Innovation

How We're Improving the Way We Showcase Our Product at SpineFrontier

Why We Value the Way We Showcase Our Products

We’re celebrating an improved product showcase and education space.

At SpineFrontier we’re always looking to improve. In 2016 we did that in a big way by relocating to our new office space in Malden, Mass. We’re closer to Boston, have a bigger lab, a bigger workshop, we’re a short drive to our manufacturing partner to facilitate in-person collaboration and we have much more room to grow in the company. With new space came empty walls and hallways, which we saw as opportunities to showcase our strengths and educate both internally and externally about our product.

Our walls speak for the company and to the company. This is one of the largest mechanisms for sharing information and engaging the team. These shouldn’t be static and dull, but ever-changing, informative and exciting.

Display Stand Development

How We're Improving the Way We Showcase Our Product at SpineFrontier

We went into this project knowing we needed to elevate our implants. Our team brainstormed multiple times to conceptualize a platform that could be modular enough to work for each system, whether it involve screws, interbodies or plates. After lots of configuring, model making and testing fit, we found a system that would be able to highlight our implants in the variety of environments that they would live. Each placard would be able to show the implant placement in situ – within a disc space or between spinous processes – while still showing the size range offered and an actual implant that could be removed for closer inspection.

We created the series of demo sets not just for the visiting surgeons, but for the employees. We believe we should be surrounded by the products we created and are so proud of. Sharing our product with people from other teams spreads excitement and awareness of the value we create for surgeons and the patients. We designed these displays to accentuate our implants – the size range, materials and companion products. highlighting their design, functionality and the ingenuity that went into their development.

Our team has attended many events since the completion of the plaques, which has given us an opportunity to take these displays on the road and showcase our work to surgeons at national spine conferences.

We look forward to connecting with those interested in our operation. Schedule a VIP Tour with us to learn more about our Less Exposure Surgery Technologies and Techniques by calling our office at 978 232 3990.

Surgeons, this New SpineFrontier Initiative Could Help You and Your Practice

Surgeons, This New 7 Steps SpineFrontier Initiative Could Help You and Your Practice

The Purpose Behind the 7 Steps of Surgeon Onboarding

SpineFrontier has unrolled a new initiative in customer support called the 7 Steps of Surgeon Onboarding. The 7 Steps are one of the tools the SpineFrontier sales and customer support teams hope will help acquaint surgeons with the many opportunities for industry support and involvement available through the SpineFrontier and KICVentures ecosystem.

The purpose behind the 7 Steps isn’t complicated – it’s not even that earth-shattering – it’s mostly about building and maintaining relationships. But, as anyone knows, a purpose as fundamental and basic as relationship-building can also be one of the hardest things to do well. Thus, the SpineFrontier Sales team decided to implement the 7 Steps of Surgeon Onboarding as an internal structure to help SpineFrontier team members do a difficult job well.

The basic premise of the initiative is this: SpineFrontier engineers, executives, reps, sales people, (basically any SpineFrontier employee’s) first goal is to understand each surgeon’s needs on an individual basis. This has, historically, been one of SpineFrontier’s greatest strengths – something that has differentiated it from the larger, faceless, medical device companies. SpineFrontier team members know their surgeons on a personal level. This level of relationship drives them to ask the most human questions. “Who is this surgeon? What gets her up in the morning? What is she passionate about? What makes her so good? Where does she want to go? How can I help her get there?”

The next step is to help surgeons understand SpineFrontier: “Does this surgeon know all the ways we can support her?” Helping each surgeon understand the opportunities available to them at SpineFrontier is the harder part. Because SpineFrontier is nimble, creative, and surgeon-led –these opportunities are often more plentiful and diverse than a surgeon-customer might imagine, and they are tailored differently to each person.

