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Current Issues in Spine

February 2-4, 2017

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January 3, 2019 OrthoSpineNews

SALT LAKE CITY, Jan. 03, 2019 (GLOBE NEWSWIRE) — SINTX Technologies (NASDAQ: SINT) today reported the independent publication of 30-year clinical outcomes of lumbar fusion surgeries, performed with silicon nitride implants. The paper titled “Anterior Lumbar Interbody Fusion Using Reaction Bonded Silicon Nitride Implants” appeared in the December 2018 edition of the World Neurosurgery journal, and the findings were also featured at the 2018 Annual Scientific Meeting of the Neurosurgical Society of Australasia.

Dr. Ralph Mobbs from the University of New South Wales, Sydney, authored the study. Dr. Mobbs stated: “This work is of historical significance, being the first clinical study of silicon nitride as an implant material, the first commercial anterior lumbar interbody fusion with a synthetic material, the first design of a spinal interbody implant with endplate porosity to promote fusion, and the longest clinical follow-up of any implant material in spine surgery. This report clearly establishes the place of silicon nitride in the annals of spine surgery,” said Professor Mobbs.

“This work reflects the only known use of silicon nitride implants, outside the spine products manufactured by our company,” said Dr. Sonny Bal, Chairman of SINTX Technologies. “Despite a much earlier material composition and implant design, silicon nitride proved itself even three decades after spinal implantation. These findings are entirely consistent with the more modern data published by us, showing earlier fusion, excellent biocompatibility, ease of radiographic imaging, and other advantages of our silicon nitride spine implants. The SINTX formulation of silicon nitride is enhanced and improved even further with sintering agents that accelerate bioactivity and confer antibacterial advantages.”

“This paper is a compelling affirmation of our full confidence in silicon nitride as the ideal spine biomaterial platform, whether as an implant, surface coating, or composite formulation with other biomaterials. This report will support our sales objectives, as we prepare an official launch in the coming months in Australia – the first place to use silicon nitride in spinal fusion surgery,” said Daniel Chon, CEO of Dallas-based CTL-Amedica, the exclusive retail channel for silicon nitride spinal implants made by SINTX Technologies.

About SINTX Technologies

SINTX Technologies is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including orthopedic, dental and arthroplasty.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”) that are subject to a number of risks and uncertainties. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. A discussion of those risks and uncertainties can be found in Sintx’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Sintx’s other filings with the SEC. SINTX disclaims any obligation to update any forward-looking statements. Sintx undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report.

Contacts:
SINTX Technologies
801-839-3502
IR@sintx.com


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January 3, 2019 OrthoSpineNews

SAN DIEGOJan. 3, 2019 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced a new organizational structure and associated executive team that chief executive officer (CEO) J. Christopher (Chris) Barry has selected to lead the Company’s next phase of growth and innovation. Barry joined NuVasive as CEO on November 5, 2018.

“After assessing the Company over the past two months as CEO, it is clear that NuVasive benefits from significant talent across the organization. Our new structure will enable us to better capitalize on this talent by fostering cross-functional collaboration, consolidating complementary functions and increasing accountability,” said Barry. “I am confident this leadership team and our new structure, along with disciplined execution, will better position NuVasive to fulfill our commitments to patients, surgeons, employees and shareholders, and drive NuVasive’s success and sustainable growth.”

As part of the new organizational structure, NuVasive announced the following leadership team, all of whom will report to Barry. The following changes are effective immediately:

