Surgeons and Investors Shouldn’t Miss this Opportunity to Discuss How to Apply Lessons from Total Joint Replacement to Spine Restorative Motion | SpineFrontier feature

AxioMed AAOS Event to Feature Dr. Mark Reiley – Surgeon, Entrepreneur, Champion of Total Segmental Restorative Motion

Surgeons and Investors Shouldn’t Miss This Opportunity to Discuss How to Apply Lessons from Total Joint Replacement to Spine Restorative Motion

AxioMed announced today that Dr. Mark Reiley, an experienced veteran of total segment motion preservation, will speak at a private event hosted by AxioMed during AAOS’s (American Academy of Orthopaedic Surgeons) Annual Meeting in Orlando, Fla. The wine and cheese tasting event will occur in a private suite at the JW Marriott, in Orlando on Thursday evening, March 3, 2016 at 8 p.m., and will give attendees the opportunity to mingle with orthopedic industry leaders from several companies, including AxioMed, Invibio, SpineFrontier and KICVentures, among others. In conjunction with Dr. Reiley’s talk, AxioMed will host a discussion about applying lessons in total joint replacement to spine motion preservation. The topic of discussion will include the latest trends in technology, the evolution of joint replacement and the practice of motion preservation in spine. To RSVP for this event, please email sarahcook@spinefrontier.com.

Dr. Mark Reiley is a board-certified surgeon who did his first total segment motion preservation procedure in Berlin over 10 years ago. Dr. Reiley co-founded Kyphon based on his invention of the Kyphon balloon device to treat fractured vertebrae. Reiley sold Kyphon to Medtronic in 2007. He then founded INBONE Technologies, Inc. in 2008, serving as its Chief Medical Officer. Among other inventions, Dr. Reiley also designed the first and only Total Ankle Replacement (TAR) to use intramedullary guidance. He is also the inventor of the triangular fusion rod and Co-founder of SI-Bone. Dr. Reiley is an international speaker and published author of several books and articles, as well as the winner of the 2008 Phoenix Lifetime Achievement Award in Medicine. AxioMed is honored to have Dr. Reiley lead a discussion on how to achieve total segmental restoration in spine.

Jake Lubinski, President of AxioMed, will give an update on AxioMed Freedom® Total Disc Replacement’s IDE progress. The AxioMed Freedom Disc is a single-piece total disc replacement with a proprietary, viscoelastic polymer core that mimics the flexibility and stiffness of a human vertebra. This next-generation technology is the only one of its kind on the market. So far, the Freedom Cervical Disc has completed a European post-market study. The USA Lumbar IDE, started in 2008, has just finished a two year follow-up. Visit this article for more information about the Freedom Disc clinical studies.

European surgeons who use the Freedom Disc have been pleased with its results. Dr. Hausmann, an EU neurosurgeon and early adopter of the Freedom Disc says, “My patients had no side effects…I am very happy with the two-year results of the disc…The AxioMed disc has a better range of movement than the ball-and-socket discs.”

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.

About KICVentures

KICVentures manages several portfolio companies (including AxioMed, LLC), investing in disruptive technology in the healthtech sector. KICVentures acquires, creates, and nurtures companies and their technologies to their fullest potential.

Best Practices: Dr. Ngu’s Focus on Patient Education | SpineFrontier spotlight

Best Practices: Dr. Bonaventure Ngu Focuses on Patient Education

This month, I had the pleasure of interviewing Dr. Bonaventure Ngu, a Texas-based orthopedic spine surgeon. I wanted to know how he had taken the patient experience into account while structuring his practice.  Dr. Ngu told me that the first thing he wanted to do was make sure his waiting room was comfortable and that patients didn’t have to wait a long time. But he also wanted patients to feel comfortable as he explained their illnesses, diagnoses and treatment to them. An exam room couldn’t provide the right atmosphere for helping a patient fully engage and understand complex medical procedures. So after their examination, Dr. Ngu ushers his patients into a conference room equipped with video capabilities and a big white board.

