Orthofix M6 Artificial Disc

The M6-C™ artificial cervical disc is an innovative next-generation option for people needing artificial disc replacement as an alternative to spinal fusion. This unique product is designed to mimic your natural disc’s structure and movement.

To learn more about the M6-C disc, visit our patient website at https://ow.ly/etq150RpsO0.

Post-Spine Summit update: Our presentation with Domagoj Coric, MD* on the"7-year Outcomes for Single-Level Total Disc Replacement with a Novel Viscoelastic Artificial Cervical Disc" and the M6-C™ Artificial Cervical Disc was a success!

Many attended to learn more about the M6-C, a next-generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration and designed to restore motion to the spine -- and an alternative to cervical fusion.

But ICYMI, Dr. Coric shared 7-year data showing that the M6-C disc produced statistically significant benefits, including:

🌟 Retained decreases in disability
🌟 Reduction in shoulder/arm pain and
🌟 One of the lowest subsequent surgical intervention rates as compared to other FDA-approved artificial cervical discs

Stay tuned for more updates as we follow up on those studied through ten years post-op!

Save the Date! 📢 Join us at Spine Summit 2024 on Friday, February 23, for an enlightening presentation by neurosurgical spine surgeon Domagoj Coric, MD*!

Don't miss the abstract "7-year Outcomes for Single-Level Total Disc Replacement with a Novel Viscoelastic Artificial Cervical Disc" presented at Session: (AB-4) Specialty Breakout 1: Minimally Invasive/Motion Preservation/General Spine Abstracts from 7:30 - 9:00 a.m. and discover the M6-C™ Artificial Cervical Disc's long-term benefits.

Plus, stop by our booth, 322, to learn more about this innovative technology designed to mimic the structure and movement of a natural disc.



*Paid consultant of Orthofix/SeaSpine

Today, we announced the publication of the five-year results from the U.S. clinical study comparing the M6-C™ artificial cervical disc with anterior cervical discectomy and fusion (ACDF).

Published in The Spine Journal, the study evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to ACDF for the treatment of single-level symptomatic cervical radiculopathy with or without cord compression. The study found that patients treated with the M6-C disc demonstrated superior clinical success at 60 months compared to ACDF patients. Secondary findings indicated significant improvements in neck and arm pain, function, and quality of life scores.

This publication coincides with reaching the milestone of more than 100,000 implantations of the M6-C artificial cervical disc and the M6-L artificial lumbar disc (only available outside the U.S.) performed worldwide since the product’s introduction in 2006.

“To date, there have been more than 100,000 implantations of M6 artificial disc technology in 20 countries around the world,” said Kevin Kenny, President of Orthofix Global Spine. “We are proud of this life-changing technology that has helped so many people get back to enjoying their lives.”

The M6-C artificial cervical disc is a next-generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration and designed to restore motion to the spine and is an alternative to cervical fusion.

To learn more, read the press release below.

Orthofix Medical Inc. - Orthofix Announces Publication in The Spine Journal of Five-Year Data for the M6-C Artificial Cervical Disc With more than 100,000 implantations worldwide, the M6-C and M6-L discs continue to demonstrate strong clinical performance, safety and patient benefits

Vertebral discs are the unsung heroes of our spine, providing us with flexibility and movement. However, they can degenerate over time, causing pain and reduced mobility.

To learn more about disc replacement and if it could be a solution for you, visit our blog on our M6-C Disc patient website at https://m6disc.com/blog/.

The M6-C artificial disc continues to value the importance of patient-focused and proven results, as demonstrated by the results of the Kaplan-Meier analysis based on 16 years of real-world evidence.

Visit https://m6disc.com/m6-c-us-ide-5-year-results-and-evidence/ for more clinical data.

While fighting a house fire, the roof collapsed and almost ended Randy's firefighting career. “It’s very rewarding that I’m getting the opportunity again to go out and do what I love — be a firefighter and serve my community.” – Randy, firefighter and a M6-C™ disc patient

Read more about Randy's experience at https://m6disc.com/patient/.