  • Matt Link will continue to serve as president in an expanded capacity to include direct management of NuVasive Clinical Services and Global Logistics. The integration of these functions rounds out oversight of the entire product life cycle, from development to launch to service to fulfillment, which will positively impact how the sales force brings disruptive innovation to surgeons and patients.
  • Raj Asarpota will continue to serve as executive vice president and chief financial officer, and lead the Company’s Finance, Accounting, Internal Audit and Tax functions.
  • Nate Sisitsky, Esq. will continue to serve as general counsel and corporate secretary, and lead the Company’s Legal function as well as the NuVasive Spine Foundation. In addition, he will also oversee the Company’s Real Estate and Facilities function.
  • Jim Garrett, Esq., chief compliance officer and leader of the Company’s Global Risk and Integrity (GRI) function, will assume an expanded role overseeing the Business and Quality Systems functions, including GRI, Regulatory Affairs/Quality Affairs, Information Technology, and Environmental Health & Safety.
  • Lucas Vitale is named chief human resources officer, and most recently served as vice president, Human Resources and Sales Training at NuVasive. He has been with the Company for more than four years.
  • Suzanne Hatcher will continue to lead the Company’s Internal and External Affairs functions, including Investor Relations, Public Relations and Internal Communications.
  • Dale Wolf will continue to oversee the Company’s manufacturing efforts, including the facility in West Carrollton, Ohio. He will leverage his significant prior experience, with Barry’s direct oversight, to facilitate successful operational and financial execution of the Company’s self-manufacturing efforts.

NuVasive’s Global Commercial regional leaders include Paul McClintock (U.S.), Erin McEachren (Europe), Takaaki Tanaka (Japan/China) and Jim Abraham (Australia/New Zealand).

As an outcome of streamlining top layers within the Company’s new organizational structure, the positions of executive vice president, People and Culture, and executive vice president, Global Process Transformation, previously held by Pete Leddy, Ph.D. and Stephen Rozow, respectively, have been eliminated. The Company thanks Pete and Steve for their commitment and dedication to NuVasive.

To read more about NuVasive’s leadership team, please visit www.nuvasive.com and click on the About section.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400-person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit  www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com


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January 3, 2019 OrthoSpineNews

SAN DIEGOJan. 3, 2019 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced a new organizational structure and associated executive team that chief executive officer (CEO) J. Christopher (Chris) Barry has selected to lead the Company’s next phase of growth and innovation. Barry joined NuVasive as CEO on November 5, 2018.

“After assessing the Company over the past two months as CEO, it is clear that NuVasive benefits from significant talent across the organization. Our new structure will enable us to better capitalize on this talent by fostering cross-functional collaboration, consolidating complementary functions and increasing accountability,” said Barry. “I am confident this leadership team and our new structure, along with disciplined execution, will better position NuVasive to fulfill our commitments to patients, surgeons, employees and shareholders, and drive NuVasive’s success and sustainable growth.”

As part of the new organizational structure, NuVasive announced the following leadership team, all of whom will report to Barry. The following changes are effective immediately:

  • Matt Link will continue to serve as president in an expanded capacity to include direct management of NuVasive Clinical Services and Global Logistics. The integration of these functions rounds out oversight of the entire product life cycle, from development to launch to service to fulfillment, which will positively impact how the sales force brings disruptive innovation to surgeons and patients.
  • Raj Asarpota will continue to serve as executive vice president and chief financial officer, and lead the Company’s Finance, Accounting, Internal Audit and Tax functions.
  • Nate Sisitsky, Esq. will continue to serve as general counsel and corporate secretary, and lead the Company’s Legal function as well as the NuVasive Spine Foundation. In addition, he will also oversee the Company’s Real Estate and Facilities function.
  • Jim Garrett, Esq., chief compliance officer and leader of the Company’s Global Risk and Integrity (GRI) function, will assume an expanded role overseeing the Business and Quality Systems functions, including GRI, Regulatory Affairs/Quality Affairs, Information Technology, and Environmental Health & Safety.
  • Lucas Vitale is named chief human resources officer, and most recently served as vice president, Human Resources and Sales Training at NuVasive. He has been with the Company for more than four years.
  • Suzanne Hatcher will continue to lead the Company’s Internal and External Affairs functions, including Investor Relations, Public Relations and Internal Communications.
  • Dale Wolf will continue to oversee the Company’s manufacturing efforts, including the facility in West Carrollton, Ohio. He will leverage his significant prior experience, with Barry’s direct oversight, to facilitate successful operational and financial execution of the Company’s self-manufacturing efforts.

NuVasive’s Global Commercial regional leaders include Paul McClintock (U.S.), Erin McEachren (Europe), Takaaki Tanaka (Japan/China) and Jim Abraham (Australia/New Zealand).