“I get one-on-one with them with a big white board, so they really get a whole understanding of the cause of their symptoms, their condition, and their treatment. After examining them I go over all the images with them, explaining everything about what is causing their symptoms and showing them videos of the surgery they need. After the appointment, they can refer back to my website and watch more videos of their conditions.”

“You’d be amazed at how many patients have gone through spine injuries and injections and no one ever went over their treatment with them,” says Dr. Ngu.

Dr. Ngu credits his emphasis on patient education to his experience watching a mentor during his fellowship be hands-on about educating his patients. “You’d be amazed at how many patients have gone through spine injuries and injections and no one ever went over their treatment with them,” says Dr. Ngu. “Most of the surgery I do is elective, so I want to make sure patients know why they are electing to have surgery. The more educated the more informed decision they can make about their surgery –the better.”

Dr. Ngu has had a hugely positive response from patients. Because of his reputation for taking the time to walk patients through their medical conditions and procedures, Dr. Ngu has patients whose insurance plans include him, but still book an educational appointment with him before having surgery with another physician. This way, patients go into their surgery with another physician fully informed from their one-on-one educational session from Dr. Ngu.

I asked Dr. Ngu if patient education gives him any definable return on investment for his practice. “I don’t measure return on investment by patient volume,” Dr. Ngu says. “I measure it by patient satisfaction. If I have five satisfied patients, then I’ve done my job. Spine surgery is very complex and we need to schedule time to talk to patients about it. I value that time, and I don’t want to feel rushed. I want the patient to feel calm.”

“Patient education is something that we [as surgeons] take for granted,” Dr. Ngu says. “We surgeons see things in three dimensions. But we need to explain things in two dimensions or one dimension, and explain everything to a patient in layman’s terms while drawing things out for people.  We need to show them the screws or bone graft that will be going into their body, and show them what the suture will look like. All the technologies I use –I have in the office in order to show the patient. It’s our place to show them and tell them what their treatment is going to be like. It’s not their place to have to ask.”

Best Practices: One Neurosurgeon's Empathetic Approach to the Patient Experience | SpineFrontier Dr. Rosenstein

Best Practices: One Neurosurgeon’s Empathetic Approach to the Patient Experience

Dr. Rosenstein makes sure he and his staff go the extra mile to make his patients feel comfortable. That commitment to patient comfort begins with an empathetic recognition of what it’s like to enter the office of a neurosurgeon, and a strategic approach to eliminating unnecessary stressors for a patient.

“As a physician, you want your office to be warm and your staff to be inviting, so that a patient feels safe and comfortable when they come into your office. Someone seeing a neurosurgeon is already nervous enough. You don’t want to add to that stress in any way.”

Dr. Rosenstein says that patients suffer from “white coat syndrome.” Their blood pressure is often high during the examination simply from the stress of being in a doctor’s office. “People are scared to see a neurosurgeon and afraid they could be on the operating table the next day,” he says.  “As a physician, you want your office to be warm and your staff to be inviting, so that a patient feels safe and comfortable when they come into your office. Someone seeing a neurosurgeon is already nervous enough. You don’t want to add to that stress in any way.”

In addition to making sure his staff are attentive in asking after his patients’ comfort and needs, one of the ways Dr. Rosenstein has taken on the issue of patient stress, is through the intentional interior design of his office. His wife and an interior designer helped create the office environment, choosing modern, cool and calming paint colors that help create a warm and professional atmosphere.

When asked what kind of feedback he receives about his office from patients, Dr. Rosenstein says patients notice the thought that went into his office and regularly comment on it. “I always get compliments about how nice the office design is and how nice the staff is. We are very patient-oriented and it shows. Patients refer their friends and family because we make them feel at home and comfortable and we take care of their needs. Our biggest referral source is former patients.”

