Information contains outcomes from five-year multi-center IDE examine in U.S. of the M6-C disc that additionally demonstrated sturdy medical efficiency, security and affected person advantages.
October 10, 2022
LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a world medical gadget firm with a spine and orthopedics focus, right this moment introduced the presentation of long-term proof highlighting the medical administration of cervical disc arthroplasty throughout the North American Backbone Society (NASS) 2022 annual assembly October 12-15 in Chicago.
“We’re happy to sponsor the presentation of knowledge supporting the medical effectiveness of cervical disc arthroplasty together with five-year information from our U.S. IDE examine,” stated Kevin Kenny, World President of Orthofix Backbone. “We’re honored to have a distinguished surgeon panel that can present their insights about cervical disc alternative and long-term outcomes of this remedy for sufferers affected by degenerative disc illness.”
The presentation might be performed on Wednesday, Oct. 12 at 12:00 pm within the Pink Theater situated within the Exhibit Corridor by Dr. Armen Khachatryan, Dr. Frank Phillips, Dr. Josh Jacobs, Steve Kurtz, Ph.D., and Gunnar Andersson, Ph.D.
Highlights that might be offered embrace:
Information lately launched from a U.S. IDE examine displaying that the M6-C™ disc produced statistically important advantages at 5 years, together with:
discount in incapacity, with an NDI rating of 8.0 – which signifies delicate incapacity in comparison with 18.0 within the anterior cervical discectomy and fusion (ACDF) group
discount in shoulder/arm ache VAS rating of 0.5 – which was considerably higher than the imply of two.1 noticed within the ACDF group
one of many lowest subsequent surgical intervention charges at 3.1 % for the M6-C disc as in comparison with different FDA-approved synthetic cervical discs
Mechanisms of Failure in Bone Ingrowth and Biologic Fixation
Proposed Taxonomy and Classification of Bone reworking in Cervical Disc Alternative (CDR)
Advice for long-term Scientific Administration of CDR
Classes Discovered from synthetic joint Hip and Knee Replacements: Implant efficiency and bone reworking
The M6‑C synthetic cervical disc is designed to take care of the pure habits of a practical spinal unit by replicating the biomechanical traits of the native disc. The disc was first commercialized outdoors of the USA in 2006 and was authorised by the U.S. Food and Drug Administration in 2019. Thus far, greater than 70,000 M6-C discs have been implanted in over 20 international locations, with 20 % of those discs having been implanted for greater than 10 years. The M6-C disc has a 0.7 % worldwide grievance charge for all M6-C discs implanted up to now.
Outcomes of a Kaplan Meier evaluation of the M6-C synthetic cervical disc based mostly on 16 years of real-world proof recommend a world cumulative survivorship (proportion of implanted gadgets which are nonetheless intact and practical at a particular time interval) of 99% at 10 years, in step with different, confirmed, joint-arthroplasty gadgets akin to hip and knee replacements.
To be taught extra concerning the M6-C disc and the complete portfolio of Orthofix options, please go to us at NASS at sales space #2416. View our M6-C interactive expertise right here.
Orthofix Medical Inc. is a world medical gadget firm with a spine and orthopedics focus. The Firm’s mission is to ship revolutionary, 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 international locations through the Firm’s gross sales representatives and distributors. For extra info, please go to www.Orthofix.com.
This communication incorporates forward-looking statements throughout the which means of Part 21E of the Securities Trade 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 instances, you possibly can determine forward-looking statements by terminology akin to “could,” “will,” “ought to,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “tasks,” “intends,” “predicts,” “potential,” or “proceed” or different comparable terminology. These forward-looking statements are usually not ensures of our future efficiency and contain dangers, uncertainties, estimates and assumptions which are tough to foretell, together with the dangers described in Half I, Merchandise 1A beneath the heading Danger Components in our Annual Report on Kind 10-Ok for the 12 months ended December 31, 2021 (the “2021 Kind 10-Ok”). Along with the dangers described there, components that would trigger or contribute to such variations could embrace, however are usually not restricted to: the chance that FDA approvals could also be delayed or not be obtained; the chance that surgeons could also be sluggish to undertake the M6-C synthetic cervical disc; the chance that future affected person research or medical expertise and information could point out that therapy with the M6-C synthetic cervical disc doesn’t enhance affected person outcomes as a lot as beforehand believed, or in any other case name into query the advantages of its use to sufferers, hospitals and surgeons; the chance that the product could not carry out as meant and should subsequently not obtain business success; the chance that rivals could develop superior merchandise or could have a larger market place enabling extra profitable commercialization; the chance that insurance coverage payers could decline to reimburse healthcare suppliers for using our merchandise.
This checklist of dangers, uncertainties and different components is just not full. We focus on a few of these issues extra totally, in addition to sure threat components 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 could turn into unsuitable (because of inaccurate assumptions that we make or in any other case), and our precise outcomes and outcomes could 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, except it’s particularly in any other case said to be made as of a special 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.
Alexa Huerta Investor Relations Tel 214 937 3190 firstname.lastname@example.org
Denise Landry Media Relations Tel 214 937 2529 email@example.com