For instance, SpineFrontier has always offered the traditional opportunities for surgeons to work on product development and innovation, but it’s also provided less traditional opportunities of supporting surgeons in business strategy for opening hospitals or surgery centers. SpineFrontier has created research opportunities for surgeons wanting to contribute to a particular research topic. It’s partnered with other surgeons to develop overseas, opportunities for medical philanthropy. Its supported surgeons in creating personalized, compelling marketing materials. It’s facilitated surgeons involvement at teaching and speaking events. The opportunities are as diverse as the customers themselves – something that the 7 Steps of Surgeon Onboarding is meant to help SpineFrontier team members communicate to their surgeons.

The final steps of the initiative hinge on documenting and planning professional milestones with each surgeon (this entails a one year plan, and a five year plan outline of what a surgeon hopes to accomplish) and brainstorming how the SpineFrontier team can specifically support them in achieving these goals. The final steps also focus on helping each surgeon execute his or her milestones while providing ongoing support from SpineFrontier.

Ultimately, the 7 Steps of Surgeon Onboarding is a tool of support and structure in pursuit of the most basic, and hardest of goals: fostering genuine relationships and reinforcing the personal and professional pursuits of those focused on better serving patients. At the end of the day, this is what SpineFrontier is: an enterprise of bettering people’s lives by investing in surgeons and patients.

SpineFrontier and AxioMed recapturing the promise of total disc replacement

Recapturing the Promise of Total Disc Replacement

The story of the AxioMed Freedom® Disc is the story about a next-generation technology that has been developed for over a decade with the enormous hope of providing a solution for back pain. But as AxioMed developed and perfected its disc, the events of the total disc replacement (TDR) world swirled around it. Nothing can be understood apart from its context and that’s why AxioMed’s story is inevitably bound up in the story of the spine industry more broadly.

AxioMed believes its Freedom Disc’s design is a resoundingly solid answer to the questions patients and doctors have about total disc replacement in general. But how did those questions come to be such disquieting figures on the landscape of the spine industry? What happened to the promise of total disc replacement nearly a decade ago? Why did the excitement and intensity surrounding the idea that doctors, researchers and engineers could actually do something new and better in spine treatment dissolve?  To understand why AxioMed believes its disc is about to change the landscape of TDR, it’s important to first understand the context into which it bursts onto the scene.

In 2004, the DuPuy Charite™ Disc was led forth on the medical device market with high expectations as the first total disc replacement to be approved in the U.S. Many believed this would be the ultimate solution for degenerative disc disease (DDD) which is one of the most common causes of back pain –an ailment that plagues over 100 million adults in the U.S.[1]

The standard treatment for DDD was much the same in 2004 as it is today: spinal fusion.  Spinal fusion attempts to lessen the pain of a degenerated disc by fixating two or more vertebrae together to keep them from moving.  Unfortunately, the immobility achieved by fusion eliminates the natural motion with which the spine is intended to function. Fusion can also place extra stress on the surrounding vertebrae, hastening spinal degeneration in those segments as well.[2]

“The ability to replace discs could open up a new era in back treatment.”

As one might imagine, the promise of a total disc replacement that would treat DDD and also allow the spine to keep its movement was wildly attractive in 2004. The DuPuy marketing machine took advantage of their position as the first FDA-cleared total disc replacement technology in the U.S., and ramped up a considerable marketing effort that gained significant media coverage. [3] One writer in the Wall Street Journal predicted, “The ability to replace discs could open up a new era in back treatment,” but also ominously noted that the Charite’s implant’s long-term durability remained to be proven.[4]

After two years, the Charite Disc had failed rather spectacularly across national headlines. Lawsuits piled up and the tides turned against the Charite.  Dr. McAfee wrote about the theoretical disadvantages of the Charite: “Since artificial hips and knees were introduced in the 1960s, doctors have explored the idea of prosthetic replacements for damaged or degenerated intervertebral discs. The disc is a very complicated joint, so the engineering challenge to partially or fully replace a disc is considerable. Also, because disc injury is a common cause of back pain in younger adults (age 30 to 50), an artificial disc needs to be designed to last for decades.”[5]

New total disc replacements with different designs received FDA approval and entered the arena. But the excitement about TDR’s had wavered –not just because of Charite device failures, but also because it was difficult for doctors and patients to obtain insurance reimbursement for a TDR procedure.