In a competitive medical landscape, patient satisfaction goes a long way in creating a solid patient pipeline. Building a reputation as a practice that cares about its patients is one of the most straightforward ways of attracting new patients in an increasingly complicated world of print, TV, online and social media marketing. Caring for a patient comes naturally to healthcare professionals, so extending that care to a focus on the holistic and fundamental elements of a practice’s physical and social environment is perhaps a more intuitive and organic marketing strategy for physicians than coming up with a gimmick or clever marketing campaign to differentiate oneself from competitors.

In a study looking at how patients experience different factors in a healthcare environment, published in the International Journal of Qualitative Studies on Health and Well-being, researchers concluded that “Analysis of the patients’ perceptions of the environment indicated a complex entity comprising several aspects. These came together in a structure consisting of three main categories: safety, partnership with the staff, and physical space.”[1]

It seems that Dr. Rosenstein is onto something with his emphasis on creating a safe, calming environment where patients feel connected to his staff. As basic as it sounds, a welcoming environment assures patients of their likelihood of receiving top-notch quality care. And yet –how many physicians’ offices have cramped waiting spaces, uncomfortable chairs, old wall paper and ugly watercolor paintings? It’s not superficial for medical professionals to attend to these physical details, just as it’s not superficial for a person to look their best on the day of a job interview. It’s a well-accepted truism that physical details make an impression (even subconsciously) on our emotional and psychological assessments of things. A professional staff and well-cared for office exposes the ethos of a practice’s attention to detail and its acknowledgment of the patient as a human being with a need for physical and emotional well-being.

LES Society Off to a Roaring Start with First Lab of the Year, Baltimore

LES Society Off to a Roaring Start with First Lab of the Year, Baltimore

The LES Society started the year with a spectacular event at Dr. Agha Khan’s impressive Vita Lab in Baltimore. Harvard-trained Dr. Jeffrey Carlson of Newport News, Virginia, stole the show with his instruction on the LES midline technique. Residents and fellows hung on his every word as they crowded around his cadaver to get a closer look at his expert techniques. Dr. Carlson has done more than 100 LES midline approach cases using SpineFrontier’s instruments and implants.

Dr. Carlson, said, “The Baltimore event was an enormous success. We enjoyed the company of a lot of great surgeons and eager fellows who were interested in LES technologies, techniques and of course AxioMed’s total disc replacement technology. It was an enriching day of education and learning for our SpineFrontier team.  All the surgeons who participated were really engaged in the hands-on labs and getting their questions answered.”

The LES Society Lab in Baltimore was the first in its series of labs and journal clubs for residents and fellows from around the country.  New York neurosurgeon, Dr. John Shiau, engaged the crowd with his energetic and passionate insights on the benefits of MIS techniques. Next, Dr. Michael Murray, an orthopedic surgeon also from New York, instructed the audience on case selection and techniques for a cervical standalone using SpineFrontier’s A-CIFT™ SoloFuse. His patience and meticulous instruction was greatly appreciated by the residents and fellows. Wrapping up the lectures, Dr. Khan, the Baltimore-based neurosurgeon, spoke eloquently about the simplicity and benefit of using an interspinous device as part of the LES philosophy.

Less Exposure Surgery (LES®) is based on a new surgical philosophy. Small open incisions are created, through which the surgeon only exposes what needs to be treated for maximum effectiveness. By developing improved technologies and techniques tailored for pinpointing a problem and fixing it without collateral damage, LES® minimizes normal tissue disruption without relying on excessive radiation.

LES® procedures are performed in an outpatient setting and are tailored to the patient’s lifestyle, health status, and body type. This personal attention decreases risk, is simpler for the surgeon to perform, reduces pain and blood loss, and decreases recovery time.

After lectures, the four LES Society surgeons served as proctors at different cadaver stations.