What is degenerative disc disease? The degeneration of a disc typically occurs as a natural part of the aging process but can be accelerated by other factors like lifestyle choices and injury.

To learn more, visit www.m6disc.com/blog.

In case you missed it… Seven-year IDE Data was presented at this year's International Society for the Advancement of Spine Surgery (ISASS) Annual Meeting in June. Evidence from the U.S. IDE clinical trial continues to demonstrate the safety and efficacy of the M6-C Artificial Cervical Disc.

Learn more about the data presented at https://ir.orthofix.com/press-releases/news-details/2023/Orthofix-Announces-First-Presentation-of-Seven-Year-Outcome-Data-for-the-M6-C-Artificial-Cervical-Disc-With-Other-Clinical-and-Scientific-Abstracts-at-the-ISASS-Annual-Meeting/default.aspx

The M6-C™ artificial cervical disc is a unique product designed to mimic your spine’s natural disc structure and movement, including all six degrees of freedom: lateral bending, lateral translation, anterior/posterior translation, flexion/extension, axial compression, and axial rotation. In addition, the M6-C disc is the only disc designed with a gel nucleus and fiber annulus that replicates the controlled range of movement and cushioning effect of the natural disc.

Visit https://www.m6disc.com/ to learn more.

After his neck injury, professional surfer Koa Rothman was warned by his spine surgeons that he needed to have surgery, or he would have to quit surfing. Koa considered his options and then chose to have an artificial cervical disc replacement procedure.

“The M6 disc definitely changed my life. I’m surfing again. I’m just looking for the next big wave. And I honestly am just enjoying life feeling normal and pain free.” – Koa, professional surfer and an M6-C™ disc patient.

Visit https://orthofix.com/patients/patient-stories/koa/ to see Koa's story.

-C

Today, Thursday, March 30, is National Doctors’ Day! We honor all doctors, surgeons, and medical professionals for their dedication, compassion, and contributions in the fight against disease and illness.

We say a special “thank you” to the many physicians we work with for always putting the health and well-being of their patients and communities first. We are proud to partner with the health care community in improving the lives of patients around the world. Happy National Doctors' Day!

This past Saturday was a great day to help our neighbors! The Orthofix team from our headquarters in Lewisville, TX, was happy to lend a hand to senior and disabled homeowners who need help with repairs and some fresh paint during the City’s For the Love of Lewisville community service project event.

We are proud to come together and make a difference in the health, wellness, and future of the communities where we live and work!

We are pleased to announce that Orthofix is merging with SeaSpine to create a leading spine and orthopedics company.

This transaction significantly advances our mission to deliver innovative, quality-driven solutions that make us a partner of choice for surgeons in their work to improve patient mobility.

The combined company will have highly complementary portfolios of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. With products distributed in 68 countries, approximately 1,600 employees and a global R&D and manufacturing footprint.

We are excited about the value we can create for the combined company’s shareholders, the new opportunities opened for employees, and our ability to now provide surgeons and hospital partners a more comprehensive procedural solution using cutting-edge technology at every level.

To learn more, visit https://ir.orthofix.com/press-releases/news-details/2022/Orthofix-and-SeaSpine-to-Combine-in-Merger-of-Equals-to-Create-Leading-Global-Spine-and-Orthopedics-Company/default.aspx

Orthofix and SeaSpine to Combine in Merger of Equals to Create Leading Global Spine and Orthopedics Company Highly complementary spine and orthopedics portfolios One of the industry’s broadest biologics and regenerative technology offerings Differentiated and synergistic enabling technologies Meaningful cross-selling revenue synergies and cost savings Financial strength to pursue growth investments with...

After a neck injury, professional surfer Koa Rothman was warned by his spine surgeons that he needed to have surgery or he would have to quit surfing. Koa considered his options and then chose to have an artificial cervical disc replacement procedure. Watch Koa’s video, https://m6disc.com/patient, and see how the M6-C disc helped Koa get back on his board and start looking for the next big wave. As Koa says, “The M6 disc definitely changed my life.”

