmatched service, sources, and experience to donors and their family members who give the present of donation, individuals who depend upon tissue and organ transplants, healthcare suppliers, and clinicians and scientists.

The Worldwide Institute for the Development of Drugs (IIAM), a Division of MTF Biologics, honors donors of non-transplantable organs by offering their items to the medical analysis neighborhood to fight and treatment ailments. Statline, additionally a Division of MTF Biologics, gives specialised communications and know-how experience to organ, tissue, and eye procurement organizations, in addition to the hospitals and sufferers that they serve. Its sister group, Deutsches Institute for Zell-und Gewebeersatz – DIZG (The German Institute for Cell and Tissue Transplantation), expands its attain to sufferers throughout the globe. For extra info, go to www.mtfbiologics.org.

Ahead-Wanting Statements

This communication comprises forward-looking statements inside the that means of Part 21E of the Securities Change Act of 1934, as amended, and Part 27A of the Securities Act of 1933, as amended, referring to our enterprise and monetary outlook, that are based mostly on our present beliefs, assumptions, expectations, estimates, forecasts and projections. In some circumstances, you possibly can establish forward-looking statements by terminology comparable to “might,” “will,” “ought to,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “tasks,” “intends,” “predicts,” “potential,” or “proceed” or different comparable terminology. These forward-looking statements should not ensures of our future efficiency and contain dangers, uncertainties, estimates and assumptions which can be tough to foretell, together with the dangers described in Half I, Merchandise 1A underneath the heading Threat Components in our Annual Report on Kind 10-Ok for the yr ended December 31, 2021 (the “2021 Kind 10-Ok”). Along with the dangers described there, elements that would trigger or contribute to such variations might embrace, however should not restricted to: the danger that surgeons could also be gradual to undertake the Trinity Elite mobile bone allograft; the danger that future affected person research or medical expertise and knowledge might point out that therapy with the Trinity Elite mobile bone allograft doesn’t enhance affected person outcomes as a lot as beforehand believed, or in any other case name into query the advantages of using these merchandise to sufferers, hospitals and surgeons; the danger that the merchandise might not carry out as meant and will subsequently not proceed or obtain business success; the danger that opponents might develop superior merchandise or might have a larger market place enabling extra profitable commercialization; the danger that insurance coverage payers might decline to reimburse healthcare suppliers for using our merchandise.

This checklist of dangers, uncertainties and different elements will not be full. We focus on a few of these issues extra absolutely, in addition to sure threat elements that would have an effect on our enterprise, monetary situation, outcomes of operations, and prospects, in experiences we file from time-to-time with the SEC, which can be found to learn at www.sec.gov. All or any forward-looking statements that we make might turn into unsuitable (as a result of inaccurate assumptions that we make or in any other case), and our precise outcomes and outcomes might differ materially from these expressed in these forward-looking statements. You shouldn’t place undue reliance on any of those forward-looking statements. Additional, any forward-looking assertion speaks solely as of the date hereof, until it’s particularly in any other case acknowledged to be made as of a unique date. We undertake no obligation to replace, and expressly disclaim any responsibility to replace, our forward-looking statements, whether or not because of circumstances or occasions that come up after the date hereof, new info, or in any other case.