Dr. Carlson ran a station on midline screw trajectories featuring the PedFuse REmind and FacetFuse® Screws.
LES Society Off to a Roaring Start with First Lab of the Year, Baltimore
LES Society Off to a Roaring Start with First Lab of the Year, Baltimore
Dr. Shiau’s station demonstrated the MISquito™ and InSpan™ technologies.
LES Society Off to a Roaring Start with First Lab of the Year, Baltimore
Dr. Murray ran a station on A-CIFT™ SoloFuse-P™, teaching residents about how to get cervical exposure.
LES Society Off to a Roaring Start with First Lab of the Year, Baltimore
Dr. Khan hosted a station on InVue and Inset® Anterior Cervical Plates. He also showcased AxioMed’s Freedom® Cervical Disc.
LES Society Off to a Roaring Start with First Lab of the Year, Baltimore
LES Society Off to a Roaring Start with First Lab of the Year, Baltimore

After cadaver labs, Frank Schnur, the CSO of SpineFrontier and KICVentures, spoke about the compelling opportunity represented by the KICVentures ecosystem and one of its portfolio companies, AxioMed. AxioMed Freedom® total disc replacement is a single piece technology with a viscoelastic polymer core that closely mimics the shock absorption and movement of a human disc. Surgeons enjoyed putting in the AxioMed Freedom® Cervical Total Disc Replacement earlier in the day.

Dr. Carlson, said, “The Baltimore event was an enormous success. We enjoyed the company of a lot of great surgeons and eager fellows who were interested in LES technologies, techniques and of course AxioMed’s total disc replacement technology. It was an enriching day of education and learning for our SpineFrontier team.  All the surgeons who participated were really engaged in the hands-on labs and getting their questions answered.”

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.

A CSRS Cervical Spine Research Society follow-up Dr. Kingsley R. Chin SpineFrontier

Dr. Kingsley R. Chin visits CSRS: A Follow Up

On Dec. 4 and 5, Dr. Chin attended CSRS (Cervical Spine Research Society) in San Diego. For the fuller story, read the Spark article: AxioMed Planning To Bring Its Cervical Viscoelastic Total Disc Replacement to the U.S. Dr. Chin reports here briefly on his experience.

“At CSRS, I met with key opinion leaders to discuss bringing the IDE for the AxioMed cervical TDR to the USA and to also discuss how to organize surgeons to participate in raising the capital to fund the IDE to bring the cervical TDR to market.  Surgeons shared that they are convinced that the viscoelastic TDR is the best available solution for treating disc disease in the cervical spine over either fusion or disc replacements with moving pieces that act as joint replacements. AxioMed’s Freedom Disc is a true replacement that mimics the natural disc to restore alignment and motion,” said Dr. Chin.

The disc is available outside the USA and is exclusively distributed by SpineFrontier.

SpineFrontier Sponsors Brother of Mine Foundation Golf Classic

SpineFrontier Sponsors Brother of Mine Foundation Golf Classic

SpineFrontier recently sponsored the Brother of Mine Foundation Golf Classic’s Inaugural Event at the Hudson National Golf Club in Croton on Hudson, N.Y. The event took place on Oct. 19, 2015.

Brother of Mine Foundation is a non-for-profit organization dedicated to supporting military men, women and their families through hardships sustained from their military service. Each year, the foundation selects a particular service member to help.

This year’s golf event honored U.S. Army/Special Forces Sergeant Jared Bullock, and its proceeds will go toward building a new home for Sergeant Bullock and his family.

The CEO of SpineFrontier, Dr. Chin said, “It was wonderful to support Sergeant Bullock and his family. They have sacrificed tremendously for our country, and it’s an honor to be able to give back to him in some way.”

About Sergeant Jared Bullock

“U.S. Army SFC Jared Bullock felt a need to do something to help after Sept. 11, 2001. A couple of years later, he and his twin brother enlisted in the Army together. With a start as an infantryman, he attended basic training and airborne school at Ft. Benning, Ga. Upon completion he served two tours to Iraq from 2005-2006 and 2007-2008, later becoming a Staff Sergeant. Jared was awarded a Green Beret after his hard work in the Special Forces Qualification Course. He was then assigned to Ft. Bragg, N.C. and eventually to Florida. Thereafter, he conducted two rotations to South America.

On Nov. 13, 2013 while on routine patrol on an ATV in Afghanistan, he ran over an improvised explosive device (IED) and lost this right arm and leg. Over 30 surgeries later, he had prosthetics and was walking with his four year-old son again.