As an outcome of streamlining top layers within the Company’s new organizational structure, the positions of executive vice president, People and Culture, and executive vice president, Global Process Transformation, previously held by Pete Leddy, Ph.D. and Stephen Rozow, respectively, have been eliminated. The Company thanks Pete and Steve for their commitment and dedication to NuVasive.

To read more about NuVasive’s leadership team, please visit www.nuvasive.com and click on the About section.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400-person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit  www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com


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December 26, 2018 OrthoSpineNews

12-26-2018 / Kain, Zeev

I’m excited to announce the 3rd Interdisciplinary Conference on Orthopedic Value based Care taking place on January 18-20, 2018 in beautiful Newport Beach, California. We’ve planned this conference to be even better than last 2 years highly-rated event!

Here’s five reasons it should be on your to-do list:

  1. One Unique Team Concept

The mission of this conference is to break the silos that exist in a patient’s orthopaedic journey. This is the only conference that brings in speakers that represent players from across the episode: orthopedic surgeons, nurses, physical therapists, healthcare executives, anesthesiologists, patients, digital health experts and futurists. In the same vein, we expect surgical teams to attend and take this opportunity to learn from each other and work toward better patient outcomes together. This worked well at last year’s conference where 40% of the participants were part of a hospital team.

  1. Two Innovative Cadaveric Workshops
    On Friday there are 2 cadaveric workshops that will focus on innovative surgical orthopedic procedures and US based regional anesthesia. Plenty of opportunity to experience new devices and surgical techniques as well the most innovative regional anesthesia techniques.
  2. Three Ambulatory Boot Camps
    Orthopedic spines are heading to the outpatient area and we need to get ready. The first bootcamp will focus on the concept of fee for value in the ambulatory environment and will include practical approaches aught by all the stakeholders. The second bootcamp will focus on the nuts and bolts of building and maintaining an Orthopaedic ambulatory center and the third book camp will focus on building an enhanced recovery model for the patients who are undergoing ambulatory surgery.
  1. Four Complementary Tracks
    To be successful in the world of fee-for-value, one needs to understand all the clinical, financial and operational aspects of this new developing world. This is the ONLY conference that offer three complementary parallel tracks that the various stakeholders can attend! We choose the 4th track, ambulatory, to be held on Friday with no other programing at the same time because of the high interest in this concept.
  2. Five Times the Networking
    Each day offers four opportunities for networking, including breakfast, lunch and two breaks for exchanging best practices and comparing notes. Plus, a free meet and greet wine networking reception on Saturday night will offer a relaxed atmosphere to share insights from day one.

  3. A Six-Star Speaker Lineup
    The agenda has 38 world-class, interdisciplinary speakers. Ortho experts include speakers such as Alexander R. Vaccaro, President and Surgeon-in-Chief at Rothman Institute Orthopedics; Joseph Iannotti, Chair at Cleveland Clinic, Kevin Bozic, Chair at Dell School of Medicine and Tony Romeo from the Rothman Institute of New York. The Executive leaders include individuals such as the CMO of Humana, CMO of Optum, COO of Rothman, Vice Chancellor of UC Davis and others.

Register today!


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December 18, 2018 OrthoSpineNews

Lots is happening in the healthcare area and it’s clear that the orthopaedic fee-for-value space will continue to evolve in 2019. Here are some insights from three speakers the 3rd Interdisciplinary Conference on Orthopedic Value based Care taking place on January 18-20, 2018 in beautiful Newport Beach, California.

Alexander R. Vaccaro, MD, PhD, MBA

Richard H. Rothman Professor and Chairman of Orthopedic Surgery

President, Rothman Orthopedic Institute

  • Can you share your best advice for motivating your teams?

Make sure they clearly understand goals and objective of any initiatives and have the opportunity for feedback and buy in. Show that you care about them and their opinions, be humble, celebrate/ recognize/ reward small and large wins, roll up your sleeves.

  • How do you break the silos in your organization?

Communicate , Communicate, Communicate. Reward the Mngt team based on team goals/ targets so that it incentives to work “across lines/ departments”. Have each leader “walk in the other’s shoes” so they get a better understanding of the position, responsibilities, problems / issues, work product. Constantly motivate, meet as a leadership team often, teak the team to dinner/ drinks – get to   know each other personally.