Kari Zimmers, Sr. VP of Research and Development of AxioMed says, “One part of the story of total disc replacement is that no one queued up reimbursement as the first disc, Charite, was being approved for the U.S. market. This heavily impacted sales for Charite and the discs to follow.”

The small army of doctors excited to learn the newest and greatest total disc replacement treatment backed off until they could see long-term evidence of total disc replacement’s legitimacy and better insurance reimbursement. The bubble of total disc replacement was popped, leaving in its place a lingering attitude of skepticism that would become one of TDR’s greatest future opponents.

It’s been over ten years since Charite and other total disc replacements came out, and TDR treatments are starting to show long-term clinical results. From these studies, a few things about total disc replacement have become clear. Several clinical studies for cervical TDR’s have shown positive results. They indicate that TDR’s are at least as effective as fusion, and on certain points, statistically superior to fusion.[6]

Studies are showing that in the long run disc replacement is less expensive than fusion –an important point for those hoping that TDR’s can gain better reimbursement. A study in the June issue of Journal of Neurosurgery: Spine calculated the cost per quality-adjusted life year (the estimated cost of money associated with a medical intervention) for cervical disc replacement was $3,042, versus $8,760 for anterior cervical discectomy and fusion (ACDF)[7].  Another study in the peer-reviewed JAMA Surgery, showed that a two-level Mobi-C® Cervical Disc procedure was more cost-effective than performing a two-level ACDF.[8] Industry insiders are hopeful these results will underscore the value of TDR’s.

Lamenting the lingering skepticism about TDR’s in the face of sound clinical proof, Neel Anand, MD, Clinical Professor of Surgery and Director of Spine Trauma at Cedars-Sinai Spine Center in Los Angeles tells Becker’s Spine Review, “There has not been a single product in the history of orthopedics that has been studied as much as disc replacement or has more scientific data, cost analysis, radiographic outcomes and is still questioned by some in healthcare.“[9]

Although the long-term studies about total disc replacement are encouraging, existing designs have not yet been perfected. One of the major reasons total disc replacement suffered a setback is because early discs were designed as ball and socket joints, similar to the devices used for hip and knee replacements. These designs didn’t provide the right amount of motion and flexibility because the human disc is not a ball and socket joint, but is compressible and made of over 75% water.

This is where the strength of AxioMed’s disc design shines. The AxioMed Freedom Disc is a single-piece technology made of proprietary polymer that is permanently bonded between two titanium plates.  The polymer has viscoelastic qualities, meaning that it possesses the flexibility and stiffness similar to a normal human disc. AxioMed has an exclusive license on the polymer.  The Freedom Disc has been shown to respond to loading the way a human spine does and tests show it can stand the wear of decades of use.[10] Ultimately, the disc restores the stability, cushioning and three dimensional movement of a healthy, human disc.

For Kingsley R. Chin, the CEO of KICVentures and AxioMed, and a practicing orthopedic spine surgeon the history of AxioMed is an important link. KICVentures acquired AxioMed in 2014. The AxioMed Corporation was started in 2001 by a number of key surgeons, thinkers and engineers who used to work with Art Steffee on the AcroFlex Disc.  Art Steffee was one of the most prominent spine surgeons, entrepreneurs and innovators in the ‘80’s and ‘90’s.[11] AxioMed was a continuation of his work on TDR’s with the intent of solving the problems posed by the AcroFlex disc.