Jared shared, “I knew that my life wasn’t over, and this was just another challenge. Challenges have always motivated me to push harder in life.” With the help of his wife and son, his team and community, it has given him the positive attitude that he needed to help him carry on. He continues to show people that they are capable regardless of obstacles in their path.”[1]

For more information on Brother of Mine Foundation visit their website.

[1] http://www.brotherofminefoundation.com/events/honoring-usfc-sergeant-jared-bullock/

SpineFrontier: From Hospital to Ambulatory Surgery Center: Midline Cortical Pedicle Screws Vs. Traditional Pedicle Screws

From Hospital to Ambulatory Surgery Center: Midline Cortical Pedicle Screws Vs. Traditional Pedicle Screws

Kingsley R. Chin, MD1, 2

Fabio J.R. Pencle, MB BS1

André V. Coombs, MB BS3

Mohamed Elsharkawy, MD3

Corrine F. Packer, MB BS3

Elijah A. Hothem, MD3

Jason A. Seale, MB BS1

  1. Less Exposure Surgery Specialists Institute (LESS Institute).
  2. Florida Atlantic University (FAU) & Florida International University (FIU)
  3. Less Exposure Surgery (LES) Society.
Conflicts of interest and sources of funding: We did not seek or receive any funding from the National Institutes of Health (NIH), Wellcome Trust, Howard Hughes Medical Institute (HHMI), or others for this work. KRC is a shareholder in and receives other benefits from SpineFrontier Inc., none of the other authors (FJRP, AVC, ME, CFP, EAH or JAS) have any potential conflicts of interest to declare for this work.

Abstract

Introduction

Modern advances in spine surgery including less invasive procedures have propelled the design of instruments and implants to achieve greater posterior spinal fixation, with decreased tissue destruction and higher safety margins.  Static and dynamic biomechanical studies have validated the superior pullout strength of cortical screws versus the traditional pedicle screws and might represent an opportunity to perform safe lumbar fusions in ambulatory surgery centers (ASC).  The authors aim to compare the outcomes of midline cortical pedicle screw surgical technique for posterior lumbar fixation in the ASC compared to traditional pedicle screws in a hospital.

Method

The medical records of 60 patients with prospectively collected data were reviewed. Two matched cohort groups consisting of 30 patients each, midline cortical pedicle screws performed in ASC patients (Group 1) was compared to traditional pedicle screws performed in Hospital patients (Group 2). Outcomes were measured using Visual Analog Scale (VAS) scores, Oswestry Disability Index (ODI) scores, estimated blood loss (EBL) and Radiologic fusion rate.

Results

33 males and 27 females, age range (28-75), average 58±3 years. Average BMI was 29±1.15 kg/m2. Significant improvement noted in VAS back pain scores in Group 1 from 7.8±0.5 to 2.5±0.7, p=0.001. Comparing VAS back pain scores and ODI scores, significant improvement demonstrated between group 1 and 2, p=0.004 and p=0.027 respectively. Mean EBL in group 1 was significantly less, p=0.025 than group 2. Intergroup fusion rate at two year was similar, p=0.855.

Conclusions

We successfully transitioned our lumbar fusions from hospitals to ambulatory surgery centers using a midline cortical pedicle screw technique. Although traditional pedicle screw placement was effective and may be viable in an ambulatory surgery center we see more advantages to use midline cortical screws over traditional pedicle screws.

SpineFrontier: From Hospital to Ambulatory Surgery Center: Midline Cortical Pedicle Screws Vs. Traditional Pedicle Screws
SpineFrontier: From Hospital to Ambulatory Surgery Center: Midline Cortical Pedicle Screws Vs. Traditional Pedicle Screws
SpineFrontier: From Hospital to Ambulatory Surgery Center: Midline Cortical Pedicle Screws Vs. Traditional Pedicle Screws
Why Our Team Went Questing at Boda Borg (and Why Yours Should, Too...)