  • OP Surgery is moving to the outpatient area; how do you get ready for it?

Develop OP ASC’s (we now have 8 – and will got up to 12-14 with Northern Jersey and NY). Larger OR’s and PACU bays ; risk assessment all patients for appropriateness of care, visit existing ASC’s that are performing Spine/ Joints on an OP basis. Define specific criteria for cases qualifying for OP ASC. Ensure that the OR’s are big enough.

 

AnnMargaret McCraw

Chief Executive Officer

Midlands Orthopaedics & Neurosurgery, PA

   What’s the best thing you’ve read lately?

The Ideal Team Player by Patrick Lencioni | What Customers Crave by Nicholas Webb | Start With Why by Simon Sinek (not a recent read, but my “go-to” leadership philosophy)

   How do you promote innovation within your organization? 

Promoting innovation is easier to do when you’re the only private ortho-neuro group left in your MSA of 750,000 people, and you’re surrounded by 45 hospital-employed orthopaedists and 11 hospital-employed neurosurgeons – our survival literally depends on it. We first disrupted our market in 2012 when BCBS SC began to cover outpatient joint replacements in our ASC. Soon after, we began adding spine procedures. The average cost-savings is 15k-$40k per total joint replacement based on the average claims paid by BCBS SC to 3 hospital systems in the area per their own Treatment Cost Estimator. This distinction as the lowest cost surgical provider for complex ortho/spine procedures coupled with excellent outcomes has become our identity. Of course, once you have disrupted a market, you must continue to innovate or be disrupted by the competitors who are always nipping at your heels. To continue thriving, the innovation cycle must become part of the organization’s culture.

   In the past 12 months, how have you adapted to new patient experience expectations in the age of consumerism? 

What Customers Crave by Nicholas Webb is a great resource for this issue. In the previous 12 months, we have focused on reducing the amount of information we’re collecting at the front desk to enhance the intake process; we have initiated an internalPAINLESS (Patients are in Need. Lead Employees Share Solutions.) campaign; and we are in the process of implementing a scheduling platform that will allow patients to self-schedule via an app by Q4 2018.

 

Scott Sigman, MD

Orthopedic Surgery

National Leader in Opioid Sparing Orthopedic Surgery

Orthopedic Surgical Associates

  How Do You Break Silos In Your Organization?

Specifically, within orthopedics with the use of more expensive non-opioid medications, we found that pharmacy silos give us severe limitation in the ability to use these medications at a number of hospitals across the country.  Our focus has been to try and carve out the use of these medications, so that insurance companies will pay for these medications outside of the typical DRG or payment for an individual surgery.  We did this specifically by lobbying congress as well as CMS, both in person in Washington, D.C. as well as through letter writing campaigns.  We were fortunate to hear that as of January 1st some of these changes will be implemented going forwards through CMS.

  In the past 12 months, how have you adapted to new patient experience expectations in the age of consumerism?

I am a huge believer in social media.  I have postings on Linkedin for my business

friends.  I am also on Facebook for my older population of patients as well as  Instagram for my younger population of patients.  I remain connected with my patients.  With these avenues, we can express the latest state of the art techniques that we are performing and in engaging patients directly, we have found that we have great success.

  Surgeries moving to the outpatient area.  How do you get ready for it?

This has been the natural progression for us in the opioid sparing space. We are now successfully operating on patients near opioid free, which opens up the realm of possibility for outpatient surgery for even more extensive operations such as  total hip and knee replacements as well as outpatient spine surgery.  The patient expectations as well as patient selection I think are paramount to make sure that you have the best chance of success for patient experience.

 

FOR MORE INFORMATION

 

 


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December 18, 2018 OrthoSpineNews

Largo, FL – VGI Medical is dedicated to creating the next generation of spinal implants and procedures to improve the quality of life for its patients. One of the disruptive technologies, SiJoin, that has been developed by VGI Medical has achieved a significant milestone of over 5,000 implants used in more than 1,750 surgical procedures throughout the United States.

