Orthofix Announces the Full Commercial Launch of WaveForm A 3D Printed Anterior Lumbar Interbody

The 3D printed WaveForm A interbody for ALIF procedures contains a proprietary wave-like design that gives a stability of energy, porosity and stability, with a big implant graft aperture for bone graft materials.

LEWISVILLE, Texas, June 19, 2023–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a number one world spine and orthopedics firm, at the moment introduced the complete business launch of the WaveForm^® A interbody for Anterior Lumbar Interbody Fusion (ALIF) procedures. The WaveForm A interbody seamlessly integrates with the corporate’s Meridian ALIF system for treating sufferers in want of fusion attributable to degenerative disc illness. The proprietary wave-like design of the WaveForm A interbody offers a stability of energy, porosity and stability, with a big implant graft aperture for bone graft materials to help in creating an osteoinductive setting to optimize supplemental fixation procedures.

“Implant design and floor expertise play an important function within the bone development course of throughout fusion,” mentioned Dr. Neil Arif Tayyab, orthopaedic spine surgeon at Girard Orthopaedic Surgeons, in San Diego, CA. “Newer designs such because the WaveForm A interbody might help stimulate a greater bone development response and provides me better confidence that the affected person may have a profitable fusion.”

The Meridian ALIF system is a modular instrument and implant system designed to assist streamline ALIF procedures by offering various fixation choices for single and multilevel ALIFs in a diminished variety of trays. Meridian is appropriate with each the WaveForm A interbody and the corporate’s Reef^™ A interbody that includes its proprietary NanoMetalene^® floor expertise and Reef Topography^™. With the launch of WaveForm A, the Meridian system can extra utterly deal with the roughly $200 million greenback ALIF market phase within the U.S.¹

The 3D printed WaveForm A implants function WaveForm^® expertise, a repeating and steady wave-like construction. WaveForm was created to resist excessive compressive hundreds whereas delivering an endplate porosity that maximizes the potential for early stabilization^2,3. This stability of energy to porosity presents elevated alternative for bone packing, decreased stiffness profile and enhanced imaging properties.³

“Our Meridian ALIF system integrates essentially the most superior applied sciences into our surgical units, minimizing the necessity for a number of instrument units through the process,” mentioned Kevin Kenny, President of World Backbone. “The WaveForm A interbody is an thrilling addition to our portfolio of options for ALIF procedures and permits us to supply a extra streamlined possibility so surgeons can do extra for his or her sufferers.”

Advancing Care with ALIF

The ALIF market may be segmented by materials into non-3D printed steel, PEEK (normal and titanium-based superior floor applied sciences), 3D printed steel, and machined bone markets. It’s estimated that greater than half of the U.S. ALIF interbody market at the moment is addressed by PEEK units. As a consequence of their medical benefits, 3D printed and superior floor technologies-based interbody units are anticipated to develop sooner than the general interbody market in upcoming years as they take market share from PEEK units, finally resulting in a bigger market share than normal PEEK.⁴

The WaveForm A interbody and the Meridian ALIF system can be found within the U.S. Study extra concerning the Firm’s interbody techniques right here.

¹Market analysis on file. Based mostly off iData Analysis Inc. 2021 numbers.
²Kelly, Cambre N., et al. “Design and construction–operate characterization of 3D printed artificial porous biomaterials for tissue engineering.” Superior healthcare supplies 7.7 (2018): 1701095.
³O. Al-Ketan, R. Rowshan, R.Ok. Abu Al-Rub, Topology-mechanical property relationship of 3D printed strut, skeletal, and sheet primarily based periodic metallic mobile supplies, Addit. Manuf. 19 (2018) 167-183.
⁴Knowledge on file.

About Orthofix

The newly merged Orthofix-SeaSpine group is a number one world spine and orthopedics firm with a complete portfolio of biologics, progressive spinal {hardware}, bone development therapies, specialised orthopedic options and a number one surgical navigation system. Its merchandise are distributed in additional than 68 nations worldwide.

The Firm is headquartered in Lewisville, Texas and has major workplaces in Carlsbad, CA, with a give attention to spine and biologics product innovation and surgeon schooling, and Verona, Italy, with an emphasis on product innovation, manufacturing, and medical schooling for orthopedics. The mixed firm’s world R&D, business and manufacturing footprint additionally contains amenities and workplaces in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Department, MS, Maidenhead, UK, Munich, Germany, Paris, France, and São Paulo, Brazil.

Ahead-Trying Statements

This information launch could embody forward-looking statements throughout the that means of Part 21E of the Securities Trade Act of 1934, as amended, and Part 27A of the Securities Act of 1933, as amended. In some circumstances, you possibly can determine forward-looking statements by terminology equivalent to “could,” “will,” “ought to,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “initiatives,” “intends,” “predicts,” “potential,” “proceed” or different comparable terminology. Orthofix cautions you that statements included on this information launch that aren’t an outline of historic information are forward-looking statements which can be primarily based on the Firm’s present expectations and assumptions. Every forward-looking assertion contained on this information launch is topic to dangers and uncertainties that might trigger precise outcomes to vary materially from these expressed or implied by such assertion. Relevant dangers and uncertainties embody, amongst others: the power of newly launched merchandise to carry out as designed and supposed and to fulfill the wants of surgeons and sufferers, together with because of the dearth of strong medical validation; and the dangers recognized beneath the heading “Danger Components” in Orthofix Medical Inc.’s Annual Report on Type 10-Ok for the fiscal yr ended December 31, 2022, which was filed with the Securities and Trade Fee (SEC) on March 6, 2023. The Firm’s public filings with the Securities and Trade Fee can be found at www.sec.gov. You’re cautioned to not place undue reliance on forward-looking statements, which converse solely as of the date when made. Orthofix doesn’t intend to revise or replace any forward-looking assertion set forth on this information launch to replicate occasions or circumstances arising after the date hereof, besides as could also be required by regulation.