“The Acroflex Disc was one of the first viscoelastic discs, and that’s a true disc replacement,” says Dr. Chin. “If you look at the disc replacements on the market today, these are not real disc replacements. These are really multi-piece devices that move. They are ball and socket joints. The normal human disc is not a joint –it doesn’t move around –rather it acts as a shock absorber, compressing in multiple planes. The AxioMed technology that was developed since 2001 is now a true disc replacement, and it’s exciting to have a technology like this in spine.  In orthopedics we have knee, hip and shoulder replacements, and these are real joints and those technologies change lives and improve the quality of life. In spine, we did not have that before the AxioMed Freedom Disc. We had technologies that fuse the spine –screws and rods and bone graft that limit motion. Now with the AxioMed viscoelastic disc, we have a true opportunity to replace someone’s diseased disc and preserve motion. No more fusion and no excessive motion from ball and socket joints that may over time loosen or shed debris and create all kinds of problems.”

“It’s very important to us that this technology works to the highest standard,” says Dr. Chin.

Over the past 14 years, over $80 million has been spent by AxioMed to develop the Freedom Disc technology. Much of that money went toward making sure that the materials and amount of shock absorption were right and that the material was biocompatible. “It’s very important to us that this technology works to the highest standard,” says Dr. Chin. “We’ve done testing on this disc to show that if it is in the body for decades, it still functions as if you just put it in.”[12]

European studies published in peer-reviewed medical journals about the AxioMed Disc are backing up the talk with clinical results. In the EU there have been no device failures noted in the clinical literature for either the Freedom Cervical or Lumbar Discs at the time of this publication. In an EU clinical study, after two years, half of the patients with a Freedom Lumbar Disc had less than 10% disability score and reported less than 1/10 on the pain scale. [13] The Freedom Lumbar Disc provides better pain relief than anterior lumbar interbody fusion (ALIF) according to an EU clinical study.[14]  The Freedom® Lumbar Disc also performed better than competitor TDRs and is the first device to restore a normal center of rotation to patients (an important factor in keeping the rest of a patient’s spine aligned after the device is implanted). [15] [16]Both the lumbar and cervical discs are CE-marked and the lumbar disc has been implanted in patients in Europe since 2005. Dr. Oliver Hausmann, a neurosurgeon based in Switzerland and one of the early adopters of the AxioMed disc, says that the technology has performed well for him. His patients have had no side effects due to the device itself, and he is very happy with the two year results of the disc.  Dr. Hausmann chose the Freedom Disc because he likes the concept of the disc’s viscoelastic nucleus, its range of movement, its easy handling and its mobility on axial compression. When comparing the Freedom Disc to other TDRs, Dr. Hausmann says, “The Axiomed [disc] has a better range of movement than the ball and socket [discs].”

AxioMed is currently finishing its IDE on the lumbar disc and hoping to submit a PMA to the FDA by the fall of 2016. Ultimately, they hope to see the Freedom Lumbar Disc on the U.S. market in 2017. The Freedom Cervical disc completed preliminary clinical trials in Europe. AxioMed is raising capital in the United States to bring the cervical disc to the United States and start the IDE by 2016.

Meanwhile, the market for total disc replacement is strong and growing stronger. In Europe, the spine surgery devices market size is predicted to reach 2.37 billion by 2020, as the popularity of non-fusion devices and minimally invasive techniques grow with Europe’s aging population.[17] The Asia-Pacific spinal implant market is expected to double through 2022, reaching nearly $7 billion.[18] Others predict that motion preservation treatment will become the fuel for the spine industry, with 23% growth over next 5 years, $1.8 billion and a 45% of market share is here in US.[19]

For any company in the spine industry, these numbers represent exciting potentials for business growth. But for the people behind AxioMed, these numbers also represent countless opportunities to lessen people’s pain and give them a newer, better solution than the one the spine industry has been stuck in for decades.