The sacroiliac (SI) joint is well documented as a potential source for lower back pain (LBP) and it is estimated that SI joint pain affects 15-25% of patients suffering from LBP. A number of publications have found that SI joint degeneration is present in patients who had previously undergone lumbar fusion surgery and pregnancy related pelvic instability is a common and disabling problem.

SiJoin offers significant clinical advantages to the other technologies currently on the market such as:

  • Tried and True Fusion – The SiJoin procedure utilizes a tried and true method for achieving joint fusion by preparing the joint (decortication), stabilizing the joint via cortical allograft implants, and using bone graft material to enhance  fusion across the joint
  • Less risk – Compared to lateral based SI joint methods, the SiJoin procedure minimizes the risk of the neural complications due to the direct posterior approach
  • Flexibility – The surgeon can choose to use a minimally invasive surgery (MIS), mini-open, or an open approach all while allowing for direct visualization of the SI joint
  • Biomechanics – Biomechanical stabilization of SiJoin is equivalent to lateral rod systems by taking advantage of the “lever arm” concept
  • Revision – Due to its unique design and approach, SiJoin can be used to revise other SI joint fusion procedures
  • Economic advantages – Due to the straight forward and lean business model employed by VGI Medical, SiJoin offers significant advantages to the facility (Acute, Outpatient and ASC) compared to the competition.

VGI Medical was founded in 2007 based on an invention developed by Tov Vestgaarden, PhD. It has become a leader in bringing innovation to the market including VerteLoc, CerLoc, SiJoin and VerteLP. The VerteLoc and CerLoc systems are specifically designed to stabilize and fuse the facet joint by utilizing a unique patented dual geometric design to limit motion of the affected spinal segment. Applying the principles of this success, VGI Medical added SiJoin for Sacroiliac Fusion. VerteLP is one of the latest innovations offering an improved implant for lateral procedures featuring its proprietary Talon Technology.

“ While it is exciting to achieve the 5,000 implant milestone, of greater importance is the number of successful patient outcomes we have seen with SiJoin. It is especially rewarding to see the satisfaction of our surgeon customers and their patients after a successful SiJoin procedure. This milestone demonstrates that SiJoin is the ideal solution for both primary and revision SI cases.” said Tov Vestgaarden, founder and CEO of VGI Medical.

_______

About VGI Medical

VGI Medical is a disruptive force in the spinal implant industry by creating four unique technologies specifically designed to enhance patient outcomes and improve the overall surgeon experience. Our calling is to provide the ideal solution to each clinical challenge faced with the existing technologies on the market today. With over 12,500 implants used since our inception, our implants and instruments have been thoroughly tested with exceptional results.

 


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December 18, 2018 OrthoSpineNews

PITTSBURGH, PA, December 5, 2018 // — Dr. Jocelyn Idema, Orthopaedic Spine Surgeon at The Center for Disc Replacement Surgery at Advanced Orthopaedics and Rehabilitation (AOR), recently implanted Centinel Spine’s newest generation of the prodisc L lumbar artificial disc replacement.  The prodisc L® is a Total Disc Replacement (TDR) technology platform that offers a surgical alternative to spinal fusions. Patients usually suffer from a single level degenerated disc in the lower (lumbar) spine and this technology works to relieve pain while allowing the potential for motion at the diseased spinal segment. 

As lower spine treatments continue to make advancements through innovative technologies and motion preserving techniques, patients are seeking out alternatives to lumbar fusions.  The goal at The Center for Disc Replacement Surgery at AOR is to improve the motion and function of the spine while maintaining the highest quality and highest standards of care related to both surgical and non-surgical spine interventions through evidence based medicine practices.  “By using newer motion preserving techniques, spinal discs can help retain the forward-to-back, bending side-to-side, and turning left-to-right spinal motion you were intended to have.” says Dr. Idema.  “This in turn helps to reduce the wear and tear associated with your spine above and below the damaged area.”  “I can’t begin to describe how this newest generation of lumbar artificial discs will continue to be a game-changer for patients.” reports Dr. Idema after the procedure.  She further  continues  “I have been doing cervical (neck) artificial disc replacement for years with really high success rates but the lumbar artificial discs only recently are making a resurgence because of various limitations including insurance companies authorizing the procedures.”