Why Our Team Went Questing at Boda Borg (and Why Yours Should, Too…)

Recently, a Swedish company called Boda Borg opened a few blocks from KICVentures’ headquarters in Malden, Massachusetts.  With seven locations in Sweden and one in Ireland, Boda Borg is staking its first claim in North America. Chad Ellis, the head of Boda Borg Boston believes that Boston is a perfect market for Boda Borg. It has everything: corporations seeking healthy team building activities, educated families wanting to do smart things with their families and college kids looking for cheap entertainment.

Chad Ellis, the head of Boda Borg Boston believes that Boston is a perfect market for Boda Borg. It has everything: corporations seeking healthy team building activities, educated families wanting to do smart things with their families and college kids looking for cheap entertainment.

As part of their opening promotions, Boda Borg invited a team from SpineFrontier to check out the facilities and “quest.” Mike Perry and I tagged along to take photos and see what the team’s experience was like.  A week later, my creative team from KICVentures followed suit and quested together for an evening.

“Questing” is a sort of real-life gaming experience. Teams of 3-5 people enter a quest together –physical and mental challenges set up in a series of rooms. Once a team successfully solves a quest, they can move onto the quest’s next level. Completing an entire quest the first time is rare. Teams fail frequently and must start over from the beginning –repeating rooms until they successfully reach their quest’s conclusion.

In fact, failure is foundational to the Boda Borg experience. David Spigner, President and CEO of Boda Borg Corporation and Boda Borg Europe greeted the SpineFrontier team and explained the rules of Boda Borg, concluding with: “We sell failure. You are going to fail, fail, fail until you find a way out.”

Boda Borg is an alternate universe in which failing is…well…fun.

With so many recent editorials and studies lauding the importance of failure in developing tools for success, the invitation to fail as a team seemed timely, like a mini experiment in team dynamics. Actual failures –in life and in the work place –while incredibly valuable for gaining understanding and self-knowledge -are not exactly carefree team-building activities.  Boda Borg is an alternate universe in which failing is…well…fun.

There is an addictive element to questing, to entering into a room, looking at all the clues and trying to figure out how to pass through its obstacles without signaling the red alarm that blares when you’ve failed. Jeremy Crossgrove, an industrial designer at SpineFrontier, explained the addiction of an analytical problem-solving that engages you experientially, “Almost every failure was a learning experience but there was no direct feedback so you don’t always know why you had failed. Our team’s response wasn’t really frustration. I think we had our own ideas of what caused the failure so we wanted to get back into it to try new hypotheses.”

I found that questing with people I work with every day was fun. Strengths came out in quirky and comical ways –ways that I was entertained by and ultimately grateful for.  It turns out that our media guru, Anders Johnson, is a really good rock climber, and figured out how to hack the obstacle course room on the second time through. Our graphic designer Mike Perry revealed a heretofore disguised energy of puppy proportions –pushing us onto the challenge after challenge when our team’s energy threatened to flag. And Brett Clair, KICVenture’s Director of Art, solved the trivia room faster than I could read its clues.

But the interesting thing –beyond the strengths that were displayed, was the attitude toward failure that emerged. The team’s responsibility for moving through the obstacles together removed any sort of individual assignment of blame for when we did fail. Added to the problem-solving teamwork was refreshing sense of working out together –in the truest sense of the term. Some challenges were physically taxing, so when you failed them, there was disappointment but there was also that secret sense of satisfaction that you would probably have sore muscles the next day, and that was at least something.

Charles Maneval, Research & Test Engineer at SpineFrontier said his impression was that Boda Borg was “…thrilling, exciting, great team-building. I’d definitely go back. The challenges were very exciting –physical in nature, but they also tested your mind and required teamwork.”

If you ever have a chance to go questing at Boda Borg, the SpineFrontier and KICVentures teams recommend it.  As Winston Churchill once said: “Success is stumbling from failure to failure with no loss of enthusiasm.” Boda Borg is a valuable venue for experiencing that relationship between failure and success.