[10] Benzel EC, Lieberman IH, Ross ER, Linovitz RJ, Kuras J, Zimmers K.  Mechanical Characterization of a Viscoelastic Disc for Lumbar Total Disc Replacement.  Journal of Medical Devices 5 (1), 2011.
[12] Benzel EC, Lieberman IH, Ross ER, Linovitz RJ, Kuras J, Zimmers K.  Mechanical Characterization of a Viscoelastic Disc for Lumbar Total Disc Replacement.  Journal of Medical Devices 5 (1), 2011.
[13] Rischke B, Ross RS, Jollenbeck BA, Zimmers KB, Defibaugh ND.  Pre-Clinical and Clinical Experience with a Viscoelastic Total Disc Replacement.  SAS Journal 5 (4); pp. 97-107, 2011.
[14] Rischke B, Zimmers K, Smith E.  Viscoelastic Disc Arthroplasty Provides Superior Back and Leg Pain Relief in Patients with Lumbar Disc Degeneration Compared to Anterior Lumbar Interbody Fusion.  International Journal of Spine Surgery 9; July 2015.
[15] Rischke B, Kammermeier V, Runkel M, Zimmers K, Kuras J.  Clinical Outcomes for a Viscoelastic Total Disc Replacement Compared to Other Total Disc Replacements in the SWISSspine Registry.  Presented at the International Society for the Advancement of Spine Surgery (ISASS) Annual Meeting, Barcelona, Spain, March 2012.
[16] Newton Ede M, Ross ERS, Rischke B, Joellenbeck B, Hipp J, Zimmers K. An Association Between the Center of Rotation and Clinical Outcome in Patients Implanted with a Viscoelastic Total Disc Replacement.  Proceedings of the British Orthopaedic Association Congress, 2011.
[17] Ibid.
AxioMed to Bring its Cervical Viscoelastic TDR to US

AxioMed Plans to Bring Cervical Viscoelastic Total Disc Replacement to US

Plans underway to initiate the Cervical IDE for the Freedom Disc in the USA

There have been many surgeons lamenting the lack of innovation at national spine conferences. “We aim to change that perception starting with the CSRS meeting this year in San Diego,” says Dr. Kingsley R. Chin, Orthopaedic Spine Surgeon and CEO of KICVentures. Dr. Chin is a Henry Bohlman fellowship-trained spine surgeon who has the same strong interest in cervical spine surgery as his mentor, so it was no surprise when he convinced the KICVentures team to acquire AxioMed Corporation in November 2014.

Dr. Chin will be attending the Cervical Spine Research Society (CSRS) meeting in San Diego, Calif. on Friday, Dec. 4 and Saturday, Dec. 5 to meet with other surgeons who have shown an interest in bringing the AxioMed viscoelastic total disc replacement technology to the U.S. Market to initiate IDE trials in 2016.

AxioMed’s total disc replacement, the Freedom® Disc, is a single-piece technology made of proprietary polymer that is permanently bonded between two titanium discs. Its viscoelastic core simulates the stability and flexibility of a healthy human disc. The Freedom Disc has been implanted in over 800 patients globally and has performed well on the European market. Clinical results show that the AxioMed discs display superior strength, durability and enhanced range of motion when compared to that of a healthy, human disc.

“This technology is the next generation of total disc replacement and is designed to mimic the natural anatomy of a human disc.”

“This technology is the next generation of total disc replacements and is designed to mimic the natural anatomy of a human disc. Unlike current discs on the market that are miniaturized versions of a total knee replacement ball and socket joints, the AxioMed lumbar and cervical discs are compressible, single-piece devices with no moving parts. The proprietary viscoelastic material is the only proven material to perform as a disc replacement in the spine and KICVentures has the exclusive license in the spine for its lumbar and cervical discs and any other applications. We want to bring back the excitement and optimism for disc replacement that we experienced in 2004 with the introduction of the first FDA cleared lumbar disc replacement,” says Dr Chin.

Plans underway to initiate the AxioMed Cervical IDE for the Freedom Disc in the USA

The Freedom Disc has received global attention. Dr. Pflugmacher, Head of Spine Orthopedics, University Hospital of Bonn, Germany, calls the Freedom Disc the “best disc on the market.” The lumbar disc IDE trials are coming to an end in a few months and AxioMed plans to submit the PMA to the FDA in 2016 and hopes to release the lumbar disc in the USA in 2017. The disc is available outside the USA and is exclusively distributed by SpineFrontier.