The M6-C™ Artificial Cervical Disc is designed to mimic the structure and movement of a natural disc. Learn more at M6Disc.com.

Thank you to all who attended the presentation of clinical trial data at ISASS from Dr. Frank Phillips, Professor of Orthopedic Surgery at Rush University Medical Center and an investigator in the five-year IDE U.S. study of the M6-C™ artificial cervical disc as well as that of Dr. Avinash Patwardhan’s analysis of the clinical data, regarding the likelihood of achieving physiological range of motion after cervical disc arthroplasty.

At Orthofix, we’re committed to developing new products in all areas of our business, and we do this through Investigational Device Exemption Studies (IDEs), as well as post-approval and post-market studies. IDE studies are used to bring new products or existing products with new indications to market. Post-market studies allow us to further evaluate a product, like the M6-C, and examine its effectiveness in a real-world setting with this in mind: improving patients’ lives by providing superior solutions to physicians worldwide.

Learn more at M6disc.com or Orthofix.com

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Orthofix hosted a breakfast workshop this morning at the ISASS: ISASS: The International Society for Advancement of Spine Surgery Conference, featuring a surgeon panel speaking on the long-term evidence, bony changes, and clinical management of cervical disc arthroplasty.

Thank you Drs. Gunnar Andersson, Josh Jacobs, Armen Khachatryan, Steve Kurtz, Todd Lanman, Carl Lauryssen and Frank Phillips for sharing their knowledge and experience with surgeons looking to add the M6-C™ artificial cervical disc and cervical approach to their options for treating degenerative conditions and our shared efforts in changing patient lives.

At a session earlier this afternoon from the ISASS Conference Dr. Avinash Patwardhan, Director of the Musculoskeletal Biomechanics Laboratory at Edward Hines Jr. VA Hospital, shared further analysis of five-year clinical IDE U.S. study data of the M6-C™ artificial cervical disc.

This research aimed to calculate what proportion of reconstructed disc segments yield flexion-extension in the physiological motion range by analyzing 24-month postoperative data reported from clinical trials of various cervical disc prostheses. On average, two-thirds of implanted segments in this cohort achieved two-year post-cervical disc arthroplasty in the 5–16-degree range, meeting the functional goals of mobility and stability after Cervical Disc Arthroplasty (CDA).

“The M6-C disc with its inherent stiffness due to the nucleus-annulus design yielded the highest proportion (103/131 or 79 percent) of implanted segments in the physiological motion range compared to the cohort average of 65.8 percent. These results support the functional goals of CDA which are restoring range of motion and reducing the risk of accelerated adjacent segment degeneration.”

Learn more at M6Disc.com

At the five-year endpoint, a U.S. IDE clinical trial study reveals that the M6-C™ artificial cervical disc continues to have one of the lowest subsequent surgical intervention rates at 3.1% when compared to other FDA-approved artificial cervical discs, demonstrating safety and efficiency compared to anterior cervical discectomy and fusion (ACDF) as the standard of care.

Learn more at M6Disc.com

Millions of people around the world suffer from cervical disc degeneration, resulting in chronic pain of the neck, shoulders, arms, and hands. The M6-C™ artificial cervical disc offers an innovative non-fusion solution in treating degeneration of the cervical disc and the results of a five-year U.S. IDE study indicate
significant benefits were observed in shoulder/arm pain Visual Analog Scale scores at five years for M6-C disc study patients compared to anterior cervical discectomy and fusion (ACDF) participants. In addition, 9 out of 10 M6-C patients reported improvement in neck pain.

Learn more at M6Disc.com

The M6-C™ artificial cervical disc offers an innovative non-fusion solution for treating cervical disc degeneration. The M6-C device is the only artificial cervical disc that mimics the structure and movement of a natural disc. With its unique design, the M6-C disc is the natural choice over spinal fusion (ACDF), and the results of the five-year U.S. IDE clinical trial study demonstrate the safety and efficacy of the M6-C artificial cervical disc.