Centinel Spine is currently the only company in the United States to offer both upper and lower spine Total Disc Replacement devices.  The prodisc I implant, the predecessor of the prodisc L implant, was first implanted in 1990. The prodisc L implant that is used today was introduced outside the United States in 1999. It was approved by the Food and Drug Administration (FDA) for use in the United States in August 2006.   A prodisc L IDE clinical study evaluated the prodisc L Total Disc Replacement surgery compared to spinal fusion surgery*. The study demonstrated that prodisc L surgery is a safe and effective alternative to fusion surgery* for qualified patients.

About Centinal Spine
From the foundation of knowledge gained from the long-term clinical success of its lumbar products, Centinel launched its cervical product in 2008. Today, Centinel Spine still embraces the pioneering culture from 1924.  In 2006, the FDA Approved the prodisc L—the 2nd U.S. Lumbar Total Disc Replacement device and in 2007, the  FDA approved the  prodisc C—the 1st Complete U.S. Cervical and Lumbar offering.

For more information, please visit www.centinelspine.com and connect on Twitter and Facebook.


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December 13, 2018 OrthoSpineNews

WARSAW, Ind., Dec. 13, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today the full-scale U.S. launch of its 26th surgical system, the RESPONSE 4.5/5.0mm System following U.S. Food and Drug Administration (FDA) 510(k) clearance in October. The Company’s newest system represents a significant product expansion for physicians to treat complex scoliosis in smaller stature patients at a younger age.

The RESPONSE 4.5/5.0mm System, designed in collaboration with pediatric orthopedic surgeons, builds upon the successful implant and instrument technology of the RESPONSE 5.5/6.0mm System to expand the platform offering. The new small stature scoliosis system offers a hybrid implant technology allowing the option of either a 4.5mm rod in cobalt-chromium or 5.0mm rod in titanium or cobalt-chromium, multiple implant connector options, and innovative, new instrumentation.

Dr. Jonathan Phillips, Pediatric Orthopedic Surgeon & Associate Professor of Orthopedics at University of Central Florida, College of Medicine, served as a design surgeon for the small stature system and commented, “I am excited for the launch of the highly anticipated small stature RESPONSE system from the leader in children’s orthopedic technologies. Conceived to mesh seamlessly with the exceptionally successful RESPONSE system for larger statures, this instrumentation has been designed to serve a unique weight and size demographic in children’s orthopedics and extends the versatility of OrthoPediatrics’ spinal instrumentation options. I look forward to this radical improvement to care for a diverse cohort of the most underserved children.”

RESPONSE™ Spine System
Designed with a complete focus on children, the RESPONSE system offers a simple, technologically advanced system of instruments and implants to treat the distinct needs of pediatric patients with spinal deformities. The system features advanced instrument & implant technology including 1) innovative, low profile screw design including a proprietary set screw thread design for improved fixation and reduced potential for cross threading, and 2) unique pedicle screw head accepts multiple rod diameters in either cobalt chrome or titanium. Additionally, the system has versatile reduction & de-rotation capabilities with rod reducer instrument designed for easy snap on and off 2-in-1 rod reduction instrument enables each surgeon to perform reduction and de-rotation technique of choice and serves as a rod reducer and de-rotator in one.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 26 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com


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December 12, 2018 OrthoSpineNews

Reston, Virginia, Dec. 12, 2018 (GLOBE NEWSWIRE) — The Virginia Institute of Robotic Surgery at Reston Hospital Center has acquired a second Mazor X System for their rapidly growing spine program, making it the first in the nation to have two of these robotic systems at one hospital location.

The Reston Hospital Center (RHC) Spine Team is comprised of nationally-recognized spine surgeons who excel in implementing the latest in surgical advancements for spinal procedures. One of the first in the country to acquire and use Mazor Technology in 2012, RHC, in collaboration with its surgeons, has been a pioneer in using advanced technology and procedures in the operating room.  In 2016, the facility was the first in the Mid-Atlantic to acquire and perform a procedure using the latest Mazor X platform. More than 1,500 spine surgeries are performed annually at RHC, with over 600 of these procedures utilizing the advanced technology of the Mazor X system, offering patients an advanced, minimally invasive surgical option for the spine.