About AxioMed

Founded in 2001, AxioMed began its journey of exhaustively proving the Freedom Disc through research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology. Visit AxioMed at axiomed.com.

About KICVentures

KICVentures manages several portfolio companies, investing in disruptive technology in the health-tech sector. KICVentures acquires, creates, and nurtures companies and their technologies to their fullest potential. Visit KICVentures at KICVentures.com.

Medtronic Divergence Validates SpineFrontier’s Current Solutions

SpineFrontier is excited to hear about the release of the Medtronic Divergence as it validates our current ACDF solutions Inset and SoloFuse-P™.

We launched our Inset plate in 2012. Having a plate and cage married together provides the fixation of a plate with the most minimal proximity to the adjacent disc. Our Inset plate was originally designed as an adjacent segment solution for surgeons to add a level above or below an existing construct during revision surgery. It has since become extremely popular as a one-level primary plate to eliminate the occurrence of adjacent segment disease caused by the plate. Its extremely low-profile design also reduces dysphasia. This, combined with streamlined trial drill guide instrumentation and a zero-step locking mechanism, dramatically improves the usability for the surgeon.

Our latest step in the journey to develop the ultimate anterior cervical solutions happened earlier this  year, with the release of our PEEK-OPTIMA® HA interbody system earlier this year. SpineFrontier is the first company in the United States to market a device with this exceptional material. This means is our PEEK cages are now impregnated with a homogoneous mixture of hydroxyapatite (HA) and PEEK, which provides the mechanical properties of PEEK and the biological advantages of HA to encourage bony apposition to the implant itself. Traditional PEEK Optima is bio-inert and only provides structural support for bone to grow around it but this new PEEK-OPTIMA HA takes cervical fusion to the next level by utilizing the implant as part of the patient’s biological construct.

Our SoloFuse-P™ standalone cervical plate offer an even less profile solution that provides a magnificent bone graft window and the largest diameter screws in its class for maximal purchase and fixation. The SoloFuse-P standalone will be available with HA PEEK later this year. We welcome the Medtronic Divergence device to the family as it complements the surgical approach that we started in 2012. We have had great results ever since!

Texas Back Institute Embraces Sterilized Single Use Instruments

I was excited to read about the use of sterilized single-use spine surgery instruments at the Texas Back Institute. SpineFrontier is also developing sterilized single-use spine surgery instruments to be manufactured here in the U.S. We are looking for partner surgical centers (ASC) and hospitals to help us demonstrate the clinical and economic benefits of this new technology.

Dr. Guyer, the orthopedic surgeon (and past president of the North American Spine Society –NASS), together with orthopedic surgeon Dr. Zigler (a past president of the American Spinal Injury Association –ASIA) performed the minimally invasive lumbar fusion using Safe Orthopaedics’ single-use instruments. In Safe Orthopaedics’ press release, Dr. Guyer reported that the product was easy to use and generated substantial time savings.

In the same press release, Dr. Zigler commented on the easy training and time savings for surgeons: “For mini-invasive screw implantation the system is as user-friendly as any of the standard systems we use. The learning curve is minimal limited to 1or 2 cases for most if not all surgeons.”

By providing instrument kits and implants in packaging that’s already sterilized and easier to use, SpineFrontier wants to help customers improve patient care and significantly reduce healthcare cost. We believe sterilized, single-use instruments like Peel Pack will decrease infection rates and operational costs, eliminate the need for in-house sterilization and reduce the cost through bulk-purchasing. They will also help surgery centers reduce storage space for bulky kits and create an easy-to-manage inventory. Pre-sterilized surgical kits have the potential to deliver cost and time savings to surgeons in OR’s across the nation.