“We are pleased to see that at five years post-op, participants in the study who received the M6-C artificial cervical disc continue to show significant benefits in Neck Disability Index scores and neck and shoulder/arm pain Visual Analog Scale scores compared to patients who received anterior cervical discectomy and fusion (ACDF),” said Dr. Frank Phillips, Professor of Orthopedic Surgery at Rush University Medical Center and an investigator in the study. He will present the data at the ISASS: The International Society for Advancement of Spine Surgery Conference on Friday, June 3.

Learn more at M6Disc.com

Orthofix today announced the upcoming presentation and results of the M6-C artificial cervical disc U.S. IDE study ahead of the 22nd Annual Meeting of ISASS: The International Society for Advancement of Spine Surgery Conference held in the Bahamas, June 1-4. The five-year study shows retention of statistically significant benefits at five years. Additionally, analysis of two-year physiological range of motion data from multiple artificial cervical disc IDE studies has shown benefits of the nucleus-annulus design of the M6-C disc.

“We continue to be pleased with the U.S. IDE clinical data that now includes five-year outcomes,” said Orthofix President of Global Spine Kevin Kenny. “We recognize the importance of continuously collecting data from the U.S. study and from implanting centers around the globe to expand the body of evidence that supports the clinical performance and safety of the M6-C artificial cervical disc, and we look forward to the ongoing dissemination and publication of that data.”

Read the full press release here: https://ir.orthofix.com/press-releases/news-details/2022/Orthofix-M6-C-Artificial-Cervical-Disc-IDE-Study-Data-to-be-Presented-at-ISASS-Demonstrates-Continued-Statistically-Significant-Benefits-at-Five-Years/default.aspx

Orthofix M6-C Artificial Cervical Disc IDE Study Data to be Presented at ISASS Demonstrates Continued Statistically Significant Benefits at Five Years Additionally, analysis of two-year physiological range of motion data from multiple artificial cervical disc IDE studies to be presented showing benefits of the nucleus-annulus design of the M 6-C disc Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics....

The only FDA-approved artificial cervical disc designed to mimic the natural motion of a native cervical disc with six degrees of motion and with more than 60,000 discs implanted in over 20 countries since 2006, 12,000 having been implanted for more than ten years, Orthofix has even more clinical data to share about the M6-C™ as we head to the 2022 ISASS: The International Society for Advancement of Spine Surgery Conference this week. Stay tuned for the results of a five-year U.S. IDE study.

To learn more about M6, visit M6Disc.com.

In more patient-focused, proven results: a Kaplan Meier analysis based on 16 years of implantation of the M6-C™ artificial cervical disc shows an overall global device survivorship of 99%, consistent with other proven joint-arthroplasty devices such as hip and knee replacements.

Orthofix is collecting data from implanting centers around the globe that have received the M6-C artificial cervical disc as we continue to monitor the clinical performance and safety of the device. We continue to be pleased with the real-world evidence and look forward to sharing U.S. IDE clinical data that includes five-year outcomes next week ahead of the 2022 ISASS: The International Society for Advancement of Spine Surgery Conference.

Millions of people around the world suffer from cervical disc degeneration. The M6-C™ artificial cervical disc offers an innovative non-fusion solution for treating cervical disc degeneration. The M6-C device is the only artificial cervical disc that mimics the structure and movement of a natural disc.

While we’re attending the Spine Society of Australia Annual Scientific Meeting this weekend, let us share two pieces of data about the M6-C. To date, more than 60,000 patients worldwide have received the M6-C disc, and in Australia specifically, the M6-C is the number one implanted cervical disc and the most studied in the Australian Orthopedic Association Joint Replacement Registry.

Will you be at ISASS in the Bahamas next week? Join us at the Orthofix hosted Breakfast Workshop! RSVP to [email protected]

Don’t miss Dr. Avinash Patwardhan present on IDE Clinical Trial Data for the M6-C disc next week at ISASS! Visit us at Booth #400!