“Providing our surgeons with the technology and resources they need to keep our surgical program at the forefront of innovation means that our patients receive the most advanced care in the safest environment,” said John Deardorff, CEO of Reston Hospital Center and President of HCA’s Northern Virginia Market. “As a leader in spine surgery we are committed to delivering exceptional care and the best possible outcomes for our patients.”

Reston Hospital Center is one of only eight Visiting Clinician Programs (VCP) in the United States where surgeons from around the world come to train on the latest in Mazor technology.  The VCP gives surgeons the opportunity to learn about the latest in robotic-assisted spine surgery capabilities from the proctoring surgeon, Dr. Christopher Good of the Virginia Spine Institute. In addition to the surgical training, surgeons also learn how a comprehensive robotic surgical program runs from an operational and administrative perspective.

About Reston Hospital Center

Part of HCA Virginia Health System, Reston Hospital Center is a 197-bed, acute-care medical and surgical facility that has garnered high honors for attentive patient care and nursing excellence.  Reston Hospital Center is home to the region’s newest Level II Trauma Center and the most comprehensive robotic surgery in the Mid-Atlantic. Statewide, HCA Virginia Health System operates 14 hospitals and more than 30 outpatient centers and is affiliated with 3,000 physicians. It is Virginia’s fourthlargest private employer, provides $190.8 million in charity and uncompensated care, and pays $72.6 million in taxes annually. For more information about Reston Hospital Center visit www.restonhospital.com

Erin Echelmeyer
Reston Hospital Center
703-689-9030
Erin.Echelmeyer@hcahealthcare.com

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December 10, 2018 OrthoSpineNews

MISGAV, IsraelDec. 10, 2018 /PRNewswire/ — ZygoFix Ltd. (“ZygoFix”), a portfolio company of The Trendlines Group Ltd.(“Trendlines”) (SGX: 42T) (OTCQX: TRNLY), announced the successful start of a first In human clinical study for its zLOCK spinal facet joint fixation system. The clinical study comprised several procedures to date and a 6-month follow-up of the first case. The first case, a fusion procedure using the zLOCK system, was performed on a 67-year-old female suffering from severe back and leg pain. The patient reported a drop in her VAS (Visual Analog Scale of 0-10 for pain measurement) from 9 pre-operation, to 1 one day post-operation and to 0 at 6 months post-op.

Spinal fusion is a common surgical procedure for the treatment of severe back and leg pain due to conditions such as degenerative discs or “slipped” discs. Spinal fusion is one of the most common surgical procedures – fifth in terms of OR procedure frequency1.

The zLOCK implant is designed as a miniature facet fusion cage to stabilize the segment. Its unique combination of rigid and flexible elements withstands loads and accommodates the anatomy of any facet joint. zLOCK utilizes the natural anatomy of the spine to form a “bridge” between the two adjacent vertebrae, without screws and rods. A percutaneous approach allows placement of zLOCK with only one small incision per side, making it significantly less invasive than the standard pedicle screw procedure.

Prof. Attila Schwarcz, Vice-Chairman and Leader of Spine Surgery, Department of Neurosurgery, University of Pecs, Hungary, and principal investigator in ZygoFix’s study, commented, “The zLOCK implantation is a significantly less invasive procedure compared to other posterior spinal stabilization systems. It appears superior to pedicle screw procedures, since zLOCK has an almost zero risk of causing nerve root injury that can happen in pedicle screw misplacement. Additionally, the zLOCK implant may have the ability to provide better long-term stabilization due to solid bony fusion of the facet joints.”

ZygoFix CEO Ofer Levy remarked, “We are extremely pleased with this successful start to our clinical study – another step toward making spinal fusion simpler, faster and less invasive. zLOCK’s unique design simplifies fusion procedures by self-adjusting to the spine’s anatomy, eliminating the need for pedicle screw placement.”

1 https://www.hcup-us.ahrq.gov/reports/statbriefs/sb186-Operating-Room-Procedures-United-States-2012.jsp

Contact:    
Ofer Levy, CEO ZygoFix   
ofer@zygofix.com    
+972-52-2664-981

www.zygofix.com

SOURCE ZygoFix Ltd